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                              Generations at Rock Island, DAB CR6128 (2022)
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Generations at Rock Island, DAB CR6128 (2022)








  
  
    

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





Generations at Rock Island
(CCN: 145950),
Petitioner,

v.

Centers for Medicare & Medicaid Services.
Docket No. C-19-1111Decision No. CR6128July 27, 2022

        
              
    

      DECISION

As explained below, I conclude that Generations at Rock Island (Petitioner or facility) was not in substantial compliance with program participation requirements from June 14, 2019 through August 16, 2019, and that its noncompliance posed immediate jeopardy to resident health and safety.  I also conclude that the civil money penalties (CMPs) imposed for the noncompliance are reasonable.

I.  Background and Procedural History

Petitioner is a skilled nursing facility (SNF) located in Rock Island, Illinois that participates in the Medicare program.  Centers for Medicare & Medicaid Services (CMS) Exhibit (Ex.) 10 at 1.  Beginning on June 14, 2019, the Illinois Department of Public Health (state agency) completed eight surveys over a two-month period.  CMS Ex. 4 at 1; CMS Ex. 6 at 1; CMS Ex. 7 at 1; CMS Exs. 10-17.  On June 14, 2019, the state agency conducted a complaint survey and determined Petitioner was not in substantial compliance with three participation requirements.  CMS Ex. 6 at 1; CMS Ex. 10.  On July 2, 2019, the state agency conducted complaint, health, life and safety code, and emergency preparedness surveys and cited Petitioner with 40 deficiencies.  CMS Ex. 7 at 1; CMS Exs. 11-14.  The state agency cited two of the deficiencies, 42 C.F.R.

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§ 483.25(i) (Tag F695) (Respiratory/Tracheostomy Care and Suctioning) and 42 C.F.R. § 483.35(a)(3)-(4), (c) (Tag F726) (Competent Nursing Staff), at scope and severity (s/s) level "K," which constituted immediate jeopardy.  CMS Ex. 11 at 5-25; CMS Ex. 12 at 31-41.  The immediate jeopardy situation lasted 14 days, from June 14 through 27, 2019.  CMS Ex. 4 at 1; CMS Ex. 11 at 6, 17; CMS Ex. 12 at 32.  Petitioner's noncompliance with 42 C.F.R. § 483.25(i) also constituted substandard quality of care, which triggered an extended survey.  CMS Ex. 4 at 1; CMS Ex. 12 at 1, 31-41.  Based on the findings from the June 14 and July 2 surveys, the state agency imposed a discretionary denial of payment for new admissions (DPNA), effective August 14, 2019, and recommended that CMS impose a CMP.  CMS Ex. 7 at 1-2.

The state agency conducted another complaint survey on August 7, 2019, and determined Petitioner was not in substantial compliance with two additional participation requirements.  CMS Ex. 15.  On August 16, the state agency completed a fourth complaint survey and a revisit survey and cited Petitioner for two deficiencies previously cited in the annual health survey.  CMS Exs. 16, 17.  Petitioner returned to substantial compliance with all participation requirements on August 17, 2019.  CMS Ex. 1 at 1; CMS Ex. 3.

On August 29, 2019, CMS issued an initial determination adopting the state agency survey findings.  CMS imposed a $9,345 per‐day CMP for 14 days from June 14 through 27, 2019, and a $415 per-day CMP for 50 days from June 28 through August 16, 2019, for a total CMP of $151,580.  CMS Ex. 4 at 2-3.  In addition, because Petitioner was subject to an extended survey, Petitioner was prohibited from offering or conducting a Nurse Aide Training and/or Competency Evaluation Program (NATCEP) for two years beginning July 2, 2019.  CMS Ex. 4 at 4.

In a September 20, 2019 letter, CMS confirmed the discretionary DPNA from August 14 through 19, 2019 and the $151,580 CMP.  CMS Ex. 1 at 1-2.  Following a request for a reduction of the CMP due to financial hardship (P. Ex. 5), CMS reduced the CMP to $75,790 and approved a 12‐month extended payment plan.1  CMS Ex. 2 at 1-2.

Petitioner requested a hearing before an administrative law judge (ALJ) to dispute the findings in the state agency's July 16, 2019 notice imposing the discretionary DPNA.  The Civil Remedies Division docketed the case as C‐19‐1110 and assigned the case to ALJ Carolyn Cozad Hughes.  Petitioner filed a second hearing request to dispute the August 29, 2019 CMS notice imposing the CMP.  The case was docketed as C‐19‐1111 and also assigned to Judge Hughes.  On December 3, 2019, Judge Hughes consolidated the cases under docket number C‐19‐1111 and dismissed docket number C‐19‐1110.  This case was reassigned to me on February 19, 2021.

Page 3

In accordance with Judge Hughes' Standing Order, CMS filed a prehearing brief (CMS Br.) and 94 proposed exhibits (CMS Exs. 1-94).  CMS offered written direct testimony for five witnesses.  Petitioner filed a prehearing brief (P. Br.) and 11 proposed exhibits (P. Exs. 1-11).  Petitioner also filed objections to CMS Exs. 10-17 (P. Obj.).  CMS filed a rebuttal to Petitioner's prehearing brief (CMS Reply).

II.  Evidentiary Rulings and Decision on the Record

Petitioner objected to CMS Exs. 10-17, the Statement of Deficiencies (SOD) for each survey, on the grounds that the statements in the SODs are hearsay.  P. Obj. at 1-3.  Petitioner argues that the statements in the SODs should only be viewed as allegations CMS is seeking to prove.  P. Obj. at 1-3.

I overrule Petitioner's objections.  In this administrative proceeding, all relevant and material evidence must be admitted into the record.  42 C.F.R. § 498.60(b)(1).  I may admit evidence, including hearsay, that would be inadmissible under the Federal Rules of Evidence.  42 C.F.R. § 498.61; *Lifehouse of Riverside Healthcare Ctr.*, DAB No. 2774 at 9 (2017); *Britthaven Inc. d/b/a/ Britthaven of Smithfield*, 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.").

Further, interviews with facility staff would be admissible under the Federal Rules of Evidence.  Fed. R. Ev. 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 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); *see Richardson v. Perales*, 402 U.S. 389, 410 (1971).  Additionally, the surveyors recounted their interviews with Petitioner's staff and residents in their sworn written direct testimony.  Therefore, I admit CMS Exs. 1-94 and P. Exs. 1-11 into the record.

On May 19, 2020, the parties agreed to have the case decided based on the written record.  *See* Standing Order § 5b.  Therefore, I issue this decision based on the written record. 42 C.F.R. § 498.66.

Page 4

III.  Issues

Whether Petitioner was in substantial compliance with Medicare participation requirements at 42 C.F.R. § 483.25(i) (Tag F695) and 42 C.F.R. § 483.35(a)(3)-(4), (c) (Tag F726); 2
	If Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(i) (Tag F695) and 42 C.F.R. § 483.35(a)(3)-(4), (c) (Tag F726), then whether CMS's immediate jeopardy determination is clearly erroneous; and
	Whether the CMPs imposed are reasonable.IV.  Discussion

**A. Statutory and Regulatory Background**

The Social Security Act (Act) sets requirements for SNFs to participate in the Medicare program and authorizes the Secretary of Health & Human Services (Secretary) to promulgate regulations implementing those statutory provisions.  Act § 1819 (42 U.S.C. § 1395i-3).  The Secretary's regulations are found at 42 C.F.R. part 483 and 488.

To participate in the Medicare program, a SNF must maintain substantial compliance with program requirements.  42 U.S.C. § 1395i-3(a)(3), (b)-(d); 42 C.F.R. pt. 483, subpt. B.  To maintain substantial compliance, a SNF's deficiencies may "pose no greater risk to resident health or safety than the potential for causing minimal harm."  42 C.F.R. § 488.301.  A deficiency is a violation of a participation requirement established by section 1819(b)-(d) of the Act (42 U.S.C. § 1395i-3(b)-(d)), or the Secretary's regulations at 42 C.F.R. pt. 483, subpt. B.  *Id.*  "Noncompliance" means "any deficiency that causes a facility to not be in substantial compliance."  *Id.*

Broadly, noncompliance that subjects an SNF to enforcement remedies is divided into two levels.  One level is comprised of deficiencies that immediately jeopardize the health or safety of residents and the other level is composed of deficiencies that do not.  42 U.S.C. § 1395i-3(h)(1).  "Immediate jeopardy" exists when "the provider's

Page 5

noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident."  42 C.F.R. § 488.301.

The Secretary contracts with state agencies to conduct periodic surveys to determine whether SNFs are in substantial compliance with the participation requirements.  Act § 1864(a) (42 U.S.C. § 1395aa(a)); 42 C.F.R. § 488.10.  The Act also authorizes the Secretary to impose enforcement remedies against SNFs that do not comply with the participation requirements.  Act § 1819(h)(2) (42 U.S.C. § 1395i-3(h)(2)).  The regulations specify the enforcement remedies that CMS may impose if a facility is not in substantial compliance.  42 C.F.R. § 488.406.  When CMS selects an enforcement remedy to impose on an SNF, it determines the scope (i.e., the number of residents affected or potentially affected) and severity (i.e., the degree of harm or potential harm) for each deficiency.  *See* 42 C.F.R. § 488.404(a)-(b); *see also* 42 U.S.C. § 1395i-3(h)(2)(B)(ii)(III)(bb).

Among other enforcement remedies, CMS may impose a per-instance CMP for each instance that a facility is not in substantial compliance.  42 C.F.R. § 488.430(a).  The CMP amounts may range as follows:  $2,140 to $21,393 for per-instance CMPs; $107 to $6,418 per day for less serious noncompliance; or $6,525 to $21,393 per day for more serious noncompliance that poses immediate jeopardy to the health and safety of residents.3  45 C.F.R. § 102.3 (2019); 83 Fed. Reg. 51,369, 51,369-90 (Oct. 11, 2018); *see* 42 C.F.R. § 488.438(a)(1), (2) (original CMP amounts before statutory inflation adjustments).  CMS may also impose a DPNA when a SNF is not in substantial compliance.  Act § 1819(h)(2)(B)(ii) (42 U.S.C. § 1395i-3(h)(2)(B)(i)); 42 C.F.R. §§ 488.406(a)(2)(ii), 488.417(a)).

Depending on the nature of a facility's noncompliance and the type of remedy imposed by CMS, a facility may also by operation of law lose its ability to offer or conduct a NATCEP for two years.  42 C.F.R. § 483.151(b)(2).  Pursuant to 42 C.F.R. § 483.151(b)(2) and (f), a state may not approve and must withdraw any prior approval of a NATCEP offered by a SNF or nursing facility that has been:  (1) subject to an extended or partial extended survey under sections 1819(g)(2)(B)(i) or 1919(g)(2)(B)(i) of the Act; (2) assessed a CMP of not less than $10,697 (45 C.F.R. § 102.3 (Table) (2018)); or (3) subject to termination of its participation agreement, a DPNA, or the appointment of temporary management.  Ineligibility or withdrawal of approval to conduct a NATCEP is mandatory if the conditions are satisfied; it is not a remedy that the state agency or CMS may decline to impose.  *See* 42 C.F.R. § 488.406.

Page 6

If CMS imposes a remedy, such as a CMP, based on a noncompliance determination, then the facility may request a hearing before an ALJ to determine whether there was a basis for the deficiency findings that led to the imposition of the remedy and whether the CMP imposed was reasonable.  Act §§ 1128A(c)(2) (42 C.F.R. § 1320a-7a(c)(2)), 1819(h)(2)(B)(ii) (42 C.F.R. § 1395i(h)(2)(B)(ii); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13)).  However, the facility may not appeal CMS's choice of remedies.  42 C.F.R. § 488.408(g)(2).

A facility may only challenge CMS's determination as to the scope and severity of noncompliance if a successful challenge would affect the range of the CMP that may be imposed or impact the facility's authority to conduct a NATCEP.  42 C.F.R. § 498.3(b)(14), (d)(10)(i).  The CMS determination as to the level of noncompliance, including the finding of immediate jeopardy, "must be upheld unless it is clearly erroneous."  42 C.F.R. § 498.60(c)(2); *Woodstock Care Ctr.*, DAB No. 1726 at 9, 39 (2000), *aff'd*, *Woodstock Care Ctr. v. Thompson*, 363 F.3d 583 (6th Cir. 2003).  The net effect of the regulations is that a provider has no right to challenge the scope and severity level assigned to a noncompliance finding, except in the situation where that finding was the basis for an immediate jeopardy determination.  *See, e.g*., *Koester Pavilion*, DAB No. 1750 (2000).

CMS must make a prima facie showing that the facility failed to comply substantially with federal participation requirements.  If this occurs, the facility must prove substantial compliance by a preponderance of the evidence to rebut CMS's showing and to prevail.  *Hillman Rehab. Ctr.*, DAB No. 1611 at 8 (1997), *aff'd sub nom Hillman Rehab. Ctr. v. U.S. Dep't of Health & Human Servs.*, No. Civ. A 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999); *Batavia Nursing & Convalescent Ctr.*, DAB No. 1904 (2004), *aff'd sub nom Batavia Nursing & Convalescent Ctr. v. Thompson*, 129 F. App'x 181 (6th Cir. 2005); *Emerald Oaks*, DAB No. 1800 (2001); *Cross Creek Health Care Ctr.*, DAB No. 1665 (1998).

**B. Findings of Fact, Conclusions of Law, and Analysis**

***I find the following facts by a preponderance of the evidence.***An annual assessment conducted on November 22, 2017, showed that Petitioner had one respiratory director and eight respiratory therapists (RTs).  CMS Ex. 34 at 13.  In June 2019, despite having four residents with tracheostomies and without conducting another assessment, Petitioner phased out respiratory therapy services and directed nursing to perform tracheostomy and ventilator care.  CMS Ex. 11 at 21; CMS Ex. 31 at 3.  The interim Director of Nursing (DON) confirmed that "nursing is responsible for the physician ordered respiratory treatments when respiratory therapy is not here."  CMS Ex. 11 at 13.  Petitioner previously had enough RTs to provide 24-hour respiratory care, however, at the time of the survey, only one Certified Respiratory Therapist (CRT) and

Page 7

one Registered Respiratory Therapist (RRT) remained on staff.  CMS Ex. 11 at 6; *see also* CMS Ex. 11 at 10.  The sole CRT worked Monday through Friday, from 10:00 a.m. to 6:30 p.m.  CMS Ex. 11 at 7.

Petitioner's job description for RTs included duties such as:  develop a plan of care based on assessment data and standards of care; perform therapy modalities as ordered by physician and according to training and experience; differentiate between resident and equipment problems and intervene appropriately; perform tracheal, endotracheal, and nasopharyngeal suctioning including the instillation of pharmacologic agents in accordance with the facility's policies; and select, assemble, and check equipment for proper function, operations and cleanliness.  CMS Ex. 36 at 1-2.  According to the state surveyor, the job descriptions for registered nurses (RNs) and licensed practical nurses (LPNs) did not include respiratory therapy duties.  CMS Ex. 11 at 13.

On June 13, 2019, the CRT provided an in-service training on ventilator troubleshooting to nursing staff.  CMS Ex. 37.  The training was limited to the three most common problems related to ventilator care.  CMS Ex. 92 ¶ 28.  Two RNs and five LPNs attended the training.  CMS Ex. 37.  Of the participants, six worked the day shift and only one worked the second and third shift.  CMS Ex. 37.  In addition, the in-service training was insufficient for nursing staff to become proficient in tracheostomy and ventilator care.  An LPN who attended the training told the surveyor she "[did not] feel comfortable with the vents" and if "the whole trach came out, [she would] have to call 911."  CMS Ex. 11 at 10.

Other staff also told the surveyor that they could not provide adequate tracheostomy and ventilator care to residents.  An LPN told the surveyor that at times, she was the only staff member on a floor because RNs and respiratory staff did not work in the evenings.  CMS Ex. 11 at 9.  She did not know how to replace a tracheostomy tube and would need to call 911 if a resident extubated himself or herself.  CMS Ex. 11 at 9.  She mentioned that Resident 83 needed to have her ventilator unplugged while being transported to dialysis, but she did not know how to place or take off a ventilator and would not know how to respond if a problem arose.  CMS Ex. 11 at 9-10.  An RN stated that she recently helped transport a ventilator resident to dialysis but "didn't mess with the vent or any of the settings" because she was not comfortable weaning a resident on or off a vent.  CMS Ex. 11 at 10.  She also did not have any training on how to respond if a resident's tracheostomy came out.  CMS Ex. 11 at 10.  According to the CRT, staff need to act quickly if a resident's tracheostomy comes out because the stoma, the opening in the neck, starts to swell immediately.  CMS Ex. 11 at 9.

Because Petitioner reduced respiratory therapy staff and nursing staff did not have the training and skills to provide proper tracheostomy and ventilator care, Petitioner failed to ensure that its four residents with tracheostomies received adequate care.  The facility had four residents, Residents 13, 32, 44, and 83, with tracheostomies.  CMS Ex. 31 at 3; CMS

Page 8

Ex. 12 at 76.  Resident 32 also required ventilator support at night and Resident 83 was fully dependent on a ventilator.  CMS Ex. 11 at 7, 8.

Resident 13 was admitted to the facility on March 15, 2019, with diagnoses including:  acute respiratory failure, unspecified whether with hypoxia or hypercapnia; chronic obstructive pulmonary disease; unspecified diastolic (congestive) heart failure; malignant neoplasm of upper lobe, right bronchus or lung; hypertension; hyperlipidemia; and generalized anxiety disorder.  CMS Ex. 40 at 1.  He did not have any signs of cognitive impairment.  CMS Ex. 40 at 6-7.  Resident 13's physician ordered staff to check liter flow, administer cool aerosol, monitor and document oxygen saturation, administer oxygen, and perform tracheal stoma care during each shift and as needed.  CMS Ex. 40 at 4.  Resident 13 informed the surveyor that he "worried when [the RTs] are not working because he does not know if the nurses will know how to help him."  CMS Ex. 11 at 11; CMS Ex. 92 ¶ 29.

Resident 32 was admitted to the facility on April 19, 2017, with diagnoses including: chronic respiratory failure, unspecified whether with hypoxia or hypercapnia – vent; other acute kidney failure; shortness of breath; diabetes mellitus; panic disorder; and obstructive sleep apnea.  CMS Ex. 41 at 1.  Resident 32 was cognitively intact.  CMS Ex. 41 at 7-8.  She had functional deficits with bed mobility and required the assistance of one staff member.  P. Ex. 2.  Resident 32's physician ordered staff to check liter flow, administer cool aerosol to the tracheostomy, monitor and document oxygen saturation, and perform tracheal stoma care during each shift and as needed.  CMS Ex. 41 at 5.

Resident 44 was admitted to the facility on April 19, 2005, with diagnoses including:  anoxic brain damage; chronic respiratory failure, unspecified whether with hypoxia or hypercapnia; gastroesophageal reflux disease without esophagitis; contracture of the hip and hand; metabolic encephalopathy; cerebral edema; hypertension; and unspecified dementia without behavioral disturbance.  CMS Ex. 42 at 1.  Resident 44's care plan noted that she was at risk for potential complications related to her tracheostomy.  CMS Ex. 42 at 6-7.  She had an increased potential for complications or respiratory distress related to respiratory failure, tracheostomy, and anoxic brain injury.  CMS Ex. 42 at 8-9.  Resident 44's physician ordered staff to monitor and document oxygen saturation and perform tracheal stoma care during each shift and as needed.  CMS Ex. 42 at 3.

Resident 83 was readmitted to the facility on June 22, 2019, with diagnoses including acute respiratory failure with hypoxia – ventilator dependent, chronic obstructive pulmonary disease, end stage renal disease, and congestive heart failure.  CMS Ex. 11 at 8.  The CRT informed the surveyor that she had "refused to take [Resident 83] back because [Resident 83] is ventilator dependent 24/7 and [she] no longer had the staff."  CMS Ex. 11 at 9.  Petitioner readmitted Resident 83 despite the CRT's concerns about adequate respiratory therapy staff.

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The weekend of June 22 and 23, 2019, was the first weekend Petitioner did not have RTs working at the facility.  CMS Ex. 11 at 8.  Resident 83 was readmitted on Saturday, June 22.  CMS Ex. 11 at 8.  Because the CRT was the only staff who knew how to insert Resident 83's speaking valve, the CRT went to the facility to place Resident 83 on a ventilator and insert his speaking valve.  CMS Ex. 11 at 9.  While at the facility, the CRT also placed Resident 32 on a ventilator.  CMS Ex. 11 at 7.  The CRT went back the next morning to take Resident 32 off the ventilator.  CMS Ex. 11 at 7-8.

During the evening on June 23, Resident 13 was bleeding in his tracheostomy.  CMS Ex. 11 at 11.  The CRT was at the facility again to place Resident 32 on a ventilator and a certified nursing assistant (CNA) asked the CRT to look at Resident 13's bleeding tracheostomy.  CMS Ex. 11 at 11.  The CRT told the surveyor that Resident 13 had a lot of bleeding, which could have resulted from a dry tracheostomy or stoma.  CMS Ex. 11 at 11.  The CRT explained that Resident 13's tracheostomy tended to bleed if it became dry, therefore, staff needed to monitor the water level in the tracheostomy's humidifier bottle.  CMS Ex. 11 at 11.  Although the CRT did not recall whether the humidifier bottle was empty on the evening of June 23, the bottle was completely empty on the morning on June 25, indicating that staff had allowed the bottle to empty overnight.  CMS Ex. 11 at 11.

Later that evening, Residents 32 and 83 required assistance with suctioning their tracheostomies at the same time.  CMS Ex. 11 at 8.  The only LPN on the floor suctioned Resident 83's tracheostomy.  CMS Ex. 11 at 8; CMS Ex. 35 at 4.  By the time the LPN went to Resident 32's room, Resident 32 had already suctioned her tracheostomy tube to remove a mucus plug.  CMS Ex. 11 at 7; CMS Ex. 92 ¶ 29.  According to Surveyor Wiening, Resident 32 could have injured herself because Resident 32 was not trained on tracheostomy suctioning.  CMS Ex. 92 ¶ 29.  Resident 32 informed the CRT in a text message at 3:00 a.m. the next morning that she suctioned her own tracheal tube because a nurse had not been available.  CMS Ex. 11 at 8.

The record also shows that nursing staff did not perform all tracheostomy care ordered by the residents' physicians.  The LPN who failed to assist Resident 32 suction her tracheostomy on June 23 admitted that she checked Resident 32's oxygen saturation and administered a nebulizer treatment but did not check the ventilator settings.  CMS Ex. 11 at 8-9.  June 2019 respiratory flowsheets for Residents 13, 44, and 83 show that nursing staff did not document whether they checked liter flow, monitored and documented oxygen saturation, provided tracheal stoma care, and administered aerosol to the residents' tracheostomies on June 22 and 23.  CMS Ex. 40 at 8; CMS Ex. 42 at 5; CMS Ex. 43.  According to the interim DON, nursing staff had access to the respiratory flowsheets, which were kept in the respiratory book on the respiratory cart, but "were not aware of the flowsheets as it was not part of the inservice given by [the] CRT."  CMS Ex. 11 at 12.

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***Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(i) because it failed to provide four residents with necessary tracheostomy care and tracheal suctioning.***The Act requires SNFs to "provide services to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident, in accordance with a written plan of care."  42 U.S.C. § 1395i-3(b)(2).  The Secretary promulgated the general quality of care regulation, which states that a SNF "must ensure that residents receive treatment and care in accordance with professional standards of practice," based on a comprehensive resident assessment, a comprehensive care plan, and resident choice.  42 C.F.R. § 483.25.  Subsection 483.25(i) provides that a "facility must ensure that a resident who needs respiratory care, including tracheostomy care and tracheal suctioning, is provided such care, consistent with professional standards of practice, the comprehensive person-centered care plan, the residents' goals and preferences, and [42 C.F.R. § 483.65]."  42 C.F.R. § 483.25(i).  The facility must provide the required respiratory therapy services, or, in accordance with § 483.70, obtain the required services from qualified personnel through an outside resource that is a provider of respiratory therapy services.  42 C.F.R. § 483.65.

CMS alleges Petitioner failed to ensure that residents who required respiratory care, including tracheostomy care and tracheal suctioning, received that care consistent with professional standards of practice, care plans, and physician orders.  CMS Br. at 10.  CMS asserts that because Petitioner reduced its respiratory staff and did not have a RT available at night and on weekends, residents did not receive necessary tracheostomy and ventilator care.  CMS Br. at 10.  CMS also argues that nursing staff were not competent to provide tracheostomy and ventilator care, did not provide suctioning and tracheostomy care when needed, and did not assess residents to monitor and document their conditions.  CMS Br. at 10.

Petitioner argues that the regulation does not require it to provide a respiratory therapist and an updated assessment would show that the reduction in respiratory staff was necessary.  P. Br. at 6, 8.  Petitioner further argues it appropriately believed that staff had been trained and educated on respiratory care because nurses and LPNs learned basic tracheostomy, ventilator, and other respiratory care during nursing school, clinical experiences, and "on-going as needed."  P. Br. at 6, 8-9.  Petitioner also asserts that although its nurses and LPNs are highly skilled, emergency issues sometimes arise, which may require skills and knowledge beyond their abilities to resolve.  P. Br. at 6, 8-9.  For that reason, staff are trained on policies and procedures for contacting emergency medical assistance.  P. Br. at 6, 7.

Petitioner also contends that because it had just reduced respiratory staff, nursing staff were still adjusting to assuming respiratory care responsibilities.  Petitioner claims that staff were "upset about the perceived increase in their [workload]" and their responses to

Page 11

the state surveyor's questions "reflect[ed] their reluctance to accept and adjust to this change."  P. Br. at 7.  Additionally, Petitioner claims the four residents were "dealing with changes" because "they lost employees who they had become accustomed to seeing over the years."  P. Br. at 7.

As CMS points out, the regulation does not mandate that a facility have a certain number of staff or specific types of staff such as respiratory therapists.  CMS Reply at 5.  Rather, the regulation mandates that facilities provide respiratory care, including tracheostomy care and tracheal suctioning, to residents in accordance with professional standards of practice and the residents' care plans.  42 C.F.R. § 483.25(i).  Because Petitioner had four residents with tracheostomies, including two who were also ventilator-dependent, Petitioner was required to ensure that those four residents received necessary tracheostomy and ventilator care from qualified personnel.  CMS Ex. 31 at 3; CMS Ex. 12 at 76.

Surveyor Heitzler and Surveyor Wiening both testified that the facility's failure to ensure residents had access to respiratory care from competent nursing staff was likely to cause serious harm to the residents.  CMS Ex. 90 ¶ 19; CMS Ex. 92 ¶ 30.  Surveyor Wiening stated that Petitioner should have had round-the-clock competent staff, either specialized RTs or nurses with sufficient training, to address respiratory problems when they arose.  CMS Ex. 92 ¶ 30.  Surveyor Heitzler and Surveyor Wiening explained that tracheostomy and ventilator-dependent residents are unable to breathe without assistance and problems can arise at any time.  CMS Ex. 90 ¶ 19; CMS Ex. 92 ¶ 30.  If an issue arose with one of the residents' tracheostomies and competent staff were not available, a resident could suffer brain damage or death due to lack of oxygen waiting for emergency assistance to arrive.  CMS Ex. 90 ¶ 19; CMS Ex. 92 ¶ 30.  I find the testimony of the state surveyors credible as they have been RNs for more than 25 years, have worked in SNFs, hospitals, and long-term care facilities, and have worked as state agency surveyors for over 10 years.  CMS Ex. 90 ¶¶ 1-3; CMS Ex. 92 ¶¶ 1-2.

Despite having four residents with tracheostomies, Petitioner reduced respiratory therapy services and directed nursing staff to perform tracheostomy and ventilator care when the one remaining CRT was not on duty.  CMS Ex. 11 at 21.  However, nursing staff responsibilities did not include any of the duties performed by the facility's RTs.  CMS Ex. 11 at 13; *see* CMS Ex. 36 at 1-2.  Petitioner also failed to confirm that nursing staff could competently provide respiratory care before reducing its respiratory therapy staff.  The surveyors opined that nursing staff likely could not provide specialized tracheostomy and ventilator care if they had not received intensive training.  CMS Ex. 90 ¶ 19; CMS Ex. 92 ¶ 28.  Although Petitioner asserts that it appropriately believed nursing staff had been trained and educated on respiratory care, the record establishes that nursing staff lacked the knowledge and skills to provide necessary tracheostomy and ventilator care.

Page 12

Less than two weeks prior to the reduction in respiratory staff, Petitioner offered one in‐service training on basic ventilator troubleshooting.  CMS Ex. 37.  Only two RNs and five LPNs attended the training, and only one participant worked the evening and overnight shifts.  CMS Ex. 37.  Despite attending the in-service, an LPN told the surveyor that she did not feel comfortable with ventilator care and would need to call for emergency assistance if a residents' tracheostomy came out.  CMS Ex. 11 at 10.  Another LPN and an RN also stated that they were not comfortable with ventilator care and did not know how to replace tracheostomies.  CMS Ex. 11 at 9-10.

During the first weekend that the facility did not have an RT on duty, respiratory flow sheets indicated that nursing staff did not document whether they checked liter flow and oxygen saturation, provided tracheal stoma care, or administered aerosol to the residents' tracheostomies as ordered by the residents' physician.  CMS Ex. 40 at 4, 8; CMS Ex. 41 at 5; CMS Ex. 42 at 3, 5; CMS Ex. 43.  Nursing staff were not even aware of the flowsheets.  CMS Ex. 11 at 12.  Petitioner argues that there are no staff statements to support CMS's allegation that staff did not provide respiratory care based on the missing documentation in the respiratory flow sheets.  P. Br. at 10.  Yet, the LPN on duty during the June 23 to 24 overnight shift admitted that she checked Resident 32's oxygen saturation and administered a nebulizer treatment but did not check Resident 32's vent settings.  CMS Ex. 11 at 8-9.

Moreover, Petitioner misstates the burden of proof in this case.  CMS has the burden to come forward with evidence sufficient to make a prima facie case that Petitioner is out of substantial compliance with participation requirements to establish a basis to impose an enforcement remedy.  *See, e.g., Evergreene Nursing Care Ctr.*, DAB No. 2069 at 7 (2007).  If CMS makes this prima facie showing, then a facility must show, by a preponderance of the evidence that it was in substantial compliance with participation requirements.  *Id*.  Petitioner can overcome CMS's prima facie case either by rebutting the evidence upon which that case rests, or by proving facts that affirmatively show substantial compliance.  *Id.* (citing *Tri-County Extended Care Ctr.*, DAB No. 1936 (2004)).  Petitioner has both the burden of coming forward and the burden of persuasion as to any affirmative defense.  *Evergreene Nursing Care Ctr.*, DAB No. 2069 at 7; *Batavia Nursing & Convalescent Inn*, DAB No. 1911 (2004), *aff'd, Batavia Nursing & Convalescent Ctr.* *v. Thompson*, 129 F. App'x 181 (6th Cir. 2005).  I conclude that the respiratory flow sheets with the missing documentation on June 22 and 23 are sufficient to support a prima facie case of noncompliance by Petitioner and Petitioner has not rebutted CMS's case to show that it was in substantial compliance with 42 C.F.R. § 483.25(i).

The lack of adequate respiratory care resulted in Resident 13 bleeding in his tracheostomy and Resident 32 resorting to suctioning her own tracheostomy.  On the evening of June 23, a CNA observed that Resident 13 had blood in his tracheostomy.  CMS Ex. 11 at 11.  The CRT confirmed to the surveyor that Resident 13 had blood in his

Page 13

tracheostomy and explained that an empty humidifier bottle could have caused the bleeding.  CMS Ex. 11 at 11.

Petitioner does not dispute that Resident 13 had blood in his tracheostomy.  Instead, Petitioner asserts that there is no evidence to support that the humidifier bottle was empty and that even if it was empty, that it caused the bleeding.  P. Br. at 10.  However, the resident's bleeding tracheostomy, not the cause of the bleeding, is the basis for Petitioner's noncompliance with 42 C.F.R. § 483.25(i).  Petitioner violated 42 C.F.R. § 483.25(i) because it failed to provide sufficient care to prevent Resident 13's tracheostomy from bleeding.  Further, nursing staff were not capable of resolving Resident 13's bleeding tracheostomy.  CMS Ex. 11 at 11.

Petitioner also violated 42 C.F.R. § 483.25(i) when staff failed to suction Resident 32's tracheostomy.  Residents 32 and 83 required assistance with suctioning their tracheostomies at the same time.  CMS Ex. 11 at 8.  Because only one LPN was on duty, the LPN was unable to timely suction both residents' tracheostomies.  CMS Ex. 11 at 7.   As a result, Resident 32 suctioned her own tracheostomy tube to remove a mucus plug, endangering herself because she was not trained on tracheal suctioning.  CMS Ex. 11 at 7; CMS Ex. 92 ¶ 29.

Petitioner asserts that there is no documentary evidence to support that Resident 32 suctioned her own tracheostomy tube and claims that Resident 32 had "a motive for making an unsupported and unlikely claim that she had suctioned herself."  P. Br. at 10.  Petitioner contends that it was highly unlikely that Resident 32 could suction her own tracheostomy because she was morbidly obese and had limited bed mobility.  P. Br. at 9; P. Ex. 2 at 1.  Petitioner points to a progress note indicating that Resident 32 was resting quietly in bed at 9:01 p.m. on June 23.  P. Br. at 9; P. Ex. 3.  Petitioner also points to a progress note dated July 5, which indicated that Resident 32 had unsuccessfully attempted to remove her speaking valve and set off an alarm.  P. Br. at 9; P. Ex. 4.

Resident 32's limited bed mobility and her failed attempt to remove her speaking valve on July 5 supports that there was a greater likelihood that Resident 32 could have endangered herself if a problem arose when she suctioned her own tracheal tube.  Additionally, while the evidence does not establish exactly what time Resident 32 suctioned her own tracheal tube, Resident 32 texted the CRT at 3:00 a.m. on June 24, several hours after the June 23, 9:01 p.m. progress note.  CMS Ex. 11 at 8.  I conclude that Petitioner's evidence does not sufficiently rebut Surveyor Wiening's testimony that Resident 32 reported suctioning her own tracheostomy tube (CMS Ex. 92 ¶ 29).

Moreover, Petitioner's argument that staff are trained on policies and procedures for contacting emergency assistance lacks merit.  A facility does not meet its regulatory obligation if it sent a resident to the emergency room for tracheal care but did not provide the necessary care and services in accordance with the resident's orders and care plans.

Page 14

*Autumn Ridge Rehab. Ctr.*, DAB No. 2467 at 15-16 (2012).  If Petitioner's nursing staff lacked the training or expertise to provide necessary tracheostomy and ventilator care, it was legally obligated to arrange for that nursing service to be performed by a competent outside medical professional.  *Id.* at 10.  Thus, Petitioner is still obligated under the regulation to provide respiratory care as ordered by the residents' physician.  Additionally, Petitioner offers no support for its assertion that staff were trained on policies and procedures for contacting emergency assistance.  Petitioner does not present any evidence of facility policies directing nursing staff to call for emergency assistance if an emergency arose.

Finally, Petitioner does not provide any support for its claim that the statements of nursing staff and residents reflected an ongoing adjustment to the reduction of respiratory therapists.  Petitioner did not offer testimony from its nursing staff or the residents to rebut the statements nursing staff and residents made to the surveyor.  Further, even if the nurses were reluctant to accept additional responsibilities, the record shows that nursing staff ultimately lacked the specific competencies and skill sets necessary to care for residents' needs.

The unrebutted evidence offered by CMS establishes that Petitioner failed to provide tracheostomy and ventilator-dependent residents with adequate respiratory care in accordance with physician orders and care plans and professional standards of care.  Despite the need for respiratory services, Petitioner reduced the RT staff and relied on nursing staff who did not have the knowledge, skills, or training to provide necessary tracheostomy and ventilator care.  As a result, Petitioner did not have competent staff available to monitor residents, prevent and address Resident 13's bleeding tracheostomy, or suction Resident 32's tracheal tube, placing the residents at risk for respiratory complications.  Therefore, I conclude that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(i).

***Petitioner was not in substantial compliance with 42 C.F.R. § 483.35(a)(3)-(4), (c) because nursing staff did not have the competencies and skills to provide sufficient tracheostomy and ventilator care to residents in accordance with residents' assessments and care plans.***According to 42 C.F.R. § 483.35, facilities are required to have:

[S]ufficient nursing staff with the appropriate competencies and skills 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

Page 15

and diagnoses of the facility's resident population in accordance with the facility assessment required at § 483.70(e).

Subsection 483.35(a)(3), (4) specifies:

(a) *Sufficient staff.*

(3) The facility must ensure that licensed nurses have the specific competencies and skill sets necessary to care for residents' needs, as identified through resident assessments, and described in the plan of care.

(4) Providing care includes but is not limited to assessing, evaluating, planning and implementing resident care plans and responding to resident's needs.

The facility must also ensure that nurse aides demonstrate competency in skills and techniques necessary to care for residents' needs, as identified through resident assessments, and described in the plan of care.  42 C.F.R. § 483.35(c).

CMS alleges that Petitioner was not in substantial compliance with 42 C.F.R. § 483.35(a)(3)-(4), (c) because it did not have sufficient staff who were competent in tracheostomy and respiratory care.  CMS Br. at 9-10.  CMS points out that the facility only provided basic tracheostomy and ventilator care training and only seven nurses attended the training.  CMS Br. at 9.  CMS also argues that there is no evidence Petitioner confirmed the competence of staff who participated in the in-service training.  CMS Br. at 9.

Petitioner argues that nursing staff were competent because they learned basic respiratory care in nursing school and through clinical experiences.  P. Br. at 6, 8-9.  Petitioner also asserts that nursing staff are trained to contact emergency assistance if issues requiring skills and knowledge beyond their abilities arise.  P. Br. at 6, 8-9.

Under the regulation, Petitioner's licensed nurses and nurse aides must have the specific competencies and skill sets necessary to care for residents' needs.  42 C.F.R. § 483.35(a)(3), (c).  Because the facility had four residents with tracheostomies, and two who were also ventilator-dependent, the regulation requires Petitioner to have licensed nurses and nurse aides capable of providing necessary tracheostomy and ventilator care.

The state surveyors opined that nursing staff, unless they had received intensive training, likely could not competently provide care such as maintaining equipment, adjusting tracheostomy tubes, monitoring ventilator settings, and assessing and documenting

Page 16

residents' statuses.  CMS Ex. 90 ¶ 19; CMS Ex. 92 ¶ 28.  They explained that these tasks are more specialized than basic nursing care and are not taught in nursing school because nurses do not typically perform specialized respiratory care.  CMS Ex. 90 ¶ 19; CMS Ex. 92 ¶ 28.  Surveyor Heitzler explained that despite decades of direct nursing experience, including in hospitals and long-term care facilities, she has never had to provide ventilator care.  CMS Ex. 90 ¶ 19.  Further, before working in an intensive care unit, she received an intensive week-long training on suctioning tracheostomy tubes.  CMS Ex. 90 ¶ 19.

Petitioner's argument that nursing staff should be presumed competent because they completed nursing school and clinical experiences is contradicted by the evidence.  The facility's nursing staff did not have the skills and knowledge to provide tracheostomy and respiratory care consistent with professional standards and the residents' needs as defined in their care plans and physician orders.  Three nurses, including one that attended the in-service training, expressed to the surveyor that they did not have the skills to provide basic ventilator care, such as placing and taking a resident off a ventilator or replacing a tracheostomy.  CMS Ex. 11 at 9-10.

Petitioner's RRT confirmed that the facility's nursing staff did not have the competency to provide the level of respiratory care required for ventilator-dependent residents because "it takes years of education and training to troubleshoot ventilator equipment" and ventilator-dependent residents need frequent monitoring by trained staff who can troubleshoot equipment and quickly assess a resident if problems arise.  CMS Ex. 11 at 21.  She also explained that some of the nurses have never used an Ambu bag, which is necessary if a resident with a tracheostomy goes into cardiac arrest.  CMS Ex. 11 at 21.  Petitioner does not present any evidence to support that its nursing staff had received sufficient training before they assumed respiratory care responsibilities or that nursing staff already possessed the knowledge and expertise to provide adequate tracheostomy and ventilator care to Residents 13, 32, 44, and 83.

Finally, Petitioner's assertion that nursing staff relied on emergency services in situations requiring skills beyond their capabilities does not excuse its obligations under the regulation.  The regulation requires that nursing staff have the specific competencies and skill sets necessary to care for residents' needs, as defined in the residents' assessments and care plans.  In this case, nursing staff did not have the skills and competencies to perform tracheostomy and ventilator care tasks ordered by the residents' physicians.

Despite knowing that four of its residents required regular tracheostomy care, two of whom were also ventilator-dependent, the facility did not ensure that nursing staff were trained and competent to meet the residents' respiratory needs.  Before reducing RT staff, Petitioner did not confirm that nursing staff could competently provide tracheostomy and ventilator care or provide nursing staff with intensive training on respiratory care.  Petitioner did not rebut the evidence showing that nursing staff did not have the skills and

Page 17

knowledge to provide sufficient tracheostomy and ventilator care to Residents 13, 32, 44, and 83.  Therefore, I find that Petitioner was not in substantial compliance with 42 C.F.R. § 483.35(a)(3)-(4), (c).

***CMS's determination that Petitioner's noncompliance with 42 C.F.R. § 483.25(i) and 42 C.F.R. § 483.35(a)(3)-(4), (c) posed immediate jeopardy to resident health and safety is not clearly erroneous.***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.  The regulation does not require that a resident actually be harmed.  *Lakeport Skilled Nursing Ctr.*, DAB No. 2435 at 8 (2012).  I must uphold CMS's determination as to the level of a facility's substantial noncompliance (which includes an immediate jeopardy finding) unless it is "clearly erroneous."  42 C.F.R. § 498.60(c).  The "clearly erroneous" standard imposes on facilities a heavy burden to overcome a finding of immediate jeopardy.  Appellate panels of the DAB have sustained determinations of immediate jeopardy where CMS presented evidence "from which '[o]ne could reasonably conclude' that immediate jeopardy exists."  *See, e.g., Barbourville Nursing Home*, DAB No. 1962 at 11 (2005) (citing *Florence Park Care Ctr.*, DAB No. 1931 at 27-28 (2004)), *aff'd, Barbourville Nursing Home v. U.S. Dep't of Health & Human Servs.*, 174 F. App'x 932 (6th Cir. 2006).

CMS alleges that Petitioner's violation of 42 C.F.R. § 483.25(i) and 42 C.F.R. § 483.35(a)(3)-(4), (c) constituted immediate jeopardy to resident health and safety because nursing staff did not have the necessary skills to adequately meet the needs of tracheostomy and ventilator-dependent residents.  CMS Br. at 21.  CMS asserts that the facility's failure to ensure the availability of competent respiratory therapy staff was likely to cause serious physical and mental harm, or even death, to the residents.  CMS Br. at 22.

Petitioner argues that there is insufficient factual justification for a finding of immediate jeopardy.  P. Br. at 11.  Petitioner asserts that CMS's immediate jeopardy determination is clearly erroneous because staff provided quality care to the four residents with respiratory needs.  P. Br. at 11.  Petitioner also argues that its nurses and LPNs could provide the level of care the residents required because the facility's nurses had been trained throughout their careers on providing basic respiratory services.  P. Br. at 11.  Petitioner further asserts that the residents did not suffer any harm.  P. Br. at 10.

Petitioner did not provide quality care to Residents 13, 32, 44, and 83.  By reducing the number of respiratory staff and relying on nursing staff who did not have the skills to provide specialized respiratory care, Petitioner failed to ensure that the residents received necessary tracheostomy and ventilator care and placed the residents at risk for harm or death.  Potential complications related to tracheostomies include respiratory failure and

Page 18

anoxic brain injury.  CMS Ex. 42 at 8-9.  Issues with tracheostomies and ventilators could arise at any time and can interfere with a resident's ability to breathe.  CMS Ex. 90 ¶ 19; CMS Ex. 92 ¶ 30.  A resident unable to breathe could suffer brain damage or even death while waiting for emergency services to arrive.  CMS Ex. 92 ¶ 30.

Petitioner's Medical Director stated that not having RTs available at all times placed tracheostomy and ventilator-dependent residents at risk for harm.  CMS Ex. 11 at 14.  The physician for Residents 13, 32, and 83 noted that residents with tracheostomies and ventilators were at risk for complications unless staff were trained to recognize problems.  CMS Ex. 11 at 13-14.  He stated that Resident 32 required a high level of respiratory care and could not be left off a ventilator for an entire weekend and Resident 83 would be at significant risk of adverse events if no qualified staff were available.  CMS Ex. 11 at 13.  Yet, nursing staff failed to even monitor and assess the residents to ensure that no problems arose.  CMS Ex. 40 at 8; CMS Ex. 42 at 5; CMS Ex. 43; *see* CMS Ex. 11 at 12.

Although Petitioner argues that the residents did not suffer any harm, Resident 13 suffered harm when staff failed to prevent his tracheostomy from bleeding.  Further, the CNA on duty that night did not know how to resolve Resident 13's bleeding tracheostomy, but fortunately, the CRT was at the facility and was able to care for Resident 13.  CMS Ex. 11 at 11.  Petitioner's noncompliance was also likely to cause serious harm or even death to Residents 13, 32, 44, and 83, which is sufficient to support a finding of immediate jeopardy.  To remove a blockage in her tracheal tube, Resident 32 resorted to suctioning herself and could have injured herself because she was not trained in tracheostomy suctioning.  CMS Ex. 11 at 7; CMS Ex. 92 ¶ 29.

Petitioner's noncompliance also caused actual psychological harm to the residents.  Resident 13 told the surveyor that he was afraid that nursing staff would not know what to do if issues arose.  CMS Ex. 11 at 11; CMS Ex. 92 ¶ 29.  Petitioner even acknowledged that the reduction of respiratory therapists could have been "frightening" for the ventilator-dependent residents because they were used to respiratory therapists providing them with ventilator care.  P. Br. at 7-8.

There is no doubt that Petitioner placed Residents 13, 32, 44, and 83 in immediate jeopardy.  Petitioner did not have respiratory staff available in the evenings, overnight, and on weekends and nursing staff were not capable of providing adequate tracheostomy and ventilator care.  Resident 13 suffered actual harm and all four residents were at risk for complications such as respiratory failure, anoxic brain injury, or death.  Accordingly, I conclude that CMS did not clearly err in determining that Petitioner's noncompliance with 42 C.F.R. § 483.25(i) and 42 C.F.R. § 483.35(a)(3)-(4), (c) posed immediate jeopardy to the health and safety of its residents.

Page 19

***The $75,790 CMP is appropriate under relevant statutory and regulatory factors for determining the amount of CMPs.***CMS imposed a $9,345 per‐day CMP for 14 days from June 14 through 27, 2019, and a $415 per-day CMP for 50 days from June 28 to August 16, 2019, for a total CMP of $151,580.  CMS Ex. 4 at 2-3.  After granting Petitioner's request for a reduction of the CMP due to financial hardship, CMS reduced the CMP to $75,790 and approved a 12‐month extended payment plan.  CMS Ex. 2 at 1-2.

Petitioner did not challenge the duration of the CMP.  The SNF bears the burden of showing that its noncompliance was of shorter duration than alleged by CMS.  *Owensboro Place & Rehab. Ctr.*, DAB No. 2397 at 12 (2011) (citing *Kenton Healthcare, LLC*, DAB No. 2186 at 24-25 and *Lake Mary Health Care*, DAB No. 2081 at 30 (2007)).  Therefore, I accept the duration as found by CMS.

To determine the amount of the CMP, I apply the factors listed in 42 C.F.R. § 488.438(f).  The factors listed in 42 C.F.R. § 488.438(f) apply when reviewing the CMP amount:  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.  *See* 42 U.S.C. §§ 1320a-7a(d)(2), 1395i-3(h)(2)(B)(ii)(I).  The absence of culpability is not a mitigating factor.  42 C.F.R. § 488.438(f).  The factors listed 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.  *See* 42 U.S.C. §§ 1320a-7a(d)(1), (3), 1395i-3(h)(2)(B)(ii)(I).

The regulations leave the decision regarding the choice of remedy to CMS, and the amount of the remedy to CMS and the ALJ, requiring only that the regulatory factors at 42 C.F.R. §§ 488.438(f) and 488.404 be considered when determining the amount of a CMP within a particular range.  42 C.F.R. §§ 488.408, 488.408(g)(2); 498.3(d)(11); *see also* 42 C.F.R. § 488.438(e)(2) and (3); *Alexandria Place*, DAB No. 2245 at 27 (2009); *Kenton Healthcare, LLC*, DAB No. 2186 at 28-29 (2008).  Unless a facility contends that a particular regulatory factor does not support the CMP amount, the administrative law judge must sustain it.  *Coquina Ctr.*, DAB No. 1860 at 32 (2002).

Petitioner has a long history of noncompliance.  In the three years prior to the survey cycle at issue, Petitioner was cited for deficiencies at or above s/s level "D" in 14 separate complaint surveys.  CMS Ex. 5 at 1-4.  During July 2017 and March 2019 surveys, Petitioner was cited for three deficiencies at s/s level "G," which constitutes actual harm.  CMS Ex. 5 at 1, 3.  Petitioner also was cited in July 2017 at s/s level "F" for failure to have sufficient competent nursing staff, which is the basis for Petitioner's noncompliance with 42 C.F.R. § 483.35(a)(3)-(4), (c) in this case.  CMS Ex. 5 at 3.  In

Page 20

the survey cycle at issue here, Petitioner was cited for 45 different deficiencies, including 20 at or above s/s level "D."  CMS Exs. 1, 10-17.  Therefore, Petitioner's history of noncompliance supports the CMP imposed.

Petitioner argues that is "unfair" for CMS to use Petitioner's poor compliance history as justification to impose a CMP because Petitioner was not afforded the right to contest those deficiencies in front of ALJ.  P. Br. at 15.  However, the regulation itself states that a facility's history of noncompliance is one factor in determining the amount of a CMP.  42 C.F.R. § 488.438(f).  Although Petitioner does not have a history of many deficiencies involving actual harm, Petitioner has consistently failed to be in substantial compliance with participation requirements.  Further, the other factors at 42 C.F.R. § 488.438(f) strongly support a substantial CMP amount.

Both deficiencies at issue in this case involve Petitioner's failure to provide adequate tracheostomy and ventilator care to residents, which caused immediate jeopardy to resident health and safety.  Petitioner's noncompliance resulted in one resident with a bleeding tracheostomy and another resident who could have injured herself while suctioning her own tracheal tube.  The lack of competent staff placed the residents at significant risk for brain damage or death due to lack of oxygen if a problem arose with their tracheostomies and ventilators.  The factors at 42 C.F.R. § 488.404 support the CMP amount.

Petitioner's arguments regarding its financial condition do not support a further reduction of the CMP.  The facility has the burden of demonstrating by a preponderance of the evidence its inability to pay the CMPs.  *Gilman Care Center*, DAB No. 2357 at 7 (2010) (citing *Western Care Mgt. Corp. d/b/a Rehab. Specialties,* DAB No. 1921 at 91 (2004)).  The " correct inquiry" in evaluating such a claim is "whether the facility can show that it lacks adequate assets to pay the CMP without having to go out of business or compromise resident health and safety."  *Oceanside Nursing & Rehab. Ctr.*, DAB No. 2382 at 22-23 (2011).

As an initial matter, I cannot further reduce the CMP because the $75,790 amount is below the minimum amount for the immediate jeopardy noncompliance.  *Oceanside Nursing & Rehab.*, DAB No. 2382 at 23 (2011) (citing 42 C.F.R. §§ 488.408, 488.438).

Petitioner asserts that the financial reports and audits show that the "facility itself is not profitable at this time."  P. Br. at 12.  Petitioner contends that the CMP should be reduced further because the current amount of the CMP still "jeopardizes the Facility's ability to continue to improve the resident experience."  P. Br. at 12.  Petitioner points to the statement of cash flows for the first half of 2019 shows a net loss of approximately $1.3 million.  P. Ex. 7.

Page 21

However, partial information, such as information about a facility's "annual profits or losses, may not be an accurate reflection of a facility's financial health or ability to pay, and must be considered in the light of such other indicators as the facility's financial reserves, assets, credit-worthiness, and 'other long-term indicia of its survivability."'  *Guardian Care Nursing & Rehab. Ctr.*, DAB No. 2260 at 8 (2009) (citing *Kenton Healthcare, LLC*, DAB No. 2186 (2008) (all indicia of financial situation, as well as financing options, not merely cash flow, considered for this factor) and *Windsor Health Care*, DAB No. 1902 (2003) (adequacy of assets, not profits, the relevant inquiry)).

Although the facility presents losses of $1.3 million in the first half of calendar year 2019, there is no indication that the losses of those amounts have forced the facility to go out of business.  The balance sheet for June 30, 2019 shows that Petitioner's total assets were $2,174,185.  P. Ex. 6 at 4.  A total CMP of $75,790 represents just 3% of the value of the total assets.  CMS also approved a 12-month payment plan, with Petitioner paying only $6,685.20 per month.  CMS Ex. 2 at 1-2.  Petitioner also provided the financial statements for Generations Network, which shows total assets of $1,932,802 at the end of 2018, and Rock Island Real Estate, the property owner, which shows total assets of $5,217,760 at the end of 2018.  P. Ex. 11 at 4.  Petitioner has not established that it cannot pay the CMP due to its financial condition.  Therefore, I do not find that Petitioner has met its burden of showing that a reduction of the CMP amount is warranted.

Finally, Petitioner was very culpable.  Petitioner had four residents with tracheostomies, two of whom were also ventilator dependent.  Yet, Petitioner reduced respiratory therapy services so that no RTs were available in the evening, overnight, and on weekends.  Petitioner relied on its nursing staff to provide respiratory care, but nursing staff did not have the necessary knowledge and skills to provide adequate respiratory care.  Nursing staff expressed that they did not have the training and experience to handle respiratory care needs.  Petitioner's failure to ensure Residents 13, 32, 44, and 83 received necessary tracheostomy and ventilator care placed the residents at risk for harm, brain damage, or even death and demonstrates neglect and disregard for resident care, comfort, and safety.

The seriousness of the deficiencies, Petitioner's noncompliance history, and Petitioner's culpability fully justify the CMP amount in this case.  Therefore, I conclude that the $75,790 CMP is reasonable.

Page 22

V.  Conclusion

For all these reasons, I find that:  1) from June 14, 2019 through August 16, 2019, Petitioner was not in substantial compliance with Medicare program requirements; 2) from June 14, 2019 through June 27, 2019, its deficiencies posed immediate jeopardy to resident health and safety; and 3) the penalties – $9,345.00 per day for 14 days of immediate jeopardy; and $415.00 per day from June 28, 2019 through August 16, 2019, for 50 days of substantial noncompliance that was not immediate jeopardy – are reasonable.

Endnotes

1  Including interest, the total amount of the CMP is $80,222.40.

2  CMS also alleges Petitioner failed to substantially comply with 43 other Medicare participation requirements.  CMS Ex. 10; CMS Ex. 11 at 1-5; CMS Ex. 12 at 1-31, 41-48, 58-91; CMS Exs. 13-17.  I need not address those deficiencies because I conclude that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(i) and 42 C.F.R. § 483.35(a)(3)-(4), (c) at the immediate jeopardy level, which is a sufficient basis to fully support the CMPs that CMS imposed on Petitioner.  *See Claiborne-Hughes Health Ctr. v. Sebelius*, 609 F.3d 839, 847 (6th Cir. 2010); *Carrington Place of Muscatine*, DAB No. 2321 at 20-21 (2010).

3  CMS increases the CMP amounts annually to account for inflation in compliance with the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, Pub. L. No. 114-74, § 701, 129 Stat. 584, 599 (2015).  *See* 81 Fed. Reg. 61,538 (Sept. 6, 2016).
  
          /s/
        Catherine Ravinski

                      Administrative Law Judge Back to top
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