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
                              2022
                              Palolo Chinese Home, DAB CR6189 (2022)
 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

                    




Palolo Chinese Home, DAB CR6189 (2022)








  
  
    

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





Palolo Chinese Home
(CCN: 125059),
Petitioner,

v.

Centers for Medicare & Medicaid Services.
Docket No. C-21-147Decision No. CR6189November 14, 2022

        
              
    

      DECISION

Palolo Chinese Home (Petitioner or facility) is a nursing facility, located in Honolulu, Hawaii, that participates in the Medicare program.  Based on a survey completed on June 23, 2020, the Centers for Medicare & Medicaid Services (CMS) determined that the facility was not in substantial compliance with program participation requirements and imposed a $725.00 per-day civil money penalty (CMP), beginning on June 22, 2020 and continuing through August 25, 2020, for a total amount of $47,125.00.  On August 11, 2022, CMS notified Petitioner that it had revised the date that the facility returned to substantial compliance to July 27, 2020, with a resulting change in the CMP to $25,375.00.  Petitioner here challenges those determinations and filed a request for hearing on November 12, 2020.

For the reasons discussed below, I find that the facility was not in substantial compliance with Medicare requirements set forth in 42 C.F.R. § 483.10(a)(1)(2), (b)(1)(2), 42 C.F.R. § 483.12(a)(1), 42 C.F.R. §§ 483.10(e)(1), 483.12(a)(2), and 42 C.F.R. § 483.40(d), and I affirm, as reasonable, the imposition of a $25,375.00 CMP.

**Page 2**

I.      Background

The Social Security Act (Act) sets forth requirements for nursing facility participation in the Medicare program and authorizes the Secretary of Health and Human Services (Secretary) to promulgate regulations implementing the 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 with program participation requirements.  Act § 1864(a); 42 C.F.R. § 488.20.  The regulations require that each facility be surveyed once every twelve months, and 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.

In this case, surveyors from the Hawaii State Department of Health, Office of Health Care Assurance-Medicare Section (State Survey Agency) completed an abbreviated survey on June 23, 2020.  CMS Ex. 2 at 1.  Based on the survey findings, CMS determined that the facility was not in substantial compliance with federal requirements for nursing homes participating in the Medicare and Medicaid programs.  Specifically, CMS found that the facility did not meet federal requirements under:  42 C.F.R. § 483.10(a)(1)(2), (b)(1)(2) (Tag F550 – Resident Rights/Exercise of Rights); 42 C.F.R. § 483.12(a)(1) (Tag 600 – Free from Abuse and Neglect); 42 C.F.R. §§ 483.10(e)(1), 483.12(a)(2) (Tag F604 – Right to be Free from Physical Restraints); and 42 C.F.R. § 483.40(d) (Tag 745 – Provision of Medically Related Social Service).  CMS Ex. 1.  CMS imposed a CMP of $725.00 per day for the period from June 22, 2020, the first day of the abbreviated survey, continuing through August 25, 2020, for a total amount of $47,125.00.  CMS Ex. 2 at 2.  Petitioner timely requested a hearing.

On November 13, 2020, Judge Leslie A. Weyn issued an Acknowledgment and Prehearing Order, setting forth prehearing procedures.1  Both parties filed their prehearing exchanges, including prehearing briefs.  In its exchange, CMS filed a motion for summary judgment (CMS Br.).  Petitioner filed a responsive brief, in which it opposed summary judgment (P. Br.).  With its motion and brief, CMS submitted 14 proposed exhibits, including the written direct testimony of one witness (CMS Exs. 1‐14).  With its response, Petitioner submitted seven proposed exhibits, including the written direct testimony of two witnesses (P. Exs. 1-7).  Petitioner filed a request to

**Page 3**

cross‐examine the witness identified by CMS and additionally requested to cross-examine State Survey Agency Chief Keith R. Ridley as a hostile witness.  CMS filed a request to cross-examine Petitioner’s proposed witnesses and objected to the inclusion of Keith R. Ridley as a hostile witness.

I held a prehearing conference on April 14, 2022.  In an Order dated April 15, 2022, I summarized the discussions that took place during the prehearing conference.  During the prehearing conference, the parties did not dispute my framing of the issues as to whether Petitioner failed to comply with the aforementioned participation requirements, when the facility returned to substantial compliance, and whether the CMP was reasonable.  I denied CMS’s motion for summary judgment on the basis that I believed there were genuine issues of material fact in dispute.  As neither party objected to any of the proposed exhibits, I admitted CMS Exs. 1-14 and P. Exs. 1-7 into the record.2  I denied Petitioner’s motion to cross-examine Mr. Ridley as a hostile witness on the basis of lack of relevance to the issues before me.  I explained that the quality of the inspection is immaterial because the compliance issues presented are ones that the Administrative Law Judge (ALJ) decides de novo based on the evidence presented by the parties to the ALJ.  *See* *Lifehouse of Riverside* *Healthcare Ctr.*, DAB No. 2774 at 13-14 (2017).  CMS’s case must stand or fall on the evidence it presents to the ALJ.  As the Departmental Appeals Board (Board) has stated, “an ALJ hearing is not a ‘review of how or why CMS decided to impose remedies,’ nor is it ‘restricted to the facts or evidence that were available to CMS when it made its decision.’  Rather, the ALJ hearing provides a fresh look by a neutral decision-maker at the legal and factual basis for the deficiency findings underlying the remedies.”  *Oaks of Mid City Nursing & Rehab. Ctr.,* DAB No. 2375 at 33 (2011) (citing *Britthaven of Chapel Hill*, DAB No. 2284 at 6 (2009) (citations and internal quotations omitted)).

On July 28, 2022, I convened a video-teleconference hearing for the purpose of allowing cross-examination of CMS witness, Barbara Pennial, R.N., M.S., and Petitioner’s witnesses, Darin Yoshimoto, Administrator, and Susanna Arai, R.N., Assistant Director of Nursing (ADON).  Based on that testimony, CMS Ex. 9 and P. Exs. 1 and 6 were admitted.  The parties stipulated to the admission of CMS Ex. 15, a Notice of Correction by CMS dated August 11, 2022.  Transcript (Tr.) at 6.  The notice informed Petitioner that CMS had revised the date that the facility returned to substantial compliance to July 27, 2020, reducing the CMP to $25,375.00.  CMS Ex. 15; *see also*Tr. at 6.  After the hearing, the parties submitted post-hearing briefs.  (P. PH Br. and CMS PH Br.).  The record is closed and the case is ready for a decision on the merits.

**Page 4**

II.     Issues

On the merits, the issues before me are:  1) whether the facility was in substantial compliance with 42 C.F.R. § 483.10(a)(1)(2), (b)(1)(2), 42 C.F.R. § 483.12(a)(1), 42 C.F.R. §§ 483.10(e)(1), 483.12(a)(2), and 42 C.F.R. § 483.40(d); (2) if the facility is found not to be in substantial compliance, when did it return to substantial compliance; and (3) if the facility was not in substantial compliance, is the penalty imposed, a $725.00 per-day CMP, for a total of $25,375.00, reasonable?

It is also necessary to identify the issues that are not before me for adjudication.  In the Request for Hearing, Petitioner argued that “the assignment of three ‘G’ level ratings and one ‘D’ level rating to four alleged deficiencies was clearly erroneous.”  Request for Hearing at 1.3  In its post-hearing brief, Petitioner asserts that “the ALJ must reduce the deficiencies to Severity Level 1 or scope/severity ‘A’” because of the lack of evidence of actual or potential for more than minimal harm.  P. PH Br. at 9.  However, I have no authority to review CMS’s determination of the level of noncompliance in this case.  I may review CMS’s scope and severity findings only 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); *NMS Healthcare of Hagerstown*, DAB No. 2603 at 6-7 (2014); *Cedar Lake Nursing Home*, DAB No. 2344 at 9 (2010); *Heritage Park Rehab. & Nursing Ctr*., DAB No. 2231 at 15- 16 (2009).

The assessed per-day penalty in this case of $725.00 is already in the lower range of per day penalties, as defined in 42 C.F.R. § 488.438(a)(ii), so the level of noncompliance here does not affect the range of the CMP.  While there is no evidence of a nurse aide training program here, if I approve a penalty of $25,375.00 or more, which I do, CMS’s scope and severity finding will not affect approval of the facility’s nurse aide training program.  Under the statute and regulations, the State Survey Agency cannot approve the program if CMS imposes a penalty of $5,000.00, as adjusted annually, or more.  Act § 1819(f)(2)(B); 42 C.F.R. § 483.151(b)(2)(iv); 82 Fed. Reg. at 9174, 9188 (Feb. 3, 2017).  As a result, the scope and severity findings are not subject to review in this adjudication.

**Page 5**

III.    Discussion

******The facility was not in substantial compliance with 42 C.F.R. §§ 483.10(e)(1) and 483.12(a)(2).***4***These facts are not in dispute.  On June 16, 2020, Resident #1 (R1) was a 98-year-old woman with a diagnosis of vascular dementia with behavioral disturbance, including combative behaviors, such as yelling, kicking, spitting, biting, hair pulling, and throwing objects during care administration.  CMS Ex. 5 at 1, 21, 26, 34.  She had impaired functional mobility, was unable to ambulate, and required assistance for activities of daily living but was frequently not cooperative.  CMS Ex. 7 at 1.  She was incontinent of bowel and bladder with resulting risk of impaired skin integrity.  CMS Ex. 7 at 6.  According to a Social Services evaluation in January 2020, “Resident’s combative behavior is her baseline.”  CMS Ex. 5 at 42.  Because of the agitation and associated refusal of care, the care plan contained provisions to keep her routine consistent, provide consistent care givers to decrease confusion, explain procedures before touching her, and leave the resident and return in 30 minutes if she refused care.  CMS Ex. 7 at 1, 4, 9, 11-15.

At approximately 4:45 AM on June 16, 2020, two certified nursing assistants (CNAs) entered R1’s room to provide care.5  CMS Ex. 12 at 1, 2.  After being awakened at that time, R1 began yelling, “Get out, get out!”  CMS Ex. 12 at 2; CMS Ex. 13 at 2.  According to the statement of the involved male CNA, R1 began yelling, spitting and scratching and so, to protect himself, he tied the long sleeves of her jacket together.  CMS Ex. 13 at 4.  Subsequent investigation established that the female CNA had also been in the room and she was the one who tied R1’s sleeves together.6  P. Ex. 6 at 10; P. Ex. 1 at 12-13.  R1’s hands remained tied during incontinence care and while being placed in a wheelchair to complete the morning care routine.  P. Br. at 5; CMS Ex. 12 at 2; *see also* CMS Ex. 13 at 3.  A Registered Nurse (RN) overheard yelling and entered the room.  CMS Ex. 13 at 1.  She observed R1 in the wheelchair with her sleeves tied together while

**Page 6**

the CNA was combing her hair.  *Id*.  The RN untied R1, assessed her for injuries, and took her outside, where she was observed to be banging on a table and throwing a tissue box.  *Id*.

Congress has placed strict limitations on the use of restraints by a facility.  The use of restraints has been associated with numerous negative outcomes, such as emotional desolation, agitation, fractures, chafing, burns, nerve damage, circulatory impairment, decubitus ulcers, strangulation, and death.  *Cross Creek Health Care Ctr.*, DAB No. 1665 at 6 (1998) (citing 57 Fed. Reg. 27,397, 27,398 (June 19, 1992)).  Driven by such concerns, the Omnibus Budget Reconciliation Act of 1987 (Pub. L. 100-203) amended section 1819 of the Act to address the use of restraints directly.  The statute *expressly* required Medicare skilled nursing facilities to protect and promote the residents’ freedom from restraints.  Section 1819(c)(1)(A)(ii) established “[t]he right to be free from physical and mental abuse, corporal punishment, involuntary seclusion and any physical or chemical restraints . . . not required to treat the resident’s medical symptoms.”  Congress explicitly required that skilled nursing facilities protect and promote the rights of each resident “to be free from any physical or chemical restraints imposed for purposes of discipline or convenience and not required to treat the resident’s medical symptoms.”  Restraints may only be imposed “to ensure the physical safety of the resident or other residents,” and, except in an emergency, only upon the written order of a physician that “specifies the duration and circumstances under which the restraints are to be used.”  Act § 1819(c)(1)(A)(ii).

In implementing these provisions of the Act, 42 C.F.R. § 483.10(e)(1) provides that the resident has a right to be treated with respect and dignity, including:

**(1)** The right to be free from any physical or chemical restraints imposed for purposes of discipline or convenience, and not required to treat the resident's medical symptoms, consistent with § 483.12(a)(2).

42 C.F.R. § 483.12(a)(2) similarly indicates that the facility must:

**(2)** Ensure that the resident is free from physical or chemical restraints imposed for purposes of discipline or convenience and that are not required to treat the resident's medical symptoms. When the use of restraints is indicated, the facility must use the least restrictive alternative for the least amount of time and document ongoing re-evaluation of the need for restraints.

As the Board has noted, these regulations impose on the facility an independent obligation to ensure that its use of restraints, even with a doctor’s order, meets the regulatory criteria.  *Cross Creek*, DAB No. 1665 at 11.

**Page 7**

Petitioner has established a policy regarding the use of restraints.  In the policy statement entitled PALOLO CHINESE HOME FACILITY POLICY/PROCEDURE, the facility affirmed the right of the resident “to be free from any physical or chemical restraints administered for the purpose of discipline or convenience.”  CMS Ex. 4 at 1.  The policy statement does indicate that “restraints may be used for the purposes of protection and/or for safety reasons.”  *Id*.  However, the policy statement further specifies that “[t]he decision to apply restraints is based on clinical assessment and the care plan process” with a “comprehensive assessment of the resident’s level of function, the identification of any pre-existing medical conditions or safety needs, the consideration of any physical disabilities or limitations and the evaluation of the least restrictive alternatives or interventions.”  *Id*.  Hence, under the statute, regulations, and facility policy, use of restraints on a resident is permissible only if necessary to treat a medical condition or for protection or safety reasons.

Petitioner somewhat concedes that R1 was restrained.  It puts forward, however, several arguments as to why this action should not be considered a deficiency.  Petitioner initially argues that the restraint was applied because the involved staff “believed the situation dangerous enough to require such action to prevent R1 from hurting herself or them, and so they could safely and timely provide incontinent care in accordance with R1’s care plan.”  P. Br. at 4.  In its post-hearing brief, Petitioner asserts that “the objective of CNA2(F)’s actions followed R1’s Care Plan by keeping her safe from self-injury and treating R1’s incontinence in a timely manner to avoid potentially unsafe skin infection and degradation.”  P. PH Br. at 11.  Petitioner reinforces the argument that somehow this action was in accordance with the care plan by noting that “[w]hen faced with seconds to decide (1) how to protect R1 from inflicting self-injury, (2) how to prevent injury to R1’s own caretakers, and (3) whether to allow R1 to remain in her soiled diaper for longer than the timeframe recommended by the Care Plan, CNA2(F) calculated her actions as necessary to comply with R1’s Care Plan and keep R1 safe.”  *Id*.

There is nothing in this record to establish that restraints were required to treat any of R1’s medical symptoms.  A review of the care plan does not contain *any* indication that any of her symptoms required restraints to be successfully treated.  Moreover, there is nothing in the care plan to indicate that a “comprehensive assessment” of the need for restraints was ever conducted.  Thus, the care plan provided no support for the argument that the use of restraints was necessary and authorized in the care plan for the purpose of avoiding skin irritation from incontinence.

Petitioner concurrently raises the argument that the use of restraints was for the safety of the staff or the resident.  It asserts that “[t]o prevent R1 from causing injury to herself, and to protect themselves from injury by R1, CNA2(F) tied together the sleeves of a zip‐up jacket worn by R1.  CNA1(M) and CNA2(F) believed the situation dangerous enough to require such action to prevent R1 from hurting herself or them, and so they

**Page 8**

could safely and timely provide incontinent care in accordance with R1’s care plan.”  P. Br. at 4.

To be sure, as noted above, the facility policy does contain a provision for the use of restraints in emergency or dangerous circumstances.  It indicates that an “emergency restraint is used in the event that the resident is in a perilous situation causing harm or imminent danger to self or others.”  CMS Ex. 4 at 3.  However, a delay in providing incontinence care cannot be considered an emergency or a perilous situation likely to cause imminent danger to R1.  Moreover, the continued use of the restraints while combing R1’s hair would further negate any such implication.  In addition, even under emergency or dangerous circumstances, which are not documented in this record, the authority to apply an emergency restraint is given to the “licensed nursing staff.”  *Id*.  The facility’s own policy does not authorize a CNA, even in an emergency situation, to apply a restraint.  And, while there certainly could be a risk of injury to staff and R1 from the behavioral outbursts, the intervention specified in the care plan was to leave for 30 minutes and then return, rather than restraining the resident.7

Petitioner’s other argument on this issue is that, while there was a deficiency, there was no evidence of actual harm or the potential to cause more than minimal harm from the use of the restraint; the necessary elements for a finding of not being in “substantial compliance.”  *See* 42 C.F.R. § 488.301.  It asserts that “the record does not contain the necessary proof to support a severity level that indicates R1 suffered a potential for more than minimal harm, let alone actual harm, as a result of the incident.”  P. PH Br. at 17.

Petitioner is correct that a “deficiency” – that is, a violation of a participation requirement – constitutes “noncompliance” (lack of substantial compliance) only if it causes actual harm or the potential for more than minimal harm.  *See Kindred Transitional Care and Rehab – Greenfield*, DAB No. 2792 at 2, 10 (2017); *Liberty Commons Nursing and Rehab – Alamance*, DAB No. 2070 at 10 (2007), *aff’d, Liberty Commons Nursing & Rehab. Ctr.– Alamance v. Leavitt*, 285 F. App’x 37 (4th Cir. 2008).  However, proof that a deficiency resulted in actual harm is unnecessary; CMS need only show that a deficiency created a “potential” to cause more than minimal harm in order to find a skilled nursing facility (SNF) out of substantial compliance.*Oak Ridge Ctr.*, DAB No. 2913 at 29 (2018) (citing *Lakeport Skilled Nursing Ctr*., DAB No. 2435 at 5 (2012)).

**Page 9**

Petitioner characterizes the incident as an “intervention,” which consisted of “(tying the soft sleeves of a jacket) was brief, involved no physical harm, and affected only the resident’s ability to swing her arms to hit or scratch herself and the two CNAs providing care.  Neither CNA1(M) nor CNA2(F) hit or degraded R1.  As discussed infra, there is no evidence from which a reasonable factfinder could conclude the intervention caused R1 any additional agitation or physical or psychosocial harm following the incident.”  P. Br. at 15-16.  In its post-hearing brief, Petitioner argues that there is no “evidence of actual harm or the potential for more than minimal harm” from what it characterizes as the “isolated nature of the incident.”  P. PH Br. at 9.

Petitioner acknowledges that R1 had experienced “physical, mental, and behavioral decline” following the restraint incident but attributed this to the progression of the dementia and the increased frequency of monitoring performed after the incident, “which necessarily resulted in increased recorded behaviors post-incident.”  P. PH Br. at 10.  This position is echoed by a statement from the ADON that, even with higher number of entries secondary to R1’s placement on an alert charting system, “the Interdisciplinary Team did not detect any changes in R1’s behavior linked to the incident.”  P. Ex. 6 at 7.  Similarly, the Administrator indicated the “Interdisciplinary Team did not detect any changes in R1’s behavior linked to the incident” following the increased monitoring.  P. Ex. 1 at 9.

The nursing records suggest otherwise.  During the five days prior to the incident on June 16, 2020, from June 10, 2020 through June 15, 2020, R1 refused a meal five times, with one response of Not Applicable, which is presumed to indicate she was not served a meal.  P. Ex. 4 at 10.  Following the incident on June 16, 2020, she refused all meals on June 19, 2020, June 21, 2020, and June 22, 2020, and ate only 25% or less of only one meal on June 20, 2020.  P. Ex. 4 at 10-11.  A similar trend is seen in the Behavioral Log, contained in CMS Ex. 14.  In the week prior to the June 16, 2020 restraint incident, there were four reported episodes of yelling, two episodes of combative behavior, and four refusals of care.  CMS Ex. 14.  In the six days after the incident on June 16, 2020, there were nine episodes of yelling, 18 episodes of combative behavior, and 15 refusals of care.  CMS Ex. 14.  These objective records document a significant change in R1’s behavior following the restraint episode on June 16, 2020.  It was the opinion of Ms. Pennial, the surveyor, that “[w]ithout the ability to communicate her feelings directly, an increase in these behaviors can indicate that Resident 1 suffered emotional or psychological harm and is trying to express those feelings.”  CMS Ex. 9 at 8.  This opinion is given great weight because of Ms. Pennial’s specialized background and the fact that it was not countered by evidence suggesting otherwise.

As noted earlier, Petitioner argued that the increased behaviors were merely the result of increased monitoring and the progression of the dementia.  P. PH Br. at 10; P. Br. at 7.  The ADON stated that “R1’s name entry on the Alert Log, as of June 16, 2020, directed staff to increase observation frequency for R1 to day, evening, and overnight shifts for

**Page 10**

seven days and to record all behaviors by R1 (as opposed to the normal procedural standards of recording only exceptions), even if such behaviors are normally considered baseline.”  P. Ex. 6 at 6.  Petitioner’s argument seems to be that the increased behaviors recorded after the June 16, 2020 restraint incident would not be reliable indications of increased stress or anxiety because earlier such behaviors, characterized as R1’s baseline behaviors, would not normally be recorded by staff.  However, the written record again suggests otherwise.  The Behavioral Log contained in CMS Ex. 14 clearly demonstrates monitoring three times a day, with ongoing documentation of yelling, combativeness, and refusal of care prior to the June 16, 2020 restraint incident.  Thus, it cannot be said that the facility records did not record R1’s baseline behaviors prior to the incident on June 16, 2020.  They were recorded on a daily basis so the increase in those behaviors after June 16, 2020 is consistent with evidence of actual harm resulting from the incident.  Moreover, the fact that R1’s dementia was apparently progressing does not negate the obvious change in her behaviors *immediately* following the restraint.

R1’s behaviors at the time of the incident and immediately after indicate actual harm.  RN1 reported that she was in the hallway and “[s]uddenly heard someone yelling like someone is upset” and found R1 in a wheelchair with her sleeves tied together.  After untying her and bringing her outside the room, “Resident was upset banging on the table and throwing the tissue box.”  CMS Ex. 13 at 1.  RN1 further stated that she “tried to calm her down but resident was upset.”  CMS Ex. 13 at 1.  In another statement, RN1 indicated that R1 “was really agitated and started to throw her tissue box on [the] table.”  CMS Ex. 13 at 5.  As a result, I find there is evidence of actual harm from the restraint applied on June 16, 2020.

Even assuming that there was no evidence of actual harm to R1, 42 C.F.R. § 488.301 requires only that the identified deficiency pose no greater risk to resident health or safety than the “*potential* for causing minimal harm” in order to find a lack of substantial compliance.  (emphasis added).  Ms. Pennial testified that she applied a reasonable person standard in determining that there was a potential for more than minimal harm.  Petitioner notes that there were revisions to the CMS guidance on applying this standard, which are not yet effective and to apply these revised standards “is unfair to facilities and lacks any element of due process.”  P. PH Br. at 14.  I do not see that the revisions to the guidance, which contains examples of behaviors that might be evidence of more than minimal harm, in any way interferes with Petitioner’s due process rights.  The “reasonable person” standard had been utilized previously in determining the potential for causing minimal harm so the use of this standard should not have come as a surprise to the facility.  Moreover, there is nothing in the revisions that undercuts the surveyor’s conclusion that a reasonable person, in these circumstances, would likely experience more than minimal harm.  It is abundantly clear that the actions of restraining R1 posed a greater risk to resident health or safety than the potential for causing minimal harm.  A reasonable person, being awakened at 4:45 AM for toileting and dressing, being restrained against her will after rejecting this activity, and continuing to be restrained

**Page 11**

while being placed in a wheelchair and having her hair combed, would likely experience more than minimal harm.  When an elderly, confused 98-year-old resident with complicated psychological and behavioral problems was forced to face this situation, more than minimal harm could reasonably be expected.  Accordingly, I find that the facility was not in substantial compliance with 42 C.F.R. §§ 483.10(e)(1) and 483.12(a)(2).

In reaching this conclusion, I further find that CMS has met its burden of establishing a prima facie case that the facility was not in substantial compliance with the relevant statutory and regulatory provisions, and Petitioner has not established by the preponderance of the evidence that it was in substantial compliance.  *Hillman Rehabilitation Ctr.*, DAB No. 1611 at 8 (1997), *aff’d*, *Hillman Rehabilitation Ctr. v. U.S. Dep’t of Health and Human Servs.*, No. 98-3789 (GEB) (D.N.J. May 13, 1999).

***The facility was not in substantial compliance with 42 C.F.R. § 483.12(a)(1).***According to the provisions of 42 C.F.R.§ 483.12, a resident of a nursing facility has “the right to be free from abuse, neglect, misappropriation of resident property, and exploitation as defined in this subpart.  This includes but is not limited to freedom from corporal punishment, involuntary seclusion and any physical or chemical restraint not required to treat the resident’s medical symptoms.”  42 C.F.R. § 483.12(a)(1) stipulates that the facility must:

**(1)** Not use verbal, mental, sexual, or physical abuse, corporal punishment, or involuntary seclusion.

Abuse is defined as “the willful infliction of injury, unreasonable confinement, intimidation, or punishment with resulting physical harm, pain or mental anguish.”  42 C.F.R. § 488.301.  Palolo’s Policy on Abuse, Neglect, Mistreatment and Misappropriation of Resident Property cites the identical definition of abuse.  CMS Ex. 6 at 2.

The phrase “willful infliction” has been interpreted by the Board to mean that the actor must have acted deliberately, not that the actor must have intended to inflict injury or harm.  *Merrimack Cty. Nursing Home*, DAB No. 2424 at 5 (2011); *Britthaven, Inc*., d/b/a *Britthaven of Smithfield*, DAB No. 2018 at 4 (2006).  Palolo’s policy also uses an identical definition of “willful.”  CMS Ex. 6 at 2.

Petitioner does not directly argue that restraining R1 against her will, without authorization or justification in the care plan or its own policies, was not abuse.  Instead, it argues that “CMS’ argument that CNA2(F)’s actions rose to the level of abuse is absurd.  While [Petitioner] does not condone CNA2(F)’s conduct, the taking of an unapproved action to timely address an imminent risk to R1 while protecting both R1 and

**Page 12**

her caregivers is a far cry from the abusive behaviors targeted by the regulations.”  P. PH Br. at 11-12.  As noted above, Petitioner characterizes the restraint as “necessary to comply with R1’s Care Plan and keep R1 safe.”  P. PH Br. at 11.  Petitioner’s argument seems to suggest some kind of sliding scale for evaluating abuse, i.e., unauthorized physical restraints aren’t really abuse if they were applied to help R1 or protect her or someone else.  However, I see no support in the regulation for such an interpretation.  As discussed above, there was no indication in the care plan that a restraint was necessary to provide care to R1, there was nothing that met the definition of an emergency event, and nothing to support the use of restraints in these circumstances.  Petitioner’s act of restraining R1 without authorization constitutes abuse, as defined in 42 C.F.R. § 488.301.

The regulations, furthermore, make it clear that evidence of actual harm is not necessary to establish abuse.  42 C.F.R. § 488.301, in the definition of “Abuse,” states that “[i]nstances of abuse of all residents, irrespective of any mental or physical condition, *cause* physical harm, pain or mental anguish.”  (emphasis added).  Thus, the regulatory definition contains the presumption that abuse causes harm, regardless of the condition of the resident.

As a result, I find that the facility was not in substantial compliance with 42 C.F.R. § 483.12(a)(1).

***The facility was not in substantial compliance with 42 C.F.R. § 483.10(a)(1)(2) and (b)(1)(2).***42 C.F.R. § 483.10 sets forth the rights of a resident in a skilled nursing facility.  Under 42 C.F.R. § 483.10(a), a resident has a right to a dignified existence, self-determination, and communication with and access to persons and services inside and outside the facility, including those specified in this section.  The regulation further states:

**(1)** A facility must treat each resident with respect and dignity and care for each resident in a manner and in an environment that promotes maintenance or enhancement of his or her quality of life, recognizing each resident's individuality. The facility must protect and promote the rights of the resident.

**(2)** The facility must provide equal access to quality care regardless of diagnosis, severity of condition, or payment source. A facility must establish and maintain identical policies and practices regarding transfer, discharge, and the provision of services under the State plan for all residents regardless of payment source.

42 C.F.R. § 483.10(a)(1), (2).

**Page 13**

42 C.F.R. § 483.10(b) provides that a resident has the right to exercise his or her rights as a resident of the facility and as a citizen or resident of the United States.  The regulation further provides:

**(1)** The facility must ensure that the resident can exercise his or her rights without interference, coercion, discrimination, or reprisal from the facility.

**(2)** The resident has the right to be free of interference, coercion, discrimination, and reprisal from the facility in exercising his or her rights and to be supported by the facility in the exercise of his or her rights as required under this subpart.

42 C.F.R. § 483.10(b)(1), (2).

Petitioner had a written policy governing residents’ rights.  CMS Ex. 8.  Included were the residents’ rights to “[n]ot be humiliated, harassed, injured, or threatened,” to “be free from chemical and physical restraints,” and to “[b]e treated with consideration, respect and in full recognition of their dignity and individuality.”  *Id*.  Residents of Palolo also had the right to refuse treatment after being informed of the medical benefits of treatment and the consequences of refusal.  *Id*.

CMS found that Petitioner was not in substantial compliance with the above regulatory provisions because it provided R1 with incontinence care and other routine morning care over her refusals of such care.  Petitioner argues that the conduct of the CNAs in question was not a violation of § 483.12(a)(1), which only prohibits “any physical or chemical restraint **not required to treat the resident’s mental symptoms.”**Request for Hearing at 22 (emphasis in original).  It asserts that, in compliance with the care plan, the CNA’s “timely provision of incontinent care was necessary to treat R1’s urinary and bowel incontinence and her dementia” and the “use of the intervention was to allow her to timely and safely treat R1’s incontinence, and to ameliorate the risk of a dangerous infection and skin degradation associated with non-treatment.”  Request for Hearing at 22-23.

It must first be noted that, consistent with the facility’s own statement of resident rights, R1 had the right to refuse treatment and the right to refuse to be awakened and dressed at 4:45 AM, as acknowledged by the Administrator and ADON in their testimony.  Tr. at 64, 74.  More significantly, under the facility’s own policy, R1 had the right to be free from physical restraints.  That policy did include an exception for use of physical restraints “in an emergency, when necessary, to protect the resident from injury to the resident’s self or others.”  CMS Ex. 8.  However, Petitioner did not and could not plausibly argue that providing incontinence care was an emergency.  Instead, it asserts that the restraint “affected only the resident’s ability to swing her arms to hit or scratch herself and the two CNAs providing care.”  P. Br. at 15.  Presumably, this is presented as an argument that the restraint was necessary to protect the resident or staff from injury.

**Page 14**

However, as discussed above, this was *not* an emergency situation.8  Thus, the restraining of R1 was clearly a violation of her rights under the facility policy.

The restraining of R1 was also a violation of her right to be treated with respect and dignity.  While Petitioner states that the involved CNAs did not degrade her, P. Br. at 16, it is difficult to imagine how else to characterize what happened to R1.  Using Petitioner’s own description of the incident, R1 was awakened at 4:45 AM to receive routine morning care.  She began to yell “Get out, get out,” and started swinging her arms, kicking and spitting.  Her sleeves were tied together to complete incontinence care, and then she was moved to her wheelchair to continue her normal morning care, including combing her hair, all while being restrained and yelling loud enough for a nurse outside the door to hear.  Request for Hearing at 4.  Treating R1 with respect and dignity would have included following the care plan’s interventions of stopping or pausing care when she became agitated or combative and returning later.  CMS Ex. 7 at 4, 9.   Instead, she was restrained and forced to accept care so that the night shift could finish getting everyone up and ready before the day shift started.  CMS Ex. 13 at 3; CMS Ex. 1 at 9.  This was not treating R1 with the dignity and respect to which she was entitled under the regulations and facility policy and constitutes a violation of her rights under 42 C.F.R. § 483.10(a) and (b).

***The facility was not in substantial compliance with 42 C.F.R. § 483.40(d).***42 C.F.R. § 483.40(d), governing behavioral health services, indicates that the facility must provide medically-related social services to attain or maintain the highest practicable physical, mental and psychosocial well-being of each resident.

As discussed above, there was a documented increase in problem behaviors immediately following the restraint incident.  CMS Ex. 14.  Petitioner attributed this to increased monitoring and R1’s continuing decline and asserted there was no actual change in R1’s behaviors.  P. Ex. 1 at 7, 9, 10.  Petitioner’s witnesses both indicated that, “notwithstanding the higher number of entries in R1’s Behavioral Log following the incident due to R1’s temporary placement in [Petitioner’s] Alert Charting System, the Interdisciplinary Team did not detect any changes in R1’s behavior linked to the incident.”  P. Ex. 1 at 9; P. Ex. 6 at 7.  The team was comprised of “[Petitioner’s] management and staff, including, but not limited to, the Director of Nursing, ADON, Administrator, Nurse Managers, [Social Services Coordinator (SSC)], Activity Manager,

**Page 15**

Rehab Director, Business Office, Admissions, and Dieti[t]ian.”9  P. Ex. 1 at 8.  However, the fact that the problem behaviors continued unabated or unimproved indicates increased monitoring alone was not successful in resolving the increased symptoms and the facility’s response was inadequate to “attain or maintain the highest practicable physical, mental and psychosocial well-being” of R1.

CMS argues that there was no evidence that R1 received social services support until nearly a week after the restraint incident.  CMS Br. at 14.  Petitioner asserts that, to the contrary, the record reflects that it constantly assessed and monitored her following the incident to determine if social services or other support was needed, and despite no evidence of such need, ensured she was timely evaluated by its SSC, who also consulted with two Licensed Social Workers and a Psychiatrist Consultant.  P. Br. at 18.

In fact, Petitioner did employ an SSC, whose job description included determining the type of assistance needed by a resident and, as relevant here, investigating alleged abuse.  CMS Ex. 11 at 1.  However, the documentary record belies Petitioner’s statement that, while there was no need for it, R1 was timely evaluated by the SSC.  The SSC was interviewed by the surveyor on June 22, 2020 at 1:30 PM, indicating she was first made aware of the restraint incident two or three days after and “heard it through hearsay.”  CMS Ex. 1 at 29; *see also* CMS Ex. 9 at 9.  She reportedly told the surveyor, after reviewing her job description, that she was supposed to be monitoring residents who were victims of suspected abuse but she “really haven’t done that.”10  *Id*.  It was not until *after* the interview with the surveyor, at 3:39 PM on June 22, 2020, that the SSC “reviewed resident[’]s mood/behavior with Nursing” and “attempted to speak with resident,” who was pulling on the curtain divider and yelled to go away.  CMS Ex. 5 at 1.  During that interview, Nursing reported to the SSC that “resident[’]s behaviors have been increasing with frequency (hitting, spitting, scratching, pulling on hair).”  *Id*.  Despite the reported increased behaviors, it was not until nearly a week after the restraint incident that social services started an evaluation.  This can hardly be considered a “timely” evaluation.  Similarly, the increased behaviors reported by Nursing during the contact with the SSC are not consistent with Petitioner’s statement that there was no evidence of a need for social services support (P. Br. at 18).

Moreover, Petitioner also reported that the SSC had met with two Licensed Social Worker Consultants and a Psychiatrist Consultant but “[n]either the SSC nor the Consultants reported any changes in R1’s mood, behavior, or well-being related to the

**Page 16**

June 16, 2020 incident.”  P. Ex. 1 at 10-11.  It is not possible to know whether this is an accurate statement since the record does not contain any information as to what, if anything, these consultants reported.  In the only apparent record of this assessment, the SSC met with the consultants on June 23, 2020 and “explained the incident that occurred, *increased behaviors*, increase of poor po [by mouth] intake, and some refusals of medications.”  P. Ex. 2 at 1 (emphasis added).  The SSC’s note then indicates that “Dr. Carlton and [Licensed Social Workers] will be writing a review.”  *Id*.  Whether such a review was ever written and, if so, the contents of that review were not indicated in this record.  What this record does demonstrate is that there was an increase in problem behaviors immediately after the restraint incident that was not promptly evaluated with the provision of medically-related social services.  As a result, I find that the facility was not in substantial compliance with 42 C.F.R. § 483.40(d).

***The $725.00 per-day civil money penalty is reasonable.***As noted above, CMS initially imposed a CMP of $725.00 per day11 and determined that Petitioner was not in substantial compliance until August 26, 2020.  CMS Ex. 2 at 2.  With respect to the determination as to when it returned to substantial compliance, Petitioner initially argued that the date should be June 25, 2020, when R1 entered hospice.  Request for Hearing at 28.  It subsequently asserted that “[Petitioner] came into substantial compliance as to all regulatory requirements by June 27, 2020, or at the *latest* by July 27, 2020,” when it submitted its Plan of Correction.  P. Br. at 19, 21 (emphasis in original).  On August 11, 2022, CMS issued a Notice of Correction, determining that the facility was in substantial compliance effective July 27, 2020, reducing the CMP to $25,375.00.  CMS Ex. 15 at 2.  Petitioner has made no further argument with respect to this issue.  *See*P. PH Br.

Regarding the amount of the CMP, I must determine whether a CMP is reasonable by applying the factors listed in 42 C.F.R. § 488.438(f):  1) the facility’s history of noncompliance; 2) the facility’s financial condition; 3) the factors specified in 42 C.F.R. § 488.404; and 4) the facility’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety.  The absence of culpability is not a mitigating factor.  The factors listed in § 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.  Unless a facility

**Page 17**

contends that a particular regulatory factor does not support the CMP amount that CMS proposed, the ALJ must sustain it.  *Coquina Ctr.*, DAB No. 1860 at 32 (2002).

The regulations specify that a per-day CMP will fall into one of two ranges of penalties.  42 C.F.R. §§ 488.408, 488.438.  As relevant here, the lower range of a CMP, $112 to $6,695 per day, is reserved for deficiencies that do not pose immediate jeopardy, but either cause actual harm to residents, or cause no actual harm but have the potential for causing more than minimal harm.  42 C.F.R. § 488.438(a)(1)(ii); *see also*85 Fed. Reg. 2869, 2880 (Jan. 17, 2020).  The reasonableness of a CMP amount is assessed based on the per-day amount, rather than the total accrued CMP.  *See Kenton Healthcare, LLC*, DAB No. 2186 at 28 (2008).  The regulations leave the decision regarding the amount of the remedy to CMS and the ALJ, requiring only that the regulatory factors be considered when determining the amount of a CMP within a particular range.  42 C.F.R. §§ 488.408, 488.408(g)(2), 498.3(d)(11); *see also* 42 C.F.R. § 488.438(e)(2) and (3); *Alexandria Place*, DAB No. 2245 at 27 (2009); *Kenton Healthcare, LLC*, DAB No. 2186 at 28-29.

In this case, considering the relevant factors, I find the penalty is reasonable. First, except to argue that its deficiencies did not rise to the level of even minimal harm, which would make no penalty appropriate, Petitioner does not directly challenge the amount of the per-day penalty.  CMS imposed a CMP of $725.00 per day, which is in the lower third of the available penalty range.

With respect to the regulatory factor of prior noncompliance, Petitioner points to its 5‐star rating by CMS and notes a minimal history of noncompliance.  P. Br. at 22 (citing P. Ex. 1 ¶ 2).  CMS, however, identifies past deficiencies justifying the imposed CMP, which I note include a deficiency in the area of dignity and respect of residents.  CMS Ex. 10 at 2-3.  In regard to consideration of Petitioner’s financial condition, I cannot conclude that this is a reason to reduce the penalty amount in this case.  The record neither contains any information about Petitioner’s financial condition nor has Petitioner even argued that I should consider its financial condition as a basis to reduce the CMP.

Petitioner asserts that mitigating factors, such as self reporting the incident and implementing system wide changes to address it, justify the relief it seeks.  P. PH Br. at 18.  However, the self-report was mandated and the system wide changes it identifies as mitigation were required as part of the POC.  CMS Ex. 9 at 3; CMS Ex. 1. I consider Petitioner to have a medium degree of culpability in this case.  Although the deficiencies cited were not at the immediate jeopardy level, Petitioner’s violations were still significant.  Two of Petitioner’s employees were jointly involved in applying restraints on a resident without any authorization.  The facility did not provide the necessary care and services to its residents, which is central to a facility’s participation in the Medicare program.  Medicare pays for placement in a SNF specifically so that residents can receive the care they need.  Petitioner failed to provide that needed care to

**Page 18**

R1.  Given the above factors, a CMP in the low range of non-immediate jeopardy noncompliance is reasonable.

IV.     Conclusion

For the reasons discussed above, I find that Petitioner was not in substantial compliance with 42 C.F.R. § 483.10(a)(1)(2), (b)(1)(2), 42 C.F.R. § 483.12(a)(1), 42 C.F.R. §§ 483.10(e)(1), 483.12(a)(2), and 42 C.F.R. § 483.40(d) during the period from June 16, 2020 through July 27, 2020, and a $725.00 per-day CMP is reasonable.

Endnotes:

1  The case was originally assigned to Judge Weyn, but was reassigned to me on February 2, 2022.

2  I provisionally admitted the testimony of witnesses who had submitted direct testimony, CMS Ex. 9 and P. Exs. 1 and 6, subject to authentication at the hearing.

3  While this is cited as page one of this document, it is actually the third page.  However, to avoid confusion, I have used the pagination provided by Petitioner throughout this decision.

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

5  The initial reports of this incident indicated that only one male CNA entered the room to provide care.  CMS Ex. 12 at 2; CMS Ex. 13 at 3.  Subsequent investigations established that two CNAs, a male and a female, were in the room at the time of the incident.  P. Ex. 6 at 10.

6  In the Request for Hearing, Petitioner makes much of the fact that the surveyor concluded that the male CNA had tied the sleeves of the jacket together and the Adult Protective Services investigators “did not make this mistake.”  Request for Hearing at 17.  Petitioner misses the point, which is that an employee of the facility physically restrained the resident.

7  One of the involved CNAs indicated that he had to get R1 up at 4:45 AM “because the day shift want NOC (night) shift to get her up” so it was necessary for him to restrain her so he could finish his rounds.  CMS Ex. 1 at 9, 14; CMS Ex. 13 at 3.  The ADON confirmed that residents begin receiving morning care between 4:00 AM and 5:00 AM to ensure sufficient time to safely and thoroughly provide care to each resident before arrival of the Morning Shift at or around 6:00 AM.  P. Ex. 6 at 8.  These statements suggest that facility convenience may have been a factor in the decision to restrain.

8  The facility policy of use of physical restraints in the case of an emergency also required that, in such an event, the resident’s physician be notified as soon as possible and further orders obtained for the care of the resident.  CMS Ex. 8.  The absence of any indication that R1’s physician was contacted after this incident is further evidence it was not considered, even by the facility, to be an emergency.

9  It is somewhat questionable whether all members of this team would be qualified to evaluate changes in behaviors and the etiology of any changes identified.

10  While these statements are clearly hearsay, Petitioner has provided no evidence to challenge their authenticity, including by offering the SSC as a witness.

11  At one point, Petitioner appeared to challenge the choice by CMS to impose a per-day CMP, as opposed to a per-instance CMP.  Request for Hearing at 28.  However, 42 C.F.R. § 488.408(g)(2) provides that a facility may not appeal the choice of remedy, including the factors considered by CMS in selecting a remedy.  As a result, that issue is not further addressed.
  
          /s/
        Mary M. Kunz

                      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