Brenham Nursing and Rehabilitation Center, DAB CR6076 (2022)

DECISION

This case involves a long-term-care facility’s response to the Covid pandemic.  I consider whether the facility implemented its policies and imposed basic measures necessary to protect its residents from the infectious disease and to care for them when they contracted it. 

Brenham Nursing and Rehabilitation Center is a long-term-care facility, located in Brenham, Texas, that participates in the Medicare program.  Following a survey, completed on May 15, 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 a civil money penalty (CMP) of $21,350 per day for 20 days.  Petitioner has appealed, and CMS moves for summary judgment. 

For the reasons set forth below, I grant CMS’s motion.  The “material facts” cited by Petitioner are not facts at all; they are the ultimate legal conclusions that I must resolve in order to decide this case.  Petitioner has not come forward with evidence that any of the underlying facts material to this decision are in dispute.  Those facts establish that the

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facility was not in substantial compliance with Medicare program requirements, that its deficiencies posed immediate jeopardy to resident health and safety, and that the penalty imposed is 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 may 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). 

In this case, surveyors from the Texas Department of Aging and Disability (state agency) completed a survey of the facility on May 15, 2020.  Based on their findings, CMS determined that the facility was not in substantial compliance with the following Medicare participation requirements: 

• 42 C.F.R. § 483.25 (Tag F684) (quality of care) cited at scope and severity level J (isolated instance of substantial noncompliance that poses immediate jeopardy to resident health and safety);
• 42 C.F.R. § 483.35(a)(1)(2) (Tag F725) (nursing services – sufficient staff) cited at scope and severity level K (pattern of substantial noncompliance that poses immediate jeopardy to resident health and safety);
• 42 C.F.R. § 483.70 (Tag F835) (administration) cited at scope and severity level L (widespread substantial noncompliance that poses immediate jeopardy to resident health and safety);
• 42 C.F.R. § 483.70(d)(1)(2) (Tag F837) (administration – governing body) cited at scope and severity level L; and

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• 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.

CMS Exs. 1, 3. 

Thereafter, CMS determined that the facility returned to substantial compliance on May 16, 2020.  CMS Ex. 2. 

Based on the deficiencies cited, CMS has imposed against the facility a penalty of $21,350 per day for 20 days of substantial noncompliance that posed immediate jeopardy to resident health and safety (April 16, 2020 through May 5, 2020) (total $427,000).  CMS Exs. 2, 3.

Petitioner appealed, and CMS has moved for summary judgment.

With its motion and brief (CMS Br.), CMS submitted 28 exhibits (CMS Exs. 1-28).  With its response and pre-hearing brief (P. Br.), Petitioner submitted three exhibits (P. Exs. 1-3).  Petitioner objects my admitting CMS Exs. 24, 25, 26, and 28, as well as portions of CMS Exs. 6, 8, and 23.  In deciding a case on summary judgment, I must consider all proffered evidence to determine whether any of it creates a material fact in dispute.  However, I need not rule on the parties’ objections to exhibits.  Lilia Gorovits, M.D., P.C., DAB No. 2985 at 3 n.4 (2020), aff’d, Gorovits v. Becerra, No. CV 20-1850 (E.D. Pa. May 17, 2021).1

Issues

As a threshold matter, I consider whether summary judgment is appropriate.

On the merits, the issues are:

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• From April 16 through May 5, 2020, was the facility in substantial compliance with Medicare program requirements;
• If the facility was not then in substantial compliance, did its deficiencies pose immediate jeopardy to resident health and safety; and
• If the facility was not in substantial compliance with program requirements, is the penalty imposed – $21,350 per-day – 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 (6^th 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. v. Zenith Radio Corp., 475 U.S. 574, 586 n.11 (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 (5^th 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 non-moving party’s legal conclusions.  W. Tex. LTC Partners, Inc., DAB No. 2652 at 6-7; cf.

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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 (5^th Cir. 2019) (citing Cedar Lake Nursing Home v. U.S. Dep’t of Health & Human Servs., 619 F.3d 453, 457 (5^th Cir. 2010)); see Fal-Meridian, Inc. v. U.S. Dep’t of Health & Human Servs., 604 F.3d 445, 449 (7^th 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 E. Pa., DAB No. 2451 at 4 (2012); Vandalia Park, DAB No. 1939 at 5-6, citing Crestview Parke Care Ctr. v. Thompson, 373 F.3d at 750 (6^th Cir. 2004).  As the 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 at 4; Vandalia Park, DAB No. 1939 at 5-6. 

Here, Petitioner concedes that “some of the facts and occurrences recited in CMS’s [m]otion are accurate” but argues that these “limited facts,” by themselves, do not constitute substantial noncompliance.  Petitioner also argues that, even if the undisputed facts establish substantial noncompliance, “fact issues” remain:  whether the facility’s substantial noncompliance rose to the level of actual harm and/or immediate jeopardy; and whether the penalty is reasonable/proportionate based on the level of noncompliance.  P. Br. at 17.  These, of course, are not disputes of fact.  Whether the undisputed facts establish that: 1) the facility was not in substantial compliance; 2) its substantial noncompliance posed immediate jeopardy to resident health and safety; and 3) the penalty imposed is reasonable are conclusions of law.  Indeed, they are the ultimate conclusions that I must reach in order to decide this case.  Disputes over conclusions of law do not preclude summary judgment.  W. Tex. LTC Partners, Inc., DAB No. 2652 at 6-7; Guardian, DAB No. 1943 at 11. 

1. CMS is entitled to summary judgment because the undisputed evidence establishes that, contrary to facility policies and the resident’s care plan, staff conducted no assessment, took no vital signs, and provided no treatment to a Covid-positive resident when she returned from the hospital emergency room.  Because it failed to provide these basic but necessary services, the

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1. facility was not in substantial compliance with 42 C.F.R. §§ 483.25 and 483.80(a).2

The parties dispute whether the facility followed the specialized infection-control guidance that the Centers for Disease Control and Prevention (CDC) provided to nursing homes.  CMS maintains that the facility did not adhere to those guidelines, while Petitioner complains that the guidance “was continuously changing and no clear guidelines existed” for managing the virus effectively.  CMS Br. at 13-14; P. Br. at 21.  I need not reach this issue.

As discussed below, the infection-control regulation requires that the facility have in place infection control policies and that it follow those policies.  Where, for example, the undisputed evidence established that a facility’s medical director opted not to follow the facility policy (and CDC protocols) in prescribing prophylactic medications, the Departmental Appeals Board found that the facility violated the infection control regulation and that the ALJ appropriately granted summary judgment.  Golden Living Ctr. – Superior, DAB No. 2768 at 7 (2017).

This is consistent with a long line of Board 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 & Rehab. Ctr., DAB No. 2947 at 6, citing The Laurels at Forest Glenn, DAB No. 2182 at 18 (2008); N. Las Vegas Care Ctr., DAB No. 2946 at 6 (2019); Hanover Hill 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 policies as well as a resident’s care plan, I find that the facility was not in substantial compliance with program requirements and need not consider the facility’s failure to follow CDC guidelines.

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Program requirement:  42 C.F.R. § 483.25 (Tag F684).  As an overarching proposition, the Medicare statute and the “quality-of-care” regulation mandate that the facility ensure that each resident receive, and the facility provide, the necessary care and services to allow the resident to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the resident’s comprehensive assessment and plan of care.  Act § 1819(b)(2); see 42 C.F.R. § 483.20 (requiring the facility to conduct, initially and periodically, a comprehensive, accurate, standardized, reproducible assessment of each resident’s functional capacity); 42 C.F.R. § 483.21(b) (requiring the facility to develop and implement a comprehensive, person-centered care plan for each resident, consistent with the resident’s rights, that includes measurable objectives and timeframes to meet a resident’s medical, nursing, and mental and psychosocial needs that are identified in the comprehensive assessment). 

The Departmental Appeals Board has determined that the “necessary care and services” mandated by section 483.25, include the care and services called for by the facility’s own resident care policies.  N. Las Vegas Care Ctr., DAB No. 2946 at 6; Rockcastle Health & Rehab. Ctr., DAB No. 2891 at 19 (2018) (holding that, absent contrary evidence, it is reasonable to presume that a facility’s resident care policies reflect professional standards of quality); Life Care Ctr. of Tullahoma, DAB No. 2304 at 34 (2010), aff’d, Life Care Ctr. Tullahoma v. Sec’y of U.S. Dep’t of Health & Human Servs., 453 F. App’x 610 (6^th Cir. 2011); see also Good Shepherd Home for the Aged, Inc., DAB No. 2858 at 12 (2018) (stating that section 483.25 obligates the facility to follow its own resident care policies). 

Program requirement:  42 C.F.R. § 483.80(a)(1)(2)(4)(e)(f) (Tag F880).  The facility must 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: 

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

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

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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 infections should be reported;

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

iv) when and how isolation should be used for a resident, including:

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

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

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

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

*  *  *  *  *

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

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

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

See Social Security Act § 1819(d)(3) (requiring facilities to establish and maintain infection control programs that prevent the development and transmission of disease and infection and protect the health and safety of residents.)

Facility policy:  Covid-19 assessment and reporting protocol.  For facility residents who are Covid-negative, the facility’s policy requires staff to monitor and document the resident’s vital signs every shift.  These include temperature, heart rate, blood pressure, respiratory rate, oxygen saturation, and lung sounds.  CMS Ex. 11.

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If any of the following respiratory parameters are found, staff must notify an advanced practice provider or MD: 

• Blood pressure below 110/60
• Oxygen saturation level (SPO2) less than 90%
• Temperature above 99.6
• Respiratory rate greater than 20 beats per minute (bpm) or less than 10 bpm
• Lung sounds – any changes from the previous assessment (considering any significant changes from the resident’s baseline).

CMS Ex. 11.

The policy instructs staff to complete a BIMS (Brief Interview for Mental Status) score every shift and to notify the advanced practice provider or MD of any reduction in the BIMS score category. 

Staff are to monitor fluid intake and output every shift and notify the advanced practice provider or MD if, for a 12-hour shift, output is less than 500 ccs or fluid intake is less than 40 ounces or 1200 ccs. 

Staff must also monitor PO (oral) meal intake.  If it falls below 50% for 12 consecutive meals (taking into consideration the resident’s previous consumption), notify the advanced practice provider or MD. 

The policy also instructs staff to consider testing, for Covid-19 or other testing, residents not known to be Covid positive.  CMS Ex. 11.  

For residents who are confirmed Covid-19 positive, staff must monitor and document their vital signs every six hours.  This includes temperature, heart rate, blood pressure, respiratory rate, oxygen saturation, and lung sounds.  Id. 

The policy then lists parameters that require staff to notify an advanced practice provider or MD: 

• Blood pressure below 110/50
• Oxygen saturation level (SPO2) less than 90% on room air
• Temperature above 100.6
• Respiratory rate greater than 22 beats per minute (bpm) or less than 10 bpm
• Lung sounds – any changes from previous assessment (considering any significant changes from the resident’s baseline).

CMS Ex. 11.

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The policy instructs staff to complete a BIMS score every shift and to notify the advanced practice provider or MD of any reduction in the BIMS score category. 

Staff are to monitor fluid intake and output every shift and notify the advanced practice provider or MD if, for a 12-hour shift, output is less than 500 ccs or fluid intake is less than 40 ounces or 1200 ccs. 

Staff also monitor PO (oral) meal intake.  If it falls below 50% for 12 consecutive meals (taking into consideration previous consumption), staff must notify the advanced practice provider or MD.  

Staff should transfer the resident to the emergency room “on the above single or combination of vital signs and/or clinical assessment by MD/APP [advanced practice provider].”  CMS Ex. 11. 

The facility’s Covid response plan.  In a memorandum dated April 16, 2020, the facility’s medical director, Francisco Leal, M.D., set forth basic guidelines, designed to contain the Covid-19 contagion.4  The guidelines include:  

1. Quarantine/isolate and test any resident with fever, cough, dropping oxygen saturations, shortness of breath, or other symptoms suggestive of Covid‑19. Move to a dedicated area (100-200 hall).  Health care personnel in these areas should wear N95 masks, if available, or, at a minimum, surgical facemasks.  Consider full PPE (personal protective equipment), if appropriate.  
2. Stress frequent, proper hand-hygiene practice (soap and water superior to alcohol sanitizer). This is basic but essential throughout the entire facility.  Avoid face touching. 
3. Implement transmission-based precautions:

a) mask all patients and anyone in the building;

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b) avoid “HHN – use MDI with spaces” (“if must use HHN – staff with face shield and N95”);

c) avoid BiPAP/CPAP unless in isolated room.

4. Dedicate specific staff to care for only those affected and suspected residents in the dedicated areas. Two groups of caregivers (positive or suspected) vs. (negative or asymptomatic).  
5. Use bare minimum staffing, as much as possible.
6. If a resident becomes newly sick with symptoms, isolate to dedicated area (100/200 hall) and test as soon as possible.
7. Cohort existing Covid-19 residents to dedicated area (100/200 hall). Be quick to move to dedicated area.  Even if a resident has tested negative, if there is reason to suspect infection, such as roommate exposure or symptoms, move that resident.  As a single hallway for isolated patients is used, there will be an area to don/doff PPE to minimize further spread to the facility. 
8. Suspend all group activities.
9. Limit physical, occupational, and speech therapy. Allow therapy to continue ONLY on patients whose sole reason for admission is therapy, ideally with a test-negative therapist. 
10. Attempt/encourage testing of all employees. This should come from their primary care physician, if possible.  Consider using BNRC [Petitioner’s] lab.  Can use BSW [Baylor Scott and White] testing site if the employee wishes.  Unfortunately, supplies are limited, and turnaround time is longer than ideal.  This is an effort to catch asymptomatic carriers who may inadvertently be spreading the virus. 
11. Restrict new admissions. Expect staffing shortages as health care professionals test positive or withdraw, fearing contagion.  Once contained, reopen admissions.  Ideally, new patients should be in private rooms (for two weeks) as they too may be asymptomatic carriers. 
12. Meals to be served in patient rooms, not common areas.
13. Staff should be screened at entry at the start of each shift, during the shift, and after the shift, for symptoms or fever. Temperature elevation, even if subjective, should be reported to appropriate personnel.

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14. Environmental clean and disinfect often. Develop a schedule for regular cleaning and disinfection of shared equipment and frequently-touched surfaces in resident rooms and common areas. 
15. Redirect all patients to their rooms. Close doors if the patients allow it. 
16. Place ill healthcare professionals on furlough until they test negative on two tests, at least 24 hours apart and after one week without symptoms. Consider other means deemed appropriate by the CDC. 
17. Reinforce sick leave policies and remind health care personnel not to report to work when ill.
18. All health care personnel should be reminded to practice social distancing when at work, in break rooms, or in common areas. Ask healthcare personnel to be responsible citizens and practice physical distancing at home and to shelter in place as feasible. 
19. Not everyone who is Covid-19 positive needs to be moved to the hospital. If positive and stable, they should remain in the facility.  If unstable, move only if critically ill or worsening.  First, consult the ER about the desired transfer.  Note that the facility may be asked to take back the resident after hospitalization. 
20. Abide by guidelines from the CDC and local and state health authorities.

CMS Ex. 18. 

Facility policy:  Outbreak of novel Coronavirus.  The facility policy mandates that a suspected outbreak of the Coronavirus within the facility be identified promptly and handled appropriately, following CDC recommendations.  The facility administrator or director of nursing (DON) must notify the local health department of the outbreak.  Personal protective equipment (PPE) (e.g., gowns, gloves, NIOSH-certified N95 respirators)5 will be provided to the employees.  CMS Ex. 19. 

Resident 1 (R1).  R1 was a 93-year-old woman, admitted to the facility on January 29, 2016, suffering from multiple impairments, including:  dementia without behavioral disturbance; an anxiety disorder; atrial fibrillation; osteoporosis; hypertension; peripheral vascular disease; tinea unguium (a fungal infection); anemia; gout; and hypokalemia (low potassium).  She had a history of falls.  CMS Ex. 12; CMS Ex. 14 at 26, 27. 

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As of March 30, 2020, R1 had a BIMS score of 9, indicating that she had a moderate cognitive impairment.  CMS Ex. 14 at 7.  She required a one-person physical assist for activities such as repositioning herself in bed, walking, and toilet use.  She required a walker.  CMS Ex. 14 at 15, 16.  She was totally dependent on staff for bathing.  CMS Ex. 14 at 16. 

R1’s pre-Covid care plan.  R1 was at high risk for communicable respiratory infections because of her age and living situation (in close proximity to others).  To address the problem, her care plan called for flu and pneumonia vaccinations and current immunization records.  Staff were required to monitor the facility for trends in respiratory infections.  CMS Ex. 17 at 3. 

On March 13, 2020, R1’s care plan was amended to add that the resident was at risk for signs and symptoms of Covid-19.  To address the issue, her plan required that staff, the resident, her family, and visitors be educated as to the signs and symptoms of Covid and Covid precautions.  Staff were required to follow the facility’s protocol for Covid-19 screening and precautions.  Staff were also required to observe the resident for signs and symptoms of Covid-19 and to document and report promptly those signs and symptoms:  fever, coughing, sneezing, sore throat, respiratory issues.  CMS Ex. 17 at 19. 

Post-exposure additions to R1’s care plan.  R1’s care plan was amended again on April 23, 2020.  The plan noted that R1 was at risk for deterioration of her medical condition related to her possible exposure to other Covid-19 positive individuals.  The results from her own Covid-19 test were pending.  Her risk factors included atrial fibrillation, peripheral vascular disease, and hypertension.  CMS Ex. 17 at 20. 

The amended plan included a long list of interventions: 

• educating staff on the use of personal protective equipment;
• instructing staff on proper donning, doffing, and disposal of items used;
• educating staff, the resident, the resident’s family, and visitors on Covid-19 signs and symptoms and precautions;
• following the facility’s Covid-19 protocols for screening and precautions;
• maintaining the resident in a private room or cohort with other Covid-19 positive residents;
• providing all care and services in the resident’s room;
• keeping the resident’s door closed whenever possible;
• “educate and encourage use of respiratory etiquette and frequent hand hygiene”;
• notify transport personnel or a receiving healthcare facility of the potential for Covid-19 illness and necessary precautions;
• observe R1 for deterioration of clinical/medical status and update her medical practitioners as clinically indicated;

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• observe for and promptly report signs and symptoms of Covid-19: fever, coughing, sneezing, sore throat, respiratory issues, change in vital signs;
• offer and encourage fluids to maintain hydration; and
• provide medications or treatments as ordered and observe for effectiveness.

CMS Ex. 17 at 20-21. 

R1’s positive Covid-19 test and care plan.  A nursing note entered at 4:08 a.m. on April 24, 2020, indicates that R1 tested positive for Covid-19 and that the facility was in the process of moving her to an isolation room.  Her vital signs were reported as:  blood pressure 115/69; pulse 97; temperature 98.6, respiratory rate 16, oxygen level 91% on room air.  At that time, she exhibited no signs of respiratory distress or discomfort.  CMS Ex. 16 at 4.  After she tested positive for Covid-19, R1’s care plan was again amended to reflect that she was at risk for deterioration in her medical condition.  Nevertheless, the interventions listed were essentially unchanged except to add that contact/droplet precautions were in place.  CMS Ex. 17 at 22-23. 

R1’s April 24, 2020 ER visit and return to the facility.  The nurses’ notes describing the events of April 24 were not entered chronologically (many were late entries) and must be carefully parsed to determine the sequence of events.  They establish the following: 

• A note entered at 4:08 a.m. indicates that the facility learned that R1 tested positive for Covid-19. According to the nurse’s note, the facility planned to move her to an isolation room.  At that time, her vital signs were within acceptable levels (BP 115/69; P 97; T 98.6; RR 16; SPO2 91% on room air), and she was resting comfortably, without signs of respiratory distress.  CMS Ex. 16 at 2; see CMS Ex. 11. 
• The resident was subsequently transferred to a room on the 100 hall. She was not doing well.  At 10:45 a.m. Nurse Practitioner Aurbrey Eikenhorst, FNP-C assessed her.6   Her oxygen saturation level was 85% on room air.  She was administered two liters of oxygen per nasal cannula and her level rose to 92%.  Her other vital signs were:  T 101.4; BP 133/72; P 134; RR 16.  CMS Ex. 16 at 1. 

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• R1was sent to the emergency room at 11:25 a.m. CMS Ex. 16 at 1. 
• At approximately 3:30 p.m., R1 returned to the facility from the emergency room. She was on two liters of supplemental oxygen.  No record suggests that staff took her vital signs (or provided any other treatment) then or at any time during the next seven hours.  CMS Ex. 16 at 1, 3. 
• More than seven hours later, at 10:40 p.m., the nurse practitioner ordered R1 returned to the emergency room for evaluation and treatment. The resident was suffering from hypoxia (insufficient oxygen to meet the body’s needs) and respiratory distress.  CMS Ex. 16 at 1, 3. 
• A nurse’s note entered at 3:23 a.m. on April 25, 2020 reports that the emergency room called earlier that night to report that R1 expired. CMS Ex. 16 at 1, 3. 

Hospital records establish that R1 returned to the emergency room in critical condition.  Her oxygen saturation levels at the nursing home had been 50% on room air.  The emergency medical team treated her with oxygen via nasal cannula and gave her a shot of epinephrine (adrenaline) for wheezing.  CMS Ex. 20 at 1.  R1 died at 12:50 a.m. on April 25, 2020.  Her diagnosis was pneumonia due to the Covid-19 virus.  CMS Ex. 20 at 1, 4. 

That no vital signs were taken between 3:30 and sometime between 10:00 and 10:40 p.m. is undisputed.  Interviewed by surveyors, the facility’s medical director confirmed that, from the time she returned from the hospital at 3:30 p.m., facility staff had documented no assessment or vital signs.  CMS Ex. 6 at 9, 14.  Surveyors interviewed “LVN B,” who was the sole nurse on duty in the Covid unit during the 2-10 p.m. shift on April 24.  The nurse confirmed that she was not able to take the resident’s vital signs or otherwise assess her because she “had a lot going on.”  She finally checked on the resident after about 10:00 p.m. because a nurse aide informed her that the resident “did not look good.”  CMS Ex. 6 at 15-16; CMS Ex. 24 at 4 (Wiktorik Decl. ¶ 10). 

Petitioner does not deny that staff failed to take R1’s vital signs or assess her condition between 3:30 and approximately 10:00 p.m., but, citing records from the earlier emergency room visit, declares that the resident would have died anyway, and “no amount of monitoring would have changed the fact that [her] condition was expected to worsen before she ever left the hospital.”  P. Br. at 18, citing CMS Ex. 20 at 9. 

I find significant problems with Petitioner’s arguments.  First, the claim that the medical professionals considered R1’s death inevitable is not supported by the hospital records or any other evidence.  Second, nothing in the statute, regulations, facility policies, resident assessment, or resident care plan allows the facility to ignore a critically ill resident for up to seven hours. 

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Petitioner does not accurately represent what transpired in the emergency room at the time of R1’s earlier visit.  This is not a question of drawing a reasonable inference in Petitioner’s favor.  It is not even a question of the assertions being unsupported.  Petitioner’s claim that hospital staff expected R1’s condition to worsen and that they predicted that she would die is flatly contradicted by the hospital records.  Those records show that (with treatment) the resident’s oxygen saturation levels had improved to 92% on room air and 98% on two liters of oxygen.  She was in no distress.  Her fever was improving.  The emergency room found no definite requirement for hospital admission.  While staff explained, and R1’s daughter recognized, the possibility for decompensation, given the resident’s age and Covid status, R1’s daughter opted to return the resident to the facility, thinking that she would be more comfortable there.  R1 was discharged and returned to the facility in stable condition.  CMS Ex. 20 at 9.  This is a far cry from Petitioner’s claim that hospital staff declared it inevitable that R1 would decompensate and die. 

The resident’s care plan also reflects her assessment team’s opinion that R1 could be treated successfully for Covid.  After she contracted the disease, her care plan’s goal was that she “remain free from significant adverse effects related to Covid-19 positive test, including hospitalization.”  CMS Ex. 17 at 20. 

Moreover, nothing justifies the facility’s failing to assess or monitor the resident’s progress until she was on the verge of death.  As reflected in the facility’s Covid policy and the resident’s care plan, heightened, not less, monitoring was called for.  CMS Ex. 11 (requiring staff to monitor and document a Covid-positive resident’s vital signs every six hours); CMS Ex. 17 at 20-21 (requiring that staff observe R1 for deterioration of clinical status and signs and symptoms of Covid 19).  Even assuming that her death was inevitable (which the evidence does not support), she should not have spent her final hours suffering the kinds of extreme discomfort associated with low oxygen levels.  At a minimum, she was entitled to comfort care; she received none. 

Instead of producing evidence that anyone was monitoring R1, Petitioner argues that the “absence of formal, written assessments does not mean that the [r]esident was entirely left alone from the time she arrived back at the facility and until her second transfer to the hospital.”  P. Br. at 19.  So where is there even a modicum of evidence that anyone checked on her between 3:30 and 10:00 p.m.?  The record includes no notes, no witness statements, and no written declaration from anyone who claims to have done so.  The surveyors interviewed staff on duty that afternoon and evening.  No one claimed to have checked on or provided any care to the resident.  See CMS Ex. 6. 

Citing the statement of deficiencies, Petitioner argues that staff’s attention to R1 “is documented” by the nurse aide’s 10:00 p.m. observation and her report to the LVN and the LVN’s subsequent assessment.  P. Ex. 3 at 1 (Sterling Decl.); P. Br. at 19.  I agree that this well documents the level of care and services the facility provided to R1.  It

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shows that, prior to approximately 10:00 p.m., the facility provided NO care or services to this seriously ill resident. 

This neglect is all the more inexcusable because R1 could have been admitted to the hospital, where she could have been cared for.  At a minimum, the facility should have informed the hospital and R1’s daughter that it did not have adequate staff to provide even minimal care and services, much less the level that R1 required. 

Petitioner now blames the presence of the HHSC (Health and Human Services Commission) Strike Team for disrupting its ability to provide care.7   However, the undisputed evidence establishes that the facility was not providing necessary care and services well before that team arrived.  CMS Ex. 6 at 4.  Indeed, the facility’s deficiencies predated (and likely triggered) the arrival of this team.8   See CMS Ex. 23 (Loesch Decl.) and discussion below regarding the multiple ways in which, prior to April 24, the facility failed to follow its policies and implement physician recommendations for preventing and combatting Covid. 

The absence of care on April 24, was the most dramatic instance of the facility’s failing to provide R1 with necessary care and services in accordance with her assessment and care plan, but it was not the only instance.  For Covid-negative residents, the facility’s policy required staff to monitor and document the resident’s vital signs – temperature, heart rate, blood pressure, respiratory rate, oxygen saturation, and lung sounds – every shift.  CMS Ex. 11.  R1’s treatment record reflects multiple instances in which the facility failed to provide the services called for in her care plan and in the facility’s policies: 

• From March 28 through April 21, 2020, no progress notes were recorded;
• Staff documented no temperatures for R1 on April 11, 18, and 21, 2020;
• Staff documented no pulse or blood pressure readings for R1 on April 7, 11, 18, and 21, 2020;

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• Staff did not document R1’s respiratory rate on April 5, 7, 11, 17, 18, and 21, 2020;
• Staff did not document any oxygen saturation levels for R1 on April 5, 11, 18, and 21, 2020;
• Staff did not document any skilled assessments on April 1, 2, 3, 4, 5, 6, 7, and 8, 2020.

CMS Ex. 6 at 15; see CMS Ex. 16. 

Petitioner has neither claimed nor presented evidence to establish a dispute as to whether staff provided these services to R1 on the dates listed. 

Because the undisputed evidence establishes that the facility did not follow the policies it had in place to treat this Covid-infected resident and because the undisputed evidence establishes that, for approximately seven hours, staff did not assess, take vital signs, or otherwise provide necessary care and services to R1, the facility was not in substantial compliance with 42 C.F.R. §§ 483.25 and 483.80(a).  

2. CMS is entitled to summary judgment because the undisputed evidence establishes that the facility did not follow its infection control policies nor the written instructions and recommendations of its medical director. These failings put the facility out of substantial compliance with 42 C.F.R. § 483.80. 

The deficiencies described above more than justify the penalty imposed here (see discussion, below).  CMS has come forward with additional evidence showing that the facility’s failure to comply with the infection control regulation was not limited to its treatment of R1.  Petitioner has not tendered evidence showing that a dispute exists over any of these facts: 

• The facility was not adequately cleaned. Surveyor Wiktorik and Alex Daniels, an epidemiologist with the Department of State Health Services, toured the facility on April 25.  Hallways and handrails were dirty.  Trash and gloves were on the floors and wedged into the handrails.  Epidemiologist Daniels recommended that the facility remove items, such as lifts and equipment, from the hallways and alcoves.  Multiuse equipment should have been tagged to indicate that it had been cleaned after use.  The surveyor and the epidemiologist agreed that the facility needed more staffing to keep the facility clean.  CMS Ex. 6 at 5; CMS Ex. 24 at 7, 10 (Wiktorik Decl. ¶¶ 19, 29); see CMS Ex. 18 at 2 (¶ 14). 

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• During their tour, Surveyor Wiktorik and Epidemiologist Daniels observed that isolation room doors, which should have had been closed, were standing open. CMS Ex. 6 at 5; CMS Ex. 24 at 7, 10 (Wiktorik Decl. ¶¶ 19, 29); see CMS Ex. 18 at 2 (¶ 15); CMS Ex. 23 at 4 (Loesch Decl. ¶ 13).  Nurse Practitioner Eikenhorst reported that she “repeatedly” told staff to keep isolation room doors closed.  CMS Ex. 24 at 10 (Wiktorik Decl. ¶ 30). 
• During their tour, Surveyor Wiktorik and Epidemiologist Daniels observed that the facility staff member responsible for training staff on the proper use of PPE was not donning his own PPE correctly. He omitted hand hygiene and put his equipment on out of sequence.  CMS Ex. 24 at 10 (Wiktorik Decl. ¶ 29). 
• The following day, April 26, Surveyor Wiktorik again toured the facility, accompanied by Epidemiologist Daniels and Michelle Dionne-Vahalik, Associate Commissioner for the Texas Health and Human Services Commission. The multiuse equipment was still in the hallways and alcoves.  It still lacked labels indicating that it had been cleaned.  The floors remained dirty.  Residents were not wearing masks.  Covid-positive residents had not been moved to the Covid unit.  Isolation room doors remained open.  CMS Ex. 24 at 11 (Wiktorik Decl. ¶ 32). 
• On April 30, the epidemiologist continued expressing his concerns about the state of the hallways and alcoves. He noted that resident belongings, which were potentially contaminated, were in the halls.  He opined that housekeeping staff needed “to pick up the pace on getting rooms cleaned out that are empty that had Covid positive residents in them.”  CMS Ex. 24 at 12 (Wiktorik Decl. ¶ 37). 
• The nurse practitioner reported that the facility kept PPE in containers outside isolation rooms, but those containers would run out of PPE. The isolation rooms did not contain biohazard boxes.  CMS Ex. 24 at 10 (Wiktorik Decl. ¶ 30). 
• During an April 16 meeting, attended by Drs. Loesch and Leal, Administrator Holder, Regional Vice President Phillip Sterling, and other corporate officials, Nurse Practitioner Eikenhorst warned that staff were not practicing appropriate safe distancing, were not using personal protective equipment, and were not practicing safe hand hygiene. Loesch and Leal recommended “that interventions be made to quickly remedy this.”  CMS Ex. 23 at 3 (Loesch Decl. ¶ 12); see CMS Ex. 18 (¶¶ 2, 3, 18); CMS Ex. 19. 
• The facility allowed staff to work on both the Covid-positive and Covid-negative units.  CMS Ex. 24 at 6 (Wiktorik Decl. ¶ 14).  Nurse Practitioner Eikenhorst expressed concern that the nurse for the 100 hall (Covid) was also working on the 200 hall (non-Covid).  CMS Ex. 6 at 1-2; CMS Ex. 24 at 6-7 (Wiktorik Decl.

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• ¶ 15). Allowing staff to work in both the Covid unit and other sections of the facility violated the facility’s infection control policy and Medical Director Leal’s explicit instructions and put the facility out of substantial compliance with section 483.80.  See Golden Living Ctr. – Superior, DAB No. 2768 at 19; CMS Ex. 18 at 1 (¶ 4). 

• The nurse practitioner reported to surveyors that the facility moved residents “on the roster” to make it appear that they had been moved to a different room, when they had not been. CMS Ex. 24 at 10 (Wiktorik Decl. ¶ 30).  On April 26, Surveyor Wiktorik confirmed that 13 Covid-positive residents on the 300 and 400 halls had not been moved to the isolation unit.  CMS Ex. 24 at 11 (Wiktorik Decl. ¶ 33). 
• The facility’s administration refused to follow Dr. Leal’s and Dr. Loesch’s recommendations that therapy be strictly limited and that efforts be made to test residents and staff. CMS Ex. 23 at 3 (Loesch Decl. ¶ 12); CMS Ex. 24 at 10 (Wiktorik Decl. ¶ 30); see CMS Ex. 24 at 10 (Wiktorik Decl. ¶ 30) (reporting that on April 10, the nurse practitioner instructed the facility to test all residents); Golden Living Ctr. – Superior, DAB No. 2768 at 19-20; CMS Ex. 18 at 1 (¶ 9).  
• At the April 16 meeting, the corporate officials agreed to one of Dr. Loesch’s recommendations; they promised that an isolation wall for the 100 hall would be “up within 24 to 48 hours.” However, the promised wall was not in place within 48 hours.  CMS Ex. 23 at 3-4 (Loesch Decl. ¶¶ 12-13); see CMS Ex. 18 at 1 (¶ 7). 

3. CMS is entitled to summary judgment because the undisputed evidence establishes that the facility did not have adequate nursing staff to provide the services necessary to assure the highest practicable physical, mental, and psychosocial well-being of each resident. Inadequate staffing put the facility out of substantial compliance with 42 C.F.R. § 483.35(a)(1)(2).  

Program requirement:  42 C.F.R. § 483.35(a)(1)(2) (Tag F725).  The facility must have sufficient nursing staff with appropriate competencies and skill sets to provide nursing and related services to assure resident safety and attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident, as determined by resident assessments and individual plans of care and considering the number, acuity, and diagnoses of the facility’s resident population and in accordance with the facility-wide assessment.  To this end, it must provide services by sufficient numbers of licensed nurses and other nursing personnel, including, but not limited to, nurse aides on a 24-hour basis to provide nursing care to all residents in accordance with resident care plans. 

The facility must designate a licensed nurse to serve as a charge nurse on each tour of duty. 

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Staffing.  Federal staffing requirements for long-term-care facilities are tied to the needs of the residents.  Westgate Healthcare Ctr., DAB No. 1821 at 11 (2002).  CMS is entitled to summary judgment when the undisputed evidence establishes that a facility’s staffing levels are inadequate for providing the care and services necessary to keep residents safe.  Golden Living Ctr. – Mountain View, DAB No. 2953 (2019); Nightingale Home Healthcare, Inc., DAB No. 2784 at 24-25 (2017). 

Covid patients, especially the elderly and infirm, are subject to rapid changes in condition, requiring an immediate and prompt response.  CMS Ex. 24 at 5 (Wiktorik Decl. ¶ 13).  It is thus critically important that they be closely monitored.  As evidenced by the treatment – or total lack of treatment – given to R1, the facility did not have sufficient nursing staff to provide nursing and related services to assure resident safety and to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident.  

The undisputed staffing evidence confirms this.  On April 24, 2020, 36 Covid-positive residents were living on the Covid unit (100 Hall).  CMS Ex. 24 at 7 (Wiktorik Decl. ¶¶ 17, 18); see CMS Ex. 10 at 14-15.  Surveyor Melanie Wiktorik and others (who are named in her notes) toured the Covid unit at 5:45 p.m. that day.  She reviewed staffing and verified that the staffing in the Covid unit consisted of one housekeeper, two nurse aides, one LVN, and one medication aide.  CMS Ex. 6 at 5; CMS Ex. 24 at 7 (Wiktorik Decl. ¶¶ 18, 21).  The on-duty nurse herself told surveyors that she was the only nurse on duty at that time.  CMS Ex. 6 at 15-16; CMS Ex. 24 at 4, 7 (Wiktorik Decl. ¶¶ 10, 18); see CMS Ex. 6 at 8.  The facility’s regional nurse consultant confirmed that only one nurse was on duty that shift.  CMS Ex. 6 at 16; CMS Ex. 24 at 4 (Wiktorik Decl. ¶ 9). 

Petitioner’s response to this evidence is puzzling.  It claims that the allegations “are from alleged anonymous statements made to surveyors,” which can neither be “corroborated or refuted.”  P. Br. at 20.9   This is objectively not so.  Even assuming that the facility can’t identify its regional nurse consultant (and it hasn’t explained why it can’t), it certainly knows the name of the LVN who was on duty.  If, in fact, she did not tell surveyors that she was the sole nurse working in the Covid unit on the night of April 24, Petitioner could have submitted her testimony saying so, which it did not do.  See Beatrice State Developmental Ctr., DAB No. 2311 at 17‑18.  Or, it could have submitted statements from other staff working at the time, indicating that more nurses were assigned to and working on the Covid unit.  Petitioner did not do so. 

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In any event, the facility is responsible for staffing.  It should have had a staffing plan but was not able to provide one (and has not produced one for these proceedings).  CMS Ex. 24 at 8 (Wiktorik Decl. ¶ 24).  The facility is expected to know how many and which employees are working at any given time.  If it doesn’t have this basic information, how could it possibly comply with the regulation?  See 42 C.F.R. § 483.35(a). 

Any responsible facility should be able to submit documents or testimony establishing the number of staff, including their names and positions, working on any particular shift.  Petitioner has not come forward with actual evidence establishing that a dispute exists as to how many nurses were working on the Covid unit.  Its general and unsupported denials do not create a dispute concerning a material fact.  Ill. Knights Templar, DAB No. 2274 at 4; Livingston Care Ctr., DAB No. 1871 at 5.  The undisputed evidence thus establishes that the facility was not adequately staffed to provide necessary care to Covid-infected residents, and, for this reason, CMS is entitled to summary judgment. 

CMS presents additional evidence that staffing was inadequate to meet residents’ needs.  Nurse Practitioner Eikenhorst told the surveyors that the facility had been understaffed for two weeks.  She took lab tests, which showed that residents were dehydrated.  She “did not feel like the residents were getting the care they need[,] such as hydration, feeding assist[,] and just general care.”  CMS Ex. 24 at 7 (Wiktorik Decl. ¶ 20).  Petitioner has not responded to the nurse practitioner’s assertion. 

Nurse Practitioner Eikenhorst also reported that “corporate” was asked for more staffing but refused.  CMS Ex. 24 at 6 (Wiktorik Decl. ¶ 15).  Petitioner counters this claim with identical statements from all of its witnesses – Administrator Holder; its Senior Vice President of Operations, Victoria Palm; and VP Sterling.  They do not deny that one LVN and no RNs were assigned to the Covid unit during the 2 to 10 p.m. shift on April 24.  In fact, they offer no specific information as to the staffing levels at any time.  Instead, each asserts that he or she “personally did not observe any occasion where the facility was known to be short-staffed and refused sufficient assistance in order to take care of residents.”  P. Ex. 1 at 12 (Holder Decl.); P. Ex. 3 at 7 (Sterling Decl.).10  

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For purposes of summary judgment, I accept their statements at face value but find them immaterial.  The witnesses do not claim that the facility had more than one nurse working in the Covid unit, only that they were not aware of any request for additional staffing being denied.  I can draw no inference from this that is particularly favorable to Petitioner.  Either no one asked for additional staff (and someone should have), or requests were made but neither the facility administrator nor the regional vice president were aware of it.  How or why the facility was understaffed is not material; that the facility was, in fact, inadequately staffed so that residents were not receiving necessary treatment is the dispositive issue.  And the undisputed evidence establishes that the facility lacked adequate nursing staff to meet the residents’ needs.11  

Other evidence – which Petitioner does not challenge – shows that the facility was not adequately staffed.  As detailed above, during their tours of the facility, Surveyor Wiktorik and Epidemiologist Daniels observed that halls were dirty and that the facility needed to increase housekeeping.  CMS Ex. 6 at 5; CMS Ex. 24 at 7 (Wiktorik Decl. ¶ 19). 

Call lights were not promptly answered.  On April 27 at 1:15 p.m., Surveyor Wiktorik observed call lights going off on the Covid unit.  They continued for 15 minutes with no response.  One of the residents (R2) was in her doorway yelling “Hey” to someone who passed her room, and she finally got help.  The surveyor asked an RN who was responsible for answering call lights.  The RN responded that anyone could answer them and directed the surveyor to the nurses’ station.  At the nurses’ station, the surveyor asked multiple staff who was responsible for answering call lights.  Staff repeated that anyone could answer them.  When the surveyor reported that call lights had been going off for more than 15 minutes, staff finally responded.  CMS Ex. 24 at 8 (Wiktorik Decl. ¶ 23); see CMS Ex. 24 at 7 (Wiktorik Decl. ¶ 19) (reporting surveyor observation that call lights were not promptly answered during the April 25 tour). 

Taking a different approach, Petitioner complains that CMS does not recognize that the staffing problems were simply beyond the facility’s control.  P. Br. at 20.  Relying on the written declaration of Administrator Holder, Petitioner points out that one staff member, whose position is not identified, became ill on April 4, and a charge nurse became ill on April 6.  P. Br. at 20, citing P. Ex. 1 at 3 (Holder Decl.).  This argument would be more persuasive if any evidence suggested that the facility attempted to bring in more staff (by contacting an agency, for example). 

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Dr. Leal’s Covid Response Plan anticipated staffing shortages.  CMS Ex. 18 at 2 (¶ 11).  Yet the facility’s management developed no backup plans – and Petitioner points to no plans – for ensuring that its staffing would be adequate to keep residents safe.  CMS Ex. 24 at 12 (Wiktorik Decl. ¶ 38).  Its only articulated approach was that it would not share employees with other facilities.  The facility’s corporate administrators were certainly free to make that call, but, having done so, they were required to address potential staffing shortages.  Petitioner presents no evidence suggesting that they did.12  

Petitioner cites no support for the proposition that it should be exempted from providing necessary services because of staffing shortages that were purportedly beyond its control.  To my knowledge, the Departmental Appeals Board has never held that any circumstances justify a facility’s failing to have sufficient staff to provide necessary services, particularly in the absence of evidence that it took steps to resolve its staffing problems.  Indeed, in other contexts, the Board has rejected arguments that, due to circumstances beyond its control, a long-term-care facility is simply not adequately staffed or equipped to provide necessary services.  Instead, the Board has emphasized that facilities must be staffed to ensure the mandated quality of care.  See, e.g., Green Valley Healthcare & Rehab. Ctr., DAB No. 2947 at 11; Sunview Care & Rehab Ctr., L.L.C., DAB CR1620 at 6 (2007) (disregarding Petitioner’s argument that it should be afforded more time to correct its deficiencies because it was difficult to recruit nurse aides in the facility’s rural setting).  

4. CMS is entitled to summary judgment finding that the facility was not in substantial compliance with 42 C.F.R. §§ 483.70 and 483.80 because CMS has presented evidence establishing that the facility management failed to implement – and in some cases actively obstructed – facility policies and physician recommendations designed to prevent the spread of infection, and Petitioner has not tendered evidence of specific facts showing that a dispute of material fact exists on this issue.13

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

Program requirement:  42 C.F.R. § 483.70(d)(1)(2) (Tag F837).  The facility must have a governing body, or designated persons functioning as a governing body, that is legally responsible for establishing and implementing policies regarding the management and operation of the facility.  The governing body appoints the facility’s administrator.  The administrator is responsible for managing the facility and reports to and is accountable to the governing body. 

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

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

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

Administrative failings.  Although I may find substantial noncompliance with section 483.70 based solely on the facility’s other deficiencies, as the above discussion suggests, many of the facility’s failures were directly attributable to its administration, which was, after all, ultimately responsible for the facility’s response to the Covid outbreak. 

CMS presents the testimony of William R. Loesch, M.D., FACP (Fellow of the American College of Physicians).  Dr. Loesch is the Local Health Authority for Washington County (where the facility is located).  CMS Ex. 23 at 1 (Loesch Decl. ¶ 2).  He also supervised

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Nurse Practitioner Eikenhorst.  He worked closely with Dr. Leal and the facility administrator in developing the facility’s response to the Covid outbreak.  Dr. Loesch describes, in some detail, his experience with the facility’s administrator and corporate officers.  For the most part, his testimony is unchallenged. 

With the number of verified and suspected Covid cases climbing, Dr. Loesch participated in an April 7 conference call with Administrator Holder and Nurse Practitioner Eikenhorst.  During that call, Dr. Loesch recommended that all Covid-positive residents be sequestered away from the general population, preferably moved to the 300 hall.  If that were not possible for logistical reasons, he recommended that they be moved to an isolated area in the 100 hall, with an isolation ward to assist with donning/doffing personal protective equipment.  CMS Ex. 23 at 2 (Loesch Decl. ¶ 8).14   See CMS Ex. 18 at 1 (¶¶ 1, 6, 7).  

Dr. Loesch subsequently consulted Dr. Seth Sullivan, an infectious disease specialist and the Local Health Authority for Brazos County, and they agreed that testing all staff was “paramount.”  Dr. Loesch also recommended to Dr. Leal that the facility “basically stop all unnecessary movement within the facility, stop physical therapy, close all doors, test all staff, and, if possible, all patients.”  Dr. Leal agreed to take the lead on implementing these recommendations.  CMS Ex. 23 at 2 (Loesch Decl. ¶ 9).  See CMS Ex. 11; CMS Ex. 18 (¶¶ 8, 9, 10, 11, 15). 

According to Dr. Loesch, the “corporate doctors” did not agree with their recommendations.  They strongly opposed testing anyone who did not have symptoms.  Nevertheless, on or about April 14 or 15, Drs. Leal and Loesch developed a plan and the physicians ordered that all residents be tested.  CMS Ex. 23 at 3 (Loesch Decl. ¶ 10).  Late in the day on April 15, Nurse Practitioner Eikenhorst informed Dr. Loesch that, at the direction of “corporate,” the patient testing that the doctors had ordered would not be performed and the orders were cancelled.  CMS Ex. 23 at 3 (Loesch Decl. ¶ 11).15

At 5:30 p.m. on April 16, Dr. Loesch, Dr. Leal, and Nurse Practitioner Eikenhorst met with Administrator Holder, VP Sterling, and other corporate officials.  Dr. Loesch describes “significant pushback” and quotes VP Sterling as saying “[W]hat does it matter if we test?  What if they all already have it?”  Dr. Loesch opines that VP Sterling “did not

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grasp the severity of the situation.”  Dr. Loesch again recommended that they test, that doors be closed, and that therapy cease except where absolutely indicated.  He was told that “that was impossible” and that therapy was “as important as dialysis.”  CMS Ex. 23 at 3 (Loesch Decl. ¶ 12). 

Administrator Holder does not deny any of this.  He acknowledges Dr. Leal’s recommendations but complains that the medical professionals offered no recommendations regarding how, logistically, to test all staff and residents.  He also acknowledges that approximately 110 staff and 100 residents had not been tested.  P. Ex. 1 at 5 (Holder Decl.); CMS Ex. 23 at 4 (Loesch Decl. ¶ 13). 

In his written declaration, VP Sterling complains that Dr. Loesch misstated his remarks and took them out of context.  According to VP Sterling, the facility was having problems obtaining test kits.  “What I was saying is that, even if the test kits were available, the response to a positive test result would not change the current practice of monitoring symptoms, using PPE, and, if necessary, isolation and quarantine of symptomatic staff and residents.”  He asserts that he was “fully aware of the gravity of the situation” but the “constant prompting” to test was pointless, especially “when the ultimate response would not change based on those test results.”  P. Ex. 3 at 7 (Sterling Decl.). 

Dr. Loesch’s and VP Sterling’s versions of the April 16 meeting are, in fact, pretty consistent.  To the extent that VP’s Sterling’s statement creates a dispute, I must draw all inferences in the light most favorable to Petitioner and therefore accept VP Sterling’s account.  However, VP Sterling’s version does not help Petitioner’s case. 

Both Dr. Loesch and VP Sterling agree that the physicians strongly recommended widespread testing, and that the physicians got significant push-back.  I accept VP Sterling’s assertion that there were two reasons for this: 1) the facility did not have adequate resources for wide-spread testing and did not know how to acquire additional testing;16 and 2) in the administration’s view, testing served no purpose because a positive test would not change the facility’s response. 

Not everyone who is infected with Covid exhibits symptoms, and by testing, the facility could identify “asymptomatic carriers [who] may inadvertently be spreading the virus.”  CMS Ex. 18 at 1 (¶ 10).  VP Sterling’s views regarding testing overlook this reality and are inconsistent with the undisputed advice of the facility’s administrator, the Local Health Authority (Dr. Loesch), and facility policies, which absolutely required that the facility respond differently when residents or staff tested positive for Covid.  See, e.g.,

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CMS Ex. 11 (requiring that Covid-positive residents be monitored more closely); CMS Ex. 18 at 1 (¶ 7) (requiring that Covid-positive residents be separated from other residents).  Testing staff would have kept asymptomatic but infected staff away from residents.  Testing residents to cohort those who were infected protects uninfected residents.  CMS Ex. 18 at 2 (¶ 11). 

Petitioner claims generally that it “presented ample evidence that the governing body was involved with the facility and encouraged and assisted it with compliance with infection control and patient care recommendation and rules.”  P. Br. at 22.  Again, general denials do not create a dispute concerning a material fact.  Ill. Knights Templar, DAB No. 2274 at 4; Livingston Care Ctr., DAB No. 1871 at 5. 

The undisputed evidence thus establishes that the facility was not administered in a manner that enabled it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident.  CMS is therefore entitled to summary judgment finding that the facility was not in substantial compliance with 42 C.F.R. § 483.70. 

5. 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 7-8 (2005), citing Koester Pavilion, DAB No. 1750 (2000); Daughters of Miriam Ctr., DAB No. 2067 at 7, 9 (2007). 

Once CMS presents evidence supporting a finding of substantial noncompliance, it need not offer evidence to support its immediate jeopardy determination.  The burden is on the facility to show that CMS’s determination is clearly erroneous.  Grace Healthcare of Benton, DAB No. 2189 at 13 (2008), citing Liberty Commons Nursing & Rehab. Ctr. – Johnston, DAB No. 2031 at 17-18 (2006), aff’d, Liberty Commons Nursing & Rehab Ctr. – Johnston v. Leavitt, 241 F. App’x 76 (4^th Cir. 2007).  The harm or threatened harm is presumed to be serious, and the facility has the burden of establishing that the harm or threatened harm “did not meet any reasonable definition of ‘serious.’”  Maysville Nursing & Rehab., DAB No. 2874 at 21 (2018), quoting Libertywood Nursing Ctr., DAB No.

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2433 at 18 (2011), aff’d, Libertywood Nursing Ctr. v. Sebelius, 512 F. App’x 285 (4^th Cir. 2013). 

Here, Petitioner has come forward with virtually nothing to establish that the immediate jeopardy determination is clearly erroneous.  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 probabl[e] than not that an outcome will occur as a consequence of the [f]acility’s noncompliance.”  P. Br. at 23.  This is not a standard that the Board has ever applied.  In fact, in Bibb Medical Ctr. Nursing Home, DAB No. 2457 at 7 (2012), the Board explicitly rejected the Petitioner’s reliance on Tara, noting that an ALJ decision is not binding upon the Board. 

In an argument that strains credulity, Petitioner asserts that the facility should not be held accountable because the surveyors were not board-certified infectious disease specialists nor experts on Covid-19, and, besides, no one had really studied how to halt the spread of Covid-19 within a nursing facility.  P. Br. at 24. 

Although much was unknown about Covid-19 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.17   At a minimum, facilities were required to follow basic infection control guidelines.  Those guidelines were incorporated into the facility’s policies.  Because the disease was so infectious and because nursing home residents were so vulnerable, the facility’s failing to follow basic infection control guidelines was likely to cause serious harm or death to residents.  And the facility wasn’t even following guidelines for an ordinary infectious disease. 

By April 24, the number of cases in the facility had risen to 60, and, as of April 25, 11 deaths were reported.  CMS Ex. 23 at 4 (Loesch Decl. ¶ 13). 

Further, the facility neglected a seriously ill resident, who required careful monitoring because her condition could rapidly deteriorate and her ability to breathe was compromised.  Failing to monitor her condition was not only “likely” to cause serious harm or death, it actually caused R1serious harm.  When she left the emergency room, her oxygen saturation level was 92% on room air (98% with two liters of oxygen).  By the time anyone from the facility assessed her condition (more than seven hours later),

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her oxygen saturation level had dropped to 50%.  Whether the neglect caused her death or not, she was undeniably seriously harmed. 

Petitioner’s complaint that the surveyors were not Board-certified infectious disease specialists is easily rejected.18   The facility itself determined which practices it needed to implement in order to protect its residents from Covid and other infectious diseases.  The surveyors, who were qualified medical professionals and who were working closely with Epidemiologist Daniels and other state experts, were fully capable of observing whether those practices were, in fact, implemented.  Had they made mistakes in their observations, Petitioner could have come forward with evidence establishing that, but it has not. 

This case is on all fours with Golden Living Ctr. – Superior.  There, the facility failed to implement 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 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.  The Board therefore 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. 

The facility’s deficiencies generally – and its treatment of R1 specifically – were likely to cause – and, in fact, did cause – serious harm.  CMS’s determination that those deficiencies posed immediate jeopardy to resident health and safety is therefore not clearly erroneous. 

6. The undisputed evidence establishes that the penalty imposed is 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) the 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.  

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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. 1683 at 8 (1999).  

I determine whether a penalty is reasonable based on the per-day penalty, not the total accrued penalty.19   Crawford Healthcare & Rehab., 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, April 26, 2020.  CMS Ex. 3; 85 Fed. Reg. 2869, 2880 (Jan. 17, 2020).  Here, CMS imposed a penalty of $21,350 per day for 20 days of immediate jeopardy, which is at the high end, although not the top, of the penalty range ($6,808 to $22,320).  42 C.F.R. §§ 488.408(e), 488.438; 45 C.F.R. § 102.3; 85 Fed. Reg. 2869, 2880 (Jan. 17, 2020).  

Apparently unaware that penalty ranges have been inflation-adjusted, Petitioner incorrectly cites the penalty range at $3,050 to $10,000 per day.  P. Br. at 3, 6.  CMS is aware that the penalties have been inflation-adjusted, but its witness’s declaration states, incorrectly, that, at the time this penalty was imposed, the maximum per-day penalty was $21,393.  CMS Ex. 22 at 4 (McElroy Decl.).  That figure is out of date.  It represents the maximum penalty as of October 11, 2018.  Penalties were readjusted twice between then and when the penalty was assessed here (November 5, 2019, and January 17, 2020).  (See 84 Fed. Reg. 59549, 59559 (Nov. 5, 2019). 

Applying the relevant factors here, the penalty is reasonable. 

CMS offers no evidence of the facility’s history. 

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

With respect to the remaining factors, Petitioner argues that the penalty is out of proportion to the scope and severity of the non-compliance.  P. Br. at 26-27.  In fact, the scope and severity of the noncompliance are about as extreme as the regulations allow – immediate jeopardy that was isolated, a pattern, and widespread.  CMS Exs. 1, 3. 

With respect to the isolated instance of substantial noncompliance, I have discussed in some detail how R1 was neglected to an unprecedented degree.  Although suffering from a serious disease, she was not assessed or otherwise treated for seven hours after her return from the emergency room.  The facility did not even warn the hospital or her daughter that inadequate staffing could affect the facility’s ability to care for her.  I do not fault the nurse on duty; the demands on her far exceeded one individual’s capabilities.  I fault the facility’s administration, and especially its corporate superiors, who were plainly making the decisions, and were ultimately responsible for the deteriorating conditions. 

I have also discussed in some detail the widespread deficiencies:  inadequate staffing; inadequate cleaning and disinfecting; inappropriate use of PPE and handling of used PPE; unsafe hand hygiene; allowing staff to move between the Covid unit and other sections of the facility; refusing to follow physician recommendations that therapy be strictly limited; opposing efforts to procure testing for residents and staff, when the responsible medical experts agreed that testing was paramount.  For all of these, the facility is culpable.  Any one of these, combined with the disgraceful neglect of R1, justifies the penalty imposed. 

Conclusion

For all of these reasons, I grant CMS’s motion for summary judgment.  The undisputed evidence establishes that the facility was not in substantial compliance with Medicare program requirements, specifically 42 C.F.R. §§ 483.25, 483.35(a)(1)(2), 483.70, 483.70(d)(1)(2), and 483.80(a)(1)(2)(4)(e)(f).  The facility’s deficiencies posed immediate jeopardy to the facility’s vulnerable residents.  The penalty imposed – $21,350 per-day – is reasonable. 

1. For the most part, Petitioner’s objections are based on the Rules of Evidence.  Unquestionably, I may receive evidence that would be inadmissible under those rules.  42 C.F.R. § 498.61; Lifehouse of Riverside Healthcare Ctr., DAB No. 2774 at 9 (2017); Britthaven Inc., DAB No. 2018 at 3 (2006) (“In administrative proceedings generally and in Chapter 498 proceedings expressly, hearsay is admissible and can be probative on the issue of the truth of the matter asserted, where sufficient indicia of reliability are present.”).  Moreover, much of the content to which Petitioner objects – interviews with facility staff – would be admissible under the federal rules.  Fed. R. Evid. 801(d)(2)(D); 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).
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2. My findings of fact/conclusions of law are set forth, in italics and bold, in the discussion captions of this decision.
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3. Section 483.70(e) mandates that the facility conduct and document a facility‑wide assessment to determine what resources are necessary to care for its residents competently during both day-to-day operations and emergencies.
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4. Dr. Leal developed the guidelines with input from Drs. William Loesch (from the Local Health Authority for Washington County), Mark Heard (chief medical officer with Regency Integrated Health Services, the facility’s parent company), and Seth Sullivan (infectious disease specialist at Baylor Scott and White, College Station).  CMS Ex. 18 at 1.  Notwithstanding their roles in developing the facility’s Covid response, Petitioner has not listed any of these individuals as witnesses – not even the medical director, who played such an integral role (although, as discussed below, the undisputed evidence shows that many of his recommendations were not implemented).  CMS lists Dr. Loesch as one of its witnesses and has submitted his written declaration (CMS Ex. 23).
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5. NIOSH is the acronym for National Institute for Occupational Safety and Health.
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6. Nurse Practitioner Eikenhorst is, without question, emblematic of the dedication and bravery of many healthcare professionals during the pandemic.  Her sole purpose was the care of nursing home patients.  CMS Ex. 23 at 1 (Loesch Decl. ¶ 3).  As the evidence establishes, she regularly did not wait for overworked staff to request her assistance but, putting herself at risk, she took the initiative in assessing and caring for Covid-infected residents.  Here, for example, she asked the licensed vocational nurse (LVN) on duty, LVN A, whether she had taken R1’s vital signs, and LVN A responded that she hadn’t had time.  Rather than wait for the LVN to do so, the nurse practitioner, herself, assessed the resident.  CMS Ex. 6 at 15.
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7. In fact, that team brought the facility much-needed staff support.  CMS Ex. 24 at 8 (Wiktorik Decl. ¶ 24).
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8. Petitioner’s witnesses assert that surveyors and other state employees visited the facility multiple times prior to the May 15, 2020 survey, with their attention focused on infection control.  According to Petitioner’s witnesses, the surveyors “had no issues with the care provided.”  See, e.g., P. Ex. 1 at 2 (Holder Decl.); P. Ex. 2 at 2 (Palm Decl.).  I find these gratuitous and generally unsupported assertions irrelevant.  Moreover, sending a “Strike Team” into the facility to assume operations does not suggest that state examiners had been satisfied with the quality of care the facility was providing.
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9. Many staff members complained to the survey team about the conditions in the facility, asking to remain anonymous because they feared for their jobs.  Their complaints are documented in the survey notes.  However, in reaching this decision, I do not rely on any anonymous complaints.
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10. Because their statements are so imprecise, they create more questions than they answer.  Should I infer that they consider one nurse sufficient to care for 36 Covid-infected residents so, in their view, the facility was not short-staffed?  Such a claim would not preclude my entering summary judgment; whether the facility’s staffing levels were adequate is a conclusion, not a fact.  See Guardian, DAB No. 1943 at 11 (characterizing as “conclusory in nature” terms such as “effective,” or “appropriate”).  Moreover, the statements do not explain the procedures the facility had in place, if any, for supplementing staff when necessary.  Nor do the witnesses claim that they had any direct involvement in the process.  They do not say if or when the facility asked for assistance.  They do not say from whom the facility sought the assistance (if someone did) or should have sought assistance (if they did not).
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11. Neither these witness statements nor any other evidence establishes a dispute as to the other aspects of the nurse practitioner’s concerns:  that the residents were not properly hydrated, assisted with feeding, or otherwise cared for.
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12. Again, that the facility was well aware of its staffing shortages and had no plan in place to address the problem makes it all the more unforgiveable that it did not advise the hospital and R1’s daughter that its staffing was insufficient to provide the resident with the monitoring and care she required.
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13. Petitioner’s witnesses list the steps the facility took in responding to the Covid outbreak.  See, e.g., P. Ex. 1 at 2-4 (Holder Decl.); P. Ex. 3 at 1-3 (Sterling Decl.).  That it took these actions does not establish that the facility complied with the regulations.  As the Board observed in Avalon Place Trinity, reciting the “interventions” implemented is insufficient to establish that the facility complied with the quality-of-care regulation.  The “more pertinent question” is whether, regardless of the interventions employed, the facility eliminated or reduced the foreseeable risks.  DAB No. 2819 at 17 (2017).
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14. In his “timeline of events,” Administrator Holder does not mention this call, although Petitioner does not deny that the call occurred.  See P. Ex. 1 at 4 (Holder Decl.).
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15. Dr. Loesch understood that testing materials were locked in the administrator’s office “to keep out of the hands of nursing.”  CMS Ex. 23 at 3 (Loesch Decl. ¶ 11); CMS Ex. 24 at 10, 11 (Wiktorik Decl. ¶¶ 30, 34) (nurse practitioner reporting that she provided swabs for testing, which corporate staff took away).  Administrator Holder denies locking test kits in his office and, for purposes of summary judgment, I accept his denial as true.  P. Ex. 1 at 12 (Holder Decl.).
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16. Apparently, the Local Health Authority figured it out.  With assistance from a state senator, Dr. Loesch and others were able to test the residents, which they completed on or about April 22.  CMS Ex. 23 at 4 (Loesch Decl. ¶ 13).
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17. As my colleague pointed out in Life Care Ctr. of Copper Basin, the danger that Covid posed to the elderly and infirm residents of long-term-care facilities was established early on.  Citing an article in USA Today and statistics released by CMS, Judge Kessel noted that, by June 1, 2020, 25,923 residents of federally-regulated skilled nursing facilities had died from Covid.  DAB CR5943 at 17 (2021).
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18. I note that none of Petitioner’s witnesses are Board-certified infectious disease specialists either.  See P. Exs. 1-3.  Moreover, the Local Health Authority (Dr. Loesch) would be expected to know something about infectious diseases.
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19. The total penalty obviously depends on the duration of the substantial noncompliance.  Petitioner presented no evidence or argument regarding duration.  In any event, to lessen duration, a facility must demonstrate, affirmatively, that it has achieved substantial compliance and implemented appropriate measures to ensure that similar incidents will not recur.  Ridgecrest Healthcare Ctr., DAB No. 2493 at 2-3 (2013); Libertywood Nursing Ctr., DAB No. 2433 at 15 (citing Life Care Ctr. of Elizabethton, DAB No. 2367 at 16 (2011)); accord 42 C.F.R. § 488.454(a) and (e); 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.
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