Crouse Community Center, Inc., DAB CR6028 (2022)

DECISION

I grant summary judgment in favor of the Centers for Medicare & Medicaid Services (CMS) and against Petitioner, Crouse Community Center, a skilled nursing facility.  Undisputed material facts establish that Petitioner failed to comply substantially with a regulation, 42 C.F.R. § 483.80(a), and that its noncompliance was so egregious as to put residents of Petitioner’s facility at immediate jeopardy.  I sustain imposition of remedies against Petitioner consisting of the following civil money penalties:  $9,485 for each day of a period that began on December 4, 2020, and that ran through December 10, 2020; and $225 for each day of a period that began on December 11, 2020, and that ran through January 6, 2020.

I.  Introduction

The setting for CMS’s case against Petitioner is a wave of infections of COVID-19 (“Covid”) that spread rapidly through Petitioner’s facility beginning in early December 2020, ultimately infecting nearly all of Petitioner’s residents and many members of Petitioner’s staff.  CMS charges that Petitioner failed to:

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• create and implement a comprehensive infection control plan for dealing with Covid;
• screen its staff to determine whether individual members were infected and thus should be excluded from working on Petitioner’s premises;
• “cohort” its residents in order to separate infected residents from uninfected residents; and
• manage the use of personal protective equipment (“PPE”) in a way that protected staff and residents from becoming infected.

The facts offered by CMS address these alleged failures by Petitioner and its staff to comply with regulatory requirements.  Those facts are highly specific and come from Petitioner’s own records and statements that Petitioner’s staff made to New York State Department of Health (Department of Health) surveyors. 

Petitioner attempts to establish fact disputes primarily by sworn testimony of various individuals, including members of Petitioner’s staff but also of an expert who asserts that Petitioner and its staff acted reasonably and in compliance with regulatory requirements.  In its brief opposing CMS’s motion Petitioner relies almost exclusively on its proffered testimony with barely any reference to facility records.  Petitioner’s Pre-hearing Brief and Opposition to Respondent’s Motion for Summary Judgment (Petitioner’s brief). 

I have read Petitioner’s witness statements and Petitioner’s additional exhibits closely and I find that they do not raise genuine disputes as to the critical facts alleged by CMS.  As I shall discuss, Petitioner’s proffered testimony consists in large measure of conclusions that are without foundation and not supported by any reference to Petitioner’s records. 

CMS offered a total of 69 exhibits, identified as CMS Ex. 1-CMS Ex. 69, in support of its allegations.  Petitioner offered 29 exhibits in opposition, identified as P. Ex. 1-P. Ex. 29.  Neither party objected to my admitting exhibits.  I do not receive these exhibits into evidence because I am granting summary judgment in this case.  I do cite to the exhibits to illustrate facts that are not in dispute or to explain why Petitioner failed to raise a genuine issue of material fact.

II.  Issues, Findings of Fact and Conclusions of Law

1. Issues

The issues are whether undisputed material facts establish that:  Petitioner failed to comply substantially with the regulation governing infection control; Petitioner’s

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noncompliance placed residents of its facility at immediate jeopardy; CMS’s remedy determinations are reasonable.

2. Findings of Fact and Conclusions of Law

1. Petitioner’s Responsibilities to its Residents

Pertinent here is 42 C.F.R. § 483.80(a), which establishes a skilled nursing facility’s obligation to prevent if possible, and to control infections.  The regulation requires a facility to establish an infection control program that includes these elements:

(1) A system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases . . . following accepted national standards;

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

(i) A system of surveillance designed to identify possible communicable diseases or infections before they can spread to other persons in the facility;

. . .

(iii) Standard and transmission-based precautions to be followed to prevent spread of infections;

(iv) When and how isolation should be used for a resident; [and]

(v) The circumstances under which the facility must prohibit employees with a communicable disease . . . from direct contact with residents or their food . . . .

42 C.F.R. § 483.80(a)(1),(2).

These requirements are critical to protecting residents’ safety during the Covid pandemic.  It is undisputed that Covid is a highly infectious respiratory virus that can spread like wildfire once introduced to a vulnerable population in an enclosed space.  It has infected tens of millions of Americans and caused hundreds of thousands of deaths.  It is a particularly deadly disease among elderly individuals and especially the elderly who are already sick and weakened from other issues.  Covid has wreaked havoc in this country’s skilled nursing facilities.  About one-third of all Covid deaths have been nursing facility residents.  Matthew Conlen, et al., Nearly One-Third of Coronavirus Deaths are Linked

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to Nursing Homes, New York Times, June 21, 2021, https://www.nytimes.com/interactive/2020/us/coronavirus-nursing-homes.html. 

The stakes during this pandemic are very high for the residents of any skilled nursing facility.  And because the stakes are so high the burden on a facility to comply closely with the infection control requirements during the Covid pandemic is especially heavy.  Scrupulous compliance is literally a life and death matter for residents and the regulation does not allow for lax application of its requirements.

Petitioner is in the State of New York, and it must comply with the requirements for infection control established by that state’s Department of Health.  Federal regulations governing skilled nursing facilities’ participation in Medicare explicitly require a facility to comply with all federal state and local laws and regulations.  42 C.F.R. § 483.70(b). Petitioner’s own policy states that it will comply with state-issued directives.  CMS Ex. 17.

2. Noncompliance

Petitioner failed in multiple ways to comply with the requirements of the regulation.  In brief summary it failed to:  adopt a written infection control plan that accounted for the uniquely infectious and dangerous qualities of Covid; adopt a plan for screening its staff to ensure that infected staff would not infect other staff or residents; implement measures to screen staff; cohort (segregate) residents who were infected with Covid from those who were not; and take additional measures required to prevent the spread of infection.

Any of these compliance failures, viewed in isolation, is sufficient to establish noncompliance by Petitioner with the requirements of 42 C.F.R. § 483.80(a).  Failure by Petitioner, for example, to develop a written infection control plan that specifically addresses Covid is in and of itself enough to establish failure to comply with overall regulatory requirements.  Petitioner’s multiple compliance failures serve to underscore the seriousness of its noncompliance.

1. Failure to Adopt a Written Infection Control Plan for Covid

By December 2020 Covid had ravaged skilled nursing facilities throughout the United States.  No skilled nursing facility management could have been unaware of the potential consequences of a Covid infection within a facility.  Notwithstanding, Petitioner had no infection control plan that specifically addressed Covid and its unique potential to wreak havoc among nursing facility residents.  Petitioner’s failure to have a plan violates 42 C.F.R. § 483.80(a).

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Surveyors employed by the Department of Health requested Petitioner’s management to provide them with a copy of Petitioner’s Covid infection prevention and control plan.  CMS Ex. 62 at ¶¶ 127-128.  In response, management produced a document dated March 13, 2020, that states:

It is the policy of Crouse Community Center to follow all Centers for Medicare/Medicaid Services (CMS) guidelines, NYS Department of Health (DOH) Dear Administrator letters (DALs) and all NY Governor’s Executive Orders (EOs) issued in regards to Nursing Homes during the COVID-19 Pandemic.

CMS Ex. 17.  The document states additional procedures that delineate the responsibility of Petitioner’s management to implement whatever policies and guidelines that management receives.  Id.  It does not describe any of these policies and guidelines nor does it explain how they would apply to Petitioner, its staff, and its residents.

Petitioner’s policy isn’t a Covid infection prevention and control plan so much as it is a statement of good intentions.  It merely recites that Petitioner will meet its obligations to comply with laws and regulations.  It fails wholesale to address the specific requirements established by 42 C.F.R. § 483.80(a).  It does not establish a system of surveillance to identify the presence of Covid in the facility.  It does not define the precautions that Petitioner would take to prevent the transmission and spread of Covid.  It does not describe when and how residents would be isolated.  It does not explain how residents would be protected from contact with potentially infected staff.  

The regulation does not mandate that an infection prevention and control plan be contained in a single, discrete document.  A facility might incorporate by reference specific elements of a plan into an overall statement of intent and comply with regulatory requirements.  There is nothing to suggest that Petitioner did that.  Petitioner produced no documents – either as separate statements or in the form of a comprehensive plan – explaining how it would satisfy the requirements of 42 C.F.R. § 483.80(a) in addressing Covid.  There are no separate plans designed to implement the regulation’s requirements.  To the contrary, Petitioner’s approach to dealing with Covid in December 2020 when the virus invaded the facility was ad hoc and haphazard, precisely what one might expect in the absence of a comprehensive infection prevention and control plan.

Petitioner’s several witnesses testify at great length about the measures that Petitioner and its staff undertook once Covid invaded Petitioner’s facility.  See  P. Ex. 1; P. Ex. 3-P. Ex. 8.  However, what the staff did in reaction to the spread of the virus is not tantamount to a comprehensive plan for dealing with infection.  Indeed, the many actions documented by these witnesses are testament to the staff’s reaction in the absence of a comprehensive plan that predated Covid’s arrival.

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It is not enough for a facility to contend that it reacted vigorously once the infection began to spread.  The regulation requires comprehensive pre-planning for a possible infection, something that Petitioner failed to do.  Petitioner’s failure to pre-plan for possible Covid infection is especially glaring in that Petitioner had plenty of advance notice that it had to plan for the worst and yet failed to do so.  Covid had been ravaging nursing facilities for months before it appeared at Petitioner’s premises in December 2020.

Three of Petitioner’s witnesses, Marina Keller, M.D., Donald J. Raux, and Connie White, R.N., assert that Petitioner had a robust infection prevention and control plan.  P. Ex. 1; P. Ex. 3; P. Ex. 7.  Dr. Keller avers that: 

Even before the pandemic Crouse has had in place a robust and comprehensive set of . . . [infection prevention and control plan] policies and procedures, including for standard and transmission based precautions, and ensured that they were communicated to employees.  The policies and procedures serve as a guide to all staff on the minimum measures required in order to prevent the spread of infection at Crouse.

P. Ex. 1 at ¶ 18. Dr. Keller contends that her conclusions are based on her “personal knowledge and review of records and files” maintained by Petitioner but cites nothing to support this contention. Id. at ¶ 7.

Dr. Keller’s conclusions are free-floating, without support in the record and thus, without foundation.  Dr. Keller’s assertion that Petitioner had a “robust and comprehensive” set of infection prevention and control policies does not substitute for, nor is it the equivalent of, documentary proof showing that Covid prevention policies existed in December 2020. 

Although Dr. Keller never identifies the policies that she claims to be robust and comprehensive, she might be referring to a pre-pandemic infection control plan that Petitioner adopted in 2016.  See P. Ex. 9.  As I explain below that plan – if that is what Dr. Keller refers to – was on its face inadequate to address the unique dangers of Covid.  The 2016 plan was silent about Covid, and Petitioner did not update that plan to address Covid.

In evaluating alleged facts advanced by a party in support of or in opposition to a motion for summary judgment I am required to accept as true for purposes of deciding the motion any facts that are based on admissible evidence.  That would include conclusions by an expert or lay witness if those conclusions are grounded on evidence.  But I am not required to accept assertions and conclusions, including those offered by an expert, that are unsupported.  An affidavit that is otherwise admissible evidence will not suffice to raise a dispute about a material fact if the testimony in that affidavit is without

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foundation.  Pennsylvania Dental Association v. Medical Service Association of Pennsylvania,745 F.2d 248, 262 (3d Cir. 1984) cert. denied, 471 U.S. 1016 (1985).  

Ms. White makes similarly unsupported assertions.  She is Petitioner’s infection control practitioner.  P. Ex. 7 at ¶ 8.  She, of all witnesses, should know whether Petitioner had an infection prevention and control plan to address Covid.  She affirms that:  “During Covid-19, Crouse adopted a comprehensive plan to address, among other things, swab collection, hand hygiene, donning and doffing of personal protective equipment . . . and eye protection through the use of face shields.”  Id. at ¶ 11.  However, her statement is without foundation.  She cites to no document in the record that constitutes this allegedly comprehensive plan.  Petitioner did not produce any document containing this alleged plan.

Moreover, Ms. White’s testimony addresses only some of the requirements of 42 C.F.R. § 483.80(a).  The regulation requires that a comprehensive infection prevention and control plan address other things beyond hygiene and the use of personal protective equipment, especially screening of staff for possible infection and isolation of infected residents.  Ms. White does not aver that Petitioner had a plan to address these requirements.  Consequently, Ms. White’s testimony does not establish disputed facts as to whether Petitioner developed a comprehensive plan to deal with Covid.

Petitioner offers three exhibits that it contends show that it had a comprehensive infection control plan in place to deal with Covid.  One of these is the infection control plan that Petitioner adopted in 2016, four years prior to the onset of the Covid pandemic.  P. Ex. 9.  It is a generic infection control plan. This pre-pandemic plan does not address the issues raised uniquely by Covid.  For example, it does not contain a mechanism for screening members of Petitioner’s staff for possible Covid infection.  Nor does it address other problems that are unique to a highly infectious respiratory virus like Covid. 

Petitioner’s pre-pandemic plan’s generic instructions do touch on some subjects implicated by a Covid infection.  However, these generic instructions do not take into account Covid’s uniquely infectious nature.  For example, the pre-pandemic plan contains a section addressing resident placement.  P. Ex. 9 at 7.  It is a single paragraph with several bulleted points that describe principles to be considered in the event of infection.  It does not contain any instructions about how to implement these principles.  By December 2020 Petitioner certainly knew about the infectiousness of Covid and its potential for explosive contagion within any skilled nursing facility.  The pre-pandemic plan says nothing about this risk. 

This pre-pandemic plan’s failure to anticipate the problems presented by Covid is obvious, not only from the plan’s failure to address the specific issues posed by Covid, but also by the many ad hoc actions that Petitioner took once the virus invaded its premises, that were not mentioned in the 2016 plan.  As I have discussed, Petitioner knew

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for months about the threat posed to its residents by Covid but made no effort to revise its 2016 plan to address that threat.

A second document, P. Ex. 11, duplicates CMS Ex. 17.  I have explained why this document is not a comprehensive infection prevention and control plan to deal with Covid.

Petitioner offered a third document, P. Ex. 12, which it asserts is its Covid infection prevention and control plan.  Petitioner’s brief at 5.  I do not find that this document is a comprehensive infection prevention and control plan, nor do I find that it raises an issue of fact as to whether Petitioner had such a plan.

This 185-page exhibit is a welter of documents, many unsourced, some under the letterheads of institutions other than Petitioner’s facility, that appear to have been thrown together in a hodgepodge, to create the appearance of a plan.  Many of the pages in this exhibit appear to have been cobbled together at random.  There is no organization of the disparate documents in the exhibit. 

It is true that there are pages within the exhibit that appear to be someone’s plan to deal with Covid infections.  However, Petitioner has offered nothing to show that these pages were adopted and implemented by Petitioner, so much as they were collected by it.  I note, moreover, that the pages that appear to be part of someone’s plan give instructions with which Petitioner did not comply.  For example, on one page, there is this statement:

Roommates or other residents and employees exposed to a resident with confirmed COVID-19 will be closely monitored for 14 days.  Do not place unexposed residents in a shared space with these residents.

P. Ex. 12 at 11. As I shall discuss, Petitioner housed uninfected residents in the same rooms as those who had tested positive for Covid.

None of Petitioner’s witnesses offer evidence explaining how the exhibit was constructed, why it was put together in the form that it is in, or how it would guide a facility staff.  Petitioner’s medical director, Todd Podkowka, D.O., avers that the exhibit is Petitioner’s Covid infection prevention and control plan, that the facility allegedly adopted in March 2020 but says nothing more about it.  P. Ex. 6 at ¶ 12.  Petitioner could not possibly have adopted this document in March 2020 because some of the items in the document are dated as late as September 2020.  See, e.g., P. Ex. 12 at 111. 

Finally, Petitioner relies on the testimony of Mr. Raux, Petitioner’s executive director.  P. Ex. 3.  Mr. Raux asserts that:  “we had in place a COVID-19 pandemic plan that addressed every infection control and prevention aspect from hand hygiene to direct testing to . . . [personal protective equipment] use.  Id. at ¶ 58.  But as is the case with

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Petitioner’s other witnesses, Mr. Raux cites to nothing to support his assertion.  His claim that Petitioner had a Covid infection prevention and control plan is entirely without foundation and does not establish a fact dispute.

In its brief Petitioner cites Mr. Raux’s testimony as support for its contention that P. Ex. 12 is Petitioner’s Covid plan.  Petitioner’s brief at 5.  But Mr. Raux does not refer to this exhibit in his testimony.  Moreover, and as I have discussed, this document on its face does not constitute the plan that the regulation requires. 

2. Failure to Implement Infection Controls for Covid

Petitioner failed, not only to have an infection prevention and control plan as is required by 42 C.F.R. § 483.80(a), but also to address the elements of infection prevention and control. 

1. Failures to Have a System of Surveillance to Protect Residents from Infection and to Protect Residents from Possibly Infected Employees

As a required part of its infection prevention and control plan a skilled nursing facility must adopt a system of surveillance designed to prevent the spread of infection to individuals within the facility and it must also protect residents against disease transmission from infected employees.  42 C.F.R. § 483.80(a)(i),(v).

It is not enough for a facility to have a written plan, but it must implement that plan.  Otherwise, the regulation’s requirements would be meaningless.

The regulation’s requirements are augmented, both by the Centers for Disease Control (CDC) policy and by policy adopted by the Department of Health in New York.  Petitioner was obligated to implement these policies as accepted standards.  The CDC’s policies require, among other things, that a facility screen all employees at the beginning of each work shift for fever and for other Covid symptoms.  CMS Ex. 60 at 3-4.  That policy also directs all employees to notify their supervisors of any symptoms of Covid and to leave work if they are symptomatic.  A facility must have in place a plan for identifying and performing a risk assessment of exposed residents and co-workers.  Id.

The Department of Health policy is entirely consistent with that published by the CDC.  As with the CDC, the Department of Health requires a facility to screen all staff at the beginning of each work shift for fever or respiratory symptoms.  Staff are instructed to monitor themselves for signs of Covid and not to report to work if they are feeling ill, have a fever, or are experiencing any respiratory symptoms.  CMS Ex. 42 at 1; CMS Ex. 48 at 1.

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The undisputed facts establish that Petitioner did not have a written surveillance plan that would detect infected staff members and assure that they did not spread infection to other members of the staff and to residents of Petitioner’s facility.  As I have discussed Petitioner’s 2016 infection control plan was silent concerning screening of staff for Covid.  P. Ex. 9.  Petitioner drafted no revision of that plan to address the unique challenges posed by Covid.

What measures Petitioner implemented to screen its staff were porous and done casually, at best.  Petitioner failed to screen its staff in a way that identified ill or potentially ill individuals and protected its residents.  That failure manifested in several ways, as is shown by undisputed facts.  Petitioner did not check its staff systematically and consistently for signs of Covid before staff encountered residents.  Petitioner’s management did not review its staff’s status timely or test possibly infected staff in a timely manner.  It allowed staff who complained of Covid-like symptoms to continue working and to continue interacting with residents, sometimes for hours.  It did not send these staff members home.  Petitioner did not assure that its staff clearly understood their responsibilities.

It should have been obvious to Petitioner that allowing potentially infected members of its staff to walk through its premises and to treat residents posed a great risk of spreading infection to those residents.  Yet, Petitioner had no policy to screen its staff at its facility’s entrances.  Instead, staff’s temperatures were checked at duty stations, well within the facility, meaning that potentially infected staff walked through the facility even before being screened.  CMS Ex. 1 at 11-14; CMS Ex. 62 at ¶¶ 66, 98; CMS Ex. 64 at ¶¶ 46, 55.

Petitioner required its staff to fill out logs in which they recorded possible signs and symptoms of Covid.  However, it had no clearly communicated written policies or procedures governing recording Covid signs and symptoms.  Consequently, members of Petitioner’s staff had varying ideas about what they were supposed to record.  CMS Ex. 62 at ¶¶ 66, 85, 87; CMS Ex. 64 at ¶¶ 46, 55-58, 69, 87.

The undisputed facts establish that Petitioner’s management failed to review staff’s recorded symptoms consistently at the beginning of each work shift.  A supervising nurse acknowledged that she was supposed to review the logs but that she only did so when she made rounds and not at the beginning of the work shift.  More than three hours had elapsed from that day’s shift’s beginning when she made this admission and she had yet to look at the logs.  CMS Ex. 64 at ¶ 57.  Another supervisor admitted that she did not check the logs and averred that she had not been told that it was her duty to do so.  Id. at ¶ 69.

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Undisputed facts show that multiple members of Petitioner’s staff were unaware that they were required to report signs or symptoms of Covid to their supervisors.  CMS Ex. 64 at ¶¶ 55, 56, 67, 74.

The undisputed facts establish that Petitioner failed to identify timely members of its staff who tested positive for Covid and failed to send these staff members home before verifying that they were infected with Covid.  One licensed practical nurse, who eventually tested positive for Covid, felt ill for several days but had failed to report her symptoms in Petitioner’s screening log or to advise her supervisor of her illness.  CMS Ex. 62 at ¶¶ 67, 70-72.

Other members of Petitioner’s staff reported symptoms but were permitted to work for several hours before they were tested for Covid.  For example, on December 10, 2020, at 6:00 a.m., a nursing assistant reported having a cough, shortness of breath, fatigue, headache, a loss of senses of taste and smell and congestion.  Petitioner did not test this staff member for possible Covid infection until 1:10 p.m. on that date, about seven hours after the nursing assistant reported symptoms consistent with Covid.  CMS Ex. 64 at ¶ 67.  Another nursing assistant reported having Covid-like symptoms at 2:00 p.m. on December 10 but continued to work for more than an hour before she was tested.  Id.

Petitioner did not rebut the facts that I have enumerated and therefore, they are undisputed.  It has not produced statements from any of the individuals whose admissions that I cite, denying those admissions.  It produced no direct proof whatsoever to challenge the undisputed facts on which I rely. I would have found disputed issues of material fact if those admissions and facts were rebutted by Petitioner but there is no dispute in the absence of any rebuttal.

For example, Petitioner offers nothing to challenge evidence showing that there were delays between staff’s reporting of Covid-like symptoms and the testing of these employees for infection.  Nor does it rebut the undisputed facts showing that it allowed staff members who complained of Covid-like symptoms to continue working.  My conclusion that Petitioner allowed possibly infected employees to work for hours before testing them thus stands unrebutted.  Petitioner asserts that these employees eventually tested negative for Covid.  That is fortuitous, but it does not detract one iota from my conclusion.

Petitioner contends that CMS relies on “unverified” statements attributed to Petitioner’s infection control nurse: “who had no personal responsibility for oversight of staff screening of the maintenance or completion of the symptom log.”  Petitioner’s brief at 15.  Ms. White is Petitioner’s infection control practitioner and Petitioner submitted her affidavit.  P. Ex. 7.  Ms. White avers that she did not personally supervise Petitioner’s nursing staff and that she lacks personal knowledge of how the supervising nurses

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reviewed the log.  I do not make findings of fact from any statements attributed to her about oversight or screening.

On the other hand, Ms. White asserts in her affidavit that:  “In my role as Infection Preventionist, CIC (Certified Infection Control) at Crouse, I was responsible for implementing infection control policies and procedures while also educating staff on these procedures.”  Id. at ¶ 10.  Her assertion of responsibility puts her in the best position to describe precisely what policies and procedures Petitioner adopted to combat Covid and precisely what education she conducted.  She is qualified to assert that Petitioner had a written staff screening plan to protect residents from contact with infected staff, if such a plan existed.  She does not make this assertion, and therefore, CMS’s contention and my finding that Petitioner lacked such a plan stands unrebutted and is undisputed.

Ms. White is also qualified to challenge admissions by Petitioner’s staff of their varying and inconsistent ideas about what their reporting responsibilities were.  If there is documentation of staff education about Covid signs and symptoms reporting, Ms. White would know about it and would be able to identify that documentation.  She offered nothing to rebut the staff’s admissions.

Petitioner argues that there is nothing in the governing regulation or in CDC or Department of Health policies that specifically requires it to screen its staff for possible Covid infection before staff enter Petitioner’s premises.  That is so, but that does not give Petitioner license to allow possibly infected staff to walk through its facility before being screened (or to work for hours after reporting symptoms consistent with Covid before being tested).  The policies governing screening allow for some discretion by facilities about where they screen their staff.  That acknowledges the reality that very few, if any, skilled nursing facilities are configured precisely in the same manner.  That said, common logic supports my conclusion that no facility should permit its staff to walk through the premises – to duty stations well within its facility – before being screened for possible Covid infection.

Petitioner asserts that it required its staff to enter its premises through a back hallway and to wear masks before reporting to their duty stations and being screened for infection.  Petitioner’s brief at 15.  However, Petitioner does not argue, nor does it produce proof to show, that entering through a back hallway completely separated staff from exposure to areas where residents lived or congregated.  Indeed, that would not be possible because eventually all staff had to report to their duty stations before being screened, locations that clearly were not in some back hallway of Petitioner’s facility.

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2. Failure to Cohort Residents

A facility must develop a plan that establishes when and how it will isolate residents to prevent the spread of infection.  42 C.F.R. § 483.80(a)(2)(iv).  Instructions by the CDC and policies published by the Department of Health render this general requirement explicit in the context of Covid.

The CDC instructs facilities to place any resident with a suspected or confirmed case of Covid in a single room with the door closed.  CMS Ex. 59 at 6.  A facility should separate infected residents from those who are not infected and establish locations to isolate residents with suspected infections pending confirmation.  CMS Ex. 58 at 8. A Department of Health directive issued in April 2020 required skilled nursing facilities in New York to establish protocols to separate residents into cohorts (distinct groups) of positive, negative, and unknown Covid status.  CMS Ex. 44 at 1.  In a May 13, 2020 directive, the Department of Health explicitly addressed the question of how a facility should deal with a resident who tests negative for Covid but who shares a room with a resident who has tested positive:

Roommates of a resident who tests positive for COVID-19, who themselves have a negative test, are at high risk of being infected and having a positive test within the next 14 days.  They should be immediately separated from the resident who tests positive and placed in a private room.

CMS Ex. 46 at 2.  The doors of rooms housing infected residents must be closed.  CMS Ex. 48 at 2.

The undisputed facts establish that Petitioner failed wholesale to comply with these requirements.  It did not develop a plan to cohort residents if residents became ill with Covid.  Rather, it reacted on an ad hoc basis to the rise of infections within its facility.  It did not separate residents who tested negative from those who tested positive for Covid.  Its staff left residents’ room doors open.

I have previously discussed Petitioner’s failure to plan for the possibility of a Covid infection on its premises and I will not repeat that discussion in detail.  Suffice it to say that it is undisputed that in the months between March 2020 when Covid became a known threat and the beginning of December 2020, Petitioner did not generate any plan to cohort residents if Covid invaded its facility.  That failure is, in and of itself, sufficient to establish that Petitioner failed to comply with regulatory requirements.

Covid infections surfaced in Petitioner’s facility around the first of December 2020.  By December 9, 2020, when Department of Health surveyors visited Petitioner’s facility, 47 of Petitioner’s residents had become infected along with multiple members of the staff.

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CMS Ex. 1 at 6; CMS Ex. 16 at 1.  Petitioner’s facility has three residential wings and there were infected residents on each of them.  Id.

As of December 9, Petitioner admits that it continued to house five of its residents – all having tested negative for Covid and asymptomatic – in rooms with Covid-positive residents.  Petitioner’s request for hearing at 3-4.  The surveyors confirmed that there were Covid-positive and Covid-negative residents housed in the same rooms.  CMS Ex. 1 at 6-8; CMS Ex. 9 at 9-10, 12; CMS Ex. 14; CMS Ex. 16 at 1; CMS Ex. 62 at ¶¶ 55, 62, 65, 121-125; CMS Ex. 64 at ¶ 50.  None of these residents wore masks.  The doors to all the residents’ rooms, including those who were infected with Covid, were left open.  CMS Ex. 62 at ¶ 82.

This is a blatant violation of the regulation, and the Department of Health’s requirement, that residents who are negative or of unknown status be separated from those who test positive for Covid.  Moreover, although Petitioner had not created a policy for dealing with Covid, it had asserted that it would comply with federal and state requirements.  CMS Ex. 17.  Petitioner violated its agreement and its announced policy by failing to separate infected from uninfected residents.

Petitioner asserts four arguments in its defense.  First, it claims that separating residents who tested negative from residents who tested positive would have been an exercise in futility.  Second, it asserts that it lacked sufficient space at its facility to cohort its residents in accord with the regulation’s requirements and Department of Health policy.  Third, it argues that Department of Health representatives did not provide it with assistance in devising a plan to cohort residents.  Finally, Petitioner contends that it could not transfer its infected residents out of its facility because other facilities were unable or unwilling to accept them.  Petitioner’s brief at 18-21.

None of these arguments address the undisputed failure of Petitioner at any time prior to December 2020 to develop a plan to cohort its residents in the event of Covid infections.

Moreover, I find each of Petitioner’s arguments to be without merit.

Petitioner asserts that:  “reasonable clinical judgment has been given great deference as medical professionals have had to navigate the COVID-19 pandemic.”.  It argues that it:  “used clinical judgment to conclude that the best way to save as many residents as possible was to leave roommates of COVID-positive residents in place.”  Petitioner’s brief at 20.  Petitioner relies on executive director Raux’ affidavit as support for these assertions.  P. Ex. 3 at ¶¶ 16-19.

In fact, and as Mr. Raux fails to acknowledge, the Department of Health had made a clinical judgment, expressed in a policy statement that Petitioner had agreed to follow, that residents testing negative for Covid must be separated from those who tested positive for the virus.  CMS Ex. 46 at 2.

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Mr. Raux is not a medical professional – his background is in facility management.  His testimony is without foundation, without probative value, and establishes no disputed issue of fact.  He cites to no clinical assessments of any of Petitioner’s residents to support his contention that Petitioner used clinical judgment to decide to continue to house Covid-negative residents with residents who were infected.  He and Petitioner offer no treatment records, no physician’s evaluations of the five residents, no nursing assessments – in fact, nothing of substance – to support Petitioner’s argument.

Petitioner’s medical director, Dr. Podkowka, asserts that:  “Given the highly contagious nature of COVID, it was my professional opinion that if a resident tested positive, their roommate had been highly exposed, was already likely infected, and would shortly test positive.”  P. Ex. 6 at ¶ 27.  He offers this assertion as justification for Petitioner’s failure to separate residents who tested negative for Covid infection from their roommates who had tested positive.

Dr. Podkowka’s assertion directly contradicts the Department of Health’s requirement.  His opinion does not justify Petitioner’s contravention of that explicit requirement.  Furthermore, Dr. Podkowka does not aver that he evaluated the circumstances of each of the residents who tested negative and made a clinical judgment in each case that the resident should remain with his or her Covid-positive roommate.  Indeed, Dr. Podkowka does not aver that Petitioner consulted him about how to cohort residents.  His opinion is simply a post hoc justification for Petitioner’s actions and raises no issue of disputed fact.

Petitioner’s assertion that it lacked the capability to separate its Covid-negative residents from those who tested positive is also without foundation.  Petitioner contends that it did not have enough single rooms for the roommate of each infected resident.  Petitioner’s brief at 20.

Petitioner’s argument does not address CMS’s allegation of noncompliance and is irrelevant for that reason.  CMS does not contend that Petitioner should have relocated the roommate of each of Petitioner’s dozens of infected residents.  CMS’s allegation centers only on the five residents who tested negative but who Petitioner continued to house with infected roommates.  Petitioner may not have had the capability to house dozens of infected residents or their roommates (many of whom were also infected) in private rooms, but that does not address the question of whether it could have accommodated the five residents who tested negative.

Petitioner relies on Dr. Keller’s testimony to support its argument.  P. Ex. 1 at ¶ 14.  Dr. Keller provided no foundation for her testimony.  She cites to no facility records.  She did not aver that she had even visited Petitioner’s facility much less reviewed its resident census and counted the available beds.

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Petitioner contends that it reduced its bed capacity from 120 beds to 105 beds as an infection-fighting measure.  Petitioner’s brief at 21.  Accepting that assertion as true, that left Petitioner with plenty of bed space to house the five uninfected residents in rooms that were not already home to residents who were infected.  On December 9, 2020, when surveyors visited Petitioner’s facility, it had a census of 94 residents, significantly fewer residents than available beds.  CMS Ex. 1 at 5. 

Petitioner devotes much attention to its assertion that Department of Health employees did not provide Petitioner with meaningful assistance when Covid overran Petitioner’s facility in December 2020.  Petitioner’s brief at 7-9.  In a nutshell, Petitioner contends that one employee, Patricia Many, M.S., R.N., was not helpful prior to the December 9, 2020, survey and provided Petitioner with conflicting advice after the survey was conducted.  Ms. Many is a Department of Health epidemiologist.  See CMS Ex. 66.1

This argument is a red herring.  Petitioner’s noncompliance began long before the December 9, 2020, survey and long before Petitioner had any communications with Ms. Many.  Petitioner’s failure to create an infection prevention and control plan cannot be attributed to anything that Ms. Many allegedly told Petitioner.  Petitioner’s failure to screen its staff for infection had nothing to do with Ms. Many.  Its failure to separate Covid-negative residents from infected residents prior to December 9 also had nothing to do with Ms. Many.  There is zero evidence to show that Petitioner’s staff communicated with Ms. Many about housing Covid-negative and infected residents together prior to December 9, 2020, when surveyors discovered that practice at Petitioner’s facility.  

The advice that Ms. Many gave to Petitioner – whatever it may have been – related to Petitioner’s correction of the deficiencies that were discovered on December 9, 2020.  Petitioner has not alleged that it would have corrected those deficiencies sooner but for Ms. Many’s advice. 

The Department of Health and its staff are not on trial in this case.  Petitioner, and Petitioner alone, was responsible for complying with the regulation’s requirements and with Department of Health policy.  

Finally, as to Petitioner’s assertion that it was unable to transfer residents out of its facility, I find that argument also to be a red herring.  CMS does not allege that Petitioner violated regulatory requirements by not transferring its residents to another facility.

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3. Failure to Implement Standard and Transmission-based Precautions

As part of its infection control obligation a skilled nursing facility must implement standard and transmission-based precautions designed to protect its residents from becoming infected.  42 C.F.R. § 483.80(a)(2)(iii).  These requirements include planning for the availability, manner of use, and disposal of personal protective equipment such as masks, gowns, and gloves.  As with other infection control plans, plans involving personal protective equipment must be implemented because even the most carefully written plan is meaningless if it is not implemented.

In March and July 2020, the Department of Health gave explicit and mandatory instructions to skilled nursing facilities in New York about the use of personal protective equipment if there are confirmed cases of Covid within a facility:

Facilities may implement extended use of eye protection and facemasks/N95s when moving from resident to resident (i.e. do not change between residents) unless other medical conditions which necessitate droplet precautions are present.  However, gloves and gowns must be changed and hand hygiene must be performed.

CMS Ex. 48 at 2 (emphasis added).

CMS alleges that undisputed facts establish that a registered nurse on Petitioner’s staff failed to comply with the mandate in that she did not change her gown between providing care for residents.  Specifically, CMS asserts that in the process of testing residents for Covid infection on December 9, 2020, on five occasions the nurse exited a resident’s room without changing her gown.  CMS Ex. 64 at ¶¶ 41-43, 49.  The nurse was observed walking through the facility while wearing her gown.  On three occasions the same nurse did not sanitize her hands after removing her gloves.  Id.  This nurse tested positive for Covid infection the day after she was observed violating the Department of Health’s mandate.  CMS Ex. 11 at 2.

As I have stated, the Department of Health requirement that staff change their gowns and gloves and perform hand hygiene when moving from resident to resident in a facility with Covid infections is mandatory.  There is no flexibility built into the requirement and staff are not allowed to deviate from it.  The nurse’s failure to change gowns in between testing residents and her failure to perform mandatory hand hygiene are obvious violations of Department of Health policy and of 42 C.F.R. § 483.80(a)(2)(iii).

Petitioner does not dispute any of these facts.  It argues that CDC guidance allows staff to wear the same gown while testing multiple individuals for possible Covid infection.  Petitioner’s brief at 13-14; CMS Ex. 57 at 2.  It asserts that the nurse in question was

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testing residents for Covid on December 9, 2020, but not providing other care to these residents.  It contends further that the nurse avoided having any contact with residents other than swabbing them for possible Covid.  P. Ex. 5.  Thus, according to Petitioner, the nurse’s failure to change gowns between visits to residents and her failure to perform hand hygiene in between visits was consistent with CDC guidance. 

The CDC guidelines allow for a person who tests individuals for Covid, who does not come into close personal contact with those individuals (other than administering the test), and who is not providing other care, to wear the same gown for more than one test.  CMS Ex. 57 at 2.  However, what is permitted under CDC guidelines is impermissible in New York.  CMS Ex. 48 at 2.  Regulations governing skilled nursing facilities make it clear that a skilled nursing facility must comply with state requirements and that would be so even if a state requirement is stricter than a federal requirement.  42 C.F.R. § 483.70(b).  Moreover, Petitioner’s own policy is to comply with all requirements, including those published by New York’s Department of Health.  Consequently, it is no defense that CDC guidelines may have been more liberal than the requirements published by the Department of Health. 

3. Immediate Jeopardy

CMS determined that Petitioner’s noncompliance was so egregious as to put residents at immediate jeopardy.  “Immediate jeopardy” means noncompliance that causes or is likely to cause serious injury, harm, impairment, or death to one or more residents of a skilled nursing facility.  42 C.F.R. § 488.301.  A finding of immediate jeopardy must be sustained unless proven to be clearly erroneous.  42 C.F.R. § 488.60(c). 

I would examine the evidence to decide whether an immediate jeopardy finding is clearly erroneous if I held an evidentiary hearing.  The test is slightly different in deciding a motion for summary judgment.  Here, I decide whether Petitioner has adduced facts from which I might reasonably infer that the finding of immediate jeopardy is clearly erroneous.

There are no such facts in this case.  The undisputed facts overwhelmingly support CMS’s determination of immediate jeopardy level noncompliance.

Covid is a particularly lethal illness when it infects elderly individuals.  CMS Ex. 60 at 1-3.  Hundreds of thousands of older Americans have died from Covid.  The disease is especially lethal with elderly individuals who suffer from co-morbidities.  It is axiomatic that a very high percentage of skilled nursing home residents fall into the category of individuals most threatened by Covid.  By definition, a resident of a skilled nursing facility is an individual who is so ill and infirm that he or she can no longer care for his or her own needs.  As Petitioner acknowledges, its residents’ average age is 91, with many of them suffering from dementia.  Petitioner’s brief at 3; P. Ex. 3 at ¶ 6.

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Exposing a resident of a skilled nursing facility to possible infection by Covid may be a death sentence for that resident.  For that reason, failures by a skilled nursing facility to comply scrupulously with requirements for Covid infection prevention and patient protection create the likelihood that residents of that facility will suffer serious injury, harm, or death.  Petitioner’s several well-documented failures to comply with infection control requirements are the essence of immediate jeopardy.  

CMS asserts that immediate jeopardy began at Petitioner’s facility at least as early as December 4, 2020, and continued through December 10, 2020.  Undisputed facts support this assertion.   On December 4, Petitioner failed to separate residents who had tested negative for Covid from their Covid-positive roommates.  CMS Ex. 66 at ¶¶ 66, 73.  On December 10, Petitioner allowed ten symptomatic members of its staff to work in the facility without screening or testing them.  CMS Ex. 62 at ¶ 101.

Petitioner’s primary argument against CMS’s immediate jeopardy determination is to contend that it complied with Medicare participation requirements.  Petitioner’s brief at 22.  I have addressed Petitioner’s noncompliance and need not revisit that.

Petitioner argues also that it was proactive in fighting Covid in its facility and touts the fact that it did not have a single case of Covid among its staff or residents prior to December 2020.  Petitioner’s brief at 22-23.  I accept as true Petitioner’s assertion that its facility was Covid-free prior to December 2020.  I make no finding whether this was due to Petitioner’s efforts.  Whatever happened prior to December 2020 does not in any respect mitigate the jeopardy that residents were put in beginning that month.  

4. Remedies

CMS determined to impose remedies consisting of civil money penalties of $9,485 for each day of a period that began on December 4, 2020 and that ran through December 10, 2020, and $ 225 for each day of a period that began on December 11, 2020 and that ran through January 6, 2021.  I find these remedies to be supported by the undisputed facts.

CMS imposed the larger penalty amounts to remedy Petitioner’s immediate jeopardy level noncompliance.  The smaller amounts cover a period after Petitioner had alleviated immediate jeopardy but was still in the process of completing remedial actions to eliminate its noncompliance.  Petitioner does not contend that it completed its remedial actions prior to January 6, 2021, although it disputes that it ever was noncompliant with participation requirements.

The penalty amounts are within the permissible ranges for immediate jeopardy level and non-immediate jeopardy level civil money penalties.  42 C.F.R. § 488.438(a)(1)(i),(ii), 45 C.F.R. Part 102.  The penalty amounts are modest when compared to the maximum

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permissible amounts.  The immediate jeopardy level penalties, for example, amount to less than one-half the maximum amount allowed by regulation.

There are factors to be utilized in assessing the reasonableness of a civil money penalty.  These factors include the seriousness of noncompliance and a facility’s culpability for its noncompliance among other things.  42 C.F.R. §§ 488.438(f)(1)-(4); 488.404 (incorporated by reference into 42 C.F.R. § 488.438(f)(3)).

The penalties are justified both by the undisputed facts establishing the seriousness of Petitioner’s noncompliance and by its culpability for the noncompliance.  As I have discussed, the introduction of Covid infections into a skilled nursing facility can be a death sentence for several or even many of that facility’s residents.  For that reason, any failure by a facility to comply with infection prevention and control requirements puts its residents at great risk.  Here, there were several failures, and these failures were the result of a failure to do the basic planning and implementation that the regulation and the Department of Health required.

I also find that Petitioner shows significant culpability for its noncompliance.  The undisputed facts establish that Petitioner was aware that it had to comply with regulatory requirements and directives from the Department of Health.  Indeed, its management acknowledged those requirements and directives in a policy statement that it issued in March 2020.  CMS Ex. 17.  Petitioner’s subsequent failure to create and implement a plan for confronting Covid is inexcusable.

Petitioner argues that the penalties are unreasonable.  It asserts that the facts fail to establish a pattern of noncompliance and that its previous compliance history is nearly impeccable.  Petitioner’s brief at 24.  I accept Petitioner’s representations about its compliance history as true for purposes of deciding the motion for summary judgment.  But even if true, they do not mitigate either the seriousness of Petitioner’s noncompliance or its culpability.

Petitioner also asserts that other facilities located in the same region of New York experienced Covid outbreaks and were not penalized.  Petitioner’s brief at 24-25.  It argues that it is unfair to be singled out for noncompliance findings and remedies.  I find this argument to be without merit for two reasons.  First, remedies are not imposed based on a comparative standard.  Second, compliance is not measured simply by whether a facility has a Covid outbreak on its premises.  Conceivably, a facility could comply scrupulously with infection control requirements and still sustain a Covid outbreak.  In that event there would be no liability and no basis to impose a remedy against that

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facility.  Here, however, the undisputed facts plainly establish noncompliance, and it is this noncompliance that justifies CMS’s remedy determinations.

1. CMS moved to supplement its pre-hearing submission to address Petitioner’s assertions about Ms. Many and Petitioner effectively cross-moved to respond to CMS’s supplemental evidence.  I deny the motion and the cross-motion as moot.
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