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Northridge Village, DAB CR6540 (2024)


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

Northridge Village,
(CCN:  165613),

Petitioner,

v.

Centers for Medicare & Medicaid Services
 

Docket No. C-23-402
Decision No. CR6540
September 23, 2024

DECISION

Petitioner, Northridge Village, is a long-term-care facility, located in Ames, Iowa, that participates in the Medicare program.  This case stems from a complaint-investigation survey, completed on October 20, 2022, by the (then called) Iowa Department of Inspections and Appeals (state agency). 

Based on the survey findings, the Centers for Medicare & Medicaid Services (CMS) determined that, from October 10 through November 18, 2022, the facility was not in substantial compliance with Medicare requirements, including 42 C.F.R. § 483.25(e), and that, from October 10 through 17, 2022, its deficiencies posed immediate jeopardy to resident health and safety.  CMS imposed civil money penalties (CMPs) of $7,685 per day for eight days of immediate jeopardy and $585 per day for 32 days of substantial noncompliance that did not pose immediate jeopardy.  

Petitioner appealed. 

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For the reasons set forth below, I find that the facility was not in substantial compliance with 42 C.F.R. § 483.25(e), that this deficiency posed immediate jeopardy to resident health and safety, and that the per-day CMPs ($7,685 and $585) are reasonable.  

Although I affirm the amounts of the per-day penalties, for reasons discussed below, I decline to rule on whether the facility’s substantial noncompliance continued beyond November 13, 2022, because that issue is not properly before me. 

Background

The Social Security Act (Act) sets forth requirements for nursing facilities to participate in the Medicare program and authorizes the Secretary of Health and Human Services to promulgate regulations implementing those statutory provisions.  Act § 1819.  The Secretary’s regulations are found at 42 C.F.R. Part 483.  To participate in the Medicare program, a nursing facility must maintain substantial compliance with program requirements.  To be in substantial compliance, a facility’s deficiencies may pose no greater risk to resident health and safety than “the potential for causing minimal harm.”  42 C.F.R. § 488.301. 

The Secretary contracts with state survey agencies to conduct periodic surveys to determine whether skilled nursing facilities are in substantial compliance.  Act § 1864(a); 42 C.F.R. § 488.20.  Each facility must be surveyed annually, with no more than fifteen months elapsing between surveys.  Facilities must be surveyed more often, if necessary, to ensure that identified deficiencies are corrected.  Act § 1819(g)(2)(A); 42 C.F.R. §§ 488.20(a), 488.308.  The state agency must also investigate all complaints.  Act § 1819(g)(4). 

Here, responding to a complaint, surveyors from the Iowa state agency completed an investigation survey on October 20, 2022.  CMS Ex. 1 at 1; CMS Ex. 2.  Based on the survey findings, CMS determined that (among other findings) the facility was not in substantial compliance with 42 C.F.R. § 483.25(e) (Tag F690) (quality of care – incontinence), cited at scope-and-severity level J (isolated instance of substantial noncompliance that poses immediate jeopardy to resident health and safety).  CMS Exs. 1, 2.1 

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Thereafter, CMS determined that the facility returned to substantial compliance on November 19, 2022.  CMS Exs. 1, 3; see CMS Ex. 12.  

Based on the deficiency cited under section 483.25(e), CMS has imposed against the facility a $7,685 per-day CMP for eight days of immediate jeopardy (October 10-17, 2022) ($61,480) and a $585 per-day CMP for 32 days of substantial noncompliance that did not pose immediate jeopardy (October 18 – November 18, 2022) ($18,720).  (Total CMP:  $61,480 + $18,720 = $80,200). 

Petitioner timely requested a hearing. 

On January 23, 2024, I held a hearing via video teleconference, from the offices of the Departmental Appeals Board in Washington, D.C.  Ms. Fahryn E. Hoffman, representing CMS, appeared from Lawrence, Kansas.  Transcript (Tr.) at 1.  Ms. Rebecca Brommel, representing Petitioner, appeared from Ames, Iowa.  Transcript (Tr.) at 1-2. 

The parties have submitted pre-hearing briefs (CMS Pre-hrg. Br.; P. Pre-hrg. Br.), post-hearing briefs (CMS Post-hrg. Br.; P. Post-hrg. Br.), and reply briefs (CMS Reply; P. Reply). 

Issues

  • From October 10 through November 18, 2022, was the facility in substantial compliance with 42 C.F.R. § 483.25(e);
  • If, from October 10-17, 2022, the facility was not in substantial compliance with section 483.25(e), did that deficiency then pose immediate jeopardy to resident health and safety; and
  • If the facility was not in substantial compliance, are the remedies imposed – CMPs of $7,685 per-day and $585 per-day – reasonable?

Duration of the substantial noncompliance.  Petitioner’s hearing request does not challenge the duration of the facility’s substantial noncompliance, so CMS, which filed first, can hardly be blamed for not addressing that issue when it submitted its brief and exhibits.  Buried in a footnote in Petitioner’s pre-hearing brief, Petitioner mentions that, 

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because surveyors found that the facility achieved substantial compliance on November 14, 2022, any penalty should end on November 13.  P. Pre-hrg. Br. at 2 n.2.  In its post-hearing brief, Petitioner repeats the assertion in the text, although Petitioner mentions it as part of the “Background Facts.”  Petitioner does not include the assertion as part of its argument.  P. Post-hrg. Br. at 2; CMS Ex. 3. 

Although their findings are important, the surveyors do not determine when the facility achieves substantial compliance; CMS does.  See 42 C.F.R. § 488.452.  By not raising the issue in its hearing request, Petitioner arguably waived any challenge to CMS’s findings as to the duration of its substantial noncompliance.  See 42 C.F.R. § 498.40(b) (requiring the hearing request to identify the specific findings of fact and conclusions of law with which Petitioner disagrees and to specify the basis for contending that the findings and conclusions are incorrect). 

Here, however, CMS does not dispute that, effective November 14, the facility corrected the deficiency cited under section 483.25(e).  According to CMS, the penalty continued because the facility did not achieve substantial compliance with Life Safety Code requirements until November 19, 2022.  CMS’s Reply at 4.  The problem with CMS’s position is that the remedy here was based solely on the deficiency cited under section 498.25(e).  The notice letter does not mention a Life Safety Code survey; it does not indicate that any penalties were imposed based on the Life Safety Code deficiencies.  CMS Ex. 1.  That matter is therefore not before me, and I am not in a position to determine whether the facility is subject to additional penalties based on the Life Safety Code survey.  I therefore leave that issue unresolved. 

Exhibits

I admitted into evidence CMS Exs. 1-47 and P. Exs. 1-34.  Order Summarizing Pre-hearing Conference at 3-4 (December 6, 2023); Tr. at 2. 

With its post-hearing brief, CMS submitted four additional exhibits, CMS Exs. 48-51: 

  • CMS Ex. 48 is an excerpt from the Long-Term Care Survey Process Procedure Guide, which was in effect at the time of the October 2022 survey.
  • CMS Ex. 49, titled “Hospitalization Critical Element Pathway,” is another sub-regulatory document that provides guidance to surveyors in assessing resident treatment.  
  • CMS Exs. 50 and 51 are documents from the Life Safety Code Survey and Post-Certification Revisit Report, indicating that the facility corrected its Life Safety Code Deficiencies as of November 19, 2022.   

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CMS Exs. 48 and 49 are official CMS documents (like the State Operations Manual) to which I could refer without entering them into the record as exhibits.  However, I do not find them particularly relevant.  I am not concerned with the means by which either CMS or the state agency reached its determination; rather I take a “fresh look” at the legal and factual bases for the deficiency findings to determine whether those findings accord with the Act and regulations.  Britthaven of Chapel Hill, DAB No. 2284 at 6 (2009), and cases cited therein; Avalon Place Trinity, DAB No. 2819 at 12 n.8 (2017) (pointing out that, on appeal, the ALJ does not review CMS’s conclusions or determinations about earlier state agency-level review but rather reviews the record de novo and determines whether the facility was in substantial compliance with applicable requirements).  Therefore, I decline to admit CMS Exs. 48 and 49. 

With respect to CMS Exs. 50 and 51, because the Life Safety Code deficiencies are not before me, the documents are irrelevant, and I decline to admit them.  42 C.F.R. § 498.60(b)(1) (requiring me to receive evidence that is relevant and material). 

Discussion

Program requirements:  42 C.F.R. § 483.25(e) (Tag F323).  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 “quality-of-care” regulation requires that the facility ensure that each resident 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).  The regulation “imposes on facilities an affirmative duty designed to achieve favorable outcomes to the highest practicable degree.”  Sheridan Health Care Ctr., DAB No. 2178 at 14 (2008) (citing Windsor Health Care Ctr., DAB No. 1902 at 16-17 (2003)); Woodstock Health Care Ctr., DAB No. 1726 at 3-4 (2000), aff’d, Woodstock Care Ctr. v. Thompson, 363 F.3d 583 (6th Cir. 2003).  To this end, the facility, among other provisions, “must ensure” that a resident who is continent of bladder and bowel on admission receives services and assistance to maintain continence unless the resident’s clinical condition is or becomes such that continence is not possible to maintain.  42 C.F.R. § 483.25(e)(1).  

For a resident with urinary incontinence, based on the resident’s comprehensive assessment, the facility must ensure that:  i) a resident who enters the facility without an indwelling catheter is not catheterized unless the resident’s clinical condition demonstrates that catheterization is necessary; ii) a resident who enters the facility with an indwelling catheter, or subsequently receives one, is assessed for removal of the catheter as soon as possible unless the resident’s clinical condition demonstrates that catheterization is necessary; and iii) a resident who is incontinent of bladder receives 

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appropriate treatment and services to prevent urinary tract infections and to restore continence to the extent possible.  42 C.F.R. § 483.25(e)(2). 

We consider here whether the facility complied with this regulation and the facility’s policies in its treatment of two residents:  Resident 28 (R28), who had an indwelling catheter; and Resident 34 (R34), who suffered an undetected urinary tract infection. 

Facility policies.  As the Board has repeatedly explained, a facility’s policy for implementing a regulatory requirement reflects the facility’s own judgment about how best to achieve substantial compliance.  Failing to comply with its own policies “can support a finding that the facility did not achieve compliance with the regulatory standard.”  Bivins Memorial Nursing Home, DAB No. 2771 at 9 (2017); see The Bridge at Rockwood, DAB No. 2954 at 29 (2019) (ruling that, absent contrary evidence, it is reasonable to presume that the facility’s policies reflect professional standards); Green Valley Healthcare and Rehab. Ctr., DAB No. 2947 at 6 (2019) (citing The Laurels at Forest Glenn, DAB No. 2182 at 18 (2008)); North Las Vegas Care Ctr., DAB No. 2946 at 6 (2019); Hanover 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.”); Life Care Ctr. of Bardstown, DAB No. 2233 at 21-22 (2009) (finding that a facility’s failing to comply with its own policies can constitute a deficiency). 

Facility policy:  handwashing/hand hygiene.  The facility had in place a policy for hand hygiene, declaring that it “considers hand hygiene the primary means to prevent the spread of infection.”  CMS Ex. 7 at 1. 

The policy requires that all personnel be trained and regularly in-serviced on the importance of hand hygiene in preventing the transmission of healthcare-associated infections and that staff follow the facility’s handwashing and hand hygiene procedures.  Id. 

The policy directs that hand hygiene products and supplies (sinks, soap, towels, alcohol-based hand rub, etc.) be readily accessible and convenient for staff.  Staff must wash hands with soap and water:  a) when hands are visibly soiled; and b) after contact with a resident with infectious diarrhea.  Id. 

The policy lists additional situations that require staff to use an alcohol-based hand rub or soap and water: 

  • Before and after coming on duty;
  • Before and after direct contact with residents;

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  • Before preparing or handling medications;
  • Before performing any non-surgical invasive procedures;
  • Before and after handling an invasive device (e.g., urinary catheters, IV access sites);
  • Before donning sterile gloves;
  • Before handling clean or soiled dressings, gauze pads, etc.;
  • Before moving from a contaminated body site to a clean body site during resident care;
  • After contact with a resident’s intact skin;
  • After contact with blood or bodily fluids; after handling used dressings, contaminated equipment, etc.;
  • After contact with objects (e.g., medical equipment) in the immediate vicinity of the resident;
  • After removing gloves;
  • Before and after entering isolation precaution settings;
  • Before and after eating or handling food;
  • Before and after assisting a resident with meals; and
  • After personal use of the toilet or conducting your personal hygiene.   

Id. 

The policy describes hand hygiene as the “final step after removing and disposing of personal protective equipment.”  Id. 

The policy also warns that the use of gloves does not replace hand washing/hand hygiene.  Integration of glove use along with routine hand hygiene is recognized as the best practice for preventing healthcare-associated infections.  Single-use disposable gloves should be used:  before aseptic procedures; when anticipating contact with blood or body 

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fluids; and when in contact with a resident or the equipment or environment of a resident who is on contact precautions.  CMS Ex. 7 at 2. 

The policy outlines, in some detail, the procedures staff must follow in washing their hands, using alcohol-based hand rubs, and applying and removing gloves.  CMS Ex. 7 at 2-3. 

Facility policy:  change in a resident’s condition or status.  The facility policy requires staff to notify the resident, the attending physician, and the resident representative of changes in the resident’s medical/mental condition and/or status.  Specifically, the nurse must notify the resident’s attending physician or the physician on call when there has been: 

  • An accident or incident involving the resident;
  • Discovery of injuries of an unknown source;
  • An adverse reaction to medication;
  • A significant change in the resident’s physical/emotional/mental condition;
  • A need to alter significantly the resident’s medical treatment;
  • A need to transfer the resident to a hospital/treatment center;
  • A discharge without proper medical authority; and/or
  • specific instructions to notify the physician of changes in the resident’s condition. 

CMS Ex. 8 at 1. 

According to the policy, a “significant change” is a “major decline or improvement in the resident’s status” that: 

  • will not normally resolve itself without intervention by staff or by implementing standard disease-related clinical interventions (is not “self-limiting”);
  • affects more than one area of the resident’s health status;
  • requires interdisciplinary review and/or revision to the care plan; 

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  • ultimately is based on the judgment of the clinical staff and the guidelines outlined in the Resident Assessment Instrument.

Id. 

Before notifying the physician or healthcare provider, the nurse must make “detailed observations and gather relevant and pertinent information for the provider.”  Except in medical emergencies, notifications must be made within 24 hours of the change in medical/mental condition or status.  Id.2 

Within 24 hours of a significant change in the mental or physical condition of a resident with a mental disorder or intellectual disability, staff must notify the state mental health agency or state intellectual disability agency (in addition to notifying the resident and/or representative).  CMS Ex. 8 at 2. 

Finally, the nurse must record, in the resident’s medical record, information “relative to the changes in the resident’s medical/mental condition or status.”  Id. 

Facility policy:  notifying physicians of clinical problems.  The facility policies include guidelines for staff “to ensure” that 1) they communicate resident medical problems to medical staff in a timely, efficient, and effective manner; and 2) all significant changes in resident status are assessed and documented in the medical record.  CMS Ex. 10 at 1.  

The policy directs the charge nurse or supervisor to contact the resident’s attending physician “at any time” if “they feel” that a clinical situation “requires immediate discussion and management.”  Id. 

When contacting the practitioner (especially at night and on weekends), the nurse should have the following information available:  1) a detailed description of the current problem, including a chronological story of symptoms and treatment to date, vital signs, and results of a physical assessment; 2) a list of active medical problems; 3) pertinent information from any recent hospital admissions; 4) current medications and orders; 5) allergies to medications and food; 6) advance directives and orders for life-sustaining treatment; and 7) family/contact person.  Id. 

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The practitioner is required to:  1) respond in a timely manner to calls, especially those regarding immediate notification problems; and 2) communicate “sufficient detail to appropriate staff about the assessment and management of the problem and the resident.”  Id. 

The policy lists categories of problems requiring physician notification.  They include (but are not limited to): 

  • Acute problems requiring immediate notification.  “Immediate” means that the physician should be notified “as soon as possible,” either by phone, pager, text messaging, or other means.  The situations include:  1) witnessed cardiac or respiratory instability for individuals who have full code status; and 2) rapid decline or continued instability (e.g., marked fluctuating vital signs), unless the individual is receiving only palliative care.  
  • The following symptoms:  1) sudden onset or marked change (e.g., more severe or frequent) compared to usual status; that is 2) unrelieved by measures already prescribed.  Some examples include:  abdominal pain with distension or fever; chest pain, pressure, or tightness; new or worsening confusion; new or progressive gait or balance problem; persistent severe headache; persistent or recurrent nausea and vomiting; new onset of slurred or incoherent speech; suicidal thoughts with expressed plan; abrupt or rapidly progressive vision changes; new onset weakness of an arm or leg.  
  • The following signs (again, the list is not inclusive):  1) change in vital signs; 2) sudden loss of consciousness; 3) seizure activity; 4) more than minimal bleeding; 5) fall with an identified or suspected injury; 6) new and/or severe gastrointestinal signs; 7) sudden onset of new confusion, paranoia, and delusions, and/or severe worsening of existing condition; and 8) tachypnea (abnormal rapid breathing) and dyspnea.  
  • Any laboratory result, normal or abnormal, the physician requests on a “STAT” basis.  
  • A significant medication error if:  1) it involves a medication with significant side effects, risks, or adverse consequences; 2) the nature of the medication or severity of the reaction to the medication warrants discussion with the physician.   

CMS Ex. 10 at 1-2. 

The policy also lists non-immediate notification situations, which should be reported to the physician, either at the time of the next routine communication or the next time the 

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physician is making rounds (whichever is sooner):  1) any persistent or recurrent symptoms that are not life-threatening or causing severe distress and that cannot be addressed (or are not resolving) satisfactorily with existing information or physician orders; 2) any substantial change in the physical condition or functional status that is not accompanied by debilitation or more than minimal distress; and 3) other situations, including consultant reports not involving life-threatening or an unstable medical or psychiatric situation; nursing observations that might require physician action; and medication errors that have not affected an individual’s physical or mental condition.  CMS Ex. 10 at 2-3. 

Facility policy:  catheter care competency assessment.  The facility had in place a policy titled “Competency Assessment for Urinary Catheter Care.”  Its stated purpose is to prevent catheter-associated urinary tract infections. 

Staff are directed to review the resident’s care plan.  Generally, staff must follow aseptic (free from contamination) techniques for inserting or replacing the catheter.  They must use standard precautions when handling or manipulating the drainage system.  CMS Ex. 11 at 1.  They should maintain clean techniques when handling or manipulating the catheter, tubing, or drainage bag.  Specifically:  1) do not clean the periurethral area with antiseptics while the catheter is in place.  Routine hygiene (e.g., cleansing the metal surface during daily bathing or showering) is appropriate; 2) The drainage bag should always be positioned below the resident’s bladder to prevent back-flow into the bladder.  Be sure the catheter tubing and drainage bag are kept off the floor; 3) empty the drainage bag regularly, using a separate, clean collection container for each resident; and 4) empty the collection bag at least every eight hours.  CMS Ex. 11 at 2, 5. 

The policy includes instructions for changing catheters.  They should be changed based on clinical indications, such as infection, obstruction, or when the closed system is compromised.  In changing catheters, ensure that it remains secured with a leg strap to reduce friction and movement at the insertion site.  (Tubing should be strapped to the resident’s inner thigh.)  Id. 

Staff are directed to observe the resident for complications: 

  • If the resident indicates that the bladder is full or the resident needs to void, staff should notify the physician or supervisor.  
  • Staff should check the urine for unusual appearance (e.g., color, blood, etc.).  
  • Staff should notify the physician or supervisor of bleeding or accidental removal.  
  • Staff should report any complaints of burning, tenderness, or pain in the urethral area.   

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  • Staff should observe for other signs and symptoms of a urinary tract infection or urinary retention and report findings to the physician or supervisor immediately.

CMS Ex. 11 at 2-3. 

The policy also includes procedural steps for catheter care and instructions for documenting that care in the medical record.  The following information must be recorded:  1) date and time catheter care is given; 2) name and title of the individual providing the care; 3) all assessment data obtained; 4) character of urine, such as color (straw-colored, dark, red), clarity (cloudy, solid particles, blood), and odor; 5) problems at the catheter-urethral junction during perineal care (drainage, redness, bleeding, irritation, crusting, or pain); 6) problems or complaints made by the resident related to the procedure; 7) how the resident tolerated the procedure; 8) if the resident refused the procedure, explain why the resident refused and describe the intervention taken; and 9) signature and title of the person recording the data.  CMS Ex. 11 at 3-6. 

Finally, the policy directs staff to notify the supervisor if the resident refuses the procedure and to report other information “in accordance with facility policy and professional standards of practice.”  CMS Ex. 11 at 6. 

Standing order: urinary tract infections.  The facility had in place standing orders for a variety of problems, including urinary tract infections (UTIs).  Their purpose was to “allow for the prompt treatment of minor illnesses, injuries, or conditions that may occur with a resident” and to “allow additional assessment parameters and interventions to the nursing staff in these situations.”  P. Ex. 1 at 1.  

For UTIs, the order directs nursing staff to notify the physician or nurse practitioner if three or more of the following symptoms presented: 

  • Temperature of 2.4 degrees above baseline
  • Burning pain on urination
  • Frequent urination
  • Hematuria (blood in the urine)
  • Flank or suprapubic pain
  • Mental status change for over 24 hours
  • Bladder spasms 

P. Ex. 1 at 2.3

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Additional criteria for identifying UTIs.  Petitioner points to two checklists that could be used for assessing whether a resident has a UTI.  It does not appear that staff completed one of these for R34.  Nor were they specifically intended to alert staff to the symptoms of a UTI, since they require blood or urine tests, to which staff would not have access.  Nevertheless, they list some criteria for determining whether a resident has a UTI.  The Revised McGeer Criteria for Infection Surveillance Checklist lists separate criteria for assessing an individual without an indwelling catheter and for an individual with an indwelling catheter.  P. Ex. 12. 

An individual without an indwelling catheter must have at least one of the following signs or symptoms: 

  • Acute dysuria (painful urination) or pain, swelling, or tenderness of testes, epididymis, or prostate.  
  • Fever or leukocytosis (high white blood cell count) with an additional symptom: acute costovertebral angle pain (angle formed on either side of the back, between the 12th rib and the vertebral column); suprapubic pain; gross hematuria; new or marked increase in incontinence; new or marked increase in urgency; or new or marked increase in frequency.  Because the facility did not test for leukocytosis (usually by taking a complete blood count), it had no way of knowing that R34 had a high white blood cell count.  
  • If no fever or leukocytosis, two of the following symptoms:  suprapubic pain (above the pubis); gross hematuria (blood in the urine); new or marked increase in incontinence; new or marked increase in urgency; or new or marked increase in frequency.   

The individual must also meet certain microbiologic criteria.  Because the facility did not perform urine tests, at least not with R34, it would not have known whether the criteria were met.  In that respect, the checklist seems inappropriate for R34 and did not substitute for an appropriate, person-centered plan. 

An individual with an indwelling catheter must have at least one of the following signs or symptoms:  fever, rigor, or new onset hypotension, with no alternate sign or symptom; acute change in mental status or acute functional decline with no alternate diagnosis and leukocytosis; new-onset suprapubic pain or costovertebral angle pain and tenderness; purulent discharge from around the catheter or acute pain, swelling, or tenderness of the testes, epididymis, or prostate.  In addition, the individual must meet certain 

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microbiologic criteria, which, again, the facility would not have known about because it did not perform a urine test.  P. Ex. 12.  

The second checklist is titled “Suspected UTI SBAR” (Situation, Background, Assessment, and Recommendation).  P. Ex. 13.  The form poses a series of questions about the resident’s background.  It includes an assessment section, with separate criteria for someone with an indwelling catheter and for someone without an indwelling catheter. 

For an individual with an indwelling catheter, the criteria are met to initiate an antibiotic if the resident has one of the following symptoms:  fever of 100º or repeated temperature of 99º or a temperature of 2º above baseline for someone who regularly runs a lower temperature; new back or flank pain; acute pain; rigors/shaking chills; new dramatic change in mental status; hypotension (significant change from baseline BP or systolic BP below 90). 

For an individual without an indwelling catheter, the criteria are met if one of the following applies:  acute dysuria alone; single temperature of 100º with an additional symptom; or no fever but two or more of the listed symptoms (urgency; frequency; incontinence; suprapubic pain; gross hematuria.  P. Ex. 13. 

Again, no evidence shows that staff used this form to assess whether R34 had a UTI. 

  1. The facility was not in substantial compliance with section 483.25(e) because it did not provide one of its residents with incontinence care that was consistent with professional standards of practice, facility policies, and the resident’s care plan. Specifically, staff practiced poor hand hygiene when caring for a resident who had an indwelling catheter, putting her at greater risk of infection.4 

Resident 28 (R28).  R28 was an 88-year-old woman, admitted to the facility on June 10, 2022, and readmitted, on July 12, 2022, following an acute-care hospital stay.  CMS Ex. 20 at 1; CMS Ex. 21 at 2, 3, 4.  She suffered from a long list of impairments, including end stage renal disease, an overactive bladder, stress incontinence, diseases of the biliary tract, chronic kidney disease, obstructive and reflux uropathy (blockage in the urinary tract), and anemia.  She required dialysis.  She had a fractured femur.  CMS Ex. 20 at 9; CMS Ex. 21 at 22; CMS Ex. 23 at 1-3; CMS Ex. 45 at 4 (Carzoli Decl. ¶ 12a).  

R28 had a BIMS (Brief Interview for Mental Status) score of 3, which meant that she was severely cognitively impaired.  CMS Ex. 21 at 6.  She required extensive assistance (one to two person assist) for most activities of daily living, including toilet use, bathing, and 

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personal hygiene.  CMS Ex. 21 at 11-12, CMS Ex. 22 at 1-3; CMS Ex. 45 at 4 (Carzoli Decl. ¶ 4a).  She used a walker and a wheelchair.  CMS Ex. 21 at 12, CMS Ex. 22 at 5. 

R28 was incontinent of bowel and bladder and had an indwelling catheter in place.  CMS Ex. 21 at 20; CMS Ex. 45 (Carzoli Decl. ¶ 12a). 

R28’s care plan.  To address the problems associated with her foley catheter, R28’s care plan directs staff to position the catheter tubing below the level of her bladder.  The catheter bag must be positioned “out of the line of sight of those walking by.”  It should be placed on the side of the bed or chair that faces away from the door.  CMS Ex. 20 at 8. 

Staff are also directed to monitor R28’s intake and output.  They are required to watch the resident for signs and symptoms of a urinary tract infection – pain, burning, blood-tinged urine, cloudiness, no output, deepening of urine color, increased pulse, increased temperature, urinary frequency, foul-smelling urine, fever, chills, altered mental status, change in behavior, change in eating patterns – and report them to her physician.  CMS Ex. 20 at 8. 

The facility’s substantial noncompliance in treating R28.  As the following discussion shows, in treating R28, facility staff did not follow the facility’s policies, the resident’s care plan, nor professional standards of practice. 

Surveyor Susan Carzoli describes her observations in some detail.  At 8:37 a.m. on October 12, 2022, Surveyor Carzoli observed the lower half of R28’s catheter urine collection bag lying on the carpeted floor, beside the resident’s bed.  It did not have a “dignity cover” over it.  CMS Ex. 2 at 51; CMS Ex. 45 at 4 (Carzoli Decl. ¶12a); see CMS Ex. 11 at 2, 5 (policy requiring staff to be sure the catheter drainage bag is kept off the floor). 

A few minutes later, Surveyor Carzoli observed a nurse aide, identified as Nurse Aide E, remove the resident’s pants and disposable brief.  A second nurse aide, Nurse Aide F, picked up the catheter bag from the floor and placed it in a dignity cover.  Nurse Aide F then picked up a trash can and placed it by the resident’s bed.  Without changing her gloves, Nurse Aide F pulled disposable wipes from a package and handed them to Nurse Aide E, who used them to cleanse R28’s peri-area.  CMS Ex. 2 at 51; CMS Ex. 45 at 4 (Carzoli Decl. ¶ 12b); see CMS Ex. 7 at 1 (hand hygiene policy). 

After Nurse Aide E finished cleansing the resident’s peri-area, Nurse Aide F continued to hand her disposable wipes, which Nurse Aide E used to cleanse the resident’s bottom and her catheter tubing.  Nurse Aide F then put a clean brief under R28 and attached the brief tabs, fastening the brief onto the resident.  CMS Ex. 2 at 51; CMS Ex. 45 at 4 (Carzoli Decl. ¶ 12c). 

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After she cleansed and changed R28, Nurse Aide E changed her gloves and used hand sanitizer.  She then opened a closet door, retrieved the resident’s clothes, and closed the door.  She pulled the catheter bag and tubing through the pants, which she then pulled up.  Without changing her gloves or performing hand hygiene, Nurse Aide E adjusted the resident’s bed, using the bed remote.  She attempted to hand the resident a drink of water, helped the resident change her top, and put the resident’s walker in front of her to move her to a wheelchair.  She assisted the resident to the sink to wash her face and brush her teeth.  CMS Ex. 2 at 51-52; CMS Ex. 45 at 4-5 (Carzoli Decl. ¶¶ 12d, 12f, 12g); see CMS Ex. 7 at 1.  

Surveyor Carzoli interviewed Nurse Aide E, who told her that the clip on R28’s catheter bag was broken (which may explain – but does not excuse – leaving the catheter bag on the floor).  The nurse aide also said that she planned to get another dignity cover.  CMS Ex. 2 at 52; CMS Ex. 45 at 5 (Carzoli Decl. ¶ 12e). 

Petitioner has not contested the deficiencies cited with respect to the facility’s treatment of R28.  P. Pre-hrg. Br. at 1 n.1, 23.  Thus, even without considering the significant problems associated with the facility’s treatment of Resident 34 (discussed below), the undisputed evidence establishes that the facility was not in substantial compliance with section 483.25(e).  R28 was totally dependent on staff.  With an indwelling catheter, she was particularly susceptible to infection.  Yet, as shown by Surveyor Carzoli’s observations – which Petitioner has not challenged – staff were not following “the primary means to prevent the spread of infection” – basic hand hygiene procedures.  This failure jeopardized the resident’s health and safety, putting the facility out of substantial compliance with section 483.25(e). 

  1. The facility was not in substantial compliance with section 483.25(e) because staff did not care plan a vulnerable resident for potential urinary tract infections. When his level of urinary continence changed, the facility did not update his care plan to reflect the changes.  Staff disregarded the care plan instructions for urinary care.  Staff did not recognize or respond to the resident’s symptoms of a urinary tract infection.  The facility thus did not provide incontinence care consistent with professional standards of practice, facility policies, and the resident’s comprehensive, person-centered care plan. 

Resident 34 (R34).  R34 was an 89-year-old man, admitted to the facility on June 24, 2022.  He suffered from a long list of impairments, including, gastrointestinal hemorrhage; iron deficiency anemia; Parkinson’s disease; chronic kidney disease, stage 4; persistent proteinuria (elevated protein in the urine); and chronic systolic congestive heart failure.  He had a history of stroke and diseases of the nervous system and sense organs.  He had an automatic cardiac defibrillator (pacemaker) in place.  CMS Ex. 24 at 8; CMS Ex. 25 at 1, 20, 21; P. Ex. 3 at 1.  He had just one kidney, which functioned at 31%.  CMS Ex. 27 at 17; Tr. at 16.  According to his assessment, he was both continent 

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and incontinent of urine at the time of his admission.5  The onset of his incontinence was not new.  His urine was clear and yellow, and he did not have a catheter in place.  CMS Ex. 27 at 28-29; CMS Ex. 28 at 34; P. Ex. 3 at 2. 

Facility records indicate that, at the time of his admission, R34 was 5’10” tall and weighed 152.6 pounds.  CMS Ex. 27 at 27. 

R34 used a wheelchair and a walker but needed staff assistance to propel the wheelchair.  CMS Ex. 27 at 29.  He was alert and oriented, communicated verbally, and his speech was clear.  He was pleasant and cooperative with staff.  CMS Ex. 27 at 27.  His cognition and memory were intact.  P. Ex. 3 at 1. 

R34’s care plan – inaccurate, not updated, and not followed.  In arguing that the facility was in substantial compliance with section 483.25(e), Petitioner suggests that the question “boil[s] down to whether [the facility] provided appropriate treatment and services to [R34] to assess, intervene, and obtain treatment for a UTI when a significant change occurred.”  P. Post-hrg. Br. at 15-16.  But Petitioner disregards an important section of the regulation – that the facility have in place and follow an appropriate care plan that addresses the resident’s urinary health.  Without the required care-planning, the facility cannot comply with the regulation. 

As noted above, section 483.25(e) requires the facility to ensure that each resident receives treatment and care in accordance with his comprehensive, person-centered care plan.  For a resident with urinary incontinence, the facility must ensure that he is not catheterized unless necessary because of his clinical condition.  If the resident has a catheter, he must be assessed for its removal as soon as possible, unless the catheter is necessary because of his clinical condition.  Any resident who is incontinent of bladder must receive appropriate treatment and services to prevent urinary tract infections. 

R34’s condition was complicated, and it is not always possible to attribute his symptoms to any one particular cause.  Petitioner argues that the resident’s rapid decline and death were attributable to Parkinson’s disease and other impairments, rather than to an overlooked urinary tract infection, even though R34 unquestionably developed sepsis following an undetected (by the facility) urinary tract infection (UTI).  Petitioner misunderstands the issue presented.  I need not decide which of his conditions led directly to his death.  Rather, I must decide whether the facility ensured that R34 received treatment and care in accordance with professional standards of practice and his 

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comprehensive, person-centered care plan.  And the evidence overwhelmingly establishes that it did not. 

On the day of R34’s admission, the facility developed a care plan.  The plan, initiated on June 24, 2022, describes R34 as “occasionally incontinent of urine.”  The plan directs staff to “promote continence” by toileting him every three hours, which includes waking him at night to toilet him.  CMS Ex. 24 at 5.  As review of the record shows, this seems to have been the facility’s sole effort to address the resident’s bladder issues in any systematic way.  

From the beginning, the plan was deficient in at least one key respect.  Because R34 suffered from kidney disease, he had a higher risk of developing a UTI.  Tr. at 54.  Yet, his care plan did not mention his susceptibility for UTIs.  It did not alert staff to watch for signs and symptoms; it did not identify interventions.  CMS Ex. 24; Tr. at 44-45.  Compare CMS Ex. 20 at 8 (R28’s care plan, describing signs and symptoms of a UTI). 

Petitioner, however, argues that the facility was not required to care plan R34 for UTIs because, unlike R28, he did not have a catheter.  This is simply incorrect.  First, the requirement is not limited to those with catheters.  Anyone at risk of developing a UTI must be care planned for the condition.  Not only was R34 at risk because of his kidney disease, he was at risk because of his incontinence.  The regulation recognizes that anyone who is incontinent is at risk: “any resident who is incontinent of bladder must receive appropriate treatment and services to prevent urinary tract infections.”  42 C.F.R. § 483.25(e).  Since this treatment must be “in accordance with his comprehensive, person-centered care plan,” the facility was required to develop a person-centered care plan for R34 that described the treatment and services necessary to prevent a UTI.  The facility did not do so. 

Second, the facility’s record-keeping was poor, and R34’s status changes were not well-documented.  Nevertheless, as discussed below, the more reliable evidence supports the finding that R34 had a catheter, at least part of the time while he was in the facility. 

In any event, staff were apparently not aware of the directive that they toilet R34 every three hours, and the facility’s toileting documentation establishes that they did not do so.  Petitioner provides a “toilet use” form for September, which purports to record “Toilet use.  Wake resident to toilet at 12AM, 3AM, 6AM, per family/resident request.”  P. Ex. 10 at 1. 

As noted above, R34’s care plan, which staff seem to have forgotten about, directed staff to toilet the resident every three hours, including waking him at night to toilet him.  CMS Ex. 24 at 5.  Plainly, staff had not been following that directive, since the resident’s family had to ask them to do what they should have been doing all along. 

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According to the document, R34 took himself to the bathroom, with varying degrees of staff assistance – limited (“resident highly involved in activity; staff provide guided maneuvering or other non-weight-bearing assistance”); extensive (“resident involved in activity, staff provide weight”); and total dependence (“full staff performance”).  P. Ex. 10.  The resident refused once.  P. Ex. 10 at 17.  The document shows that staff were not toileting the resident as called for in his care plan or as directed by the document’s instructions: 

  • September 1 – toileted at 5:56 a.m.; 1:59 p.m.; and 9:59 p.m.  P. Ex. 10 at 1-2.  
  • September 2 – toileted at 5:59 a.m.; 12:10 p.m.; and 9:59 p.m.  P. Ex. 10 at 3-4.  
  • September 3 – toileted at 1:55 a.m.; 1:11 p.m.; and 2:11 p.m.  P. Ex. 10 at 5-6.  
  • September 4 – toileted at 1:59 p.m.; and 7:15 p.m.  P. Ex. 10 at 6-7.  
  • September 5 – toileted at 12:26 a.m.; 9:40 a.m.; and 2:46 p.m.  P. Ex. 10 at 7-8.  
  • September 6 – toileted at  4:40 a.m.; 10:58 a.m.; and 8:18 p.m.  P. Ex. 10 at 9-10.  
  • September 7 – toileted at 12:22 a.m.; 1:41 p.m.; and 2:36 p.m.  P. Ex. 10 at 10-11.  
  • September 8 – toileted at 1:09 a.m.; 10:04 a.m.; and 2:20 p.m.  P. Ex. 10 at 12-13.  
  • September 9 – toileted at 4:29 a.m.; 10:24 a.m.; 2:51 p.m.; and 10:40 p.m.  P. Ex. 10 at 14-15.  
  • September 10 – toileted at 1:33 p.m.; and 3:45 p.m.  P. Ex. 10 at 16-17.  
  • September 11 – toileted at 5:51 a.m.; 11:30 a.m.; and 3:10 p.m.  P. Ex. 10 at 17-18.  
  • September 12 – toileted at 5:43 a.m.; 1:21 p.m.; and 3:08 p.m.  P. Ex. 10 at 19-20.  
  • September 13 – toileted at 1:29 a.m.  P. Ex. 10 at 21

As the document shows, staff did not toilet R34 every three hours, as called for in his care plan.  Nor did they honor the request of the family.  Only twice did staff toilet R34 within one hour of 12:00 a.m.; and only four times did they toilet him within one hour of 6:00 a.m.  He was never toileted at 3:00 a.m.  It was not unusual for them to allow five or 

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six hours to elapse, and, on occasion, more than nine hours elapsed before he was taken to the toilet.6 

If facility staff fail to provide care and services in accordance with the resident’s comprehensive assessment and plan of care, it violates section 483.25.  White Sulphur Springs Ctr., DAB No. 2520 at 7 (2013); Deltona Health Care, DAB No. 2511 at 7-8 (2013); Venetian Gardens, DAB No. 2286 at 5 (2009); 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 plans.)  Thus, even if R34’s initial care plan were adequate (which it was not), the staff’s failure to follow its instructions for toileting the resident put the facility out of substantial compliance with section 483.25(e). 

Moreover, within a week of its drafting, the already-inadequate plan was unquestionably obsolete and should have been amended. 

July 1, 2022 assessment.  On July 1, 2022, the facility completed R34’s initial assessment.  The assessment does not rate R34’s urinary continence because he had a catheter in place.  CMS Ex. 30 at 24, 47.7  Contrary to the requirements of the regulation, the assessment did not consider the potential for removing the catheter, another failing that put the facility out of substantial compliance with section 483.25(e).  Nor were any changes made to the resident’s care plan, which should have been amended to modify his toileting program and to address his increased risk of UTI’s and other pertinent issues related to his catheter.  See CMS Ex. 11 (catheter care assessment policy); CMS Ex. 20 at 8 (care plan describing signs and symptoms staff should watch for in treating a resident with a catheter).  

Without addressing the unequivocal findings of the July 1 assessment, Petitioner denies that R34 ever had a catheter.  P. Post-hrg. Br. at 6 n.2; P. Reply Br. at 5. 

Petitioner acknowledges that its witnesses – all facility employees – said otherwise but characterizes their testimony as “some confusion.”  P. Reply at 5.  I agree that much of the witness testimony can be disregarded.  Memories were faulty; testimony is contradictory, and frankly, some of the testimony is self-serving. 

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However, regarding whether R34 had a catheter, the witnesses were not confused; they were consistent and definite.  Although they were uncertain as to when it was inserted and when it was removed (in part, because of the facility’s inadequate record keeping), all agreed that R34 had a catheter in place.  Further, because the facility did not maintain adequate records describing R34’s bladder status, and its records are inconsistent, we have no idea when R34 was catheterized or why.  Nevertheless, the facility’s witnesses confirmed that, while in the facility, R34 had a catheter in place. 

  • Nurse Aide Katelind Tate (nee Zuck) testified that R34 had a catheter and that she “believe[d] he always had it.” at 65-66.  When told that his admission records indicate that he did not have one at the time of his admission, she testified that she could have been wrong about having one when he was admitted, but stated:  “I know at one point he did [have a catheter].”  Tr. at 67.  Further, when asked about her written testimony that the nurse aides charted R34’s urine output each shift, she explained that they would “document how many cc’s or milliliters of urine [were] contained in the . . . catheter bag.”  Tr. at 65; see P. Ex. 33 at 3 (Tate Decl. ¶ 17).  I find this testimony so specific as to be credible.  It is also consistent with the testimony of the other witnesses. 
    Moreover, at least one record entry supports Nurse Aide Tate’s recollection that R34 had a catheter early on in his stay at the facility.  Petitioner produced a record of R34’s bladder elimination schedule.  P. Ex. 9.  According to that document, R34 was catheterized during the day shift on June 25.  P. Ex. 9 at 1, 2 (entry “3” indicating “continence not rated due to indwelling catheter”).8  There are multiple problems with this document; it is incomplete, and its entries are inconsistent with R34’s assessment and other records.  Nevertheless, considered together with witness testimony, it supports the proposition that R34 was catheterized early on. 
  • In her written declaration, Registered Nurse Kelly Riggan testified that R34 “also had an indwelling Foley catheter.” Ex. 31 at 2 (Riggan Decl. ¶ 9).  When cross-examined, she confirmed that statement:  “I stand by the Foley catheter.”  Tr. at 83. 
  • Registered Nurse Leo Ponce De Leon twice alluded to “the Foley bag” and confirmed that R34 had a catheter. Tr. at 107-108. 

I do not believe that all three of these witnesses were wrong regarding their basic premise:  they knew that R34 was catheterized during his stay at the facility. 

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July and August 2022 – a period of general stability notwithstanding R34’s COVID diagnosis.  In July 2022, R34 was diagnosed with COVID.  CMS Ex. 27 at 17.  He also suffered a series of falls, attributed to his Parkinson’s disease.  His family complained that the facility’s erratic schedule for administering his medications made his Parkinson’s symptoms worse and may have contributed to his falls.  He lost weight.  Nevertheless, through the end of August, he was consistently described as alert and oriented, pain-free, and, considering his diagnoses, seems to have been doing fairly well. 

  • Progress notes, dated July 18, describe R34 as “alert and oriented x4 . . . pleasant and cooperative.” He had no complaints of pain or discomfort.  CMS Ex. 27 at 17 (emphasis added). 
  • In an evaluation, dated July 20, Nurse Practitioner Erica Hendricks found no recent changes. She described R34’s sleep as “fair most nights.”  He was incontinent of bladder (which suggests that he did not then have a catheter in place – although the records are silent as to when it was removed, and no changes were made to his care plan).  He seldom experienced severe pain and consumed about 50% of his meals.  His mood was positive, his behavior appropriate.  He could ambulate.  He had COVID but was doing well, with no complaints, although he had experienced some falls.  CMS Ex. 26 at 100.  He weighed 147 pounds.  Id. 
  • On July 28, 2022, the facility amended R34’s care plan to address his multiple falls. The plan directed staff to keep R34’s blinds closed when he was sleeping “to minimize stimuli that could draw the resident’s attention.”  They were directed to “determine and address” what caused the fall, to keep Kleenex in reach at all times, to keep his walker in reach at all times, and to offer to toilet him at 5:00 p.m.  CMS Ex. 24 at 6-7.9  No changes were made to the care plan to address his increasing urinary incontinence or to protect him from UTIs. 
    The “toilet use form” establishes that, throughout the first two weeks of September, staff did not once toilet R34 at 5:00 p.m.  P. Ex. 10. 
  • A dietary note, dated August 3, 2022, indicates that R34’s weight was down to 142 pounds, which represented a 5% weight loss in 30 days. The dietician noted that R34 had recently been diagnosed with COVID and suggested that the illness may have contributed to his weight loss.  She reported that he was eating 50-100% of his meals and that his daughter reported that he ate well when she took him out for meals.  CMS Ex. 27 at 13. 

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  • R34 was assessed by his nephrologist on August 16, 2022. The nephrologist reported that, after moving into the facility, the resident had contracted COVID and lost weight; he was down to 141 pounds.  He recovered from the disease with conservative management and was slowly gaining back his strength.  He was alert and oriented.  CMS Ex. 26 at 80.  His gait and balance were impaired, and he had a history of falls.  CMS Ex. 26 at 81. 
  • In a message, dated August 22, 2022, R34’s daughter complained to Nurse Practitioner Caitlin Jardon about the facility’s dosing schedule for the resident’s Parkinson’s medications – carbidopa/levodopa. She complained that staff administered his evening dose at 3-4 p.m., after administering the pills in the morning and at noon.  She said that she would like the nurse practitioner, Dr. Spencer, and the facility to coordinate her father’s care; she did not want the facility making changes without their input.  CMS Ex. 26 at 75.  Nurse Practitioner Jardon agreed that, to manage Parkinson’s symptoms, the medications carbidopa/levodopa should be administered about 30-60 minutes prior to the resident’s meals, which is best achieved by maintaining a concrete schedule, e.g., 7:30 a.m., 12:00 p.m., 6:00 p.m.  She worried, however, that, because of the nursing home’s staffing, this “is not always doable.”  CMS Ex. 26 at 96.10 
  • On August 24, 2022, Nurse Practitioner Erica Hendricks conducted a routine 60-day evaluation of R34. She reported no recent changes.  She described his sleep as “fair most nights.”  He was incontinent of bladder.  He seldom experienced severe pain, he consumed about 75% of his meals, and weighed 141 pounds.  His mood was positive, his behavior normal.  He could ambulate.  He had no acute concerns.  CMS Ex. 26 at 69. 
    According to this entry, during the two months that he had been at the facility, R34 moved from “continent/incontinent” to catheterized to incontinent.  Yet, his care plan does not reflect any changes.11 

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  • Neither the assessment nor his care plan explains why continence “is impossible to maintain” nor describes any services or assistance provided to help him achieve continence. 
  • A dietician’s note, dated August 26, confirms that, at 141.6 pounds, R34’s weight had been stable for three weeks, and he was eating 75-100% of his meals. CMS Ex. 27 at 8. 
  • Nurse Practitioner Jardon examined R34 again on August 31, 2022. She described the family’s “multiple” calls, complaining about (among other issues) the nursing home staff’s inconsistent timing of his carbidopa/levodopa medications, which, they thought increased his Parkinson’s symptoms.  Weight loss was an on-going problem.  His family pointed to his difficulties swallowing and with sleep.  CMS Ex. 26 at 63; see CMS Ex. 26 at 70.  Nurse Practitioner Jardon decided to update R34’s carbidopa/levodopa prescription to state the specific times the medications were to be administered.  Id. 
    Notwithstanding the family’s complaints, Nurse Practitioner Jardon found that R34 was able to walk with a walker and seemed “doing really well with his mobility.”  CMS Ex. 26 at 63.  He was alert and oriented.  His attention and concentration were normal.  CMS Ex. 26 at 64. 

Petitioner has submitted R34’s medication administration record for August 2022.  It shows that he was virtually pain-free the entire month.  On only one day did staff document that he was in pain.  On August 3, his pain level was 3 (presumably of 10).  Otherwise, it was 0 throughout the month.  P. Ex. 5 at 1. 

September 2022 – rapid decline, and symptoms of a UTI that were disregarded.  Beginning on September 8, R34’s period of relative stability ended.  Staff reported that he hallucinated.  He was confused and no longer fully oriented.  He complained of pain in his abdomen and anus.  The color of his urine darkened and had a strong odor.  Yet, either staff did not recognize that these were symptoms of a UTI, or they simply disregarded them. 

  • Progress notes, dated September 8, 2022, describe R34 leaving his room with his walker; he was unattended. He told staff that he wanted someone to help pick up his phone, which was on the floor.  Staff assisted him back to his room, but no phone was on the floor.  They opined that he had “hallucinated” the dropped phone.  CMS Ex. 27 at 5.  It seems that staff did not treat the incident as significant. 
    Citing examples of R34’s behaviors while sleeping, Petitioner claims that this behavior was not new.  P. Post-hrg. Br. at 21.   But a nightmare or a sleep disorder

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  •  is not the same as a daytime hallucination, and Certified Medical Assistant Shelly Sharp opined that R34 was exhibiting symptoms of a “REM behavior sleep disorder.”  CMS Ex. 26 at 163. 
  • On September 9, staff described R34 as “anxious,” improving when given 1:1 supervision. He complained that he was cold and that his anus hurt.  He had also been complaining of stomach issues.  CMS Ex. 27 at 4. 
  • A progress note, entered at 7:56 a.m. on September 10, 2022, indicates that R34 was complaining of abdominal pain. CMS Ex. 27 at 4.  He complained of chills and not feeling well.  CMS Ex. 32 at 7. 
  • A September 10, 2022 neurological assessment (completed at 1:45 p.m.) found that R34 was oriented to person but, for the first time, he was not oriented to place, time, or situation. He was confused.  CMS Ex. 32 at 11.  Assessments, completed at 2:00 p.m., 2:45 p.m., 3:15 p.m., and 5:06 p.m. found the same results.  CMS Ex. 32 at 14, 17, 20, 23, 33; CMS Ex. 33 at 2. 
    At 3:10 p.m. that day, a nurse found R34 on the floor of his room.  CMS Ex. 27 at 3; CMS Ex. 32 at 9; CMS Ex. 33 at 1. 
  • At 4:19 p.m. on September 10, 2022 (a Sunday), R34’s daughter called the office of her father’s personal physician, Arul Molian, M.D., spoke to Nurse Erica Feigen, RN, and reported her father’s distress. He had not eaten that day, and he weighed 137 pounds.  He was confused and fell while attempting to go to the bathroom on his own.  He had been complaining of stomach and anal pain for five days.  He was “[a]lmost acting as if having a stroke, with jaw movements, very cold in afternoons and Parkinson’s tremors entente.”  She asked the physician to see him the following day.  CMS Ex. 26 at 51; CMS Ex. 32 at 26. 
    At 4:33 p.m. the same day, R34’s daughter called Nurse Practitioner Jardon, spoke to a medical assistant, and conveyed the same information.  She also said that R34’s “daytime visual dreams/distortions” were troubling and complained that the nursing home delayed restorative care because the Director of Nursing (DON) “forgot” to write down the orders after their August 31 conversation.  CMS Ex. 26 at 52, 55; CMS Ex. 32 at 27.  The daughter concluded her message, asking, “Do we need to hire private duty nursing care, admit [him] to [the] hospital, or is it time to discuss hospice.”  CMS Ex. 26 at 54, 55. 
  • At 6:50 a.m. and 6:52 p.m. on September 11, 2022, assessments indicated that R34 was still confused and oriented to person only. CMS Ex. 34 at 1, 6.  

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  • Assessments performed at 7:48 a.m. and 8:33 p.m. on September 12, 2022, indicated that R34 was still confused and oriented to person only. CMS Ex. 34 at 13, 18. 
  • At 7:48 a.m. on September 12, 2022, R34’s daughter sent the following email to DON Angela Anderson:
    • It’s imperative that I meet with you today.  [R34] had several Parkinson’s “episodes” since last Thursday:  calling my sister Friday afternoon in pain and panicking; falling on Saturday[;] calling out and looking for Mom [who was deceased] on Sunday.  It was a very stressful week for him last week.  Could we discuss his needs and how we can support each other going forward with his care? 

CMS Ex. 34 at 21-22. 

  • On September 12, responding to R34’s daughter’s multiple messages, Nurse Practitioner Jardon suggested that R34 “be checked for any infectious process given the quick turn in his health.” CMS Ex. 26 at 54 (emphasis added).  This appears to be the first time anyone considered that R34’s symptoms could have been caused by an infection, even though the symptoms began days earlier.  
  • Early in the morning on September 13, 2022, Charge Nurse Medina reported that a nurse aide called her into R34’s room because he was “not acting right and needing someone to check him out.” The nurse found him sitting back in his recliner, with his mouth wide open, mouth-breathing.  He was very pale.  The nurse aide reported that he had been complaining of discomfort when transferred.  His urine was tea-colored that morning and had been for a few days.  The nurse reported odor in the room.  He had been unable to answer the nurse’s questions that morning.  CMS Ex. 27 at 2; P. Ex. 29 at 2-3 (Medina Decl. ¶¶ 11- 15).  
  • Other evidence suggests that, as early as September 9, a nurse aide reported that R34’s urine was foul-smelling. Ex. 29 at 3 (Medina Decl. ¶ 19).  Nevertheless, according to Charge Nurse Medina, the changes could not have occurred at that time, or facility staff would have entered a progress note.  P. Ex. 29 at 4 (Medina Decl. ¶ 21).  
    I reject this, for two reasons:  1) as this discussion shows, staff did not reliably record changes in the resident’s bladder condition; and 2) facility staff cannot agree on the R34’s bladder status at any particular time.  Charge Nurse Medina claims that the urine’s color and odor were normal until September 13; Nurse Aide Tate claims that the urine was always abnormal (see below).  The documentary 

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  • evidence, which is sparce, indicates that it was normal until September 9, when it darkened and developed a strong odor. 
  • Nurse Aide Katelind Tate agreed that, on September 13, R34’s urine was amber-colored and had a stronger smell than normal but claimed that this was not new. According to her written declaration, his urine was “always” amber-colored and malodorous.  Ex. 33 at 2 (Tate Decl. ¶ 9).  This assertion is belied by the facility’s written records.  At the time of his admission, his urine was “clear yellow in color.”  CMS Ex. 27 at 28.  The first reference to changes in color or odor is the September 13 nursing note, which said that the changed color and odor had been present for a few days.  Tr. at 63. 
  • The nurse contacted the facility’s nurse practitioner, reporting that R34 was pale, mouth-breathing, had increased weakness, and was not responsive. His room smelled of urine.  CMS Ex. 27 at 2; P. Ex. 29 at 2-3 (Medina Decl. ¶ 15).  The nurse did not report dysuria or that the resident’s urine was the color of tea.  at 70.  The Nurse Practitioner offered two options, depending on the family’s wishes:  1) send him to the emergency room; or, if the family declined, 2) run blood tests.  P. Ex. 29 at 3 (Medina Decl. ¶ 16).  

Hospitalization, hospice, and death.  The family opted to send R34 to the emergency room.  A transfer/discharge report notes that he had been complaining of abdominal pain and dysuria (pain when urinating).  It also says, “Mental status change noted today,” which is incorrect.  According to facility records, significant mental status changes began as early as September 8.  The report also describes increased weakness, needing a two-person assist when he usually requires one (which is not completely consistent with his assessments).  Tea-colored urine was also noted.  CMS Ex. 34 at 25.  

Hospital records, dated September 13, 2022, indicate that R34 was taken to the emergency room suffering from generalized weakness and an altered mental status since the night before.  Staff reported concerns that he had a urinary tract infection.  He was hypoxic (low levels of oxygen in tissues), with an oxygen saturation level of 68% (95 to 100% is normal).  He was “extremely altered and confused” when examined.  He could not answer the physician’s questions.  CMS Ex. 26 at 43. 

Emergency room staff placed a foley catheter.  His urinalysis was “grossly abnormal”; he had significant leukocytosis (high white blood cell count, indicating an infection) and worsened renal function.  He was admitted to the hospital, with diagnoses of urinary tract infection, acute, chronic renal insufficiency, and encephalopathy.  CMS Ex. 26 at 48. 

On the morning of September 14, R34’s family notified the facility that he would not be returning but would go into hospice care.  CMS Ex. 27 at 1.  The resident’s hospital discharge diagnoses included:  “Severe Sepsis/bacteremia 2/2 Ecoli UTI”; “Hypoxic 

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respiratory failure”; and “Acute metabolic encephalopathy.”  CMS Ex. 37 at 1.  He was treated with IV antibiotics, but his daughters declined more invasive measures.  CMS Ex. 37 at 2. 

On September 18, 2022, R34 died while in hospice care.  His immediate cause of death was “severe sepsis” due to or as a consequence of a urinary tract infection and Parkinson’s disease.  CMS Ex. 40. 

Petitioner’s substantial noncompliance:  inadequate care-planning, failing to follow the care plan, and failing to recognize significant symptoms.  CMS points to R28’s care plan as an example of an adequately developed, person-centered care plan for an individual at risk for UTIs.  Petitioner objects to the comparison, pointing out that R28 had an indwelling catheter, and claiming that R34 did not.  But Petitioner’s objection misses the point.  I agree that R28’s care plan was designed to address her unique needs and would not have been appropriate for another resident.  For the same reason, R34 required a care plan designed to address his specific needs.  Staff could not have known which of the multiple symptoms of a UTI they should have been watching for in R34’s case.  A policy, a check-list, or a standing order is no substitute for a personalized care plan. 

Because the facility did not have in place a comprehensive person-centered care plan that addressed R34’s urinary incontinence and other bladder issues, it was not in substantial compliance with section 483.25(e).  

Because staff did not provide the treatment and care called for in the resident’s care plan, the facility was not in substantial compliance with section 483.25(e). 

The evidence also establishes that the resident’s condition deteriorated sharply beginning on or about September 8, when he exhibited many of the symptoms that, according to the facility’s own documents, generally suggest the presence of a UTI.  But staff did not follow-up until days after the symptoms first appeared.  Specifically: 

  • At the time of his admission and thereafter, R34 was occasionally continent. CMS Ex. 24 at 5; CMS Ex. 27 at 28-29; CMS Ex. 28 at 34; P. Ex. 3 at 2; P. Ex. 9 at 1, 3, 5. 
    As of September 8, R34 was never again described as continent.  P. Ex. 9 at 7; see P. Ex. 12 (identifying as a symptom of a UTI, a new or marked increase in a resident’s incontinence).   

Petitioner, however, argues that R34’s level of continence did not “severely worsen” during his time at the facility and, in support, produces a document labeled “Documentation Survey Report v2.”  P. Ex. 9.  Putting aside the inconsistencies between 

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this document and other (more reliable) records, I agree that it shows that, from the time of his admission, R34 had more instances of incontinence than continence.  However, the document also shows that the resident was continent at times until September 8: 

  • In June, there are 21 possible entries on the form.  One (night shift, June 24) is blank.12   Of the 20 that are filled in:  one indicates that continence is not rated because of an indwelling catheter (day shift, June 25); four indicate that the resident is continent (day shift, June 28; evening shifts June 25, 26, and 30); the remaining 15 entries indicate that the resident is incontinent.  P. Ex. 9 at 1.13
  • In July, there are roughly 93 possible entries.  Twelve are blank (day shifts, July 7, 22, 25, 27, and 31; evening shifts on July 16 and 22; night shifts, July 12, 22, 25, 27, and 30).  Of the 81 remaining, 20 indicate that he is continent; 59 indicate that he is incontinent; and two indicate that he is continent at the beginning of the night shift and incontinent at the end of the shift.  P. Ex. 9 at 3.  
  • In August, there are roughly 93 possible entries.  Thirteen are blank (mostly on the night shift).  Of the remaining 80, 12 indicate he is continent; 65 indicate that he is incontinent; two indicate that he is continent at the beginning of the shift and incontinent at the end of the shift; and one indicates that he did not void.  P. Ex. 9 at 5.  
  • In September, there are roughly 39 possible entries.  Three are blank (night shift, September 1, 4, 10).  One indicates that the resident is not available (evening shift, September 13).  The entry for the night shift on July 13 (indicating that the resident is incontinent) must be inaccurate because R34 left the facility at 7:29 a.m. that day and did not return.  Of the remaining 34 entries, R34 is continent three times.  P. Ex. 9 at 7.  

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I find enough verifiable inaccuracies with this data, to question its reliability as a whole.  Nevertheless, assuming a modicum of accuracy, the data indicates that, after September 8, the same time his other UTI symptoms appeared, R34 was never again continent.14 

R34 displayed additional symptoms of a UTI, which staff did not address:  

 

  • When R34 entered the facility, his urine was described as “clear yellow.”  No assessment, progress note, or other record suggests that this changed until September 8 or 9.  CMS Ex. 27 at 28.  
    On September 9, a staff member reported that R34’s urine had a strong smell.  On September 13, R34’s urine was tea-colored, and staff reported that it had been that way for “a few days.”  CMS Ex. 27 at 2; P. Ex. 29 at 2-3, 5 (Medina Decl. ¶¶ 15, 19); Tr. at 63.  See CMS Ex. 11 at 3; CMS Ex. 20 at 8 (identifying, as a symptom of a UTI, deepening urine color); P. Ex. 21 at 1 (identifying cola-colored urine and strong-smelling urine as symptoms of a UTI).  
  • From the time of his admission through early September, R34 was consistently described as “alert and oriented,” “pleasant,” and “cooperative,” with his cognition and memory intact.  CMS Ex. 26 at 64, 69, 80, 100; CMS Ex. 27 at 17, 27; P. Ex. 3 at 1.  
    Beginning September 8, R34’s mental condition deteriorated rapidly.  CMS Ex. 26 at 52, 55; CMS Ex. 27 at 4, 5; CMS Ex. 32 at 11, 14, 17, 20, 23, 27, 33; CMS Ex. 34 at 1, 6, 13, 18, 21-22; see P. Ex. 22 at 1 (identifying changes in mental status as symptoms of a UTI).  
  • From the time of his admission through early September, R34 reported no complaints of pain.  CMS Ex. 26 at 100; P. Ex. 5 at 1.  
    From September 9, Petitioner complained of significant abdominal/anus pain.  CMS Ex. 26 at 51; CMS Ex. 27 at 4; CMS Ex. 32 at 26; see P. Ex. 21 at 1 (identifying lower belly discomfort as a symptom of a UTI).   

Thus, the evidence establishes that R34’s condition began to deteriorate significantly on September 8 or 9, showing symptoms of a UTI (from which he was, in fact, suffering). The abdominal pain and worsening incontinence, by themselves, should have alerted staff to consider that R34 had a UTI.  CMS Ex. 15 at 8 (listing minimum criteria for initiating antibiotics for a UTI); P. Ex. 13; P. Ex. 21 at 1; Tr. at 83.  The facility was not free to 

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disregard the possibility of a UTI simply because some (although not all) of R34’s comorbidities could have accounted for his symptoms.  Because the facility did not provide R34 with appropriate care and services to prevent and treat a UTI, it was not in substantial compliance with section 483.25(e). 

  1. CMS’s determination that, from October 10 through 17, 2022, the facility’s substantial noncompliance with section 483.25(e) 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 Ctr. – Johnston, DAB No. 2031 at 17-18 (2006), aff’d, Liberty Commons Nursing & Rehab Ctr. – Johnston v. Leavitt, 241 F. App’x 76 (4th Cir. 2007).

The Board has observed repeatedly that the “clearly erroneous” standard imposes on facilities a “heavy burden” to show no immediate jeopardy and has sustained determinations of immediate jeopardy where CMS presented evidence “from which ‘[o]ne could reasonably conclude’ that immediate jeopardy exists.”  Florence Park Care Ctr., DAB No. 1931 at 27-28 (2004), citing Koester Pavilion, DAB No. 1750 (2000); Daughters of Miriam Ctr., 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.”).

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.’”  Daughters of Miriam Ctr., DAB No. 2067 at 9 (emphasis added). 

Petitioner has not met this burden.  It dismisses entirely staff’s (mis)treatment of R28, pointing to an “IJ Template” provided to the facility during the survey.  P. Pre-hrg. Br. at 23-24, citing P. Ex. 24.  The document discusses R34 only.  But, on its face, the document warns:  “Disclaimer:  The findings on this IJ (immediate jeopardy) template are preliminary and do not represent an official finding against a Medicare provider or 

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supplier.  Form CMS-2567 is the only form that contains official survey findings.”  P. Ex. 24 at 2.  

The survey report form (CMS-2567) indicates that the facility is not in substantial compliance with section 483.25(e), which it cites at the immediate jeopardy level.  In explaining the deficiency, the form lists surveyor findings that support the immediate jeopardy determination.  Those findings include the care and treatment provided to R28 (CMS Ex. 2 at 50-53), as well as the care and treatment provided to R34.  CMS Ex. 2 at 36-50. 

With respect to R28, the survey report form explains that failing to follow adequate infection control practices could “result in the staff spreading bacteria from the resident’s feces into the resident’s urinary area,” causing a UTI.  A catheter bag left on the floor can be contaminated, allowing bacteria to move up the catheter and into the resident’s body, causing a UTI.  CMS Ex. 2 at 50.  Petitioner has not shown that the threatened harm of staff’s exposing a vulnerable resident to a UTI does not meet any reasonable definition of serious. 

With respect to R34, Petitioner argues that, because “CMS cannot show that the alleged delay” in treating R34’s UTI “was the reason for the [resident’s] death,” its deficiency “does not equate to immediate jeopardy.”  P. Post-hrg. Br. at 23; P. Pre-hrg. Br. at 23.  This is not the correct standard for assessing immediate jeopardy.  The regulation does not require a finding of actual harm, only the likelihood of serious harm.  Mississippi Care Ctr. of Greenville, DAB No. 2450 at 15 (2012); Kenton Healthcare, LLC, DAB No. 2186 at 23 (2008).  

As the above discussion shows, R34 was seriously ill and, unquestionably, his contracting a UTI presented the likelihood of extremely serious harm.  He was often incontinent, was catheterized at least once, and had an increased risk of developing a UTI.  Notwithstanding the regulation’s explicit instructions that he receive treatment and services to prevent UTIs, the facility did not even address the issue in his care plan. 

R34’s care plan included one intervention to address his incontinence:  that staff toilet him every three hours.  Staff did not do so.  When R34 began to show symptoms, staff either did not recognize them as symptoms of a potential UTI, or they recognized the symptoms but did not act.  All of these failings – to develop an adequate care plan, to follow the limited instructions in his plan, and to respond appropriately when the resident showed symptoms – were likely to cause serious harm.  CMS’s finding that the facility’s deficiency posed immediate jeopardy to resident health and safety is therefore not clearly erroneous. 

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  1. The penalties imposed – $7,685 per day for the period of immediate jeopardy and $585 per day for the period 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 Rehab., DAB No. 2738 at 20 (2016). 

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

Penalties are inflation-adjusted and change annually.  The amount is determined as of the date the penalty is assessed, in this case, February 7, 2023.  CMS Ex. 1; 87 Fed. Reg. 15,100, 15,111-12 (Mar. 17, 2022).  For each day of immediate jeopardy, CMS imposed a CMP of $7,685 per day, which is barely above the minimum amount for situations of immediate jeopardy ($7,317 to $23,989).  CMS imposed a penalty of $585 per day for the period of substantial noncompliance that did not pose immediate jeopardy, which is 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. 

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Regarding the facility’s history, the record is silent.15  

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

As to the remaining factors, I have discussed in some detail the facility’s deficiencies under section 483.25(e).  At least two of its residents were at significant risk of developing UTIs, which, considering their compromised physical conditions, would have been very serious – perhaps fatal.  To prevent the spread of infections, staff must follow basic hand hygiene procedures.  Yet, in caring for R28, staff did not do so, disregarding the facility’s policies, the resident’s care plan, and professional standards of practice.  For this, the facility is culpable. 

As section 483.25(e) recognizes, an incontinent resident is susceptible to acquiring a UTI.  R34 was especially susceptible because of his underlying kidney disease.  Yet, in developing his care plan, facility staff did not include treatment and services to prevent UTIs.  The plan contained one intervention to address the resident’s incontinence:  staff were directed to toilet him every three hours.  In fact, staff never complied with this directive.  Then, when R34 began to display symptoms of a UTI, staff did not respond.  For all of these failings, the facility is culpable. 

Because of the facility’s culpability, CMS justifiably imposed a CMP that is slightly higher than the mandatory minimum amounts.  I therefore find reasonable the $7,685 per-day penalty for the days of immediate jeopardy and the $585 per-day penalty for the days of substantial noncompliance that did not pose immediate jeopardy. 

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Conclusion

From October 10 through November 13, 2022, the facility was not in substantial compliance with 42 C.F.R. §§ 483.25(e), and, from October 10-17, 2022, that deficiency posed immediate jeopardy to resident health and safety.  I find reasonable the relatively low CMPs that CMS has imposed. 


Endnotes

1  The surveyors cited multiple D-level deficiencies (isolated instance of substantial noncompliance that causes no actual harm with the potential for more than minimal harm).  CMS Ex. 2 at 1-11, 21-35.  The surveyors also cited a G-level deficiency (isolated instance of substantial noncompliance that causes actual harm that is not immediate jeopardy) under 42 C.F.R. § 483.10(g) (resident rights:  information and communication).  CMS Ex. 2 at 11-21.  Because CMS imposed no remedies for these deficiencies (not even the one that purportedly caused actual harm), those determinations are not reviewable.  A facility may challenge a finding of noncompliance for which CMS imposes one of the remedies specified in 42 C.F.R. § 488.406.  42 C.F.R. § 498.3(b)(13); see 42 C.F.R. § 498.3(a).  A facility has no right to a hearing unless CMS imposes one of the specified remedies.  The remedy, not the citation of a deficiency, triggers the right to a hearing.  The Lutheran Home – Caledonia, DAB No. 1753 (2000).  See Order Summarizing Pre-Hearing Conference at 2-3 (Dec. 6, 2023). 

2  This policy is not consistent with the 42 C.F.R. § 483.10(g)(14).  Under that section, the facility must immediately consult the resident’s physician of a significant change in the resident’s physical, mental, or psychosocial status.  Changes involving non-emergency clinical complications are significant and mandate physician consultation.  Stone Cnty. Nursing & Rehab. Ctr., DAB No. 2276 at 6 (2009).  “Immediately” means as soon as the change is detected, without an intervening interval of time.  River City Care Ctr., DAB No. 2627 at 8 (2015); Magnolia Estates Skilled Care, DAB No. 2228 at 8 (2009). 

3  The standing order is not comprehensive.  As the facility recognized in developing R28’s care plan, strong-smelling urine and changes in its color (blood-tinged, cloudy, deepening color) are significant symptoms that should be evaluated.  CMS Ex. 20 at 8; P. Ex. 13 (listing incontinence as a criterion). 

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

5  Although she initially suggested that the continent/incontinent entry was a mistake, Facility Nurse Kelly Riggan, R.N., ultimately opined that the entry meant that R34 “was continent at times and incontinent at times.”  Tr. at 85.  Facility documentation seems to support this view.  See P. Ex. 9. 

6  In fact, staff toileted the resident so infrequently that he had little opportunity to demonstrate that he was continent. 

7  Both parties overlooked this critical evidence, which I consider more reliable than the progress notes or staff record entries, many of which are incomplete, inconsistent, or verifiably inaccurate. 

8  The document includes two explanations for an entry of “3.”  One is for the indwelling catheter; the other is the presence of an “ostomy.”  Inasmuch as an ostomy involves a surgical procedure – and no evidence suggests that R34 had such a procedure – I find it far more likely that the entry refers to an indwelling catheter, not to an ostomy. 

9  R34 continued to experience falls.  Tr. at 49. 

10  The surveyors cited staffing as a problem.  They found that nursing staff did not answer call lights within a reasonable amount of time and cited a deficiency under 42 C.F.R. § 483.35 (nursing staff).  However, the surveyors also determined that the deficiency caused no actual harm with the potential for no more than minimal harm (scope and severity Level B).  Although the facility was required to correct the deficiency, it did not constitute substantial noncompliance with the staffing regulation.  CMS Ex. 2 at 53-55. 

11  On the other hand, this evaluation is again not completely consistent with the bladder elimination schedule, which indicates that R34 was continent on occasion through the first week in September.  P. Ex. 9 at 5, 7.  

12  Many of the entries are left blank.  Staff should have indicated why the entry was not filled in (99 indicating resident not available; 98 indicating resident refused).  P. Ex. 9 at 1, 3, 5, 7. 

13  Curiously, R34 is virtually never described as continent on the night shift – an observation that should have been considered in his care planning.  Then again, he was so seldom toileted that it is impossible to determine whether he might have been continent, at least part of the time. 

14  The facility may not benefit from the inadequacies of its own record-keeping.  See 42 C.F.R. § 483.70(i)(1) (requiring that medical records be complete and accurately documented).  

15  Petitioner points to the state agency’s “factor form,” which, among other issues, asks the reviewer to discuss the “past history of the facility, within the last 24 months of the violation as it relates to the nature of the violation:  56.9(22).”  The section is left blank.  P. Ex. 14 at 1, 3.  This does not establish that the facility did not have a history of substantial noncompliance.  First, the section is left blank.  Second, as the question itself shows, the state rule standard for assessing the facility’s history is narrower than that of the federal regulation, which includes the facility’s prior history of noncompliance in general as well as deficiencies similar to those cited in the survey.  In any event, I am not bound by the state agency’s analysis. 

/s/

Carolyn Cozad Hughes Administrative Law Judge

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