Tomball Rehab & Nursing, DAB CR6492 (2024)

DECISION

Petitioner, Tomball Rehab & Nursing, is a long-term care facility located in Tomball, Texas, that participates in the Medicare program.  Here, I consider, among other issues, whether the facility provided adequate care to its residents whose breathing was so impaired that they required tracheostomies.

On February 15, 2023, the Texas Health and Human Services Commission (state agency) completed a complaint investigation survey of the facility.  Based on the survey findings, the Centers for Medicare and Medicaid Services (CMS) determined that, from January 22 through March 16, 2023, the facility was not in substantial compliance with Medicare program requirements and that, for 19 of those days (January 22 through February 9), its deficiencies posed immediate jeopardy to resident health and safety.  CMS imposed civil money penalties (CMPs) of $9,675 per day for 19 days of immediate jeopardy and $360 per day for 35 days of substantial noncompliance that did not pose immediate jeopardy, for a total penalty of $196,425.

Petitioner appealed and CMS has moved for summary judgment.

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For the reasons set forth below, I grant CMS’s motion.  Based on the undisputed facts, and drawing all reasonable inferences in Petitioner’s favor, I find that, from January 22 through March 16, 2023, the facility was not in substantial compliance with Medicare program requirements and that from January 22 through February 9, 2023, its deficiencies posed immediate jeopardy to resident health and safety.

Background

The Social Security Act (Act) sets forth requirements for nursing facility participation 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.  The regulations require that each facility be surveyed annually, with no more than fifteen months elapsing between surveys.  42 C.F.R. § 488.308(a).  Facilities must be surveyed more often, if necessary, to ensure that identified deficiencies are corrected.  Act § 1819(g)(2)(A); 42 C.F.R. § 488.20(a).

Here, on February 15, 2023, state agency surveyors completed a complaint investigation survey of the facility.  Based on the survey findings, CMS determined that the facility was not in substantial compliance with three program requirements:

• 42 C.F.R. § 483.25(g)(4)(5) (Tag F693 – quality of care:  assisted nutrition and hydration) cited at scope and severity level D (isolated instance of noncompliance that causes no actual harm with the potential for more than minimal harm);
• 42 C.F.R. § 483.25(i) (Tag F695) – quality of care:  respiratory care, including tracheostomy care and tracheal suctioning) cited at scope and severity level K (pattern of substantial noncompliance that poses immediate jeopardy to resident health and safety); and
• 42 C.F.R. § 483.80(a)(1)(2)(4)(e)(f) (Tag F880) (infection control – prevention and control program), cited at scope and severity level E (pattern of substantial noncompliance that causes no actual harm with the potential for more than minimal harm).

CMS Exs. 1, 3.

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Thereafter, CMS determined that the facility returned to substantial compliance on March 17, 2023.  CMS Ex. 4.

CMS has imposed CMPs of:

• $9,675 per day for 19 days of immediate jeopardy (January 22 through February 9, 2023) (subtotal:  $183,825); and
• $360 per day for 35 days of substantial noncompliance that did not pose immediate jeopardy (February 10 through March 16, 2023) (subtotal:  $12,600).

Total:  $196,425 ($183,825 + $12,600 = $196,425).  CMS Ex. 4.

Petitioner timely requested review and has limited its appeal to the deficiency cited under 42 C.F.R. § 483.25(i) (Tag F695).  P. Br. at 3.  CMS now moves for summary judgment, which Petitioner opposes.

Exhibits.  With its motion and brief (CMS Br.), CMS submitted 24 exhibits (CMS Exs. 1-24).  Petitioner submitted a response and pre-hearing brief (P. Br.) with six exhibits (P. Exs. 1-6).

Petitioner has objected to my admitting CMS Exs. 20, 21, and 23.  CMS Exs. 20 and 21 are the written declarations of the surveyors.  CMS Ex. 23 is the “Automated Survey Processing Environment (ASPEN) Enforcement Manager,” showing the facility’s compliance history from June 12, 2014, through June 12, 2023.  See CMS Pub. 100-7, State Operations Manual (SOM), ch. 7, § 7001 (Rev. 213, eff. Feb. 10, 2023).

Under the federal rules, the evidence considered in determining whether the case presents a dispute of material fact must be admissible.  Fed. R. Civ. P. 56(c)(1)(B), (c)(2).¹

Petitioner’s objections are without merit.  The documents are admissible.  Under the regulations that govern these proceedings, I have broad discretion to admit evidence.  I am required to “inquire[] fully into all of the matters at issue” and to admit any documents that are relevant and material.  42 C.F.R. § 498.60(b).

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Without pointing to any specifics, Petitioner asserts generally that the exhibits “contain inadmissible hearsay.”²  But the pertinent regulation is explicit:  I may receive evidence, including hearsay, that would be inadmissible under the federal 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.”).

With respect to CMS Ex. 20, Petitioner also complains that, because the surveyor is not a physician, she is not qualified to opine on:  whether nursing staff were properly trained; whether the facility kept the necessary equipment at a resident’s bedside; and whether the facility maintained adequate respiratory equipment.  Petitioner has not explained why these fairly straight-forward observations would require the expertise of a physician.  Moreover, who is more qualified to comment on the training of nursing staff than an experienced and well-trained registered nurse?  With respect to the missing equipment, it was either where it was supposed to be, or it was not.  Making that observation hardly requires significant medical expertise.

In any event, as the Departmental Appeals Board has observed, surveyors “are professionals who use their judgment, in concert with Federal forms and procedures, to determine compliance.”  CMS provides them with “comprehensive training” in multiple areas, including applying and interpreting regulations, survey techniques and procedures, and techniques for auditing resident assessments and care plans.  Surveyors are perfectly capable of making and reporting their observations.  In fact, that is their job.  42 C.F.R. §§ 488.26(c)(3); 488.314(b); Omni Manor Nursing Home, DAB No. 1920 (2004) (finding that a registered nurse surveyor is qualified to explain how underlying facts constitute program deficiencies); see Lakeport Skilled Nursing Ctr., DAB No. 2435 at 5-7 (2012) (describing registered nurse surveyors’ qualifications to opine on the potential harm posed by staff failing to follow physician orders in caring for diabetic residents).

Finally, even if their opinion testimony required significant, specialized expertise, the testimony would be admissible, although the weight it merited would depend on the witness’s qualifications to render the opinion.  See Copperas Cove LTC Partners, Inc., DAB No. 3049 at 16 (2021); River City Care Center, DAB No. 2627 at 13-16 (2015); Golden Living Center, DAB No. 2296 at 6-8 (2009).

I cannot take seriously Petitioner’s objection to CMS Ex. 23.  I find disingenuous Petitioner’s purported ignorance of CMS’s data collection practices.  As every participating

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facility must know, CMS tracks each facility’s compliance history and maintains a record of it.  ASPEN Reports at 21, available at https://qtso.cms.gov/system/files/qtso/ASPEN_11.9.3_Reports_FINAL.pdf (last visited Jun. 12, 2024) (discussing “Facility Enforcement History report”).  These are official records, maintained by CMS, and would be admissible, even under the federal rules.  Fed. R. Evid. 803(6)(B), (C); Fed. R. Civ. P. 44(a)(1).  And Petitioner is obviously well aware of its own compliance history; were CMS’s records incorrect, it could have presented evidence to refute the contents of the report.

CMS’s exhibits would therefore be admissible, and I may consider them when I determine whether this case presents a dispute of material fact.

Issues

I consider whether summary judgment is appropriate.

On the merits, Petitioner abandoned its appeal of the deficiencies cited under 42 C.F.R. §§ 483.25(g)(4)(5) and 483.80(a)(1)(2)(4)(e)(f).  I therefore find that, from January 22 through March 16, 2023, the facility was not in substantial compliance with Medicare program requirements, and I must sustain a penalty of at least $120 per day (the minimum regulatory amount).  See 87 Fed. Reg. 15,100, 15,111-12 (Mar. 17, 2022) and discussion below.

The remaining issues are:

• From January 22 through March 16, 2023, was the facility in substantial compliance with 42 C.F.R. § 483.25(i);
• If, from January 22 through February 9, 2023, the facility was not in substantial compliance with 42 C.F.R. § 483.25(i), did that deficiency then pose immediate jeopardy to resident health and safety; and
• Are the penalties imposed – $9,675 per day for 19 days of immediate jeopardy and $360 per day for 35 days of substantial noncompliance that did not pose immediate jeopardy – reasonable?

Discussion

Summary judgment.³  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.  Fed. R. Civ.

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P. 56, Southpark Meadows Nursing & Rehab. Center, DAB No. 2703 at 5 (2016); W. Texas LTC Partners, Inc., DAB No. 2652 at 5 (2015), aff’d 843 F.3d 1043 (5th Cir. 2016); 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, and cases cited therein.

The moving party may show the absence of a genuine factual dispute by presenting evidence so one-sided that it must prevail as a matter of law or by showing that the non-moving party has presented no evidence “sufficient to establish the existence of an element essential to [that party’s] case, and on which [that party] will bear the burden of proof at trial.”  Livingston Care Ctr. v. U.S. Dep’t of Health & Human Servs.,388 F.3d 168, 173 (6th Cir. 2004) (quoting Celotex, 477 U.S. at 322).  To avoid summary judgment, the non-moving party must then act affirmatively by tendering evidence of specific facts showing that a dispute exists.  Matsushita Elec. Indus. Co. 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, DAB No. 2652 at 6; 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).  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 or draw inferences that are not reasonable.  W. Tex. LTC, DAB No. 2652 at 6-7; cf. Guardian, DAB No. 1943 at 11 (“A dispute over the conclusion to be drawn from applying relevant legal criteria to undisputed facts does not preclude summary judgment if the record is sufficiently developed and there is only one reasonable conclusion that can be drawn from those facts.”); see Green Valley Health Care

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& 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.”); Brightview, DAB No. 2132 at 10 (entry of summary judgment upheld where inferences and views of non-moving party are not reasonable).

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 a motion for summary judgment, without an evidentiary hearing.  Shah v. Azar, 920 F.3d 987, 996 (5th Cir. 2019), citing Cedar Lake Nursing Home v. U.S. Dep’t of Health & Human Servs., 619 F.3d 453, 457 (5th Cir. 2010); see Fal-Meridian, Inc. v. U.S. Dep’t of Health & Human Servs., 604 F.3d 445, 449 (7th Cir. 2010).

There seems to be some confusion about applying such well-founded principles of civil litigation to these proceedings, with some suggesting that, to do so, denies a party a fundamental right.  In one succinct observation, Judge Posner of the Seventh Circuit Court of Appeals shattered this misconception:  “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.”  Fal-Meridian, 604 F.3d at 449 (emphasis added).

Summary judgment applied to CMPs.  Whether the penalty amount is reasonable is a legal, not a factual issue.  To overcome a summary judgment motion as to the reasonableness of the penalties, the facility must proffer evidence sufficient to create a genuine dispute about facts affecting how the regulatory factors should be assessed.  Vibra Hospital of Charleston, DAB No. 3094 at 30 (2023); Crawford Healthcare and Rehab., DAB No. 2738 at 19 (2016).

Petitioner’s unsupported allegations of facts purportedly in dispute.  Petitioner provides a long list of what it purports are material facts in dispute.  P. Br. at 5-7.  Many of these purported facts are not disputed (e.g., the circumstances surrounding R1 dislodging his tracheostomy ⁴ on January 22) and, as the following discussion establishes, many are not material (e.g., whether staff’s disregard of facility policies caused harm to residents).  Some are simply irrelevant (e.g., whether trach suctioning occurs above or below the vocal cords).

Most important, an unsupported list of purported facts does not establish that material facts are in dispute.  The question is whether Petitioner has tendered evidence of specific facts showing that a genuine dispute exists.  For example, Petitioner alleges as genuine disputes of material fact:  whether facility staff were trained in tracheostomy care and whether they were experienced in caring for tracheostomy patients.  P. Br. at 5.  However, as discussed below,

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Petitioner has not come forward with evidence to create a genuine dispute that all staff who cared for residents with tracheostomies had been properly trained.

And, as discussed below, not only has Petitioner failed to tender evidence establishing material facts in dispute, it has remained silent on a critical fact:  that, contrary to the facility’s policy and the residents’ care plans, the facility did not have emergency trach replacement tubes at the bedsides of at least two residents.  P. Br. at 12.  As explained below, this alone puts the facility out of substantial compliance with section 483.25(i).

1. CMS’s unchallenged determinations that the facility was not in substantial compliance with 42 C.F.R. §§ 483.25(g)(4)(5) and 483.80(a)(1)(2)(4)(e)(f) are final and binding, and, based on those deficiencies, CMS may impose a penalty⁵

CMS’s findings of substantial noncompliance that result in its imposing a remedy are considered initial determinations that the affected party may appeal.  The regulations governing such actions dictate that CMS mail notice of an initial determination to the affected party, setting forth the basis for and the effect of the determination, and the party’s right to a hearing.  42 C.F.R. §§ 498.20(a)(1); 498.3; 498.5.  The affected party may then challenge the determination by filing a hearing request within 60 days of its receiving the notice.  An initial determination is final and binding unless reversed or modified by a hearing decision, or under other circumstances not applicable here.  42 C.F.R. § 498.20(b).

In this case, CMS sent the appropriate notice, and, in its hearing request, Petitioner challenged “each and every factual allegation” and the allegations that the facility was not in substantial compliance with the cited regulations.  Hearing Request at 3.  Such a broad assertion does not comport with the regulation governing these procedures, which requires a more specific statement of the issues, findings of fact, and conclusions of law with which a petitioner disagrees.  42 C.F.R. § 498.40(b).  Although it seems that an inadequate hearing request should be dismissed, the Board has directed administrative law judges to “exercise discretion” to accept “as adequate to preserve a right to hearing” requests that fall short of the specificity requirements of the regulations.  The Carlton at the Lake, DAB No. 1829 at 9 (2002), citing Fairview Nursing Plaza, Inc., DAB No. 1715 (2000); Alden-Princeton Rehab. and Health Care Ctr., DAB No. 1709 (1999).  As the record is developed, a petitioner must eventually satisfy the regulation by articulating the specific bases for its appeal.

To develop the record and determine the specific bases for a petitioner’s appeal, my standing pre-hearing order requires that the parties submit pre-hearing briefs that contain all the arguments they intend to make.  Standing Order at 3 (¶ 4(c)(1)).  Here, in its pre-hearing

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brief, Petitioner discusses only the deficiencies cited under section 483.25(i); it abandons its challenges to sections 483.25(g) and 483.80(a).

CMS’s determinations that the facility did not substantially comply with sections 483.25(g) and 483.80(a) are therefore final and binding:

• Facility staff did not follow proper tube feeding protocols for a vulnerable resident, identified as R1 (described below), who needed enteral feeding.  The facility was therefore not in substantial compliance with section 483.25(g)(5).
• Facility staff did not follow proper infection control and prevention procedures.  Specifically, when providing care for four residents (R3, R5, R6 and R7), they did not wash or sanitize their hands; they improperly disposed of soiled materials after treating R3’s tracheostomy; and they did not sanitize a blood pressure cuff used on R6 and R7.  These failures put the facility out of substantial compliance with section 483.80(a)(1) and (2).

The facility was thus not in substantial compliance with Medicare program requirements, and CMS has the discretion to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406, which include the per-day CMP imposed here.  Act § 1819(h); 42 C.F.R. § 488.402.  So long as CMS has a basis for imposing a remedy, I have no authority to review its determination to do so (42 C.F.R. § 488.438(e)), nor may I review CMS’s choice of remedy.  42 C.F.R. § 488.408(g)(2).

2. The undisputed evidence establishes that, in caring for residents with tracheostomies, the facility did not follow its own policies nor the residents’ care plans, which put the facility out of substantial compliance with 42 C.F.R. § 483.25(i).

Program requirement:  42 C.F.R. § 483.25(i) (Tag F695).  Quality of care “is a fundamental principle that applies to all treatment and care provided to facility residents.”  42 C.F.R. § 483.25.

The statute and regulation require that the facility ensure that residents receive treatment and care in accordance with professional standards of practice, the resident’s comprehensive person-centered care plan, and the resident’s choices.  42 C.F.R. § 483.25; see Act § 1819(b).  To this end, the facility must, among other requirements, ensure that a resident who requires respiratory care, including tracheostomy care and tracheal suctioning, is provided such care, consistent with professional standards of practice, the individual’s comprehensive person-centered care plan, the resident’s goals and preferences, and 42 C.F.R. § 483.65.  42 C.F.R. § 483.25(i).

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Section 483.65 governs specialized rehabilitation services and mandates that the facility provide required respiratory therapy services, or, in accordance with section 483.70, it must obtain those services from qualified personnel through an outside resource that is a provider of respiratory therapy services.

Facility policy:  tracheostomy care.  The facility had in place a written policy for tracheostomy care.  The policy defines “trach care” as the “process of aseptically cleaning a tracheostomy site and trach tube from mucous buildup, maintaining tube patency, reducing risk of infection, and maintaining the skin integrity around the stoma site.”  CMS Ex. 15 at 1.  The policy directs staff to provide the care every 8-12 hours (once per shift) or as indicated in the physician’s order.  Id.

The policy describes, in detail, the procedure that staff must follow.  Among the steps listed, staff must gather the necessary equipment/supplies, which include an emergency trach tube replacement of the same size and one size smaller.  The policy directs that these “should always be at patient’s bedside.”  CMS Ex. 15 at 1 (emphasis added).⁶

Resident 1 (R1).  Resident 1 (R1) was a 34-year-old man, admitted to the facility from an acute care hospital on November 23, 2022.  CMS Ex. 7 at 6.  He had suffered a cerebral infarction (stroke) and was very ill, with a long list of serious impairments, including  pulmonary fibrosis (scarring in the lungs, making it difficult to breathe), hypertrophic cardiomyopathy (abnormally thick heart muscle), atherosclerotic heart disease, type 2 diabetes, heart failure, acute respiratory failure, muscle wasting, and dyspnea (shortness of breath).  CMS Ex. 7 at 1, 28, 29.  He had a tracheostomy.  CMS Ex. 7 at 73.

R1 was also severely cognitively impaired.  His Brief Interview for Mental Status (BIMS) score was 5.  CMS Ex. 7 at 9.  He required extensive assistance (two+ persons physical assist) with bed mobility and dressing.  He was totally dependent on staff for eating, bathing, and other activities of daily living.  CMS Ex. 7 at 17-18, 20, 59, 63.  Even using a wheelchair, he required substantial assistance to move from place to place.  CMS Ex. 7 at 22.  He required a feeding tube and routinely required oxygen.  CMS Ex. 7 at 65, 71.  He was incontinent of bowel and bladder.  CMS Ex. 7 at 26, 61.

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R1 was full code.  CMS Ex. 7 at 60.

R1’s care plan.  R1’s care plan identifies his need for oxygen therapy, related to his respiratory failure.  To address the problem, his plan directs clinical nursing (CN) staff to administer oxygen therapy as ordered by the physician; suction as needed; and monitor for signs and symptoms of respiratory distress, reporting to the physician, as needed.  The plan explains that respiratory distress “could include” an increased respiratory rate, tachycardia, diaphoresis (excessive sweating), lethargy, confusion, persistent cough, pleuritic pain, accessory muscle use, decreased oxygen saturation, or changes to skin color (a bluish or gray tint).  CMS Ex. 7 at 71.

The plan also identifies, as a problem, R1’s impaired respiratory status, putting him at risk for shortness of breath, respiratory distress, increased anxiety, and hypoxia (absence of sufficient oxygen in tissues to sustain bodily functions).  The plan directs clinical nursing staff to:

• monitor the resident for shortness of breath, respiratory distress, wheezing, fatigue, and increased anxiety, and to implement “appropriate interventions.”  If the interventions are ineffective, the nurse should notify the physician.
• Monitor the resident’s pulse oximetry as ordered and report abnormal findings to the physician.
• Assess lung sounds and monitor the resident’s vital signs per physician orders.  Assess respiratory status, including:  rate, depth, pattern, peripheral skin color, and pulse oximetry.
• Provide nebulizer therapy as ordered.
• Provide oxygen therapy as ordered by the physician.
• Encourage and remind the resident to use his call light for assistance and instruct him to report, immediately, any shortness of breath.

CMS Ex. 7 at 72.

The care plan identifies R1’s tracheostomy as a problem.  The plan explains that the tracheostomy puts the resident at risk for potential complications such as weight loss, increased secretions, congestion, infection, and respiratory distress.  The plan warns that tracheostomy status is related to respiratory failure.  CMS Ex. 7 at 73.  To address the problem, the plan directs clinical nurses and respiratory therapy staff to:

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• Provide oxygen, humidity, tracheostomy care, and tubing changes, as indicated by the physician’s orders.
• Ensure that the trach ties are secured at all times.
• Suction, as needed, for increased secretions and congestion.
• Provide oral care daily and as needed.
• Every shift, or as ordered by the physician, monitor and document the resident’s respiratory rate, depth, and quality.
• Monitor the resident for restlessness, agitation, confusion, increased heart rate (tachycardia) and bradycardia (abnormally slow heart rate) and document.
• Keep an extra trach by the resident’s bedside.  If the trach tube is coughed out, and the tube cannot be reinserted, obtain medical help immediately.  Monitor for signs of respiratory distress and document, elevate the head of the resident’s bed, and stay with the resident.
• Monitor labs and x-rays, as ordered and report the results to the physician.
• Monitor and document changes in the resident’s level of consciousness, altered mental status, and lethargy.  Report any changes to the physician.

CMS Ex. 7 at 73. 

R1’s physician orders.  Among R1’s many physician orders was one for enteral feeding, once a day.  CMS Ex. 7 at 76.

R1’s physician also ordered staff to change his respiratory lines, trach tube, and mask weekly and as needed.  Id.  The physician ordered staff to suction every shift and as needed, and to report abnormal secretions to the physician.  They were to provide trach care twice a day (“BID”) and as needed.  “Notify MD with changes every day and night shift for trach care.”  The trach type ordered is “Portex 6.0.”  CMS Ex. 7 at 79.

R1’s trach crises and death.  Nursing notes record that, at 12:40 p.m. on December 4, 2022, R1 had “hard secretions in [his] tracheostomy site[,] not allowing [the] suction catheter to pass.”  The facility’s director of nursing wanted to transfer the resident to the emergency department so that a new tracheostomy could be performed.  R1’s physician subsequently ordered R1 to the hospital so that his trach could be “switched out,” and R1 was transferred to the hospital that day.  CMS Ex. 7 at 137-138.

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R1 later returned to the facility, although the record does not include his hospital discharge documents nor even nursing notes reflecting his readmission.  See CMS Ex. 7 at 135 et seq.

Surveyor Patrice Haynes, R.N., interviewed R1’s family on December 6, 2022.  Family members told her that, according to the hospital physician, R1’s cannula was clogged because it had not been suctioned and changed as it should have been.⁷  A family member reported that he and other family members “had to constantly stay on the staff to provide trach care” and that they had reported this to the facility’s administrator.  The family member also complained that staff were “very slow to answer [the resident’s] call light.”  Family would have to look for staff to assist the resident.  CMS Ex. 20 at 4 (Haynes Decl. ¶ 16).⁸

On the other hand, undisputed evidence supports the claim that staff did not consistently answer the resident’s call light.  At 11:05 a.m. on December 6, 2022, Surveyor Haynes turned on R1’s call light.  A staff member was in the hall outside his room at 11:42 a.m., but, even though his call light was on, did not enter R1’s room.  At 12:05 p.m., the staff member left the hall without ever responding to the call light.  CMS Ex. 20 at 5 (Haynes Decl. ¶ 17).  Surveyor Haynes spoke to the nurse aide assigned to care for R1 (identified as Nurse Aide SS).  The nurse aide said that she had already provided the resident’s incontinent care (which, presumably, was the reason she did not answer his call light).  She acknowledged that she should have answered the call light.  CMS Ex. 20 at 5.  Petitioner has not come forward with any evidence, including a statement from Nurse Aide SS or anyone else, suggesting a dispute over these facts.  Nor has anyone asserted that staff consistently answered call lights promptly.

Although Petitioner does not respond to the evidence that the nurse aide opted not to answer R1’s call light on December 6, it points to an entry in the survey report form and suggests that staff promptly responded to the resident’s call light when he dislodged his trach on January 22.  P. Br. at 9 (citing CMS Ex. 1 at 18-19).  For purposes of summary judgment, I will infer from that entry that staff responded timely on that occasion.  But I do not find that fact material for two reasons:  1) it does not create a genuine dispute that staff consistently answered the resident’s call light when other, undisputed evidence establishes that they did not; and 2) this case does not turn on whether staff responded promptly to the resident’s call

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light.  Staff’s other failures to follow facility policies and the residents’ care plans put it out of substantial compliance, without regard to whether they answered the call lights.

At 10:10 p.m. on January 22, 2023, R1’s trach dislodged.  He told the licensed vocational nurse (identified as LVN T) that his coughing might have dislodged it.  CMS Ex. 7 at 124; P. Ex. 3.  Nurse Aide SS was present.  When Surveyor Haynes interviewed Nurse Aide SS on January 30, the nurse aide confirmed R1’s family’s complaints.  She told the surveyor that LVN T “was not concerned about suctioning . . . or checking on” R1.  The resident’s family “constantly” had to “stay on LVN T to provide trach care” for him.  CMS Ex. 20 at 10 (Haynes Decl. ¶ 29).  Again, the nurse aide has not denied making this statement; however, this decision does not rest on her assertions (see discussion, below).

The nurse aide also told Surveyor Haynes that, when the trach dislodged on January 22, LVN T attempted to reinsert the trach but could not do so because it was the wrong size (although it is not clear how she would have known this).  The nurse left the room to look for another trach.  CMS Ex. 20 at 10-11 (Haynes Decl ¶ 29).  Contrary to facility policy and the resident’s care plan, the facility did not keep an extra trach by the resident’s bedside.

When the Emergency Medical Services (EMS) team arrived at his bedside, R1’s oxygen saturation level was at 100%, and he could speak to them.  However, about ten minutes after his trach dislodged, as EMS personnel attempted to move him, his oxygen saturation levels plummeted, dropping to 50%.  The resident went into cardiac arrest.  When he arrived at the hospital, EMS personnel were still administering CPR.  CMS Ex. 7 at 139; P. Ex. 4 at 1.

At the emergency room, a physician tried, unsuccessfully, to reinsert R1’s tracheostomy.  A second physician was eventually able to do so, after a few attempts.  Unfortunately, the patient remained unstable, and, notwithstanding all of the hospital’s efforts, R1 died at 1:08 a.m. on January 23, 2023.  CMS Ex. 7 at 145-148; P. Ex. 4 at 7-9.

Resident 2 (R2).  R2 was a 29-year-old woman, initially admitted to the facility on January 21, 2023, suffering from acute and chronic respiratory failure with hypoxia, dysphagia, sepsis, anemia, malnutrition, Parkinson’s disease, anoxic brain damage, and depression.  CMS Ex. 8 at 1, 35.  She had an indwelling catheter and was incontinent of bowel.  CMS Ex. 8 at 32.

She had a tracheostomy in place and required oxygen therapy, suctioning, and tracheostomy care.  CMS Ex. 8 at 1, 7, 47, 76.

She could not speak and could rarely make herself understood.  She rarely (if ever) understood others.  CMS Ex. 8 at 14.  Her cognition was severely impaired.  CMS Ex. 8 at 16.  She was totally dependent on staff for activities of daily living.  CMS Ex. 8 at 23-24.

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Her physician ordered staff to replace her inner cannula every day and as needed; suction every shift and as needed; and provide trach care every shift and as needed.  CMS Ex. 8 at 7.

R2’s care plan.  To prevent hypoxia, R2’s care plan directed staff to administer oxygen therapy according to physician orders and to suction, as needed.  CMS Ex. 8 at 76.

According to her care plan, the resident’s trach size was 8.  To address the problem of the tracheostomy, R2’s care plan directs staff to:

• provide oxygen, humidity, tracheostomy care, and tubing changes as indicated by physician orders;
• ensure that the trach ties are secured at all times;
• suction, as needed, for increased secretions and congestion;
• provide oral care daily and as needed;
• monitor the resident for restlessness, agitation, confusion, increased heart rate and bradycardia and document the findings;
• keep an extra trach at her bedside.  If her tube is coughed out and cannot be reinserted, staff should obtain medical help immediately; they should monitor and document signs of respiratory distress, elevate the head of her bed, and stay with the resident; and
• staff should provide the resident with appropriate communication tools, such as pen and paper or a communication device, based on her cognitive and functional abilities.

CMS Ex. 6 at 78.

She was full code.  CMS Ex. 8 at 68.

Surveyor observations.  On the morning of February 7, 2023, Surveyor Haynes noted that R2 did not have an Ambu bag at her bedside.  CMS Ex. 20 at 15 (Haynes Decl. ¶ 44).

Surveyor Haynes then questioned the responsible nurse, identified as LVN Q.  LVN Q conceded that R2 had no Ambu bag, inner cannula, or emergency trach kit at her bedside.  She acknowledged that such supplies should be kept at the bedside of any resident who has a tracheostomy, in the event of an emergency.  However, in the eight months she had been at the facility, she had not observed trach supplies or Ambu bags at the bedsides of residents who had trachs.  CMS Ex. 20 at 15-16 (Haynes Decl. ¶ 45).  LVN Q could not explain why

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the required trach supplies were not there.  She said that “Central Supply” and the nurses were responsible for keeping resident rooms stocked with trachs and trach supplies.  Id.

She also said that some inner cannulas of different sizes were on her cart, but she did not know R2’s trach size and would not know the size unless she changed the trach.  When Surveyor Haynes checked the cart, she found one inner cannula “Shiley,” size 5.5 mm and two Portex brand inner cannulas, 5.0 mm.  CMS Ex. 20 at 16 (Haynes Decl. ¶ 45).  LVN Q searched the facility but could not find any Ambu bags on Station A, Station B, or in any supply rooms.  She found just one emergency trach kit with an “obturator” (a device used to insert a trachesotomy tube).  Id.

Surveyor Haynes interviewed the Central Supply Manager, who told her that, although she ordered whatever supplies the respiratory therapist asked for, she had never ordered any trach insertion kits for emergency trach dislodgment.  CMS Ex. 5 at 11; CMS Ex. 20 at 18 (Haynes Decl. ¶53).  The Supply Manager has not come forward to deny making that statement, and neither the Supply Manager nor any other witness asserts that the statement is untrue.  Beatrice State Development Ctr., DAB No. 2311 at 17, 18 (2010) (pointing out that the facility could have but did not present employee testimony that refuted the statements that 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).

Nurses’ training.  LVN R was assigned to care for Resident 3 (R3), a 34-year-old man suffering from chronic respiratory failure and other disorders.  CMS Ex. 9 at 1; CMS Ex. 20 at 18 (Haynes Decl. ¶ 52).  R3 also had a tracheostomy.  CMS Ex. 9 at 65.  LVN R told Surveyor Haynes that she would not know how to reinsert R3’s trach if it became dislodged.  An obturator was at the resident’s bedside, which LVN R said she did not know how to use.  LVN R explained that she had last been trained on trach care when she was in nursing school.  She had been a nurse for a year and had started working at the facility the previous week.  CMS Ex. 5 at 11; CMS Ex. 20 at 18 (Haynes Decl. ¶ 52).  Again, LVN R has not denied making this statement, and neither she nor any other witness denies that it is true.  Beatrice State Development Ctr., DAB No. 2311 at 17, 18; Omni Manor Nursing Home, DAB No. 1929 at 11.  Further, Petitioner has produced no evidence suggesting that, before she was assigned to care for a resident with a trach, the facility confirmed that LVN R was capable of caring for him or that it provided her with any training in trach care.

The facility’s substantial noncompliance.  The undisputed evidence establishes that the facility was not in substantial compliance with section 483.25(i) for two reasons:  1) the facility did not assure that staff assigned to care for residents with tracheostomies had been properly trained; and 2) most significant, facility staff did not comply with accepted standards of care, the facility policies, and the residents’ care plans that required them to keep, next to the resident’s bedside, an emergency trach tube replacement of the same size and one that was one size smaller.  CMS Ex. 7 at 73; CMS Ex. 15 at 1.  In fact, the

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undisputed evidence establishes that, when questioned about those supplies, staff searched the facility but could not locate them.

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 [its] residents’ highest practicable physical, mental, and psychosocial well-being, as required by section 483.25.”  Green Valley Healthcare and Rehab. Ctr., DAB No. 2947 at 6 (2019) (citing The Laurels at Forest Glen, DAB No. 2182 at 18 (2008)); North Las Vegas Care Ctr., DAB No. 2946 at 6 (2019); Bivins Mem’l Nursing Home, DAB No. 2771 at 9 (2017) (finding that a facility’s failure to comply with its own policies supports the finding that the facility was not in substantial compliance with regulatory requirements); 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.”); see Green Oaks Health & Rehab. Ctr., DAB No. 2567 at 5 (2014) (holding that the methods a facility chooses to protect its residents are reflected in its policies, assessments, and care plan).

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 6-7 (2013); Deltona Health Care, DAB No. 2511 at 7-8 (2013); Venetian Gardens, DAB No. 2286 at 5 (2009).

Petitioner’s defenses.  Petitioner, nevertheless, argues that, with respect to R1, the outcome would not have been different even if the required supplies had been available.  In support, Petitioner presents a written declaration from Teresa T. Guerrero, M.D., who became the facility’s medical director in January 2023.  P. Ex. 2 at 1 (Guerrero Decl. ¶ 2).⁹  Dr. Guerrero disagrees with CMS’s conclusion that the facility violated section 483.25(i).  P. Ex. 2 at 1 (Guerrero Decl. ¶ 3).  This is a legal conclusion, not a finding of fact, so I would not have to defer to Dr. Guerrero’s opinion as to whether the standard is met.¹⁰

But Dr. Guerrero’s claims are limited.  She does not defend the facility’s failing to have critical supplies available.  She opines simply that having the emergency supplies available

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would not have made any difference to the outcome to this particular resident.  P. Ex. 2 at 2 (Guerrero Decl. ¶ 7).  “This was a very unfortunate but isolated incident and was a complication of [R1’s] medical problems and having a tracheostomy.”  Id. (Guerrero Decl. ¶ 10).  No one, including Dr. Guerrero, has claimed that it isn’t vitally important to have these supplies readily available for all tracheostomy residents.

For purposes of summary judgment, I accept that the absence of emergency trach supplies would not have changed the outcome for R1.  However, the standard for finding substantial noncompliance is not whether the substantial noncompliance killed the resident or even whether it caused him actual harm.  The standard is whether the deficiency presents “the potential for more than minimal harm.”  42 C.F.R. § 488.301.  It does.  Moreover, R1 was not the only resident with a trach.  Failing to have emergency supplies readily available presents the potential for harming any of those other residents.

With respect to staff training, Petitioner submits an attendance sheet for in-service training conducted on March 16, 2022.  The training topic is listed as:  “Breath sounds, nebulizer therapy, trach & suction/care, emergency preparedness.”  Only nine staff members attended.  LVN R, who was not working at the facility in March 2022, obviously did not attend.  Further, no evidence describes what that training entailed.  P. Ex. 6.  In any event, one in-service training, held more than nine months before R1’s crisis, hardly creates a genuine dispute that staff charged with caring for residents who had trachs were trained properly.  And the undisputed evidence establishes that at least one nurse, charged with caring for such a resident, was, by her own admission, not properly trained.

3. The undisputed evidence establishes that CMS’s determination that, from January 22 through February 9, 2023, the facility’s substantial noncompliance with section 483.25(i) 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.  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).  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.  Woodland Oaks Healthcare Facility, DAB No. 2355 at 17-18 (2010); Grace Healthcare of Benton, DAB No. 2189 at 13 (2008), citing Liberty Commons Nursing & Rehab Center- Johnston, DAB No. 2031 at 17-18, aff’d, Liberty Commons Nursing & Rehab Ctr. – Johnston v. Leavitt, 241 F. App’x 76 (4^th Cir. 2007).

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

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of immediate jeopardy where CMS presented evidence “from which ‘[o]ne could reasonably conclude’ that immediate jeopardy exists.”  Florence Park Care Ctr., DAB No. 1931 at 27-28 (2004), citing Koester Pavilion, DAB No. 1750 (2000); Daughters of Miriam Center, DAB No. 2067 at 7, 9 (2007); see Yakima Valley School, DAB No. 2422 at 8 (2011) (holding that the “clearly erroneous” standard is highly deferential and “places a heavy burden on the facility to upset CMS’s finding regarding the level of noncompliance.”).

Citing the Board decision in Daughters of Miriam Center, DAB No. 2067 (2007) (again, without providing any page numbers) and Appendix Q, a provision of the State Operations Manual, Petitioner argues that immediate jeopardy “has been interpreted as a ‘crisis situation’ in which the health and safety of individuals are at serious risk in the very near future.”  P. Br. at 8.  Although the Daughters of Miriam decision mentions Appendix Q, it does not say that immediate jeopardy requires a crisis situation.  Instead, the Board recognized that distinguishing between the levels of noncompliance is necessarily imprecise and observed that this “inherent imprecision is precisely why CMS’s immediate jeopardy determination, a matter of professional judgment and expertise, is entitled to deference.”  Id. at 15.  Because CMS’s immediate jeopardy determination is presumed to be correct – that is, “the harm or threatened harm resulting from the noncompliance was in fact serious” – the facility must rebut that presumption “with evidence and argument showing that the harm or threatened harm did not meet any reasonable definition of ‘serious.’”  DAB No. 2067 at 9 (emphasis added).

Since it decided Daughters of Miriam, the Board has affirmatively discouraged reliance on Appendix Q, pointing out that the provisions of the State Operations Manual are “instructive,” but not binding.  Instead, we are bound by the regulatory definition of immediate jeopardy found in section 488.301.  Countryside Rehab. and Health Ctr., DAB No. 2853 at 25 (2018) (“The imminence of resident harm is not an element of the regulatory definition of immediate jeopardy”); Kindred, DAB No. 2792 at 20; Miss. Care Ctr. of Greenville, DAB No. 2450 at 15-16 (2012); Foxwood Springs Living Ctr., DAB No. 2294 at 9 (2009).  That definition “neither defines the term ‘likelihood’ nor sets any parameters as to the timing of potential harm.”  Miss. Care Ctr., DAB No. 2450 at 16 (quoting Agape Rehab. of Rock Hill, DAB No. 2411 at 19 (2011)).  Thus, the Board has concluded that a facility’s deficiencies may pose immediate jeopardy even though they do not create a “crisis situation.”  Miss. Care Ctr., DAB No. 2450 at 16.¹¹

Here, the facility’s residents relied on their tracheostomies so that they could breathe properly.  When a trach became dislodged, promptly replacing it was critical for preventing serious injury, harm, or even death.  The facility recognized this when it required – in both its policies and the individual resident care plans – that replacement supplies be kept at bedside.  Not only did the facility fail to keep the supplies at hand, staff could not even find

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them anywhere in the facility.  Thus, if a tracheostomy became dislodged, staff would be unable to replace it, likely putting the resident at significant risk.  CMS’s finding that the facility’s deficiency posed immediate jeopardy to resident health and safety is therefore not clearly erroneous.

4. The penalties imposed – $9,675 per day for 19 days of immediate jeopardy and $360 per day for 35 days of substantial noncompliance that did not pose immediate jeopardy – are reasonable.

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

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

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

Penalties are inflation-adjusted and change annually.  The amount is determined as of the date the penalty is assessed, in this case, March 14, 2023.  CMS Ex. 3; 87 Fed. Reg. 15,100, 15,111-12 (Mar. 17, 2022).  For each day of immediate jeopardy, CMS imposed a penalty of $9,675, which is close to the bottom of the penalty range for situations of immediate jeopardy ($7,317 to $23,989).  CMS imposed a penalty of $360 per day for the period of substantial noncompliance that did not pose immediate jeopardy, which is again at the very low end of the penalty range ($120 to $7,195).  42 C.F.R. §§ 488.408(e), 488.438; 45 C.F.R. § 102.3; 87 Fed. Reg. at 15,111-12 (Mar. 17, 2022).

Considering the relevant factors, these amounts are reasonable.

The facility has a less than perfect compliance history, and its prior deficiencies included quality-of-care and infection control deficiencies cited during the February 15, 2023 survey.
For example,

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• During the annual recertification survey, completed on June 23, 2022, the facility was not in substantial compliance with 42 C.F.R. § 483.45(c)(3), (e) (Tag F758 – pharmacy services:  psychotropic drugs) cited at scope and severity level E;
• During a complaint investigation survey, completed on October 5, 2021, the facility was not in substantial compliance with 42 C.F.R. § 483.35(a) (Tag F725 – nursing services:  sufficient staff) cited at scope and severity level D;
• During an abbreviated recertification survey, completed on March 24, 2021, the facility was not in substantial compliance with 42 C.F.R. § 483.25(c) (Tag F688 – quality of care:  mobility) cited at scope and severity level E;
• During a complaint investigation survey, completed on December 15, 2020, the facility was not in substantial compliance with two requirements:  42 C.F.R. § 483.10 (Tag F558 – resident rights) and 42 C.F.R. § 483.80(a) (Tag F880 – infection control:  infection prevention and control), both cited at scope and severity level E;
• During a complaint investigation survey, completed on January 7, 2020, the facility was not in substantial compliance with 42 C.F.R. § 483.20(b) (Tag F637 – comprehensive assessments) cited at scope and severity level D; and
• During the facility’s annual recertification survey, completed July 26, 2019, the facility was not in substantial compliance with two requirements:  42 C.F.R. § 483.25(e)  (Tag F690 – quality of care:  incontinence care) and (again) 42 C.F.R. § 483.80(a)  (Tag F880 – infection control:  infection prevention and control), both cited at scope and severity level E.

CMS Ex. 23 at 1-3.  The facility’s history, by itself, justifies greater-than-minimum penalties.

With respect to the facility’s financial condition, Petitioner argues that CMS has not considered the facility’s financial condition and that no regulatory requirement mandates that Petitioner provide financial information to CMS.  P. Br. at 15 (also asserting generally that CMS “has not offered any reliable summary judgment evidence to support the assertion that the CMPs were reasonable.”).

Petitioner’s position is mistaken.  As the moving party on summary judgment, CMS must simply show that no genuine factual dispute exists.  CMS has done so here by pointing out that Petitioner “has not alleged an inability to pay the CMPs imposed.”  CMS Br. at 24.  As explained above, to overcome a summary judgment motion on the issue, the facility must then proffer evidence sufficient to create a genuine dispute about facts affecting how the

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regulatory factors (including financial condition) should be assessed.  Vibra Hospital of Charleston, DAB No. 3094 at 30; Crawford Healthcare, DAB No. 2738 at 19.  Petitioner has proffered no such evidence.  Nor does Petitioner claim that it is unable to pay the penalty.

As to the remaining factors, I have discussed in some detail the facility’s deficiencies under section 483.25(i).  Knowing how vulnerable its tracheostomy-dependent residents were, and how vital it was for staff to respond immediately if a trach became dislodged, the facility did not keep handy the supplies that were needed.  In fact, staff searched the facility but were unable to find them.  For this, the facility is culpable.

Nor was section 483.25(i) the facility’s only deficiency.  As discussed above, R1 was seriously ill and required enteral feeding.  Yet, in feeding him, staff did not follow proper tube feeding protocols, which put the facility out of substantial compliance with section 483.25(g)(5).

In significant ways, facility staff did not follow proper infection control and prevention procedures.  Specifically, when providing care for four residents (R3, R5, R6 and R7), they did not wash or sanitize their hands; they improperly disposed of soiled materials after treating R3’s tracheostomy; and they did not sanitize a blood pressure cuff used on R6 and R7.  These failures put the facility out of substantial compliance with section 483.80(a)(1) and (2).  As review of its history shows, the facility repeatedly violated the infection control regulation.

Based on these considerations, I find reasonable the $9,675 per-day penalty for the days of immediate jeopardy and the $360 per-day penalty for the days of substantial noncompliance that did not pose immediate jeopardy.

Conclusion

I grant CMS’s motion for summary judgment.

The undisputed evidence establishes that, from January 22 through March 16, 2023, the facility was not in substantial compliance with Medicare program requirements.  From January 22 through February 9, 2023, its deficiencies posed immediate jeopardy to resident health and safety.

The penalties imposed are reasonable.

Endnotes

¹ The Federal Rules of Civil Procedure (Fed. R. Civ. P.) are not binding in these administrative appeals; however, in determining whether summary judgment is appropriate, I am guided by those rules and by judicial decisions on summary judgment.  See Wade Pediatrics, DAB No. 2153 at 16 (2008).

² It is not the judge’s job to parse through an exhibit in order to determine which sections a party might find objectionable.  My standing order directs the parties to cite the “exhibit number and page number” of any exhibit upon which it relies.  Standing Order at 3 (¶ 4c(1)) (emphasis added).  Petitioner disregarded these instructions.

³ Deciding a case on summary judgment (or based on the written record) does not mean that it is decided without a hearing, and, in applying the principles of summary judgment to administrative proceedings, courts have been careful to avoid any suggestion that the case is decided without a hearing.  Throughout their decisions, they refer to deciding the case without an “oral hearing” or without an “evidentiary hearing.”  Although a case may be decided on summary judgment (or based on the written record), an administrative law judge, by considering the evidence and applying the law, has granted the petitioner a hearing, as required by sections 205(b) and 1866(h) of the Act.  See 42 C.F.R. § 498.66(d) (on conducting a hearing without oral testimony); CNG Transmission Corp. v. FERC, 40 F.3d 1289, 1293 (D.C. Cir. 1994) (holding that a “paper hearing” satisfies statutory requirements for “notice and opportunity for hearing.”).

⁴ A tracheostomy is a surgical procedure that creates an opening in the neck and inserts a tube into the windpipe to help a person breathe.  The term “tracheostomy” refers to both the procedure and the surgically-created hole (stoma) in the patient’s windpipe.

⁵ My findings of fact/conclusions of law are set forth, in italics and bold, in the discussion captions of this decision.

⁶ The facility’s policy reflects the accepted standards of care for treating tracheostomy patients:  “To ensure patient safety, a replacement tracheostomy tube, an obturator, a bag valve mask (Ambu bag), and suction catheter kit must always be available in the [resident] room.”  Open Resources for Nursing (Open RN), Nursing Skills, ch. 22 Tracheostomy Care & Suctioning Introduction, available at https://www.ncbi.nlm.nih.gov/books/NBK593189/#:~:text=To%20ensure%20patient%20safety%2C%20a,be%20available%20in%20the%20room (last visited Jun. 12, 2024).

⁷ Trach tubes often have an “inner cannula” or “inner tube.”  This is a tube within the outer tube that can be removed and cleaned more easily, without having to change the whole (outer) tracheostomy tube.

⁸ Hard secretions can be caused by a number of factors, including low humidity.  See Tracheostomy Complications and their Management, available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5531884/ (last visited Jun. 13, 2024).  The evidence here is insufficient to determine what caused R1’s trach to be clogged.

⁹ Notably, Dr. Guerrero does not claim to have been at the facility while R1 was a resident; she does not claim to have any personal knowledge of the care he received.  See P. Ex. 2 at 1 (Guerrero Decl. at 1 ¶¶ 3, 4) (“I am aware of the survey at Tomball”); (“To form my opinions in this matter, I reviewed [R1’s] medical record.”).

¹⁰ CMS objected to Dr. Guerrero’s testimony, pointing out that the immediate jeopardy determination is a legal issue “solely within the ALJ’s purview to decide.”  CMS Objections at 1-2 (DAB E-File Doc. No.8 at 1-2).  I agree.  Although I admit her written declaration, I give no weight to the doctor’s legal opinion.

¹¹ This approach comports with the Supreme Court’s comments as to the value of sub-regulatory guidance.  See Azar v. Allina Health Servs., 139 S. Ct. 1804 (2019).