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                              Lincoln Glen Skilled Nursing, DAB CR5189 (2018)
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Lincoln Glen Skilled Nursing, DAB CR5189 (2018)








  
  
    

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





Lincoln Glen Skilled Nursing,
	(CCN: 55-5363),
	Petitioner,
v.
Centers for Medicare & Medicaid Services.
Docket No. C-17-190Decision No. CR5189September 20, 2018

        
              
    

      DECISION
Petitioner, Lincoln Glen Skilled Nursing (“Lincoln Glen” or “the facility”), challenges the determination by the Centers for Medicare & Medicaid Services (CMS) that it was not in substantial compliance with the Medicare program participation requirement that each resident receives adequate supervision and assistance devices to prevent accidents.  42 C.F.R. § 483.25(h).  Petitioner also challenges the imposition of a per-instance civil money penalty (CMP) of $3,663.  For the reasons discussed below, I affirm CMS’s determination.
I.  Background
The Social Security Act (Act) establishes requirements for skilled nursing facility (SNF) participation in the Medicare program and authorizes the Secretary of Health and Human Services (the Secretary) to promulgate regulations implementing those statutory provisions.  *See*42 U.S.C. § 1395i-3; 42 C.F.R. parts 483 and 488.1
  To participate in the
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Medicare program, an SNF must maintain substantial compliance with program participation requirements.  In order to be in substantial compliance, an SNF’s deficiencies may “pose no greater risk to resident health or safety than the potential for causing minimal harm.”  42 C.F.R. § 488.301.  “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.”  42 C.F.R. § 488.301.
The Secretary contracts with state agencies to conduct periodic surveys to determine whether SNFs are in substantial compliance with participation requirements.  42 U.S.C. § 1395aa(a); 42 C.F.R. §§ 488.10, 488.20.  The Act and its implementing regulations require that facilities be surveyed on average every twelve months, and more often if necessary, to ensure that identified deficiencies are corrected.  42 U.S.C. § 1395i-3(g)(2)(A); 42 C.F.R. §§ 488.20(a), 488.308.  Among other enforcement remedies, CMS may impose a per-day CMP for the number of days an SNF is not in substantial compliance or a per-instance CMP for each instance of the SNF’s noncompliance.  42 C.F.R. §§ 488.430(a), 488.438(a)(2).  At the time of the survey, the baseline CMP range was from $1,000 to $10,000 prior to adjustment for inflation.2
  42 C.F.R. § 488.438(a)(2).
If CMS imposes a remedy based on a noncompliance determination, then the facility may request a hearing before an administrative law judge (ALJ) to challenge the noncompliance finding and enforcement remedy.  42 U.S.C. §§ 1320a-7a(c)(2), 1395i‐3(h)(2)(B)(ii); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13).
The California Department of Public Health (state agency) completed an “abbreviated survey regarding investigation of entity reported incidents,” otherwise referred to as a “complaint survey,” at Petitioner’s facility in San Jose, California, that concluded on October 24, 2016.  CMS Exhibits (Exs.) 1 at 1; 3 at 1.  CMS informed Petitioner that it would impose, *inter alia*,a $3,663 per instance CMP for noncompliance with 42 C.F.R. § 483.25(h) (Tag F323), which the state agency had cited at the “G” level of scope and severity.3
 CMS Exs. 1 at 3; 3 at 1.  In a November 22, 2016 letter, CMS advised
Page 3
Petitioner that it had returned to substantial compliance, effective November 16, 2016.  CMS Ex. 4 at 2.
Petitioner timely requested a hearing on December 13, 2016.  Pursuant to my Acknowledgment and Pre-Hearing Order (Pre-Hearing Order), CMS filed a pre-hearing brief (CMS Br.) and 11 proposed exhibits (CMS Exs. 1-11), and Petitioner filed a pre‐hearing brief (P. Br.) and 24 proposed exhibits (P. Exs. 1-24).
Neither party filed any objections to any proposed exhibits, and in a June 1, 2017 Order, I admitted all exhibits.4
 All three witnesses appeared at the July 25, 2017 hearing, and therefore, I have admitted all proposed exhibits.  *See*Transcript (Tr.) at 9-10.  The parties submitted post-hearing briefs (CMS Post-Hearing Br.; P. Post-Hearing Br.), and Petitioner filed a post-hearing reply brief (P. Reply).  The record is closed, and the matter is ready for a decision on the merits.
II.  Issues
The issues presented are:
1.   Whether Petitioner failed to be in substantial compliance with the Medicare program participation requirement at 42 C.F.R. § 483.25(h).
2.   If so, whether the $3,663 per-instance CMP for noncompliance with 42 C.F.R. § 483.25(h) is reasonable.
Page 4
III.  Discussion5
***A.  Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(h) because it did not provide the supervision and assistance devices necessary to prevent foreseeable accidents.***
**Factual Background**
**Resident # 1**
Resident # 1, a 94-year-old female, was admitted to the facility on May 28, 2014.  CMS Ex. 7 at 14.  Resident # 1’s medical history included diagnoses of hemiplegia following unspecified cerebrovascular disease affecting the right dominant side, dysphagia following unspecified cerebrovascular disease, vascular dementia with behavioral disturbance, and unspecified psychosis not due to a substance or a known physiological condition.  CMS Ex. 7 at 74.
Petitioner conducted a rehabilitation screening in December 2015, at which time it reported that Resident # 1 “normally has been independent in functional transfers and ambulation within the facility with her 4 wheel walker but recently staff has observed her leaning to the left as she ambulates.”  CMS Ex. 7 at 87.  The physical therapist recommended that Resident # 1 use a foot bike for five minutes, twice per day, and “attend any of several exercise classes during the week to strengthen extremities and improve balance.”  CMS Ex. 7 at 87.
On May 30, 2016, Petitioner completed a Minimum Data Set (MDS) in which it reported that Resident # 1 had a Brief Interview for Mental Status (BIMS) score of 14.6
  CMS Ex. 7 at 29.  Petitioner reported that Resident # 1 wandered and was at risk of getting to a dangerous place and that her behavioral symptoms had worsened.  CMS Ex. 7 at 31.  Petitioner reported that Resident # 1 had delusions, directed physical and verbal symptoms toward others, and put others at risk of injury.  CMS Ex. 7 at 30-31.  With respect to functional status, Petitioner reported that Resident # 1 was not steady but was able to stabilize herself without staff assistance with various balancing tasks.  CMS Ex. 7
Page 5
at 32.  Resident # 1 could transfer with limited assistance and walk on her own without supervision, and used a walker.  CMS Ex. 7 at 32.
Resident # 1 had a care plan dating back to her admission on May 28, 2014, which included a goal that she “will have no fall/injury daily.”  CMS Ex. 7 at 56.7
  Petitioner’s records indicate that this care plan goal was not reviewed or revised through December 5, 2016.  CMS Ex. 7 at 56.  Interventions, dated May 28, 2014, included maintaining a clutter-free environment, answering the call bell promptly, and making sure the call bell and personal items were within reach at all times.  CMS Ex. 7 at 56.  Another care plan goal directed that Resident # 1 will not have any signs or symptoms of spontaneous fracture, and the care plan interventions included gentle handling of the resident and providing a safe environment.  CMS Ex. 7 at 57.  Resident # 1’s care plan also identified that she was at risk for falls and injury due to her unsteady gait secondary to a cerebrovascular accident with resulting one-sided weakness that necessitated using a four-wheel walker, as well as due to her impaired vision.  CMS Ex. 7 at 58.  Petitioner added handwritten annotations to the care plan in which it documented falls in April 2015, July 2015, October 2015, and July 2016.  CMS Ex. 7 at 58.  Petitioner did not add any new ongoing interventions after any of these falls, with the exception of noting the need for precautions when the floor needs to be shampooed and a request that the responsible party provide Resident # 1 with shoes with better traction.  CMS Ex. 7 at 58.  Another care plan goal was for Resident # 1 to continue to perform activities of daily living with minimal assistance, and interventions included having Resident # 1 ambulate through the facility with a four-wheeled walker independently.  CMS Ex. 7 at 60.  Resident # 1 also had, based on elopements in July 2014, May 2015, and September of 2015, a care plan goal of remaining safely inside the facility.  CMS Ex. 7 at 63.
A June 29, 2016 care plan addendum reported that Petitioner initiated treatment with Seroquel based on Resident # 1’s symptoms that included hallucinations/delusions, living in the past “which causes extreme stress and cannot be redirected,” episodes of hitting and scratching Petitioner’s staff, extreme anger and agitation when re-directed by staff, and attempts to leave the facility unaccompanied.  CMS Ex. 7 at 66.  The addendum noted there had been an increase in elopement attempts, to include that there had been
Page 6
multiple attempts that were “escalating in frequency and inability to redirect.”  CMS Ex. 7 at 66-67.  A subsequent July 27, 2016 care plan addendum focused on Resident # 1’s treatment with Seroquel and “noted improvement in cognitive/conversation ability” such as that she could “carry on a conversation like a couple years ago.”  CMS Ex. 7 at 64.  Despite the fact that the form listed dizziness, somnolence, dysarthria, and hypotension as clinically significant adverse effects, and that Resident # 1 had a recent fall, as will be discussed below, the care plan addendum did not address the recent fall; in fact, Petitioner did not enter a response to a question asking whether there had been a change in status over the last quarter or since the last MDS review.  CMS Ex. 7 at 64-65.
Petitioner completed fall risk evaluation reports on Form QA7000A in March and June 2016, and Petitioner assigned Resident # 1 a fall risk score of 8 on both occasions.8
  *See*CMS Ex. 7 at 85-86.  The form assigns an unspecified number of points if the subject of the evaluation has a history of falls within the past 90 days.  CMS Ex. 7 at 85-86.  Similarly, the form assigns an unspecified number of points if the resident receives medication for behavior.  CMS Ex. 7 at 85-86.  Although Resident # 1 had been prescribed Seroquel for her behavior in June 2016 and had a fall in July 2016, Petitioner did not conduct another fall risk assessment, to include a quarterly assessment, after June 6, 2016.9
Page 7
Facility notes document that on July 10, 2016, a staff member found Resident # 1 “sitting on floor with support on sofa chair on her back.”  CMS Ex. 7 at 12.  A nurse reported that it “seems [the] resident tried to transfer herself to sofa chair from wheelchair.”  CMS Ex. 7 at 12.  No apparent injury was found.  CMS Ex. 7 at 12.  A fall scene investigation report indicated that on July 10, 2016, Resident # 1 had an unwitnessed fall in which she was found on the floor of her room.  CMS Ex. 7 at 18.  Petitioner determined that Resident # 1 had lost her balance and strength and appeared to get weak, and, as a result, she fell while ambulating and attempting to self-transfer and slid out or fell from a wheelchair.  CMS Ex. 7 at 18.  Petitioner documented that Resident # 1 “denies to tell [sic] what exactly happened.”  CMS Ex. 7 at 18.  The report notes that Resident # 1 had been taking Seroquel since June 28, 2016; however, Resident # 1 had refused all pills on July 9, 2016, and had refused her morning pills on July 10, 2016.  CMS Ex. 7 at 19.  Petitioner reported that, in the three hours prior to the fall, Resident # 1 had kept trying to go out the front door and became agitated at staff efforts to redirect her, to include trying to hit the staff at 11:00 am.  CMS Ex. 7 at 20.  Petitioner determined that root causes of the fall included “[m]ood or mental status” and “[l]ast 3 hours ‘re-creation’ issue/s.”  CMS Ex. 7 at 20.  Petitioner concluded that “Resident’s mood changes might be contribute [sic] to fall,” and that she “[m]ay fall when having episodes of agitation.”  CMS Ex. 7 at 21.  Petitioner reported that it was waiting on a psychiatric evaluation and that the “responsible party has been given info[rmation]” and Petitioner was “awaiting his response.”  CMS Ex. 7 at 21.  Despite Petitioner’s conclusion that mood and mental status caused the fall, Petitioner’s investigation did not reveal how Resident # 1’s mood or mental status caused her to lose balance, lose strength, or get weak, which were all factors observed at the time of the fall.  CMS Ex. 7 at 18.
After this fall, Petitioner did not update Resident # 1’s care plan goal that she “will have no fall/injury daily . . . .”  CMS Ex. 7 at 56.  With respect to Resident # 1’s care plan problem that she is at risk for falls/injury with an associated goal that she have no falls or injury, Petitioner did not add any new interventions following the fall, aside from notifying the responsible party and physician and monitoring for changes or injury.  CMS Ex. 7 at 58.
The record includes a cover sheet, purportedly sent via facsimile on July 10, 2016, to the company Petitioner used for consultant pharmacist services, entitled, “Medication Review Facsimile Cover Sheet.”  CMS Ex. 7 at 79.  Petitioner did not check the field indicating the type of review it was seeking, nor did it check the field indicating the condition(s) experienced by the resident, but it circled a pre-printed word, “falls.”10
  CMS Ex. 7 at 79.  Although the form instructed that Petitioner attach a physician order sheet and a medication administration record, the cover sheet does not indicate that Petitioner
Page 8
appended any pages to the form, and if so, how many.  CMS Ex. 7 at 79.  The record does not contain a medication regimen review in response to a July 2016 inquiry.11
On July 13, 2016, the consultant pharmacist submitted a request that Resident # 1’s physician “review the current antipsychotic therapy and provide an appropriate diagnosis for use” and advised that other medications may be more appropriate.  CMS Ex. 7 at 80.  In response, Petitioner’s “physician/prescriber” reported, in a handwritten and undated response, that Resident # 1 had psychotic symptoms and delusional thoughts that might be “causing her to repeatedly try to go outside the facility by herself.”  P. Ex. 6.
Resident # 1 had an annual physical examination with Dr. Chiong on July 17, 2016, and Dr. Chiong reported that Resident # 1 was able to ambulate with a walker.  CMS Ex. 7 at 82.  Dr. Chiong discussed that Resident # 1 “developed confusion that has been progressive along with delu[s]ional ideations (thinking that her son just passed away, she has her car in the parking lot and she needs to go out and drive, she is not [her name]) that are distressing to her.”  CMS Ex. 7 at 82.  Dr. Chiong reported that Resident # 1 began taking low dose Seroquel several weeks earlier, and he noted “much less delusional thoughts and the frequency of her trying to get out of the facility has been much lower.”  CMS Ex. 7 at 82.  Diagnoses provided by Dr. Chiong included hemiplegia and hemiparesis following cerebral infarction affecting the right side and dementia, and the report makes no reference to Resident # 1’s fall only a week earlier.  CMS Ex. 7 at 82-84.  Even though Petitioner had, only days earlier, attributed Resident # 1’s fall to her mood changes and agitation (CMS Ex. 7 at 21), Dr. Chiong reported that Resident # 1’s use of Seroquel “has been helpful in reducing the delu[s]ional ideation and behavior
Page 9
problem (try[]ing to go out of the facility)” and that she is calmer and “much better clinically.”  CMS Ex. 7 at 82-83.
Petitioner completed a quarterly MDS assessment on August 29, 2016, at which time it assessed that Resident # 1 had a BIMS score of 15, and also reported that Resident # 1 had delusions and directed physical behavioral symptoms toward others.  CMS Ex. 7 at 44-45.  Petitioner assessed, for purposes of the MDS assessment, that she required limited assistance for transfers, and required supervision for walking and locomotion tasks.  CMS Ex. 7 at 45-46.  Shortly thereafter, an interdisciplinary team conducted its quarterly assessment and reported that it had reviewed and updated Resident # 1’s care plan; the care plan does not include any requirement for supervision during walking and locomotion.  CMS Ex. 7 at 25.
Resident # 1 had another fall on October 2, 2016.  CMS Ex. 7 at 11, 14-17.  At that time, two visitors discovered Resident # 1 on the floor when they passed her room.  CMS Ex. 7 at 11.  Resident # 1 explained that she was trying to close her blinds and lost her balance.  CMS Ex. 7 at 15.  Petitioner observed that Resident # 1 had lost her balance and had lost strength or appeared to get weak and that environmental factors were present.12
  CMS Ex. 7 at 14.  Root causes were identified as the amount of assistance in effect and environmental factors/items out of reach.  CMS Ex. 7 at 16.  Specifically, Petitioner determined that Resident # 1 could not reach the window blinds control because a chair was in the way.  CMS Ex. 7 at 17.  Resident # 1 complained of pain following the fall, and an x-ray determined that Resident # 1 had a fracture of the left femoral neck.  CMS Ex. 7 at 11.  Petitioner ultimately transferred Resident # 1 to the hospital via an ambulance service.  CMS Ex. 7 at 11.  Unlike the July 2016 fall, Petitioner obtained a medication regimen review following the October 2016 fall.  CMS Ex. 7 at 77-78.
Resident # 1 was admitted to Good Samaritan Hospital on October 3, 2016, and discharged a week later.  CMS Ex. 7 at 107.  A surgeon performed hemiarthroplasty to repair a displaced subcapital fracture of the left hip.  CMS Ex. 7 at 102.
**Resident # 2**
Resident # 2, a 95-year-old man, was admitted to the facility on June 20, 2014, with multiple diagnoses, to include Parkinson’s disease, and previous bilateral total hip arthroplasty.  CMS Ex. 8 at 16; P. Ex. 20 at 1.  Resident # 2’s care plan identified that his history of falls was a problem.  P. Ex. 19 at 1.  The care plan listed falls in September, November, and December of 2015, and in April and July of 2016.  P. Ex. 19.
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Resident # 2’s physician reported in July 2016 that he is “bed and wheelchair bound.”  CMS Ex. 20 at 1.
Resident # 2 had an unwitnessed fall on April 5, 2016, at which time he reported “he was ambulating to the restroom to use when he fell loosing [sic] his balance.”  CMS Ex. 8 at 9.  The fall scene investigation report stated that Resident # 2 fell because he did not use a walker and also did not use his call light for help.  CMS Ex. 8 at 11.  A charge nurse reported that Resident # 2 had a skin tear of his left elbow.13
  CMS Ex. 8 at 7.  The fall scene investigation report listed the following as additional care plan and nurse aid assignment updates:
Add additional grab bar in bathroom
	Discuss [with Resident’s daughter] unclutter room if possible
	Discuss [risks and benefits] of self transfer [with resident] and daughter
	Offer bedside commode
	[Physical therapy] screen – walk in room
CMS Ex. 8 at 11.  Of particular significance, the record does not contain evidence that Petitioner contacted Resident # 2’s daughter to unclutter his room, nor does the record evidence that Petitioner provided a physical therapy screening for Resident # 2.14
Resident # 2 had another fall on July 31, 2016, following which he reported that he was trying to urinate into the urinal and had been leaning on the wheelchair and had forgotten to lock the wheels.  CMS Ex. 8 at 12-13.  The fall scene investigation report also stated that Resident # 2 slid out or fell from a wheelchair, but this account is otherwise not supported by the remainder of the report.  CMS Ex. 8 at 12.  The fall scene investigation
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report determined that the root causes of the fall were that Resident # 2 forgot to lock the wheelchair wheels and that he did not want to call for help and “wanted to do it by himself.”  CMS Ex. 8 at 15.  The fall scene investigation report provided the following “Additional Care Plan/Nurse Aide Assignment Updates”:
Pad under bedside table
	Encourage to go to bathroom instead of using urinal
	Cue to use toilet every two hours
	Talk about different pants that don’t fall down as easily
	Verify pendant, “[resident] insists on being indep[endent]”
CMS Ex. 8 at 15.  In particular, the record does not indicate that Petitioner subsequently placed a pad under the bedside table.  *See*P. Ex. 19.
*Facility policies*
Petitioner has a falls policy and procedure.  CMS Ex. 6 at 1-2.  That policy directs that residents will be re-evaluated with a fall risk assessment “on a quarterly basis, annually or with a significant change in condition.”  CMS Ex. 6 at 1.  The policy also requires that “[a] care plan will be started or updated immediately after each fall,” and will “identify the fall, goals and approaches to provide care.”  CMS Ex. 6 at 1.  The policy instructs that after completion of the MDS, “if a resident triggers a risk for falls, the resident will have further assessment for risk of falls utilizing the CAA guidelines and the plan of care will be enhanced, if indicated, to further minimize the risk of falls.”15
  CMS Ex. 6 at 1.  Petitioner’s medication regimen review and reporting policy requires that the consultant “reviews the medication regimen of each resident at least monthly,” and that more frequent medication reviews may be necessary, such as when the medication regimen is thought to contribute to an acute change in status.  CMS Ex. 6 at 3.
Page 12
*Relevant authority*
Medicare program requirements include 42 C.F.R. § 483.25, which states that “[e]ach resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care.”  Subsection 483.25(h) imposes specific obligations upon a facility related to accident hazards and accidents, as follows:
(h)  *Accidents*.  The facility must ensure that —
(1) The resident environment remains as free of accident hazards as is possible; and
	(2) Each resident receives adequate supervision and assistance devices to prevent accidents.
The Departmental Appeals Board (DAB) has held that subsection 483.25(h)(1) requires that a facility address foreseeable risks of harm from accidents “by identifying and removing hazards, where possible, or, where the hazard is unavoidable because of other resident needs, managing the hazard by reducing the risk of accident to the extent possible.”  *Maine Veterans’ Home - Scarborough*, DAB No. 1975 at 10 (2005) (explaining the inherent standard of care in section 483.25(h)(1)).  The provisions of section 483.25(h) “come into play when there are conditions in a facility that pose a known or foreseeable risk of accidental harm.”  *Meridian Nursing Ctr.*, DAB No. 2265 at 10 (2009), *aff’d*,*Fal-Meridian, Inc. v. U.S. Dep’t of Health & Human Servs.*, 604 F.3d 445 (7th Cir. 2010).  The DAB has held that subsection 483.25(h)(2) requires that a facility take “all reasonable steps to ensure that a resident receives supervision and assistance devices that meet his or her assessed needs and mitigate foreseeable risks of harm from accidents.”  *Briarwood Nursing Ctr.*, DAB No. 2115 at 11 (2007), citing *Woodstock Care Ctr. v. Thompson*, 363 F.3d 583, 590 (6th Cir. 2003) (facility must take “all reasonable precautions against residents’ accidents”), *aff’g* *Woodstock Care Ctr.*, DAB No. 1726 (2000).  “Though a facility has the flexibility to choose the methods of supervision and assistance used to prevent accidents, it must also ‘provide supervision and assistance devices that reduce known or foreseeable accident risks to the highest practicable degree, consistent with accepted standards of nursing practice.’”  *Heritage Plaza Nursing Ctr.*, DAB No. 2829 at 6 (2017), quoting *Century Care of Crystal Coast*, DAB No. 2076 at 6-7 (2007), *aff’d*, *Century Care of Crystal Coast v. Leavitt*, 281 F. App’x 180 (4th Cir. 2008).
Page 13
**Analysis16**
The evidence supports that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.25(h).  Petitioner did not take reasonable steps to protect Resident # 1 and Resident # 2 from foreseeable accidents, which resulted in both residents suffering harm.
**Fall risk evaluations**
March and June 2016 fall risk evaluations determined that Resident # 1 was not at risk for falls.  CMS Ex. 7 at 85-86.  But shortly thereafter, Resident # 1 began taking antipsychotic medication to address her behavior of “multiple attempts to leave facility – escalating in frequency and inability to redirect.”  CMS Ex. 7 at 67.  And less than two weeks after she began taking Seroquel, Resident # 1 had a fall on July 10, 2016.  CMS Ex. 7 at 18.
Petitioner does not dispute CMS’s argument that it was required to provide a quarterly fall risk assessment pursuant to its fall risk assessment policy.  CMS Br. at 6, citing CMS Ex. 6 at 1-2.  While Petitioner argues that it complied with this policy, it cites to documents that are *not*fall risk assessments.  P. Br. at 9, citing P. Exs. 7 and 11.  Further, Petitioner’s fall policy directs that if there is a significant change in condition or if a “resident triggers a risk for falls,” then a resident should be reevaluated for his or her risk of falls.  CMS Ex. 6 at 1.  Petitioner was obligated to complete another fall risk assessment after the June 2016 assessment and July 2016 fall, and it did not do so prior to Resident # 1’s subsequent fall nearly four months later.
**Review of Resident # 1’s medication regimen**
Petitioner does not dispute CMS’s assertion that its Medication Review and Reporting policy required that it conduct a medication regimen review after Resident # 1’s July and October 2016 falls.  CMS Br. at 7.  Petitioner erroneously argues, with respect to the July 2016 fall, that it conducted medication regimen reviews “a number of times.”  P. Br. at 7.  Not only is Petitioner mistaken, its response demonstrates a lack of understanding of its own policy.
Petitioner’s medication regimen review and reporting policy explains that a *consultant* *pharmacist*reviews each resident’s medication regimen at least monthly and that more frequent reviews are necessary when the medication regimen is thought to contribute to an acute change in status or an adverse consequence.  CMS Ex. 6 at 3.  The *consultant pharmacist* makes “[f]indings and recommendations” to “those with the authority and/or responsibility to implement the recommendations,” to include the administrator, director
Page 14
of nursing, attending physician, and medical director, as appropriate.  CMS Ex. 6 at 3.  Petitioner’s policy requires that “[a] record of the consultant pharmacist’s observations and recommendations is made available in an easily retrievable format to nurses, physicians and the care planning team.”  CMS Ex. 6 at 4.
Petitioner contends that P. Exs. 6, 7, 12, 21, and 22 demonstrate its compliance with its medication regimen review policy.  P. Br. at 7-8.  However, none of the records cited by Petitioner demonstrate that it complied with this policy after the July 2016 fall, in that *none*of the records indicate that a consultant pharmacist reviewed the Resident # 1’s medication regimen, identified irregularities, and provided observations, findings, and/or recommendations.  CMS Ex. 6 at 3-4; *see*CMS Ex. 7 at 77 (example of a consultant pharmacist’s medication regimen review following another fall, in which the consultant pharmacist recommended that Dr. Chiong consider a lower dosage of Seroquel, that certain vitals be monitored, and advised of potential adverse effects that could cause falls).  Petitioner has not demonstrated that it obtained a medication regimen review *after*the July 2016 fall and *prior*to the October 2016 fall.
Petitioner inaccurately argues that “as demonstrated by P. Ex. 6, the pharmacist provided a medication review and a note to the attending physician regarding antipsychotic medications.”  P. Br at 7.  However, P. Ex. 6 is the consultant pharmacist’s request that *Dr. Chiong*review the current antipsychotic therapy and “provide an appropriate diagnosis for use,” and *Dr. Chiong’s*undated response.17
  P. Ex. 6 contains no
Page 15
observations, findings, or recommendations regarding Seroquel, much less any of Resident # 1’s other prescribed medications, but rather, it asks Dr. Chiong to review his decision to prescribe Seroquel, to provide an appropriate diagnosis, and to specifically consider an alternate medication if Resident # 1 did not have psychosis with physical aggressiveness.  P. Ex. 6.
Likewise, P. Ex. 7 is an IDT conference summary that does not list a consultant pharmacist as a participant, nor does it list any medications other than Seroquel, and P. Ex. 12 is Dr. Chiong’s annual history and physical examination report, which makes no reference to any recommendations by a consultant pharmacist following Resident # 1’s July 2016 fall.  The remaining documents cited by Petitioner, P. Exs. 21 and 22, are declarations of Ruth Deane Kirchner, a nurse, and Dr. Chiong, neither of which references that a consultant pharmacist was consulted and provided recommendations following the July 2016 fall.
Petitioner’s medication regimen review policy, when adhered to, can yield useful information that can prevent future foreseeable accidents.  Petitioner, in October 2016 after a subsequent fall, obtained a “medication assessment” from a consultant pharmacist based on its report to the consultant pharmacist that Resident # 1 “had a fall” and was “currently in [the] hospital.”  CMS Ex. 7 at 77-78.  The consultant pharmacist advised that three of Resident # 1’s other medications could each cause dizziness, and that Seroquel could cause somnolence and orthostatic hypotension, along with dizziness.  CMS Ex. 7 at 77.  The consultant pharmacist further advised that Resident # 1’s orthostatic blood pressure readings should be routinely monitored while she is on Seroquel and also recommended that certain laboratory tests be administered.  CMS Ex. 7 at 77.  The consultant pharmacist also cautioned that the prescription for Seroquel, a psychoactive medication, may require additional documentation regarding treatment goals and target behaviors.  CMS Ex. 7 at 77.  Finally, the consultant pharmacist recommended that the dosage for Seroquel be reduced if the target behaviors were controlled.  CMS Ex. 7 at 77.  The evidence does not indicate that, at the time of Resident # 1’s second fall in October 2016, any of these recommended interventions were in place or that Petitioner had taken into account that Resident # 1 was taking four separate medications that could cause dizziness.  One can only speculate, if Resident # 1 had been monitored in accordance with a consultant pharmacist’s recommendations following her first fall, whether her second fall that resulted in a fracture with hospitalization could have been prevented.  But certainly, obtaining a medication regimen review months earlier would have undoubtedly reduced the foreseeable risk of harm due to another fall.
Page 16
**Failure to implement recommendations**
After Resident # 2’s April 2016 fall, Petitioner determined that Resident # 2’s care plan/nurse aid assignment updates should include, *inter alia*, a physical therapy screening for walking in his room.  There is no evidence that Petitioner obtained such a screening for Resident # 2.  *See* CMS Ex. 8; P. Ex. 19.  Petitioner directed that it would attempt to “de-clutter” Resident # 2’s room; however, it appears that maintaining a “clutter-free environment” was a longstanding care plan intervention that was in place prior to Resident # 2’s fall, and facility records do not indicate that Petitioner acted on this recommendation.  CMS Ex. 8 at 6-7.  Further, after Resident # 2’s July 2016 fall, which was, at least, his fifth fall in the facility in little more than one year (P. Ex. 19), Petitioner recommended that a pad be placed under the bedside table.  CMS Ex. 8 at 15.  However, the evidence does not indicate that such a pad was placed.  CMS Ex. 8 at 15; *see*CMS Ex. 8 at 5 (August 2016 nursing notes); P. Ex. 19 (care plan omitting such an intervention and leaving unchecked the approach of “Matt [sic] on floor to prevent injury”).  Petitioner failed to implement several care plan interventions that could have reduced Resident # 2’s risk for future falls.
The DAB “has repeatedly held that section 483.25(h) obligates a facility to take ‘all reasonable steps to ensure that a resident receives supervision and assistance devices that meet his or her assessed needs and mitigate foreseeable risks of harm from accidents.’”  *Heritage Plaza*, DAB No. 2829 at 6, quoting *Briarwood*, DAB No. 2115 at 5.  The DAB has also explained:
For a risk to be foreseeable, it need not have been made obvious by having already materialized.  The regulation speaks in terms of ensuring that what is “practicable” and “possible” to do is done.  What is thus required of facilities is not prescience but reason and professional judgment in assessing what can be done to make residents (given their special needs) safe, through removing accident hazards, providing appropriate devices, and ensuring adequate supervision.
*Josephine Sunset Home*, DAB No. 1908 at 15 (2004).  As previously mentioned, Petitioner failed to adhere to its own falls and medication regimen review policies with respect to Resident # 1, and it failed to implement “care plan updates” that could have prevented another fall by Resident # 2.  It is clear that Petitioner did not take all reasonable steps to prevent further falls by two of its residents, and Petitioner therefore failed to provide the supervision and assistance devices necessary to prevent foreseeable accidents.  Resident # 1 ultimately fell and broke her femoral neck, necessitating a transfer to the hospital, surgery, and a week-long hospitalization, and Resident # 2
Page 17
suffered a skin tear, necessitating three weeks of dressing changes and application of antibiotic ointment.
***B. A per-instance CMP of $3,663 is a reasonable enforcement remedy for Petitioner’s noncompliance with 42 C.F.R. § 483.25(h).***
If a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406, including a CMP.  In determining whether the CMP imposed against Petitioner is reasonable, I apply the factors listed in 42 C.F.R. § 488.438(f).  42 C.F.R. 488.438(e)(3).  These factors include:  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.  42 C.F.R. § 488.438(f).  The absence of culpability is not a mitigating factor.  *Id.*  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 above 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.  *See, e.g.*,*Barn Hill Care Ctr.*, DAB No. 1848 at 21 (2002).  Unless a facility contends that a particular regulatory factor does not support the CMP amount, an ALJ must sustain it.  *Coquina Ctr.*, DAB No. 1860 (2002)
CMS imposed a per-instance CMP of $3,663 for the noncompliance with 42 C.F.R. § 483.25(h).  Petitioner does not argue with any specificity that the per-instance CMP is unreasonable, which alone gives reason to sustain it.  *Coquina*, DAB No. 1860; 42 C.F.R. §§ 488.404, 488.438(f).  Additionally, the two residents who were the subject of the cited deficiencies both had fallen only three months earlier, and again fell, with injury, after Petitioner did not follow its own policies and implement interventions that could have prevented another fall.  One was seriously injured, in that she sustained a displaced left hip fracture that required surgical repair.  CMS Ex. 7 at 102.  Further, Petitioner has not offered any evidence showing an inability to pay the per-day CMP.  The per-day CMP of $3,663 is at the low end of the authorized penalty range.18
  42 C.F.R.
Page 18
§§ 488.408(d)(1)(iii), 488.438(a)(1)(ii).  Based on consideration of the relevant factors, the CMP is entirely reasonable; in fact, a much higher CMP would have been justified based on the significant harm that could possibly have been avoided.
IV.  Conclusion
For the foregoing reasons, I conclude that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(h), which is a program participation requirement.  A per‐instance CMP of $3,663 is a reasonable enforcement remedy.


          /s/
        Leslie C. Rogall

                      Administrative Law Judge
      1. Federal long-term care facility regulations substantially changed beginning on November 28, 2016. 81 Fed. Reg. 68,688 (Oct. 4, 2016). Based on the date of the survey, which preceded the regulatory revisions, I refer to the regulations that were in effect at the time of the survey. back to note 1
                      2. CMP amounts increased, beginning August 1, 2016, for deficiencies cited after November 2, 2015, to “reflect the statutorily mandated amounts and ranges as adjusted for inflation.” See 81 Fed. Reg. 61,538, 61,573-61,574 (Sept. 6, 2016). CMS failed to acknowledge that CMPs had been adjusted for inflation. See CMS Br. at 9 (“Here, CMS imposed a per-instance CMP of $3,663, which is on the lower end of the single range of $1,000-$10,000 for per instance CMPs.”). back to note 2
                      3. Scope and severity levels are used by CMS and state survey agencies when selecting remedies. The scope and severity level is designated by letters A through L. Pub. 100-7, State Operations Manual, § 7400.5.1 (Factors That Must be Considered When Selecting Remedies), “Assessment Factors Used to Determine the Seriousness of Deficiencies Matrix” (table), https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107c07.pdf (last visited September 13, 2018); see 42 C.F.R. § 488.408. As relevant here, a scope and severity level of G, H, or I indicates a deficiency that involves actual harm that does not amount to immediate jeopardy. back to note 3
                      4. In my Order, I provisionally admitted CMS Exs. 10 and 11 (written direct testimony and résumé of the state agency surveyor, Mariela Palomo George) and P. Exs. 21, 22, and 23 (testimony of Ruth Deane Kirchner, R.N., Dominic Chiong, M.D., and J.T. (redacted to protect the privacy of Resident # 1, for whom he served as the responsible party)). CMS later withdrew its request to cross-examine J.T., and the remaining witnesses presented for cross-examination. Therefore, all proposed exhibits are admitted into the evidentiary record. back to note 4
                      5. Findings of fact and conclusions of law are in bold and italics. back to note 5
                      6. A BIMS score of 14/15 indicates that the subject is “cognitively intact.” See Long Term Care Facility Resident Assessment Instrument (RAI) 3.0 User’s Manual, Ch. 3 (Overview to the Item-by-Item Guide to the MDS 3.0), § C0500 (Summary Score) at C-14, https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/Downloads/MDS-30-RAI-Manual-V113.pdf (last visited September 13, 2018). back to note 6
                      7. Petitioner submitted a duplicate copy of Resident # 1’s care plan as P. Ex. 2, along with numerous other proposed exhibits that CMS had already submitted, despite a specific instruction that it not do so. Pre-Hearing Order § 4 (“Petitioner is directed NOT to file as proposed exhibits any documents that CMS has already filed among its proposed exhibits. Petitioner therefore may not submit duplicate copies of CMS form 2567, resident treatment records, or any other document that CMS has already filed as one of its proposed exhibits.”). Owing to CMS’s lack of objection to any of Petitioner’s duplicative submissions, I will not exclude, sua sponte, any of Petitioner’s proposed exhibits. Nonetheless, I caution Petitioner that the disregard of such orders burdens the adjudicator with the needless review of duplicative evidence. back to note 7
                      8. Pursuant to Petitioner’s falls policy and procedure, a fall risk score of 15 or higher signifies that a resident is at risk for falls. CMS Ex. 6 at 1. Likewise, the form contains the following instructions: “If points total 15 or more, identify resident as a risk for falls on care plan. Have [interdisciplinary team] review risk with resident, family or responsible party.” CMS Ex. 7 at 85-86. Petitioner’s fall risk assessment form indicates that a resident is at additional risk for falls if he or she is prescribed prescription medication for behavior. CMS Ex. 7 at 85-86. The form also reports that the risk score increases if the subject has poor vision; although Resident # 1’s care plan addresses her impaired vision (CMS Ex. 7 at 58), Petitioner did not factor poor vision into Resident # 1’s fall risk assessment score. CMS Ex. 7 at 85-86. back to note 8
                      9. Petitioner makes a misleading argument regarding the fall risk assessments, arguing that Ms. George gave “incorrect” testimony that “Resident 1 did not have an assessment between the July 10, 2016 and October 2, 2016 falls” as required each quarter by its falls policy. P. Br. at 9, citing CMS Ex. 10 at 5. Petitioner argues that Ms. George is incorrect because “[t]here was an assessment on July 10, 2016 (see P. Ex. 11) and another assessment in September 2016 (see P. Ex. 7).” P. Br. at 9. However, neither of the documents Petitioner relies upon is a fall risk assessment; P. Ex. 7 is a September 2016 interdisciplinary team (IDT) conference summary and P. Ex. 11 is the July 2016 fall investigation report. back to note 9
                      10. I note that the fall investigation report indicates a root cause of mood disturbance, yet Petitioner did not select the field, “Depression, mood disturbance” on the facsimile cover sheet purportedly requesting a medication regimen review. CMS Ex. 7 at 21, 79. back to note 10
                      11. Petitioner, again, gives incorrect information in its brief, arguing that it conducted “medication regimen reviews after the resident falls in July and October.” P. Br. at 10. Petitioner states that P. Ex. 5 “demonstrates” that “a review of the medication regimen demonstrated that there were no adverse effects to the Seroquel.” P. Br. at 10. Petitioner submitted P. Ex. 5, which is a duplicate of CMS Ex. 7 at 64-65, and is a care plan addendum, not a medication review; in fact, P. Ex. 5 makes no reference whatsoever to Resident # 1’s July 2016 fall. And contrary to Petitioner’s baseless assertions, P. Ex. 6 is not a medication regimen review, but rather, a warning from the consultant pharmacist to Dr. Chiong regarding a single medication, and the consultant pharmacist’s request that Dr. Chiong provide an appropriate diagnosis for use of that medication. Likewise, and contrary to Petitioner’s misunderstanding of the evidence, Dr. Chiong did not conduct a medication regimen review because he is not a consultant pharmacist. See P. Br. at 7, citing P. Ex. 22; P. Br at 10, citing P. Ex. 12 (which is a duplicate submission of CMS Ex. 7 at 82-84). Petitioner either has deliberately presented misleading information or is genuinely unfamiliar with its own policy regarding medication regimen reviews, neither of which lends weight to Petitioner’s contention that it provided the supervision and assistance devices necessary to prevent foreseeable accidents. back to note 11
                      12. Petitioner’s investigation report asked the preparing official to “circle or write in” the specific environmental factor, which included “clutter, furniture, item out of reach, lighting, wet floor, other (specify).” CMS Ex. 7 at 14. Petitioner did not circle or write in the specific factor. CMS Ex. 7 at 14. back to note 12
                      13. Petitioner contends that Resident # 2 had “only minor skin tears in connection with his falls” and that Resident # 2 therefore suffered no harm. P. Reply at 5. I disagree with Petitioner, and there is no doubt that a skin tear is an injury that can amount to actual harm. In fact, Petitioner’s April 2016 fall caused a 16 cm x 7 cm skin tear, which is not an insignificant injury for a 95-year-old man. CMS Ex. 8 at 7. And after the subsequent fall in July 2016, a physician ordered a 21-day course of treatment that included triple antibiotic ointment and daily dressing changes. CMS Ex. 8 at 5. back to note 13
                      14. Petitioner submitted a portion of Resident # 2’s care plan, dating back to July 2015, which identified as a problem that Resident # 2 had a potential for fall and injury due to a history of falls. P. Ex. 19. Significantly, the care plan addresses prior falls in September, November, and December of 2015, in addition to the falls in April and July of 2016. P. Ex. 19. The care plan, in pertinent part, instructed Petitioner to “maintain [a] clutter free environment.” P. Ex. 19 at 1. Petitioner’s determination that it should “unclutter room if possible” presumably should have been unnecessary if Petitioner had adhered to Resident # 2’s care plan. CMS Ex. 8 at 11. back to note 14
                      15. It appears that Petitioner’s reference to “CAA guidelines” is to the “Care Area Assessment” process that is addressed in Chapter 4 of CMS’s RAI Version 3.0 Manual. See https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/MDS30RAIManual.html (last visited September 13, 2018). CMS instructs that facility should use an assessment to “identify and address the underlying cause(s) of the resident’s fall(s), as well as to identify any related possible causes and contributing and/or risk factors.” RAI Version 3.0 Manual, Overview of the RAI and CAAs, at 4-30, 4-31. The CAA lists fall risk assessment criteria that include wandering, balance problems, “at least one [fall] since admission or the prior assessment,” and receiving antianxiety and antidepressant medications. Id. back to note 15
                      16. I decline to address each and every allegation of noncompliance raised by CMS, and instead focus on several of the bases for noncompliance with section 483.25(h). back to note 16
                      17. The record demonstrates that a post-fall medication review was not performed after the July 2016 fall, and such an assessment was not performed until after the October 2016 fall. In July 2016, the consultant pharmacist asked Dr. Chiong to review the prescribed antipsychotic therapy and provide an appropriate diagnosis for use. CMS Ex. 7 at 80. The consultant pharmacist explained that antipsychotic agents should be reserved “for psychosis where physical aggressive behavior is a concern.” P. Ex. 6. In response, Dr. Chiong neither identified a diagnosis nor identified symptoms involving physically aggressive behavior. P. Ex. 6. Neither the consultant pharmacist’s request for physician review and an appropriate diagnosis, nor Dr. Chiong’s response in which he fails to provide the requested information, indicates that a medication regimen review was being undertaken as a result of Resident # 1’s July 10, 2016 fall. P. Ex. 6. In fact, the consultant pharmacist’s request that Dr. Chiong provide an appropriate diagnosis apparently remained pending more than six weeks later on August 25, 2016, at which time the consultant pharmacist again cautioned Dr. Chiong regarding Seroquel, warning that Resident # 1 “is receiving Seroquel, an atypical antipsychotic and is NOT FDA indicated for anxiety.” CMS Ex. 7 at 81. The consultant pharmacist further states that “Seroquel use for dementia residents with behavioral disturbances is an off-label use . . . and is limited to use for behaviors which are a danger to self or . . . others.” CMS Ex. 7 at 81. Approximately seven weeks after Resident # 1’s fall, it appears that Petitioner, or Dr. Chiong, “clarified” that the order for Seroquel is “for ‘hallucinations/delusions which cannot be redirected.’” CMS Ex. 7 at 81. back to note 17
                      18. I reiterate that neither party addressed the inflation-adjusted penalty range that was in effect at the time the deficiency was cited. Nonetheless, I point out that the inflation adjusted CMP range is from $2,063 through $20,628, and therefore, a CMP of $3,663 is at the very low end of the inflation-adjusted CMP range. See 81 Fed. Reg. 61,538, 61,573-61,574 (Sept. 6, 2016). back to note 18 Back to top
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