Skip to main content


U.S. flag
      An official website of the United States government
              Here’s how you know
        Here’s how you knowDot gov**Official websites use .gov**
                 A **.gov** website belongs to an official government organization in the United States.
                  HTTPS**Secure .gov websites use HTTPS**
                 A **lock** (A locked padlock) or **https://** means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites. 
  Menu Close
          HHS Search block
    Search
        








  
  
    

  
      

                                      About HHS
    
                        
                              
      
      
      Programs & Services
    
                        
                              
      
      
      Grants & Contracts
    
                        
                              
      
      
      Laws & Regulations Breadcrumb
    Home
                              About
                              Agencies
                              DAB
                              Decisions
                              ALJ Decisions
                              2023 ALJ Decisions
                              Alal, LLC d/b/a Kei-Ai Los Angeles Healthcare Center, CR6280 (2023)
 Navigate to:
  Departmental Appeals Board (DAB)
    
                                                  
                                                    
            
      
      
      
      About DAB
                                            
            
            Organizational Overview
    
                                                  
                              
            
      
      
      
      Who are the Judges?
    
                                                  
                              
            
      
      
      
      DAB Divisions
    
                                                  
                              
            
      
      
      
      Contact DAB
    
                                                  
                                                    
            
      
      
      
      Filing an Appeal Online
                                            
            
            DAB E-File
    
                                                  
                              
            
      
      
      
      Medicare Operations Division (MOD) E-File
    
                                                  
                                                    
            
      
      
      
      Different Appeals at DAB
                                            
            
            Appeals to DAB Administrative Law Judges (ALJs)
                          
            
            Forms
    
                                                  
                              
            
      
      
      
      Procedures
    
                                                                
                                                    
            
      
      
      
      Appeals to Board
                          
            
            Practice Manual
    
                                                  
                              
            
      
      
      
      Guidelines
    
                                                  
                              
            
      
      
      
      Regulations
    
                                                  
                              
            
      
      
      
      National Coverage Determination Complaints
    
                                                                
                                                    
            
      
      
      
      Appeals to the Medicare Appeals Council (Council)
                          
            
            Forms
    
                                                  
                              
            
      
      
      
      Fully Integrated Duals Advantage (FIDA) Demonstration Project
    
                                                  
                                                    
            
      
      
      
      Alternative Dispute Resolution Services
                                            
            
            Sharing Neutrals
    
                                                  
                              
            
      
      
      
      ADR Training
    
                                                  
                              
            
      
      
      
      Other ADR Services
    
                                                  
                                                    
            
      
      
      
      DAB Decisions
                                            
            
            Board Decisions
    
                                                  
                              
            
      
      
      
      DAB Administrative Law Judge (ALJ) Decisions
    
                                                  
                              
            
      
      
      
      Medicare Appeals Council (Council) Decisions
    
                                    
                              
            
      
      
      
      Stakeholder Feedback
    
                                                  
                                                    
            
      
      
      
      Careers
                                            
            
            Open Career Opportunities
    
                                                  
                              
            
      
      
      
      Internships & ExternshipsText resize icon

                    




Alal, LLC d/b/a Kei-Ai Los Angeles Healthcare Center, CR6280 (2023)








  
  
    

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





Alal, LLC d/b/a Kei-Ai Los Angeles Healthcare Center
(CCN: 555438),
Petitioner,

v.

Centers for Medicare & Medicaid Services
Docket No. C-21-823Decision No. CR6280May 9, 2023

        
              
    

      **DECISION**

This case involves a resident of a long-term-care facility, who suffered from multiple impairments, several of which cause pain:  osteoarthritis, fractured leg, and nerve pain.  He arrived at a hospital emergency room with severe bladder distention and was diagnosed with obstructive uropathy.  Fearful that his bladder would rupture, emergency room staff drained between five and more than seven liters of dark, then bloody, urine from his bladder. The question here is whether, prior to his hospital admission, the facility properly assessed and managed his pain.

Petitioner, Alal, LLC d/b/a Kei-Ai Los Angeles Healthcare Center, is a long-term-care facility, located in Los Angeles, California, that participates in the Medicare program.  Based on a complaint investigation, completed on October 19, 2020, the Centers for Medicare & Medicaid Services (CMS) determined that the facility was not in substantial compliance with the Medicare program requirement governing quality of care and pain management.  Based on this finding, CMS imposed a per-instance civil money penalty (CMP) of $11,715.

Petitioner appealed.

Page 2

For the reasons set forth below, I find that the facility was not in substantial compliance with the quality-of-care requirements for pain management and that the modest penalty imposed is reasonable.

**Background**

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

The Secretary contracts with state survey agencies to survey skilled nursing facilities in order to determine whether they 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, and 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, the daughter of a facility resident complained to the California Department of Public Health (state agency) that the facility had neglected her father.  CMS Ex. 8.  Surveyors from the state agency investigated.  They began an abbreviated standard survey on August 28, 2020, and completed it on October 19, 2020.  CMS Ex. 1; CMS Ex. 21 at 3 (Abel Decl. ¶ 5).  Based on their findings, CMS determined that the facility was not in substantial compliance with **42 C.F.R. § 483.25(k) (Tag F697) (quality of care:  pain management)**, cited at scope and severity level G (isolated instance of substantial noncompliance that causes actual harm that is not immediate jeopardy).  CMS Ex. 1; Originating Case Decision (April 13, 2021) (efile #1a).1

Based on a revisit survey, completed November 18, 2020, CMS determined that the facility returned to substantial compliance on that date.  Originating Case Decision at 2 (e-file #1a).

Page 3

CMS imposed one per-instance CMP of $11,715.  *Id*.

Petitioner timely requested a hearing.

On November 10, 2022, I held a hearing, via video teleconference, from the offices of the Departmental Appeals Board in Washington, D.C.  Mr. Kevin Pease, representing CMS, appeared from Concord, California.  Transcript (Tr.) at 1.  Mr. Thomas Swann, representing Petitioner, appeared from Brea, California.  *Id*.

I have admitted into evidence CMS Exs. 1-14, 16-18, and 20-25 and Petitioner’s Exs. 26-35.  Order Summarizing Pre-Hearing Conference at 2 (November 2, 2022).  The parties have filed prehearing briefs (CMS Br., P. Br.), closing briefs (CMS Cl., P. Cl.) and reply briefs (CMS Reply, P. Reply).

**Issues**

The issues before me are:

Was the facility in substantial compliance with Medicare program requirements, specifically, 42 C.F.R. § 483.25(k); and
	If the facility was not in substantial compliance, is the penalty imposed – $11,715 per instance – reasonable?Petitioner also challenges CMS’s determination as to the scope and severity of the deficiency.  P. Cl. at 1-2, 5.  I may review CMS’s scope-and-severity findings if:  1) a successful challenge would affect the range of the CMP; or 2) CMS has made a finding of substandard quality of care that results in the loss of approval of a facility’s nurse aide training program.  42 C.F.R. §§ 498.3(b)(14), 498.3(d)(10); *Madison Cty. Nursing Home*, DAB No. 2895 at 16 (2018); *NMS Healthcare of Hagerstown*, DAB No. 2603 at 6-7 (2014); *Cedar Lake Nursing Home*, DAB No. 2344 at 9 (2010); *Heritage Park Rehab. and Nursing Ctr*., DAB No. 2231 at 15-16 (2009); *Evergreen Commons*, DAB No. 2175 (2008); *Aase Haugen Homes, Inc.*, DAB No. 2013 (2006).

For a per-instance penalty, the regulations provide only one range (at the time the penalty was imposed, the range was from $2,233 to $22,320), so the level of noncompliance here does not affect the range of the CMP.  42 C.F.R. §§ 488.408(d)(1)(iv), 488.438(a)(2); 45 C.F.R. § 102.3.2

Page 4

Certain types of deficiencies, including quality-of-care, can lead to a finding of “substandard quality of care,” which might result in the facility’s losing approval to conduct nurse aide training and would allow me to review scope and severity.  However, that can happen only if the deficiency is cited at one of the following scope-and-severity levels:  immediate jeopardy (levels J, K, L); a pattern of or widespread actual harm that is not immediate jeopardy (level I); or widespread deficiencies with the potential for more than minimal harm (level F).  42 C.F.R. § 488.301.  Because the deficiencies here were cited at scope and severity level G, there has been no finding of substandard quality of care.

Moreover, if I approve a penalty of $11,715 (inflation adjusted) or more, as I do here, CMS’s scope and severity finding will not affect approval of the facility’s nurse aide training program, assuming that it has one.  Under the statute and regulations, the state agency cannot approve the program if CMS imposes a penalty of $11,160 or more.  Thus, even if CMS had found substandard quality of care, the facility would lose its approval without regard to the scope and severity finding.  Act § 1819(f)(2)(B); 42 C.F.R. § 483.151(b)(2)(iv); 85 Fed. Reg. 2869, 2886 (Jan. 17, 2020).

**Discussion**

***1. The facility was not in substantial compliance with 42 C.F.R. § 483.25(k) because, contrary to professional standards of practice, the facility’s own policies, and R4’s care plan, nurses administered an opioid pain medication to a resident who was experiencing no pain; staff did not timely assess the effectiveness of the pain medication they administered; and licensed nurses did not assess and document adequately R4’s pain.***3

**Program requirements:  42 C.F.R. § 483.25(k) (Tag F697)**.  “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 the quality-of-care regulation require that the facility ensure that each resident receive, and the facility provide, the necessary care and services to allow the resident to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the resident’s comprehensive assessment and plan of care.  Act § 1819(b)(2); 42 C.F.R. § 483.25.  To this end, the regulations mandate (among other requirements) that the facility “ensure” that pain management is provided to residents who require such services, consistent with professional standards of practice, the resident’s person-centered care plan, and the resident’s goals and preferences.  42 C.F.R. § 483.25(k).

Page 5

**Facility policy:  pain management**.  The facility’s pain management policy requires that all residents *be assessed for pain* upon admission, each time vital signs are monitored, *when a pain medication is given*, and as indicated.  A licensed nurse teaches the resident/surrogate the facility pain scale.  Pain medications are given before the pain becomes severe*.*  The resident’s *response is documented* on the Medication Administration Record (MAR) *within one half hour* of the medication being administered.  CMS Ex. 13 at 13.

The policy lists specific procedures that staff must follow:

*A licensed nurse must* assess each resident for pain during the initial nursing assessment, using the pain scale approved by the facility.
	The licensed nurse must instruct the resident or the resident’s surrogate regarding the pain scale.
	The *licensed nurse* reviews the resident for pain *when vital signs are taken*. Review includes *origin of pain, location of pain, severity of pain, alleviating and exacerbating factors, current treatment, and response to treatment*.
	Assessment of pain is based on the pain scale. If the resident can’t verbally indicate the intensity or severity of the pain using the pain scale, the nurse must assess using non-verbal cues, i.e., anxious, agitation, grimacing, moaning, sad expression, etc., to indicate the severity of the pain.  If the nurse can’t determine whether the resident’s facial expressions are related to pain, the policy advises the nurse to consider administering pain medication.  If the resident improves with pain medication, the nurse should consider administering it routinely since the resident can’t request it.
	The licensed nurse must *administer pain medication as ordered* and document on the Medication Administration Record (MAR) the drug, time of administration, dose, *pain scale rating, and*, *within a half hour of its being administered, the resident’s response*.
	If pain is new onset, has changed in nature, is not relieved by current medications, etc., staff must notify the physician for a review of medications.
	Staff must notify the resident’s family or surrogate decision-maker regarding any new pain medications.
	Staff must document, in the resident’s medical record, the weekly summary, and progress notes, the resident’s complaint and response to interventions.Page 6

CMS Ex. 13 at 13-14.

**Facility policy:  assessment and reassessment**.  The facility’s policy for assessing and reassessing its residents mandates that a licensed nurse assess the resident within 24 hours of admission.  The resident must be *reassessed each shift, and the nurse must document the assessment in the progress notes*.  Assessments must include a weekly summary of the resident’s progress or lack of progress.  The resident must also be reassessed and his care plan updated with each change of condition, new problem, and/or resolution of a problem.  Documentation must be maintained in the resident’s medical record.

Among other specific requirements, the policy requires that the initial nursing assessment *assess the resident’s pain, including its origin, location, severity (using a pain scale), alleviating and exacerbating factors, current treatment, and response to treatment*.  CMS Ex. 13 at 16.

The policy requires that reassessments be completed with any change of condition, weekly, quarterly, and as often as indicated by changes in orders, new observations, incidents, etc.  The assessments must be documented in the nurses’ progress notes.  Physicians must be notified of any change in condition or unusual observation.  CMS Ex. 13 at 17.

The interdisciplinary team charts the resident’s progress on the interdisciplinary progress notes in the health record.  Licensed nurses chart progress at least weekly on the weekly summary record.  The resident’s care plan must be reviewed and updated as appropriate.  CMS Ex. 13 at 17.

**Facility policy:  change in condition reporting**.  The purpose of the facility’s change in condition reporting policy is to “define guidelines” for timely reporting an identified change in a resident’s condition.  The policy is to identify changes in a resident’s condition and to communicate that change to the resident’s primary physician and/or the resident’s designee.  CMS Ex. 13 at 20.

In addition to reporting life-threatening changes, the policy requires the following:

The licensed nurse must advise the physician, and the resident’s designee of any sudden or serious change in the resident’s condition, “manifested by a marked change in physical or psychosocial status.” The nurse must also ask the physician to visit promptly and/or request an acute care evaluation.
	If the licensed nurse can’t timely contact the resident’s attending physician or alternate, the nurse must notify the facility’s medical director for follow-up regarding the change in the resident’s condition.Page 7

The licensed nurse must notify the responsible party of the change in the resident’s condition and actions taken to manage the identified change.
	Nursing interventions must be documented in the progress note section of **PointClick Care** as soon as possible after the resident needs have been met.CMS Ex. 13 at 20-21.

The policy also directs staff to report promptly, to the attending physician or designee, “unusual signs and symptoms and any deviation from the resident’s baseline condition.”  CMS Ex. 13 at 21.  The policy defines “routine change” as a non-life-threatening minor change in physical and mental behavior, abnormal laboratory and x-ray results.

The licensed nurse must notify the attending physician prior to the end of the nurse’s shift or as soon as possible when a change in condition is noted.  If the nurse is not able to reach the attending physician, the nurse must document the calls made in the progress note section of **PointClick Care**.  If the physician has not returned the call by the end of the shift, the licensed nurse on the next shift must do a follow-up call.  If the nurse is not able to contact timely the attending physician or alternate, the nurse must notify the facility’s medical director for response and follow-up regarding the change.

The licensed nurse must document the change-of-condition and response in the nursing progress notes and on the *24-Hour-Report Form* and update the resident’s care plan, as indicated.  All attempts to reach the attending physician or designee must be documented in the progress notes section in **PointClick Care**.

The policy also requires follow-up:

The assigned licensed nurse continues observation, assessment, and documentation every shift for at least seventy-two (72) hours or until the condition is stable.
	Residents with acute changes (and some routine changes) are listed on the 24-hour report. The resident’s progress and needs must be “clearly communicated” to each shift.CMS Ex. 13 at 21.

**Resident 4 (R4)**.  R4 was a 71-year-old man when he was admitted to the facility on May 18, 2020.  He had a fractured tibia (shinbone) and required orthopedic aftercare.  He suffered from multiple other serious impairments, including diffuse large B-cell lymphoma (cancer), diverticulitis of the large intestine, osteoarthritis, gastro-esophageal

Page 8

reflux disease, and benign prostatic hyperplasia (enlarged prostate).  CMS Ex. 3; P. Ex. 30 at 1.4

The facility’s records inconsistently report whether R4 was continent.  An assessment completed on the day of his admission indicates that he was continent of bowel and bladder.  P. Ex. 30 at 12-13, 30.  A second assessment, however, dated May 24, indicates that he was incontinent of bowel and bladder.  CMS Ex. 12 at 24.  Progress notes consistently report that he was continent of bladder but inconsistently report his bowel continence.  CMS Ex. 14 at 20, 27, 28, 32, 29, 49, 54, 59.  Not all of these records can be accurate, but, if R4’s condition changed, staff should have assessed and reported the change, which they did not do.

A progress note, entered at the time of R4’s admission, describes R4’s abdomen as “distended.”  CMS Ex. 14 at 59.  Thereafter, however, progress notes, which I find unreliable (see discussion below), consistently describe the abdomen as flat, nondistended, and pain-free.

On May 25, 2020, a licensed vocational nurse (LVN) reported that R4’s condition had changed.  His abdomen was enlarged, and he was increasingly confused.  A bladder scan showed that he had over 1,000 ml of urine in his bladder, which dangerously exceeds a normal bladder’s capacity.  When the facility nurses were unable to insert a Foley catheter, his physician ordered him transferred to the hospital, where he arrived, confused and in pain.  CMS Ex. 6 at 2; CMS Ex. 7; CMS Ex. 14 at 23, 25; P. Ex. 30 at 95.

**R4’s pain assessment (or lack thereof)**.  R4’s assessments did not adequately assess the resident’s pain:  its origin, location, severity, alleviating and exacerbating factors, current treatment, and response to treatment.  The May 18 assessment indicates the presence of pain but provides no further information.  A second pain management assessment, dated May 24, 2020, indicates that, within the previous five days, R4 received PRN (as needed) pain medications, or they were offered and declined.  However, R4 denied having had pain over the previous five days, and all further questions regarding pain went unanswered.  CMS Ex. 12 at 20.  R4’s self-report was obviously wildly inaccurate, as facility staff should have known.  He had been at the facility for more than five days, and staff had administered narcotic pain medications daily, for moderate to moderately strong pain (pain levels 4-6).  (*See* detailed discussion below).

**R4’s care plan**.  R4’s care plan, initiated on May 19, 2020, identified “alteration in comfort due to pain related to:  recent fall and fracture, osteoarthritis, nerve pain.”  CMS Ex. 4 at 3-7.  Among the care plan’s long list of interventions were:

Page 9

monitor bowel pattern;
	provide the resident and his family with information about and options available for pain management;
	notify his physician if interventions are unsuccessful or *if his current complaint is a significant change from his past experience of pain*;
	*evaluate the effectiveness of pain intervention*, review for compliance, alleviating symptoms, dosing schedules, and resident satisfaction with result, impact on functional mobility and ADL function;
	use pillows to facilitate proper body alignment, as needed;
	provide nonpharmacological interventions, as ordered;
	observe and report changes in usual routine, sleep patterns, decrease in functional abilities, decreased range of motion, withdrawal or refusal of care;
	communicate any change in usual activity attendance patterns or refusal to attend activities related to complaint of pain or discomfort;
	*document characteristics of pain*, using pain management scales;
	*observe/assess pain, location, duration, frequency, strength*;
	*determine cause of pain and activity that aggravates pain*;
	*identify and treat existing conditions that may increase pain and discomfort*;
	anticipate the resident’s need for pain relief and respond immediately to any complaint of pain;
	assure/assist to maintain proper body alignment for comfort and positioning;
	divert attention from pain by conversing with resident during short, frequent visit;
	*administer prescribed pain medication*;
	*observe for side effects of pain medication*, such as constipation, new onset or increased agitation, restlessness, confusion, hallucinations, dysphoria (state of unease), nausea, vomiting, dizziness, and intervene accordingly;Page 10

administer one *gabapentin capsule* (an anticonvulsant and nerve pain medication) by mouth every twelve hours, as needed for *nerve pain*;
	*administer one tablet of hydrocodone-acetaminophen every four hours as needed for moderate pain (4-6)*, not to exceed three grams in 24 hours from all sources;5
	administer two Tylenol tablets by mouth every four hours as needed for mild pain (1-3), not to exceed three grams in 24 hours from all sources;
	observe and report any signs and symptoms of nonverbal pain; changes in breathing (noisy, deep/shallow, labored, fast/slow); vocalizations (grunting, moans, yelling out, silence); mood/behavior changes (more irritable, restless, aggressive, squirmy, constant motion, fearful facial expressions, fidgeting); eyes (wide open/narrow, slits/shut, glazed, tearing, no focus); face (sad, crying, worried, scared, clenched teeth, grimacing); body (tense, rigid, rocking, curled up, thrashing); and
	observe for presence of pain during care and during ADL performance.CMS Ex. 4 at 4-7; P. Ex. 30 at 36-39.

Consistent with R4’s care plan, his physician ordered Tylenol, gabapentin, and non-pharmacological interventions to treat his pain.  However, the record shows that nursing staff did not administer either medication nor attempt any non-pharmacological interventions.  CMS Ex. 11 at 11, 12, 13, 15; *see* CMS Ex. 14 at 9 for a list of non-pharmacological interventions.

R4’s physician also prescribed hydrocodone-acetaminophen, an opioid pain reliever.  Review of R4’s MAR shows that, from May 19, 2020 (his first full day at the facility) through May 24, 2020 (his last full day at the facility), nursing staff administered the medication at least once every day, and, on two days (May 20 and May 23), they administered it twice.  Specifically, nurses administered the opioid on the following dates and times:

May 19, 2020, at 11:58 a.m., for a pain level of 5, which is moderately strong pain.
	May 20, 2020, at 8:18 a.m., *for a pain level of 0, which is no pain*.  In doing so, staff did not follow the physician’s order or R4’s care plan, which directed staff to administer the narcotic *as needed for moderate pain*.Page 11

May 20, 2020, at 3:30 p.m., for a pain level of 6, which is moderately strong pain that interferes with normal daily activities;
	May 21, 2020, at 9:06 p.m., for a pain level of 6;
	May 22, 2020, at 6:43 p.m., for a pain level of 6;
	May 23, 2020, at 1:09 p.m., for a pain level of 4, which is moderate pain;
	May 23, 2020, at 6:21 p.m., for a pain level of 5; and
	May 24, 2020, at 5:11 p.m., for a pain level of 5.CMS Ex. 11 at 15; *see* CMS Ex. 12 at 12.  Although the MAR records pain levels at the times the medication was administered and consistently describes the dosage as effective (“E”), staff did not record the location of the pain, which, according to the ordinary standard of care, should have been recorded in the MAR or, at least, in the nursing notes.  CMS Ex. 23 at 4, 5 (Haig Decl. ¶¶ 15, 16).

**Facility adherence to policies, care plans, and physician orders**.  The Departmental Appeals Board has held repeatedly that a facility’s policies “may reflect [its] own judgment about how best to achieve compliance” with participation requirements.  Thus, failing to comply with its own policies supports the finding that the facility was not acting within the standard of care and was not in substantial compliance with sections 483.25 and 483.25(k).  *Heritage House of Marshall Health and Rehab*., DAB No. 3035 at 11 (2021) (quoting *Bivins Mem’l Nursing Home*, DAB No. 2771 at 9 (2017)); *Emery County Care and Rehab.*, DAB No. 3006 at 11 (2020) (explaining that CMS may “reasonably rely on the facility’s protocols and treatment policies as evidencing the facility’s own judgment on the care and services that are necessary at a minimum to attain or maintain its residents’ highest practicable physical, mental, and psychosocial well-being”); *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); *Golden Living Ctr. – Superior*, DAB No. 2768 at 7 (2017); *Heritage House of Marshall Health & Rehabilitation Ctr*., DAB No. 2566 at 13 (2014); *Hanover Hills 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); *see also Green Oaks Health & Rehab. Ctr*., DAB No. 1567 at 5 (2014) (holding that the methods a facility chooses to protect its residents are reflected in its policies, assessments, and care plans).

Page 12

In the absence of contemporaneous documentation justifying their failure to follow facility policy, it is “certainly reasonable” to infer that staff were not aware of it, or that they simply disregarded it.  *Oxford Manor*, DAB No. 2167 at 5-6 (2008).

It is also well-settled, that a resident’s care plan represents the facility’s judgment about what care and services are needed to keep the resident safe.  If facility staff fail to provide care and services in accordance with the resident’s comprehensive assessment and plan of care, it violates section 483.25.  *White Sulphur Springs Ctr.*, DAB No. 2520 at 7 (2013); *Deltona Health Care*, DAB No. 2511 at 7-8 (2013); *Venetian Gardens*, DAB No. 2286 at 5 (2009).

Failing to follow a physician order also puts a facility out of substantial compliance with section 483.25.  *Cedar Lake Nursing Home*, DAB No. 2390 at 3 (holding that a facility’s failure to comply with physician orders, a resident’s care plan, or its own policies can constitute a deficiency under section 483.25); *Woodland Village Nursing Ctr*., DAB No. 2053 at 9 (2006), *aff’d, Woodland Village Nursing Ctr. v. U.S. Dept. of Health & Human Services*, 239 F. App’x 80 (5th Cir. 2007) (citing*Lakeridge Villa Health Care Ctr.*, DAB No. 1988 at 22 (2005), *aff’d, Lakeridge Villa Care Ctr. v. Leavitt*, 202 F. App’x 903 (6th Cir. 2006)).

**Facility noncompliance:  administering narcotic medications to a resident who was not in pain**.  As noted above, the facility’s pain management policy required staff to “administer pain medication as ordered.”  CMS Ex. 13 at 14.  R4’s physician ordered the narcotic, hydrocodone-acetaminophen “as needed for moderate pain” which meant pain levels of 4-6.  CMS Ex. 11 at 15.  Similarly, R4’s care plan directed staff to administer the narcotic “as needed for moderate pain (4-6).”  CMS Ex. 4 at 7.

At 8:18 a.m. on May 20, 2020, R4 was experiencing no pain.  His pain level was 0.  Yet, for reasons the facility has not explained, a licensed nurse administered hydrocodone-acetaminophen.  CMS Ex. 11 at 15.  Doing so was contrary to the facility’s policies, R4’s care plan, and the standard of care, and, thus, violated section 483.25(k).

Surveyor Princess Pia Abel interviewed the facility’s Director of Nursing (DON), who agreed that staff should not have administered the narcotic when the resident was not in pain.  Doing so subjected R4 to the medication’s adverse effects (which include drug dependence) with no benefits.  CMS Ex. 21 at 5 (Abel Decl. ¶ 13).6

Page 13

When statements are made by the facility’s own employees, and those individuals have not refuted them, they may constitute substantial evidence.  *See**Beatrice State Developmental Ctr.*, DAB No. 2311 at 17, 18 (2010) (pointing out that the facility could have but did not present employee testimony that refuted the statements the surveyors claimed they made);*Omni Manor Nursing Home*, DAB No. 1920 at 11 (2004) (holding that statements of facility employees to the surveyors may be admitted in an administrative proceeding and may constitute substantial evidence).  Here, Petitioner does not deny that the DON made the statement nor that the statement is accurate.  In fact, Petitioner’s consultant and witness, Heidi Capela, R.N., agreed that providing pain medication to a resident who has no complaints of pain can unnecessarily expose him to the medication’s side effects.  Tr. at 9.

**Facility noncompliance:  staff’s failing to assess timely the effectiveness of the pain medication**.  Pursuant to the facility’s policies, the licensed nurse was required to document, *within one half hour* of its being administered, the resident’s response to the pain medication.  CMS Ex. 13 at 14.

Petitioner asserts that facility staff reevaluated R4 after administering his pain medication.  P. Cl. at 5 (citing P. Ex. 34 at 7-8 (Capela Decl. ¶ 22)).  According to Petitioner, the effectiveness of the pain medication “is clearly documented within the record.”  P. Cl. at 5 (citing CMS Ex. 11 at 15).

In fact, although nursing staff consistently indicated on the MAR that the medication was effective, the records show that they impermissibly delayed assessing the resident’s response to the medication administered.  They were supposed to report the medication’s effectiveness within one half hour of the medication being administered.  CMS Ex. 13 at 13.  Not once did staff timely report the resident’s response, and, on occasion, the delay was so long as to bear no relationship to the effectiveness of the medication.

On May 19, 2020, the nurse administered hydrocodone-acetaminophen at 11:58 a.m. and documented the resident’s response at 2:23 p.m., almost two-and-a-half hours later.
	On May 20, 2020, the nurse administered hydrocodone-acetaminophen at 3:30 p.m. and documented the resident’s response at 4:47 p.m., more than an hour and 15 minutes later.
	On May 21, 2020, the nurse administered hydrocodone-acetaminophen at 9:06 p.m. and documented the resident’s response at 10:10 p.m., more than an hour later.
	On May 22, 2020, the nurse administered hydrocodone-acetaminophen at 6:43 p.m. and documented the resident’s response at 7:45 p.m., more than an hour later.Page 14

On May 23, 2020, the nurse administered hydrocodone-acetaminophen at 1:09 p.m. and documented the resident’s response at 2:04 p.m., almost an hour later.
	On May 23, 2020, the nurse administered hydrocodone-acetaminophen at 6:21 p.m., and documented the resident’s response at 7:24 p.m., over an hour later.
	On May 24, 2020, the nurse administered hydrocodone-acetaminophen at 5:11 p.m., but did not document the resident’s “response” (which was hardly a response at that point) until 1:30 a.m. the following day, more than eight hours later.P. Ex. 30 at 65-66; *see* CMS Ex. 11 at 15; CMS Ex. 14 at 25, 30, 31, 35, 36, 42, 47, 51, 53; P. Ex. 30 at 95.

**Facility noncompliance:  staff’s inadequate pain assessments**.  The parties agree that R4 suffered significant pain throughout his stay at the facility.  Some of that pain was likely caused by his leg fracture and osteoarthritis; some was probably caused by nerve damage; and some would have been caused by severe bladder distension and fecal impaction.7  But we cannot know which of his conditions were causing his pain at any given time because, contrary to accepted national standards for pain management, the facility’s policies, and R4’s care plan, nursing staff did not adequately evaluate or document that pain:  its location, source, or other characteristics.  *See* CMS Ex. 4 at 6 (directing nursing staff to “observe/assess pain, location, duration, frequency, strength”); CMS Ex. 13 at 13 (directing nursing staff to assess for pain when a pain medication is given); CMS Ex. 23 at 4, 5 (Haig Decl. ¶¶ 15, 16).

R4’s pain was not properly assessed at any time during his stay at the facility.  His May 18, 2020 assessment offers no information except that the resident had pain.  P. Ex. 30 at 13.  His May 24 assessment is more deficient.  It does not even acknowledge his documented pain.  The assessing nurse asked R4 if he had experienced any pain over the previous five days and then accepted his incorrect answer that he had not.  CMS Ex. 12 at 20.  At the time of his assessment, R4 had been in the facility for more than five days – from May 18 through 24.  During the previous five days, he experienced moderate to moderately strong pain daily, for which he was administered an opioid.  CMS Ex. 11 at 15.  Yet, this assessment is limited to his own inaccurate self-report.  The assessing nurse asked no additional questions and provided no additional evaluation.  CMS Ex. 12 at 20.

Nor did nurses properly assess R4’s pain when they took his vital signs or administered his pain medication.  Instead, the nurses asked him for a pain level, again accepted what he told them, and recorded it on the MAR.  They did not try to determine the source of his pain.  CMS Ex. 11 at 15.

Page 15

Citing the opinion of Consultant Capela, Petitioner claims that the facility provided medications to R4 “consistent with his baseline need for pain management related to right knee pain, osteoarthritis, and nerve pain, which was consistent with his care plan.”  P. Cl. at 5 (citing P. Ex. 34 at 7 (Capella Decl. ¶ 22)).  But Consultant Capela makes the same mistake facility staff made.  She does not differentiate among the three sources of R4’s pain.  It was particularly important for nursing to do so because R4’s physician had prescribed different medications, depending on the origin of his pain:  gabapentin to treat pain caused by nerve damage; and hydrocodone-acetaminophen to treat pain caused by other conditions.  The nurses made no distinction and simply treated all of his pain the same by administering the opioid, hydrocodone-acetaminophen, without regard to the source of the resident’s pain.  CMS Ex. 11 at 15.  The facility, thus, did not provide medications consistent with R4’s baseline needs, care plan, or physician order, and was out of substantial compliance with section 483.25(k).8

Petitioner argues that nursing staff adequately evaluated the resident’s pain because they were able to rely on him to report his needs.  The argument fails for two reasons:  1) R4 demonstrated that he could not accurately self-report; and 2) even assuming the resident had been able to do so, a resident’s self-assessment is insufficient; national standards, facility policies, and the resident’s care plan require much more.

**R4’s competence to self-report**.  At the time he entered the facility, R4 demonstrated that he was cognitively intact.  CMS Ex. 12 at 38.  He was described as alert and able to communicate his needs.  CMS Ex. 14 at 4; P. Ex. 30 at 3.  The evidence establishes, however, that he was not consistently and accurately able to identify his pain.  Either his condition deteriorated after his initial assessment, or he was never capable of reporting accurately.

CMS claims that, from May 18 through 25, 2020, R4 was not aware of the events around him, which may be true, although the record is far from definitive on that question.  CMS Reply at 3.  For the most part, R4’s treatment records show that he was alert and oriented X3, with some forgetfulness.  CMS Ex. 14 at 19, 27, 32, 38, 43, 60.  This means that he was oriented to person, place, and time but not to “event” or “situation.”  Tr. at 13.  He would have known his name, his present location, and the date, but not necessarily what

Page 16

was happening to him.  Just one progress note, written on the day he was admitted, describe him as alert and oriented X4.  P. Ex. 30 at 30.

I am willing to accept that, at the time of his admission, R4 was alert and fully oriented.  I do not accept that he remained so throughout his stay.  And, even if he had, I do not accept that he was capable of assessing and reporting his pain accurately.

Two incidents suggest R4’s diminishing mental capacity:

At 7:00 p.m. on May 22, R4’s daughter called the facility, asking to speak to him. Thirty minutes later, she called back to report that the resident had been looking “around the area” for his cell phone but couldn’t find it.  When the nurse checked, the phone was on the table at the resident’s bedside.  CMS Ex. 14 at 1, 35-36.
	At 9:00 p.m. that day, R4’s daughter called back to report that her father complained that nobody gave him water and that he had been waiting a long time. The nurse checked and found a bottle of water and cup on the bedside table, close to the resident. The nurse recommended more frequent checks, which suggests her heightened concern for him. CMS Ex. 14 at 1, 35-36.As Consultant Capela opined, by themselves, these two incidents might not say much about R4’s mental status.  Tr. at 34-35.  Far more significant is the fact that he could not accurately recall having experienced pain while at the facility.  Notwithstanding his daily complaints of pain, on May 24, he told the nurse conducting his assessment that he had not experienced any pain over the previous five days (May 19-24).  CMS Ex. 12 at 20.  Staff should have realized at that point that he was not a reliable historian.

Moreover, medical personnel outside the facility were not at all confident of the resident’s ability to report his condition accurately.  A consulting physician, who examined R4 on June 9, 2020, well after his acute problems had resolved, reported that the resident had “some dementia.”  The physician determined that the resident was not a reliable historian.  CMS Ex. 5 at 209; P. Ex. 31 at 32.

**Even a competent resident is not qualified to conduct a pain assessment**.  Even if R4 had been capable of accurately reporting his pain level, more is required.  As the facility’s policies and R4’s care plan recognize, the facility may not rely solely on the resident to self-assess.  A *licensed nurse* must review the resident’s pain, including its *origin, location, severity, alleviating and exacerbating factors, current treatment, and response to treatment*.  CMS Ex. 4 at 6; CMS Ex. 13 at 13-14.

The facility’s DON conceded that staff had not adequately assessed R4’s pain.  She told Surveyor Abel that the facility had no documentation indicating the location of R4’s pain throughout the time nurses were administering hydrocodone-acetaminophen (May 19

Page 17

through 24, 2020).  The DON agreed that the pain location should have been documented.  She said that:

follow-up and assessment of the pain location was important for evaluation of the effectiveness of the medication, to address the correct location and characteristics of the pain, and to evaluate if [the] resident was experiencing acute pain . . . or chronic pain.

CMS Ex. 21 at 4-5 (Abel Decl. ¶ 11).  The DON also confirmed that, given R4’s various admission diagnoses, it was important to determine the location of his pain.  CMS Ex. 21 at 5 (Abel Decl. ¶ 12).  Again, Petitioner has not refuted the DON’s statements.  *See Beatrice State*, DAB No. 2311 at 17, 18; *Omni Manor*, DAB No. 1920 at 11.

Failing to evaluate the location of pain can result in changes of condition going unnoticed, allowing illnesses and conditions to go untreated and inflicting unnecessary harm.  CMS Ex. 21 at 5 (Haig Decl. ¶ 17).

**R4’s bladder distention**.  The circumstances surrounding R4’s extreme bladder distension are obviously deeply disturbing, and raise significant questions about the staff’s pain assessments, the accuracy of its reporting, and the quality of care they provided.  This case, however, does not turn on the facility’s response to R4’s bladder distention.  As discussed above, even before R4 suffered his acute bladder distention and renal failure, staff failed to follow the facility’s policies, R4’s care plan, and physician orders for assessing and managing his pain.  That failure alone put the facility out of substantial compliance and justifies the penalty imposed.

Nevertheless, the facility’s response to R4’s obstructive uropathy strengthens the finding of substantial noncompliance.  The evidence establishes that R4’s urinary retention was likely a problem when, at the time of his admission to the facility, he presented with a distended abdomen.  CMS Ex. 14 at 59.  For the next week, however, staff reported no problems with his abdomen.

Another undeniable and troubling sign – significant and unexplained weight gain – suggests that Petitioner’s urinary problems dated back to the time of his admission.  Less than two weeks prior, on May 6, 2020, R4 weighed 167 pounds (75.6 kg).  P. Ex. 29 at 7.  We do not know how much he weighed on the day of his admission, because no weight is recorded on his initial assessment (as it should have been).  CMS Ex. 16 at 1; P. Ex. 30 at 2.  When staff finally weighed him on May 21, his weight had jumped to 199 pounds.  CMS Ex. 14 at 19, 26, 42.  That is an enormous weight gain in just two weeks, but facility staff did not seem to notice it.  On the night of May 25, after his bladder had been emptied, R4’s weight dropped to 187 pounds (85 kg).  P. Ex. 31 at 15, 29.

Page 18

The facility did not consider that hydrocodone-acetaminophen can affect a resident’s ability to urinate.  Petitioner’s witnesses minimized the problems (Tr. at 9, 48), but it is well-documented that opioids can interfere with urinating and contribute to urinary retention.  By providing opioid pain medications, nursing personnel may have been worsening R4’s condition.  CMS Ex. 23 at 5 (Haig Decl. ¶ 19); *see e.g.,* Skyler B. Suchovsky, PharmD, Pamela D. Reiter, PharmD, Hannah E. Lewis, MA, and Amy C. Clevenger, MD, PhD, *Methylnaltrexone in the Management of Opioid-Associated Urinary Retention in Children*, National Library of Medicine (May 1, 2023, 1:05 PM), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9088432/; Winifred G Teuteberg MD, *Drug-Induced Acute Urinary Retention*, Palliative Care Network of Wisconsin (May 1, 2023, 1:10 PM), https://www.mypcnow.org/fast-fact/drug-induced-acute-urinary-retention/; Winnie Teuteberg, MD, *Urinary retention, the sometimes-neglected medication side effect*, University of Pittsburgh (May 1, 2023, 1:20 PM), https://dom.pitt.edu>2021/07>June2013.pdf; Manuchehr Habibi and Peggy Y. Kim, *Hydrocodone and Acetaminophen*, National Library of Medicine (May 3, 2023, 2:00 PM), https://www.ncbi.nlm.nih.gov/books/NBK538530/.

I do not accept Petitioner’s contention that, throughout his stay at the facility, R4 voided normally, nor that his abdomen remained flat, nondistended, and pain-free.  I find that the progress notes making these claims are unreliable.9  As late as 10:40 a.m. on the morning of May 25, nurses continued to describe R4’s abdomen as “flat and non-tender” and his urine as “clear yellow,” and reported that R4 had “no urinary complaints.”  P. Ex. 30 at 105.  This was plainly inaccurate, as evidenced by progress notes entered later that day.  A progress note entered at 4:47 p.m. on May 25 indicates that, at 10:30 a.m., the resident exhibited “increased confusion.”  He was lethargic and had “abdominal enlargement.”  P. Ex. 30 at 108-110.  Consistent with that revised note, an examining physician reported that, on the morning of May 25, the resident was confused and had abdominal distention.  Upon examination, R4’s abdomen was “diffusely distended and tender.”  P. Ex. 30 at 103.

The evidence establishes that staff reported a problem with R4’s bladder on the morning of May 25.  However, the nurse’s assessment of a change in the resident’s condition is inadequate and inaccurate.  In a confusing and inconsistent report, the LVN indicates that R4’s condition changed that morning.  Asked whether the resident’s signs or symptoms have gotten worse, better, or stayed the same, the LVN responded, “Unable to determine.”  Asked to explain why the reviewer was unable to determine, the LVN did

Page 19

not respond.  Asked whether the symptom or sign had occurred before, the reviewer answered “unknown.”  CMS Ex. 6 at 2.

Summarizing his observations, evaluation, and recommendations, the LVN described the resident’s *increased confusion*, *lethargy*, and *abdominal enlargement*.  He notified Dr. Lisa Ma, the resident’s physician, who ordered a bladder scan and directed the nurse to insert a Foley catheter, as needed.  According to the report, the resident had more than 1,000 ml of urine in his bladder (which would indicate more than a full bladder).  A registered nurse attempted to insert a Foley catheter but was unable to get urine.  Staff notified Dr. Ma, who ordered that R4 be transferred to the hospital.  CMS Ex. 6 at 2; CMS Ex. 7; *see* CMS Ex. 14 at 23, 25; P. Ex. 30 at 95.

Notwithstanding his reporting that the resident exhibited *increased confusion and lethargy*, the LVN checked “no changes observed” regarding R4’s mental health status.  Even though the nurse reported “increased confusion,” he did not even check “increased confusion,” which was one of the options on the form.  *Id*.  On the other hand, under “functional status changes,” the LVN reported a change in R4’s level of consciousness (LOC) and increased confusion.  CMS Ex. 6 at 2-3.

The LVN reported that R4 was experiencing abdominal tenderness, which the nurse described as “persistent discomfort not associated with other acute symptoms.”  CMS Ex. 6 at 6.  The nurse described decreased urine output, either over the last 1-2 days or a new onset of “post-void residual” greater than 400 cc.  *Id*.  According to the report, a pain assessment is relevant to the resident’s change in condition.  Yet, notwithstanding the resident’s “abdominal tenderness” and “persistent discomfort,” the LVN checked that the resident had no pain.  CMS Ex. 6 at 7.

A May 25 nurse’s note indicates that, at 10:30 a.m., the nurse noted “increased confusion, lethargic, and has abdominal enlargement.”  The nurse inserted a Foley catheter but was unable to get urine.  The nurse notified R4’s physician, who ordered the resident transferred to the hospital.  CMS Ex. 14 at 23, 24, 25.

Hospital records underscore that facility staff had improperly assessed the resident’s condition, including his level of pain.  R4 was admitted to the emergency department and diagnosed with obstructive uropathy, which means that urine cannot flow through the urethra due to an obstruction.  The emergency department reported that R4 had *become confused* and his *abdomen distended*“since yesterday.”  CMS Ex. 5 at 11.  R4 was also experiencing rapid, shallow breathing (tachypneic).  *He had abdominal pain*.  A CT scan of his abdomen and pelvis showed severe bladder dilation.  “[G]iven concerns for bladder rupture,” a urinary catheter was immediately placed, and *seven liters* of urine were drained, initially dark yellow, then bloody.  CMS Ex. 5 at 13-15; P. Ex. 31 at 5, 6, 10, 12.  This is *seven times* the bladder’s maximum capacity.  CMS Ex. 23 at 4 (Haig Decl. ¶ 12).

Page 20

The color of the urine (dark) is consistent with urinary retention “over the course of [R4’s] stay” in the facility.  CMS Ex. 23 at 6 (Haig Decl. ¶ 21).

Petitioner accuses CMS and its witness, Andrew J. Haig, M.D., of exaggerating the amount of urine drained from R4’s bladder, pointing out that, initially, “only” 5.2 liters of urine were drained.  Even if Petitioner were correct, the fact that the resident’s bladder was holding substantially more than five times its capacity, putting it in danger of a rupture, hardly strengthens Petitioner’s case.10

In any event, the medical evidence establishes that R4’s bladder held *more* than 5.2 liters of urine.  After the Foley catheter was placed, the resident put out 5.2 liters of urine.  Medical staff then clamped the catheter, not because R4’s bladder was empty but because they were concerned about “likely post-obstructive diuresis.”  CMS Ex. 5 at 15.  Post-obstructive diuresis is an abnormal prolonged polyuria (excessive urination), involving both excessive salt and water loss, after the acute drainage and decompression of a distended bladder, typically (as here) from urinary retention.  Tr. at 23-25.  After several hours, an additional 2.4 liters of urine was collected.  CMS Ex. 5 at 15; *see* P. Ex. 31 at 20 (indicating that R4 was administered normal saline because he was “putting out significant amounts of urine”).

R4’s bladder held many times its maximum capacity of urine and was on the verge of bursting.  He required catheterization.  Yet, he told hospital personnel that he did not have a problem with voiding.  Consultant Capela asserted that “this was [R4’s] personal assessment of his own body’s function and is consistent with documentation of the nursing staff.”  P. Ex. 34 at 7 (Capela Decl. ¶ 20).  It may have been R4’s personal assessment, which the facility nurses accepted, without further inquiry, but it could not have been accurate.  An individual who has no problems voiding does not end up with a bladder so full of urine that is on the verge of bursting and a diagnosis of acute renal failure due to obstructive uropathy.  The hospital physician obviously did not believe R4 because the physician listed as R4’s chief complaint “unable to void.”  P. Ex. 31 at 27.  I find the hospital physician the more credible of the two.

That R4 made this claim underscores that he could not reliably describe his condition. That facility staff accepted it shows that they did not accurately assess his condition.  That Consultant Capela accepted it so uncritically undermines the reliability of her opinions.  *See W. Texas LTC Partners, Inc.*, DAB No. 2652 at 15.

Page 21

Draining R4’s bladder relieved the distension, and R4’s respiratory distress resolved.  He had, however, suffered acute renal failure with hyperkalemia (high level of potassium in the blood).11  CMS Ex. 5 at 14, 29.  The urine had flowed backward (refluxes) into the kidneys.  CMS Ex. 1 at 5.  The physician attributed R4’s *initial confusion* to uremia (high levels of waste products in the blood).  CMS Ex. 5 at 14.

R4 was also suffering from severe constipation.  CMS Ex. 5 at 29.  A CT scan showed “a significant fecal impaction in the rectum.”  CMS Ex. 5 at 15, 21; P. Ex. 31 at 19.

I do not accept Petitioner’s argument that R4 was drinking normally and voiding normally right up to the morning of May 25, when his bladder was suddenly on the verge of bursting.  If he were truly ingesting 430 to 720 cc’s of liquid per day and voiding normally, as Petitioner claims (P. Reply at 7), how did he suddenly accumulate between 5,200 cc’s (5.2 liters) and 7,600 cc’s (7.6 liters) of urine overnight?  The answer is that he did not.  The urine had been accumulating over time.

It is almost certain that R4’s extreme bladder distension caused him pain.  However, because their pain assessments were so superficial, nursing staff did not recognize, analyze, and treat the pain that was caused by stretching R4’s bladder to many times beyond its maximum capacity.  CMS Ex. 23 at 4 (Haig Decl. ¶ 12); *see* Tr. at 21 (conceding that pain can be a symptom of a distended bladder); Tr. at 25 (agreeing that R4 experienced pain resulting from his obstructive uropathy).

Petitioner, however, continues to deny that R4 suffered abdominal pain.  The record – including the facility’s own assessment – establishes otherwise.  Although the facility LVN checked that R4 had no pain (CMS Ex. 5 at 7), that conclusion is belied by the nurse’s more specific descriptions of “abdominal tenderness” and “persistent discomfort.”  CMS Ex. 6 at 6.  Hospital records confirm that R4’s “abdominal tenderness” and “persistent discomfort” were pain.  CMS Ex. 5 at 13, 15, 27.

Because staff did not adequately assess R4’s pain related to his bladder distention, the facility was not in substantial compliance with section 483.25(k).

***2. The penalties imposed 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,

Page 22

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).

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)).

Here, CMS imposes a per-instance penalty of $11,715, which is in the lower-middle range for per-instance penalties ($2,233 to $22,320).  Originating Case Decision at 2 (efile #1a); *see* 42 C.F.R. §§ 488.408(d), 488.438(a)(2); 45 C.F.R. § 102.3; 85 Fed. Reg. 2869, 2880 (January 17, 2020).  Considering what CMS might have imposed – a comparable per-day penalty for days of substantial noncompliance – this penalty is modest.  *See Plum City Care Ctr.*, DAB No. 2272 at 18-19 (2009) (observing that even the maximum per-instance CMP can be “a modest penalty when compared to what CMS might have imposed”).

Except to argue that it was in substantial compliance, Petitioner has come forward with no argument or evidence to establish that the penalty imposed is unreasonable.

In any event, applying the section 488.438(f) factors more than justifies the penalty.  The facility has a less than stellar history:

For the survey completed in September 2019, the facility was not in substantial compliance with multiple health and life safety requirements, including one quality-of-care requirement (failing to prevent accidents), which was cited at scope and severity level E (pattern of noncompliance that causes no actual harm, with the potential for more than minimal harm) and two deficiencies related to the facility’s administering unnecessary medications and inadequate pharmacy services. CMS Ex. 25 at 3-6.
	Similarly, for the survey completed in September 2018, the facility was not in substantial compliance with multiple health and life safety requirements,Page 23

including quality-of-care requirements for accident prevention and for treating bowel and bladder incontinence. It was also cited for problems with pharmacy services and for providing unnecessary drugs (as occurred here).  *Id*.

The facility’s history thus justifies increasing the penalties above the minimum.

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

Applying the remaining factors, as the above discussion shows, nursing staff failed to assess adequately R4’s pain, which demonstrates a disregard for his care, comfort, and safety, for which the facility is culpable.  Such culpability justifies the relatively modest $11,715 per-instance penalty.

**Conclusion**

The facility was not in substantial compliance with Medicare program requirements governing quality-of-care:  pain management, 42 C.F.R. § 483.25(k).  The penalty imposed – $11,715 per instance – is not unreasonable.

1  Following a second survey, completed on October 20, 2020, CMS found that the facility was not in substantial compliance with 42 C.F.R. § 483.80(a) (Tag F880) (infection control – prevention and control program), cited at scope and severity level D (isolated instance of substantial noncompliance that causes no actual harm, with the potential for more than minimal harm).  Originating Case Decision at 2 (e-file #1a).  Petitioner has not appealed those survey findings, which are therefore final and binding.  P. Br. at 2; 42 C.F.R. § 498.20(b).

2  Penalties are inflation-adjusted and change annually (more or less).  The amount is determined as of the date the penalty is assessed, in this case, on April 13, 2021.  Originating Case Decision (e-file #1a); 42 C.F.R. §§ 488.408(d), 488.438; 45 C.F.R. § 102.3; 85 Fed. Reg. 2869, 2880 (Jan. 17, 2020).

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

4  R4’s high-grade B-cell lymphoma may have caused the pathologic tibia fracture.   CMS Ex. 5 at 209.

5  The facility rated pain on a scale of 0 to 10, with 0 representing no pain, and 10 representing the worst possible pain.  CMS Ex. 23 at 4 (Haig Decl. ¶ 16).

6  Hydrocodone-acetaminophen’s side effects include:  drowsiness, sleepiness, stomach pain, dry mouth, muscle tightening, and constipation.  Administering the medication to a resident who has no complaints of pain can also make it more difficult to diagnose the resident’s underlying condition.  Tr. at 8-10.

7  I discuss separately, below, the circumstances surrounding R4’s bladder distention and fecal impaction.

8  I am not required to accept opinions that do not accurately reflect the underlying evidence.  *See W. Tex. LTC Partners, Inc.*, DAB No. 2652 at 15 (2015); *Guardian Healthcare Ctr.*, DAB No. 1943 at 13 (citing *Shaw by Strain v. Stackhouse*, 920 F.2d 1135, 1144 (1990) (expert affidavits that are conclusory and lacking in specific facts are insufficient to create a genuine factual dispute)).  Nor am I bound to accept the witness’s legal conclusions.  *See*, *e.g.*, *Beatrice State Development Ctr*. at 12-14 (affirming that the ALJ decides the legal issues).

9  CMS and Dr. Haig challenged the reliability of these records, and no facility witness came forward to defend them.  Petitioner’s witnesses simply accepted them as accurate, even the May 25 entries, which were directly contradicted by other records and could not possibly have been accurate.  *See also* CMS Ex. 16 at 3 (reporting R4’s temperature, even though he had left the facility two hours earlier).

10  Normal bladder capacity is less than one liter; it is about 450 cc to 500 cc.  Stephen W. Leslie; Hussain Sajjad; Sandeep Sharma, *Postobstructive Diuresis,*National Library of Medicine (May 3, 2023, 1:45 PM), https://www.ncbi.nlm.nih.gov/books/NBK459387.  There are 1,000 cc’s (cubic centimeters) in a liter.  Concerns arise after the amount of urine in the bladder exceeds a liter.

11  Hyperkalemia can cause life-threatening cardiac arrhythmias, muscle weakness, or paralysis.  Fortunately, R4 suffered no EKG changes.  CMS Ex. 5 at 14.
  
          /s/
        Carolyn Cozad Hughes

                      Administrative Law Judge Back to top
    Contact HHS
    
                        
                                            
      
      
      Careers
    
                        
                                            
      
      
      HHS FAQs
    
                        
                                            
      
      
      Nondiscrimination NoticeHHS Archive
    
                        
                                            
      
      
      Accessibility Statement
    
                        
                                            
      
      
      Privacy Policy
    
                        
                                            
      
      
      Viewers & PlayersBudget/Performance
    
                        
                                            
      
      
      Inspector General
    
                        
                                            
      
      
      Web Site Disclaimers
    
                        
                                            
      
      
      EEO/No Fear ActFOIA
    
                        
                                            
      
      
      The White House
    
                        
                                            
      
      
      USA.gov
    
                        
                                            
      
      
      Vulnerability Disclosure Policy
        Sign Up for Email Updates

Receive the latest updates from the Secretary, Blogs, and News Releases.

Sign Up
  HHS Headquarters
          200 Independence Avenue, S.W.
                  Washington, D.C. 20201
                  Toll Free Call Center: 1-877-696-6775​ Disclaimer Policy: Links with this icon () mean that you are leaving the HHS website. The Department of Health and Human Services (HHS) cannot guarantee the accuracy of a non-federal website.
                  Linking to a non-federal website does not mean that HHS or its employees endorse the sponsors, information, or products presented on the website. HHS links outside of itself to provide you with further information.
                  You will be bound by the destination website's privacy policy and/or terms of service when you follow the link.
                  HHS is not responsible for Section 508 compliance (accessibility) on private websites. For more information on HHS's web notification policies, see Website Disclaimers.
 Continue
                  Go back