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                              Life Care Center of Copper Basin, DAB CR5943 (2021)
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Life Care Center of Copper Basin, DAB CR5943 (2021)








  
  
    

  
      
Department of Health and Human Services 
    DEPARTMENTAL APPEALS BOARD
          Civil Remedies Division





Life Care Center of Copper Basin,
(CCN: 445310),
Petitioner,

v.

Centers for Medicare & Medicaid Services.
Docket No. C-21-199Decision No. CR5943September 17, 2021

        
              
    

      DECISION

I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) to impose civil money penalties against Petitioner, Life Care Center of Copper Basin, a skilled nursing facility, in the following amounts:

$15,975 for each day of a period beginning July 11, 2020, and running through August 17, 2020, and;
	$435 for each day of a period beginning August 18, 2020, and running until September 25, 2020.I.   Background

I held a hearing in this case on June 8, 2021, for the purpose of receiving exhibits into evidence and hearing the cross-examination testimony of witnesses.  I received exhibits from CMS, identified as CMS Ex. 1-CMS Ex. 64, and from Petitioner, identified as P. Ex. 1-P. Ex. 31.  Each party filed a post-hearing brief.

Page 2

II.   Issues, Findings of Fact, and Conclusions of Law

**A. Issues**

The issues are whether Petitioner failed to comply substantially with Medicare participation requirements, whether CMS’s determination that Petitioner’s noncompliance posed immediate jeopardy for residents of Petitioner’s facility is clearly erroneous, and whether CMS’s civil money penalty determinations are reasonable.

**B. Findings of Fact and Conclusions of Law**

CMS alleges that Petitioner failed to comply with three Medicare participation requirements.  Regulations state these requirements:  42 C.F.R. § 483.80 (infection control); 42 C.F.R. § 483.70 (administration) and 42 C.F.R. § 483.75 (quality assurance).  CMS’s allegations concerning the administration and quality assurance regulations derive from its assertions that Petitioner failed to comply with the infection control regulation.

In this decision I address each of CMS’s allegations of regulatory noncompliance.  I then address CMS’s determination that Petitioner’s noncompliance was so egregious as to put residents in a state of immediate jeopardy.  Finally, I make findings as to the reasonableness of CMS’s civil money penalty determinations.

This case is about Petitioner’s implementation of its policy to prevent the spread of COVID-19 (Covid) within its premises.  CMS alleges that, although Petitioner developed a comprehensive policy to deal with Covid, it failed to implement that policy effectively.

Covid is highly transmissible by respiratory droplets.  CMS Ex. 63 at 3; P. Ex. 30 at 4.  An infected person sheds viral droplets through respiration.  Droplets that are emitted from the nose or mouth can reach people who are within a few feet of the infected person and can thus transmit infection to those people.  *Id.*It is a well-known fact that Covid is a potentially lethal illness.  It is particularly so for frail and elderly individuals or for individuals who are weakened by other illnesses, precisely the types of individuals who make up the resident census of skilled nursing facilities.  Covid has taken a terrible toll on skilled nursing facility residents throughout this country.  Many thousands have been infected.  For a very high percentage of these residents – frail, sick, and elderly individuals – infection was a death sentence.  In Petitioner’s facility, an outbreak of Covid in the summer of 2020 infected 44 residents and killed eight of them.  CMS Ex. 1 at 66.

The dangers posed by Covid impose a burden on all skilled nursing facilities to do their utmost to protect their residents against the introduction and spread of that illness within facility walls.  Failure by a facility to implement its infection control policy puts its residents at risk of critical illness and death.

Page 3

I find that Petitioner failed to implement its Covid policy effectively.  Lackadaisical implementation created a likelihood that residents of Petitioner’s facility would become infected, with catastrophic consequences for those residents.

**1. Failure to comply with 42 C.F.R. § 483.801**

The regulation at issue mandates that a skilled nursing facility establish and maintain an infection control program that is designed to provide a safe, sanitary, and comfortable environment for the facility’s residents and to help prevent the development and transmission of communicable diseases and infections.  The regulation contains requirements concerning the measures that a skilled nursing facility must implement as part of its infection control program.  42 C.F.R. § 483.80(a)-(f).  A skilled nursing facility must have written procedures establishing a system of surveillance designed to identify possible communicable diseases or infections before they can spread to other persons in the facility.  42 C.F.R. § 483.80(a)(2)(i).  The facility must establish standard and transmission-based precautions to be followed to prevent the spread of infections.  42 C.F.R. § 483.80(a)(2)(iii).

The regulation requires that a facility do more than establish an infection control policy.  Equally necessary, the facility must implement whatever policy it develops.  *Heritage House of Marshall Health & Rehab. Ctr.*, DAB No. 2566 at 12 (2014).  Even the most elaborate or comprehensive policy is without benefit if it is not implemented in a way that offers the residents of a facility meaningful protection against infection.

Petitioner has a comprehensive policy to prevent the spread of Covid within its premises.  CMS Ex. 51.  CMS does not allege that the policy is inadequate.  The gravamen of CMS’s case is that Petitioner did not put its policy’s requirements into practice.

CMS’s case rests on the following allegations:  (1) Petitioner did not implement its policy governing the use of personal protective equipment (PPE) by members of its staff; (2) Petitioner did not ensure that members of its staff understood the need to self-screen for signs of Covid infection and to respond appropriately to the presence of such signs; and (3) Petitioner did not properly screen its staff members and send them home when they exhibited signs of being infected.

The evidence overwhelmingly establishes CMS’s allegations to be true.

Page 4

Petitioner issued directives for the use of PPE by staff members.  CMS Ex. 51; CMS Ex. 58.  Petitioner mandated that its staff wear facemasks at all times while on Petitioner’s premises.  CMS Ex. 51 at 24.  It required all staff to wear a “NIOSH-approved N95 filtering respirator. . . .”or to wear cloth facemasks, but only if respirators were unavailable.  CMS Ex. 58 at 3.2
Petitioner told the staff that respirator straps should be placed at the crown of the head and the base of the neck.  *Id.*  Petitioner made it clear that staff should not wear facemasks or respirators with exhalation valves because:  “they allow for unfiltered exhaled air . . . .”  CMS Ex. 51 at 2.

The staff frequently violated Petitioner’s directives.  Petitioner’s environmental services director told surveyors that he saw staff failing to wear facemasks properly so often that “[i]t got to the point where you’re feeling like you’re beating your head against the wall.”  CMS Ex. 64 at 8-9.  He asserted that nurses and certified nursing assistants (nursing assistants) often failed to wear facemasks at all, or wore them improperly.  *Id.*He averred that he had seen members of Petitioner’s staff wearing facemasks with exhalation valves.  *Id.* at 11.  These assertions were corroborated and elaborated upon by the maintenance director’s wife, who was a nursing assistant employed by Petitioner.  *Id.* at 10.

Staff members provided additional evidence that members of Petitioner’s staff either did not wear facemasks or wore them improperly.  Petitioner’s director of nursing reprimanded a nursing assistant for not wearing a facemask appropriately when entering Petitioner’s facility.  CMS Ex. 64 at 11.  On August 15, 2020, after Petitioner had experienced its Covid outbreak, the director of nursing reprimanded three of Petitioner’s nurses who were observed not wearing facemasks while at a nursing station.  CMS Ex. 48 at 3.  Petitioner’s infection preventionist stated that she constantly had to provide reminders to staff members to wear facemasks properly.  CMS Ex. 64 at 14.

Residents provided additional corroboration.  Resident #11 reported to a surveyor that she had repeatedly observed a nursing assistant working on the night shift wearing her facemask around her neck.  CMS Ex. 64 at 16-17.  Resident #15, who had tested positive for Covid, said that he had observed a staff member in his room but not wearing a facemask.  *Id.*

Surveyors observed staff not complying with Petitioner’s PPE policy.  A state agency surveyor saw a licensed practical nurse wearing an N95 respirator with the bottom strap dangling from her chin.  That prevented the respirator from forming a proper seal and allowed unfiltered air to pass below the mask.  CMS Ex. 64 at 10-11.  Two surveyors witnessed a licensed practical nurse wearing a mask with an exhalation valve while she provided care to residents.  CMS Ex. 63 at 10-11; CMS Ex. 64 at 10-11.  The surveyors

Page 5

witnessed Petitioner’s activities director wearing a mask with an exhalation valve while she provided water to residents.  *Id.*  A dietary aide admitted to the surveyors that she sometimes failed to wear a facemask while working in Petitioner’s kitchen.  She acknowledged that she’d seen other kitchen staff also unmasked.  *Id.*

The surveyors made their observations in August 2020, after a Covid outbreak had infected numerous residents at Petitioner’s facility and killed eight of them.  Despite that grim reminder of the necessity to rigorously follow infection control policy, members of Petitioner’s staff continued not to wear masks properly or, in some instances, at all.

The many assertions, admissions, and observations of improper masking add up to a systemic failure by Petitioner’s staff to follow its own PPE policy.  There are far too many of these events to label them as isolated or inadvertent.  I infer from this systemic policy violation that Petitioner’s management was ineffective in constraining the staff to wear masks appropriately. Furthermore, the evidence does not show that Petitioner’s management forcefully intervened to compel staff to wear masks, aside from issuing a few reprimands.

On July 11, 2020, a nursing assistant (nursing assistant G) reported to work the night shift at Petitioner’s facility feeling feverish.  CMS Ex. 63 at 6; CMS Ex. 64 at 6.  Nursing assistant G felt progressively worse as the evening progressed.  She experienced “chilling” cold sensations, she felt tired, and she had a headache.  She wanted to sit down because she felt that her bones ached.  *Id.*

After having worked for a while, nursing assistant G reported her condition to her supervisor.  However, the supervisor failed to assess nursing assistant G’s condition, report nursing assistant G’s complaints to her supervisor, or send her home.  CMS Ex. 63 at 6; CMS Ex. 64 at 6.  The nursing assistant finished working her shift.  The next day, nursing assistant G tested positive for Covid.  Several of the residents to whom she had provided care during the July 11 night shift subsequently tested positive for Covid.  *Id.*

Petitioner’s Covid policy provides explicitly that staff members should be educated to regularly monitor themselves for fever, respiratory symptoms, and symptoms indicative of Covid and to contact their supervisor(s) if they have any symptoms and not report to work.  CMS Ex. 51 at 12.  The policy provides further that a staff member who screens positive with fever or symptoms consistent with Covid should be excluded from work.  *Id.* at 13.

Petitioner’s policy defines a “mild” infection of Covid as including “any” of the following signs and symptoms:  “fever, cough, sore throat, malaise, headache, muscle pain. . . .”  CMS Ex. 51 at 2.  Importantly, that policy does not require the existence of multiple signs and symptoms to raise suspicion of a Covid infection.  The presence of any one of these signs and symptoms, including a fever, will suffice to trigger that suspicion.

Page 6

Petitioner’s management should have immediately sent nursing assistant G home when she reported her symptoms.  I infer that nursing assistant G’s supervisor either was ignorant about the policy or failed to understand the implications of nursing assistant G’s symptoms.  Either way, the failure to send the nursing assistant home when she reported feeling ill was a clear failure by Petitioner to implement its Covid policy.

Moreover, nursing assistant G should have reported her symptoms sooner than she did.  The evidence shows that her symptoms at the beginning of her July 11 shift consisted of feeling feverish and running a slight temperature.  Petitioner’s Covid policy required that the nursing assistant report her fever to her supervisor.  She failed to do so. She waited until she was experiencing a panoply of signs and symptoms in addition to a fever, including a headache, body aches and fatigue, before reporting them.

Nursing assistant G may have attributed her fever at the beginning of her shift to something other than Covid.  Petitioner’s policy identifying fever as a sign of Covid infection does not allow staff to make value judgments as to the cause of the fever.  Nursing assistant G was obligated to report her fever immediately.  I infer from her failure to do so that nursing assistant G had not been adequately educated in the requirements of Petitioner’s Covid policy.

Petitioner contends that CMS’s case is beset with two “fatal flaws.” Petitioner’s post-hearing brief at 2.  First, it asserts that CMS’s allegations of noncompliance do not accurately reflect the plain language of Petitioner’s Covid policy or of CDC guidelines.  Second, it argues that there is no specific regulatory requirement that supports CMS’s noncompliance allegations.  Petitioner argues additionally that CMS’s allegations are without evidentiary support.  Finally, Petitioner contends that, even if it may have technically violated regulatory requirements, those violations were harmless and posed no threat to its residents.  Petitioner’s post-hearing brief at 2-3.

I find these arguments to be without merit.

Petitioner’s protestations notwithstanding, CMS’s noncompliance allegations track precisely the explicit terms of Petitioner’s Covid policy.  That policy requires all of Petitioner’s staff to wear NIOSH-approved N95 masks while on facility premises.  CMS Ex. 51 at 2; *see*CMS Ex. 58 at 3.  It also explicitly tells staff not to wear masks with exhaust vents.  CMS Ex. 51 at 2, 24.  CMS offered overwhelming proof that staff frequently disregarded these policy instructions, either by wearing vented masks or by not wearing masks.  The policy instructs staff how to wear their masks in order to assure that there is no leakage of exhalations.  CMS offered convincing evidence that at least one member of Petitioner’s staff wore her mask improperly.  I have cited other examples of explicit policy violations, above, and I need not reiterate them.

Page 7

Petitioner argues that, as of mid-2020, Covid remained a novel illness that caused great confusion, including within the CDC, about how to respond to it.  It asserts that the CDC’s own guidelines were constantly shifting during the first half of 2020, as the experts learned more about the illness.  Petitioner’s post-hearing brief at 21.  As Petitioner would have it, Petitioner was held hostage by the evolving knowledge of the causes and consequences of Covid and by the CDC’s ever-changing guidelines.  It raises this question:  how could it be held responsible for violating CDC guidelines if those guidelines were constantly changing?

However, this case does not rest on allegations that Petitioner failed to comply with CDC guidelines.  Rather, it results from Petitioner’s failure to implement its own policy.  That policy – in writing, clear, and explicit – told staff exactly what was required of them.  The evidence shows, overwhelmingly, that staff failed to comply.  The possible presence of additional CDC policies, whether they changed over time or not, is irrelevant to this case because CMS does not argue that Petitioner failed to comply with them.

In arguing that CMS’s allegations of noncompliance find no support in regulatory language, Petitioner contends that CMS makes its allegations of noncompliance in a vacuum absent specific regulatory requirements for Covid policy.  Petitioner’s post-hearing brief at 22.  According to Petitioner, CMS’s noncompliance allegations are simply ad hoc claims without any basis in regulation.  *Id.* at 23.  Petitioner seems to be saying that it has no responsibility to enact a Covid policy absent some sort of laundry list from CMS of instructions about how to protect residents against Covid infection.

Taking Petitioner’s argument to its logical end, Petitioner is saying that it cannot be held noncompliant for failing to enforce staff masking requirements or other provisions of its own policy absent specific regulatory language addressing masking requirements.

The regulation that was in effect in the July-September 2020 period when Petitioner was noncompliant did not specifically address Covid infection prevention and control.  However, its general provisions and the specific instructions that it gave to skilled nursing facilities were more than enough to tell those facilities what they needed to do.  Petitioner was not at sea when it came to what to do and how to do it.

The regulation’s requirement that a facility adopt an anti-infection policy is sufficiently broad to mandate a policy to protect residents against Covid.  Although that is made evident by the regulation’s plain language, it is underscored by the fact that Petitioner cites the regulation and quotes part of it verbatim as part of its own Covid policy.  CMS Ex. 51 at 3-4; CMS Ex. 58 at 1-2.

Page 8

The regulation grants broad discretion to skilled nursing facilities to develop and implement infection control policies.3
  However, it also contains specific requirements concerning elements of infection control that a skilled nursing facility must address.  I have discussed these requirements above, but to reiterate, a skilled nursing facility must develop and implement a system of surveillance designed to identify possible communicable illnesses before they can be spread, and it must develop and implement standard and transmission-based precautions intended to protect its residents against infection.  Petitioner clearly understood these requirements in developing its Covid policy because it explicitly addressed both the need for surveillance and reporting and the need to wear masks in order to prevent the spread of the disease.  CMS Ex. 51 at 2, 4, 5, 12-13; CMS Ex. 58 at 3.

The adequacy of Petitioner’s Covid policy is not at issue here.  CMS has not challenged that policy, implicitly finding it consistent with professionally recognized standards of health care.  Therefore, Petitioner cannot say with a straight face that it is being held hostage to some arbitrary policy judgments by CMS.  To the contrary, this case rests on the answer to one question:  did Petitioner do what it promised to do?

I have held that the evidence offered by CMS overwhelmingly proves that Petitioner did not make good on its promises.  Petitioner’s fact assertions do not in any respect undercut or vitiate that evidence.

Petitioner begins its discussion of the evidence by addressing Petitioner’s failure to send nursing assistant G home on the evening of July 11, 2020, when she exhibited symptoms of Covid.  Petitioner’s brief at 6-12.  It protests that it was testing its staff for Covid weekly as of July 2020 and that nursing assistant G had tested negative on July 1 and July 8.  Petitioner’s brief at 8.  However, the fact that nursing assistant G tested negative for Covid, even in the recent past, offers no excuse for Petitioner’s failure to respond to her signs and symptoms on the evening of July 11, 2020.  Nothing in Petitioner’s policy suggests that recent negative testing excuses a failure to screen a member of staff for possible infection.  *See*CMS Ex. 51.

Petitioner asserts that there was nothing about nursing assistant G’s signs or symptoms on that evening suggesting that she was possibly infected.  Therefore, according to Petitioner, it was under no obligation to send nursing assistant G home on that evening, even after she reported her symptoms to her supervisor.  As support for this assertion, Petitioner contends that Petitioner’s surveillance of Covid signs was limited by CDC

Page 9

guidance to include only fever with cough, shortness of breath, or sore throat.  Petitioner’s post-hearing brief at 7, *see*P. Ex. 9 at 1.

That contention is wrong.  Petitioner’s own policy mandated that nursing assistant G be sent home.  Petitioner’s policy defines a “mild” case of Covid as exhibiting signs and symptoms that include “fever, cough, sore throat, malaise, headache, muscle pain[] without shortness of breath, dyspnea or abnormal chest imaging.” CMS Ex. 51 at 2.  Nursing assistant G exhibited fever, headache, malaise and pain on the evening of July 11.

Petitioner also argues that, at the inception of her shift, nursing assistant G exhibited a temperature of only 99.1 or 99.2 degrees Fahrenheit, a temperature that, according to Petitioner, was too low to suggest the possibility of a Covid infection.  It claims that her supervisor was not constrained to send nursing assistant G home absent the presence of a temperature of at least 100 degrees Fahrenheit and signs or symptoms of a respiratory infection.  Petitioner’s post-hearing brief at 9.Petitioner asserts further that nursing assistant G averred that she was “feeling fine” at the beginning of her shift, therefore dispelling any possible suspicion that she might be infected.  *Id.*

These assertions are belied both by the plain language of Petitioner’s policy and by the evidence.

The evidence is conclusive that nursing assistant G did not feel fine during her July 11 shift.  She may have attributed her feverish feeling at the beginning of the shift to some non-illness related cause, but as the shift progressed she felt sicker and sicker and reported her illness to her supervisor.

Perhaps recognizing that its own policy demanded that nursing assistant G be sent home on the evening of July 11, Petitioner argues that what really matters is the CDC guidelines that were in effect on that date.  Petitioner contends that these guidelines required the presence of a fever of 100 degrees Fahrenheit or respiratory symptoms as a threshold for suspicion of a Covid infection.  Petitioner’s post-hearing brief at 10; *see*P. Ex. 30 at 8.  From this, Petitioner contends that there was no reason to suspect that nursing assistant G was infected on July 11 and no grounds existed to send her home on that evening.

Petitioner’s argument to the contrary, it was not CDC guidelines as of July 11, 2020, that governed whether nursing assistant G’s supervisor should have sent her home.  Rather, Petitioner’s own policy provided guidance.  Nursing assistant G’s symptoms on July 11 included several of the signs and symptoms of Covid as stated in Petitioner’s policy.  Petitioner’s own policy demanded that nursing assistant G be excluded from work the moment that she reported her signs and symptoms.

Page 10

Petitioner’s policy identified these grounds for excusing a staff member from work:  (1) fever; (2) respiratory symptoms; and (3) symptoms indicative of Covid.  CMS Ex. 51 at 12.  As I have noted, elsewhere in Petitioner’s Covid policy it defines Covid signs and symptoms as including the presence of any of the following:  fever, malaise, muscle pain, and headaches.  Under Petitioner’s policy, the presence of any one of those Covid symptoms is grounds to suspect the presence of Covid and to excuse a staff member from work.

Nothing in Petitioner’s policy says that a staff member must exhibit a temperature of at least 100 degrees Fahrenheit as a condition for suspecting Covid infection.  The policy only identifies the presence of a fever as a sign of infection.  Under Petitioner’s policy, nursing assistant G’s fever of more than 99 degrees Fahrenheit on the evening of July 11 should have been grounds for sending her home that evening even if she manifested no other signs of a Covid infection.  Of course, the nursing assistant also manifested other signs of Covid infection – identified by Petitioner’s policy – on that evening.

Finally, with respect to nursing assistant G, Petitioner speculates that by the time she was symptomatic for Covid, the damage had already been done, because she was probably infected for two or three days prior to her signs and symptoms emerging.  Petitioner’s brief at 12.  Thus, according to Petitioner, no harm could possibly result from nursing assistant G’s failure to send her home on the night of July 11, 2020.

The issue here is not whether nursing assistant G was the source of the infection that plagued Petitioner’s facility after July 11 or whether she might have infected residents earlier than the evening of July 11.  Rather, the issue is whether Petitioner’s staff implemented Petitioner’s policy to protect residents against Covid.  The evidence unequivocally proves that Petitioner failed to implement that policy when nursing assistant G reported to her supervisor with signs and symptoms pointing to a possible infection.  The failure to understand the implications of those symptoms and to identify the need to protect residents is the violation.4

Petitioner begins its argument concerning its staff’s failure to follow facemask directives by asserting that in March and April 2020 there were nationwide shortages of PPE, including facemasks.  According to Petitioner, CDC guidelines during this period were designed to conserve scarce resources by directing facilities, including Petitioner, to “implement strategies to conserve, reuse, and even substitute for, masks, gowns and even gloves in circumstances that otherwise would be prohibited.”  Petitioner’s post-hearing

Page 11

brief at 14.  The point, according to Petitioner, is that in mid-2020, CDC guidelines directed staff to wear PPE, including facemasks, only when providing direct care to residents.  *Id.* at 14-15.  Petitioner contends that CMS holds Petitioner to an unreasonable standard – a requirement that Petitioner’s staff wear appropriate facemasks at all times while on Petitioner’s premises – given the asserted CDC guidance that facemasks were necessary only while providing care directly to residents.

This argument fails on several levels.

To begin with, Petitioner does not allege – nor does it offer any evidence to prove – that it was encountering a shortage of facemasks in July-September 2020.  It has not, for example, offered any evidence to show that its staff lacked access to NIOSH-approved N95 respirators, the masks that Petitioner’s policy explicitly required the staff to wear.  CMS Ex. 51 at 2, 24.  Whatever guidance the CDC may have issued about conservation of PPE in a shortage situation is, therefore, irrelevant.

Petitioner’s own policy explicitly states that its staff should wear facemasks at all times while on Petitioner’s premises.  CMS Ex. 51 at 24.  The policy brooks no exceptions to that rule in the absence of shortages of equipment.  *Id.*  The staff violated Petitioner’s policy whenever they failed to wear facemasks, wore improper masks, or wore masks improperly.

Indeed, Petitioner’s management did not operate on the premise that there was a “direct care” limitation on the use of masks.  It reprimanded three of its nurses for failing to wear masks while they were at Petitioner’s nursing station, a setting that evidently was not a direct care setting.

Petitioner argues that the evidence that CMS relies on to show that Petitioner’s staff disregarded facemask mandates is flimsy and unreliable.  I disagree.  There is direct proof of noncompliance – unrefuted by Petitioner.  There is also considerable additional reliable evidence from which I infer noncompliance.

Direct proof lies in the observations made by surveyors and in the statements given to surveyors by residents of the Petitioner’s facility.  As I have discussed, surveyors observed staff members caring for residents while wearing improper equipment.  CMS Ex. 63 at 11; CMS Ex. 64 at 11.  Two residents reported observing staff members violating Petitioner’s facemask policy.  CMS Ex. 63 at 17; CMS Ex. 64 at 17.

The statements of Petitioner’s manager, his wife, and other members of Petitioner’s staff describe casual disregard of masking requirements by Petitioner’s staff.  I infer from this evidence that staff members were not following Petitioner’s guidelines while providing care to residents.  For example, statements that staff members were wearing masks with exhalation valves – explicitly prohibited by Petitioner’s policy – leads easily to the

Page 12

inference that they were wearing those prohibited masks while providing care to residents.  It is beyond reason to infer that a staff member who is wearing an improper mask while not treating residents would go to the effort to remove that mask and replace it with a permitted mask each time he or she entered a resident’s room or came into direct contact with residents.  To be blunt, that inference would be absurd.

Petitioner contends that surveyors actually observed nearly perfect PPE compliance.  “Indeed, nearly everyone the Surveyors interviewed – residents and staff alike – denied observing *any* PPE noncompliance.”  Petitioner’s post-hearing brief at 18 (emphasis in text).  However, even slight deviation from policy can have catastrophic consequences where Covid is concerned.  Petitioner’s own policy makes that plain, by requiring staff to wear appropriate masks at all times while on Petitioner’s premises, without exceptions.

Furthermore, the evidence – which Petitioner has not rebutted – doesn’t support a finding that Petitioner’s staff exhibited near perfect compliance with Petitioner’s policy.  Petitioner’s assertions notwithstanding, several members of Petitioner’s staff and two residents told surveyors that there was systemic noncompliance with mask wearing requirements.  Surveyors saw noncompliance with their own eyes.

Petitioner attacks the evidence of noncompliance offered by CMS as being based on “hearsay reports of dubious reliability and specificity.”  Petitioner’s post-hearing brief at 18.  Some of the evidence offered by CMS is hearsay. I might not afford a lot of credibility to one or two isolated hearsay statements.  But here, there are numerous observations from Petitioner’s own staff, from members of Petitioner’s management, and from residents, all reporting that Petitioner’s staff failed to follow Petitioner’s policy.  The cumulative weight of these statements washes away any doubts that I might harbor if there were only one or two of them.  Those reports of noncompliance, as I have stated, are corroborated by first-hand observations of noncompliance and admissions by members of Petitioner’s staff that they were noncompliant.

Petitioner argues that Petitioner’s environmental services director, who accused the staff of wholesale violations of Petitioner’s policy, offered statements that are “riddled with internal contradictions.”  Petitioner’s post-hearing brief at 19.  Petitioner claims to find a contradiction in this individual’s statement that he had seen staff not wearing masks properly on a weekly basis with other statements that he made that he had seen staff not wearing masks properly a couple of times or a statement that he made identifying a particular staff member not wearing a mask properly.  *Id.*; *see*CMS Ex. 47 at 3, 9, 38, 49.

I find nothing contradictory in these statements.  The environmental services director stated some broad conclusions but also offered some concrete examples to support those conclusions.  The fact that he offered a few specific examples does not undercut the broader point that he made.

Page 13

Petitioner argues also that the environmental services director was a “disgruntled employee,” suggesting by that assertion that he was biased and unreliable.  Petitioner’s post-hearing brief at 19.  However, Petitioner offers no evidence proving that this individual was disgruntled, much less the reasons for his alleged unhappiness.  Absent some proof of bias, I do not find that the employee’s unhappiness (if he was unhappy) discredits him.  Indeed, it is not unreasonable to infer that he may have been unhappy because of the policy violations he witnessed.

Additionally, Petitioner asserts that the environmental services director was a source of the vented masks that some staff members wore.  Petitioner’s post-hearing brief at 20.  If that is so, it does Petitioner no good.  Vented masks were specifically prohibited by Petitioner no matter what the source of those masks may have been.

Petitioner contends that the state agency surveyors “simply cited every apparent anomaly or allegation as a deficiency and called it a day, *without* doing even the most rudimentary corroboration of even the most implausible accusations.”  Petitioner’s post-hearing brief at 20 (emphasis in text).  Petitioner’s aspersions notwithstanding, the evidence shows only that the surveyors made a very thorough investigation.  The surveyors provided substantial corroborating evidence for the statements they obtained, consisting of direct observation of staff failing to comply with Petitioner’s policy.  I have discussed that corroborating evidence, above.

I address Petitioner’s allegations as to absence of harm, below, in my discussion of why Petitioner’s noncompliance posed immediate jeopardy for residents of its facility.

**2. Failure to comply with 42 C.F.R. §§ 483.70 and 483.75**

A skilled nursing facility must be managed in an effective manner that promotes its residents’ highest practicable levels of physical well-being.  42 C.F.R. § 483.70.  Failure to comply with this requirement derives from failure by a facility’s management to implement or satisfy requirements contained in other regulations governing skilled nursing facilities.  *Barbourville Nursing Home*, DAB No. 1962 at fn. 2 (2005).

Evidence, which I have discussed in detail, showing a systemic failure by Petitioner’s management to enforce its Covid policy is more than enough to prove that Petitioner was not effectively managed.  Indeed, the failure was not just a case of failing to correct individual instances of noncompliance by staff members.  The evidence shows that Petitioner’s management failed to conduct formal audits or reviews of the staff’s wearing of facemasks.  CMS Ex. 63 at 21-22; CMS Ex. 64 at 21-22.  I infer that this failure contributed to an attitude among staff that wearing of approved facemasks at all times while on premises was simply not a high-level priority at Petitioner’s facility.

Page 14

Regulations require a skilled nursing facility to develop, implement, and maintain an effective, comprehensive, and data-driven quality assurance and performance improvement program that focuses on indicators of the outcomes of care and quality of life.  42 C.F.R. § 483.75.  The essence of this requirement is that a facility develop specific programs that enable it to measure objectively the performance of its staff in providing care to residents.

As with its allegations concerning management failures, CMS asserts that Petitioner’s failure to comply with this regulation derives from proof that it failed, systemically, to enforce its Covid policy.  CMS reasons that an effective quality assurance program would have detected and documented the numerous failures by Petitioner’s staff to comply with mask wearing requirements.  Moreover, Petitioner – if it had an effective quality assurance program – would have developed and implemented a plan to improve mask wearing by the staff.  But, as CMS asserts, policy violations continued unchecked without any evidence that Petitioner recognized them as a quality of care performance issue.

I agree with CMS’s analysis.  The evidence in this case establishes that failures by Petitioner’s staff to comply with Petitioner’s Covid policy were systemic and not random or inadvertent.  These failures are precisely the sort of policy violations that Petitioner would have identified had it implemented a quality assurance and performance improvement program.

Petitioner has not offered any arguments responding to CMS’s noncompliance assertions except to argue that there were no violations of the infection control regulation’s requirements.

**3. Immediate jeopardy**

Regulations define “immediate jeopardy” to mean noncompliance so egregious as to cause, or to be likely to cause, serious injury, harm, impairment, or death to a resident or residents of a skilled nursing facility.  42 C.F.R. § 488.301.  Where noncompliance exists, the burden falls on the facility to prove that a finding of immediate jeopardy is clearly erroneous.  42 C.F.R. § 498.60(c)(2).

CMS did not attempt to prove that the infection that ultimately ran rampant in Petitioner’s facility emanated from a specific staff member or was caused directly by Petitioner’s failure to enforce its Covid policy.  Proof of causation is not a necessary element of CMS’s case; here, a finding of immediate jeopardy rests on the likelihood that noncompliance put residents at risk of harm or death.  There is abundant evidence to support that conclusion and, in any event, Petitioner did not prove it to be clearly erroneous.

Page 15

As I have discussed, and as evidence establishes, Covid is a highly infectious illness, easily transmitted by exhaled droplets containing virus particles.  P. Ex. 30 at 4.  It is dangerous to anyone who is infected but particularly lethal for frail, sick, and elderly individuals, precisely the census of the typical skilled nursing facility. *Id.*

Petitioner was well aware of the risks that a Covid infection posed for its residents.  The danger that Covid held for our country’s elderly and sick population was a matter of common knowledge by the summer of 2020.5
  At least one other facility owned by the entity that owns and manages Petitioner had experienced a lethal Covid outbreak by then.6

However, even if Petitioner's management was totally ignorant of events occurring outside of its facility, it knew of the terrible danger of Covid, because an infection had run rampant through the facility in the month prior to the survey on which I premise my findings of noncompliance.  Forty-four residents had become infected, and eight died.  Petitioner could not have been presented with more conclusive proof that any breech in its infection control program was likely to cause residents to suffer harm or death.

It was therefore absolutely critical that Petitioner do its utmost to protect its residents from infection given the lethality of Covid for nursing home residents and given Petitioner’s certain knowledge of that lethality.  One of the particular risks posed by Covid is that asymptomatic individuals may carry the illness and infect others.  P. Ex. 30 at 4.  That risk made it all the more imperative that Petitioner enforce its mask policy with utmost strictness.

Petitioner asserts that CMS offered no evidence or explanation of how Petitioner’s failure to enforce its infection control policy posed even a potential for harm to Petitioner’s residents.  Petitioner’s post-hearing brief at 24-25.  I disagree with that characterization: the evidence offered by CMS, which I have discussed, graphically delineates the risk that residents faced as a consequence of Petitioner’s failure to enforce its policies.

Page 16

Petitioner argues, however, that even if its staff violated facility policy, those omissions posed no risk of conceivable harm to residents.  The argument relies on Petitioner’s contention that no breach of policy occurred while staff were involved in what Petitioner characterizes as direct resident care.  By this, Petitioner evidently means hands-on care of residents by members of Petitioner’s staff.  Petitioner contends that failure by staff to wear appropriate masks in non-direct care settings posed no danger to residents.  *See* P. Ex. 30 at 10-11.

This argument fails to address evidence showing that members of Petitioner’s staff were wearing inappropriate masks, not wearing masks properly, or not wearing masks at all while they were in residents’ rooms or providing care to residents.

Furthermore, the argument is premised in large measure on Petitioner’s contention that, if staff wore improper equipment (vented masks, for example), they were only observed doing so in non-treatment locales. That isn’t true, as I have explained.  But, even if it was true, it would be absurd to infer that staff who wore improper masks wore them only in non-treatment locales.

Petitioner’s argument also ignores a basic reality: infected staff not involved in direct resident care could easily infect staff who were involved in such care, thereby creating a chain of disease transmission that ultimately infected residents.  For example, Petitioner argues that a kitchen worker who failed to wear a mask could not have infected residents because she did not deal with them face to face.  However, that worker might easily have infected other staff members with whom she came into contact and, eventually, that would lead to spreading infection facility-wide.  As another example, Petitioner reprimanded three nurses who failed to wear masks while they were conversing at Petitioner’s nurse’s station.  In that circumstance an infected nurse could easily have infected the others, leading to a chain of infections within the facility.

**4. Remedies**

CMS determined to impose two remedies against Petitioner, consisting of civil money penalties of:  $15,975 for each day of a period beginning July 11, 2020, and running through August 17, 2020, and; $435 for each day of a period beginning August 18, 2020, and running until September 25, 2020.  CMS predicated its remedies on conclusions that Petitioner was noncompliant at the immediate jeopardy level of scope and severity during the period that ran from July 11 through August 17, 2020, and of less than immediate jeopardy from August 18 until September 25, 2020.

Although Petitioner asserts that it was compliant with participation requirements at all times, it does not specifically challenge either CMS’s duration of noncompliance determinations or the remedy amounts imposed by CMS.

Page 17

The penalty amounts that CMS determined to impose fall within permissible ranges for such penalties.  During the July-September period at issue here, permissible daily civil money penalties addressing immediate jeopardy level noncompliance fall within a range from $6,808 to $22,320.  42 C.F.R. § 488.438(a)(1)(i); 45 C.F.R. § 102.3.  Permissible daily civil money penalties addressing non-immediate jeopardy level noncompliance fell within a range that did not exceed $6,695.  42 C.F.R. § 488.438(a)(1)(ii); 45 C.F.R. § 102.3.

Deciding where within a range of civil money penalties a particular penalty amount should fall is a matter of considering the evidence in light of regulatory criteria.  These criteria may include, among other things, the seriousness of a facility’s noncompliance as well as its culpability.  42 C.F.R. §§ 488.438(f)(1)-(4); 488.404 (incorporated by reference into 42 C.F.R. § 488.438(f)(3)).  Here, the seriousness of Petitioner’s noncompliance coupled with its culpability amply justify the remedies that CMS determined to impose.

I have discussed the seriousness of noncompliance at length and need not reiterate that discussion here.  Suffice it to say that Petitioner’s failure to enforce its Covid policy created a likelihood of a spread of Covid within Petitioner’s facility and a likelihood, additionally, that residents would die.

The evidence establishes a very high level of culpability.  The best evidence of Petitioner’s lackadaisical enforcement of its Covid policy lies in the fact that Petitioner was not putting a halt to its staff continuing to fail to observe mask wearing requirements even after infection ran rampant in the facility, infecting 44 of its residents and killing eight of them.


          /s/
        Steven T. Kessel

                      Administrative Law Judge
      1. At all times in this decision I refer to the version of 42 C.F.R. § 483.80 that was in effect in July-September 2020.  There were subsequent amendments to the regulation that are not at issue here. back to note 1
                      2. Petitioner does not allege that NIOSH-approved N95 facemasks were unavailable to its staff during July-September 2020. back to note 2
                      3. Regulations governing performance by Medicare-participating facilities cannot possibly address every detail of a facility’s performance with laundry lists of what they must do and must not do.  It suffices that the general language of a regulation provides broad guidance to a facility, sufficient for it to know what is expected of it.  See Omni Manor Nursing Home v. Thompson, 151 F. App’x 427 (6th Cir. 2005). back to note 3
                      4. The fact that individuals can be Covid-positive and exhibit either mild or even no signs or symptoms is precisely why it was so important that Petitioner implement its surveillance policy for possible Covid infection.  It underscores why disregarding even minimal signs and symptoms of Covid is a critical failure by Petitioner to enforce its policy. back to note 4
                      5. By July 2020 the impact of Covid on skilled nursing facility residents was widely discussed in the media.  For example, an article appearing in “USA Today” on June 1, 2020, is entitled “‘A National Disgrace’:  40,600 Deaths Tied to US Nursing Homes.”  The article cites to a CMS report that 25,923 residents of skilled nursing facilities had died from Covid as of the date of the article’s publication. back to note 5
                      6. I am aware that there is another case, involving that facility, currently pending at the Civil Remedies Division before another administrative law judge.  I have not seen the record of that case and am entirely unaware of the allegations and arguments made by the parties.  I draw no inferences here from whatever may be in the record of that case. back to note 6 Back to top
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