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                              Yukio Okutsu State Veterans Home, DAB CR6164 (2022)
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Yukio Okutsu State Veterans Home, DAB CR6164 (2022)








  
  
    

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





Yukio Okutsu State Veterans Home,
(CCN: 125058),
Petitioner,

v.

Centers for Medicare and Medicaid Services
Docket No. C-21-625Decision No. 6164September 28, 2022

        
              
    

      DECISION

Petitioner, Yukio Okutsu State Veterans Home, is a long-term-care facility, located in Hilo, Hawaii, that participates in the Medicare program.  Within one month, more than 80% of its residents contracted Covid-19 and 38% of those who contracted the disease died.  I now consider the facility’s response to the Covid-19 outbreak and its compliance with infection control and related requirements.

Following surveys, completed on October 16, 2020, and October 30, 2020, the Centers for Medicare & Medicaid Services (CMS) determined that the facility was not in substantial compliance with Medicare program requirements and that its deficiencies posed immediate jeopardy to resident health and safety.  CMS imposed civil money penalties (CMPs) of $7,460 per day for 41 days of immediate jeopardy, $11,825 per day for an additional 15 days of immediate jeopardy, and $435 per day for 63 days of substantial noncompliance that did not pose immediate jeopardy.

Petitioner appealed.

Page 2

For the reasons set forth below, I find that, from September 9, 2020, through January 5, 2021, the facility was not in substantial compliance with Medicare program requirements; that, from September 9 through November 3, 2020, its deficiencies posed immediate jeopardy to resident health and safety; and that the penalties imposed are reasonable.

Background

The Social Security Act (Act) sets forth requirements for nursing facilities to participate in the Medicare program and authorizes the Secretary of Health and Human Services to promulgate regulations implementing those statutory provisions.  Act § 1819.  The Secretary’s regulations are found at 42 C.F.R. Part 483.  To participate in the Medicare program, a nursing facility must maintain substantial compliance with program requirements.  To be in substantial compliance, a facility’s deficiencies may pose no greater risk to resident health and safety than “the potential for causing minimal harm.”  42 C.F.R. § 488.301.

The Secretary contracts with state survey agencies to conduct periodic surveys to determine whether skilled nursing facilities are in substantial compliance.  Act § 1864(a); 42 C.F.R. § 488.20.  Each facility must be surveyed annually, with no more than fifteen months elapsing between surveys.  Facilities must be surveyed more often, if necessary, to ensure that identified deficiencies are corrected.  Act § 1819(g)(2)(A); 42 C.F.R. §§ 488.20(a), 488.308.  The state agency must also investigate all complaints.  Act § 1819(g)(4).

Pursuant to section 1135(b) of the Act, CMS prioritized infection control surveys, creating a survey tool that focused on infection control, and, specifically, on critical elements associated with the transmission of Covid-19.  Facilities were expected to comply with CMS guidance in effect at the time of the survey.

**The surveys**.  This case involves two surveys, completed October 16 and October 30, 2020.

On September 9, 2020, surveyors from the Hawaii State Department of Health (state agency) began a Covid-19 Focused Infection Control Survey, which they completed on **October 16, 2020**.  Based on the survey findings, CMS determined that the facility was not in substantial compliance with:

42 C.F.R. § 483.80(a)(1)(2)(4)(e)(f) (Tag F880) (infection control – prevention and control program) cited at scope and severity level J (isolated instance of substantial noncompliance that poses immediate jeopardy to resident health and safety).Page 3

CMS Ex. 1; CMS Ex. 48 at 1; *see* CMS Ex. 50 at 2-3 (Mitchell Decl. ¶ 3); CMS Ex. 51 at 2-3 (Baroza Decl. ¶ 3).

Surveyors returned to the facility and completed a follow-up investigation on **October 30, 2020**.  Based on those survey findings, CMS determined that the facility was not in substantial compliance with:

42 C.F.R. § 483.70 (Tag F835 – administration), cited at scope and severity level F (widespread substantial noncompliance that causes no actual harm with the potential for more than minimal harm);
	42 C.F.R. § 483.70(d)(1)(2) (Tag F837 – administration:  governing body), cited at scope and severity level F;
	42 C.F.R. §§ 483.20(f)(5) and 483.70(i)(1)-(5) (Tag F842 – resident assessment: identifiable information and administration, medical records), cited as scope and severity level D (isolated instance of substantial noncompliance that causes no actual harm with the potential for more than minimal harm);
	42 C.F.R. § 483.75(a)(2)(h)(i) (Tag F865 – quality assurance and performance improvement program), cited at scope and severity level L (widespread substantial noncompliance that poses immediate jeopardy to resident health and safety);
	42 C.F.R. § 483.75(g)(2)(ii) (Tag F867 – quality assurance and performance improvement: quality assessment and assurance), cited at scope and severity level F; and
	42 C.F.R. § 483.80(a)(1)(2)(4)(e)(f) (Tag F880) (infection control – prevention and control program) cited at scope and severity level L (repeat deficiency).CMS Ex. 28; CMS Ex. 48 at 1-2; *see* CMS Ex. 50 (Mitchell Decl. ¶ 3); CMS Ex. 51 at 2-3 (Baroza Decl. ¶ 3); CMS Ex. 52 at 4 (Weinhardt Decl. ¶ 3); CMS Ex. 54 at 2 LeTourneur Decl. ¶ 3).

Thereafter, CMS determined that the facility returned to substantial compliance on January 6, 2021.  CMS Ex. 48 at 2.

Based on the deficiencies cited, CMS has imposed against the facility penalties of $7,460 per day for 41 days of substantial noncompliance that posed immediate jeopardy to resident health and safety (September 9 through October 19, 2020), $11,825 per day for 15 additional days of substantial noncompliance that posed immediate jeopardy to resident health and safety (October 20 through November 3, 2020), and $435 per day for

Page 4

63 days of substantial noncompliance that  did not pose immediate jeopardy (November 4, 2020 through January 5, 2021).  (Total:  $305,860 + $177,375 + $27,405 = $510,640).  CMS Ex. 48 at 3.

Petitioner appealed.

CMS submitted a pre-hearing brief (CMS Br.), a closing brief (CMS Cl. Br.), and 54 exhibits (CMS Exs. 1-54).  Petitioner submitted a pre-hearing brief (P. Br.), a closing brief (P. Cl. Br.), and 16 exhibits (P. Exs. 1-16).   In the absence of any objections, I admit into evidence CMS Exs. 1-54 and P. Exs. 1-16.

**Decision on the written record**.  My initial order directed the parties to exchange, as a proposed exhibit and in the form of an affidavit or written declaration, the written direct testimony of any proposed witness.  Acknowledgment and Pre-hearing Order at 3, 5 (¶¶ 4, 8) (April 5, 2021).  The order also directed each party to indicate whether it wanted to cross-examine the opposing party’s witnesses.  Order at 5 (¶ 9).  The order pointed out that a hearing would be necessary only if a party files admissible, written direct testimony, and, in compliance with the order, the opposing party asks to cross-examine.  Order at 4 (¶ 10).

Each party listed multiple witnesses and provided their written direct testimony.  But neither side asked to cross-examine the opposing side’s witnesses.  Because the witnesses’ direct testimonies are already in the record, and no witnesses will be cross-examined, an in-person hearing would serve no purpose.  This matter may therefore be decided based on the written record.  *HeartFlow, Inc.*, DAB No. 2781 at 16-17 (2017) (citing *Vandalia Park*, DAB No. 1940 at 28-29 (2004), *aff’d*,*Vandalia Park v. Leavitt*, 157 F. App’x 858 (6th Cir. 2005)).1

Issues

The issues are:

From September 9, 2020, through January 5, 2021, was the facility in substantial compliance with Medicare program requirements;Page 5

If, from September 9 through November 3, 2020, the facility was not in substantial compliance with program requirements, did its deficiencies then pose immediate jeopardy to resident health and safety; and
	If the facility was not in substantial compliance with program requirements, are the penalties imposed – $7,460 per-day for 41 days of immediate jeopardy, $11,825 per day for an additional 15 days of immediate jeopardy, and $435 per day for 63 days of substantial noncompliance that did not pose immediate jeopardy – reasonable?Discussion

**The October 16, 2020 Survey.**

***1.   The facility was not in substantial compliance with 42 C.F.R. § 483.80(a) because, contrary to facility policies and CDC (Center for Disease Control and Prevention) guidelines, it did not adequately screen staff and visitors before allowing them to enter the facility; did not timely implement droplet precautions for residents suspected of having Covid; did not timely quarantine staff and residents who were exposed to or suffering from Covid; did not follow guidelines for thorough and prompt contact tracing; and did not timely or properly cohort residents.  Staff misused personal protective equipment (PPE) and did not properly clean their hands after doffing contaminated PPE.***2

**A.  Program requirements:**  **Section 1819(d)(3)** of the Social Security Act mandates that a skilled nursing facility must (A) establish and maintain an infection control program to provide a “safe, sanitary, and comfortable environment in which residents reside and to help prevent the development and transmission of disease and infection,” and (B) be designed, constructed, equipped, and maintained in a manner that protects the health and safety of residents, personnel, and the general public.

Consistent with section 1819(d)(3), **42 C.F.R. § 483.80(a)(1)(2)(4)(e)(f) (Tag F880)** requires the facility to establish and maintain an infection prevention and control program designed to provide a safe, sanitary, and comfortable environment and to help prevent the development and transmission of communicable diseases and infections.

The program must include:

Page 6

1)   a system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for all residents, staff, volunteers, visitors, and other individuals providing services under a contractual arrangement based upon the facility assessment conducted according to § 483.70(e) and following accepted national standards;3

2)   written standards, policies, and procedures for the program, which must include:

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

ii)   when and to whom possible incidents of communicable disease or other infections should be reported;

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, including:

A)   the type and duration of the isolation, depending upon the infectious agent or organism involved: and

B)   a requirement that the isolation should be the least restrictive possible for the resident under the circumstances.

v)   the circumstances under which the facility must prohibit employees with a communicable disease or infected skin lesions from direct contact with residents or their food, if direct contact will transmit the disease; and

vi)   the hand hygiene procedures to be followed by staff involved in direct resident contact.

* * * * *

4)   a system for recording incidents identified under the infection prevention and control program and the corrective actions to be taken by the facility.

Personnel must handle, store, process, and transport linens so as to prevent the spread of infection.

Page 7

The facility must also conduct an annual review of its infection prevention and control program and update the program, as necessary.

The infection-control regulation thus requires that the facility have written policies in place, and that it *implement* those policies.  If it does not, it violates section 483.80(a).4  *Golden Living Ctr. – Superior*, DAB No. 2768 at 7 (2017); *Heritage House of Marshall Health & Rehab. Ctr*., DAB No. 2566 at 13 (2014).5

**B.  Facility policies:  infection prevention and control – testing**.  In a policy dated September 23, 2020 (which was during the October 16 survey), the facility put into place an infection prevention and control program to address Covid-19.  The policy’s stated purpose is to assist the facility in promptly identifying residents suffering from Covid “so measures can be implemented to protect non-infected residents and staff” and to minimize further transmission.  CMS Ex. 30 at 3.

The policy calls for testing staff and residents.  The policy defines “staff” broadly and includes employees, consultants, contractors, students, volunteers, and caregivers “who provide care and services to residents on behalf of the facility.”  Anyone unable or unwilling to be tested is to be managed as if the person has tested positive for the virus.  CMS Ex. 30 at 3.

According to the policy, a resident with signs or symptoms of Covid or known exposure to the virus is offered a test.  If the resident tests positive or refuses the test, transmission-based precautions are implemented in accordance with CDC guidelines.  Staff exhibiting signs or symptoms of Covid who refuse to be tested are restricted from work or from entering the facility until return-to-work criteria are met, based on CDC guidelines.  CMS Ex. 30 at 4.

Page 8

In the event of an outbreak, the facility is required to test symptomatic and asymptomatic residents and staff.  Staff who refuse to be tested during an outbreak are denied entry into the building until the process for outbreak testing has been completed.  A resident who refuses outbreak testing and is asymptomatic is re-educated about wearing a face mask, practicing appropriate distancing from other residents, and hand hygiene.  Staff also monitor and assist the resident in complying until the process for outbreak testing is completed.  If there is a facility outbreak, and a symptomatic resident or one exposed to Covid refuses to be tested, the resident is placed on or remains on transmission-based precautions until symptom-based criteria for discontinuing precautions are met.  Staff refusing routine testing are not permitted to enter the facility and face disciplinary action, up to and including termination.  CMS Ex. 30 at 4.

**Facility policy:  Covid-19**.  A separate policy, dated September 9, 2020 (which was the first day of the survey), requires the facility to isolate symptomatic residents “*as soon as possible*.”  CMS Ex. 30 at 14 (emphasis added).  To accomplish this, the policy lists some methods, including, “but not limited to”:  place the resident in a private room with a private bathroom, keep the door closed, as possible, implement contact and droplet precautions.  If a private room is not feasible, the facility will leave the resident with his/her current roommate, and infection control practices will be implemented, which include keeping the privacy curtain pulled; maximizing the space between beds; educating the residents on hand hygiene and social distancing; and using masks to the extent possible.  Residents are also placed on contact and droplet precautions.  CMS Ex. 30 at 14; *see* CMS Ex. 27 at 32-33 (describing droplet precautions, which include:  isolation; cohorting; wearing masks and other PPE).6

With respect to protecting healthcare personnel, the policy requires that the facility: emphasize hand hygiene; *cohort residents with Covid*; limit the number of staff caring for suspected or confirmed Covid residents; and *follow CDC guidelines* for personal protective equipment.  CMS Ex. 30 at 14-15.

In directing staff to follow CDC guidelines, the policy notes that the measures recommended to prevent Covid-19 mimic routine interventions for preventing the spread of influenza and similar respiratory-based infections.  CMS Ex. 30 at 15.  It provides that the facility’s “Infection Preventionist,” Director of Nursing (DON), and Medical Director are “actively engaged” in executing the facility’s Infection Prevention and Control Program.  The DON and Infection Preventionist are charged with reviewing the Infection

Page 9

Prevention and Control binder routinely to keep it current and accurate and to identify trends in illness patterns.  CMS Ex. 30 at 15.

The policy also calls for a “Pandemic Committee” to follow guidelines published for the “Pandemic Influenza Checklist.”  The facility must maintain a listing of available personal protective equipment (PPE) – surgical masks, N95 masks, gowns, face shields, goggles, gloves.  The listing should be updated regularly, and supplies ordered routinely, with suppliers notified of necessary increases.  Alcohol-based sanitizers are to be available at entrances and throughout the facility.  CMS Ex. 30 at 15.

The policy includes surveillance measures.  It requires the facility to maintain “high vigilance” for evidence of residents and employees with respiratory symptoms, such as fever, cough, sore throat, and muscle aches and pains.  Residents with symptoms are placed on “Alert Charting,” and a documented assessment is completed at least every shift.  Staff are to advise the physician of any significant change in condition.  During morning clinical review and during afternoon “stand-down,” a status report on residents with respiratory illness is reviewed.  And a facility “line-listing and mapping process” is used to track and trend the incidence of suspected and confirmed cases.  CMS Ex. 30 at 16.

The policy includes directions for educating facility employees on the signs and symptoms of Covid-19, “cough etiquette,” and the importance of prompt assessment and communication when a resident develops symptoms.  Employees are taught the importance of managing personal risk factors that could put them at risk for contracting Covid-19.  They are also educated on providing care to symptomatic residents and those diagnosed with Covid-19.  CMS Ex. 30 at 16.

The policy requires the facility to educate employees on the importance of hand hygiene and use of PPE.  The policy calls for periodic, random monitoring to validate the employees’ good hand hygiene and PPE techniques (including hand hygiene for employees providing non-patient care services).  CMS Ex. 30 at 16.

As part of their initial orientation, temporary personnel are educated on Covid-19 and must complete a screen before being allowed to start work.  CMS Ex. 30 at 16.

The policy requires that *everyone entering the facility be screened according to CDC guidelines*.  Entry is allowed in accordance with those guidelines.  For essential visits (such as compassion care at end of life), visitors must be screened in accordance with CDC guidelines and directed to wear a face mask or cloth face covering during the visit.  CMS Ex. 30 at 16.  According to the policy, Covid-19 informational posters are placed at visitor entrances to educate visitors on the importance of hand hygiene.  The informational posters stress proper hand hygiene and cough etiquette.  CMS Ex. 30 at 17.

Page 10

The policy includes directions for handling suspected or confirmed cases of Covid-19:

The facility contacts the local and/or state health department for guidance as to whether a symptomatic person should be evaluated for Covid-19.
	The resident’s attending physician or the facility’s medical director is notified.  The Infection Preventionist or designee must monitor the CDC website for updates to the case definition and communicate any changes to facility staff.
	As laboratory testing is available, the physician should order Covid testing.
	When symptoms are identified, use of PPE should be implemented.  The CDC recommends that personnel wear gown, gloves, facemask, goggles or face shield, and N95 masks.  If there are shortages of PPE, the facility must follow CDC guidelines.  If a resident meets the definition of a suspected case, the resident must “immediately don a face mask” until transfer to a single room (as available) is completed.
	Staff must promptly report any respiratory illness outbreak to the local health department.
	A line listing of symptomatic residents and employees should be maintained and communicated daily to the local health department or as directed by that department.
	After reviewing the pattern of Covid-19, the facility must consider cohorting residents or groups by confining symptomatic residents and exposed roommates to their rooms.  Where possible, staff assigned to affected units would not work in unaffected units.
	The policy directs housekeeping to use solutions known to be effective against influenza.  Staff clean surfaces at least twice daily and more frequently when there is an active outbreak.  The facility administrator arranges for frequent monitoring, which is documented and filed in the Infection Control binder.CMS Ex. 30 at 17-18.

Finally, the policy addresses new admission referrals.  According to the policy, the facility uses a “Clinical Admission Grid” to assist in determining if a resident is appropriate for the facility and/or to prompt a detailed review of the referral before the person is accepted.  In consultation with others (the Regional Nurse Consultant (RNC) and the Regional Vice President (RVP)), the DON or designee reviews in detail residents

Page 11

exhibiting respiratory symptoms at the time of the referral to determine if the facility is capable of meeting the resident’s clinical needs.  If the resident is admitted, the DON coordinates the services provided.  CMS Ex. 30 at 18.

If the facility considers admitting someone with a confirmed or suspected Covid diagnosis, it does so in consultation with the local health department.  The DON or designee advises the department of the facility’s ability to provide care, including providing airborne precautions.   CMS Ex. 30 at 19.

New admissions are placed in a room in the observation unit, where available.  If a private room is not available, the new admission is placed in a semi-private room.  CMS Ex. 30 at 19.

**C.  The facility’s deficiencies.**The facility’s Covid statistics are dramatic.  As of August 17, 2020, 87 residents lived in the facility.  CMS Ex. 14 at 1.  Over the next month, *71 of those residents became infected with Covid, and 27 died*.  CMS Ex. 17 at 1-5.  During this same time, *31 to 32 facility employees tested positive* for the disease.  CMS Ex. 16 at 7-8.7  CMS concedes that, dramatic as these number appear to be, they do not establish that the facility was not in substantial compliance with program requirements.  CMS Br. at 6; CMS Cl. Br. at 2-3.  However, in CMS’s view, the level of infection at the facility is related to its inadequate response to the pandemic.8

Petitioner concedes that the facility experienced a severe Covid outbreak and that the loss of life from the outbreak was “significant,” but suggests that its experience was typical for nursing homes in the area at the time and was caused by factors beyond the facility’s control, such as the community’s rate of infection.  P. Br. at 1.9  I agree that the facility’s

Page 12

overall Covid statistics, while significant, are not dispositive.  I also agree that outside factors, such as the community’s rate of infection, can make a facility more susceptible to an outbreak (although the evidence here does not establish a high community infection rate in the facility’s location).  But the important question is:  did the facility implement its policies (and follow CDC guidelines) for preventing the spread of the infection?  If it did, it was likely in substantial compliance with section 483.80(a), notwithstanding the prevalence of the disease within the facility.  But if it did not implement its policies, it was not in substantial compliance.  *Golden Living Ctr. – Superior*, DAB No. 2768 at 7; *Heritage House of Marshall*, DAB No. 2566 at 13.

Petitioner also concedes that the surveyors observed what it characterizes as “isolated incidents” where staff did not engage in “the best” infection control practices.  Nevertheless, Petitioner argues, “any occasional deviations” from the facility’s policies or procedures “would not have changed the outcome of the outbreak at [the facility] anyway.”  P. Br. at 1-2.  This assertion doesn’t further Petitioner’s case.  First, *multiple instances* of staff failing to follow facility policies means that the incidents were not so “isolated.”  Moreover, I am not inclined to view so dismissively undisputed evidence of staff failing to follow infection control policies.  With a highly infectious disease, like Covid, a so-called “isolated incident” or “occasional deviation” can have devastating consequences and can lead to a situation as dire as that experienced by the facility here.10  Moreover, as the evidence establishes, the facility failed to implement its policies (and CDC guidelines) in significant ways.

**Inadequate screening**.  As noted above, the facility’s policy required staff to follow CDC guidelines in screening “everyone entering the facility.”  CMS Ex. 30 at 16.  CDC guidelines also provide that family members should not visit the facility if they are ill or “have known exposure to someone with Covid-19.”  CMS Ex. 24 at 3-4.  The CDC instructs facilities *to screen visitors for known exposure to someone with Covid-19 and to restrict anyone with known exposure from entering* the facility.  CMS Ex. 20 at 2; CMS Ex. 24 at 4.

Page 13

At the time of the October 16 survey, the facility had been using two versions of a screening tool in order to evaluate those entering the facility.  One was dated July 16, 2020, and the other, September 8, 2020.  CMS Ex. 37 at 15; CMS Ex. 38.  Neither screening tool asked about known exposure to someone with Covid-19.  *See* CMS Ex. 50 at 4 (Mitchell Decl. ¶ 7).  The surveyors confirmed that, when they arrived at the facility on September 9 and on subsequent visits (September 10, 15, 24, 25), staff screened them before they entered the facility, asking the questions listed on the facility’s screening tool.  Staff did not ask them whether they had had contact with someone who tested positive or was under investigation for Covid-19.  CMS Ex. 1 at 4; *see* CMS Ex. 50 at 3 (Mitchell Decl. ¶ 5); CMS Ex. 51 at 3 (Baroza Decl. ¶ 5).

Without support or further explanation, Petitioner’s consultant, Infectious Disease Physician Morgan Katz, M.D., M.H.S., comments that the facility used the screening form “for a short period.”  P. Ex. 1 at 6 (Katz Decl. ¶ 10).  What she considers a “short period” is far from clear.  However, the evidence establishes that the facility used the deficient form from April 15, 2020, through the time of the survey, about six months.  CMS Ex. 37 at 15; CMS Ex. 38; P. Ex. 13 at 6-36.  And the timing is especially critical because this was the time during which Covid was introduced into the facility, and the outbreak began.

According to the DON, the facility’s parent company used this same screening tool in 50 of its facilities.  P. Ex. 9 at 5 (Walters Decl. ¶ 9).  Its widespread use does not make the screening tool adequate, which it plainly is not.11

Petitioner characterizes CMS’s criticism of its screening tool as “nit-picking.”  P. Ex. 9 at 5 (Walters Decl. ¶ 9); *see* P. Ex. 1 at 5-6 (Katz Decl. ¶ 10).  I reject this effort to minimize the importance of screening for community exposure to Covid.  In fact, information regarding Covid exposure is critically important.  As the CDC guidelines explain, it can take up to 14 days for an infected person to show symptoms of infection, and some infected individuals never show symptoms, although they can transmit the disease.  Screening for symptoms alone will not identify these asymptomatic or pre-symptomatic individuals who have Covid-19 and can infect others.  CMS Ex. 20 at 2; CMS Ex. 50 at 4 (Mitchell Decl. ¶ 7); CMS Ex. 53 at 5-6 (Schwartzman Decl. ¶ 12).

The screening tool asked staff (and other health care personnel) if they had worked at facilities with recognized Covid cases.  CMS Ex. 38.  This question would obviously elicit useful, but limited, information.  It does not apply to facility visitors and, even for

Page 14

health care personnel, does not capture their exposure outside of work settings.  Such exposure can have alarming consequences.  For example, in a September 2020 investigative report, the Hawaii Emergency Management Agency described two instances in which exposure to family or community members may have transmitted the virus to facility staff:  1) at least 20 people were infected at a family funeral held in August 2020; and 2) a staff member who became infected had a family member who had been exposed or infected at a hemodialysis facility.  CMS Ex. 47 at 3-4.

Petitioner has produced a screening tool that the facility was using in March 2020.  Consistent with CDC guidelines, the document asks:  “Have you had contact with someone with OR under investigation for Corona Virus (COVID-19)?”  P. Ex. 13 at 1-5 (emphasis in original).  Inexplicably, however, in April 2020, the facility began using a different form that omitted the critical question.  P. Ex. 13 at 6-36.12  And the facility was using the deficient form at the time of the October 16 survey.  CMS Ex. 37 at 15; CMS Ex. 38.

A deficient tool was not the only problem with the facility’s screening efforts.  CDC guidelines direct facilities to screen for individuals who have signs or symptoms of a respiratory infection, such as fever, cough, sore throat.  CMS Ex. 20 at 2; CMS Ex. 24 at 4.  Consistent with this directive, the screening tool asks about these symptoms.  CMS Ex. 38.  Yet, on August 20, a member of the maintenance staff (referred to as MS2) was allowed into the facility even though he was “generally not feeling well” and complained of a runny nose.  CMS Ex. 16 at 7.  He was sent home after about five hours with a “hoarse throat.”  CMS Ex. 1 at 8; CMS Ex. 50 at 5 (Mitchell Decl. ¶ 10).   MS2 was tested on August 20, and, on August 22, received positive test results.  CMS Ex. 16 at 7.13

The facility’s DON suggests, without support, that the staff member misled the screeners.  She maintains that the facility trained staff to be “honest and conservative” in filling out the screening forms and to report any symptoms.  P. Ex. 9 at 7 (Walters Decl. ¶ 11).  If, in fact, the employee misled the screeners (and I see no evidence that he did), the facility is nevertheless accountable.  It is well-settled that a facility “cannot disavow responsibility

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for the actions of its employees” through which it acts.  *Springhill Senior Residence*, DAB No. 2513 at 14 (2013) (citing *Beverly Health Care Lumberton*, DAB Ruling No. 2008-5 (Denial of Petition for Reopening Decision No. 2156) at 6-7 (2008); *Emerald Oaks*, DAB No. 1800 at 7 n.3 (2001); *North Carolina State Veterans Nursing Home*, *Salisbury*, DAB No. 2256 (2009)).

**Quarantine delays:  maintenance staff**.  CDC guidelines consider “prolonged”:  Covid exposure of 15 minutes or more; or Covid exposure of any duration if the exposure occurred while performing an aerosol-generating procedure.  CMS Ex. 21 at 3, 4.  The guidelines define an interaction as a “close contact” if the individual is within six feet.  CMS Ex. 22 at 5.  The guidelines explain that exposures are not limited to those involving confirmed Covid cases but can also occur “from a suspected case or from a “person under investigation,” when testing has not yet occurred or if results are pending but not expected for 48 to 72 hours.  CMS Ex. 21 at 3.

On the same day MS2 went home with a hoarse throat and runny nose (August 20), a second member of the maintenance staff (referred to as MS1), learned that he had been in close contact with someone who tested positive for Covid.  MS1 reported this to the maintenance supervisor, who, after consulting management, sent MS1 home to quarantine.  CMS Ex. 1 at 7.  MS1 was not tested until September 5, and, on September 9, the results came back positive.  CMS Ex. 16 at 7.

A third maintenance worker (MS3) had been in close – and unmasked – contact with both MS1 and MS2.  Among other interactions, they ate together in the facility’s breakroom.  On August 20, specifically, MS1 and MS3 ate lunch together, and their interaction lasted more than 15 minutes.  Nevertheless, MS3 continued working on August 20 and 21.  CMS Ex. 16 at 7; CMS Ex. 50 at 5-6 (Mitchell Decl. ¶ 11).  When asked why he was allowed to remain, the facility’s DON told surveyors that the maintenance worker was allowed to stay at work because he was asymptomatic.  CMS Ex. 50 at 5-6 (Mitchell Decl. ¶ 11).  MS3 tested positive for Covid on August 23.  CMS Ex. 16 at 7.  In the meantime, the maintenance workers moved throughout the facility.  CMS Ex. 15 at 3-4.  Significantly, their infections marked the beginning of the facility’s outbreak.

Had the facility followed CDC guidelines, as called for in its policies, MS3 would have been quarantined based on his prolonged contact with the other two maintenance workers (who were “persons under investigation”) and the timing of those workers’ Covid test results.  Because it allowed him to remain at work, the facility failed to protect residents from serious harm.  CMS Ex. 53 at 6-7 (Schwartzman Decl. ¶ 13); *see* CMS Ex. 21 at 3.  That the DON didn’t understand this is troubling.  At the time of the outbreak, she, with the (then) Infection Preventionist and Medical Director, were supposed to be “actively engaged” in the facility’s Infection Control program, which included updating the

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facility’s Infection Prevention and Control binder.  CMS Ex. 30 at 15.14  They should have known that it can take up to 14 days for Covid symptoms to develop and that infected individuals who are pre-symptomatic or asymptomatic can transmit the disease to others.  CMS Ex. 20 at 2; CMS Ex. 45 at 4; CMS Ex. 53 at 7 (Schwartzman Decl. ¶ 14).

**Quarantine delays: resident**.  Resident M (who was not a part of the survey sample and is thus not identified by number) left the facility three times per week (Monday, Wednesday, Friday) for renal dialysis.  Before August 26, six patients and a staff member at her dialysis center had tested positive for Covid.  CMS Ex. 47 at 3.  On August 26, she had an elevated temperature, 99.7.  Two days later (August 28), she tested positive for Covid.  CMS Ex. 16 at 2.  According to CDC guidelines and the facility’s policy, the resident should have been transferred to the facility’s designated Covid unit, with Covid-dedicated staff caring for her.  CMS Ex. 30 at 18; CMS Ex. 45 at 7; *see* CMS Ex. 44 at 3-4.  However, review of the facility’s room assignments shows that she remained in the same room and was not moved to the Covid unit until August 31, increasing the risk of transmitting the virus to uninfected staff and residents.  CMS Ex. 14 at 1-10, 11; *see* CMS Ex. 47 at 1 (“A basic understanding of segregation and workflow seemed to be lacking even approximately 3 weeks after the first positive.”).15

**Inadequate contact tracing**.  Contact tracing is a “fundamental” activity that involves working with a patient (symptomatic or asymptomatic) who has been diagnosed with an infectious disease “to identify and [support] people (contacts) who may have been infected through exposure to the patient.”  CMS Ex. 22 at 2; CMS Ex. 53 at 7 (Schwartzman Decl. ¶ 15).  By separating the infected from the uninfected, the process prevents further transmission of the disease.  “It is a core disease control measure that has been employed by public health agency personnel for decades.”  CMS Ex. 22 at 3.

CDC guidelines require contact tracing for close contacts (individuals who were within six feet of an infected individual for at least 15 minutes from two days before the illness onset) of a confirmed or probable Covid patient.  CMS Ex. 22 at 5.  CDC guidelines set

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priorities for which close contacts to evaluate and monitor.  Among the groups listed in Priority 1 are healthcare personnel and *individuals working in skilled nursing and long-term care facilities*.  CMS Ex. 22 at 5-6.  The guidelines include “clear protocols” for notifying, interviewing, and advising close contacts.  CMS Ex. 22 at 6-7.

As seems obvious, the earlier it is implemented, the more effective contact tracing is in controlling or slowing an outbreak of infectious disease.  If not “thorough and prompt,” contact tracing will not be effective.  Further, as both Nurse Surveyor Veronica Mitchell, RN, MSN, and Hospital Epidemiologist, William A. Schwartzman, M.D., explain, contact tracing should include detailed facts with contemporaneous documentation of the facility’s contact-tracing efforts, which can be referred to later to ensure that relevant information is not forgotten or overlooked.  CMS Ex. 50 at 6 (Mitchell Decl. ¶ 12); CMS Ex. 53 at 7 (Schwartzman Decl. ¶ 15).  At a minimum, contact tracing should identify other individuals who were “in close contact with the subject of the contact tracing within the relevant period of time” and should record the facility’s efforts to notify those people.  CMS Ex. 53 at 7 (Schwartzman Decl. ¶ 15).

Petitioner claims that CMS determined that the facility’s contact tracing was inadequate based solely on the DON’s comment that the contact-tracing information was “in her head” and accuses CMS of mischaracterizing the complete factual record.  P. Br. at 12; P. Ex. 9 at 8 (Walters Decl. ¶ 13).  In fact, CMS determined that the facility’s contact-tracing efforts were inadequate because the facility produced no evidence – and still produces no evidence – that the facility had *contemporaneously documented* its contact-tracing efforts, if any.  When the surveyors asked the DON for evidence that the facility had conducted contact tracing for the maintenance staff who tested positive for Covid in August, she claimed that she could provide the documentation “quickly”; she did not produce anything for several days.

What the DON eventually provided was far from adequate.  She gave the surveyors a September 26 attachment to an email sent by the regional nurse consultant, who worked for the facility’s parent company.  The document discusses the maintenance staff who tested positive for Covid, focusing on the possible sources from which they might have contracted the virus.  CMS Ex. 12 at 20-21; CMS Ex. 50 at 6 (Mitchell Decl. ¶ 12).  It does not, however, consider who else might have been in close contact with the infected maintenance workers and includes no efforts to notify those people.

I do not agree that eventually sending the workers home and testing them for Covid constitutes adequate contact tracing.  *See* P. Br. at 13; P. Ex. 1 at 7 (Katz Decl. ¶ 13).  We have no idea whom the maintenance workers might have exposed in the days they were

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infectious and working at the facility.16  I agree with Dr. Schwartzman; the facility did not adequately contact trace the maintenance workers’ Covid infections.  Inasmuch as these included the first confirmed Covid cases in the facility, its failing to do so “was a missed opportunity to blunt the spread of the outbreak in the facility.”  CMS Ex. 53 at 8 (Schwartzman Decl. ¶ 16).

Petitioner also dismisses the importance of contact tracing.  According to Dr. Katz, the facility was performing “weekly surveillance testing” of all residents and staff, which she characterizes as “superior” to dedicated contact tracing.  P. Ex. 1 at 7 (Katz Decl. ¶ 13).  There are significant problems with Dr. Katz’s assertion, which she does not support by citing any studies or recognized authority.  Moreover, she does not indicate when the facility started this “universal testing.”  The evidence shows that it was not in effect when the maintenance workers became infected.  MS1 was not tested until September 5, more than two weeks after his exposure.  CMS Ex. 16 at 7.  The facility’s testing policy was not even developed until September 23, well after most of the facility residents had contracted the disease.  CMS Ex. 30.  Under that policy, testing all residents and staff would occur only in the event of an “outbreak,” which is not defined.

Moreover, if, in fact, staff, *in their professional judgment*, opt to deviate from the CDC guidelines (and, thus, the facility’s own policies), they must document that judgment and give sound reasons for it.  Nothing in this record suggests that staff affirmatively decided to disregard the CDC requirements for contact tracing.  This leaves two possibilities:  either staff were not aware of those requirements; or they simply disregarded them.  *See Oxford Manor*, DAB No. 2167 at 5-6 (2008); *Guardian Health Care Ctr.*, DAB No. 1943 at 23 (2004).  The facility’s failure to follow the guidelines it adopted to prevent the spread of infection is not mitigated by its after-the-fact disparagement of those guidelines.  *See Avalon Place Trinity*, DAB No. 2819 at 26-27 (2017), *aff’d*,*Avalon Place Trinity v. U.S. Dep’t of Health & Human Servs*., 761 F. App’x 407 (5th Cir. 2019).  Where the facility does not follow its own determination for managing risk, it “may be held to the consequences.”  *Id*. at 27.

**Droplet precautions not implemented**.  Droplet precautions are important for combating infectious diseases, including Covid, that spread via close respiratory or mucous membrane contact with respiratory secretions.  *See* CMS Ex. 27 at 32.  As noted above, facility policy required that residents suspected of having Covid be placed on droplet precautions.  CMS Ex. 30 at 14.  On August 23, Resident 4 (R4) developed a low-

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grade fever and had an oxygen saturation (O2) level of 92% – symptoms of Covid.17  Yet, staff did not put him on droplet precautions.  He was put on droplet precautions on August 25, the day the facility learned that he had tested positive for Covid.  CMS Ex. 16 at 1.  This delay, particularly considering that, by August 24, the facility had two other confirmed cases of Covid, unnecessarily increased the risk of R4 transmitting the disease to staff and other residents.  CMS Ex. 50 at 6-7 (Mitchell Decl. ¶¶ 13, 14).

**Improper hand hygiene and improper use of personal protective equipment**.  In its guidelines, the CDC notes that hand hygiene is frequently cited as “the single most important practice to reduce the transmission of infectious agents in healthcare settings” and is considered an essential element of standard precautions.  CMS Ex. 27 at 19; CMS Ex. 45 at 9 (requiring that hand hygiene be performed after removing respirator or facemask and immediately after removing gloves).

PPE includes gloves, gowns, masks or respirators, and goggles or face shields.  CMS Ex. 26; CMS Ex. 27 at 20-24.  The facility policy required that employees be educated on the importance of hand hygiene and the proper use of PPE.  It called for periodic, random monitoring of staff to ensure good hand hygiene and PPE techniques.  CMS Ex. 30 at 16.

According to the Statement of Deficiencies, surveyors observed a physician (MD2) enter the facility’s Covid unit without donning a gown.  A licensed practical nurse (LPN) also saw this, and she immediately retrieved a gown and gave it to him.  CMS Ex. 1 at 12.  When he left the unit, the physician failed to dispose of his contaminated face shield and N95 mask.  He neglected to wash his hands and left the facility wearing the contaminated PPE.  *Id.*; CMS Ex. 51 at 3-4 (Baroza Decl. ¶ 7).  When the surveyor interviewed the physician, he complained that no one told him that the “process was changed,” or that he was supposed to dispose of his face shield and N95 mask upon leaving the Covid unit.  CMS Ex. 51 at 4 (Baroza Decl. ¶ 7).

The physician’s response is disturbing.  Disposing of contaminated PPE and washing hands after providing patient care (even to patients who are not highly infectious) are not “new” practices; they are basic components of Standard Precautions.  CMS Ex. 26 at 2-3; CMS Ex. 27 at 21; CMS Ex. 51 at 4 (Baroza Decl. ¶ 8).  CDC guidelines call for washing hands after removing PPE:  “Hand hygiene after removing PPE is particularly important to remove any pathogens that might have been transferred to bare hands during the removal process.”  CMS Ex. 45 at 8; CMS Ex. 50 at 8 (Mitchell Decl. ¶ 18).  A physician treating Covid patients in the midst of a widespread facility outbreak did not follow basic safety precautions and was apparently unaware of Standard Protocol.  I agree with CMS that this shows a disturbing and fundamental failure in infection control.

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This was not the only disturbing incident of medical personnel (who should know better) failing to follow basic infection control protocols.  On September 15, Surveyor Mitchell saw a licensed practical nurse (LPN2) fail to clean her hands after she disposed of her contaminated PPE at the main entrance to the facility.  She then went to the parking lot.  CMS Ex. 50 at 8 (Mitchell Decl. ¶ 17).

**The October 30, 2020 survey.**

***2.   The facility’s substantial noncompliance with 42 C.F.R. § 483.80(a) continued because the facility still did not adequately screen staff and visitors before allowing them to enter; it had no policy that addressed isolating residents who were exposed to Covid while away from the facility; and its monthly infection surveillance reports were inaccurate.***

Once a facility has been found out of substantial compliance, it must correct its deficiencies and assure that no future incidents will occur.  *Life Care Ctr. of Elizabethton*, DAB No. 2367 at 16-17 (2011); *Premier Living and Rehab. Ctr.*, DAB No. 2146 at 23 (2008); *Lake City Extended Care Ctr.*, DAB No. 1658 at 12-15 (1998).  The burden is on the facility to prove that it has resumed complying with program requirements, not on CMS to prove that the deficiencies continued to exist after they were discovered.  *Asbury Ctr. at Johnson City*, DAB No. 1815 at 19-20 (2002).

Petitioner has not met this burden.  When a survey team returned to the facility for the follow-up survey completed October 30, 2020, it discovered ongoing deficiencies with the facility’s infection control practices.

**Inadequate screening**.  The surveyors returned to the facility on October 20, 2020, and almost immediately witnessed the facility’s inadequate screening process.  Using the facility’s new screening tool (which was amended on October 17, 2020, to add questions about community exposure), a “private biller” asked Surveyor Susan Weinhardt if she had visited any facility with recognized Covid-19 cases.  Surveyor Weinhardt answered “yes.”  As the form itself instructs (and the DON confirmed), the screener should then have contacted the facility administrator, DON, or designee to review the situation and determine whether to allow entry.  The screener did not follow those instructions.  Instead, she simply allowed the surveyor into the facility.  CMS Ex. 37 at 5; CMS Ex. 52 at 4 (Weinhardt Decl. ¶ 9).

The surveyors then reviewed other screening forms that were completed that morning.  Two individuals reported visiting facilities with confirmed Covid cases.  CMS Ex. 37 at 1, 5.  Four individuals reported working with Covid-confirmed residents.  CMS Ex. 37 at 2, 3, 4, 6.  At 12:15 p.m. that day, the DON confirmed that she was supposed to be notified of any “yes” answer to the screening questions and that she was on call “24/7.”  If she were not available, other managers acted as her back-up and should be called.  She

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also confirmed that no screener had contacted her that day.  CMS Ex. 28 at 24-25; CMS Ex. 36 at 1.

Petitioner has not challenged the truth of the DON’s statement, much less tendered evidence suggesting that a factual dispute exists as to whether, contrary to the facility’s policy, she was not consulted about the problematic answers to screening questions.  *See* *Matsushita Elec. Indus. Co. v. Zenith Radio Corp.*, 475 U.S. 574, 586 n.11; *Vandalia Park*, DAB No. 1939 (2004); *Lebanon Nursing & Rehab. Ctr.*, DAB No. 1918 (2004).  When statements are made by the facility’s own employees, and those individuals have not refuted them, they may constitute substantial evidence.  *See* *Beatrice State Development Ctr.*, DAB No. 2311 at 17, 18 (2010) (pointing out that the facility could have but did not present employee testimony that refuted the statements the surveyors claimed they made);*Omni Manor Nursing Home*, DAB No. 1920 at 11 (2004) (holding that statements of facility employees to the surveyors may be admitted in an administrative proceeding and may constitute substantial evidence); *Richardson v. Perales*, 402 U.S. 389, 410 (1971).

**No policy regarding isolation for residents potentially exposed to Covid while away from the facility**.  As noted above, facilities must have written policies dictating when and how it should isolate its residents.  42 C.F.R. § 483.80(a)(2)(iv).

CDC guidelines discuss new admissions or readmissions where the resident’s Covid status is unknown; a facility’s response may depend on the prevalence of Covid in the community.  CMS Ex. 24 at 6.  Petitioner here has suggested that Covid was prevalent in the community (P. Br. at 1), and it was, no doubt, prevalent at the dialysis center that treated some facility residents multiple times per week (see below).  The CDC guidelines recommend that someone who has been outside the facility, and whose Covid status is unknown, be placed in a single-person room or separate observation area so that the resident can be monitored.  Staff should wear PPE (N95 mask or respirator, eye protection, goggles, gloves, gown).  CMS Ex. 24 at 6-7.

Dr. Katz herself recognized the risks posed by sending dialysis patients out for treatment.  In a Morbidity and Mortality Weekly Report (MMWR) that she co-authored, she and her colleagues reported that residents leaving their rooms for dialysis “could be a potential source of SARS-CoV-2 introduction into the nursing home and might pose an unrecognized source of transmission.”  They urged “[b]etter monitoring and understanding of the risks associated with residents who regularly leave the facility for outpatient health care.”  P. Ex. 5 at 3.  “[E]arly identification of cases[,] coupled with aggressive infection prevention and control actions are needed to protect medically vulnerable populations” in nursing homes and dialysis centers.  *Id*. at 4.

The facility had recently experienced a devastating Covid outbreak and recognized that sending its residents out of the facility for medical treatment increased its risk of

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exposing residents to the virus.  To decrease that risk, the facility policies directed that elective procedures and appointments be cancelled “when clinically appropriate” and that the facility use telemedicine when possible.  CMS Ex. 30 at 14.

Not every resident could avoid leaving the facility, however.  At least three residents left the facility three times a week for dialysis.  CMS Ex. 18.  Such frequent exposure greatly increases the risk of a resident bringing the virus into the facility.  This was particularly so for the facility’s residents, who underwent renal dialysis multiple times per week at a dialysis center with a significant outbreak of Covid.  CMS Ex. 47 at 3 (reporting that two staff members and 14 patients tested positive for Covid in August 2020); *but compare* CMS Ex. 16 at 2, 3 (suggesting that the facility’s “line listing” underreported the extent of the outbreak at the dialysis center).  Notwithstanding these serious concerns, the facility had no policy to address what staff should do when its residents returned from outside medical treatment.  CMS Ex. 52 at 5 (Weinhardt Decl. ¶ 12).

The surveyors observed that residents who resided in two rooms on the Covid-negative wing had left the facility for medical treatment and returned.  Although on droplet precautions, these residents were cared for by the same staff that cared for the Covid-free residents, which is contrary to facility policy and CDC guidelines.  CMS Ex. 30 at 14-15, 18; CMS Ex. 40 at 2-3; CMS Ex. 44 at 2, 3.  The surveyors subsequently learned that another ten residents had been away for medical treatment and returned to the Covid-negative wing.  CMS Ex. 28 at 25; CMS Ex. 52 at 5 (Weinhardt Decl. ¶ 11).18

Responding to surveyor concerns, on October 22, 2020, the facility added an infection-control policy “[t]o manage the risk of potential exposure to Covid-19 secondary to external appointments.”  The policy called for quarantine and “transmission-based precautions” to protect facility residents from being exposed to Covid-19 during appointments outside the facility.  Staff were directed to:

place the resident on a 14-day quarantine in his/her room when the resident returns from outside appointments.  The quarantine includes droplet precautions;
	during quarantine, monitor the resident for signs and symptoms consistent with Covid-19;
	if, while in quarantine, a resident develops signs or symptoms of Covid-19, that resident is transferred to the PUI (person-under-investigation) unit;Page 23

Before the resident’s external appointment, the facility and the resident (or the resident’s power-of-attorney) will complete a “risk versus benefit” analysis.  Staff will explain the rationale for contact droplet isolation and quarantine following the appointment; and
	When possible, services should be provided via telehealth or with in-house options (e.g. x-rays) instead of by external appointments.CMS Ex. 30 at 6.

At the same time, the facility designated an “observation unit” so that those who left the facility for medical appointments could be cohorted together and monitored for signs and symptoms of Covid, separate from the Covid-free residents.  CMS Ex. 13 at 7; CMS Ex. 28 at 2; CMS Ex. 52 at 5-6 (Weinhardt Decl. ¶ 13).

**Inaccurate monthly infection surveillance reports**.  A facility must have in place a “system of surveillance” that is designed to identify communicable diseases or infections before they can spread.  42 C.F.R. § 483.80(a)(2)(i).  Here, the facility prepared “monthly infection surveillance reports” that purported to record the “total number of infections for the month reported on.”  Remarkably, notwithstanding the rampant spread of Covid within the facility during the months of August and September 2020, the facility reported just eight total infections in August (CMS Ex. 42 at 5) and ten total infections in September (CMS Ex. 42 at 2).  It omitted the Covid-19 cases.  CMS Ex. 42 at 2, 5.

After the surveyors questioned the accuracy of these reports, the facility amended them to add the Covid-19 infections.  CMS Ex. 50 at 9 (Mitchell Decl. ¶ 20).  For August, the amended version more accurately reflects *54 total infections*, 49 of which were developed in the facility.  CMS Ex. 42 at 4.  For September, the amended version reflects *35 total infections* for the month, all of which were developed within the facility.  CMS Ex. 42 at 1.

It is hard to fathom the purpose of an “infection surveillance report” that omits the single most infectious and deadly disease in the facility.  If not accurate, these reports are not merely useless, they are misleading and can lead to bad planning.  It is critical to have, in a centralized location, an accurate picture of the total number of infections, as well as how many of them were developed in-house.  If the information isn’t accurate, the facility may overlook patterns of infection or otherwise have a distorted picture of the outbreak, which can impair planning and response to the outbreaks.  CMS Ex. 50 at 9 (Mitchell Decl. ¶¶ 21, 22).

I do not think that gathering the raw infection data into a single report constitutes, as Petitioner claims, “make-work.”  P. Br. at 13.  Nor do I agree that the facility’s “line listing,” which lists covid-positive cases and provides other individualized information, is

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an adequate substitute for a report that pulls the information together in a way that enables reviewers to see patterns, and thus develop an effective response.  Moreover, having decided to use those reports, it was incumbent on the facility to ensure that they were accurate.

***3.   The facility was not in substantial compliance with 42 C.F.R. § 483.75(a) and (g) because:  when surveyors asked to see documentation of its quality assurance and performance improvement program (QAPI), facility staff refused (or were unable) to produce it; although a mandatory member of the QAPI committee, the facility’s medical director did not know when or if the committee met and did not attend meetings; and when, responding to CMS’s immediate jeopardy determination, the facility finally produced some documentation, CMS could not assess its compliance because the documents were so heavily redacted.***

**Program requirement:  42 C.F.R. § 483.75(a), (b) (Tag F865)**.  The facility must develop, implement, and maintain an effective, comprehensive, data-driven QAPI program that focuses on indicators of the outcome of care and quality of life.  It must document and “demonstrate evidence” that its QAPI program meets the regulatory requirements, including, but not limited to, “systems and reports demonstrating systematic identification, reporting, investigation, analysis, and prevention of adverse events,” as well as documentation demonstrating that it developed, implemented, and evaluated corrective actions or performance improvement activities.  42 C.F.R. § 483.75(a)(1).  Upon request by the state agency, federal surveyor, or CMS, *the facility must present documentation and evidence that it has implemented an ongoing QAPI program*.  42 C.F.R. § 483.75(a)(4).

The QAPI program must be ongoing, comprehensive, and must address the full range of care and services provided by the facility.  It must:  1) address all systems of care and management practices; 2) include clinical care, quality of life, and resident choice; 3) use the best available evidence to define and measure indicators of quality and facility goals that reflect processes of care and facility operations that have been shown to be predictive of desired outcomes for facility residents; and 4) reflect the complexities, unique care, and services that the facility provides.  42 C.F.R. § 483.75(b).

**Program requirement:  42 C.F.R. § 483.75(g) (Tag F867)**.  The facility must maintain a quality assessment and assurance committee that reports to the facility’s governing body.  At a minimum, the committee must include:  the DON; *the Medical Director* or designee; at least three other members, including the administrator, owner, a board member, or other individual in a leadership role; and the infection preventionist.  The committee must meet at least quarterly and as needed to coordinate and evaluate activities under the he facility’s QAPI program.  Among other duties, it must identify issues “with respect to which quality assessment and assurance activities . . . are

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necessary.”  The committee must “develop and implement appropriate plans of action to correct identified quality deficiencies.”

**Facility policy:  QAPI**.  Consistent with the regulation, the facility had in place a policy requiring it to develop a QAPI program setting forth the process for conducting QAPI activities, such as “identifying and correcting quality deficiencies as well as opportunities for improvement.”  The program would include the facility’s “systems and reports demonstrating systemic identification, reporting, investigation, analysis, and prevention of adverse events.”  It would document the “development, implementation, and evaluation of corrective actions or performance improvements.”  CMS Ex. 30 at 1.

Under the policy, the governing body and/or executive leadership is responsible and accountable for the process that addresses systems of clinical care, management practices, quality of life, and resident choice.  It provides resourcing, equipment, and technical training, as needed.  The policy requires “documentation and evidence of [the facility’s] ongoing QAPI program’s implementation” that meets federal, state, and CMS regulations.  CMS Ex. 30 at 1.

The policy requires the facility to submit its QAPI plan to the state survey agency annually, and at each annual recertification survey and *upon request during any other survey*, as well as when requested by CMS.  CMS Ex. 30 at 1.

**Facility disregard of QAPI requirements**.  Surveyors were at the facility from October 20 through 23.  They repeatedly asked facility management (including the administrator) for evidence of the facility’s QAPI plan.  They asked what QAPI activities the facility undertook in response to the Covid outbreak, what it had learned from the outbreak, and what the facility would do to prevent a future outbreak.  Facility staff refused to produce the documentation, claiming that staff had to consult the facility’s attorneys or corporate staff.  The facility administrator claimed that the facility’s QAPI activities were confidential and would not be shared with the survey team.  CMS Ex. 28 at 5-6, 16-17; CMS Ex. 54 at 4 (LeTourneur Decl. ¶ 9); *see* CMS Ex. 36 at 13 (responding to questions about the facility’s plan or strategy to address a potential outbreak, the medical director claimed, “That is confidential.  That is QAPI.”); CMS Ex. 39 at 11 (Surveyor:  “You’re telling us it’s there, but we don’t know if it’s there because we can’t see it.  Administrator:  “Yes, that’s correct.”).

Surveyors interviewed the facility’s medical director on October 26, 2020, asking him whether the facility held QAPI meetings during the Covid outbreak.  He did not claim that the facility held those meetings or that he (a mandatory member of the committee) attended any.  He said that he mostly spoke to the DON and, occasionally, the Administrator.  According to the medical director, no minutes documented those discussions, and no new policies were implemented.  CMS Ex. 28 at 17; CMS Ex. 54 at 3, 4-5 (LeTourneur Decl. ¶¶ 6, 10).  The medical director confirmed that the facility had

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not done a retrospective review of the outbreak to identify opportunities for improvement.  CMS Ex. 28 at 17.  Neither the facility administrator nor its medical director have denied making these statements.  *See* *Beatrice State Development Ctr.*, DAB No. 2311 at 17, 18 (pointing out that the facility could have but did not present employee testimony that refuted the statements the surveyors claimed they made);*Omni Manor Nursing Home*, DAB No. 1920 at 11 (holding that statements of facility employees to the surveyors may be admitted in an administrative proceeding and may constitute substantial evidence); *Richardson v. Perales*, 402 U.S. 389, 410.

Petitioner nevertheless characterizes as “inflammatory (but inaccurate)” CMS’s assertion that the facility refused to provide requested information about the facility’s QAPI program.  P. Br. at 15.  I don’t understand why this completely accurate assertion is any more “inflammatory” than the other extremely serious allegations of substantial noncompliance.  In any event, as Petitioner concedes, facility staff *refused* to turn over QAPI documentation.  Petitioner defends this refusal by claiming that the facility “had a good faith belief that the surveyors were not entitled to that information under controlling legal authorities and, indeed, should not have asked for the information in the first place.”  P. Br. at 15.

It seems inconceivable that the facility’s leadership were unaware of the explicit and unambiguous requirement of the regulations and the facility’s own policy.  42 C.F.R. § 483.75(a)(4) (requiring the facility to present documentation and evidence that it has implemented an ongoing QAPI program); CMS Ex. 30 at 1 (requiring the facility to submit its QAPI plan upon request during any survey).  There is, of course, a second explanation for the facility’s unwillingness to produce the documentation:  it didn’t have it.  In either case, the facility’s unwillingness or inability to produce the documentation put it out of substantial compliance with section 483.75(a).
After the surveyors left the facility and determined that its deficiencies continued to pose immediate jeopardy, the facility submitted some QAPI-related materials.  CMS Ex. 54 at 5 (LeTourneur Decl. ¶ 11).  For the most part, whatever QAPI plans the facility produced  are so heavily redacted that it is impossible to review whether they comply with the regulations.  *See* CMS Ex. 34 at 23-53.

The materials that are not redacted present problems.  They include a “Performance Improvement Plan Summary,” which, on its face, indicates that it was submitted on October 29, 2020 “in response to the Removal Plan for Immediate Jeopardy.”  CMS Ex. 34 at 8-9.  CMS received the documentation on October 30.  CMS Ex. 34 at 1-5; CMS Ex. 54 at 5 (LeTourneur Decl. ¶ 11).  The summary omits a lot of critical information.  First, it does not indicate, and Petitioner does not say, who prepared the summary and when it was prepared.  It does not identify the “participants in analysis and plan,” except

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by title:  “NHA, DON, Nurses, Infection Preventionist,19 CNAs, Maintenance, Environmental Services, Social Services, Dietary.”  Significantly, and contrary to the regulatory requirement, the facility’s medical director is not listed as a participant.  CMS Ex. 34 at 8.

The “summary” does not mention the initial outbreak among the maintenance workers or the facility’s response to it.  Instead, it suggests that the facility was Covid-free until August 25, 2020, when its first residents tested positive.  CMS Ex. 34 at 9.  The summary congratulates staff for setting up a Covid unit and suggests that Covid-positive residents were cohorted there “within the completion of the same shift.”  CMS Ex. 34 at 9.  But the summary does not discuss the delays in quarantining Resident M (after she was exposed to the disease, after she exhibited symptoms, and even after she tested positive).  Nor does it address any of the other problems with the facility’s Covid response:  inadequate screening; absence of contact tracing; delays in implementing droplet precautions; staff’s improper hand hygiene and improper use of PPE; and failing to develop a policy for residents exposed to Covid while away from the facility.  CMS Ex. 34 at 8-9.

Petitioner also submits what purports to be (heavily redacted) minutes from “ad hoc” QAPI meetings held on September 20, 22, and 24, 2020.  CMS Ex. 34 at 19-53.  The facility’s medical director was conspicuously absent from all of these meetings.  CMS Ex. 34 at 21, 23, 26, 29.

Petitioner concedes that, as late as October 2020, the facility had not performed a retrospective review of the outbreak.  Petitioner characterizes as “odd” CMS’s suggestion that, based on its findings, it should have done so to identify which of the facility’s infection control efforts were working and which weren’t working and made necessary adjustments.  P. Br. at 19.  In fact, this type of review is mandated by the QAPI regulation.  42 C.F.R. § 483.75(d).

The outbreak had subsided by late September, which, in Petitioner’s view, shows that the facility had evaluated what was working and made necessary adjustments. P. Br. at 19-20.  I reject this inference.  By late September, the vast majority of facility residents had contracted the disease (71 out of 87) and a third of them had died (27).  There just weren’t that many residents left to get sick.

***4.   The facility was not in substantial compliance with 42 C.F.R. § 483.70 because the facility management did not implement an effective QAPI program, for which the governing body is accountable, and no evidence***

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***establishes that the governing body met or that it established and implemented policies regarding the management of the facility during the Covid outbreak.***

**Program requirement:  42 C.F.R. § 483.70 (Tag F835)**.  The facility must be administered in a manner that enables it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident.

**Program requirement:  42 C.F.R. § 483.70(d) (Tag F837)**.  The facility must have a governing body, or designated persons functioning as a governing body, that is legally responsible for establishing and implementing policies regarding the management and operation of the facility.  The governing body appoints the facility’s administrator.  The administrator is responsible for managing the facility and reports to and is accountable to the governing body.  The governing body is “responsible and accountable” for the QAPI program.

**Substantial noncompliance under section 483.70 can be based on other deficiency findings**.  As discussed below, I find that the facility’s deficiencies posed immediate jeopardy to resident health and safety, which, *by itself*, justifies the finding that the facility was not in substantial compliance with 42 C.F.R. § 483.70.  It is settled that a finding of substantial noncompliance in the facility’s administration may derive from findings of substantial noncompliance in other areas.

[W]here a facility has been shown to be so out of compliance with program requirements that its residents have been placed in immediate jeopardy, the facility was not administered in a manner that used its resources effectively to attain the highest practicable physical, mental, and psychosocial well-being of each resident.

*Asbury Ctr. at Johnson City*, DAB No. 1815 at 11; *Lopatcong Ctr*., DAB No. 2443 at 13 (2012) (reiterating the Board’s long-standing determination that where a deficiency finding under section [then 483.75, now 483.70] derives from other findings, “i.e., was based on the surveyors’ identification of other deficient practices,” those separately identified deficiencies “may constitute a prima facie case that a facility has not been administered efficiently or effectively as required by section 483.75.”) (quoting *Odd Fellow and Rebekah Health Care Facility*, DAB No. 1839 at 7 (2002)); *see also* *Stone Cnty. Nursing and Rehab. Ctr*., DAB No. 2276 at 15-16 (2009).

**Administrative failings**.  Although I may find substantial noncompliance with section 483.70 based solely on the facility’s other deficiencies, many of the facility’s failures

Page 29

were directly attributable to its administration, which was, after all, ultimately responsible for the facility’s response to the Covid outbreak.

As set forth above, the facility failed to implement a QAPI program that complied with regulatory requirements and the facility’s own policy.  For this failing, the governing body is accountable.

Moreover, the facility’s administrator and its medical director were remarkably ill-informed of their responsibilities and the basic corporate structure.  Although the governing body purportedly appointed him, and he “reports to and is accountable to the governing body,” the administrator did not know who comprised that body.  In an October 23, 2020 interview with the administrator and the regional vice president for the facility’s parent company, the regional vice president admitted that the administrator, who had been in his position since April, had not attended a meeting of the governing body.  The Administrator confirmed, telling the surveyors, “We haven’t had a governing body meeting since I’ve been here.  I don’t know . . . the set time for the governing body meeting.”  CMS Ex. 39 at 11; CMS Ex. 51 at 5 (Baroza Decl. ¶ 12); *see* CMS Ex. 39 at 1; 42 C.F.R. § 483.70(d)(2)(iii).

The administrator conjectured that the Hawaii Health Systems Corporation was the governing body, which was incorrect.  CMS Ex. 39 at 1.  The facility’s medical director thought that the Systems Corporation’s regional board (on which he sat) oversaw the facility’s management.  It did not.  CMS Ex. 39 at 3 (“Not sure what you mean [by] governing body.  My understanding is the facility is part of the Hawaii State Hospital Board.”); CMS Ex. 39 at 20 (Per Hospital Board representative:  “We are not involved in their operational decisions.  Oversight is largely confined to determining if the vendor [the parent company] is meeting the terms of its contract.”); *see* CMS Ex. 54 at 3 (LeTourneur Decl. ¶ 5).

To date, the facility has not identified the members of its governing body nor provided evidence that it meets or otherwise “establishes and implements policies” regarding the “management and operation of the facility.”  CMS Ex. 51 at 6-7 (Baroza Decl. ¶¶ 12, 13); *See* 42 C.F.R. § 483.70(d)(1).

***5.   The facility was not in substantial compliance with 42 C.F.R. § 483.70(i) because it did not maintain complete and accurate medical records for Resident 1 (R1).***

**Program requirement:  42 C.F.R. § 483.70(i)(1)**.  Among the requirements for effective and efficient administration, the facility must, in accordance with acceptable professional standards and practices, maintain medical records on each resident that are complete, accurately documented, readily accessible, and systematically organized.  Each medical record must contain:  sufficient information to identify the resident; a record of

Page 30

the resident’s assessments; the resident’s comprehensive care plan and services provided; the results of any preadmission screening and review evaluations and determinations conducted by the state; the physician’s, nurse’s, and other licensed professional’s progress notes; and laboratory, radiology, and other diagnostic services reports.

R1 was a 72-year-old man, initially admitted to the facility on April 29, 2016.  CMS Ex. 41 at 1.  He suffered from a long list of impairments, including end stage renal disease, an unspecified intestinal obstruction, type 2 diabetes with diabetic autonomic polyneuropathy, heart failure, and anemia.  CMS Ex. 41 at 2.  On August 25, 2020, he began suffering from diarrhea and his physician prescribed Imodium A-D.  CMS Ex. 41 at 11.  He cancelled his dialysis appointment because of it.  CMS Ex. 51 at 6 (Baroza Decl. ¶¶ 16, 17).  His diarrhea continued, and on August 27, he was tested for Covid.  On August 28, the test came back positive.  CMS Ex. 16 at 2; CMS Ex. 41 at 6.

In the meantime, although his diarrhea had not resolved, on August 27, the facility sent R1 to the dialysis center for treatment.  CMS Ex. 41 at 7.  They sent with him a medical record, titled “Pre-Dialysis Assessment & Communication,” which was the means by which the facility communicated with the dialysis center about resident care issues and conditions.  CMS Ex. 41 at 12-15; CMS Ex. 51 at 7 (Baroza Decl. ¶ 19); *see* CMS Ex. 30 at 11 (facility policy requiring “ongoing communication between the facility and the dialysis center reflected in the medical record.”)  The document does not mention his diarrhea or his new prescription for Imodium A-D.  The form directs the facility to note any changes in the resident’s condition since his last dialysis.  Facility staff indicated “None.”  CMS Ex. 41 at 12 (¶ 13d).

This omission could have had serious consequences for R1.  Diarrhea causes fluid loss and loss of potassium, an important electrolyte needed for conducting electrical impulses to the heart.  Uncorrected low blood potassium can cause an irregular heart rate, chest pain, and cardiac arrest.  Had his diarrhea been reported, the dialysis nurse would have assessed R1 for low potassium and dehydration, which would include a blood test.  The nurse could correct a low potassium level while he received his dialysis treatment.

Because the record sent to the dialysis center omitted this significant condition, the facility was not in substantial compliance with section 483.70(i)(1).

***6.   The undisputed evidence establishes that CMS’s determination that the facility’s deficiencies posed immediate jeopardy to resident health and safety is not clearly erroneous.***

**Immediate jeopardy**.  Immediate jeopardy exists if a facility’s noncompliance has caused or is likely to cause “serious injury, harm, impairment, or death to a resident.”  42 C.F.R. § 488.301.  CMS’s determination as to the level of a facility’s noncompliance (which would include an immediate jeopardy finding) must be upheld unless it is “clearly

Page 31

erroneous.”  42 C.F.R. § 498.60(c).  The Board has observed repeatedly that the “clearly erroneous” standard imposes on facilities a “heavy burden” to show no immediate jeopardy and has sustained determinations of immediate jeopardy where CMS presented evidence “from which ‘[o]ne could reasonably conclude’ that immediate jeopardy exists.”  *Barbourville Nursing Home*, DAB No. 1931 at 27-28 (2004) (citing*Koester Pavilion*, DAB No. 1750 (2000)); *Daughters of Miriam Ctr.*, DAB No. 2067 at 7, 9 (2007).

Petitioner asserts that CMS has not shown “actual causation between the alleged deficiencies and any actual patient harm for purposes of an immediate jeopardy finding.”  P. Br. at 22.  Petitioner reverses the relative burdens for assessing immediate jeopardy and misstates the standard for determining whether a facility’s deficiencies pose immediate jeopardy.

Once CMS presents evidence supporting a finding of substantial noncompliance, it need not offer evidence to support its immediate jeopardy determination.  The burden is on the *facility* to show that CMS’s determination is clearly erroneous.  *Grace Healthcare of Benton*, DAB No. 2189 at 13 (2008) (citing *Liberty Commons Nursing & Rehab Ctr. – Johnston*, DAB No. 2031 at 17-18, *aff’d*, *Liberty Commons Nursing & Rehab Ctr. – Johnston v. Leavitt*, 241 F. App’x 76 (4th Cir. 2007)).  The harm or threatened harm is presumed to be serious, and the facility has the burden of establishing that the harm or threatened harm “did not meet any reasonable definition of ‘serious.’”  *Maysville Nursing and Rehab.*, DAB No. 2874 at 21 (2018) (quoting *Libertywood Nursing Ctr*., DAB No. 2433 at 18 (2011), *aff’d*,*Libertywood Nursing Ctr. v. Sebelius*, 512 Fed. App’x 285 (4th Cir. 2013)).

With respect to the standard for determining whether immediate jeopardy exists, I need not find that the facility’s noncompliance caused actual harm or injury to a resident.  So long as the deficiencies are *likely* to cause serious injury or harm, they pose immediate jeopardy.  42 C.F.R. § 488.301.

Dr. Katz asserts that “these nursing homes were in crisis, without adequate resources,” so should not be held to account for what she characterizes as “technical issues of little importance.”  P. Ex. 1 at 4 (Katz Decl. ¶ 6).  The regulations, including those cited in this case, are hardly “technical issues of little importance.”  They were developed by health care professionals to protect resident health and safety.  But even assuming that Dr. Katz has articulated a valid basis for disregarding those regulatory requirements (which I am not free to do), nothing in this record establishes that this particular facility lacked adequate resources.  The evidence does not establish that the facility was experiencing staffing shortages, and it never had a shortage of PPE.  CMS Ex. 47 at 3.

Moreover, I reject the premise that the facility was exempt from following its own policies because Covid was new, and much was unknown about how to combat it.  If I accepted that

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position, I would have to conclude that the infection control regulation does not apply in cases involving one of the most infectious and deadly diseases of modern day.  I don’t have the authority to disregard a regulation, and, even if I did, I do not believe that basic infection control procedures have no value in containing Covid infections.

I recognize that much was unknown about Covid-19 in the early days of the pandemic.  However, *much was known about which practices would exacerbate its spread (or that of any other infectious disease) within an institution*.  At a minimum, facilities were required to follow the basic infection control guidelines that were incorporated into its written policies.

Further, failing to follow infection control policies during the outbreak of an infectious disease is likely to cause serious harm to facility residents.  In *Golden Living Ctr. – Superior*, for example, the Board concluded that it was not erroneous for CMS to determine that the facility’s failure to implement – fully and promptly – influenza control precautions posed immediate jeopardy to resident health and safety.  DAB No. 2768 at 25-26.  There, the facility had failed to implement the infection control protocols specifically designed and intended to contain an outbreak of influenza, a contagious virus known to cause substantial illness and even death to many long-term-care residents.  The Board observed that the facility’s own experience established that the likelihood of serious harm to residents from the spread of the disease was neither hypothetical nor insubstantial.  Five residents contracted the disease within a two-week period.  Here, the facility’s experience even more dramatically establishes that the “likelihood of serious harm to residents from the spread of the disease was neither hypothetical nor insubstantial.”

Because Covid is so infectious and because nursing home residents are so vulnerable, keeping the virus out of the facility was critically important.  For that reason, CDC guidelines and the facility’s policy mandated that the facility screen all visitors for known exposure and to restrict anyone with known exposure from entering the facility.  CMS Ex. 20 at 2; CMS Ex. 24 at 4.  Yet, the facility used inadequate screening tools.  Even after the facility revised those tools, its screeners disregarded the answers given and, without the necessary clearance, allowed individuals to enter even though they had been exposed to the virus.  Because of its lax screening procedures, an infected person was likely to enter the facility, exposing vulnerable residents to the virus.

Indeed, a maintenance worker, with suspicious symptoms was allowed into the facility and remained there for about five hours, exposing his colleagues and others to the virus.  CMS Ex. 1 at 8; CMS Ex. 16 at 7.  Although a second maintenance worker went home that day, a third worker, who had been in close contact, was allowed to remain at work throughout that day and the following day.  A resident remained in the non-Covid unit after she had been exposed to the disease, after she presented symptoms of the disease, and even after she tested positive.

Page 33

The facility also failed to perform contact tracing, a “fundamental” activity employed by public health personnel to prevent the spread of an infectious disease.  It did not implement droplet precautions for a resident with a low-grade fever and low oxygen saturation levels, both symptoms of Covid.  Health care personnel failed to follow basic infection control guidelines for hand hygiene and use of PPE.  Any one of these deficiencies is likely to cause serious harm or death to facility residents.

Because the facility’s deficiencies were likely to cause serious harm, CMS’s determination that those deficiencies posed immediate jeopardy to resident health and safety is not clearly erroneous.

***7.   The penalties imposed – $7,460 and $11,825 per day for the periods of immediate jeopardy and $435 per day for the period of substantial noncompliance that did not pose immediate jeopardy – are reasonable.***

Petitioner challenges CMS’s authority to impose the penalties, arguing that its findings are not based on any “express directives in the relevant CMS or CDC guidance,” but are penalties based on the surveyors’ unique and *ad hoc* interpretations of which the facility was not given proper notice.  P. Br. at 24.  As the above discussion shows, this is simply not so.  The facility is subject to penalties because it plainly violated CMS regulations, CDC guidelines, and its own policies.

To determine whether a civil money penalty is reasonable, I apply the factors listed in 42 C.F.R. § 488.438(f):  (1) the facility’s history of noncompliance; (2) the facility’s financial condition; (3) factors specified in 42 C.F.R. § 488.404; and (4) the facility’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort or safety.  The absence of culpability is not a mitigating factor.  The factors in 42 C.F.R. § 488.404 include:  (1) the scope and severity of the deficiency; (2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and (3) the facility’s prior history of noncompliance in general and specifically with reference to the cited deficiencies.

I consider whether the evidence supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found, and in light of the section 488.438(f) factors.  I am neither bound to defer to CMS’s factual assertions nor free to make a wholly independent choice of remedies without regard for CMS’s discretion.  *Barn Hill Care Ctr.*, DAB No. 1848 at 21 (2002); *Cmty. Nursing Home*, DAB No. 1807 at 22 *et seq*. (2002); *Emerald Oaks*, DAB No. 1800 at 9 (2001); *CarePlex of Silver Spring*, DAB No. 1638 at 8 (1999).

I determine whether a penalty is reasonable based on the per-day penalty, not the total accrued penalty.  *Crawford Healthcare and Rehab.*, DAB No. 2738 at 20 (2016).

Page 34

Penalties are inflation-adjusted and change annually.  The amount is determined as of the date the penalty is assessed, in this case, February 21, 2021.  CMS Ex. 48 at 1-6; 85 Fed. Reg. 2869, 2880 (Jan. 17, 2020).  Here, CMS imposed penalties of $7,460 per day for the initial period of immediate jeopardy, which it raised to $11,825 per day after the facility failed to correct its immediate jeopardy deficiencies and bring itself into substantial compliance.  These amounts are in the very low and middle of the penalty range for situations of immediate jeopardy ($6,808 to $22,320).  CMS imposed a penalty of $435 per day for the period of substantial noncompliance that did not pose immediate jeopardy, which is at the very low end of the range ($112 to $6,695).  42 C.F.R. §§ 488.408(e), 488.438; 45 C.F.R. § 102.3; 85 Fed. Reg. 2869, 2880 (Jan. 17, 2020).

Considering the relevant factors, these amounts are reasonable.

The facility has a less-than stellar compliance history.  For the recertification survey immediately preceding these surveys, completed on October 4, 2019, it had multiple deficiencies, the most serious cited at scope and severity level F, which means widespread noncompliance.  Of particular importance, it was not in substantial compliance with the infection control regulation, 42 C.F.R. § 483.80 (Tag F880).  CMS Ex. 4 at 3.

A year earlier, for the survey completed in October 2018, the facility was not in substantial compliance with several requirements.  The most serious violated the quality-of-care regulation and posed immediate jeopardy to resident health and safety.  The facility also had a deficiency regarding medical records.  CMS Ex. 4 at 3.

Because the facility did not bring itself into substantial compliance following the October 16 survey, CMS justifiably raised the amount of the penalty until it corrected its immediate jeopardy deficiencies.
Petitioner does not claim that it is unable to pay the penalty.

With respect to the remaining factors, I have discussed in detail the facility’s widespread deficiencies and its disregard for its own written policies.  For this, the facility is culpable, and the penalty is reasonable.

Conclusion

From September 9, 2020, through January 5, 2021, the facility was not in substantial compliance with Medicare program requirements, and, from September 9 through November 3, 2020, its deficiencies posed immediate jeopardy to resident health and safety.

Page 35

The penalties imposed are reasonable.

Endnotes

1 Deciding a case based on the written record does not mean that it is decided without a hearing.  In reviewing administrative appeals, courts recognize that, by considering the evidence and applying the law, the ALJ has granted the petitioner a hearing, even if that hearing was not an “oral” or “evidentiary” hearing.  *See* *CNG Transmission Corp. v. FERC*, 40 F.3d 1289, 1293 (D.C. Cir. 1994) (holding that a “paper hearing” satisfies statutory requirements for “notice and opportunity for hearing.”).

2 My findings of fact/conclusions of law are set forth, in italics and bold, in the discussion captions of this decision.

3 Section 483.70(e) mandates that the facility conduct and document a facility-wide assessment to determine what resources are necessary to care for its residents competently during both day-to-day operations and emergencies.

4 The Board’s decisions in *Golden Living* and *Heritage House* are consistent with a long line of quality-of-care cases holding that CMS “may reasonably rely on a facility’s policy relating to the care and treatment of its residents as evidencing the facility’s understanding of what must be done to attain or maintain residents’ highest practicable physical, mental, and psychosocial well-being, as required by [42 C.F.R.] section 483.25.”  *Green Valley Healthcare and Rehab. Ctr.*, DAB No. 2947 at 6 (2019) (citing *The Laurels at Forest Glenn*, DAB No. 2182 at 18 (2008)); *North Las Vegas Care Ctr.*, DAB No. 2946 at 6 (2019); *Hanover Hills Health Care Ctr.*, DAB No. 2507 at 6 (2013) (observing that “the Board has long held that a facility’s own policy may be sufficient evidence . . . of what the facility has determined is needed to meet the quality-of-care requirements in section 483.25.”).

5 Since the time periods relevant to these cases, the regulation was redesignated from 42 C.F.R. § 483.65 to 42 C.F.R. § 483.80.  81 Fed. Reg. 68688 (Oct. 4, 2016).

6 “Cohorting” refers to grouping individuals with the same condition in the same location (room, wing, building).  For Covid purposes, this means keeping residents who are Covid-positive or suspected of having Covid in the same space (wing, floor, etc.), separate from those who are Covid-negative or haven’t been exposed to Covid.  “Cohorting is imperative to increase the [chance] of controlling the spread of the virus.”  CMS Ex. 44 at 1.

7 The evidence is ambiguous as to the exact number of staff members who tested positive for the disease.  On the one hand, the facility’s list of Covid-positive staff members includes 32 names.  On the other hand, unlike the other entries on that list, one entry does not indicate that the person, a nurse aide who was tested on August 31, 2020, tested positive.  CMS Ex. 16 at 7.

8 Petitioner sets up a strawman by repeatedly claiming that CMS bases its findings of noncompliance “solely on the outcome at the Facility from the COVID-19 outbreak.”  P. Br. at 9; P. Cl. Br. at 4.  This is simply not so.  CMS explicitly rejected that notion and, instead, focused on specific instances in which staff failed to implement the facility’s infection control policies and failed to follow CDC guidelines.

9 Petitioner does not support its contention that its experience was “typical” for nursing homes.  While most nursing homes may have had outbreaks, the facility’s statistics – more than 80% of the residents contracted the disease, and one-third of the residents died from it – seem extreme.  Moreover, CMS points to some interesting data showing that, at the time Covid invaded the facility, the community infection rate was low, leading the Hawaii Emergency Management Agency to find it “unlikely” that the facility’s outbreak could be attributed to community-acquired Covid.  CMS Cl. Br. at 4-5 (citing CMS Ex. 47 at 8).

10 That the surveyors observed any unsafe infection-control practices suggests that the facility had significant problems.  The surveyors were in the facility for a limited time; staff knew that they were observing and assessing facility compliance with the CDC’s infection control guidelines.  Presumably, staff would have wanted to make the best possible impression.  That the survey team observed any infractions indicates that staff did not understand what was required of them.

11 Petitioner suggests that the widespread prevalence of Covid in nursing homes shows that outbreaks were inevitable but does not seem to recognize any potential connection between the widespread use of deficient screening tools (as well as other infection-control deficiencies) and the facilities’ Covid outbreaks.  *See* P. Br. at 1.

12 The facility’s DON claims that, in June 2020, a state survey team determined that the facility’s forms were fully compliant.  P. Ex. 9 at 5-6 (Walters Decl. ¶ 9).  She does not specify which version of the screening tool the surveyors then reviewed.  In any event, I am reviewing the conditions in the facility from September 9, 2020, through January 5, 2021.  I am not reviewing surveyor performance during earlier surveys.  That surveyors may have overlooked deficiencies does not relieve the facility of its obligation to meet all program requirements and does not invalidate adequately documented deficiencies.  *See* 42 C.F.R. § 488.318.

13 As discussed below, MS2 worked closely and ate lunch with two other maintenance employees, MS1 and MS3, who subsequently tested positive for Covid.

14 The DON served as the interim Infection Preventionist from early September 2020 until early December 2020, while the facility’s regular Infection Preventionist was on maternity leave.  P. Ex. 9 at 3 (Walters Decl. ¶ 5).

15 On September 11, 2020, the Veterans Administration sent seven medical and health care experts to visit the facility.  At that time, ten residents had died from Covid and another 35 had tested positive.  In their September 21, 2020 report, the VA cites as deficiencies:  that residents were not cohorted based on Covid status; that residents used masks inconsistently; that housekeeping and maintenance staff intermixed between units; that the facility had done little proactive preparation; and that there were numerous examples of potential infection from cross-contamination.  CMS Ex. 47 at 1-2.

16 Inasmuch as the facility kept logs of the maintenance workers’ assignments (see CMS Ex. 15), at a minimum, it could have discovered and followed up with those residents and staff who were exposed to the workers when they were presumed to be infectious.

17 Normal O2 levels are 95% to 100%.  CMS Ex. 50 at 7.  R4’s condition subsequently deteriorated until September 2, when he died.  CMS Ex.16 at 1.

18 The CDC has described a “high risk” of unrecognized infection among facility residents. “A substantial proportion of residents could have Covid-19 without reporting symptoms or before symptoms develop.”  CMS Ex. 24 at 12.

19 The facility’s “Infection Preventionist” was away from the facility from early September until early December.  During that time, the DON acted as interim Infection Preventionist.  P. Ex. 9 at 3 (Walters Decl. ¶ 5).  Petitioner’s submissions do not indicate which Infection Preventionist participated in the planning.
  
          /s/
        Carolyn Cozad Hughes

                      Administrative Law Judge Back to top
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