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
                              2021
                              Presbyterian Village, DAB CR5844 (2021)
 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

                    




Presbyterian Village, DAB CR5844 (2021)








  
  
    

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





Presbyterian Village,
(CCN: 11-5490),
Petitioner,

v.

Centers for Medicare & Medicaid Services.
Docket No. C-18-855Decision No. CR5844April 7, 2021

        
              
    

      DECISION

Petitioner, Presbyterian Village, is a skilled nursing facility located in Austell, Georgia, that participates in the Medicare program.  On February 27, 2018, it was notified by the Centers for Medicare & Medicaid Services (CMS) that it was found out of compliance with participation requirements following a survey completed on February 2, 2018 and the most serious deficiency was actual harm at a scope and severity level "G."  CMS Exhibit (Ex.) 3.  A $12,500 per instance penalty was imposed.1
  The facility was cited at federal tag F656 for noncompliance with 42 C.F.R. § 483.21(b)(1) (Comprehensive Care Plans) and tag F686 for noncompliance with 42 C.F.R. § 483.25(b)(1) (Pressure ulcers).  CMS Ex. 1.  On February 26, 2018, Petitioner filed a request for Independent Informal Dispute Resolution (IIDR), seeking a face to face meeting.  CMS Ex. 22 at 6, 12.  On March 28, 2018, the Georgia Department of Community Health notified Petitioner that, after a face to face meeting, the cited deficiencies of F656 and F686 remained unchanged.  CMS Ex. 22 at 2.  Petitioner then filed a timely request for hearing on April 27, 2018.

**Page 2**

On May 9, 2018, Judge Leslie A. Weyn issued an Acknowledgement and Prehearing Order (APHO), setting forth pre-hearing procedures.2
  Included in that APHO was the directive to each party to include in its pre-hearing exchange any objection it had to any of the proposed exhibits or witnesses and to affirmatively request cross-examination of any proposed witnesses.  The APHO also stated that an in-person hearing would only be necessary if the opposing party requested an opportunity to cross-examine a proposed witness.  APHO at 6-7.

In accordance with the APHO, CMS filed a pre-hearing brief (CMS Pre-Hearing Brief) and 33 proposed exhibits (CMS Exs. 1-33), including the written direct testimony of two witnesses.  Petitioner filed a pre-hearing brief (P. Pre-Hearing Brief) and seven proposed exhibits (P. Exs. 1-7), including the written direct testimony of three witnesses.

No objections to the proposed exhibits or witnesses were received, and neither party affirmatively requested cross-examination of the opposing party's proposed witnesses.  As a result, a hearing for the purpose of cross-examination of a witness is unnecessary.  APHO ¶¶ 8-10.  This matter is ready for a decision on the merits.

As neither party objected to any of the proposed exhibits, I admit CMS Exs. 1-33 and P. Exs. 1-7 into the record.  For the reasons set forth below, I find that the facility was not in substantial compliance with the regulatory requirements for the development of comprehensive care plans and the prevention of pressure ulcers3
 and that the penalty imposed is reasonable.

Issues

The issues are:

Was the facility in substantial compliance with 42 C.F.R. § 483.21(b)(1) (Comprehensive Care Plans) and 42 C.F.R. § 483.25(b)(1) (Pressure ulcers);

If the facility was not in substantial compliance, is the penalty imposed - $12,500.00 - reasonable?

**Page 3**

Discussion

**I.  *The record establishes that the facility was not in substantial compliance with 42 C.F.R. §§ 483.21(b)(1) and 483.25(b)(1)(i) because facility staff failed to meet the regulatory requirements to develop and implement a comprehensive person-centered care plan for Resident #56 and failed to provide Resident #56 with all necessary care to prevent a pressure ulcer.*4**

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.  Facilities participating in the Medicare program must, among other requirements, "develop and implement a comprehensive person-centered care plan for each resident . . . that includes measurable objectives and timeframes to meet a resident's medical . . . needs that are identified in the comprehensive assessment" and must describe the "services that are to be furnished to attain or maintain the resident's highest practicable physical, mental, and psychosocial well-being."  42 C.F.R. § 483.21(b)(1), (b)(1)(i).  The facility is also required to ensure that "[a] resident receives care, consistent with professional standards of practice, to prevent pressure ulcers and does not develop pressure ulcers unless the individual's clinical condition demonstrates that they were unavoidable."  42 C.F.R. § 483.25(b)(1)(i).

The Secretary contracts with state survey agencies to survey skilled nursing facilities in order to determine whether they are in substantial compliance with Medicare program requirements.  Social Security Act (Act) § 1864(a); 42 C.F.R. §§ 488.10, 488.20.  Each facility must be surveyed annually, with no more than fifteen months elapsing between surveys, and must be surveyed more often, if necessary, to ensure that identified deficiencies are corrected.  Act § 1819(g)(2)(A); 42 C.F.R. §§ 488.20(a), 488.308.  The state agency must also investigate all complaints.  Act § 1819(g)(4).

A standard survey was conducted at Presbyterian Village by the Georgia Department of Community Health survey agency from January 29, 2018 to February 2, 2018.  CMS Ex. 1 at 1.  The survey found that the facility was not in substantial compliance with two participation requirements:  develop/implement comprehensive care plan and treatment services to prevent/heal pressure ulcer.  CMS Ex. 1 at 1-9.  Petitioner disagrees with these findings, asserting that it did have a "Comprehensive, person-centered Care Plan that addressed *all* the of resident's unique needs" and it "carefully and systematically implemented various Care Plan interventions to reduce the risk of Resident #56 developing a pressure ulcer."  P. Pre-Hearing Brief at 1.

**Page 4**

Resident #56, a 96-year-old man, was admitted to the facility on January 13, 2017 with diagnoses including hemiplegia and hemiparesis following cerebral infarction affecting left non-dominant side, coronary artery disease and coronary artery bypass graft, valvular heart disease, chronic congestive heart failure, pulmonary and essential hypertension, and advanced dementia.  CMS Ex. 14 at 2; P. Ex. 1 at 2-3, 25-26.  He was hospitalized on December 11, 2017 for evaluation of left leg pain after recurrent falls, and imaging demonstrated an acute, angulated and impacted subcapital left femoral neck fracture.  P. Ex. 1 at 2, 8.  Because of the high risk of complications from surgery, Resident #56 was instead treated with traction.  P. Ex. 1 at 10, 12.  Charles Markle, MD, a treating physician, ordered an "Immobilizer to Left Leg" on December 13, 2017.  CMS Ex. 10 at 3.  Resident #56 was re-admitted to the facility on December 13, 2017.  CMS Ex. 14 at 1.  On that date, nursing notes indicated some faded bruising behind the left knee and shin, a reddened left knee underneath the immobilizer, and a small red area on the left upper inner thigh.  At that time, Resident #56 was assessed as being at risk for skin problems with a risk score of 8.5
  CMS Ex. 22 at 71; *but see* CMS Ex. 22 at 72 (reflecting a risk score of 16.0).

The Plan of Care was updated on December 14, 2017 and December 21, 2017 to reflect the changes in Resident #56's condition.  CMS Ex. 11.  Subsequently, on January 30, 2018, the second day of the state agency survey, the Assistant Director of Nursing (ADON) removed the leg immobilizer and discovered that Resident #56 had developed a pressure ulcer measuring 5.0 centimeters (cm) x 1.5 cm x 0.1 cm at the proximal end of the left leg brace.  CMS Ex. 14 at 43-44; CMS Ex. 22 at 126.  The facility characterized the wound as "[f]acility [a]cquired" and "[u]nstageable."  CMS Ex. 17.

The initial issues to be addressed in this decision are whether the facility developed and implemented a comprehensive person-centered care plan for Resident #56 that included measurable objectives and timeframes to meet his needs and described the services to be furnished to accommodate the leg immobilizer and whether the facility ensured that Resident #56 received care, consistent with professional standards, to prevent pressure ulcers.

***A. Petitioner was not in compliance with the requirements of 42 C.F.R. § 483.21(b)(1).***

That section of the regulations provides, in pertinent part, that:

(1) The facility must develop and implement a comprehensive person-centered care plan for each resident, consistent with the resident rights set forth

**Page 5**

at § 483.10(c)(2) and § 483.10(c)(3), that includes measurable objectives and timeframes to meet a resident's medical, nursing, and mental and psychosocial needs that are identified in the comprehensive assessment.  The comprehensive care plan must describe the following:

(i) The services that are to be furnished to attain or maintain the resident's highest practicable physical, mental, and psychosocial well-being as required under § 483.24, § 483.25, or § 483.40.

CMS contends that Petitioner was not in substantial compliance with this section of the regulations because it failed to develop and implement a Comprehensive Care Plan for Resident #56 that included specific goals and interventions for a leg immobilizer, specifically for the risk of pressure ulcer that the immobilizer created.  CMS Pre-Hearing Brief at 1; CMS Ex. 1 at 2.  Petitioner argues that Resident #56 did have a "Comprehensive, person-centered Care Plan that addressed *all* of the resident's unique needs."  P. Pre-Hearing Brief at 1.  In its brief and in the Declarations from the Director of Nursing (DON) and ADON, it was also asserted that the care plan did address the leg immobilizer in several sections.  P. Exs. 5-6.  I note, consistent with the arguments of Petitioner, that a care plan *was* created for Resident #56.  CMS Ex. 11.  The question, however, is whether the care plan that was developed included "measurable objectives and timeframes" to meet the resident's needs and whether it described the "services that are to be furnished" to attain or maintain Resident #56's well-being.  I find that it did not.  In reaching this conclusion, I have considered the testimony provided by the DON and ADON on this issue but have given that testimony little weight because it was unsupported by the objective record, as discussed below.

Petitioner asserts that the Comprehensive Care Plan contained interventions and goals "which specifically addressed Resident #56's leg immobilizer."  P. Pre-Hearing Brief at 5.  It cites to several specific provisions in the Comprehensive Care Plan developed for him as support for this argument:

**Problem #10:6**

**Page 6**

[Resident #56] has self-care deficit related to . . . recent left femoral neck fracture (no surgical intervention).
Goal:
[Resident's] needs will be met . . .
Interventions:
4.  Turn and reposition every 2 hours and as needed.  Total care of 2.
5.  Bathe 3 times/week.  Total care of 2
9.  Bed rest until further recommendation is made from orthopedic
11. Non-weight bearing to left leg.  Left leg immobilizer to be worn.

**Problem #12:**
[Resident #56] has Discomfort / Pain related to recent left femoral neck fracture (no surgical interventions).
Goal:
Pain medication(s) will be effective in relief of discomfort
Interventions:
2.  Total care of 2 for turning and repositioning every 2 hours
4.  Assist with ADL care as needed and allow rest periods as needed to avoid fatigue
5.  Follow up with orthopedic as ordered
8.  Pressure reduction mattress on bed
9.  Non-weight bearing to left leg.  Left leg immobilizer to be worn
10. Provide gentle hands-on care especially to left leg

**Problem #13:**
[Resident 56] . . . is at risk for additional falls related to . . . fractured left femoral fracture (no surgical intervention) . . .
Goal:
No Falls
Interventions:
2.  Total care of 2 for turning and repositioning q 2 hours and as needed
3.  Total care of 2 with bathing 3 times/week
11. Bed rest until further recommendation is made by orthopedic doctor.  Nonweight-bearing to his left leg.  Left leg immobilizer is to be worn.

**Problem #14:**
[Resident 56] . . . Is at risk for pressure ulcer related to immobility, incontinence, dementia, and left femoral neck fracture (no surgical intervention).7

**Page 7**

Goal:
No pressure ulcers
Interventions:
1.  Body audits per protocol
2.  Keep skin clean and dry . . .
4.  Provide pressure relief/redistribution surface to bed
5.  Gently apply lotion to all dry skin
6.  Turn and reposition every 2 hours and as needed
7.  Provide, offer and encourage good nutritional and fluid intake
8.  Monitor for red or open area, skin tears, or skin discoloration.  Promptly report these findings to the nurse

**Problem # 15:**
[Resident #56] is at risk for Deep Vein Thrombosis related to left femoral neck fracture (no surgical repair)
Goal:
No signs and symptoms of DVT
Interventions:
1.  Administer anticoagulant medications as ordered
2.  Monitor for signs and symptoms of excessive or abnormal bleeding due to use of anticoagulant, such as . . . increased bruising . . . And notify MD of abnormal findings
4.  Provide gentle hands-on care and notify nurse of any skin break or trauma
6.  Keep MD informed of any adverse change in condition

P. Pre-Hearing Brief at 5-7 (quoting CMS Ex. 22 at 19-20, 24-31) (emphasis omitted).

In their testimony, the DON and ADON similarly cited the above provisions from the Comprehensive Care Plan as evidence that the care plan met all the resident's needs.  P. Ex. 5 at 3-4; P. Ex. 6 at 2-3.  To be sure, the plan of care that was developed specifically *referenced* the leg immobilizer.  As noted above, the statement "Left leg immobilizer to be worn" is included as an intervention for the problems of self-care deficit, discomfort/pain related to left femoral fracture, and risk of falls.  CMS Ex. 11 at 7, 12, 14.  However, when the plan of care was updated following Resident #56's return to the facility, it did not provide specific interventions or "describe . . . the services that are to be furnished" to address the complications *from* the leg immobilizer.  Petitioner consistently described the immobilizer as an intervention to address other problems, rather than as a cause of potential additional problems.  As a result, the plan of care did

**Page 8**

not indicate specifically how to manage many of the identified interventions, given the placement of the left leg immobilizer.

The plan of care identified several interventions to be performed by the facility's CNAs.  Interventions for the identified problem of self-care deficit included bathing three times a week with total care of two, with responsibility assigned to "CNA."  CMS Ex. 11 at 6.  Assistance with bathing by the CNA is also identified as an intervention for the identified problems of bowel incontinence and fall risk.  CMS Ex. 11 at 8, 13.  An intervention in the plan of care for the problem of incontinence was for the CNA to monitor for red or open areas and report to nurse.  CMS Ex. 11 at 9.  However, also cited as an intervention for the problems of self-care deficit and fall risk was "Left leg immobilizer to be worn."  CMS Ex. 11 at 7, 14.  What is lacking in the plan of care is any specific direction to the CNAs as to whether the leg immobilizer was to be removed for the bathing and skin monitoring, in light of the statements that the left leg immobilizer was "to be worn."  CMS Ex. 11 at 7, 12, 14.

The plan of care identified as a problem the risk of pressure ulcers "related to immobility, incontinence, dementia, and left femoral neck fracture."  CMS Ex. 11 at 15.8
  To address the problem of being at risk for pressure ulcers, the plan of care contains an intervention for CNAs and nursing to monitor for red or open areas, skin tears, and skin discoloration and promptly report these findings to the nurse.  CMS Ex. 11 at 16.  Again, the plan of care provides no guidance as to whether the leg immobilizer should be removed for this evaluation or how often the monitoring should occur.  Similarly, the plan of care contains an intervention to monitor for signs and symptoms of excessive or abnormal bleeding, such as increased bruising, to address the identified problem of increased risk of deep vein thrombosis related to immobility and left femoral neck fracture.  CMS Ex. 11 at 17.  However, the plan of care again fails to indicate whether the leg immobilizer was to be removed for this intervention or the frequency at which the monitoring was to be performed.

Petitioner argues that it is not necessary to include this degree of detail in the plan of care because the plan of care cannot include the "exact step by step, minute by minute implementation of a Care Plan."  P. Pre-Hearing Brief at 8.  It asserts that:

[I]f an intervention in the Care Plan is to bath [sic] the resident three times per week, the Care Plan would not say "remove the resident's clothes, and bathe the resident three times per week" because it is implicit that in order to bathe a resident, one must first remove the resident's clothing or gown and

**Page 9**

expose the resident's body.  Similarly, if a resident's Care Plan identifies that the resident is at risk for skin breakdown, and the above-mentioned interventions are implemented, it is implicit that *all* the resident's skin would be assessed, including skin that is under a leg immobilizer.

*Id.*  A similar statement was made by the ADON in her Declaration.  P. Ex. 6 at 3.  However, while it may be implicit to remove a resident's clothing before bathing, it is not "implicit" to remove a leg immobilizer or other medical device from an individual with a fractured hip without specific instruction, particularly in the face of other statements in the plan of care that "[l]eft leg immobilizer to be worn" and was, in fact worn "around the clock."  CMS Ex. 11 at 7, 12, 14; CMS Ex. 22 at 125.

In its arguments, Petitioner reinforces this apparent inconsistency, stating in its brief that the immobilizer "was a specific intervention to treat Resident #56's fractured femur."  P. Pre-Hearing Brief at 8 (citing P. Exs. 2-3).  "The facility did not have a choice whether to leave the immobilizer on - it was a physician's order that was clear:  **the left leg knee immobilizer should always be worn**."  P. Pre-Hearing Brief at 8 (emphasis added).

Petitioner made the same argument at the time of the IIDR, stating that "it was a physicians [sic] order that was clear:  **the left leg knee immobilizer should be worn at all times**."  CMS Ex. 22 at 9 (emphasis added).  At the same time, Petitioner asserted that "Resident #56 experienced pain upon movement and transfers, thereby **providing a need for the knee immobilizer to be in place at all times**."  CMS Ex. 22 at 10 (emphasis added).  Multiple times, Petitioner emphasized that the immobilizer was to be in "continual use."  *Id.*  Nursing notes show that Resident #56 wore the leg immobilizer "around the clock."  CMS Ex. 22 at 125.  Similar statements were made by Teresa R. Rowe, LPN, the Wound Treatment Nurse, who indicated in a Declaration that "the physician's orders for the knee immobilizer were clear and unambiguous:  **the knee immobilizer must stay in place**."  P. Ex. 7 at 3 (emphasis added).  The reality is that nowhere in the plan of care was there any written guidance to the CNAs as to whether they*could* remove the immobilizer, how to remove the immobilizer safely in order to bathe Resident #56, the procedures to be followed while bathing him if the immobilizer was removed, and how to safely reapply the immobilizer when finished, particularly in light of the above comments regarding the amount of pain he experienced with movement.

One of the conclusions from the survey was that "[n]o specific interventions or instructions for the use of the left leg immobilizer were ordered upon the resident's admission on 12/13/17, nor was a clarification of the physician's order found that would provide specific instructions for its use and interventions."  CMS Ex. 1 at 3.  Petitioner disagrees with this conclusion, asserting that "[t]he facility did not have a choice whether to leave the immobilizer on – it was a physician's order that was clear:  the left leg knee immobilizer should always be worn."  P. Pre-Hearing Brief at 8 (citing CMS Ex. 10 at 3).

**Page 10**

It argues, "[t]he absence of further direction by the treating orthopedic surgeon or attending physician makes it clear the facility followed the instructions correctly.  That is, there was no need for clarification of these orders in the first place because the order was already clear."  P. Pre-Hearing Brief at 8-9.  Yet, at IIDR, it alleged that "staff would have removed the immobilizer each shift" in order to assess the skin "per protocol."  CMS Ex. 22 at 10.  The discrepancy between these two positions supports the need to have obtained clarification of the physician's order regarding the left leg immobilizer.  These discrepancies also reinforce the need for specific clarification in the plan of care as to how and when to perform the identified interventions, given the medical need for the left leg immobilizer.

Petitioner also argues that the plan of care addressed all of the resident's unique needs by requiring "regularly scheduled" skin assessments and body audits on a "regular basis."9
  P. Pre-Hearing Brief at 1-2.  However, as noted above, few of the skin monitoring interventions in the plan of care included any specific indication of the frequency at which they were to be performed.  CMS Ex. 11 at 9, 15-17.  "Body audits per protocol" was identified as one of the interventions for the problem of risk of pressure ulcers, with nursing as the responsible staff.  CMS Ex. 11 at 15.  Presumably, this refers to the facility's Skin Assessments policy, which conceivably could have provided guidance on the frequency of the body audits or skin assessments.  However, a review of the facility's policy statements reveals inconsistent directives regarding skin assessments, which would not have provided clear guidance to staff on the frequency of the performance of that intervention.

The record contains two different policy statements entitled "Skin Assessments."  One was reportedly provided to the surveyors on January 31, 2018.  CMS Ex. 16 at 1.  Another policy statement entitled "Skin Assessments" was included in the documentation provided by Petitioner at the time of the IIDR.  CMS Ex. 22 at 61-62.  There is an additional handwritten statement also included in the documentation provided by Petitioner at the time of the IIDR entitled "Monitoring," which is also presumed to be facility policy on skin assessment.  CMS Ex. 22 at 63.  Finally, Petitioner had "general nursing procedures for prevention of skin problems," which also contain requirements for assessing skin problems.  CMS Ex. 22 at 64-65.

The skin assessment policy at CMS Ex. 16 at 1 provides, in relevant part, that "[a]s an integral part of the pressure area prevention program, a skin assessment should be completed on admission, weekly or PRN. . . .  Cna's will assess skin during each shower/bath and notify the Charge Nurse of any findings."  The procedures to be followed in that skin assessment policy included the need to "Document on the resident's

**Page 11**

skin assessment sheet or nurse's notes."  CMS Ex. 16 at 1.  In contrast, the skin assessment policy contained in CMS Ex. 22 at 61 does not contain *any* language about CNAs assessing the skin.  That policy statement requires documentation of the examination on "individual skin assessment sheets, 'Assessment for Potential Pressure Ulcers,' to include under observation and action taken any abnormalities, reddened areas, bruises, etc."10
  CMS Ex. 22 at 61.  Entirely different procedures are described in the policy statement entitled "Monitoring."  CMS Ex. 22 at 63.  That document stated that CNAs will inspect the skin *daily*, each shift, and document any findings on the CNA Bath and Skin Report.  Assuming the normal three shifts per 24 hour period, this could be read to suggest that the CNAs would inspect the skin three times a *day*.11
  Or, this could be interpreted as a 24-hour shift, meaning the CNAs would inspect the skin once a day, which would be consistent with the use of the term "daily."  However, the language in the facility policy reflected in CMS Ex. 16 at 1 requiring the CNAs inspect the skin during each bath, coupled with the intervention in the plan of care of assisting with bathing three times a week, would suggest that the CNAs would assess the skin three times a week.  CMS Ex. 11 at 6, 8.  As a result, the directive in the plan of care to perform the skin assessments "per protocol" does not satisfy the regulatory requirement for the care plan to include "measurable objectives and timeframes" to meet Resident #56's needs because the "protocol" did not contain consistent directives regarding the frequency of those assessments, who would perform those assessments, and even where the assessment was to be recorded.

The lack of specific directives in the plan of care to address the issues raised by the left leg immobilizer is also reflected in the Treatment Administration Record.  P. Ex. 4.  Following Resident #56's readmission to the facility on December 13, 2017, a number of very specific orders were identified:

Order Dt:  12/14/17 Order #:  80
Generic Nursing Care Order Every Shift (Eight Hour)
Request Type:  Routine
Foley catheter continuous, with foleycare Q shift, cleansing with soap and water

Order Dt: dated 12/10/17 Order #:  74
Generic Treatment Order Daily at 09:00 am
Cleanse Skin tear to Left arm/elbow with NS; Pat dry; Cover with drydressing every day until healed.

**Page 12**

Order Dt: 01/13/17 Order #:  8
Snack Hour of Sleep 09:00 pm.

Order 01/12/18 Order #:  82
Catheter Care Every Shift (Eight Hour)
Foley Catheter Continuous with CatheterCare
Every Shift, cleaning with Soap and Water.
Record Urine Output Every Shift.

P. Ex. 4 at 9.

After the left leg pressure ulcer was discovered on January 30, 2018, the Treatment Administration Record was amended to add "Order Dt: 01/30/18 Order #:  91 Generic Treatment Order Daily at 09:00 am Left lower leg-clean with normalsaline apply santy and cover with telfathen wrap with kerlix daily."  P. Ex. 4 at 9.

What is notably missing from the Treatment Administration Record is any reference to any assessments of the skin under the left leg immobilizer.  It is somewhat remarkable that while the administration of snacks was documented regularly on the Treatment Administration Record, skin assessments involving removing the leg immobilizer were not.  P. Ex. 4.  Petitioner appears to acknowledge the lack of documentation of this intervention, asserting staff would have removed the immobilizer each shift to assess the skin "per protocol" and the fact that "there is no specific documentation of the performance of these interventions does not render the Comprehensive Care Plan deficient."  CMS Ex. 22 at 10.  However, the deficiencies here go beyond the lack of documentation of the performance of the task.  The Comprehensive Care Plan failed to identify specific and quantifiable interventions to address the complications resulting from the presence of the left leg immobilizer, which ultimately caused a pressure ulcer on the resident's leg.  CMS Ex. 22 at 126.  It did so in contravention of Petitioner's own policy requiring care plans to "[i]ncorporate risk factors associated with identified problems."  CMS Ex. 22 at 58.  As a result, I find the record does not document that the facility developed and implemented a comprehensive care plan that included measurable objectives and time frames and described the services to be furnished to Resident #56, as required by 42 C.F.R. § 483.21(b)(1).

***B. Petitioner was not in compliance with the requirements of 42 C.F.R. § 483.25(b)(1)(i).***

The second issue to be resolved is whether Petitioner ensured that Resident #56 received care, consistent with professional standards of practice, to prevent pressure ulcers, as required by 42 C.F.R. § 483.25(b)(1)(i).  The relevant section of that regulation provides that:

**Page 13**

Based on the comprehensive assessment of a resident, the facility must ensure that–

(i) A resident receives care, consistent with professional standards of practice, to prevent pressure ulcers and does not develop pressure ulcers unless the individual's clinical condition demonstrates that they were unavoidable;

Under the statute and the "quality of care" regulation, each resident must receive, and the facility must provide, the necessary care and services to allow a resident to attain or maintain the highest practicable physical, mental, and psychosocial well-being in accordance with the resident's comprehensive assessment and plan of care.  Act § 1819(b); 42 C.F.R. § 483.25.  The Departmental Appeals Board (DAB) has explained that 42 C.F.R. § 483.25 imposes an implicit duty on a facility to provide care and services that, at a minimum, meet accepted "professional standards of quality."  *Spring Meadows Health Care Ctr.*, DAB No. 1966 at 17 (2005), citing 42 C.F.R. § 483.25.12
  To this end, the DAB has further explained that "[t]o be in substantial compliance, a SNF must ensure, among other requirements, that a resident who enters the facility without pressure sores does not develop pressure sores unless the individual's clinical condition demonstrates that they were unavoidable."  *The Harborage,* DAB No. 2905 at 1-2 (2018).13
  The Board has also held that a prima facie case of noncompliance exists when the evidence establishes that a nursing home resident having no pressure sores on admission develops a pressure sore in the facility, and the burden then shifts to the facility to establish that the pressure sore was clinically unavoidable.  *Koester Pavilion,* DAB No. 1750 at 34 (2000).  The Board further indicated that evidence that a resident developed a pressure sore while under a facility's care is enough to show a deficiency in the absence of clinical evidence from the facility proving such negative outcomes to have been clinically unavoidable.  *Woodland Village Nursing Ctr.,* DAB No. 2172 at 13 (2008).

The record clearly establishes that Resident #56 was re-admitted to the facility on December 13, 2017 without a pressure sore.  The record further establishes that on January 30, 2018, a "[f]acility acquired" and "[u]nstageable" pressure ulcer was discovered on Resident #56's left leg "caused by [the] leg immobilizer her [sic] wears."  CMS Ex. 17; CMS Ex. 22 at 126.  The question then becomes whether the resident received care, consistent with professional standards of practice, to prevent this pressure

**Page 14**

ulcer from developing or whether his clinical condition was such that the pressure ulcer was unavoidable.

Petitioner argues that, in fact, the facility conducted "regularly scheduled" skin assessments and implemented body audits on a "regular basis."  P. Pre-Hearing Brief at 1-2.  The DON asserted that Resident #56's skin was assessed on December 10, 2017,14
 December 13, 2017, December 14, 2017, December 20, 2017, December 24, 2017, December 29, 2017, January 3, 2018, January 7, 2018, January 14, 2018, January 21, 2018, January 28, 2018, and January 30, 2018.  P. Ex. 5 at 4-5.  Similarly, the Wound Treatment Nurse testified that the resident had skin assessments completed on the following dates:

Skincare assessment dated 12.10.2017
	Skincare assessment dated 12.13.2017
	Skincare assessment diagram dated 12.14.17
	Skincare assessment dated 12.20.2017
	Skincare assessment dated 12.24.2017
	Skincare assessment dated 12.29.2017
	Skincare assessment diagram dated 1.3.18
	Skincare assessment dated 01.07.2018
	Skincare assessment diagram dated 1.14.18
	Skincare assessment diagram dated 1.21.18
	Skincare assessment dated 01.28.2018
	Skincare assessment dated 01.30.2018P. Ex. 7 at 2-3.

The Wound Treatment Nurse further testified that the "nursing staff at the facility was aware of Resident #56's risk for potential skin breakdown, implemented the necessary interventions to reduce the risk, removed the knee immobilizer on a regular basis to assess skin integrity, and documented the assessments accordance [sic] with the Federal regulations."  P. Ex. 7 at 3.

There is no dispute that some type of an assessment was performed on the dates referenced above.  However, the inquiry here is whether those inspections included an assessment of the skin under the left leg immobilizer.  The record is clear that *some* skin assessments did include examination of the left leg under the immobilizer.  When Resident #56 was readmitted to the facility from the hospital on December 13, 2017, nursing notes indicated there was faded bruising behind the left knee and shin and a reddened left knee underneath the immobilizer.  CMS Ex. 14 at 1; CMS Ex. 22 at 98.  A small red area was noted at the left upper and inner thigh and the buttocks were also

**Page 15**

reddened.  An old scar was observed on the right knee.  CMS Ex. 22 at 98.  The following day, December 14, 2017, an untitled drawing of a body, which was alleged to be a skincare assessment diagram, indicated two bruises on the left knee, red coccyx, red areas in the inner thighs, a left elbow skin tear, and an old scar on the right knee.  CMS Ex. 22 at 87.  The next record of any skin assessment was on December 20, 2017, when a Weekly Skin and Range of Motion (ROM) Assessment form was completed.  CMS Ex. 22 at 75-76.  At that time, a bruise on the left lower leg and left knee, slight redness in the coccyx, a skin tear at the left elbow, and a discolored area of the right knee were noted.  Bruising to the upper and lower extremities was also reported on that same form.  The detailed information regarding the condition of the left leg demonstrates that the skin under the immobilizer was observed in these assessments.

However, four days later, on December 24, 2017, a Weekly Skin and ROM Assessment was conducted.  CMS Ex. 22 at 77.  There is no evidence that the skin under the left leg immobilizer was assessed during that examination.  The only abnormality reported was a skin tear in the left upper arm.  There was no mention of the bruises on the left leg observed on December 20, 2017.  The assessment notes make no comment on the left leg whatsoever, including any observation of the left leg immobilizer.  The form does not cite any limitations in the lower extremities, including the left hip.

Another Weekly Skin and ROM Assessment was conducted on December 29, 2017.  CMS Ex. 22 at 79.  Petitioner argues that an LPN assessed the area covered by the knee immobilizer on that date and reported "knee immobilizer on the left leg-skin intact."  P. Pre-Hearing Brief at 9; P. Ex. 5 at 5.  The note from this assessment merely indicates that the knee immobilizer was on the left leg and "skin intact."  CMS Ex. 22 at 79.  A skin tear on the left elbow was also observed.  *Id.*  While the actual note from this examination does not specifically indicate that the immobilizer was removed for the examination, it is accepted as such for the sake of argument.

On January 3, 2018, another untitled drawing of a body was completed.  CMS Ex. 22 at 88.  That drawing contains absolutely *no* reference to the left leg or the left leg immobilizer and provides no evidence to indicate that the skin under the immobilizer was inspected.  The drawing shows only a mole on the face and does not even report the old scar on the right knee or the skin tear on the left elbow, which appears in the examinations before and after this.

A Weekly Skin and ROM Assessment was conducted on January 7, 2018.  CMS Ex. 22 at 81.  The report of that examination notes the skin tear on the left elbow but contains no comment on the skin of the left leg or the left leg immobilizer, though it did recognize a limitation to Resident #56's leg due to a left hip fracture.  *Id.*  An untitled drawing of a body dated January 14, 2018 reported a skin tear on the left elbow and a facial mole.  CMS Ex. 22 at 89.  This drawing contains no comment on the skin of the left leg or the left leg immobilizer.  Similarly, an untitled drawing of a body dated January 21, 2018

**Page 16**

noted the skin tear on the left elbow and facial mole, but contained no comment whatsoever on the left leg or the left leg immobilizer.  CMS Ex. 22 at 90.

On January 28, 2018, a Weekly Skin and ROM Assessment was reported.  CMS Ex. 22 at 83.  On that form, no skin tears, abrasions, or breakdowns were reported.  There were no comments on the left leg, other than the statement that the resident wears the immobilizer at all times.

Two days later, on January 30, 2018, the leg immobilizer was removed during the survey.  CMS Ex. 22 at 126; CMS Ex. 14 at 43.  At that time, an open area under the left leg measuring 5 cm x 1.5 cm x 0.1 cm with yellow slough was observed.  Swelling around the wound was also reported at that time.  CMS Ex. 14 at 44.

At one point, Petitioner asserted there was also a full body assessment on January 18, 2018.15
  CMS Ex. 22 at 11.  It asserted that "the narrative nursing note from January 18, 2018 reflects a full body assessment was performed with no discoloration noted to the resident's body, except to bilateral arms which were already present."  *Id.*  A review of that treatment note, which is an Interdisciplinary Note, indicates that on January 18, 2018, Resident #56 was observed on the floor in prone position, holding his left hip, on top of the landing mat.  CMS Ex. 22 at 122.  He was noted to be moaning and groaning and guarding the left lower extremity.  A Hoyer lift was used to place the resident back into bed, and an X-ray of the left hip was ordered.  *Id.*  Petitioner points to the statement that "no discoloration noted to resident's body with assessment except to B/L arms, which were already present"16
 as evidence of a full body skin assessment.  CMS Ex. 22 at 11.  However, this note does not indicate that the left leg immobilizer was removed, at any point, during this encounter.  Moreover, it would be difficult to imagine exactly when and how this would have occurred, given the fact that Resident #56 was found on the floor, moaning and holding his left hip.  With the level of left hip pain reported and the concern for an additional hip injury requiring the use of a Hoyer lift to get Resident #56 back into bed, it would appear highly unlikely that the leg immobilizer would have been removed at that time.  Absent a specific statement that the left leg immobilizer was removed and the left leg skin was inspected during this incident, I do not find this to be a documented assessment of the skin on the left leg.

A review of the skin assessments conducted from December 14, 2017 through January 28, 2018 indicates, *at most*, three that documented an assessment of the skin under the

**Page 17**

immobilizer:  December 14, 2017, December 20, 2017, and, possibly, December 29, 2017.  CMS Ex. 22 at 87, 76, and 79.  There is no documentation of *any* examinations of the skin under the left leg immobilizer in January 2018 until January 30, 2018, when the immobilizer was removed during the survey.

Petitioner appeared to acknowledge at IIDR that documentation is lacking for its position that the immobilizer was removed and the skin underneath was inspected regularly.  It asserted that the fact "there is no specific documentation regarding the performance of these interventions does not render the Comprehensive Care Plan deficient."  CMS Ex. 22 at 10.  In a related argument, it objected to the finding of CMS that 7 of 10 skin assessments from December 14, 2017 through January 30, 2018 did not assess the skin condition of the affected left leg, stating that those assessments "only reflect those areas of skin alteration, and do not specifically mention any areas which are normal.  To do otherwise would to not be reflective of the lack of concern for the unaffected areas."  CMS Ex. 22 at 12.  While the point of the latter sentence is not clear, it appears that Petitioner was arguing that facility staff would only record findings and observations if they were positive or abnormal.  However, this position is not consistent with standard nursing or medical practice or the practice of the facility in other nursing notes.

According to Madhuri Reddy, MD, the "standard of practice for documenting skin assessment is to clearly document the observation each time the resident's skin is examined, even if no skin issues were identified."  CMS Ex. 32 at 4.  Similarly, Arnette Murphy, R.N., indicated that "standard nursing practice is to document all patient encounters and specific care/treatments provided.  Detailed documentation is critical for patient safety and continuity of care."  CMS Ex. 33 at 3.  Petitioner has not requested cross examination to challenge the statements of these witnesses regarding appropriate standards of care.  As a result, they are accepted as standard practice for skin examinations.

These standards of care are also consistent with the facility's own protocol for doing skin assessments.  CMS Ex. 16 at 1.  This policy clearly requires staff to "Inspect the skin thoroughly" and "Document on the resident's skin assessment sheet or nurse's notes."  *Id.*  Similarly, the facility policy at CMS Ex. 22 at 61 requires staff to document and "include" abnormalities, rather than *only* identifying abnormalities.  There is nothing in the facility's own written policies that indicates only abnormal findings were to be documented.  Moreover, the facility's own interdisciplinary nursing notes utilize this standard of practice and include negative findings during examinations, such as toes were warm to touch, pedal pulses were strong and regular, and lungs were clear.  CMS Ex. 14 at 5, 8-10.
Petitioner's ADON testified that skin examinations were also conducted regularly by the CNAs.  She notes that "per protocol, CNA's conduct daily skin inspections on each shift, and they document any findings."  P. Ex. 6 at 2.  While I would agree that this is the

**Page 18**

procedure described in CMS Ex. 22 at 63, I do not agree with the subsequent statement that "there is documentation that Resident #56 had routine skin assessments and received baths on a regular basis, which would have provided additional observations for staff to assess Resident #56's skin."  P. Ex. 6 at 4.  There is *no* documentation of daily skin inspections with the immobilizer removed or inspections of the skin under the left leg immobilizer during the regular baths provided by the CNAs.17
  There is no evidence that the skin inspections by the CNAs were documented on the resident's skin assessment sheet or nurse's notes, as required by the facility's skin assessment policy.  CMS Ex. 16 at 1; CMS Ex. 22 at 61.  Instead, during the survey, the CNAs were reported to record any skin changes or issues they noticed during resident bathing on a bath ticket, which was given to the unit nurse for further evaluation, but the ticket itself was not kept.  CMS Ex. 1 at 7.

Findings from the skin assessments by nursing staff strongly suggest that daily assessments of the skin under the leg immobilizer or skin assessments three times a week during bathing when the leg immobilizer was allegedly removed were *not* performed by the CNAs.  During the skin assessments performed by nursing staff on December 13, 2017 and December 14, 2017, bruises behind the left knee and redness on the coccyx were reported.  CMS Ex. 22 at 68, 71, 87.  These findings continued and were observed during the skin assessment by nursing staff one week later, on December 20, 2017.  CMS Ex. 22 at 75-76.  However, there is no record of *any* observation of these findings by CNAs during the week of December 14, 2017 through December 19, 2017, while they were purportedly doing daily skin inspections by removing the leg immobilizer every shift.  P. Ex. 6 at 2.  Even assuming the CNAs observed these findings after removing the leg immobilizer and recorded the observations on a bath ticket, there is no evidence that the unit nurse followed up on the CNAs' observations.  It is possible that nursing staff did follow up but did not record this, or nursing staff decided that follow up was not necessary until the regular weekly skin assessment on December 20, 2017 and did not record this.  It is also possible that the CNAs did not observe these findings because the leg immobilizer was not removed during bathing and skin examinations.  Regardless of the reason, I do not find that the "documentation" of routine skin assessments by the CNAs exists in this record.  As a result, I give little weight to the testimony of the above witness on this issue.  P. Ex. 6 at 2.

Petitioner's Wound Treatment Nurse claims that the absence of any evidence of skin problems prior to January 30, 2018 could be due to the fact that "pressure sores can develop quickly and be extremely advanced when they do appear."  P. Ex. 7 at 2.  She

**Page 19**

cites as support for this statement several articles from the United Kingdom.  Despite the fact that these articles were not submitted for the record, I will presume that this is an accurate statement for the purpose of evaluating Petitioner's position.  This argument is apparently made to counter the discrepancies between the treatment notes on January 28, 2018 and January 30, 2018.  As noted above, Resident #56 reportedly had a Weekly Skin and ROM Assessment on January 28, 2018.  At that time, no skin tears, abrasions, or breakdowns were reported, although this examination does not make any reference to the skin on the left leg, including whether the immobilizer was removed for the examination, other than to note that he wears an immobilizer at all times.  CMS Ex. 22 at 83.  However, *two days later*, on January 30, 2018, when the immobilizer was removed during the state agency survey, an open area with yellow slough at the proximal end of the left leg brace, measuring 5.0 cm x 1.5 cm x 0.1 cm, was observed.  CMS Ex. 14 at 43- 44; CMS Ex. 22 at 126.  The ulcer was characterized as unstageable and facility acquired.  CMS Ex. 17.

Petitioner's Wound Treatment Nurse asserts that "[e]ven if facility staff conduct appropriate and timely skin assessments . . . pressure ulcers can develop in as quickly as one (1) hour, depending on the external pressure being exerted."  P. Ex. 7 at 2.  Cited as support for this statement is the previously referenced but unsubmitted study involving human, animal, and in vitro subjects.  *Id.*  Considering this as a medical opinion, I will accept that this is medically possible.  However, I have also considered the opinions offered by Dr. Reddy, who indicated that the:

treatment nurse's description of Resident #56's pressure ulcer is consistent with the characteristics of Stage 3, Stage 4 or unstageable pressure ulcers due to the presence of slough.  Pressure ulcers first appear as red or pink discoloration of skin and gradually develop into more serious stage.  Within a reasonable degree of medical certainty, it is highly unlikely that Resident #56 developed a new pressure ulcer and that ulcer deteriorated into an unstageable open wound within a day or two.  The fact that Resident #56 developed a pressure ulcer under the immobilizer and it already had progressed into an unstageable state with slough is probable indication that the skin under the immobilizer had not been frequently monitored, certainly not on a daily basis.

CMS Ex. 32 at 4-5.

Petitioner's Wound Treatment Nurse counters this statement by noting that "Dr. Reddy opined about 'probabilities,' and she could not make a definitive statement on whether the skin under the immobilizer was monitored and assessed in accordance with industry standards."  P. Ex. 7 at 3 n.5.  Petitioner's witness somewhat mischaracterizes Dr. Reddy's opinion.  In fact, Dr. Reddy's statement was that "[i]n this case, the nursing and clinical record was entirely inadequate to show what kind of monitoring and care were provided for the skin under the immobilizer."  CMS Ex. 32 at 4.  I note again that

**Page 20**

Petitioner did not request to cross examine Dr. Reddy about the opinions expressed, and there is little basis for rejecting those opinions, which are given great weight.

In requesting IIDR, Petitioner pointed to the provisions of 42 C.F.R. § 483.25(b)(1)(i) and asserted that "guidelines allow for skin breakdown which is unavoidable and indeed, this is a case where the skin breakdown the resident had was unavoidable."  CMS Ex. 22 at 11.  However, it offers no evidence for this position.  In contrast, Dr. Reddy stated that Resident #56 was at greater risk of developing ulcers because he had limited mobility and was wearing a knee immobilizer that was in constant contact with his skin but, because there was no record that the facility took appropriate steps to adequately monitor and clean the resident's skin under the immobilizer, "Resident #56's pressure ulcer was avoidable."  CMS Ex. 32 at 5.  Dr. Reddy's position regarding the risk the leg immobilizer posed is also consistent with one of Petitioner's skin care policies, which counseled staff to "[b]e alert to areas of pressure created by casts, braces or special shoes."  CMS Ex. 22 at 65.

The Board has held that "clinically unavoidable" in this context "means not just unsurprising given the clinical condition of the resident, but incapable of prevention **despite appropriate measures taken in light of the clinical risks."***Harmony Court*, DAB No. 1968 at 11 (2005) (emphasis added), *aff'd, Harmony Court v. Leavitt*, 188 F. App'x 438 (6th Cir. 2006).  Moreover, "[a] facility cannot meet its burden of proof on the issue of whether a pressure sore is unavoidable merely by establishing that the resident's clinical condition heightens the risk that pressure sores will develop." *Id.* (quoting *Ivy Woods Health Care and Rehab. Ctr.*, DAB No. 1933 at 9 (2004), *aff'd*, *Ivy Woods Health Care & Rehab. Ctr. v. Thompson,* No. 04-4164 (6th Cir. Oct. 19, 2005)); *see also Edgemont Healthcare,* DAB No. 2202 at 7-8 (2008).  And, as noted above, the Board has stated that evidence showing that a resident developed a pressure sore while under a facility's care is enough to show a deficiency in the absence of "clinical evidence from the facility proving such negative outcomes to have been clinically unavoidable."  *Woodland Village Nursing Ctr.,* DAB No. 2172 at 13.  In this case, in the absence of any "clinical evidence from the facility" whatsoever that the pressure ulcer was "clinically unavoidable," and the lack of evidence that all "appropriate measures" were taken, as discussed above, I find that Petitioner has not met its burden of showing that Resident #56's pressure ulcer was unavoidable.

Petitioner's ADON finally alleges that "[h]ad the facility not been regularly caring for and assessing this area (given the resident's condition) skin breakdown may have occurred sooner, although I am aware of the fact that pressure ulcers can develop very quickly under certain circumstances."  P. Ex. 5 at 5.  In essence, Petitioner appears to argue that it should not be found to have been noncompliant because it took 45 days for the pressure ulcer to develop after readmission.  P. Pre-Hearing Brief at 9.  However, 42 C.F.R. § 483.25(b)(1)(i) does not establish a time limit for the provision of quality care to prevent pressure ulcers.  Whether the pressure ulcer developed on the 2nd day or the 45th

**Page 21**

day is irrelevant.  The regulatory requirement is to provide care to a resident, consistent with professional standards of practice, to prevent pressure ulcers.  In this case, Resident #56 was not afforded this level of care.

I find that Petitioner was not in substantial compliance with 42 C.F.R. §§ 483.21(b)(1) and 483.25(b)(1)(i) because facility staff did not develop and implement a comprehensive care plan for Resident #56 and failed to provide Resident #56 with the necessary care to prevent a pressure ulcer.  I also find that Resident #56 suffered actual harm as he developed a facility acquired, unstageable pressure ulcer.  This conclusion supports deficiencies cited at a scope and severity level "G" for actual harm.

***II.  The undisputed evidence demonstrates that the penalty imposed is reasonable.***

The next issue for consideration is whether the CMP is reasonable.  To resolve this issue, I have applied the factors specified 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 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.

In reaching a decision on the reasonableness of the CMP, I must make an independent determination about "whether the evidence presented on the record concerning the relevant regulatory factors 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 other factors involved (financial condition, facility history, and culpability)."  *CarePlex of Silver Spring,* DAB No. 1683 at 8 (1999).

In this case, CMS imposed a per instance CMP of $12,500.00, which is slightly above the middle range of per instance penalties ($2,097 to $20,965).  42 C.F.R. §§ 488.408(d)(1)(iv); 488.438(a)(2); 45 C.F.R. § 102.3 (2017); 82 Fed. Reg. 9174, 9182-83 (Feb. 3, 2017).  Considering that CMS might have imposed instead a comparable per-day penalty for multiple days of substantial noncompliance, this penalty is modest.  *See Plum City Care Ctr.,* DAB No. 2272 at 18-19 (2009) (observing that even the maximum per-instance CMP can be a "modest penalty when compared to what CMS might have imposed.").

Applying the relevant regulatory factors here, there is a history of facility noncompliance, including previous deficiency citations at the immediate jeopardy level in the survey conducted on January 20, 2017.  CMS Ex. 7 at 1.

**Page 22**

Petitioner asserts that it is seeking an "equitable remedy" but does not claim that its financial condition affects its ability to pay and has not submitted any financial documents indicating such payment would cause the facility a hardship should it be required to pay the CMP.  P. Pre-Hearing Brief at 10.

The facility was culpable in its failure to care plan and implement the necessary interventions to address Resident #56's elevated risk of developing a pressure ulcer, which caused him actual harm.  For these reasons, I find that the imposed CMP in the amount of $12,500.00 is reasonable.  I further find that, because of the serious harm incurred by Resident #56, either of the deficiencies, standing alone, would be sufficient to show that the penalty is reasonable.

III.  Conclusion

I find that the facility was not in substantial compliance with 42 C.F.R. §§ 483.21(b)(1) and 483.25(b)(1)(i).  The per instance penalty imposed of $12,500.00 is reasonable.


          /s/
        Mary M. Kunz

                      Administrative Law Judge
      1. Although CMS initially imposed additional remedies of Denial of Payment for New Admissions and termination of Medicare participation, these remedies did not go into effect because the facility achieved substantial compliance before the effective dates of the remedies.  CMS Ex. 5 at 1. back to note 1
                      2. The case was originally assigned to Judge Weyn, but was reassigned to me on January 6, 2021. back to note 2
                      3. Throughout this decision, the terms "pressure ulcers" and "pressure sores" are used interchangeably. back to note 3
                      4. My findings of fact and conclusions of law are set forth in bold and italic text in the discussion captions of this decision. back to note 4
                      5. According to the facility's Skin Assessment policy, if a resident has a score of 8 or higher on the skin assessment scale, the resident is considered to be at risk for skin problems.  CMS Ex. 22 at 61. back to note 5
                      6. The numbers given to the identified problems changed from the plan of care printed on December 14, 2017 and the one printed on December 21, 2017.  Compare CMS Ex. 22 at 13-31, 32-56 with CMS Ex. 11 at 1-18.  For example, the problem of self-care deficit is identified as problem #10 in the plan of care printed on December 14, 2017 and as problem #5 in the plan of care printed on December 21, 2017.  CMS Ex. 22 at 19, 38; CMS Ex. 11 at 6.  Because Petitioner has consistently referred to the specific problems with the enumeration found in the December 14, 2017 printing, those numbers will be utilized in this decision.  P. Pre-Hearing Brief at 5-7; P. Ex. 5 at 3-4; P. Ex. 6 at 2-3.  Further, Petitioner only identified in its brief some of the interventions contained in the care plan, resulting in the non-consecutive numbering for the interventions listed. back to note 6
                      7. There is a difference in the identification of the problem relating to the risk of pressure ulcers between the version printed on December 14, 2017 and the one printed on December 21, 2017.  In the earlier version, the problem is identified as "Mr. (redacted) was readmitted with redness to his buttocks.  He is at risk for Pressure ulcer related to . . . ."  CMS Ex. 22 at 28.  The reference to reddened buttocks was not contained in the versions of this problem cited at CMS Ex. 22 at 47 and CMS Ex. 11 at 15.  The reason for this change is not clear. back to note 7
                      8. Surprisingly, the presence of the leg immobilizer was not identified as a risk factor for pressure ulcers, despite the facility's own policy on Assessment of Skin Condition, which indicated that it was necessary to "[b]e alert to areas of pressure created by casts, braces or special shoes."  CMS Ex. 22 at 65. back to note 8
                      9. The difference between a skin assessment and a body audit was not explained in this record, and it is not clear whether they are the same procedure. back to note 9
                      10. This document is dated 10/96 but there is no indication it was not still in effect or had been replaced by the document at CMS Ex. 16 at 1.  That the facility submitted it at IIDR creates an inference that it was still in effect. back to note 10
                      11. This interpretation is consistent with the definition of "shift" in the Treatment Administration Record, which defines "Every Shift" as "(Eight Hour)."  P. Ex. 4 at 2. back to note 11
                      12. While the Board recognized an implicit duty under a prior version of the regulation, the current version makes the implicit explicit. back to note 12
                      13. In its decision, the DAB cited 42 C.F.R. § 483.25(c), which contains identical language to 42 C.F.R. § 483.25(b)(1), the regulation in effect at the time of the survey which provided the basis for CMS's determination of noncompliance. back to note 13
                      14. This date is noted to be prior to the placement of the left leg immobilizer. back to note 14
                      15. Petitioner did not address the January 18, 2018 assessment in its pre-hearing brief.  In an abundance of caution, I have addressed the assessment in this decision. back to note 15
                      16. Interestingly, the discoloration in the upper extremities referred to in this treatment note as "already present" was not referenced in the skin assessments conducted on January 14, 2018 or January 21, 2018.  CMS Ex. 22 at 89-90. back to note 16
                      17. There is also no documentation that the resident "received baths on a regular basis" in this record, but I will accept that to be an accurate statement.  However, the relevant inquiry here is whether the skin under the left leg immobilizer was inspected by the CNAs during the regular baths, and there is no documentation that it was. back to note 17 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