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                              Riverside Nursing and Rehabilitation, DAB CR6098 (2022)
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Riverside Nursing and Rehabilitation, DAB CR6098 (2022)








  
  
    

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





Riverside Nursing and Rehabilitation,
(CCN: 676246),
Petitioner,

v.

Centers for Medicare & Medicaid Services.
Docket No. C-21-62Decision No. CR6098June 10, 2022

        
              
    

      DECISION

Petitioner, Riverside Nursing and Rehabilitation, is a long-term-care facility, located in Austin, Texas, that participates in the Medicare program.  This case involves two surveys of that facility.  The first survey focused on its response to Covid-19.  I consider whether it implemented its policies, followed resident care plans, and imposed basic measures necessary to protect residents from the infectious disease and to care for them when they contracted it.  The second survey was a follow-up, to determine whether the facility had corrected its deficiencies and returned to substantial compliance.  In reviewing those survey findings, I consider whether the facility adequately investigated an allegation of neglect, as well as whether the facility had, by then, achieved substantial compliance with infection control requirements.

Following these surveys, completed on June 10, 2020, and September 9, 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 $15,930 per day for 25 days of immediate

Page 2

jeopardy and $225 per day for 132 days of substantial noncompliance that did not pose immediate jeopardy.

Petitioner appealed.

For the reasons set forth below, I find that, from April 10 through September 13, 2020, the facility was not in substantial compliance with Medicare program requirements; that, from April 10 through May 4, 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).

**The surveys**.  This case involves two surveys, completed June 10, 2020, and September 9, 2020.

On April 10, 2020, surveyors from the Texas Health and Human Services Commission (state agency) began a Covid-19 Focused Infection Control Survey, combined with complaint and incident investigations.1
  They completed the survey

Page 3

on **June 10, 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 L (widespread substantial noncompliance that poses immediate jeopardy to resident health and safety).CMS Exs. 1, 2; *see* CMS Ex. 11 at 1 (Hernandez Decl. ¶ 4).

Surveyors returned to the facility and completed a follow-up investigation on **September 9, 2020**.  Based on those survey findings, CMS determined that the facility was not in substantial compliance with:

42 C.F.R. § 483.12(c)(2)-(4) (Tag F610 – freedom from abuse, neglect, and exploitation), cited at scope and severity level D (isolated instance of substantial noncompliance that causes no actual harm, with the potential for more than minimal harm); 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 E (pattern of substantial noncompliance that causes no actual harm, with the potential for more than minimal harm).CMS Exs. 1, 6.

Thereafter, CMS determined that the facility returned to substantial compliance on September 14, 2020.  CMS Ex. 1 at 6.

Based on the deficiencies cited, CMS has imposed against the facility penalties of $15,930 per day for 25 days of substantial noncompliance that posed immediate jeopardy to resident health and safety (April 10 through May 4, 2020) and $225 per day for 132 days of substantial noncompliance that  did not pose immediate jeopardy (May 5 through September 13, 2020).  (Total $398,250 + $29,700 = $427,950).  CMS Ex. 1 at 6; CMS MSJ at 3; P. Resp. at 3.

Page 4

Petitioner appealed each survey separately and, on December 14, 2020, I consolidated the appeals.  E-file entry # 5.

With its pre-hearing brief (CMS Br.), CMS submitted 13 exhibits (CMS Exs. 1-13).  With its pre-hearing brief (P. Br.), Petitioner submitted two exhibits (P. Exs. 1-2).  In the absence of any objections, I admit into evidence CMS Exs. 1-13 and P. Exs. 1-2.  CMS has moved for summary judgment (CMS MSJ), which Petitioner opposes (P. Resp.).

In its initial submissions, Petitioner listed Dr. Liam M. Fry as a witness but, contrary to my standing order, did not submit her written declaration.  Absent a showing of good cause, she would therefore not be allowed to testify.  Responding to CMS’s motion for summary judgment, Petitioner submitted, for the first time, Dr. Fry’s written declaration (P. Ex. 3).  Petitioner has not asked leave to submit the new exhibit nor explained why it could not have been submitted earlier, in compliance with my standing order.  I therefore decline to admit P. Ex. 3.  *See HeartFlow, Inc.*, DAB No. 2781 at 16-18 (2017) (finding that Petitioner’s rights were not violated, where it had the opportunity to present witness testimony and to ask to cross-examine opposing witnesses but failed to do so); *accord,* *Nancy L. Clark*, DAB No. 2989 at 6 (2020), citing *Lena Lasher, aka Lena Contang, aka Lena Congtang*, DAB No. 2800 at 4 (2017), *aff’d,. Lasher v. U.S. Dept. of HHS*, 2019 WL 1382961 (D.D.C. Mar. 27, 2019).2

**Decision on the written record**.  My standing 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 (¶ 4(c)(4)) (October 21, 2020).  The order also directed each party to indicate whether it wanted to cross-examine the opposing party’s witnesses.  Acknowledgment 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.  Acknowledgment at 5 (¶ 10).

CMS withdrew its request to cross-examine Petitioner’s witnesses.  Respondent’s Withdrawal of Its Request to Cross-examine (E-file entry # 15) (Mar. 22, 2022).

Page 5

Petitioner has not asked to cross-examine CMS’s witnesses.3
  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, citing *Vandalia Park*, DAB No. 1940 at 28-29 (2004), *aff’d, Vandalia Park v. Leavitt*, 157 F. App’x 858 (6th Cir. 2005).4

Issues

The issues are:

From April 10 through September 13, 2020, was the facility in substantial compliance with Medicare program requirements;
	If, from April 10 through May 4, 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 – $15,930 per day for 25 days of immediate jeopardy and $225 per day for 132 days of substantial noncompliance that did not pose immediate jeopardy – reasonable?Page 6

Discussion

**The June 2020 Survey**

***The facility was not in substantial compliance with 42 C.F.R. § 483.80(a) because, contrary to facility policies and at least one resident care plan, the facility failed to identify the rooms of residents who were Covid-positive or symptomatic (and awaiting test results); it failed to indicate the precautions, including personal protective equipment (PPE), required for entering resident rooms; the door to a Covid-positive resident’s room remained open; and symptomatic residents were not isolated.5*****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:

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;6Page 7

written standards, policies, and procedures for the program, which must include:
	a system of surveillance designed to identify possible communicable diseases or infections before they can spread to other persons in the facility;
		when and to whom possible incidents of communicable disease or other infections should be reported;
		standard and transmission-based precautions to be followed to prevent spread of infections;
		when and how isolation should be used for a resident, including:
		the type and duration of the isolation, depending upon the infectious agent or organism involved, and
			a requirement that the isolation should be the least restrictive possible for the resident under the circumstances.
		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
		the hand hygiene procedures to be followed by staff involved in direct resident contact.* * * *

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.

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

**Facility policies:  Covid prevention**.  Although the record includes a three-sentence document titled “Infection Prevention and Control Program,” the document is very general and could not satisfy the requirements of section 483.80(a).  It refers to the infection prevention and control program as “a facility-

Page 8

wide effort involving all disciplines and individuals.”  It says that the program consists of “coordination/oversight, policies/procedures, surveillance, data analysis, antibiotic stewardship, outbreak management, prevention of infection, and employee health and safety.”  The program is coordinated and overseen by an “infection prevention specialist.”  CMS Ex. 9 at 4.

The facility had in place a more specific Covid-19 emergency plan, titled “Prevent the Spread of Respiratory Germs within Your Facility.”  According to the plan, the facility would “[p]rovide the right supplies to ensure easy and correct use of PPE.”  The plan also instructed staff to *post signs*on the door or wall outside a resident room that “clearly describe the type of precaution needed and required PPE.”  CMS Ex. 2 at 7; CMS Ex. 11 at 5 (Hernandez Decl. ¶ 19).7

A section of the emergency plan directed staff to “implement mechanism and policies that *promote situation awareness* for facility staff, including infection control, healthcare epidemiology, facility leadership, occupational health, clinical laboratory, and frontline staff *about known or suspected Covid-19 patient* and facility plans for response.”  CMS Ex. 2 at 9 (emphasis added).  More specifically, the plan directed staff to:

Isolate symptomatic patients as soon as possible;
	Set up separate, well-ventilated triage areas;
	Place patient with suspected or confirmed Covid-19 in private rooms with door closed and private bathroom (as possible).CMS Ex. 2 at 12; CMS Ex. 11 at 7, 10 (Hernandez Decl. ¶ 30, 46).

The facility’s Assistant Director of Nursing (ADON) was the designated “Infection Control Preventionist.”  In an interview, conducted at 2:44 p.m. on April 21, she told Surveyor Jacqueline Hernandez that “everyone must wear a mask,” and, after

Page 9

the first case was detected in the facility, they did so.  She also said that any resident waiting for the results of a Covid-19 test should be treated as positive, on droplet precautions, with signage posted on the resident room door.  CMS Ex. 3 at 70-71; CMS Ex. 11 at 4-5 (Hernandez Decl. ¶¶ 18).  Notably, she did not suggest that the facility lacked PPE and was therefore unable to comply with its infection control policies.  *See* *Beatrice State Developmental Ctr.*, DAB No. 2311 at 17-18 (2010) (pointing out that the facility could have but did not present employee testimony to refute 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).

Droplet precautions are imposed when respiratory droplets contain viruses or bacteria particles that may be spread to another susceptible individual.  Respiratory viruses can enter the body by way of the nasal mucosa (mucous membrane that lines the nasal cavity), conjunctivae (mucous membrane in the eye), and, less frequently, the mouth.  Pneumonia, influenza, and other respiratory viruses spread infections by means of respiratory droplets.  Ideally, a resident on droplet precautions would be placed in a private room.  If a private room is not available, the resident should be cohorted with a resident with the same infection or someone with limited risk factors.  CMS Ex. 11 at 4-5 (Hernandez Decl. ¶ 18).

**Resident 1 (R1)**.  R1 was a 47-year-old man, initially admitted to the facility on January 29, 2020, following a month-long hospitalization, and readmitted on February 20, 2020, following a second hospitalization.  He had a history of traumatic brain injury and suffered from aphasia, hemiplegia, acute kidney failure, and other disorders.  CMS Ex. 3 at 18.  On April 6, 2020, he tested positive for Covid.  According to a nurse’s note, he had no signs or symptoms of the disease.  The facility moved him to a resident room on the isolation hall (100 hall) under isolation precautions.  CMS Ex. 3 at 19, 25, 27; CMS Ex. 11 at 2, 3 (Hernandez Decl. ¶¶ 6, 9).

**R1’s care plan**.  R1’s care plan was amended to reflect his Covid diagnosis.  Among other interventions, his plan required that he remain in a private room or cohort with another Covid-positive resident.  Staff were required to follow the facility’s protocols for Covid-19, *keep the resident’s door closed whenever possible*, and encourage the resident to wear a mask when staff were providing care.  The plan instructed staff to “educate and encourage use of respiratory etiquette and frequent hand hygiene.”  *Contact/droplet precautions were in place*.  CMS Ex. 3 at 17, 20; CMS Ex. 11 at 2 (Hernandez Decl. ¶ 7).

**Absence of signs and other instructions**.  The 100 hall was designated as the isolation hall.  At 1:14 p.m. on April 10, 2020, Surveyor Hernandez observed that,

Page 10

contrary to the facility’s policies, no signs had been posted on or near the door of Covid-infected R1’s room, nor near the doors of R2 and R21, symptomatic residents whose Covid test results were pending.  CMS Ex. 3 at 4; CMS Ex. 11 at 3 (Hernandez Decl. ¶¶ 9, 10).

When the surveyors returned to the facility on April 20, 2020, additional residents, including R3, R4, R5, R7, R8, R9, R10, R11, R12, and R13, were symptomatic and awaiting the results of their Covid tests.  CMS Ex. 11 at 3 (Hernandez Decl. ¶ 11); *see* CMS Ex. 3 at 65-66.  Yet, there were no signs on their doors, and no PPE was provided for their rooms.  CMS Ex. 3 at 68; CMS Ex. 11 at 3 (Hernandez Decl. ¶ 12).  The following morning (10:00 a.m.), no signs were on the doors, and PPE was not provided.  CMS Ex. 2 at 68-69; CMS Ex. 11 at 3, 5 (Hernandez Decl. ¶¶ 13, 20, 21).

DON Brannock and the ADON/Infection Control Preventionist explained to the surveyors that the DON verbally notified staff which residents were Covid-positive or had test results pending, so, according to them, all staff should be aware of the resident status.  CMS Ex. 3 at 69-71; CMS Ex. 11 at 7 (Hernandez Decl. ¶ 29).

But all staff were not aware of resident Covid status.  Multiple staff members (two nurse aides, a licensed vocational nurse (LVN), a transportation staff member, and a housekeeper) admitted to the surveyors that they did not know which residents had Covid tests pending.  CMS Ex. 2 at 7-8; CMS Ex. 3 at 67-68; CMS Ex. 11 at 6 (Hernandez Decl. ¶¶ 24, 25).  A medication aide, sent from a sister facility, told them that no one told him who was Covid-positive, who had Covid tests pending, or where these residents were located.  CMS Ex. 3 at 70; CMS Ex. 11 at 6 (Hernandez Decl. ¶ 28).  One nurse aide and a laundry aide inaccurately assumed that all symptomatic and Covid-positive residents were in the 100 hall (see discussion below).  CMS Ex. 2 at 8; CMS Ex. 11 at 6 (Hernandez Decl. ¶ 26).

On April 20, the surveyors observed the facility’s Activity Director in R3’s room, painting the resident’s nails.  The resident was symptomatic, and her Covid test results were pending.  The resident was not wearing a face mask.  No sign was on her door, and nothing indicated that she was on droplet precautions.  CMS Ex. 3 at 68; CMS Ex. 11 at 6 (Hernandez Decl. ¶ 23).

At 3:56 p.m. on April 20, a member of the facility’s transportation staff went into the rooms of R11 and R12, residents who had Covid symptoms and were awaiting their test results.  No signs were on their doors.  The staff member was not wearing PPE.  She told the surveyors that she did not know which residents were waiting for their Covid test results.  CMS Ex. 3 at 68; CMS Ex. 11 at 3-4 (Hernandez Decl. ¶¶ 14, 15).

Page 11

**Failure to isolate symptomatic residents**.  As noted above, facility policies required staff to isolate symptomatic residents as soon as possible, to set up separate, well-ventilated triage areas, and to place residents with suspected or confirmed Covid in private rooms with the door closed.  CMS Ex. 2 at 12.

But, contrary to the facility’s policy, symptomatic residents awaiting the results of their Covid tests, were not isolated; they were scattered throughout the facility.  As of April 20, two (R7 and R8) were in the isolation hall (100 hall).  Three (R4, R5, and R9) were in the 200 hall.  Four (R3, R11, R12, and R13) were in the 300 hall.  Two (R76 and R87) were in the 400 hall.  CMS Ex. 2 at 7; CMS Ex. 3 at 66-67.

Even more problematic, residents with symptoms were tested for Covid, but their asymptomatic roommates were not.  CMS Ex. 3 at 66; CMS Ex. 11 at 10 (Hernandez Decl. ¶ 45).  Seven of these symptomatic residents shared rooms with residents who were not symptomatic and had not been tested:  R3 shared with R22; R4 shared with R16; R5 shared with R19; R9 shared with R20; R11 shared with R17; R13 shared with R23; R76 shared with R75; and R87 shared with R86.  CMS Ex. 2 at 7; CMS Ex. 3 at 66; CMS Ex. 11 at 5, 8 (Hernandez Decl. ¶¶ 20, 21, 34).

**R3 and R22**.  A progress note dated April 15, 2020, indicates that R3 then had diarrhea, which is a symptom of Covid.  The resident was tested for Covid on April 17.  According to another note, dated April 22, the resident’s temperature was elevated (99.7° F) and appetite was poor.  A May 7, 2020 progress note, entered by the nurse practitioner, confirms that R3 tested positive for Covid on April 30 and was moved to the Covid unit.  CMS Ex. 2 at 11; CMS Ex. 11 at 9 (Hernandez Decl. ¶ 42).Until April 30, R3 continued to share a room with R22, who had no symptoms.  On April 29, R22 tested negative for Covid, but, the following day, the resident presented with symptoms of fever, diarrhea, and myalgia.  R22 tested positive on May 1.  CMS Ex. 2 at 11-12; CMS Ex. 11 at 9 (Hernandez Decl. ⁋⁋ 41, 43).

**R5 and R19**.  A progress note dated April 15, 2020, indicates that R5 had Covid symptoms.  The resident was tested on April 17.  Her test results were positive, although the record does not indicate when those test results came back.  In the meantime, she remained housed in the same room with R19.  CMS Ex. 2 at 10; CMS Ex. 11 at 8 (Hernandez Decl. ¶¶ 34, 35).
	R19 was an 89-year-old woman, admitted to the facility on February 12, 2013, with diagnoses of severe, persistent asthma, congestive heart failure, and atrial fibrillation – conditions that greatly increased her risk of severe illness if she were to contract Covid.  CMS Ex. 11 at 8 (Hernandez Decl.Page 12

¶ 36). A respiratory note, dated April 30 (about two weeks after her roommate became symptomatic and was tested), reflects that R19’s breath sounds were clear; she had no shortness of breath, no cough, and no congestion. However, by May 3, 2020, she had tested positive for Covid. CMS Ex. 2 at 10; CMS Ex. 11 at 8 (Hernandez Decl. ¶ 37).

**R11 and R17**.  A nursing note, dated April 15, 2020, indicates that R11 had diarrhea.  The resident was tested on April 17.  Again, the record does not indicate when the test results came back, but the resident tested positive for Covid.  Nevertheless, R11 remained in the same room with R17.  CMS Ex. 2 at 10-11; CMS Ex. 11 at 9 (Hernandez Decl. ¶ 39).On April 21, R17 developed a cough, fever, and diarrhea.The resident was tested, and, by April 27, was confirmed positive for Covid.CMS Ex. 2 at 11; CMS Ex. 11 at 9 (Hernandez Decl. ¶ 40).

**Petitioner’s defense:  guidelines were useless**.  Petitioner admits that facility staff did not follow the facility’s written policies but defends these failures, arguing, fatalistically, that the interventions called for were useless, and, in any event, they were simply too difficult to implement.

Dr. Fry opines that the “vast majority” of Covid-prevention guidelines were essentially a waste of time, and she criticizes the state agency for expecting the facility to follow them.  P. Ex. 1 at 7.

I find it irresponsible of the state to arrogantly claim that a building who [sic] does not seem to be doing what the surveyor – in his or her “expert” opinion – thinks is the right plan of action, to then say a building has put all of his/her [sic] residents into immediate jeopardy.

P. Ex. 1 at 7.  But Dr. Fry is simply incorrect when she suggests that the surveyors (or even the state) dictated the “plan of action.”  The policies that the facility was not following were *the facility’s own policies*, presumably adopted by its governing body and, presumably, they were policies that the governing body determined the facility could and should implement.  *See* 42 C.F.R. § 483.70(d).

The infection-control regulation requires that the facility have in place infection control policies and that it implement those policies.  If it does not implement its policies, it violates section 483.80(a).  *Golden Living Ctr. – Superior*, DAB No. 2768 at 7 (2017); *Heritage House of Marshall Health & Rehabilitation Ctr*., DAB No. 2566 at 13 (2014).  Thus, where a facility’s medical director opted not to follow the facility policy to prescribe prophylactic medications, the Departmental

Page 13

Appeals Board found that the facility violated the infection control regulation.  *Golden Living*, DAB No. 2768 at 7.  Where, contrary to its policies, a facility failed to post a sign at the entrance to an infected resident’s room with instructions for those entering the room, the Board held that the facility did not comply with the infection control regulation.  *Heritage House*, DAB No. 2566 at 13.

The Board’s conclusions in *Golden Living* and *Heritage House* are consistent with a long line of decisions 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 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.”).

It is also well-settled that a resident’s care plan represents the facility’s judgment about what care and services are needed to keep the resident safe.  If facility staff fail to provide care and services in accordance with the resident’s comprehensive assessment and plan of care, it violates section 483.25.  *White Sulphur Springs Ctr.*, DAB No. 2520 at 7 (2013); *Deltona Health Care*, DAB No. 2511 at 7-8 (2013); *Venetian Gardens*, DAB No. 2286 at 5 (2009).

Because I find that the facility failed to follow its own infection-control policies as well as R1’s post-Covid care plan, I find that the facility was not in substantial compliance with section 483.80(a).

**Petitioner’s defense:  “uncharted territory.”**  Petitioner (and Dr. Fry) complain that, in April 2020, Covid-19 was “unchartered territory.”  Guidance was “continuously changing” and no clear guidelines existed on how to manage the virus.  P. Br. at 11.  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 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

Page 14

minimum, facilities were required to follow the basic infection control guidelines that were incorporated into its written policies.

**Petitioner’s defense:  separating symptomatic residents from their asymptomatic roommates was a waste of time**.  Petitioner speculates that separating roommates when one tests positive was pointless because the untested and asymptomatic roommate was probably positive as well.  P. Br. at 9.

Of course, it was possible that a Covid-infected resident’s asymptomatic roommate was also infected, but, as the facility’s isolation policy recognized, it was by no means certain.  However, leaving an asymptomatic resident closely confined with someone who is infected all but guarantees that an uninfected resident will become infected.

According to Petitioner, it was simply not possible to isolate Covid-positive residents.  P. Br. at 9-10.  If that were true, and the facility was incapable of complying with its policies, it was required to revisit those policies and develop something that was workable.  Moreover, even assuming the facility could not isolate every Covid-symptomatic resident, it should, at a minimum, have separated Covid-symptomatic residents (such as R5) from its most vulnerable residents – those with multiple risk factors for bad outcomes should they contract the disease (like R19, a very old woman suffering from significant respiratory conditions).

**Petitioner’s defense:  every resident treated as Covid-positive**.  Petitioner also argues that the facility was not required to post signs or otherwise follow its policies because the facility treated *every resident* as if he or she were suspected of suffering from Covid.

In other words, all patients in the building were being treated with droplet precautions.  All staff had on masks, face shields, and were using separate gowns as much as the supply shortages would allow.  There was no need to place signs on specific doors indicating that droplet precautions were needed for a specific resident, because the facility’s policy at the time was to treat *everyone* with droplet precautions.

P. Br. at 8-9, 13, quoting P. Ex. 2 at 2 (Brannock Decl.) (emphasis in the original).

I reject this defense for several reasons.  First, this so-called “policy” was not written, and the regulation requires “written standards, policies, and procedures.”  42 C.F.R. § 483.80(a)(2).

Page 15

Second, during the time of the survey, no one from the facility suggested to the survey team that the facility’s policy was to treat every resident the same, without regard to Covid status.  In fact, as noted above, DON Brannock and the ADON excused the absence of signage on resident doors by claiming that the DON verbally notified staff which residents were Covid-positive or had test results pending, an explanation that is not wholly consistent with the claim that staff did not need to know a resident’s Covid status.  CMS Ex. 3 at 69, 71; CMS Ex. 11 at 7 (Hernandez Decl. ¶ 29).  In his written testimony, DON Brannock does not deny making those remarks.  *See* P. Ex. 2.

Finally, I recognize that some of the facility’s training materials require all staff members to wear masks at all times in the building and require that residents wear masks when interacting with staff.  P. Ex. 1 at 26.  According to training notes, a gown should be placed inside every room (apparently to be shared by staff).  Staff were to wear the gown when interacting with the resident.  P. Ex. 1 at 27.  But this does not mean that the facility treated “every single resident” as if he or she were suspected of suffering from Covid.  In fact, PPE was not provided or worn in all cases (even with symptomatic residents).  CMS Ex. 2 at 6; CMS Ex. 3 at 68; CMS Ex. 11 at 3 (Hernandez Decl. ¶¶ 9, 10, 12).  Surveyors observed the Activity Director painting the nails of an unmasked, symptomatic resident.  CMS Ex. 3 at 68; CMS Ex. 11 at 6 (Hernandez Decl. ¶ 23).  A transportation staff member entered the rooms of symptomatic resident without wearing PPE.  CMS Ex. 3 at 68; CMS Ex. 11 at 3-4 (Hernandez Decl. ¶¶ 14, 15).8

**Petitioner’s defense:  training.**  Petitioner also maintains that it adequately trained its staff on such issues as handwashing, Covid symptoms, transmission via droplets, mask and gown usage.  P. Br. at 7.  According to Petitioner, “[t]here is no indication [in the Statement of Deficiencies] that this training was ineffective or inadequate.”  P. Br at 13.  To the contrary, as discussed above, the undisputed evidence shows that staff were not taking the appropriate precautions, which indicates that the training was ineffective.

Page 16

Petitioner acknowledges that its transportation aide did not know that all residents were on droplet precautions but argues that the facility should not be held accountable because “the aide had been trained and, despite that, was not following the [f]acility procedure.”  P. Br. at 8.  The Board has repeatedly rejected this argument.  It is well-settled that a facility “cannot disavow responsibility for the actions of its employees,” through which it acts.  *Springhill Senior Residence*, DAB No. 2513 at 14 (2013); *Sunshine Haven Lordsburg*, DAB No. 2456 at 16-17 (2012), *aff’d in part sub nom. Sunshine Haven Nursing Operations, LLC v. U.S. Dep’t of Health & Human Servs*, 742 F.3d 1239 (10th Cir. 2014); *Gateway Nursing Ctr*., DAB No. 2283 at 8 (2009); *Emerald Oaks*, DAB No. 1800 at 7 n.3 (2001); *N.C. State Veterans Home, Salisbury*, DAB No. 2256 (2009).

***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 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. 1962 at 11 (2005), (citing *Florence Park Care Center*, DAB No. 1931 at 27-28 (2004), citing*Koester Pavilion*, DAB No. 1750 (2000)); *aff’d*, *Barbourville Nursing Home v. U.S. Dep’t of Health and Human Servs.*, 174 F. App’x 932 (6th Cir. 2006); *Daughters of Miriam Center*, DAB No. 2067 at 7, 9 (2007).

Petitioner asserts that “[t]here is no evidence to support CMS’s finding of Immediate Jeopardy.”  P. Br. at 15.  Not only is this assertion factually incorrect, it reverses the relative burdens.  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 Center – Johnston*, DAB No. 2031 at 17-18 (2006), *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.’”

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*Maysville Nursing and Rehabilitation*, DAB No. 2874 at 21 (2018), quoting *Libertywood Nursing Ctr*., DAB No. 2433 at 18 (2011), *aff’d, Libertywood Nursing Ctr. v. Sebelius*, 512 F. App’x 285 (4th Cir. 2013).

In attacking the immediate jeopardy finding, Petitioner repeats its arguments that the facility was justified in failing to implement its Covid policies, but otherwise presents nothing to establish that the immediate jeopardy determination is clearly erroneous.  *See* P. Br. at 14-15.9

Petitioner suggests that I disregard the survey findings because the surveyors were not experts in infectious diseases, and their experience was limited.  P. Br. at 15; P. Resp. at 11.  But, as I’ve already discussed at some length, the survey findings were not based on surveyor opinions; they were based on surveyor observations.  The facility’s professionals determined what practices should be in place to address infection control.  If those practices were not suitable, the fault rests with the facility.  Significantly, Petitioner has not challenged the surveyor observations that the written policies were not implemented.

Petitioner also repeats its assertion that no one had really studied how to halt the spread of Covid-19 within a nursing facility.  P. Br. at 15.  As I also discussed above, even in the early days of the pandemic, 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 basic infection control guidelines, such as those included in the facility’s written policies. 
Because the disease was so infectious and because nursing home residents were so vulnerable, failing to follow basic infection control guidelines was likely to cause serious harm or death to residents.

In *Golden Living Ctr. – Superior*, 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

Page 18

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 too the facility’s experience establishes that the “likelihood of serious harm to residents from the spread of the disease was neither hypothetical nor insubstantial”:

On April 10, the facility reported that three residents (R1, R14, and R15) tested positive for Covid-19.  Two residents (R21 and R24) were awaiting the results of their tests.  CMS Ex. 3 at 33; CMS Ex. 11 at 7 (Hernandez Decl. ¶ 31).
	By April 30, the number of Covid-positive residents had risen to 38.  Five of the 38 had died and 22 remained in the facility.  CMS Ex. 2 at 10; CMS Ex. 11 at 7 (Hernandez Decl. ¶ 32).
	As of May 6, 44 residents had tested positive and 14 of them had died.  CMS Ex. 2 at 10; CMS Ex. 11 at 7 (Hernandez Decl. ¶ 33).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.

***CMS’s determinations as to the duration of the facility’s immediate jeopardy and substantial noncompliance are consistent with statutory and regulatory requirements, and I have no authority to review the timing of the revisit survey.***Once a facility has been found to be out of substantial compliance, as the facility was here, it remains so until it affirmatively demonstrates that it has achieved substantial compliance once again.  *Ridgecrest Healthcare Ctr.*, DAB No. 2493 at 2-3 (2013); *Taos Living Ctr.*, DAB No. 2293 at 20 (2009); *Premier Living & 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 is back in compliance, not on CMS to prove that deficiencies continued to exist.  *Asbury Ctr. at Johnson City*, DAB No. 1815 at 19-20 (2002).

The facility must show that the incidents of noncompliance have ceased *and* that it has implemented appropriate measures to ensure that similar incidents will not recur.  *Libertywood Nursing Ctr.*, DAB No. 2433 at 15, citing*Life Care Ctr. of*

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*Elizabethton*, DAB No. 2367 at 16 (2011); *accord*, 42 C.F.R. § 488.454(a) and (e); *Hermina Traeye Memorial Nursing Home*, DAB No. 1810 at 12 (2002) (holding that, to be found in substantial compliance earlier than the date of the resurvey, the facility must supply documentation “acceptable to CMS” showing that it was in substantial compliance and *was capable of remaining in substantial compliance* on the earlier date); *Cross Creek Health Care Center*, DAB No. 1665 (1998).  A facility’s return to substantial compliance usually must be established *through a resurvey*.  42 C.F.R. § 488.454(a); *Ridgecrest* at 2-3.

Here, surveyors returned to the facility, completing the resurvey on September 9.  Petitioner complains that “[s]urveyors waited wholly 92 days to return to the [f]acility after the June 10, 2020 survey in order to assess compliance.”  According to Petitioner, the facility achieved compliance earlier but the surveyors “have no idea when the facility returned to compliance, because they failed to return to the building in a timely manner.”  P. Resp. at 12-13.  Even if I agreed that the survey was impermissibly delayed (which I do not), I have no authority to review the timing of the surveys.  *See* 42 C.F.R. § 498.3(b).

In any event, Petitioner’s complaint rings hollow given that the facility was not in substantial compliance at the time of the September resurvey.  Those survey findings established that the facility’s substantial noncompliance with section 483.80(a)(1) continued.  They also established that the facility had not adequately investigated an allegation of neglect, which put the facility out of substantial compliance with section 483.12(c).10

**The September 2020 Survey**

***The facility was not in substantial compliance with 42 C.F.R. § 483.12(c)(2)-(4) because facility staff did not thoroughly investigate an allegation of neglect.*****Program requirement:  42 C.F.R. § 483.12(c)(2)-(4) (Tag F610)**.  “Neglect” is the failure of the facility, its employees, or service providers to provide a resident with the goods and services necessary to avoid his suffering physical harm, pain, mental anguish, or emotional distress.  42 C.F.R. §§ 483.5, 488.301.

Page 20

A facility resident has the right to be free from abuse, neglect, and exploitation.  42 C.F.R. § 483.12.  The allegations of abuse or neglect must be reported to the facility administrator and other officials (including the state agency) “immediately.”  In cases that do not involve abuse or result in serious bodily injury, this means not later than 24 hours after the allegation is made.  42 C.F.R. § 483.12(c)(1).  The facility must have evidence that all alleged violations are *thoroughly investigated*, and it must *prevent further potential abuse while the investigation is in progress*.  42 C.F.R. § 483.12(c)(2), (3).  The results of all investigations must be reported to the administrator (or designated representative) and to the appropriate state officials within five working days of the incident.  If the violation is verified, the facility must take appropriate action.  42 C.F.R. § 483.12(c)(2), (3), and (4).

**Facility policy:  Abuse/neglect prevention program**.  The facility had in place a policy, dated September 2018, that addressed preventing abuse and neglect.  Consistent with the regulation, it requires that *all reports of alleged abuse or neglect* be “promptly and thoroughly investigated by facility management.”  The policy directs the facility administrator or designee to appoint a member of management to investigate the incident.  At a minimum, the investigator must:  review the resident’s medical record to determine the events leading up to the alleged incident; *interview the person reporting the incident*; interview any witnesses; *interview the resident as medically appropriate*; interview the resident’s attending physician as needed to determine the resident’s cognitive function and medical condition; interview staff members on all shifts who had contact with the resident during the time of the incident; interview the resident’s roommate, family members, and visitors; interview other residents with whom the individual provides care or services; and review all events leading up to the alleged incident.  CMS Ex. 6 at 7-8; CMS Ex. 9 at 17.

**The facility’s substantial noncompliance**.  In an on-line review, a resident’s sister complained that the resident was refused care for four hours.  She alleged that the facility’s “physical therapist” (in fact, she was complaining about the occupational therapist) told the resident to stand up to transfer, which she was unable to do.  The therapist purportedly then threw a brief on to her bed and told her to change herself.  The therapist would not allow a nurse aide to change her, and a second aide refused, according to the complaint.  The sister also wrote that she had attempted to call the facility to complain but was unable to get through.  CMS Ex. 10 at 9.

According to the facility’s report to the state agency, the incident occurred on September 7, 2020.  The report does not indicate the specific time (“undetermined afternoon time”).  CMS Ex. 8 at 11.

Page 21

Surveyors interviewed the resident on September 9 at 3:01 p.m.  She was a 67-year-old woman suffering from a fractured patella (kneecap) and other disorders.  CMS Ex. 8 at 4, 14, 16-17.  She told the survey team that, when she asked to be changed, the occupational therapist threw a pair of pampers at her and “said a lot of cruel things.”  CMS Ex. 10 at 3.  As of the date of the survey, the facility had not thoroughly investigated the allegation or reported it to the state agency.

The facility administrator told surveyors that he did not read the sister’s review but learned of the complaint from his marketing person.  He spoke to the occupational therapist, who wrote a “little summary” of the incident.  Contrary to facility policy, he did not interview the resident or the resident’s sister.  CMS Ex. 10 at 3-4; *see* CMS Ex. 9 at 6-7.

**Petitioner’s defense:  investigation not warranted**.  Petitioner asserts that the administrator did not believe that the online review “constituted an allegation of abuse/neglect such that a full blown investigation was warranted.”  Nevertheless, according to Petitioner, he investigated the allegation, “including, reviewing the Google review, interviewing the [occupational therapist], obtaining a written statement from the [occupational therapist], and assigning someone different . . . to care for the resident at issue.”  P. Br. at 16.11

Both section 483.12(c) and the facility’s policies broadly define the types of allegations that must be reported and investigated.  *All* alleged violations must be “thoroughly investigated.”  42 C.F.R. § 483.12(c)(2); CMS Ex. 6 at 7.  The pertinent question is not whether any abuse or neglect occurred or whether the facility had reasonable cause to believe that it occurred, but whether there is an allegation that facility staff abused or neglected a resident.  *Britthaven, Inc. d/b/a Britthaven of Smithfield*, DAB No. 2018 at 15 (2006), citing*Cedar View Good Samaritan*, DAB No. 1897 at 11 (2003).12

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The Board has repeatedly and soundly rejected any suggestion that the *facility*gets to determine when and whether to investigate a suspected violation.  The requirement to investigate thoroughly is triggered by *any allegation* of mistreatment, neglect, or abuse, *whether or not it is recognized as such by the facility*.  *Beverly Healthcare Lumberton v. Leavitt*, 338 F. App’x 307, 313 (4th Cir. 2009) (agreeing that the facility’s failure to implement its policies for reporting and investigating abuse “indicated a wider systemic problem in the facility” that leaves its residents “at real risk for serious harm.”); *Rockcastle Health & Rehab. Ctr.*, DAB No. 2891 at 11 (2018).  By failing to investigate the allegation, the facility is not ensuring that its residents are free from abuse and neglect.  *See, e.g*., *Century Care of Crystal Coast*, DAB No. 2076 at 25 (2007) (concluding that, where an incident went unreported and uninvestigated, the facility could not even identify, much less correct, the flaws in its systems).  Thus, regardless of whether the facility’s administration could confirm that any neglect occurred, it was bound to investigate.

Because the facility did not adequately investigate an allegation of neglect, it was not in substantial compliance with 42 C.F.R. § 483.12(c).13

***The facility’s substantial noncompliance with section 483.80(a) (Tag F880) continued because, contrary to facility policies, facility staff did not follow proper hand hygiene procedures, disregarded instructions that they don PPE, and engaged in other unhygienic practices.*****Facility policy:  hand hygiene**.  The facility policy characterizes hand hygiene as “the primary means to prevent the spread of infections.”  Among other instructions, the policy directs staff to wash hands with soap after contact with a resident with infectious diarrhea including, but not limited to, infections caused by norovirus, salmonella, shigella, and C. difficile.  CMS Ex. 9 at 1.  The policy also lists situations in which staff must use an alcohol-based hand rub or soap and water, including:

Page 23

before and after direct contact with residents;
	before performing any non-surgical invasive procedures;
	*before donning sterile gloves*;
	before handling clean or soiled dressings, gauze pads, etc.;
	before moving from a contaminated body site to a clean body site during resident care;
	after contact with a resident’s intact skin;
	after contact with blood or bodily fluids;
	after handling used dressings, contaminated equipment, etc.;
	after contact with objects in the immediate vicinity of the resident;
	*after removing gloves*; and
	before and after isolation precaution settings.CMS Ex. 9 at 1.

The policy describes hand hygiene as “the final step after removing and disposing of personal protective equipment.”  According to the policy, “Integration of glove use along with routine hand hygiene is recognized as the best practice for preventing healthcare-associated infections.”  CMS Ex. 9 at 2.

The policy mandates that single-use disposable gloves be used:

before aseptic procedures;
	when anticipating contact with blood or body fluids; and
	*when in contact with a resident or the equipment or environment of a resident who is on contact precautions*.CMS Ex. 9 at 2.

The policy describes, in some detail, the procedure for washing hands.  Staff are required to vigorously lather hands with soap and rub them together, creating friction to all surfaces, *for a minimum of 20 seconds (or longer)* under a moderate stream of running water, at a comfortable temperature.  Rinse thoroughly.  Dry hands with paper towels and then *turn off faucets with a clean, dry paper towel*.  Discard towels into the trash.  CMS Ex. 9 at 2.

The policy also describes procedures for applying and removing gloves.

*Perform hand hygiene before applying nonsterile gloves;*
	When applying, remove one glove from the dispensing box at a time, touching only the top of the cuff;Page 24

When removing gloves, pinch the glove at the wrist and peel away from the hand, turning the glove inside out ;
	Hold the removed glove in gloved hand and remove other glove by rolling it down the hand and folding it into the first glove; and
	*Perform hand hygiene*.CMS Ex. 9 at 3.

**Inadequate hand hygiene**.  The surveyors observed multiple instances in which staff did not following proper hand hygiene techniques.

**The first set of violations**.  At 10:25 a.m. on September 9, for example, they observed an LVN perform wound care for an abscess on a resident’s sacrum.  The resident was a 54-year-old woman suffering type two diabetes and cellulitis of the buttock.  She had a cutaneous abscess on her back and open wounds on her lower back and pelvis.  CMS Ex. 6 at 12.  Signage on her door indicted that hers was a “contact droplet isolation room.”  CMS Ex. 6 at 13.

The LVN donned an isolation gown with sleeves but pushed the sleeves up, exposing the bare skin on her forearms.
	After completing the first stage of wound care, the LVN doffed her soiled gloves and donned a new pair, *without performing any hand hygiene*.
	After completing the second stage of wound care (cleaning the wound, applying collagen powder, applying a clean bandage), the LVN asked another staff member to retrieve a felt-tipped permanent marker and mark directly on the bandage, which adhered to the resident’s wound.  The absorbent felt tip came into contact with the resident.
	The LVN doffed her gloves and washed her hands with soap in the resident’s sink for *five seconds*.  She turned off the water *bare-handed*, retrieved a paper towel, and dried her hands.CMS Ex. 10 at 10; *see* CMS Ex. 6 at 13.

**The second set of violations**.  At 1:23 p.m. on September 9, the surveyors observed a second LVN enter a room that had the following sign on the door:

Page 25

COVID-RECOVERED RESIDENTS
REQUIRED PPE:

[PICTURE OF A MASK]  [PICTURE OF GLOVES]

# 1:  N-95 MASK              # 2:  CLEAN GLOVES

CMS Ex. 10 at 5.  Notwithstanding the sign, the LVN entered the room without wearing gloves.  CMS Ex. 6 at 14.

**The third set of violations**.  The facility’s written policy for incontinent care included a checklist.  Among other instructions, it required staff to wash hands:

upon entering the room;
	before performing peri care;
	if hands are heavily soiled, wash hands with soap and water between glove changes, otherwise use hand gel;
	after cleaning the resident and before touching clean linens;
	after peri care is completed and before leaving the room; and
	**ANY TIME** you are unsure if you touched something dirty.CMS Ex. 9 at 5.

At 2:52 p.m. on September 9, surveyors observed a nurse aide entering a resident room to provide peri care.  The room had a droplet isolation sign on the door, indicating that gown, gloves, mask, and face shield were required upon entry.  A plastic cart containing PPE was near the door.  CMS Ex. 10 at 10.  Yet, the nurse aide entered the room without donning PPE.  CMS Ex. 6 at 15; CMS Ex. 10 at 10.

The nurse aide subsequently donned PPE (at about 3:00 p.m.) but she did not perform hand hygiene before doing so.  CMS Ex. 6 at 15; CMS Ex. 10 at 11.  While providing the care, the nurse aide did the following:

She pulled cleansing wipes from the package while still wearing soiled gloves;
	She placed the soiled brief at the foot of the resident’s bed without placing a barrier between the soiled brief and the resident’s linens;Page 26

She put a clean brief on the resident and placed the package of wipes in the resident’s drawer without changing gloves or performing hand hygiene; and
	She put the soiled brief in the trash can at the door.CMS Ex. 6 at 16; CMS Ex. 10 at 11.

**Petitioner’s defense:  training**.  Petitioner does not deny that staff failed to follow infection control protocols, notably for hand hygiene.  Again, it maintains that because staff were trained, “there was no non-compliance.”  P. Br. at 16.  Training, alone, is insufficient.  It might, if properly implemented, help the facility achieve substantial compliance, but, by itself, does not establish substantial compliance.  The facility must demonstrate that the training is effective, i.e., that staff capably followed the training.  *See Oceanside Nursing and Rehabilitation Ctr.*, DAB No. 2382 at 19-20 (2011) (finding that training materials alone do not establish that staff put into practice the information they received from the in-service training).  And, as the above discussion shows, facility staff were not following the instructions presented in their training.

**Petitioner’s defense:  surveyor qualifications**.  Conflating the September infection-control problems with those cited in June, Petitioner again attacks the surveyor qualifications, arguing that “only a duly-licensed nurse is qualified to determine what a prudent nurse would or should do in a given situation.”  P. Resp. at 17.  I have already addressed this argument.  The facility’s policies and training materials emphasize the critical importance of hand hygiene in controlling the spread of infection in an institution.  One need not be a “duly-licensed nurse” to observe that someone didn’t wash her hands or don PPE.

Moreover, CMS’s nurse consultant, Suzanne Cruz, R.N., B.S.N., who is a “duly-licensed nurse,” explained the dangers presented by staff’s failing to perform appropriate hand hygiene care.  She testified that wearing gloves does not mean that staff can switch gloves without hand hygiene.  “The hands are considered contaminated and must be washed for at least 15 seconds after removing a contaminated glove.”  CMS Ex. 13 at 2 (Cruz Decl. ¶ 2b).  And Petitioner presents no testimony or expert opinion suggesting that the practices described by the surveyors were safe.

Because the facility’s staff did not follow proper hand hygiene procedures and did not don PPE as instructed, the facility’s substantial noncompliance with section 483.80(a) continued.

Petitioner has thus not met its burden of establishing that it returned to substantial compliance any earlier than September 14, 2020.

Page 27

***The penalties imposed – $15,930 per day for the period of immediate jeopardy and $225 per day for the period of substantial noncompliance that did not pose immediate jeopardy – are reasonable.***Except to assert that the penalty is unreasonable and out of proportion to the alleged deficiencies, Petitioner has not addressed the question of whether the penalty is reasonable.  P. Br. at 16; P. Resp. at 19-20.

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 Rehabilitation*, DAB No. 2738 at 20 (2016).

Penalties are inflation-adjusted and change annually.  The amount is determined as of the date the penalty is assessed, in this case, November 19, 2020.  CMS Ex. 1 at 1-2; 85 Fed. Reg. 2869, 2880 (Jan. 17, 2020).  Here, CMS imposed a penalty of $15,930 per day for the period of immediate jeopardy, which is at the mid-to-high end of the penalty range ($6,808 to $22,320), and $225 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.

Page 28

The facility has a less-than stellar compliance history.  This was the third enforcement action brought against it in approximately three-and-a-half years (since January 2017).  CMS Ex. 13 at 2 (Cruz Decl. ¶ 3).

Petitioner complains about the “financial burden” of depositing the penalty amount into an escrow account (as required by statute) but does not claim that it is unable to pay the penalty.  P. Resp. at 19 n.3.

With respect to the remaining factors, I have discussed in some detail the facility’s widespread deficiencies, notably the facility’s almost total disregard for its own written policies.  It failed to post signs on the doors of infected and symptomatic residents explaining the precautions staff and others needed to take in order to prevent the spread of infection; it did not provide PPE in the rooms housing infected and symptomatic residents; it failed to isolate symptomatic residents, leaving them in rooms with residents who had no symptoms and were at high risk for serious illness from the disease.  Multiple staff members disregarded Covid precautions.  For all of these deficiencies, the facility is culpable, and, because of them, the penalty is reasonable.

Conclusion

From April 10 through May 4, 2020, the facility was not in substantial compliance with Medicare program requirements, and its deficiencies posed immediate jeopardy to resident health and safety. As of May 5, 2020, its deficiencies no longer posed immediate jeopardy, but the facility remained out of substantial compliance with program requirements until September 14, 2020.

The penalties imposed are reasonable.


          /s/
        Carolyn Cozad Hughes

                      Administrative Law Judge
      1. Petitioner objects to CMS’s characterizing the survey as including “complaint and incident investigations,” arguing that the state agency “mandates these self-reports and then classifies them as ‘complaints’ in order to trigger on-site follow-up by a survey team.” P. Response to MSJ (P. Resp.) at 12. I find this objection pointless. CMS and the state agency have broad authority to survey facilities to assure their substantial compliance. The agencies are not limited to investigating complaints. They may survey at any time for virtually any reason. See, e.g., 42 C.F.R. § 488.20 (“as often as CMS deems necessary”). Moreover, facilities are required to self-report in a number of situations that CMS has determined merit further investigation. See, e.g., 42 C.F.R. § 483.12(c). For compelling reasons, CMS has determined that an outbreak of Covid in a facility is such a situation. The label attached to such self-reporting is irrelevant. back to note 1
                      2. In any event, Dr. Fry’s opinions are reflected in a July 12, 2020 letter that she sent to the state agency on behalf of the facility, and that letter is in the record. P. Ex. 1 at 7-10. Further, Dr. Fry’s opinions are echoed by the facility’s Director of Nursing (DON) Nicholas Brannock, whose written testimony is also in the record. P. Ex. 2. back to note 2
                      3. Petitioner’s general suggestion that it might add one or more of CMS’s witnesses (not identified) to its own witness list does not satisfy my order requiring the parties to identify the witnesses it wishes to cross-examine. Not only is the suggestion not a request to cross-examine (which, unlike direct examination, would limit the examination to the scope of the witness’s direct testimony), it does not identify any particular witness. My standing order’s purpose is to narrow the issues and identify the evidence and witnesses to be presented, all of which I consider necessary for the efficient adjudication of these proceedings. See 42 C.F.R. §§ 498.47(a), 498.60(b)(3). Allowing a party to add additional witnesses and exhibits, absent a showing of good cause, defeats this purpose and violates my order. back to note 3
                      4. 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.”). back to note 4
                      5. My findings of fact/conclusions of law are set forth, in italics and bold, in the discussion captions of this decision. back to note 5
                      6. 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. back to note 6
                      7. Neither party submitted a copy of the actual Covid plan. CMS points to the Statement of Deficiencies (Form CMS-2567) in which these sections of the plan are quoted, and Petitioner does not dispute that the Statement of Deficiencies accurately reflects its written policy, so I accept the document’s representation. See Oxford Manor, DAB No. 2167 at 2 (2008) (holding that a Statement of Deficiencies may function both as a notice document and as evidence of the facts asserted therein. If a finding is not disputed, CMS need not present evidence in support of that finding); Jennifer Matthews Nursing & Rehab., DAB No. 2192 at 47 n.22 (2008). back to note 7
                      8. Petitioner implies – without saying it outright – that the facility may have had a shortage of PPE. Petitioner provides no real evidence that the facility experienced such shortages; it merely alludes to the “well publicized shortages of PPE.” P. Ex. 1 at 8; P. Ex. 2 at 2 (Brannock Decl.). As noted above, the ADON told the survey team that “everyone” wore a mask. No one complained that the facility lacked PPE. CMS Ex. 3 at 70-71; CMS Ex. 11 at 5 (Hernandez Decl. ¶ 19); see P. Ex. 1 at 26-27 (indicating that PPE was distributed). Moreover, a concern about shortages made it even more important for the facility to allocate its resources wisely, making sure that PPE would be available for use with Covid-positive and symptomatic residents. back to note 8
                      9. Citing the ALJ decision in Tara at Thunderbolt, DAB CR1445 (2006), Petitioner maintains that “likely to cause” is a measure of probability. “To support a finding of immediate jeopardy, it must be more probable than not that an outcome will occur as a consequence of the [f]acility’s noncompliance.” P. Br. at 14-15. This is not a standard that the Board has ever applied when considering immediate jeopardy. Moreover, the Board has repeatedly held that ALJ decisions are not binding on the Board or other ALJs. In Bibb Medical Center Nursing Home, DAB No. 2457 at 7 (2012), it explicitly rejected the Petitioner’s reliance on Tara, noting that an ALJ decision is not binding upon the Board. back to note 9
                      10. Even if the facility had corrected its infection control deficiency (which it did not), the deficiency cited under section 483.12(c), by itself, establishes that it did not return to substantial compliance. To return to substantial compliance, a facility must correct the previously-cited deficiencies and maintain substantial compliance with all other program requirements. See Libertyville Manor, DAB No. 2849 at 19-22 (2018). back to note 10
                      11. There is no evidence, and Petitioner cites none, that the administrator ever looked at the on-line review. In fact, the record indicates that he did not. According to interview notes, he told the surveyors that he did not see the review. He has not denied making that statement. CMS Ex. 10 at 4; see Beatrice State Developmental Ctr., DAB No. 2311 at 17, 18; Omni Manor Nursing Home, DAB No. 1920 at 11. back to note 11
                      12. Although CMS has treated this as an allegation of neglect (that the resident was refused care), the resident’s sister alleged that staff threw a brief at her and told her to change herself, which could be considered abuse. Certainly, the resident’s subsequent allegation that the therapist “said a lot of cruel things” should be considered an allegation of abuse. In any event, the requirements to investigate and report apply to allegations of both neglect and abuse. back to note 12
                      13. I recognize that the resident in question had some mental health issues. However, that does not decrease the facility’s obligation to take seriously all allegations of potential abuse or neglect, no matter the source. Even the least trustworthy of residents can be abused or neglected; in fact, given their challenging personalities and problematic behaviors, they may be more susceptible than most. That those charged with protecting them will dismiss their allegations out-of-hand makes them even more vulnerable. back to note 13 Back to top
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