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                              Willow Rose Rehabilitation & Health Care, CR6321 (2023)
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Willow Rose Rehabilitation & Health Care, CR6321 (2023)








  
  
    

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





Willow Rose Rehabilitation & Health Care,
(CCN: 14-6040),
Petitioner,

v.

Centers for Medicare & Medicaid Services
Docket No. C-21-918Decision No. CR6321July 25, 2023

        
              
    

      DECISION

Petitioner, Willow Rose Rehabilitation & Health Care, is a long-term-care facility, located in Jerseyville, Illinois, that participates in the Medicare program.  This case involves three surveys of that facility:  a complaint investigation/COVID-19 Focused Infection Control survey, completed December 15, 2020; a second complaint investigation, completed December 23, 2020; and a third complaint investigation, completed January 11, 2021.

Based on the survey findings, the Centers for Medicare & Medicaid Services (CMS) determined that the facility was not in substantial compliance with Medicare program requirements, including those governing infection control.  Among other remedies, CMS has imposed civil money penalties (CMPs) of $20,000 per instance, based on the infection control deficiency cited during the December 15 survey, and $2,265 per day for 25 days of substantial noncompliance (January 4 through 28, 2021), based on the deficiency findings for the other two surveys.

Petitioner appealed, and CMS has moved for summary judgment.

Page 2

For the reasons set forth below, I grant CMS’s motion.  I find that the undisputed evidence establishes that the facility was not in substantial compliance with Medicare program requirements 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).

Section 1135 of the Act authorizes the Secretary to waive or modify certain statutory and regulatory requirements under the Medicare program in response to an emergency or disaster.  Responding to the public health crisis created by COVID-19, on March 13, 2020, the Secretary modified survey and certification requirements for long-term-care facilities.  *See* https://www.phe.gov/emergency/news/healthactions/section1135/Pages/covid19-13March20.aspx.  Thereafter, CMS prioritized infection control surveys and created a survey tool that focuses on infection control.  Specifically, the survey tool focuses on critical elements associated with the transmission of the highly infectious – and sometimes deadly – disease.  Facilities were expected to comply with the CMS guidance in effect at the time of the survey.  *See* CMS Ex. 34 at 2, 11.

**The surveys.**  This case involves three surveys, completed December 15, 2020, December 23, 2020, and January 11, 2021.

On **December 15, 2020**, LaRee Benamar, R.N., a surveyor from the Illinois Department of Public Health (state agency) completed an infection control survey.  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 F (widespread substantial

Page 3

noncompliance that causes no actual harm, with the potential for more than minimal harm).  CMS Exs. 1, 2, 7, 9; CMS Ex. 23 at 1 (Benamar Decl. ¶ 4).1

Surveyor Benamar returned to the facility to investigate another complaint and completed a second survey on **December 23, 2020**.  CMS Ex. 23 at 5 (Benamar Decl. ¶ 33).  Based on her findings, the state agency and CMS determined that the facility was not in substantial compliance with:

42 C.F.R. § 483.21(b)(3) (Tag F659) (comprehensive care plans – qualified persons), cited at scope and severity level E (pattern of substantial noncompliance that causes no actual harm with the potential for more than minimal harm); and**42 C.F.R. § 483.35(b)(1)-(3) (Tag F727) (nursing services – full time registered nurse)**,****cited at scope and severity level F.CMS Exs. 1, 3; P. Ex. 1.

On **January 11, 2021**, Kim Smith, R.N., another state surveyor, completed a third complaint investigation.  Based on those survey findings, CMS determined that the facility was not in substantial compliance with:

42 C.F.R. § 483.25(e)(1)-(3) (Tag F690) (quality of care – incontinence), 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);42 C.F.R. § 483.25(g)(4)-(5) (Tag F693) (quality of care – assisted nutrition and hydration), cited at scope and severity level D;**42 C.F.R. § 483.35(b)(1)-(3) (Tag F727) (nursing services – full time registered nurse)**, cited at scope and severity level F (repeat deficiency);**42 C.F.R. § 483.45(f)(2) (Tag F760) (pharmacy services – medication errors)**, cited at scope and severity level G (isolated instance of substantial noncompliance that causes actual harm but does not pose immediate jeopardy to resident health and safety); 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 F (repeat deficiency).Page 4

CMS Exs. 1, 4, 24; CMS Ex. 31 at 1 (Smith Decl. ¶ 4).

Thereafter, CMS determined that the facility returned to substantial compliance on
January 29, 2021.  CMS Ex. 1 at 2; CMS Ex. 5.

CMS has imposed against the facility the following remedies:

a $20,000 per-instance CMP based on the infection control deficiency cited during the December 15 survey (42 C.F.R. § 483.80(a)); anda $2,265 per-day CMP for 25 days of substantial noncompliance (January 4, through January 28, 2021) (total $56,625), based on the remaining cited deficiencies.For all of the deficiencies cited, CMS imposed additional remedies:  denial of payment for new admissions and directed plans of correction.  The facility was prohibited from offering or conducting any nurse aide training and/or competency evaluation program for two years.  I have no authority to review CMS’s choice of remedy.  42 C.F.R. § 488.408(g)(2).  However, because CMS imposed remedies for all deficiencies cited during the December 23 and January 11 surveys, those determinations are reviewable, if timely appealed.  *See* 42 C.F.R. § 498.3(b)(13); *Golden Living Ctr. – Grand Island Lakeview*, DAB No. 2364 at 4 (2011) (noting that section 483.3 extends hearing rights to providers subject to any of the remedies listed in section 488.406).The total CMP is $76,625 ($20,000 + $56,625 = $76,625).  CMS Ex. 1.

Petitioner appealed.

CMS now moves for summary judgment and has submitted a motion and brief in support (CMS Br.), with 37 exhibits (CMS Exs. 1-37).2

Petitioner submits its own brief in opposition to summary judgment (P. Br.), with ten exhibits (P. Exs. 1-10).

Page 5

Issues

Petitioner has not challenged every deficiency cited during the three surveys.  In its hearing request, Petitioner asserted, generally, that it contested the deficiencies cited during the December 15 and January 11 surveys.  It did not mention the December 23 survey.  And, in identifying the specific issues and the findings of fact and conclusions of law with which it disagreed, as required by 42 C.F.R. § 498.40(b), Petitioner limited its appeal to the specific findings made during the December 15 and January 11 surveys that supported the finding of substantial noncompliance with deficiencies cited under the infection control regulation – 42 C.F.R. § 483.80(a).  Hearing Request (E-file # 1).

In responding to CMS’s Motion for Summary Judgment, Petitioner points out that CMS did not submit evidence regarding the December 23 survey.  P. Br. at 4, 10.  Inasmuch as Petitioner’s hearing request does not challenge, or even mention, the December 23 survey, CMS had no reason to do so.  *See* CMS Br. at 2 (noting that Petitioner appealed deficiency findings and remedies associated with the December 15 and January 11 surveys).  If Petitioner were under the misapprehension that no penalties were imposed as a result of the December 23 survey (and thus its findings are not reviewable), its belief is not justified.  *See* P. Br. at 4.  While it is true that CMS did not impose *additional* remedies based on the December 23 survey, the remedies already in place continued.  CMS Ex. 3.  Further, CMS’s May 13, 2021 notice letter states plainly that penalties were imposed for *all* deficiencies cited, including those based on the December 23 survey.  All of the survey findings were therefore reviewable, if timely appealed.  CMS Ex. 1; *see* 42 C.F.R. § 498.3(b)(13).

Arguably, the determinations that Petitioner did not mention in its appeal – including CMS’s determinations that the facility was not in substantial compliance with 42 C.F.R. §§ 483.35(b) and 483.45(f) – are final and binding.  42 C.F.R. § 498.20(b).  During the development of the record, however, a party may add issues.  42 C.F.R. § 498.56.  *See The Carlton at the Lake*, DAB No. 1829 at 7-8 (2002) (suggesting that the content requirements of section 498.40(b) may be met through record development).  Here, in its brief, Petitioner addresses, at least peripherally, the deficiencies cited under 42 C.F.R. §§ 483.35(b) (absence of a full-time registered nurse) and 483.45(f) (medication errors).  P. Br. at 10-11.  CMS has not objected to these issues being included in Petitioner’s appeal, so, interpreting the appeal as liberally as possible, I will consider that those determinations were timely appealed and will review them.

Based on the deficiencies that Petitioner did not appeal or otherwise pursue (42 C.F.R. §§ 483.21(b)(3), 483.25(e), and 483.25(g)), I find that the facility was not in substantial compliance with Medicare program requirements, and the CMP must be at least $112 per day.  42 C.F.R. §§ 488.408(e), 488.438; 45 C.F.R. § 102.3; 85 Fed. Reg. 2869, 2880 (Jan. 17, 2020) (*see* discussion, below, regarding inflation-adjusted CMPs).

Page 6

As to the issues before me, I first consider whether summary judgment is appropriate.

On the merits, the issues are:

Was the facility in substantial compliance with 42 C.F.R. §§ 483.35(b), 483.45(f), and 483.80(a); andAre the penalties imposed – $ 20,000 per-instance and $2,265 per-day for 25 days – reasonable?  ****Discussion

**Summary judgment.**  Summary judgment is appropriate if a case presents no genuine issue of material fact, and the moving party is entitled to judgment as a matter of law.  *Bartley Healthcare Nursing & Rehab.*, DAB No. 2539 at 3 (2013) (citing*Celotex Corp. v. Catrett*, 477 U.S. 317, 322-25 (1986)); *Ill. Knights Templar Home*, DAB No. 2274 at 3-4 (2009), and cases cited therein.

The moving party may show the absence of a genuine factual dispute by presenting evidence so one-sided that it must prevail as a matter of law or by showing that the non-moving party has presented no evidence “sufficient to establish the existence of an element essential to [that party’s] case, and on which [that party] will bear the burden of proof at trial.”  *Livingston Care Ctr. v. U.S. Dep’t of Health & Human Servs.*,388 F.3d 168, 173 (6th Cir. 2004) (quoting *Celotex*, 477 U.S. at 322).  To avoid summary judgment, the non-moving party must then act affirmatively *by tendering evidence of specific facts showing that a dispute exists*.  *Matsushita Elec. Indus. Co., Ltd., v. Zenith Radio Corp.*,475 U.S. 574, 586 n.11, 587 (1986); *see also Vandalia Park*,DAB No. 1939 (2004); *Lebanon Nursing & Rehab. Ctr.*, DAB No. 1918 (2004).  The non-moving party may not simply rely on denials but must furnish admissible evidence of a dispute concerning a material fact.  *Ill. Knights Templar*, DAB No. 2274 at 4; *Livingston Care Ctr.*, DAB No. 1871 at 5 (2003).  In doing so, the non-moving party must show more than “some metaphysical doubt as to the material facts.”  *W. Tex. LTC Partners, Inc.*, DAB No. 2652 at 6 (2015), *aff’d*,*W. Tex. LTC Partners, Inc. v. U.S. Dep’t of Health & Human Servs.*, 843 F.3d 1043 (5th Cir. 2016); *1866ICPayday.com, L.L.C.*, DAB No. 2289 at 3 (2009) (quoting *Matsushita*, 475 U.S. at 587).

In examining the evidence for purposes of determining whether summary judgment is appropriate, I must draw all reasonable inferences in the light most favorable to the non-moving party.  *Brightview Care Ctr.*, DAB No. 2132 at 2, 9 (2007); *Livingston Care Ctr.*, 388 F.3d at 172; *Guardian Health Care Ctr.*,DAB No. 1943 at 8 (2004); *see also* *Brightview*, DAB No. 2132 at 10 (entry of summary judgment upheld where inferences and views of non-moving party are not reasonable).  However, drawing factual inferences in the light most favorable to the non-moving party *does not require that I accept the*

Page 7

*non-moving party’s legal conclusions*.  *W. Tex. LTC Partners, Inc.*, DAB No. 2652 at 6-7; *cf. Guardian*, DAB No. 1943 at 11 (“A dispute over the conclusion to be drawn from applying relevant legal criteria to undisputed facts does not preclude summary judgment if the record is sufficiently developed and there is only one reasonable conclusion that can be drawn from those facts.”); *see Green Valley Healthcare & Rehab. Ctr.*, DAB No. 2947 at 8 (2019), (*quoting Johnson v. Perez*, 823 F.3d, 701, 705 (D.C. Cir. 2016) (noting that a genuine factual dispute does not exist “when a putatively disputed body of evidentiary material could not, even assuming a sympathetic factfinder, reasonably support a finding crucial to the nonmoving party’s legal position.”)).

**Summary judgment applied to administrative review in Medicare cases.**  It is well-established that an administrative law judge is empowered to decide a case on summary judgment, without an evidentiary hearing.  *Shah v. Azar*, 920 F.3d 987, 996 (5th Cir. 2019) (citing *Cedar Lake Nursing Home v. U.S. Dep’t of Health & Human Servs.*, 619 F.3d 453, 457 (5th Cir. 2010)); *see Fal-Meridian, Inc. v. U.S. Dep’t of Health & Human Servs.*, 604 F.3d 445, 449 (7th Cir. 2010) (“All it means for a decision to be based on a grant of summary judgment is that there are *no issues that would benefit from being resolved in an evidentiary hearing*.”) (emphasis added); *Jewish Home of Eastern Pennsylvania*, DAB No. 2451 at 4 (2012); *Vandalia Park*, DAB No. 1939 at 5-6 (2004), citing *Crestview Parke Ctr. v. Thompson*, 373 F.3d 743, 750 (6th Cir. 2004).  As the Departmental Appeals Board reminded us in *Jewish Home*, the requirement for affording an oral hearing is not contravened by summary judgment if there are no genuine issues of material fact.  *Jewish Home*, DAB No. 2451 at 4 (quoting *Vandalia Park*, DAB No. 1939 at 5-6).3

Summary judgment is appropriate here because the undisputed evidence establishes that, contrary to facility policies and CMS guidance:  the facility did not affix the required signage to the room doors of residents on “Transmission-Based Precautions”; facility staff were not following CDC guidelines and facility policies for donning and removing personal protective equipment (PPE), handling contaminated linens and PPE, and hand hygiene; and a Covid-positivePage 8

***nurse remained at work, exposing others to the disease.  These failures put the facility out of substantial compliance with 42 C.F.R. § 483.80(a)***.4

**A.  Program requirements:**  **Section 1819(d)(3)** of the Act mandates that a skilled nursing facility (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;5
	*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:

Page 9

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*.

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).  *Golden Living Ctr. – Superior*, DAB No. 2768 at 7 (2017); *Heritage House of Marshall Health & Rehab. Ctr.*, DAB No. 2566 at 12 (2014).

CMS has also directed facilities to follow the guidelines issued by the Center for Disease Control and Prevention (CDC).  CMS Ex. 34 at 6, 13.  At the time of the surveys, this guidance included:  “Responding to . . . COVID-19 in Nursing Homes”; “Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the . . . COVID-19 Pandemic”; and “Preparing for COVID-19 in Nursing Homes.”  CMS Exs. 32, 35, 36.

**B.  Facility policies.**As the Departmental Appeals Board has repeatedly explained, a facility’s policy for implementing a regulatory requirement reflects the facility’s own judgment about how best to achieve substantial compliance.  Failing to comply with its own policies “can support a finding that the facility did not achieve compliance with the regulatory standard.”  *Bivins Memorial Nursing Home*, DAB No. 2771 at 9 (2017); *See Rockcastle Health & Rehab. Ctr.*, DAB No. 2891 at 19 (2018) (ruling that, absent

Page 10

contrary evidence, it is reasonable to presume that the facility’s policies reflect professional standards); *Hanover Hill Health Care Ctr.*, DAB No. 2507 at 6 (2013); *Life Care Ctr. of Bardstown*, DAB No. 2233 at 21-22 (2009) (finding that a facility’s failing to comply with its own policies can constitute a deficiency).

**1) Facility policy:  COVID-19 control measures for admissions and readmissions.**

Consistent with CDC guidelines, which direct facilities to put newly admitted and readmitted residents on Transmission-Based Precautions, the facility’s COVID policy requires that such residents with unknown COVID status be placed in a private room for 14 days.  During that time, the policy requires that “*all recommended COVID-19 PPE*” *be worn during care of residents under observation*.  The required PPE includes an *N95 respirator, eye protection, gloves, and gown*.  CMS Ex. 21 at 17; CMS Ex. 30 at 3; CMS Ex. 32 at 2; CMS Ex. 33; CMS Ex. 36 at 5 (emphasis added).  The COVID-19 control measures policy also instructs *direct care staff and other staff members who “may have close contact with residents” to wear face masks, and eye protection* (goggles/face shields).  CMS Ex. 21 at 15 (emphasis added).

**2) Facility policy:  Transmission-Based Precautions.**

The facility’s policy explains that Transmission-Based Precautions are “designed for patients documented or suspected to be infected with highly transmissible or epidemiologically important pathogens,” requiring additional precautions beyond “Standard Precautions.”6  The policy describes three types of Transmission-Based Precautions:  Airborne Precautions; Droplet Precautions; and Contact Precautions.  CMS Ex. 21 at 10-11.

**a) Facility policy:  Contact Precautions.**

The facility had in place a policy describing Contact Precautions.  The policy applies to all staff, residents, family, and visitors.  It directs staff (and the others) to use Contact Precautions (or equivalent) in addition to Standard Precautions for residents known or

Page 11

suspected to be “infected or colonized with epidemiologically important microorganisms that can be transmitted by direct contact with the resident (hand or skin to skin contact that occurs when performing resident care activities that require touching the resident’s dry skin) or indirect contact (touching . . . environmental surfaces or resident care items in the resident’s environment).”  CMS Ex. 21 at 1.

The policy instructs staff to place the resident in a private room, if available.  Staff (and others) *must wear gloves when entering the room* and change gloves after having contact with “infective material that may contain high concentrations of microorganisms (fecal material and wound drainage).”  Staff must *remove their gloves before leaving the resident’s environment and wash their hands immediately* with an antimicrobial agent or waterless antiseptic agent.  After handwashing, staff must ensure that their hands do not touch potentially contaminated surfaces or items in the resident’s room.  *Id*.

When entering the resident’s room, staff *must also wear gowns* if their clothing will have substantial contact with the resident, environmental surfaces, or items in the resident’s room, or if the resident *is incontinent* or has diarrhea, an ileostomy, a colostomy, or wound drainage not contained by a dressing.  Staff are directed to remove the gown before leaving the resident’s environment and, after removing the gown, ensure that their clothing does not contact potentially contaminated surfaces.  CMS Ex. 21 at 1.

The policy recommends that, when possible, the facility dedicate non-critical resident care equipment to a single resident (or cohort of residents “infected or colonized with the pathogen requiring precautions”) to avoid sharing between residents.  If shared use is unavoidable, *staff must clean and disinfect the equipment before it is used by another resident*.  CMS Ex. 21 at 2.

**b) Facility policy:  Droplet Precautions.**

The facility had in place a policy for Droplet Precautions.  The policy applies to staff, residents, family, and visitors.  In addition to Standard Precautions, the policy directs staff to follow Droplet Precautions for any resident known or suspected to be infected with microorganisms transmitted by droplets that the resident can generate by coughing, sneezing, talking, or “the performance of procedures.”  CMS Ex. 21 at 3.  As with Contact Precautions, the resident should be placed in a private room.  If not possible, and cohorting7 is not achievable, the facility should maintain a spatial separation of at least

Page 12

three feet between the resident and other residents and visitors by pulling the privacy curtain.  *Staff must wear masks when working within three feet of the resident*.  CMS Ex. 21 at 3.

**3) Facility policy:  handwashing.**

The facility’s policy characterizes handwashing as “an important component of the infection control and isolation precautions.”  All staff *must wash hands “as promptly and thoroughly as possible” after resident contact; after contact with blood, body fluids, secretions, and excretions; and after contact with contaminated equipment or articles*.  The policy includes a detailed procedure for handwashing and directs staff to use an available alcohol rub/gel if soap and water are not available.  CMS Ex. 21 at 6; CMS Ex. 30 at 9.

**4) Facility policy:  entering an isolation room.**

The facility’s policy for entering an isolation room applies to all personnel, family, and visitors.  As equipment, the policy lists isolation gown (if applicable), mask (if applicable), and non-sterile gloves.  The policy directs anyone entering the room to:

Check with the nurse prior to entering to see which protective apparel is required.*Wash hands or apply waterless antimicrobial agent*.Put on gown per facility policy and procedure, if applicable.Put on mask per facility policy and procedure, if applicable.Put on non-sterile gloves, for which there are no special instructions; however, if using sterile gloves for a procedure, staff should take them into the room and put them on at bedside, following facility policy and procedure.Follow the facility policy and procedure for removing protective apparel.CMS Ex. 21 at 7; CMS Ex. 30 at 10.  The policy comports with CDC guidelines for use of PPE when caring for patients with confirmed or suspected COVID-19.  CMS Ex. 35.

**5) Facility policy:  leaving an isolation room.**

Page 13

The facility’s policy for leaving an isolation room also applies to all staff members, visitors, and family.  The procedure assumes that the person leaving has been wearing a gown, mask, and gloves.  It directs anyone leaving the isolation room to:

Remove gloves.  With left hand, peel the right glove off from the cuff, “being careful not to touch your skin with your left glove.”  Remove the left glove by placing one or two fingers of the right hand inside the glove and pulling it off.  (Reverse the process, if left-handed).  Discard gloves in the appropriate container.Untie the waist ties of gown.*Wash hands*.Untie neckline ties of gown, dropping the gown over shoulders.  Do not touch the outside of the gown.Pull off the gown, touching the inside only and turning the gown inside out as you take it off.  *Fold it with all outside surfaces toward the center* and *place it in the appropriate container*.Touching the ties only, untie your mask and *discard it in the appropriate container*.*Wash hands* before leaving the room.CMS Ex. 21 at 8; CMS Ex. 30 at 11.

**6) Facility policy:  signage.**

The facility’s COVID-19 measures also instruct staff to “post signage on the door” of rooms under Contact and Droplet Precautions.  CMS Ex. 21 at 15-16.

Under the caption, “**Contact Precautions – Post signage on the door**,” the policy directs the facility to post signage on the doors of residents suspected of having any fever, respiratory symptoms, sore throat, nausea, vomiting, diarrhea, extreme fatigue, muscle pain, loss of taste and/or smell.

The policy then lists specific instructions:  wear gloves (under certain conditions); wear a gown (under certain conditions); change gloves and gowns after contact with resident and perform hand hygiene; perform hand hygiene before and after touching the resident, resident’s environment, and/or resident’s respiratory secretions (even if gloves are worn); remove PPE when leaving a resident’s room; wash hands with soap and water if they

Page 14

become contaminated with respiratory secretions or other body fluids; and use alcohol-based hand rub for routinely decontaminating hands when hands are not visibly contaminated.  Clean and disinfect non-dedicated, non-disposable resident care equipment after each use.  CMS Ex. 21 at 15-16; CMS Ex. 30 at 2.

Similarly, under the caption “**Droplet Precautions – Post signage on door**,” the policy directs the facility to post signage on the doors of residents suspected of having any fever, respiratory symptoms, sore throat, nausea, vomiting, diarrhea, extreme fatigue, muscle pain, loss of taste and/or smell.

The policy then lists specific instructions:  wear facemask/N95, gloves, gown, goggles, or face shields when entering the room or when working within six feet of residents on droplet precautions.  Place a facemask on the resident when providing direct care; remove PPE when leaving the resident’s room and perform hand hygiene.  Clean and disinfect non-dedicated, non-disposable resident care equipment after each use.  CMS Ex. 21 at 16.
CMS’s survey instructions underscore that the signage should include the “use of *specific* PPE (for staff).”  CMS Ex. 34 at 15 (emphasis added); *see* CMS Ex. 32 at 2 (requiring signage at the entrance to the COVID unit *specifying what PPE they should wear*).

**C.  Infection control findings:  December 15 survey.**  When Surveyor Benamar arrived on December 10, 2020, the facility housed residents suffering from three infectious diseases:  15 to 16 had tested positive for COVID-19; one resident (referred to as **R1**) had Methicillin-resistant Staphylococcus Aureus (MRSA);8 and another resident (referred to as **R5**) had Clostridium Difficile Colitis (C.diff.).9  CMS Ex. 23 at 2-3 (Benamar Decl. ¶¶ 15, 16, 18); P. Ex. 2 at 3 (Mika Decl. ¶ 17).  All three diseases can cause serious injury or death.  They are highly contagious and require Transmission-Based Precautions to prevent their spread.  CMS Ex. 21 at 10-11; CMS Ex. 23 at 5 (Benamar Decl. ¶ 35).

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The facility had three resident wings (A, B, and C) and, at the time of the December 15 survey, had designated the C-wing as the COVID wing, where it housed the residents who tested positive for COVID-19.  CMS Ex. 9 at 4; CMS Ex. 10; CMS Ex. 23 at 2-3 (Benamar Decl. ¶¶ 8, 15); P. Ex. 2 at 3 (Mika Decl. ¶ 13).  The facility did not have a separate hall or area for those who required observation or quarantine because of potential exposure to COVID.  Residents who were under observation or quarantine for possible COVID resided in the A and B halls and were isolated in their rooms.  CMS Ex. 9 at 4; CMS Ex. 23 at 3 (Benamar Decl. ¶ 16).  R1 and R5 also resided on these halls and were isolated in their rooms.

During the December 15 survey, Surveyor Benamar observed multiple instances of staff’s failing to follow the facility’s infection control policies.  All occurred in the non-COVID wings of the facility:

**1) Inadequate signage (December 15 survey).**

As described above, the facility’s policy – and CMS’s guidance – require, on the doors of resident rooms, signage specifying the precautions required before entering.  CMS Ex. 21 at 15, 16; CMS Ex. 34 at 15; *see* CMS Ex. 34 at 7 (advising that room signage is “important to ensuring that all staff are aware of the necessary infection control steps.”).

R1, R2, R3, R4, R5, and R6 all resided on the non-COVID wings, and all were subject to Transmission-Based Precautions.  Yet the signage posted on their doors (if any) did not convey the required information.

As noted above, R1 had contracted the infectious disease, MRSA.  CMS Ex. 23 at 3 (Benamar Decl. ¶¶ 16, 18).  An isolation cart was outside R1’s room, but no signage on the door indicated what PPE staff needed to wear or what precautions they needed to observe.  CMS Ex. 23 at 3 (Benamar Decl. ¶ 19).Because R2 went to dialysis three times per week, she was in isolation (CMS Ex. 13 at 4, 5, 6, 7) and should have been on Transmission-Based Precautions.  CMS Ex. 21 at 17; CMS Ex. 32 at 2.  On December 8, 2020, she was sent to the emergency room to have her dialysis access de-clotted, which, by itself, meant that she should have been on Transmission-Based Precautions.  CMS Ex. 13 at 8.  An isolation cart was outside her room, but no signage specified what PPE staff needed to wear or what precautions they needed to observe.  CMS Ex. 7 at 3; CMS Ex. 23 at 4 (Benamar Decl. ¶ 22).R3 was isolated because she went out for dialysis.  CMS Ex. 19 at 5-6; CMS Ex. 20.  On December 4, 2020, she was sent to the hospital, suffering from encephalopathy.  CMS Ex. 19 at 6.  Both circumstances meant that staff had to observe Transmission-Based Precautions.  An isolation cart was outside her room,Page 16

but, again, no signage specified what PPE staff needed to wear or what precautions they needed to observe.  CMS Ex. 7 at 4; CMS Ex. 23 at 4 (Benamar Decl. ¶ 25).

R4’s roommate had tested positive for COVID on December 3, 2020.  CMS Ex. 23 at 4 (Benamar Decl. ¶ 26); *see* CMS Ex. 32 at 3 (CDC guidance directing that the roommates of residents with COVID-19 be considered exposed and potentially infected).  An isolation cart was outside her room, but, again, no signage specified what PPE staff needed to wear or what precautions they needed to observe.  CMS Ex. 7 at 4; CMS Ex. 23 at 4 (Benamar Decl. ¶ 27).As noted above, R5 had contracted the infectious disease, C.diff.  CMS Ex. 23 at 3, 4 (Benamar Decl. ¶¶ 16, 28).  An isolation cart was near R5’s door, but no signage indicated what PPE staff needed to wear or what precautions they needed to observe.  CMS Ex. 7 at 5; CMS Ex. 23 at 5 (Benamar Decl. ¶ 29).R6’s roommate had tested positive on December 3, 2020.  CMS Ex. 23 at 5 (Benamar Decl. ¶ 30); *see* CMS Ex. 32 at 3.  An isolation cart was by her door, but, again, no signage specified what PPE staff needed to wear or what precautions they needed to observe.  CMS Ex. 7 at 4; CMS Ex. 23 at 5 (Benamar Decl. ¶ 31).**2) Failing to follow CDC guidelines and facility policies for handling contaminated PPE and hand hygiene (December 15 survey).**

Surveyor Benamar observed that R2’s room had two waste receptacles, one for PPE and one for soiled linens.  The bins were not covered.  They did not have biohazard bags, and nothing warned that the contents of the bins were dangerous.  Used PPE was overflowing the PPE bin, the arm of a used isolation gown touching the floor.  CMS Ex. 7 at 3; CMS Ex. 23 at 4 (Benamar Decl. ¶ 23).

**3) COVID-positive nurse remaining at work (December 15 survey).**

One of the facility’s licensed practical nurses (LPNs), referred to as LPN V5, told Surveyor Benamar that, on December 8, 2020, she was not feeling well.  At about 1:00 p.m., she tested positive for COVID.  She told the surveyor that, when she asked to go home, the facility’s Director of Nursing (DON) told her to finish her shift, which ended at 3:00 p.m.  The DON instructed her to “stay at the nurse’s station and do some charting.”  According to the LPN’s time sheets, she clocked out at 3:15 p.m.  CMS Ex. 7 at 5; CMS Ex. 23 at 5 (Benamar Decl. ¶ 32).

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*

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*Developmental 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).  Here, the LPN did not testify and thus does not deny making those statements to Surveyor Benamar and does not claim that her statement is untrue.  (As I discuss below, the DON denies telling LPN V5 to finish her shift and suggests that the LPN may have been tested later in the day than she claimed). **D.  Infection control findings:  December 23 survey.**  Surveyor Benamar returned to the facility on December 23, 2020.  By that time, all three residence halls were sealed off because the number of COVID-19 cases had increased dramatically.  CMS Ex. 23 at 5, 6 (Benamar Decl. ¶¶ 33, 36).  In her written declaration, Surveyor Benamar seems to suggest that the facility’s substantial noncompliance with section 483.80(a) continued.  She asserts that the facility’s failure to implement its infection control policies put facility residents at risk for more than minimal harm.  CMS Ex. 23 at 5 (Benamar Decl. ¶¶ 34, 35).

COVID-19 did in fact spread in the facility, as shown by the fact that between the December 15, 2020 survey and the December 23, 2020 survey[,] the facility went from having one COVID-19 wing to having COVID-19 cases in all three of the building’s wings.

CMS Ex. 23 at 6 (Benamar Decl. ¶ 36).

Nevertheless, and without explanation, CMS determined that the facility complied with the infection control regulation, 42 C.F.R. § 483.80 (although it found other deficiencies).  P. Ex. 1 at 2.  Significantly, the facility had changed the wording of its signage:  “Room isolation signs were changed to better specify what type of isolation the resident was on, and what proper PPE to wear,” which may explain CMS’s determination.  CMS Ex. 7 at 3.10

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**E.  Infection control findings:  January 11 survey.**  Notwithstanding the December 23 infection control determination, when Surveyor Smith surveyed the facility on January 11, 2021, she found ongoing infection control deficiencies, similar to those cited during the December 15 survey.

**1) Inadequate signage.**

R2a was a 33-year-old woman, suffering from a multitude of serious impairments, including epilepsy with seizures, chromosomal abnormality, encephalopathy, and paraplegia.  CMS Ex. 28 at 17; CMS Ex. 31 at 2 (Smith Decl. ¶ 11).11  She required incontinence care.  *See* CMS Ex. 26 at 6.12  She received nutrition, hydration, and medications through a gastrostomy tube (G-tube).  However, because she frequently pulled out her G-tube, she required frequent hospitalizations.  CMS Ex. 28 at 1.13

Because of her frequent hospitalizations, R2a was subject to Transmission-Based Precautions.  CMS Ex. 30 at 3; CMS Ex. 31 at 3 (Smith Decl. ¶ 26).  Yet, contrary to the facility’s signage policy and the assurances it provided in its plan of correction, no sign on her door indicated that she was quarantined or described the necessary precautions for individuals entering her room.  CMS Ex. 24 at 12; CMS Ex. 26 at 4; CMS Ex. 31 at 3 (Smith Decl. ¶ 27).

**2) Failing to follow CDC guidelines and facility policies for donning and removing PPE, hand hygiene, and sanitizing shared equipment (January 11 survey).**

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Inadequate signage was not the only problem that Surveyor Smith observed.  On January 4, 2021, she observed the following:

A nurse aide, identified as CNA V7, did not sanitize her hands or don gloves when she went into R2a’s room.  Her goggles were up on her forehead.A second nurse aide, identified as CNA V6, did not don a gown, sanitize her hands, or don gloves when she entered R2a’s room.An LPN, identified as LPN V3, entered the room “more than once” without washing her hands or donning any PPE.  She did not clean her hands when she left the room.CNA V6 removed a Hoyer lift from R2a’s room and put it in the shower room.  She did not sanitize it.A nurse aide, identified as CNA V5, was in R2a’s room without eye protection.CMS Ex. 24 at 12-13; CMS Ex. 26 at 4; CMS Ex. 31 at 4 (Smith Decl. ¶ 29); CMS Ex. 37 (Smith Supp. Decl. ¶¶ 3, 4).

On January 5, 2021, Surveyor Smith observed:

A nurse aide, identified as CNA V8, entered R2a’s room without donning a gown or gloves.  She did not sanitize her hands when she left the room.When CNAs V6 and V8 entered R2a’s room, they donned PPE but did not sanitize their hands before they put on gloves.CMS Ex. 26 at 6; CMS Ex. 31 at 4 (Smith Decl. ¶ 30).14

**F.  Petitioner’s responses.**

**1) Inadequate signage:  Petitioner’s response.**

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Petitioner limits its signage discussion to the December 15 survey and does not challenge the signage deficiency described during the January 11 survey.  Petitioner does not even claim that any signs were affixed to R2a’s door.  The undisputed evidence therefore establishes that the facility did not affix the required signage to R2a’s door, which put the facility out of substantial compliance with section 483.80(a).

With respect to the December 15 survey findings, Petitioner concedes that its policies required it to post some signage and that the signs posted did not include any specific precautions.  Petitioner produced a copy of the sign placed on resident doors at the time of the December 15 survey.  On its face, the sign is not directed at staff.  The sign reads:

VISITORS
PLEASE
CHECK AT
NURSES
DESK
BEFORE
ENTERING

P. Ex. 4; P. Ex. 8 at 2 (Mead Decl. ¶ 5).

According to Petitioner, its signage did not have to convey any specific precautions or even indicate generally that contact or isolation precautions were required:  “there was no indication as to what the signage specifically needed to state on each resident’s door.”  P. Br. at 6-7.  Petitioner does not explain how signage that does not describe – specifically or even generally – the required precautions comports with signage policies that list specific instructions – “wear gloves,” “wear a gown,” “perform hand hygiene,” etc.  CMS Ex. 21 at 15, 16; CMS Ex. 30 at 2.

Nor does Petitioner explain how signage that includes no specific precautions comports with CMS’s instruction that signage should include the “use of *specific* PPE (for staff).”  CMS Ex. 34 at 15 (emphasis added).  Moreover, in its guidance, CMS characterizes room signage as important to ensure that all staff are aware of the necessary infection control steps.  CMS Ex. 34 at 7.  If the signage does not convey the “necessary infection control steps,” it can hardly ensure that staff are aware of those steps.

Petitioner does not claim that every staff member checked at the nurses’ desk before entering the room of a resident on Transmission-Based Precautions.  Instead, Petitioner maintains that staff were aware of the required precautions and understood what the admittedly vague signage meant.  P. Br. at 8; P. Ex. 2 at 2 (Mika Decl. ¶ 9).  Inasmuch as

Page 21

staff did not comply with PPE requirements, they apparently were not so aware.15  In any event, management’s assumption that, without reminders, staff would remember and follow Transmission-Based Precautions, does not relieve the facility of its obligation to comply with its own policies and CMS guidelines.

Petitioner also suggests – without providing evidence – that more appropriate signage might have been elsewhere in the facility, but “it is not clear” if the surveyor asked about it.  P. Br. at 7.  This begs the question:  what is the point of signage if staff who must follow its instructions do not see it?  Signage is supposed to advise staff of what they must do in order to enter and exit safely the room of a potentially infected resident.  Placing a sign someplace not visible to staff entering a room does not accomplish this purpose.  Moreover, the facility’s policies are explicit:  “Post signage *on [the] door*.”  CMS Ex. 21 at 15, 16; CMS Ex. 30 at 2 (emphasis added); CMS Ex. 34 at 15 (“Is signage on the use of specific PPE (for staff) posted in appropriate locations in the facility (e.g., outside of a resident’s room, wing, or facility-wide)?”).  *See The Windsor House*, DAB No. 1942 (2004), 2004 WL 2102885 at 40 (finding that the facility’s failure to post signs warning of the need for MRSA precautions violated the infection control regulation).16

**2) Failing to follow guidelines and policies for donning and removing PPE, hand hygiene, and sanitizing shared equipment:  Petitioner’s response.**

**a) Contaminated PPE.**

Petitioner has not challenged Surveyor Benemar’s observations regarding the PPE receptacles in R2’s room during the December 15 survey but argues that leaving used PPE and soiled linens in uncovered, unmarked bags, with part of a gown touching the floor, is an acceptable practice.  P. Br. at 3, 8.

Page 22

As described above, proper handling of soiled linens and PPE is critically important to prevent the spread of infectious diseases.  CMS Ex. 21 at 8.  A used gown is potentially contaminated, and staff must remove PPE carefully, making sure not to touch the outside of the gown, and not allowing it to touch surfaces.  CMS Ex. 21 at 1, 8; CMS Ex. 30 at 11.  In *Windsor*, for example, the surveyor observed a nurse aide, who, after caring for an infected resident, placed her used gloves and gown in a regular garbage can, rather than one designated for disposal of infectious PPE.  The Board agreed that such practice put the facility out of substantial compliance with the infection control regulation.  *The Windsor House*, DAB No. 1942.

Petitioner points out that *Windsor* involved a resident in isolation for possible MRSA, while R2 was in isolation for possible COVID.  P. Br. at 8.  Both MRSA and COVID are highly infectious diseases, and both require Transmission-Based Precautions, including careful handling of used PPE.  Petitioner cites no authority for the proposition that COVID-19 requires less infection-control diligence than MRSA.

Petitioner also argues that it should not be accountable for the disposal of used PPE as Windsor House was, because unlike that facility, Petitioner did not have a “specific internal policy for disposal of waste from an isolation room.”  P. Br. at 8-9.  If anything, this argument weakens Petitioner’s case.  A facility may not successfully defend against an allegation of noncompliance by pointing to further noncompliance.  Failing to have in place an effective policy for handling contaminated PPE does not excuse the facility from its obligations to prevent the transmission of communicable diseases and infections.  As outlined above, section 483.80(a) *requires* the facility to have in place a program for controlling infections and communicable diseases.  The program must include *written standards, policies, and procedures* describing the transmission-based precautions staff must follow to prevent the spread of infections.  This necessarily includes written policies for handling soiled linens and PPE, which, if mishandled, can spread infection.

I accept Petitioner’s representation that the facility lacked an adequate policy for disposing of contaminated linens and PPE.  Nevertheless, its policy for leaving an isolation room described the proper procedure for removing a used gown.  The policy requires staff to fold the used gown, “with all outside surfaces toward the center” and to place it in the appropriate container.  This is consistent with professional standards, which recognize that the gown front and sleeves are contaminated and must therefore be removed carefully to prevent self-contamination or contact with room surfaces.  The gown should not be thrown, haphazardly, into a bin.  As the CDC instructs, it should be folded or rolled into a bundle.  CMS Ex. 33; *see* https://www.cdc.gov/hai/pdfs/ppe/ppe-sequence.pdf at 2.  Throwing a gown into an uncovered bin, with the sleeves loose and touching the floor (or any other surface in the room) risks spreading infection and is thus incompatible with professional standards and the facility’s own policy.

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Leaving soiled linens in an open bin, with no warning that the contents are dangerous, does not satisfy the regulatory requirement that linens be handled, stored, processed, and transported in ways that prevent the spread of infection.  42 C.F.R. § 483.80(e).

**b) Nursing staff’s deficient infection control practices.**

Petitioner does not challenge Surveyor Smith’s observations of facility nurses’ and nurse aides’ disregarding safe infection control practices (hand hygiene, donning and doffing required PPE) when they entered and left R2a’s room.  Instead, Petitioner throws out a couple of possible justifications:  1) instead of direct resident care, all of these nursing personnel could have been providing housekeeping services “like cleaning the floor”; or 2) the staff may have followed safe practices that the surveyor did not observe because of where she might have been “in relation to the room.”  P. Br. at 12.  None of the observed staff members provided testimony, and Petitioner has come forward with no actual evidence in support of either speculation.

CMS having come forward with evidence that facility staff were not wearing the PPE required and were not washing or sanitizing their hands when entering and leaving the room, Petitioner must present evidence of specific facts showing that a dispute exists over these facts.  *Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp.*, 475 U.S. 574, 586 n.11, 587.  It must show more than “some metaphysical doubt.”  *W. Texas LTC Partners*, DAB No. 2652 at 6.  Unsupported speculation, such as Petitioner has offered here, does not create even a “metaphysical doubt,” much less raise a genuine dispute of material fact as required to preclude summary judgment.  *Id.* at 15.

**c) Sanitizing used equipment.**

Petitioner has neither denied nor defended the surveyor observation that a nurse aide failed to follow facility policies and CDC guidelines for infection control, when she did not sanitize the Hoyer lift that she removed from R2a’s room and put in the shower room.  CMS Ex. 37 (Smith Decl. ¶¶ 3, 4); *see* CMS Ex. 35 at 9 (CDC guidelines directing that staff clean and disinfect non-dedicated, non-disposable resident care equipment according to manufacturer’s instructions and facility policies).

**3) COVID-infected nurse remaining at work:  Petitioner’s response.**

Petitioner concedes that LPN V5 tested positive for COVID-19 on December 8 and remained at work until 3:15 p.m.  P. Br. at 3.

Petitioner points out, however, that, before beginning her shift (about 6:30 a.m.), LPN V5 filled out a screening questionnaire, denying symptoms of the disease.  P. Ex. 6; P. Ex. 8 at 2 (Mead Decl. ¶¶ 9, 10).  DON Shelli Mead also claims that the LPN worked “the majority of her shift before mentioning” that she was not feeling well (an assertion that is

Page 24

not inconsistent with LPN V5’s claim that she tested positive for the disease at 1:00 p.m. having started her shift shortly after 6:30 a.m.).  P. Ex. 8 at 2-3 (Mead Decl. ¶ 12).

Even though she admits that she doesn’t know when the COVID test was administered, DON Mead asserts that she “[does] not believe that [it] was at 1 p.m.”  She “believe[s],” without pointing to any underlying evidence, that LPN V5 “tested positive shortly before leaving for the day,” although she does not say when LPN V5 tested positive.  DON Mead also denies telling the LPN to finish her shift at the nurse’s station, which, for purposes of summary judgment, I accept as true.  P. Ex. 8 at 2-3 (Mead Decl. ¶ 12).

Petitioner argues that DON Mead’s recollection, imprecise as it is, creates a material fact in dispute.  But accepting her vague assertions as true, for purposes of summary judgment, does not create *material* facts in dispute.  First, allowing an infected nurse to continue working is just one of several factors that put the facility out of substantial compliance with the infection-control regulation.  Even if I eliminated it, the facility’s other infection-control problems – inadequate signage and staff’s failing to follow Transmission-Based Precautions – would put the facility out of substantial compliance with section 483.80(a) and justify the per-instance penalty imposed.

Moreover, DON Mead does not deny that, after testing positive, LPN V5 spent some time working at the nurse’s station before she went home at the end of her shift.  The infected nurse should not have remained at the facility for any length of time and certainly not in a pivotal location, like the nurse’s station, where most nursing staff can be expected to congregate.  CMS Ex. 21 at 12, 13, 17.17  That the LPN acted on her own and not at the direction of the DON is irrelevant.  Facilities are responsible for the actions of *any* employee 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)); *North Carolina State Veterans Nursing Home, Salisbury*, DAB No. 2256 at 12 (2009); *Emerald Oaks*, DAB No. 1800 at 7 n.3 (2001).

Moreover, the facility’s defense here establishes that it failed to follow its own infection control policies in other critical respects.  Both DON Mead and the facility’s administrator, Kelsey Mika, claim that they do not know when LPN V5 tested positive because the facility kept no record of the testing or its results.  P. Ex. 2 at 2 (Mika Decl. ¶ 7); P. Ex. 8 at 2-3 (Mead Decl. ¶ 12).  They do not say whether failing to keep test

Page 25

records was the facility’s regular practice or whether this missing record is an anomaly – the facility just happened to dispose of the record on the one day that establishing the timing mattered.

Again, a facility may not successfully defend against an allegation of noncompliance by pointing to further noncompliance.  In fact, the facility was *required* to maintain a record of the testing, including the time it was performed.  The facility’s policy specifies that, if a staff member requires testing (other than facility-wide routine testing) because of symptoms, as LPN V5 did here, the facility must notify the medical director and obtain orders for the test.  Standing orders are not an option.  CMS Ex. 21 at 12; see 42 C.F.R. § 483.80(h)(3) (requiring the facility to document the testing results of each staff COVID-19 test).  If, in fact, staff notified the medical director, both the facility and the medical director should have a record of the contact.  Further, the facility’s policy required it to *document the date and time* a staff member “is noted to have signs/symptoms of COVID-19 and *the actions the facility has taken*,” such as “staff member tested, staff member sent home.”  CMS Ex. 21 at 13.  It provides that the facility *must document* testing results in a secure manner, consistent with requirements.  *Id*.

***2. Summary judgment is appropriate here because the undisputed evidence establishes that the facility was not using the services of a registered nurse at least eight consecutive hours a day, seven days a week and was thus not in substantial compliance with 42 C.F.R. § 483.35(b).18***

**A.  Program requirements:  Section 1819(b)(4)(C)(i)** requires that a skilled nursing facility provide 24-hour licensed nursing services that are sufficient to meet the nursing needs of its residents and *must use the services of a registered professional nurse at least eight consecutive hours a day, seven days a week*.

Echoing the language of section 1819(b)(4)(C)(i), 42 C.F.R. § 483.35(b)(1) requires the facility use the services of a registered nurse for at least eight consecutive hours a day, seven days a week.19  CDC guidelines provide that facilities must be prepared for potential staffing shortages and have in place plans and processes to mitigate them.  CMS Ex. 35 at 6.

Page 26

**B.  Survey findings:  No registered nurse services provided.**  The facility was unable to produce (and has not yet produced) any policies for meeting the RN staffing requirements.  It had no plan in place for providing RN services if its sole RN was unable to work.  P. Ex. 1 at 9; CMS Ex. 31 at 6 (Smith Decl. ¶ 44); *see* CMS Ex. 27 at 1.

DON Mead, who is an RN, told Surveyor Smith that the facility’s other RN quit on December 10, 2020, leaving the DON as the facility’s only RN.  CMS Ex. 31 at 5 (Smith Decl. ¶ 39).  DON Mead subsequently contracted COVID-19 and, starting December 16, 2020, was unable to work, leaving the facility without RN coverage.  CMS Ex. 31 at 5 (Smith Decl. ¶ 40).

As the following discussion shows, the absence of an RN had serious negative consequences for at least one facility resident.

**C.  Petitioner’s response:  no registered nurse.**  Petitioner offers some suspiciously vague arguments and testimony about RN coverage in December 2020 and January 2021,  
claiming – without mentioning any dates – that “[t]he DON, who is a Registered Nurse, was working 8 hours per day, 5 days per week, and [the facility] was utilizing agency coverage.”  P. Br. at 5.

In ambiguous testimony, Administrator Mika, asserts that, from December 15, 2020, through January 29, 2021, the facility employed a full-time DON.  P. Ex. 2 at 3 (Mika Decl. ¶ 19).  Of course, “employing” an RN does not satisfy the staffing requirement if that employee is unable to work, and Administrator Mika concedes that the DON contracted COVID-19 and was out of the facility “for at least ten days.”  She nevertheless claims that the facility “had an agency nurse some days as well as a full-time registered nurse who left the facility while the DON was out with COVID-19.”  P. Ex. 2 at 4 (Mika Decl. ¶ 20).  Significantly, she does not claim that the agency nurse was an RN.  Nor does she specify when the facility’s remaining DON left the facility.  The unrefuted evidence establishes December 10, 2020, was that RN’s last day at the facility.  CMS Ex. 27 at 1.

In her testimony, DON Mead concedes that she was out of the facility, suffering from COVID-19 at the time of the December 23 survey.  However, she does not say when she left and when she returned.  P. Ex. 8 at 1 (Mead Decl. ¶ 2).  DON Mead was more straight-forward in her interview with Surveyor Smith.  On January 4, she told the surveyor that she was the only RN employed at the facility and that she was out of the facility beginning December 16.  She said that the facility’s other RN had quit, and her last day was December 10.  CMS Ex. 27 at 1.

Ultimately the facility concedes that it did not provide RN coverage as required.  In fact, this is its justification for failing to administer R2a’s anti-seizure medications (discussed below).  “[T]here was not a [registered] nurse in the facility due to staffing issues including . . . the DON . . . being out with COVID-19.”  P. Br. at 11.

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***3. CMS is entitled to a summary judgment finding that the facility was not in substantial compliance with 42 C.F.R. § 483.45(f)(2) because the undisputed evidence establishes that the facility did not administer a resident’s much-needed anti-seizure medications.***

**A.  Program Requirement:  42 C.F.R. § 483.45(f)(2) (Tag F760).**  The facility must provide routine and emergency drugs to its residents and must ensure that its residents are free of any significant medication errors.

**B.  Facility policy:  medication administration.**  The facility had in place a written policy for medication administration under which only physicians and licensed nurses could administer drugs and biologicals.  CMS Ex. 30 at 4.  Among other provisions, it directs staff to notify the physician when a scheduled dose of medication has not been administered, for any reason.  CMS Ex. 30 at 6.

**C.  Survey findings:  the facility’s repeated failure to administer R2a’s anti-seizure medication (January 11 survey).**  As noted above, R2a suffered from serious impairments, including epilepsy.  Her physician prescribed multiple anti-seizure medications (Gabapentin, Lamotrigine, Phenytoin, Pregabalin, and Valproic Acid), and her medications were administered through her G-tube, which she frequently pulled out.  CMS Ex. 28 at 2.

At 6:44 p.m. on December 26, 2020, R2a was taken to the emergency room, having pulled out her G-tube.  Facility staff had replaced the dislodged G-tube with a Foley catheter.  CMS Ex. 28 at 1.  R2a was discharged and returned to the facility at 10:43 p.m. with instructions to follow up with a surgeon, who would replace the Foley catheter with a G-tube.  In the meantime, the emergency room physician ordered that the resident take only clear liquids.  CMS Ex. 28 at 4, 5, 6, 8, 11.

A few hours later, at 1:35 a.m. on December 27, R2a returned to the emergency room with the same problem:  her G-tube was out.  CMS Ex. 28 at 17.  The emergency room physician attempted, unsuccessfully, to remove the resident’s Foley catheter.  He consulted her treating physician, who said that the resident’s anti-seizure medications *should not be held*.  The emergency room physician also consulted a surgeon, who recommended that she be given nothing by mouth (NPO) and nothing by tube (NPT) and that her medications be administered intravenously (IV), which is what the emergency room physician ordered.  CMS Ex. 28 at 17-19.  R2a returned to the facility at 3:39 a.m. CMS Ex. 28 at 17.

But, as discussed above, the facility did not have an RN available, which meant that no one at the facility was qualified to administer an IV, and facility staff simply did not administer R2a’s medications.  CMS Ex. 31 at 5 (Smith Decl. ¶ 33).  Nor did they notify

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R2a’s physician that the resident was not being medicated, as directed by the facility’s medication policy.  *See* CMS Ex. 30 at 6; CMS Ex. 31 at 5 (Smith Decl. ¶ 34).

R2a missed five doses each of Lamotrigine and Valproic Acid, and six doses each of Gabapentin and Phenytoin.  Between 5:00 a.m. and 7:00 a.m. on December 27, R2a experienced at least five seizures.  Staff reported that barely bumping her bed would trigger a seizure.  CMS Ex. 24 at 9.  Although staff called the facility’s Director of Nursing (DON) to report that they needed an RN to administer the resident’s antiseizure medications, the DON did not answer.  Staff then called the resident’s mother, who instructed them to send her to the hospital.  *Id*.

R2a’s physician told Surveyor Smith that not having medications caused the seizures.  Petitioner does not deny that the physician said this nor disagree with his conclusion that the seizures occurred because R2a was not given her anti-seizure medications.  CMS Ex. 27 at 2.

R2a returned to the hospital at 8:45 a.m., the facility reporting that it could not administer her IV medications because no RN was on site.  CMS Ex. 29 at 8.  According to the hospital’s notes, nursing home staff reported witnessing six seizures within the preceding two hours.  CMS Ex. 29 at 1.  Subsequent blood labs showed that R2a’s antiseizure medications were far below their therapeutic ranges.20  CMS Ex. 29 at 11.  The hospital physician ordered “an IV load of phenytoin and valproate.”  CMS Ex. 29 at 6.

**C.  Petitioner’s response:  failure to administer medications.**  Petitioner proffers no real defense to its failing to administer the medications except to point out that the facility “did not have a Registered Nurse in the facility that could administer medications via IV.”  P. Br. at 11.

***4. The penalties imposed – $20,000 per instance for the deficiencies cited under section 483.80(a) during the December 15 survey and $2,265 per day for 25 days of substantial noncompliance for the remaining deficiencies – are reasonable.***

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

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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.

The burden is on the facility “to demonstrate, through argument and the submission of evidence addressing the regulatory factors, that a reduction is necessary to make the CMP amount reasonable.”  *Heritage Plaza Nursing Ctr.*, DAB No. 2829 at 22 (2017), quoting *Oaks of Mid City Nursing and Rehab. Ctr.*, DAB No. 2375 at 26-27 (2011).

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).

Considering the relevant factors, these amounts are reasonable.

CMS offers no evidence of the facility’s history prior to the December 15 survey.

Petitioner does not claim that its financial condition affects its ability to pay the CMP.

**The $20,000 per-instance penalty.**  Penalties are inflation-adjusted and change annually.  The amount is determined as of the date the penalty is assessed, in this case, May 13, 2021.  CMS Ex. 1; 85 Fed. Reg. 2869, 2880 (Jan. 17, 2020).  Here, CMS imposed a penalty of $20,000 per-instance for the deficiency cited under section 483.80(a) (infection control) during the December 15 survey, which, although not the maximum, is toward the upper end of the penalty range ($2,233 to $22,320).  42 C.F.R. §§ 488.408(d), 488.438; 45 C.F.R. § 102.3; 85 Fed. Reg. 2869, 2880.

Petitioner argues that the penalty should be lower because CMS did not find immediate jeopardy.  P. Br. at 12-13.  Although the $20,000 per-instance penalty is toward the top of the per-instance penalty range, it is not at the top of the range, and, considering what CMS might have imposed – a comparable per-day penalty for multiple days of substantial noncompliance – it is modest.  *See Plum City Care Ctr.*, DAB No. 2272 at 18-19 (2009) (observing that even the maximum per-instance CMP can be “a modest penalty when compared to what CMS might have imposed.”).21

Page 30

I am not inclined to dismiss as insignificant the multiple examples cited during the December 15 survey of staff failing to follow infection control policies.  With a highly infectious disease like COVID-19, any deviation from strict infection-control standards can have dire consequences.  As my colleague has noted, in the Age of COVID, a facility’s failing to comply with infection prevention and control requirements “puts its residents at great risk.”  *Crouse Community Ctr., Inc.*, DAB CR6028 at 20 (2022).  Moreover, the facility’s substantial noncompliance with the infection-control regulation was not limited to a handful of residents; it was widespread, putting at risk virtually every facility resident.

As discussed above, the facility failed to comply with infection-control requirements in multiple ways, for which it is culpable:

Facility policies and CDC guidelines required it to affix to the doors of residents who were designated to be on “Transmission-Based Precautions” signage listing necessary precautions.  The facility disregarded that requirement.Careful handling of soiled linens and used PPE is critically important for preventing the spread of infectious diseases.  Yet, the facility touts the fact that it did not have in place a specific policy for disposing of waste from isolation rooms, arguing that the absence of a policy prevents CMS from citing an infection-control deficiency.  This is obvious nonsense.  The facility was required to have such a policy, which should have been in writing, and the facility was not in substantial compliance because its staff threw these contaminated items into unmarked bins, without covers.  They were not even careful enough to make sure that used PPE was confined within its bin.The facility’s policy directed that a nurse who tested positive for COVID-19 be sent home.  We cannot know how long she remained sitting at the nurse’s station because the facility cannot verify when the nurse tested positive.  Notwithstanding its own policies requiring staff to notify the medical director promptly of an employee’s symptoms and to keep detailed records of a COVID test, the facility does not know how long the infected nurse remained working after the positive test.Petitioner has thus failed to meet its burden of establishing that the $20,000 per-instance CMP is unreasonable.

**The $2,265 per-day penalty.**  I assess whether a per-day penalty is reasonable based on the amount imposed per day, not the total accrued penalty.  *Vibra Hospital of Charlston*, DAB No. 3094 at 30-31 (2023); *Crawford Healthcare and Rehab.*, DAB No. 2738 at 20 (2016).  The $2,265 per-day penalty CMS imposed is at the low-end of the range for per-day penalties ($112 to $6,695).

Page 31

The infection-control deficiencies, cited during the January 11 survey, were repeat deficiencies, which, by itself, justifies a CMP that is higher than the minimum.

Petitioner suggests that the penalty should be lower because the deficiencies were not cited at the immediate jeopardy level.  Had CMS found immediate jeopardy, the per-day penalty would have been substantially higher.  The minimum per-day penalty for a situation of immediate jeopardy is $6,808 – more than three times higher than the penalty imposed.

I have discussed in some detail the multiple ways the facility’s substantial noncompliance continued following the December 15 survey.  Again, it failed to post the required signage on a resident’s door.  Its nursing staff disregarded CDC guidelines and facility policies for donning and doffing PPE, hand hygiene, and sanitizing shared equipment.  It did not have available the services of a registered nurse, as required.  The absence of a registered nurse had a devastating impact on R2a, who experienced multiple seizures because she did not receive the medications that she needed.

The facility is also accountable for the deficiencies it didn’t appeal:

An unqualified nurse aide performed glucose monitoring tests for multiple residents, which put the facility out of substantial compliance with 42 C.F.R. § 483.21(b)(3).  P. Ex. 1 at 2-7.Nurse aides did not follow R2a’s care plan and provided the resident with substandard incontinence care, which put the facility out of substantial compliance with 42 C.F.R. § 483.25(e).  CMS Ex. 24 at 1-3; *see* n.10, above.The facility failed to address, in her care plan, R2a’s practice of pulling out her G-tube, which put the facility out of substantial compliance with 42 C.F.R. § 483.25(g).  CMS Ex. 24 at 3-6; *see* n.11, above.Petitioner has thus not met its burden of establishing that reductions are necessary to make the CMP amounts reasonable.

Conclusion

The undisputed evidence establishes that the facility failed to follow CDC guidelines and its own infection control policies and was therefore not in substantial compliance with 42 C.F.R. § 483.80(a).

The undisputed evidence also establishes that the facility was not in substantial compliance with 42 C.F.R. §§ 483.35(b)(1)-(3) and 483.45(f)(2).

Page 32

Petitioner has not appealed the deficiencies cited under 42 C.F.R. §§ 483.21(b)(3), 483.25(e), and 483.25(g).  Those determinations are therefore final and binding.

The penalties imposed are reasonable.

Endnotes

1  I highlight, in bold, the deficiencies that are the subjects of this appeal, although, as discussed below, Petitioner’s hearing request does not specifically challenge all of the deficiency findings that I am reviewing.

2  CMS Ex. 37, which was submitted after CMS submitted its initial exchange, is a supplemental declaration that corrects an error in CMS Ex. 31, the written declaration of Surveyor Kim Smith.

3  Deciding a case on summary judgment does not mean that it is decided without a hearing.  In reviewing administrative appeals decided on summary judgment, courts describe the case as having been decided without an “oral hearing” or without an “evidentiary hearing.”  They recognize that, by considering the evidence and applying the law, the ALJ has granted the petitioner a 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.”).  Thus, granting summary judgment (or deciding a case on the written record) satisfies the hearing requirements of sections 205(b) and 1866(h) of the Act.

4  My Findings of Fact/Conclusions of Law are set forth, in italics and bold, in the discussion captions of this decision.

5  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.

6  “Standard Precautions” are infection prevention practices that apply to all residents, regardless of suspected or confirmed diagnosis or presumed infection status.  *Desert Lane Care Ctr.*, DAB No. 2287 at 16 n.10 (2009).  They include:  hand hygiene; using PPE whenever exposure to infectious material is expected; following respiratory hygiene/cough etiquette principles; properly handling, cleaning, and disinfecting patient care equipment and instruments; cleaning and disinfecting the environment; and handling laundry carefully.  CMS Ex. 34 at 13-14; *see* https://www.cdc.gov/infectioncontrol/basics/standard-precautions.html.

7  “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.  https://www.ohca.org/docs/documents/5963/Cohorting.pdf (initially published on April 4, 2020 at https://www.ahrq.gov/nursing-home/resources/cohorting-residents.html).

8  MRSA causes staph infections that are difficult to treat because of resistance to antibiotics.  Staph infections, including those caused by MRSA, can spread in healthcare facilities.  MRSA can be passed to patients directly from the *unclean hands* of healthcare workers or visitors or from contact with *contaminated bed linens, bed rails, and medical equipment*.  https://www.cdc.gov/mrsa/community/patients.html.

9  C.diff is a germ (bacterium) that causes diarrhea and colitis.  Risk factors include taking antibiotics; age (65 or older); recent stay in a hospital or nursing home; weakened immune system; and prior infection.  It is contagious.  *Frequent handwashing with soap and water* is the best way to prevent its spread.  https://www.cdc.gov/cdiff/what-is.html.  Other important interventions include timely testing; using *contact isolation precautions, including wearing gloves and a gown; and daily cleaning of patient rooms*.  https://www.cdc.gov/cdiff/clinicians/faq.html.

10  The facility does not benefit from CMS’s determining that it achieved short-lived substantial compliance with section 483.80(a).  A facility is required to *maintain* substantial compliance.  In enacting nursing home reform, Congress expressed particular frustration with facilities’ erratic compliance histories.  See H.R. Rep. No. 100-391(l), 100th Cong., 1st Sess. at 471 (1987) (expressing the goal of eliminating the “yo-yo” or “roller coaster” phenomenon); *Florida Agency for Health Care Admin. v. Bayou Shores SNF*, LLC, 828 F.3d 1297 at 1325-26 (2016); *Heartland Manor at Carriage Town*, DAB No. 1664 (1998).

11  The parties refer to this resident as R2a to distinguish her from R2, who was discussed in the December 15 survey.  CMS Br. at 6 n.1; P. Br. at 1 n.1.

12  Surveyor Smith observed nurse aides providing substandard incontinence care to R2a.  They used hand soap instead of the designated perineal cleaner; each used one towel for multiple front-to-back passes; they did not rinse and dry the resident after cleaning her; and they did not apply barrier cream, as called for in her care plan.  CMS Ex. 24 at 2; CMS Ex. 26 at 6; CMS Ex. 31 at 3 (Smith Decl. ¶¶ 19, 20, 21, 22, 23).  Based on the survey findings, CMS determined that the facility was not in substantial compliance with 42 C.F.R. § 483.25(e).  CMS Ex. 24 at 1-3; CMS Br. at 17.  Petitioner did not appeal that deficiency.  *See* Hearing Request (E-file # 1).

13  CMS also cited the facility for violating section 483.25, based on staff’s failing to care plan the resident for pulling out her G-tube or taking other steps to protect her.  Petitioner did not appeal the deficiency.  *See* Hearing Request (E-file # 1).  Nor did Petitioner respond to CMS’s discussion of the deficiency.  CMS Br. at 17-18; *see* P. Br.

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

15  Although the evidence is sketchy, it seems that, during the COVID outbreak, the facility employed outside agency nurses.  *See* P. Ex. 2 at 4 (Mika Decl. ¶ 20).  This may have been just one nurse, or it may have included additional staff.  To the extent that outside staff were brought in, the facility could not be assured that they would understand nonspecific signage.

16  Petitioner also complains that the signage had been in place since February 2020, and a July 2, 2020 survey cited no infection control deficiencies.  P. Ex. 9; P. Br. at 7.  That survey is not before me.  My review is limited to what was going on at the facility in December 2020 and January 2021.  Moreover, the record includes no evidence describing the situation in the facility, including the prevalence of infectious diseases (if any) in July 2020.

17  It is also questionable whether such speculative and unsupported testimony can create material facts in dispute.  *See* *W. Texas LTC Partners, Inc.*, DAB No. 2652 at 15 (holding that a DON’s unsupported speculation about the accuracy of the surveyor’s findings “does not even create ‘metaphysical doubt,’ much less raise a genuine dispute of material fact as required to preclude summary judgment.”).

18  Citing CMS’s May 13, 2021 notice letter, Petitioner declares that the nursing services deficiency was cited during the December 15 survey.  P. Br. at 2.  This is incorrect.  *See* CMS Ex. 7.  The nursing services deficiency was initially cited during the December 23 survey.  P. Ex. 1 at 7-11.  The May 13 notice letter combined the deficiencies cited during the December 15 and the December 23 surveys.  *See* CMS Ex. 1.

19  Under limited circumstances (not applicable here), the Secretary may waive this requirement.  *See* 42 C.F.R. § 483.35(f).

20  The therapeutic range for Phenytoin is 10.0 – 20.0 ug/ml.  R2a’s level was 1.0.  The therapeutic range for Valproic Acid is 50.0 -100.0 mcg/ml.  R2a’s level was <3.0.  CMS Ex. 29 at 11.

21  The penalty could have been as high as $6,695 per day for multiple days.  85 Fed. Reg. 2869, 2880.
  
          /s/
        Carolyn Cozad Hughes

                      Administrative Law Judge Back to top
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