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
                              2020
                              Centre Pointe Health and Rehabilitation Center, DAB CR5715 (2020)
 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

                    




Centre Pointe Health and Rehabilitation Center, DAB CR5715 (2020)








  
  
    

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





Centre Pointe Health and Rehabilitation Center
(CCN: 10-5563),
Petitioner,

v.

Centers for Medicare & Medicaid Services,
Respondent.
Docket No. C-18-1030Decision No. CR5715September 22, 2020

        
              
    

      DECISION

Found:

1) Petitioner violated 42 C.F.R. § 483.2l(b)(l)(Tag F656 – Develop/Implement Comp. Care Plan) at a D level of scope and severity; and

2) Petitioner violated 42 C.F.R. § 483.25(b)(l)(Tag F686 – Treatment/Services to Prevent/Heal Pressure Ulcers) at a G level of scope and severity; and

3) Petitioner violated 42 C.F.R. §§ 483.20(f)(5) and 483.70(i)(l)-(5)(Tag F842 – Resident Records) at a D level of scope and severity; and

4) Petitioner violated 42 C.F.R. § 483.75(g)(2)(ii)(Tag F867Quality Assessment and Assurance/Improvement Plan) at a D level of scope and severity; and

5) Petitioner be and is hereby assessed a civil money penalty (CMP) in the amount of $12,110.

**Page 2**

Glossary:

AHCA

Florida Agency for Health Care Administration

ALJ

Administrative law judge

APO

Acknowledgement and Prehearing Order

CC

Connie E. Cheren

CPHRC

Centre Pointe Health and Rehabilitation Center

CM

Centimeters

CMP

Civil money penalty

CMS

Centers for Medicare and Medicaid Services

CMS Ex.

Centers for Medicare and Medicaid Services Exhibit

CNA

Certified nursing assistant

CPHB

CMS Pre-Hearing Brief

CWCP

Contracted wound care physician

Ball

Debra Ball, Surveyor

DON

Director of Nursing

Ex.

CRD/ACTS Document number (Exhibit)

HHS

Dept. of Health and Human Services

HSC

Health Care Surrogate

ICU

Intensive Care Unit

IDR

Informal Dispute Resolution

IHA

In House Acquired

IN

Imposition Notice

KE

Karen Lou Kennedy-Evans

LPN

Licensed Practical Nurse

MASD

Moisture– associated incontinence dermatitis

MDS

Minimum Data Sheet

MS

Multiple sclerosis

MSMD

Michael Silverman, MD

P. Ex.

Petitioner Exhibit

PIP

Performance Improvement Plan

PO

Procedural Order

Petitioner

Centre Pointe Health and Rehabilitation Center

POA

Present on Admission

PPHB

Petitioner Pre-Hearing Brief

QAA

Quality Assessment and Assurance

QAPI

Quality Assurance and Performance Improvement

RIS

Resident Information Sheet

RG

Rebecca Galloway

RN

Registered Nurse

SNF

Skilled nursing facility

SOD

Statement of deficiencies

**Page 3**

S/S

Scope and Severity

TAR

Treatment Administration Record

UTI

Urinary tract infection

I.  JURISDICTION

I have jurisdiction to hear this case pursuant to my appointment by the Secretary of Health and Human Services and my authority under the Administrative Procedure Act (5 U.S.C. §§ 554-556; 5 U.S.C.A. § 3106; 5 C.F.R. §§ 930.201 et seq.; Social Security Act (Act) § 1128A(c)(2); 42 C.F.R. § 488.408(g), and 42 C.F.R. § 498.3(b)(13)).1

II.  PROCEDURAL BACKGROUND

A complaint survey was conducted April 3–4, 2018, by the Florida Agency for Health Care Administration (AHCA) which alleged Petitioner was not in substantial compliance with federal health and safety requirements.  (CMS Pre-Hearing Brief (CPHB), p. 1; CMS Ex. #1).

The Centers for Medicare and Medicaid Services (CMS) issued an Imposition Notice (IN) on April 19, 2018, imposing a civil money penalty (CMP) of $12,110.  (CMS Ex. #2).

A revisit survey was conducted on May 16, 2018, after which CMS found that Petitioner had returned to substantial compliance as of the date of the revisit.  (CMS Exs. #3 and #4).

Based on the complaint survey conducted April 3-4, 2018, CMS determined the nursing home was noncompliant with the following regulations: (CMS Pre – Hearing Brief, p. 2; CMS Ex. #1).

42 C.F.R. § 483.21(b)(1)(Tag F656 – Develop/Implement Comp. Care Plan) at a D level of scope and severity;
	42 C.F.R. § 483.25(b)(1)(Tag F686 – Treatment/Services to Prevent/Heal Pressure Ulcers) at a G level of scope and severity;
	42 C.F.R. §§ 483.20(f)(5) and 483.70(i)(l)-(5)(Tag F842 – Resident Records) at a D level of scope and severity;
	42 C.F.R. § 483.75(g)(2)(ii)(Tag F867-Quality Assessment and Assurance/Improvement Plan) at a D level of scope and severity.**Page 4**

An Informal Dispute Resolution (IDR) was conducted on May 9, 2018.  The IDR Panel agreed to uphold the deficiencies as follows:

F0686--S/S:  G – 483.25(b)(1)(i)(ii) – Treatment/svcs to prevent/heal ulcer – Upheld

F0867-- S/S:  G – 483.75(g)(2)(ii) – Qapi/qaa – Improvement activities – Upheld

(CMS Ex. #5).

Centre Pointe Health and Rehabilitation Center (CPHRC/Petitioner) filed a Request for Hearing2
 appealing all deficiencies.

On June 25, 2018, Judge Hughes issued Acknowledgment and Prehearing Orders (APO).3

CMS filed a Pre-Hearing Brief with attachments on September 24, 2018.4

Petitioner filed a Pre-Hearing Brief (PPHB) with attachments on November 5, 2018.5

CMS filed Objections to Petitioner's Exhibits and Witnesses on November 15, 2018.6

Petitioner filed a Motion for Leave to File Response to CMS' Objections to Petitioner's Exhibits and Witnesses on November 19, 2018.7

**Page 5**

CMS filed a Response to Petitioner's Motion for Leave to File Response to CMS Objections on November 20, 2018.8

Petitioner's Motion for Leave to File Response to CMS' Objections to Petitioner's Exhibits and Witnesses was granted on November 27, 2018.9

On May 11, 2020 this case was transferred to the undersigned.10

Judge Hughes' APO provided in pertinent part:

A hearing to cross-examine witnesses will be necessary only if a party files admissible, written direct testimony, and the opposing party asks to cross-examine.11

Neither party filed a request to cross examine the other's witnesses.

On May 21, 2020, I issued a Procedural Order (PO) advising the parties that since neither party had submitted a request to cross-examine opposing witness(es), this case was ready for a decision on the written record.12

III.  BACKGROUND

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

The Secretary contracts with state survey agencies to survey skilled nursing facilities in order to determine whether they are in substantial compliance.  Act

**Page 6**

§ 1864(a); 42 C.F.R. § 488.20.  Each facility must be surveyed annually, with no more than fifteen months elapsing between surveys, and may 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).

In this case the AHCA conducted a complaint survey on April 3 and 4, 2018, which alleged Petitioner was not in substantial compliance with federal and health safety requirements as set forth below.

IV.  LAW

42 C.F.R. § 483.20(f)(5)
42 C.F.R. § 483.21(b)(l)
42 C.F.R. § 483.25(b)(l)
42 C.F.R. § 483.70(i)(l)-(5)
42 C.F.R. § 483.75(g)(2)(ii)

V.  ISSUE

Whether Petitioner failed to comply with the requirements of 42 C.F.R. § 483 et seq., a regulation that governs the care a skilled nursing facility must provide to its residents in order to prevent the development of pressure sores; and whether CMS's remedy determination was reasonable.  Specifically, did Petitioner violate provisions of 42 C.F.R. § 483 et seq., as alleged in the IN?

42 C.F.R. § 483.2l(b)(l)(Tag F656 – Develop/ImplementComp. Care Plan) at a D level of scope and severity;
	42 C.F.R. § 483.25(b)(l)(Tag F686 – Treatment/Services to Prevent/Heal Pressure Ulcers) at a G level of scope and severity;
	42 C.F.R. §§ 483.20(f)(5) and 483.70(i)(l)-(5)(Tag F842 – Resident Records) at a D level of scope and severity;
	42 C.F.R. § 483.75(g)(2)(ii)(Tag F867-Quality Assessment and Assurance/Improvement Plan) at a D level of scope and severity.VI.  ADMISSION OF EVIDENCE AND TESTIMONY

All exhibits and replacement exhibits filed by the Centre Pointe Health and Rehabilitation Center (CCN: 10-5563) and Centers for Medicare & Medicaid Services respectively were received into evidence as set forth in my Order of July 1, 2020.13

**Page 7**

VII.  SUMMARY OF TESTIMONY AND EVIDENCE

**A. Agency's Case**

Centre Pointe Health and Rehabilitation Center (Petitioner) is a skilled nursing home located in Tallahassee, FL.  As of April 8, 2018, Petitioner had 118 total residents.  (CMS Ex. #7).

On April 3 and 4, 2018, Debra Ball (Ball), conducted a complaint survey of Petitioner to investigate a complaint with respect to Resident #1, but also to review records relevant to other patients.  As a part of her investigation she made observations and interviewed employees and residents, a wound care physician and the Health Care Surrogate (HSC) for Resident #1.  She took contemporaneous notes of observations and interviews, reviewed and copied resident charts and medical records.  (CMS Ex. #6).  Ball's observations and findings are set forth in CMS Ex. #1.

**1. 42 C.F.R. § 483.2l(b)(l)(Tag F656 – Develop/Implement Comp. Care Plan) at a D level of scope and severity.**

42 C.F.R. § 483.2l(b)(l) requires a facility to develop and implement a comprehensive person-centered care plan for each resident, consistent with resident rights that include measurable objectives and time frames to meet a resident's medical, nursing and mental and psychological needs that are identified in the comprehensive assessment.

CMS alleged Petitioner failed to develop a comprehensive plan of care for use of an indwelling catheter for Resident #3.  (CMS Ex. #1, p. 2).

**Resident #3**

On 04/03/18, Ball observed that Resident #3 had an indwelling Foley catheter which did not have a strap to prevent the catheter from tugging or moving.  Ball queried Employee C about the absence of a strap at the time of the observation.  Employee C, a certified nursing assistant (CNA), said she had seen a strap used before, but was unable to verbalize why a strap was needed, and then proceeded to obtain a strap to secure the catheter for Resident #3.  (CMS Ex. #1, p. 2).  Treatment Administration Record (TAR) entries specified the catheter tubing should be secured to the resident's leg.  (CMS Ex. #10, p. 96).

An interview of Employee W, the dedicated charge nurse, on 04/03/18 revealed certified nursing assistants (CNA) were responsible for performing care for the indwelling catheters, including emptying the bag and cleaning the catheter, while a licensed practical nurse (LPN) was responsible for documenting the care by the CNA on the resident's TAR.  (CMS Ex. #1, pp. 2 to 3; CMS Ex. #10, p. 96).

**Page 8**

Ball's review of the Resident #3's March and April TARs determined there was no documentation related to the care of catheter (CMS Ex. # 10, pp. 73 to 110; CMS Ex. #1, p. 3) or a plan of care for the indwelling catheter.  Review of Resident #3's care plan determined Petitioner failed to include a plan of care for use of the indwelling urinary catheter.  (CMS Ex. #1, p. 3).

On 04/03/18 the Director of Nursing (DON) reviewed the TARs and confirmed there was no documentation of catheter care being performed.  (CMS Ex. #1, p. 3).  The DON also reviewed the care plans for Resident #3 and confirmed the lack of a comprehensive care plan to address interventions for the use of an indwelling catheter.  (Id.).

An interview by Ball of the Minimum Data Set/Care Plan Coordinator on 04/03/18 determined she was not aware Resident #3 had a catheter.  She stated the resident's care plan would have been updated based on the admission orders provided at the time of Resident #3's return to the facility.  Resident #3's admission orders of 02/23/18 failed to include any orders related to the urinary catheter.  (Id.).

**2. 42 C.F.R. § 483.25(b)(l)(Tag F686 – Treatment/Services to Prevent/Heal Pressure Ulcers) at a G level of scope and severity.**

CMS alleged that based on observation, interview and record review, the facility failed to provide the necessary treatment and services to promote healing and prevent infection of resident wounds by failing to prevent the development of pressure wounds and failing to ensure pressure wounds were assessed when identified for sample residents; failing to prevent the worsening of pressure wounds; failing to obtain wound care orders when pressure wounds were identified; failing to document weekly skin assessments in accordance with facility protocol; and failing to document the provision of wound care treatments in accordance with written physician orders for sampled residents.  (CMS Ex. #1, pp. 3-4).

CMS further alleged that the wound protocol provided by the DON documented all residents would be on a weekly skin check by an LPN and that each resident would be checked head to toe and signed off on their TAR.  The protocol also provided that wound documentation should address the type of injury, the pressure ulcer stage, a description of the pressure ulcer's characteristics, the progress towards healing and identification of potential complications, if infection was present, presence of pain and description of dressings and treatments.  (CMS Ex. #1, pp. 4 to 5).

**Page 9**

**Resident #1**

Resident #1 was admitted 01/23/18 from an acute care facility with diagnoses of Intractable back pain, Lumbar Compression fracture, Urinary Tract Infection (UTI) Multiple Sclerosis (MS) and hypertension.  (CMS Ex. #8, p. 14).  The nursing admission skin assessment dated 01/23/18 documented no alteration in skin integrity.  (Id., p. 19).  However the Braden Scale for Predicting Ulcers Question #8 "Is the resident at risk for skin Breakdown" was marked "yes" and "turning/repositioning program" was marked under "[s]kin interventions."  (Id., p. 20).

An MDS dated 01/30/18 documented no pressure ulcers on admission (01/23/18), but noted the patient was at risk for skin impairment.  (CMS Ex. #1, p. 5; CMS Ex. #12, p. 16).  The MDS assessment also showed Resident #1 required extensive assistance with at least one person assistance for bed mobility, toiletry and maintenance of a urinary catheter, and documented a pressure reducing device to Resident #1's bed.  (CMS Ex. #12, pp. 9 to 10).

The January TAR failed to document weekly skin assessments in accordance with facility protocol.  (CMS Ex. #8, pp. 154 to 161).  A change in condition form dated 02/07/18 documented an "open area" on the left buttock, but failed to document measurements or an assessment.  (Id., pp. 38 to 39).  There was also no documentation of wound orders initiated following the identification of the skin impairment on 02/07/18.14
  Ball noted there was no further documentation related to the open area on Resident #1's left buttock until 02/12/18.  (CMS Ex. #1, pp. 5 to 6).

On 02/12/18, a wound assessment was conducted by an RN who documented in-facility acquired unstageable15
 pressure wounds to the coccyx (Skin Impairment #1) and sacrum (Skin Impairment #2) of Resident #1, with documentation of eschar (dead tissue) and black wound bed color for both wounds.  Skin Impairment #1 was documented as having foul, purulent odor with drainage present, and Skin Impairment #2 was documented as having serous drainage.  (CMS Ex. #1, p. 6; CMS Ex. #8, pp. 43 and 44).  The summary documented black eschar tissues covering the sacrum and coccyx covering parts of L and R buttocks measuring "16 x 10 x unmeasurable."  Further summation indicated an air mattress was ordered, pre-albumin ordered, therapy was notified of a different cushion for the wheelchair, "Staff to turn and reposition Resident Q 2 hours.

**Page 10**

Treatment started to areas that are open. . . ."  (CMS Ex. #8, p. 49).

On 02/12/18 at 1847 hours, a wound assessment by a Registered Nurse documented an in-facility acquired unstageable pressure wound to the coccyx and sacrum.  (CMS Ex. #1, p. 6).  The change in condition form documented new or worsening skin condition with a pain level of #8 to the coccyx and sacrum with no description, assessment or measurements.  (CMS Ex. #8, pp. 52 to 53).

The Narrative Summary documented:  "Resident with black eschar tissues covering sacrum and coccyx covering parts of L and R buttocks measuring 16 cm x 10 cm x unmeasurable."  The Narrative Summation documented an air mattress was ordered, pre-Albumin ordered and further indicated "Staff to turn and reposition resident Q [every] 2 hours."  (CMS Ex. #1, p. 6; CMS Ex. #8, p. 56).

On 02/15/18 the facility wound care physician evaluated Resident #1 and documented an unstageable necrotic pressure wound to the sacrum with measuring of 12.5 cm x 11 cm x 0.1 cm, with 80% neurotic tissue and 20% granulation.  Wound care orders were changed to include application of Santyl and calcium alginate to bilateral buttocks twice daily with recommendations to off-load the wound and reposition Resident #1 consistent with facility protocol.  (CMS Ex. #1, p. 6; CMS Ex. #8, pp. 57 to 58).

A nursing entry on 02/15/18 documented the presence of odor to the wound.  Skin Impairment #1 (the sacrum wound) was documented as IHA (In House Acquired) with measurements of 12.5 cm x 11 cm x 0.1 cm and unstageable.  There was eschar present, the wound bed color was black, drainage moderate-to-serous and presence of an odor to the wound.  Treatment included calcium alginate and Santyl QD.  (CMS Ex. #8, pp. 59-60).  Wound interventions in place included turning reposition program, skin protectant, and off‐loading.  (Id., p. 65).  Summation documented Resident #1 with 80% neurotic tissue, granulation 20%, medication for pain, continuation of low air loss mattress, and documented Resident #1's refusal "to be turned but staff will continue to encourage."  (Id., p. 66).

On 02/19/18 the facility's wound care physician documented the wound to be the same measurements, performed surgical debridement, and changed the wound care orders to include a Dakin's wet dry dressing, discontinue Calcium Alginate but continue with Santyl.  (CMS Ex. #1, pp. 6 to 7; CMS Ex. #8, pp. 73 to 76).

On 02/19/18 at 1100 hours, a nursing entry noted wound measurements of 12.5 cm x 11 cm x 0.1 cm, unstageable with presence of odor to the wound.  (CMS Ex. #8, p. 67).  Skin interventions included a specialty mattress, wheelchair cushion, turning/reposition program.  (Id., p. 73).

**Page 11**

On 02/21/18 the wound care physician documented measurements of 12 cm x 9.5 cm x 0.1 cm and a surface area of 114 cm2, with 80% necrotic tissue and 20% granulation tissue, and odor to the periwound radius.  Wound progress was noted as improved.  Surgical excisional debridement was performed with continuation of Santyl once daily.  (CMS Ex. #8, pp. 77 to 78).

Nurse's note of the same date 02/21/18 at 1741 hours documented moderate, serous drainage with odor.  (CMS Ex. #1, p. 7; CMS Ex. #8, p. 79).  Wound was noted as improved.  (CMS Ex. #8, p. 80).  Resident #1 was to have her sitting limited to 60 minutes daily while staff was to continue to offer and encourage turning and repositioning.  (Id., p. 86).

Nurse's note dated 02/22/18 at 1506 hours noted the skin wound as a "small dime sized open area" with no measurements.  (CMS Ex. #8, pp. 90 to 93).

Progress Notes of 02/22/18 at 2231 hours, documented resident refused to eat and refused to be turned x1, wound had necrotic tissue and a very foul smell.  (CMS Ex. #8, p. 94).  On 02/23/18 a physician's order was obtained to transfer Resident #1 to the emergency room for low blood pressure, low oxygen saturation, and fever.  (Id., p. 116).

During an interview with the DON on 04/04/18, the DON stated a treatment order was obtained by the LPN on 02/07/18, but the nurse failed to enter the order into the computer system.  (CMS Ex. #1, p. 7).

The DON reported Resident #1 was refusing to be turned, however, review of the nursing notes failed to document Resident #1 was being consistently repositioned consistent with the facility's repositioning program, and failed to document refusals to turn and reposition.  (CMS Ex. #1, pp. 7 to 8; CMS Ex. #8, pp. 94 to 114).

Review of MDS on admission dated 01/30/18, 30 day assessment dated 01/20/18 and discharge assessment dated 01/23/18 failed to document rejection of care by Resident #1.  (CMS Ex. #1, p. 8; CMS Ex. #12).

**Resident #2**

Resident #2 was admitted to Petitioner on 03/09/18.  (CMS Ex. #1, p. 8; CMS Ex. #9, p. 1).  The nursing assessment dated 03/09/18 documented an open area to the coccyx without any wound measurements or description.  (CMS Ex. #9, p. 6).  Resident #2 was documented as being at risk for skin breakdown.  (Id., p. 8).  Resident #2 was also documented as having an indwelling catheter (Id., p. 14) and to use a wheelchair.  (Id., p. 18).  The Admission Summary noted an open area on his coccyx, presence of a Foley catheter, and need for assistance with transfers, ADLs and mobility.  (Id., p. 22).

**Page 12**

On 03/10/18 physician orders were initiated to clean Resident #2's coccyx area with wound cleaner, apply Santyl and dry dressing daily.  Review of Resident #2's TAR on 03/10/18, 03/11/18, 03/13/18 and 03/15/18 documented the wound care was performed.  There was no documentation of dressing changes on 03/12, 03/14 or 03/16.  The TAR contained an area for nurses to document weekly skin checks, but the area was blank for 03/12/18 indicating no assessment had been performed.  (CMS Ex. #1, p. 9; CMS Ex. #9, pp. 52 to 56).

The medical record failed to include an assessment of the wound's measurements and appearance until 03/15/18, six (6) days after admission.  (CMS Ex. #1, p. 9; CMS Ex. #9, p. 23).

Resident #2's Pressure Grid form effective 03/15/18 documented two pressure wounds.  Skin Impairment #1 was documented as being on the right buttock and identified on 03/15/18 as IHA (in house acquired) with measurements of 3.5 cm x 3.0 cm x 0.1 cm, Stage II,16
 and indicated the treatment order was last changed on 03/09/18 for a wound identified on 03/15/18.  (CMS Ex. #9, pp. 23 and 24).  Skin Impairment #2 was documented as being on the left buttock with measurements of 2.5 cm x 1.0 cm x "?" Unstageable on left buttock and documented as having been identified on 03/09/18 and POA (present on Admission).  (CMS Ex. #9, pp. 23 to 24).

Resident #2's Pressure Grid form dated 03/21/18 documented two pressure wounds.  Skin Impairment #1 was noted as being on the right buttock with measurements of 3.0 cm x 3.5 cm x 0.1 cm, unstageable, POA on 03/09/18 documenting treatment order was changed on 03/21/18.  Skin Impairment #2 was noted as being on the left buttock with measurements of 1.0 cm x 0.4 x 0.1, Stage II, and IHA.  (CMS Ex. #9, pp. 30 to 31).

Petitioner's contract wound physician conducted an initial evaluation of Resident #2 on 3/22/18 (CMS Ex. #9, pp. 37 to 39) and documented an unstageable pressure wound to the right buttock (Site #1) measuring 3 cm x 3.5 cm x 0.1 cm (Id. at p. 38) and a Stage 2 pressure wound to the left buttock (Site #2) measuring 1.0 cm x 0.4 cm x 0.1 cm.  (Id.).  Surgical debridement was performed on Site #1.  Wound care treatment orders were updated by the physician to include "[c]alcium alginate apply once daily for 30 days, santyl apply once daily for 30 days]" for Site #1 and apply "[c]ollagen dressing once daily for 30 days" for Site #2.  (Id., p. 39).  Review of the TARs showed a failure to document consistent treatment.  (CMS Ex. #9, pp. 52 to 60).

On 04/03/18 Resident #2 was observed by Ball seated in a cushioned wheelchair.  Ball also noticed a low air loss mattress on the resident's bed.  An interview by Ball of

**Page 13**

Resident #2 determined he had acquired a pressure wound subsequent to his admission to the facility (Petitioner).  Resident #2 told Ball he needed assistance to turn and reposition in bed but stated "the staff is not consistent with assisting with the turning."  (CMS Ex. #1, p. 8).

**Resident #3**

Resident #3 was identified by the DON as 1 of 5 residents with an in-facility acquired pressure ulcer.  Resident #3 was originally admitted on 03/01/18 from an acute care facility for orthopedic surgery aftercare.  (CMS Ex. #1, p. 10; CMS Ex. #10, p. 1).  The nursing admission skin assessment documented an open area to resident's coccyx measuring 3.1 cm x 3.5 cm.  There was no description of the wound's appearance.  (CMS Ex. #1, p. 10; CMS Ex. #10, p. 8).  A wound assessment was not performed until 03/07/18 (CMS Ex. #1, p. 10; CMS Ex. #10, pp. 24 to 31) with documentation describing a Stage 2 pressure wound to Resident #3's coccyx/buttock measuring 1.0 cm x 1.0 cm x 0.1 cm.  (CMS Ex. #1, p. 10; CMS Ex. #10, pp. 24 to 31).  The wound bed was noted to be epithelial tissue without drainage or odor.  The assessment documented the wound was present on admission, but documented the date identified as 03/06/18 although Resident #3 was admitted on 03/01/18.  (Id., pp. 24-25).

The medical record and TARs failed to document wound care until 03/08/18.  (CMS Ex. #1, p. 10; CMS Ex. #10, pp. 73 to 86, especially p. 77).

On 03/23/18 the nursing admission skin assessment documented a Stage 2 wound to the resident's sacrum with dressing intact, wound appeared pink, moist with no signs of infection and documented right heel with dressing intact to prevent pressure ulcer with no broken skin noted in the area.  (CMS Ex. #1, p. 11; CMS Ex. #10, p. 37).  The pressure wounds were not assessed to include measurements or description of wound drainage, wound edges, or periwound tissue.  (CMS Ex. #1, p. 11).  The medical record failed to document any wound care on 3/23/18 or 3/24/18.  (CMS Ex. #1, p. 11; CMS Ex. #10, p. 78).

On 04/04/18, twelve (12) days after Resident #3's pressure wound was identified, Petitioner's contracted wound care physician (CWCP) was making rounds.  A concurrent interview revealed she had been consulted on 03/29/18 to assess a resident's surgical wound, but was not aware of any pressure ulcers.  The physician was observed to perform an assessment of the Resident 3's sacrum and bilateral heels.  The physician noted a large amount of drainage with foul odor and assessed the sacrum wound to be an unstageable pressure ulcer measuring 5 cm x 4.5 cm x 0.1 cm, with 20% slough and 30% granulation tissue present.  The physician stated the blackened area was necrotic tissue and stated she should have been consulted for the wound.  (CMS Ex. #1, p. 13; CMS Ex. #10, pp. 69-72).

**Page 14**

**B. Petitioner's case**

Petitioner argued each of Petitioner's Declarants reviewed the entire record for each of Residents #1, #2, and #3 and noted discrepancies and disagreements with the CMS surveyor's recitation, understanding, and analysis of the facts.  Petitioner maintained that it was in substantial compliance and requested the entry of an Order dismissing the allegations, alleging CMS had not offered sufficient evidentiary support to meet its burden.

**Resident #1**

Petitioner argued Resident #1 was suffering from a complex constellation of medical issues that substantially affected her condition and the development of the particular type of pressure ulcers she experienced.  Further, Petitioner noted "[t]he character of that pressure ulcer and the extreme rapidity with which it developed have to be considered in evaluating Centre Pointe's actions and in finding a lack of culpability in any harm that occurred."  (PPHB, p. 2).

**Resident #2**

Petitioner argued Resident #2 was actually admitted to Centre Pointe with two pressure ulcers NOT with a single pressure ulcer as understood by CMS' surveyor.  Petitioner argued, the evidence was clear that Resident #2 did NOT develop a facility-acquired pressure ulcer at Centre Pointe, as contended by CMS in concluding that a G tag was warranted.  (PPHB, p. 2).

**Resident #3**

Petitioner argued Resident #3 received all appropriate assessment and treatment for the pressure sores.  (PPHB, p. 4).

Petitioner admitted there were some documentation errors and omissions acknowledged in Petitioner's detailed Declarations, but argued numerous disagreements about whether particular documentation events occurred or were done correctly were noted.  (PPHB, pp. 2 to 3).

**KE's Declaration:**

KE stated Resident #1 was admitted with moisture– associated incontinence dermatitis (MASD) on the left and right buttocks, known as "diaper rash."  A Foley catheter was placed while at Tallahassee Hospital on 1/20/18 in hopes that it could be discontinued when she was able to self-catheterize again.  Being incontinent of bowel and having MASD placed her at high risk for pressure ulcers/pressure injuries.  (P. Ex. #4, p.

**Page 15**

2).

KE testified Resident #1 had multiple (30) diagnoses which were indicative of multiple medical issues and placed Resident #l at risk for pressure ulcer/injury formation (P. Ex. #4, pp. 3 to 4); that Resident #1 was on multiple medications (Id., pp. 4 to 5); that Resident #1 was non-compliant or refused care and treatment (Id., pp. 5 to 6); that Resident #1 had Abnormal blood laboratory results (Id., p. 6); that Resident #1 had fevers (Id., pp. 6 to 7); and that Resident #1 had a history of heavy prednisone use (Id., pp. 7 to 8).

KE acknowledged there were no official "skin checks" but argued there were 37 different times over a period of 13 days where documentation in the medical record (TAR) demonstrated the nurses did skin checks to the buttocks and peri area as demonstrated by the TAR when the nurses applied "Barrier Cream to buttock and peri area and every shift after each incontinent episode every shift for prevention and treatment."  KE testified if there was any abnormalities or open areas thought to be the beginning of a pressure ulcer/injury it would have been reported as it was on 2/7/18 when the skin presentation changed to an open area.  She further argued it was customary for nurses to report to the medical provider any abnormalities the patient may have.  As often as Resident #1 was seen, sometimes three times a week, discussion between the medical provider and the nurse would have taken place but not documented.  (Id., pp. 10 to 12).

KE stated Petitioner did initiate treatment prior to 01/25/18 based on documentation of 01/23/18 (Admission) on the Care Plan Summary (P. Ex. #4, p. 14; P. Ex. #1, p. 21), which stated "Wound skin issues addressed" and 01/23/18 (Resident Information Sheet [RlS]) Buttocks wound, treatment to buttock.  (P. Ex. #1, pp. 22-23).

KE testified although documentation failed to document turning and repositioning, such documentation was not required by any rule, regulation or law: rather, such was standard protocol at the facility and nursing homes throughout the state of Florida.  KE further argued it was the protocol, habit and practice to turn and reposition residents frequently, and at least every 2 hours.  There was no requirement that such standard, protocol, habit and practice be documented.  (Id., pp. 14 to 15).

**CC Declaration:**

CC stated she reviewed the Declaration of KE and she concurred in and supported her opinions concerning Resident #1.  (P. Ex. #7, p. 2).

**Page 16**

**Resident #2**

KE testified Resident #2 had over 33 medical diagnoses during his admission which was an indication of how sick he was.  Resident #2 had a diagnosis of diabetes mellitus and his hemoglobin A1C on 03/08/18 was 8.4, which was an indication his blood sugars were in the 200's during the previous month.  This would make it easier for him to have skin breakdown and make it more difficult for his skin breakdown to heal.  (P. Ex. #4, p. 17).

**CC Declaration:**

CC acknowledged Resident #2 had an unstageable wound on his right sacral and a left side stage 2 sacral wound on the Medical Certification for Medicaid Long Term Care (P. Ex. #7, p.1).  CC acknowledged there was a facility nurse who inadvertently juxtaposed the right and left sides when describing the wounds.  (Id., p. 1).

CC testified an interim care plan was developed and physician orders were obtained to treat the wound.  A full care plan was developed on March 12, 2018, which included a care plan for potential for pressure sore development.  CC admitted the date for potential skin breakdown obviously had an incorrect date as the initial date was after the revision date.  CC stated it was clear the potential for skin breakdown was written on March 12, 2018, when all of the other care plan sections were completed.  (P. Ex. #7, p. 2).

**Declaration of Michael Silverman, M.D.** (P. Ex. #8).

MSMD stated Resident #3 was a 79 year old woman with multiple significant medical comorbidities including hypertension, heart failure, atrial fibrillation, a pacemaker, mitral valve prolapse status-post aortic valve replacement, a history of 5 strokes, incontinence, depression, osteoporosis, and peripheral arterial disease, severe deconditioning and malnutrition with a low albumin, etc.  In addition to her multiple comorbidities and malnutrition, she had been bed‐bound since undergoing a knee arthroplasty in January of 2018.  After her admission to Petitioner in March, the surgical wound continued to deteriorate due to her multiple medical comorbidities, negative nitrogen balance, poor nutrition, and compromised physiologic reserve, and she required another hospitalization for wound debridement and surgical care.  (P. Ex. #8, pp. 1 to 2).

On readmission to Petitioner, Resident #3 was in a state of severe deconditioning with malnutrition, hypoalbuminemia and multiple areas of skin breakdown, both surgical and acquired.  MSMD argued the underlying medical conditions of Resident #3 must be taken into account as the most critical factor in the development of her wounds.  The wounds described in Resident #3 were secondary to the multiple underlying complex medical comorbidities and severe malnutrition in an elderly woman who had undergone

**Page 17**

multiple surgical procedures, and who was depressed and bed bound for approximately 3 months and not from any omission or commission on the part of the staff at Centre Point.  MSMD opined the staff at Centre Point actually under very difficult clinical conditions had given such quality care that the wounds were showing improvement.  (P. Ex. #8).

**3. 42 C.F.R. §§ 483.20(f)(5) and 483.70(i)(l)-(5)(Tag F842 – Resident Records) at a D level of scope and severity.**

42 C.F.R. § 483.20 requires a facility to conduct initially and periodically a comprehensive, accurate, standardized, reproducible assessment of each resident's functional capacity.

42 C.F.R. § 483.70 et seq., requires a facility to be administered in a manner that enables it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident.

**A. Agency's Case**

CMS alleged Petitioner failed to maintain complete and accurately document resident records by failing to enter and implement physician wound care orders, failed to include wound care assessments in a timely manner, failed to include documentation of the provision of physician ordered catheter care and by entering conflicting information in the medical record for three (3) of three (3) sampled residents (Residents #1, #2, and #3).

**Resident #1**

CMS alleged Resident #1 was admitted 01/23/18 with intact skin.  (CMS Ex. #1, p. 16; CMS Ex. #8, p. 19).  On 02/7/18 the LPN documented an open area to the resident's left buttock without any measurements or description.  (CMS Ex. #8, p. 39).  Resident #1's TAR failed to show any documentation of any wound care dressings ordered or initiated following documentation of the skin impairment on 02/07/18.  (CMS Ex. #1, p. 16; CMS Ex. #8, pp. 154 to 169).

An interview of the DON on 04/04/18 determined a treatment order was obtained by the LPN on 02/07/18 when the wound was first identified, but the nurse failed to enter the order into the computer system.  The DON stated the treatments were being done, but confirmed the medical record failed to indicate the treatments were provided.  (CMS Ex. #1, p. 16).

**Page 18**

**Resident #2**

Resident #2 was admitted on 03/09/18 with a documented open area to the coccyx.  The medical record failed to include assessment of the wound that included measurements and wound appearance.  (CMS Ex. #1, p. 16; CMS Ex. #9, pp. 6 and 22).

On 03/15/18 documentation showed two skin impairments.  Skin Impairment #1 to the right buttock was measured at 3.5 cm x 3.0 cm x 0.1, Stage II, and documented as having been identified on 03/15/18 as IHA, (in house acquired).  Skin Impairment #2 to the left buttock was measured at 2.5 cm x 1.0 cm x "?" cm, unstageable and was documented as POA, identified on 03/09/18 present on admission a pressure wound  (CMS Ex. #1, p. 16; CMS Ex. #9, pp. 23 to 24).

A subsequent wound assessment on 03/21/18 documented two skin impairments.  Skin impairment #1 was identified as being to the right buttock with measurements of 3.0 cm x 3.5 cm x 0.1 cm, unstageable, and identified as POA, (present on admission on 03/09/18).  Skin impairment #2 was identified as being to the left buttock, measuring 1 x 0.4 x 0.1, Stage II, and identified as being IHA (in house acquired) on 03/13/18.  (CMS Ex. #9, pp. 30 to 32).

**Resident #2**

Resident #2 was admitted with an indwelling urinary catheter and a physician order to perform catheter care every shift.  Review of the medical record including the March and April TARs failed to show documentation of the provision of the catheter care in accordance with the physician's orders.  (CMS Ex. #1, p. 17; CMS Ex. #9, pp. 52 to 60).

**Resident #3**

Resident #3 was admitted on 03/01/18 with a documented wound to the coccyx which measured 3.1 cm x 3.5 cm open area.  (CMS Ex. #1, p. 17; CMS Ex. #10, pp. 7 to 8, and 22).  A wound assessment on 03/07/18 documented Skin impairment #1 as a pressure wound to the coccyx measuring 1.0 cm x 1.0 cm x 0.1 cm, Stage II and recorded the impairment as having been POA (present on admission) recording a date of 03/6/18 even though Resident #3 was admitted on 03/01/18.  (CMS Ex. #1, p. 17; CMS Ex. #10, p. 24).  The summation on 03/07/18 described the skin impairment as an open wound to the coccyx/buttock, area red on admission, now open.  (CMS Ex. #10, p. 31).

A wound assessment dated 03/23/18 documented a skin impairment to the sacrum described as "Stage 2 wound noted on sacrum area, dressing intact, wound appeared pink, moist, with no signs of infection noted."  (Id., pp. 36 to 37).

**Page 19**

A subsequent wound assessment on 03/26/18 documented a pressure wound to Resident #3's sacrum that was identified on admission date of 03/23/18.  (CMS Ex. #1, p. 17).  On page 1 of the document (CMS Ex. #10, p. 52) the wound measurements were documented as measuring 1.0 cm x 0.3 cm x 0 cm.  A second wound was documented as measuring 4.0 cm x 3.0 cm x 0 cm and identified as POA (present on admission).  On page 7 of the same document (Id., p. 58) the summation documented "noted areas to sacrum x2 and right buttock area: sacrum 1.4w x 3L and sacrum 2. 1L x 0.5 w."  These measurements were noted to be different than the measurements on page 1 of the document.  An interview with the Licensed Practical Nurse, Employee D, who completed the document was conducted on 04/04/18 at which time Employee D stated the measurements documented on page 7 were the accurate measurements and she could not explain why she documented different measurements on page 1 of the document.  (CMS Ex. #1, p. 18).

When Resident #3 was readmitted on 03/23/18 she had an indwelling Foley catheter in place.  (CMS Ex. #1, p. 18).  The medical record failed to document any physician orders for the use of the catheter and failed to document any provision for catheter care until after the date of the survey.  (Id.; CMS Ex. #10, p. 45; see CMS Ex. #10, pp. 96, 99-100).

**B. Petitioner's Case**

Petitioner acknowledged there were some documentation errors and omissions acknowledged in Petitioner's detailed Declarations.  (PPHB, pp. 2, 3, and 6).

In response to the allegation that the 02/07/18 Skin impairment was not revised until 02/14/18, KE testified none was needed because other documentation covered what was needed.  (P. Ex. #4, p. 10).

KE acknowledged Regina Barkley, RN failed to enter the order or document any treatment in the resident's records.  (Id., p. 13.)

KE stated it was not necessary to document turning and repositioning because such documentation is not required by any rule, regulation or law, rather it is the standard protocol at Petitioner and elsewhere in Florida.  (Id., pp. 14 to 15).

CC acknowledged a facility nurse inadvertently juxtaposed the right and left sides when describing the wounds.  CE stated the date for potential skin breakdown obviously had an incorrect date as the initial date was after the revision date.  It was clear the potential for skin breakdown was written on March 12, 2018 when all of the other care plan sections were completed.  (P. Ex. #7, p. 2).

**Page 20**

RG stated with respect to Resident #2, although the wounds were clearly outlined on the admission and on the Form 3008, there has been some confusion regarding that these wounds were facility acquired.  The wound nurse at the time of survey had just assumed the responsibility of this position and may have made this assumption.  However, the documentation clearly showed that the wounds were present on admission.  (P. Ex. #9, pp. 2 to 3).

RG further stated Resident #2's care plan regarding potential for skin impairment date showed an initiation date of 04/12/2018 with a revision of 04/03/2018.  RG acknowledged this had to be a typo or input error.  According to RG, obviously, you cannot revise a care plan before it is initiated.  "The date of initiation for these care plans - including this portion -- was not 04/12/18 as alleged, but was in fact 3/12/2018 with a revision of 04/03/2018."  (P. Ex. #9, p. 3).

**4. 42 C.F.R. § 483.75(g)(2)(ii)(Tag F867-Quality Assessment and Assurance/Improvement Plan) at a D level of scope and severity.**

CMS alleged Petitioner failed to ensure implementation of a Quality Assessment Performance Improvement Plan (PIP) developed after the identified quality concerns related to management of pressure wounds.  (CMS Ex. #1, p. 18).

**A. Agency's Case**

During an interview of the DON on 04/04/18, the DON provided a notebook containing documents the DON identified as a four point PIP developed on 02/14/18.  (CMS Ex. #1, p. 19).  According to the DON the plan was developed after a review of the medical records of Resident #1 identified areas for improvement including concerns related to documentation.

Review of the PIP provided by the DON revealed that on 02/14/18 Petitioner identified a problem with wounds not being identified timely, delays in treatment for wounds and documentation not accurately reflecting the patient's condition.  (CMS Ex. #1, p. 19).  Actions taken with respect to the PIP included residents identified with wounds were reviewed for orders and to ensure care plans were in place.  A facility audit was conducted from 02/14/18 – 2/16/18 to identify residents that might have areas of concern related to their skin and staff education was provided.  The plan included skin sweeps to be conducted by a nurse at the time of admission with another assessment to be performed by the treatment nurse on the next business day and weekly assessments thereafter.  The plan further provided that resident wounds would be tracked and trended with reporting to the Petitioner's Quality Assurance Performance Improvement Committee on a monthly basis.  (Id.).

**Page 21**

During the complaint survey conducted 04/03/18 – 04/04/18 current issues were identified related to care and services for pressure ulcers, including Petitioner's failure to prevent the development of pressure wounds, failure to prevent the worsening of pressure wounds, failure to ensure pressure wounds were appropriately dressed when identified, failure to obtain wound care orders when pressure wounds were identified, failure to document weekly skin care assessments in accordance with Petitioner's own protocol and failure to document the provision of wound care treatments in accordance with written physician orders.  (CMS Ex. #1, pp. 19 to 20).

**B. Petitioner's Case**

Petitioner maintained that it was in substantial compliance and argued CMS had not offered sufficient evidentiary support to meet its burden.

**Resident #2**

Petitioner argued that the assertion in the 2567 (CMS Ex. #1) that the Resident #2's care plan was not updated with new interventions until the day of the survey was based on a misunderstanding of the documentation.  Petitioner argued Resident #2's full care plan did address skin integrity and showed that both the interim care plan as well as the full care plan appropriately addressed that element, and that the potential for impaired skin integrity was initiated on March 12, 2018, along with all of the other elements of the full care plan.  Review of the entire care plan made it clear that the skin integrity element of the full care plan had to have occurred on March 12, 2018.  Petitioner argued CMS relied on an obvious error in the log in concluding that it was initiated on April 12, 2018, which was eight days after the resident was discharged home to his assisted living facility, leaving a letter complimenting Centre Pointe on the quality of care and assuring the staff that he would return in the future.  (PPHB, p. 4).

**Declaration of Karen Lou Kennedy-Evans** (P. Ex. #4)

**Resident #1**

KE stated there was a care plan initiated on admission which indicated the preventative issues needed for patients "at risk."  KE testified the "Care Plan Summary," dated 01/23/18, was a baseline care plan to be used until the official care plan was completed.  (P. Ex. #4, p. 8).  This "Care Plan Summary" did address Resident #1's wound-skin issues as "being addressed."  (P. Ex. #1, p. 22).  On the Resident Information Sheet (RIS) several things were addressed for prevention.  24 hours after admission a 91 page typed care plan was created on 01/24/18 and multiple issues placing her at risk for pressure ulcer/injury were addressed.  (P. Ex. #4, p. 8).

**Page 22**

**February 7, 2018 skin impairment, no new care plan issues added, not revised until 02/14/18.**

KE testified while there was "No new date" put on the care plan, none was needed because the other documentation covered what was needed.  (P. Ex. #4, p. 10).  Resident #1's care plan was initiated the day of admission 01/23/18 and skin issues were addressed on the CARE PLAN SUMMARY (Id.; P. Ex. #1, pp. 21) and Resident Information Sheet (RIS) (P. Ex. #1,  p. 23).

**No skin checks during 15 days from admission.**

KE testified while there are no official "skin checks" there were 37 different times over a period of 13 days where documentation in the medical record (TAR) demonstrated that the nurses did skin checks to the buttocks and peri area as demonstrated by the TAR when the nurses applied "Barrier Cream to buttock and peri area and every shift after each incontinent episode every shift for prevention and treatment."  (P. Ex #4, pp. 10 to 11).  KE stated if there were any abnormalities or open areas thought to be the beginning of a pressure ulcer/injury it would have been reported as it was on 2/7/18 when the skin presentation changed to an open area.  (P. Ex. #4, p. 11).  KE further argued, it was customary for nurses to report to the medical provider any abnormalities the patient may have.  As often as Resident #1 was seen, sometimes three times a week, KE stated discussion between the medical provider and the nurse would have taken place but not documented.  (Id., p. 12).

**No treatment orders until discovered unstageable open are[a] 16x10 covered with black eschar and foul smelling drainage.**

KE acknowledged Regina Barkley, RN claimed she obtained treatment orders and provided the treatment but admitted that Barkley failed to enter the order or document any treatment in the resident's records.  (P. Ex. #4, p. 13).

**Admitted with this condition and facility did not initiate treatment until 01/25/18 two days after admission.**

KE testified while the documentation may look like "No treatment was initiated until 01/25/18," this was not true.  (P. Ex. #4, p. 14).  KE stated the 01/23/18 (Admission) on the Care Plan Summary (P Ex. #1, p. 21) stated "Wound skin issues addressed."; 01/23/18 (Resident Information Sheet [RIS]) "Buttocks noted, "[b]uttocks wound, treatment to buttock P. Ex. #1, p. 23)."  KE stated the nurse's aide was the first defense of eyes and ears for the patient to the nurse.  It was normal and customary practice to apply barrier creams that were non-prescription to patients who were incontinent that needed it.

**Page 23**

Therefore the application of these would not be charted, but done as routine care by the nurse's aide.  (P. Ex. #4, p. 14).

**Declaration of Connie Cheren** (P. Ex. #7).

CC reviewed the Declaration of Karen Lou Kennedy-Evans, RN, FNP, APRN-BC and concurred in and supported KE's opinions concerning Resident #1.  (P. Ex. #7, p. 2).

**Resident #2**

CC stated an interim care plan was developed and physician orders obtained to treat the wound.  A full care plan was developed on March 12, 2018, which included a care plan for potential for pressure sore development.  The date for potential skin breakdown obviously had an incorrect date as the initial date was after the revision date.  It was clear the potential for skin breakdown was written on March 12, 2018, when all of the other care plan sections were completed.  (P. Ex. #7, p. 2).

**Declaration of Rebecca Galloway** (P. Ex. #9).

RG argued CMS's allegation on page 17 of its pre-hearing brief that Petitioner's performance improvement plan of action was just "going through the motions" was not at all correct.  RG argued a PIP was initiated in February of 2018, was strictly implemented and included a house wide skin sweep to identify any undocumented wounds and assess for appropriate treatment.  She argued Petitioner implemented managers reviewing the weekly skin sweeps performed per line staff for accuracy.  She stated Petitioner had their wound physician see every wound identified on the sweep for an initial consultation.  Petitioner provided staff training on assessment, prevention, identification and proper treatment of skin and wounds to both licensed and certified nursing staff members.  Petitioner provided education to licensed staff on reporting and documentation of wounds when identified and continued to provide 1:1 coaching and counseling if and when expectations are not met.  The QA process is ongoing and has been a focus in this facility.  (P. Ex. #9, pp. 1 to 3).

RG argued Resident information sheets (RIS) served as the plan of care for Petitioner's residents and a quick reference for direct care staff.  The RIS was implemented upon admission and updated with order changes and was reviewed in the daily clinical meeting as the interdisciplinary team discusses and makes changes.  (P. Ex. #1 to 3).

RG argued Resident #2 came in to Petitioner with 2 sacral wounds noted on the Form 3008, Medical Certification for Medicaid Long Term Care Services and Patient Transfer Form.  The 3008 read, "Sacrum right side unstageable.  90% necrosis and 10%

**Page 24**

granulation.  Left side of sacral wound with shading and pressure."  RG argued although the wounds were clearly outlined on the admission and on the 3008, there was some confusion regarding whether these wounds were facility acquired.  RG stated the wound nurse at the time of survey had just assumed the responsibility of this position and may have made this assumption.  However, the documentation clearly showed that the wounds were present on admission.  (P. Ex. #9, p. 2).

RG argued, Resident #2's care plan regarding potential for skin impairment, initiated 04/12/18 with a revision of 04/03/2018, has to be a typo or input error.  Obviously, you cannot revise a care plan before it is initiated and the resident had other care plans for actual skin impairment.  The date of initiation for these care plans - including this portion -- was not 04/12/18 as alleged, but was in fact 03/12/18 with a revision of 04/03/18.  (P. Ex. #9, p. 3).

**Declaration of Jacquinn Griffith** (JG) (P. Ex. #10).

JG stated she met with Resident #1 on February 13, 2018, relating to a skin area that was rapidly digressing despite nursing interventions and physician directed care, to ensure that Resident #1 was involved in her plan of care and to come up with a team approach relating to same.  (P. Ex. #10, p. 1).

VIII.  CREDIBILITY DETERMINATION(S)

I find the evidence and declarations submitted by both parties are credible.

IX.  DISCUSSION OF EVIDENCE AND TESTIMONY

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

Petitioner was not in substantial compliance with 42 C.F.R. § 483.21(b)(1) because Petitioner failed to develop and implement a comprehensive care plan for Resident #3's indwelling catheter.

**42 C.F.R. § 483.2l(b)(1)(Tag F656 – Develop/Implement****Comp. Care Plan) at a D level of scope and severity provides:**

(b) Comprehensive care plans. (1) The facility must develop and implement a comprehensive person-centered care plan for each resident, consistent with the resident rights set forth at § 483.10(c)(2) and § 483.10(c)(3), that includes measurable

**Page 25**

objectives and timeframes to meet a resident's medical, nursing, and mental and psychosocial needs that are identified in the comprehensive assessment.

The statute sets forth the requirements of a comprehensive care plan.

When Resident #3 was readmitted to Centre Pointe on March 23, 2018, she had an indwelling Foley catheter.  (CMS Ex. #1, p. 3; CMS Ex. #10, p. 45; see CMS Ex. #10, pp. 96, 99-100).

During Ball's survey of Petitioner on 04/03/18, she observed that Resident #3 had an indwelling Foley catheter which did not have a strap to prevent the catheter from tugging or movement.  TAR entries specified the catheter tubing should be secured to the resident's leg.  (CMS Ex. #10, p. 96).  Review of the Resident #3's March and April TARs (CMS Ex. # 10, pp. 73 to 110) by Ball determined there was no documentation related to the care of catheter or a plan of care for the indwelling catheter.  Review of Resident #3's care plan determined Petitioner failed to include a plan of care for use of the indwelling urinary catheter.  (CMS Ex. #1, p. 3; CMS Ex. #10, pp. 73 to 110).  On 04/03/18 the Director of Nursing (DON) reviewed the TARs and confirmed there was no documentation of catheter care being performed.  (CMS Ex. #1, p. 3).  The DON also reviewed the care plans for Resident #3 and confirmed the lack of a comprehensive care plan to address interventions for the use of an indwelling catheter.  (Id.).

Resident #3's admission orders of 02/23/1018 failed to include any orders related to the urinary catheter.  (Id).

RG argued CMS's allegation, on page 17 of its pre-hearing brief that Petitioner's performance improvement plan of action was just "going through the motions" was not at all correct.  (CPHB, p. 17).  I find no evidence that Petitioner's performance improvement plan of action was just "going through the motions" and put no weight in CMS's characterization to that effect.

After reviewing all the evidence herein, I find and conclude Petitioner was not in substantial compliance with 42 C.F.R. § 483.21(b)(1) because Petitioner failed to develop and implement a comprehensive care plan for Resident #3's indwelling catheter.

**B. Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(b)(1).**

Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(b)(1) because Petitioner failed to ensure that Residents #1, #2, and #3 were provided treatment and services to prevent pressure ulcers from developing and to promote healing of pressure ulcers, and prevent infection.

**Page 26**

**42 C.F.R. § 483.25(b)(1)(Tag F686 – Treatment/Services to Prevent/Heal Pressure Ulcers) at a G level of scope and severity;**

(b) Skin integrity –

(1) Pressure ulcers.  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; and
(ii) A resident with pressure ulcers receives necessary treatment and services, consistent with professional standards of practice, to promote healing, prevent infection and prevent new ulcers from developing.

**Resident #1**

When Resident #1 was admitted on 01/23/18 the nursing admission skin assessment documented no alternation of skin integrity.  (CMS Ex. #8, p. 19).  The Braden Scale for Predicting Ulcers Question #8 was marked "yes" and documented skin interventions as "turning/repositioning program."  (Id., p. 20).  An MDS dated 01/30/18 documented no pressure ulcers on admission (01/23/18), but noted the patient was at risk for skin impairment.  (CMS Ex. #1, p. 5; CMS Ex. #12, p. 16).

The January TAR failed to document weekly skin assessments in accordance with facility protocol.  (CMS Ex. #8, pp. 154 to 161).  A change in condition form dated 02/07/18 documented an "open area" on the left buttock (CMS Ex. #8, pp. 38 to 39) but failed to document wound order initiation following the identification of the skin impairment on 02/07/17.17
  (Id., pp. 38 to 39).  Ball noted there was no further documentation related to the open area to Resident #1's left buttock until 02/12/18.  (CMS Ex. #1, pp. 5 to 6).  Failure to document suggests no wound orders were initiated and no care was provided.

**Page 27**

On 02/12/18, a wound assessment was conducted by an RN who documented in-facility acquired unstageable18
 pressure wounds.  The summary documented the need for "Staff to turn and reposition Resident Q 2 hours. . . ."  (CMS Ex. #8, pp. 49, 56).

On 02/15/18 the facility wound care physician evaluated Resident #1, documented the wounds, and noted the need to reposition Resident #1 consistent with facility protocol.  (CMS Ex. #1, p. 6; CMS Ex. #8, pp. 57 to 58).

A nursing entry on 02/15/18 described wounds and treatment, and documented the wound interventions in place, which included a turning/reposition program.  (CMS Ex. #8, p. 65).  Summation in the same documented Resident #1's refusal "to be turned but staff will continue to encourage."  (Id., p. 66).

On 02/19/18 a nursing entry noted wound measurements and documented skin interventions to include a turning/reposition program.  (CMS Ex. #8, p. 73).

Nurse's note of the same date 02/21/18 documented Resident #1 was to have her sitting limited to 60 minutes daily while staff was to continue to offer and encourage turning and repositioning.  (Id., p. 86).

Progress Notes of 02/22/18 documented resident refused to be turned x1.  (CMS Ex. #8, p. 94).

The DON reported Resident #1 was refusing to be turned, however, review of the nursing notes failed to document Resident #1 was being consistently repositioned consistent with the facility's repositioning program, and failed to document refusals to turn and reposition.  (CMS Ex. #1, pp. 7 to 8; CMS Ex. #8, pp. 94 to 114).

Review of MDS on admission dated 1/30/18, 30 day assessment dated 1/20/18 and discharge assessment dated 1/23/18 failed to document rejection of care by Resident #1.  (CMS Ex. #1, p. 8; CMS Ex. #12).

Petitioner argued Resident #1 was suffering from a complex constellation of medical issues that substantially affected her condition and the development of the particular type of pressure ulcers she experienced.  Petitioner argued the character of the

**Page 28**

pressure ulcers and the extreme rapidity with which they developed had to be considered in evaluating Centre Pointe's actions and in finding a lack of culpability in any harm that occurred.  (PPHB, p. 2).

KE testified Resident #1 had multiple (30) diagnoses which were indicative of multiple medical issues and placed Resident #l at risk for pressure ulcer/injury formation.  (P. Ex. #4, pp. 3 to 4); that Resident #1 was on multiple medications (Id., pp. 4 to 5); that Resident #1 was non-compliant or refused care and treatment (Id., p. 5 to 6); that Resident #1 had abnormal blood laboratory results (Id., p. 6); that Resident #1 had fevers (Id., pp. 6 and 7); and that Resident #1 had a history of heavy prednisone use, which KE stated was a known risk factor for pressure ulcer formation.  (Id., pp. 7 to 8).

KE acknowledged there were no official "skin checks," but argued there were 37 different times over a period of 13 days where documentation in the medical record (TAR) demonstrated the nurses did skin checks to the buttocks and peri area as demonstrated by the TAR, when the nurses applied "Barrier Cream to buttock and peri area and every shift after each incontinent episode every shift for prevention and treatment."  KE stated if there were any abnormalities or open areas thought to be the beginning of a pressure ulcer/injury it would have been reported as it was on 2/7/18 when the skin presentation changed to an open area.  She further argued it was customary for nurses to report to the medical provider any abnormalities the patient may have.  As often as Resident #1 was seen, sometimes three times a week, KE testified discussion between the medical provider and the nurse would have taken place but would not have been documented.  (Id., pp. 10 to 12).  I find that argument speculative, unsupported by the record and contradicted by the entirety of record which contains numerous omissions and errors especially given the declarant's admission that Regina Barkley, RN claimed she obtained treatment orders and provided the treatment but admitted that she failed to enter the order or document any treatment in the resident's records.  (Id., p. 13).

KE testified Petitioner did initiate treatment prior to 01/25/18 based on documentation of 01/23/18 (Admission) on the Care Plan Summary (P. Ex. #1, p. 21) which stated "Wound skin issues addressed" and 01/23/18 (Resident Information Sheet [RlS]) Buttocks wound, treatment to buttock (P. Ex. #1, p. 23).  Again, I find the argument speculative, unsupported by the record and contradicted by the totality of the record which contains too many omissions and errors to assume these entries are correct.

KE stated although documentation failed to document turning and repositioning, such documentation was not required by any rule, regulation, or law: rather, such was standard protocol at the facility and nursing homes throughout the state of Florida.  KE further argued it was the protocol, habit, and practice to turn and reposition residents frequently, and at least every 2 hours.  There was no requirement that such standard, protocol, habit, and practice be documented.  (P. Ex. #4, pp. 14 to 15).  That argument is rebutted by the facility's own documentation requiring staff to turn and reposition as set

**Page 29**

forth above.  The record clearly demonstrates that instructions were set forth to turn and reposition Resident #1 but not followed through by staff.

CC stated she had reviewed the Declaration of KE and she concurred in and supported her opinions concerning Resident #1.  (P. Ex. #7, p. 2).  For reasons set forth hereinabove, I find the arguments are unsupported by the totality of the evidence and unpersuasive.

**Resident #2**

Resident #2 was admitted to Petitioner on 03/09/18 (CMS Ex. #1, p. 8; CMS Ex. #9, p. 1) with a documented open area to the coccyx.  (CMS Ex. #1, p. 8; CMS Ex. #9, p. 1).  Resident #2 was also documented as having an indwelling catheter.  (CMS Ex. #9, p. 14).

Review of Resident #2's TAR on 03/10, 03/11, 03/13 and 03/15 documented wound care was performed.  There was no documentation of dressing change on 03/12, 03/14, or 03/16.  The TAR contained an area for nurses to document weekly skin checks, but the area was blank for 03/12/18 indicating no assessment had been performed.  (CMS Ex. #1, p. 9; CMS Ex. #9, pp. 52 to 56).

Petitioner's contract wound physician conducted an initial evaluation of Resident #2 on 3/22/18 (CMS Ex. #9, pp. 37 to 39), documented the wounds, performed surgical debridement to Site #1, and updated wound care treatment orders (Id., p. 39).  Review of the TARs showed a failure to document consistent treatment (CMS Ex. #9, pp. 52 to 60), suggesting the treatment was not performed.

On 04/03/18 Resident #2 was observed by Ball seated in a cushioned wheelchair.  Ball noticed a low air loss mattress on the resident's bed.  An interview by Ball of Resident #2 determined he had acquired a pressure wound subsequent to his admission to the facility (Petitioner).  Resident #2 told Ball he needed assistance to turn and reposition in bed but stated "the staff is not consistent with assisting with the turning."  (CMS Ex. #1, p. 8).

Petitioner argued Resident #2 was actually admitted to CPHRC with two pressure ulcers, NOT with a single pressure ulcer as understood by CMS's surveyor.  Petitioner argued the evidence was clear that Resident #2 did NOT develop a facility-acquired pressure ulcer at Centre Pointe, as contended by CMS in concluding that a G tag is warranted.  (PPHB, p. 2).

**Page 30**

KE testified Resident #2 had over 33 medical diagnoses during his admission.  With this many diagnoses, it was an indication of how sick he was, which would make it easier for him to have skin breakdown and make it more difficult for his skin breakdown to heal.  (P. Ex. #4, p. 17).

CC acknowledged Resident #2 had an unstageable wound on his right sacral and a left side stage 2 sacral wound on the Medical Certification for Medicaid Long Term Care.  (P. Ex. #1, p. 1).  CC admitted a facility nurse inadvertently juxtaposed the right and left sides when describing the wounds.  CC testified an interim care plan was developed and physician orders obtained to treat the wound.  A full care plan was developed on March 12, 2018, which included a care plan for potential for pressure sore development.  CC admitted the date for potential skin breakdown obviously had an incorrect date as the initial date was after the revision date.  CC stated it was clear the potential for skin breakdown was written on March 12, 2018, when all of the other care plan sections were completed.  CC then argued statements clearly indicated that staff provided appropriate care and treatment to Resident #2's wounds.  (P. Ex. #7).

I find and conclude Petitioner's arguments fail to rebut CMS's allegations that Resident #2 was admitted with one pressure ulcer and developed an additional pressure ulcer on his buttock during his stay at Petitioner.  The surveyor discovered that the facility's documentation of his pressure ulcers incorrectly identified the location of the pressure ulcers on his buttocks (right vs. left), and that staff failed to document a weekly skin check on March 12, 2018.  In addition, the facility failed to document wound care treatments in accordance with the written physician orders.  (CMS Ex. #1, pp. 4, and 8-10).  Petitioner's argument is contradicted by Resident #2's unrebutted interview by Ball which determined he had acquired a pressure wound subsequent to his admission to the facility.

**Resident #3**

Resident #3 was identified by the DON as 1 of 5 residents with an in-facility acquired pressure ulcer.  Resident #3 was originally admitted on 03/01/18 from an acute care facility for orthopedic surgery aftercare.  (CMS Ex. #1, p. 10; CMS Ex. #10, p. 1).  The nursing admission skin assessment documented an open area to resident's coccyx measuring 3.1 cm x 3.5 cm.  There was no description of the wound's appearance.  (CMS Ex. #1, p. 10; CMS Ex. #10, p. 8).  A wound assessment was not performed until 03/07/18 (CMS Ex. #1, p. 10; CMS Ex. #10, pp. 24 to 31) with documentation describing a Stage 2 pressure wound to Resident #3's coccyx/buttock measuring 1.0 cm x 1.0 cm x 0.1 cm.  (CMS Ex. #10. p. 24).  The wound bed was noted to be epithelial tissue without drainage or odor.  The assessment documented the wound was present on admission, but documented the date identified 03/06/18 although Resident #3 was admitted on 03/01/18.

**Page 31**

The medical record and TARs failed to document wound care until 03/08/18 (CMS Ex. #1, p. 10; CMS Ex. #10, pp. 73 to 86, especially p. 77).

On 03/23/18 the nursing admission skin assessment documented a Stage 2 wound to the resident's sacrum.  (CMS Ex. #1, p. 11; CMS Ex. #10, p. 37).  The pressure wounds were not assessed to include measurements or description of wound drainage, wound edges, or peri-wound tissue.  (CMS Ex. #1, p. 11).  The medical record failed to document any wound care on 3/23/18 or 3/24/18.  (CMS Ex. #1, p. 11; CMS Ex. #10, p. 78).

On 04/04/18, twelve (12) days after Resident #3's pressure wound was identified, Petitioner's contracted wound care physician (CWCP) was making rounds.  A concurrent interview revealed she had been consulted on 03/29/18 to assess a resident's surgical wound, but was not aware of any pressure ulcers.  The physician was observed to perform an assessment of Resident #3's sacrum and bilateral heels.  The physician noted a large amount of drainage with foul odor and assessed the sacrum wound to be an unstageable pressure ulcer measuring 5 cm x 4.5 cm x 0.1 cm, with 20% slough and 30% granulation tissue present.  The physician stated the blackened area was necrotic tissue and stated she should have been consulted for the wound.  (CMS Ex. #1, p. 13; CMS Ex. #10, pp. 69 to 72).

Petitioner argued Resident #3 received all appropriate assessment and treatment for the pressure sores.  Petitioner admitted there were some documentation errors and omissions acknowledged in Petitioner's detailed Declarations, but argued numerous disagreements about whether particular documentation events occurred or were correctly noted.  (PPHB, pp. 4 and 5).

KE stated Resident #3 had a past history of not healing very well, a diagnosis of peripheral vascular disease (PVD), diagnosis of peripheral artery disease (PAD), and stated she had been laying on a gurney for 11 hours with no turning and repositioning.  (P. Ex. #4, p. 18).

MSMD stated Resident #3 was a 79 year old woman with multiple significant medical comorbidities and had been bed bound since undergoing a knee arthroplasty in January of 2018.  After her admission to Petitioner in March, the surgical wound continued to deteriorate requiring another hospitalization for wound debridement and surgical care.  On readmission to Petitioner, Resident #3 was in a state of severe deconditioning with multiple areas of skin breakdown both surgical and acquired.  MSMD argued the underlying medical conditions of Resident #3 must be taken into account as the most critical factor in the development of her wounds.  The wounds described in Resident #3 were secondary to the multiple underlying complex medical comorbidities and severe malnutrition in an elderly woman who had undergone multiple surgical procedures, and who was depressed and bed bound for approximately 3 months,

**Page 32**

and not from any omission or commission on the part of the staff at Centre Point.  MSMD opined the staff at Centre Point actually under very difficult clinical conditions had given such quality care that the wounds were showing improvement.  (P. Ex. #8).

For reasons set forth hereinabove, I find the arguments unpersuasive.

With respect to Residents #1, #2, and #3, I find and conclude Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(b)(1), because Petitioner failed to ensure that Residents #1, #2, and #3 were provided treatment and services to prevent pressure ulcers from developing and to promote healing of existing pressure ulcers and prevent infection and prevent new ulcers from developing.

**C. Petitioner was not in substantial compliance with 42 C.F.R. § 483.20(f)(5) and 42 C.F.R. § 483.70(i)(1)-(5).**

Petitioner failed to maintain complete and accurately documented residential records by failing to enter and implement physician wound care orders, failing to include wound care assessments in a timely manner, failing to include documentation of the provision of physician ordered catheter care and by entering conflicting information in the medical record for three (3) of three (3) sampled residents (Residents #1, #2, and #3).

**Resident #1**

Resident #1 was admitted 01/23/18 with intact skin.  (CMS Ex. #1, p. 16; CMS Ex. #8, p. 19).  On 02/07/18 the LPN documented an open area to the resident's left buttock without any measurements or description.  (CMS Ex. #8, p. 39).  Resident #1's TAR failed to show any documentation of any wound care dressings ordered or initiated following documentation of the skin impairment on 02/07/18.  (CMS Ex. #1, p. 16; CMS Ex. #8, pp. 154 to 169).

An interview of the DON on 4/4/18 determined a treatment order was obtained by the LPN on 02/07/18 when the wound was first identified, but the nurse failed to enter the order into the computer system.  The DON stated the treatments were being done, but confirmed the medical record failed to indicate the treatments were provided.  (CMS Ex. #1, p. 16).

**Resident #2**

Resident #2 was admitted on 03/09/18 with a documented open area to the coccyx.  The medical record failed to include assessment of the wound that included measurements and wound appearance.  (CMS Ex. #1, p. 16; CMS Ex. #9, pp. 6 and 22).

**Page 33**

On 03/15/18 documentation showed two skin impairments.  Skin Impairment #1 to the right buttock was measured at 3.5 cm x 3.0 cm x 0.1 cm, stage II, and documented as having been identified on 03/15/18 as IHA, (in house acquired).  Skin Impairment #2 to the left buttock was measured at 2.5 cm x 1.0 cm x "?" cm, unstageable and was documented as POA, identified on 03/09/18 present on admission a pressure wound.  (CMS Ex. #1, p. 16; CMS Ex. #9, pp. 23 to 24).

A subsequent wound assessment on 03/21/18 documented two skin impairments.  Skin impairment #1 was identified as being to the right buttock with measurements of 3.0 cm x 3.5 cm x 0.1 cm, unstageable, and identified as POA, (present on admission on 03/09/18).  Skin impairment #2 was identified as being to the left buttock, measuring 1.0 cm x 0.4 x 0.1, Stage II, and identified as being IHA (in house acquired) on 03/13/18.  (CMS Ex. #9, pp. 30 to 32).

The admission documentation of 3/9/18, wound assessment of 03/15/18 and wound assessment of 03/21/18 document conflicting dates and information.  Records failed to include measurements and wound appearance and/or document a care plan.  (CMS Ex. #9, pp. 52 to 60).

**Resident #2**

Resident #2 was admitted with an indwelling urinary catheter and a physician order to perform catheter care every shift.  Review of the medical record including the March and April TARs failed to show documentation of the provision of the catheter care in accordance with the physician's orders.  (CMS Ex. #1, p. 17; CMS Ex. #9, pp. 52 to 60).

**Resident #3**

Resident #3 was admitted on 03/01/18 with a documented wound to the coccyx which measured 3.1 cm x 3.5 cm.  (CMS Ex. #1, p. 17; CMS Ex. #10, pp. 7 to 8, and 22).  A wound assessment on 03/07/18 documented Skin impairment #1 as a pressure wound to the coccyx measuring 1.0 cm x 1.0 cm x 0.1 cm, Stage II, and recorded the impairment as having been POA (present on admission), recording a date of 03/06/18 even though Resident #3 was admitted on 03/01/18.  (CMS Ex. #1, p. 17; CMS Ex. #10, p. 24).  The summation on 03/07/18 described the skin impairment as an open wound to the coccyx/buttock, area red on admission, now open.  (CMS Ex. #10, p. 31).

A wound assessment dated 03/23/18 documented a skin impairment to the sacrum described as "Stage 2 wound noted on sacrum area, dressing intact, wound appeared pink, moist, with no signs of infection noted."  (Id., pp. 36 to 37).  No measurements or further assessment were recorded.

**Page 34**

A subsequent wound assessment on 03/26/18 documented a pressure wound to Resident #3's sacrum that was identified on admission date of 03/23/18.  (CMS Ex. #1, p. 17).  On page 1 of the document (CMS Ex. #10, p. 52) the wound measurements were documented as measuring 1.0 cm x 0.3 cm x 0 cm.  A second wound was documented as measuring 4.0 cm x 3.0 cm x 0 cm, and identified as POA (present on admission).  (Id., p. 53).  On page 7 of the same document (Id., p. 58), the summation documented, noted areas to sacrum x2 and right buttock area:  sacrum 1.4w x 3L and sacrum 2.1L x 0.5w.  These measurements were noted to be different than the measurements on page 1 of the document.  An interview with the Licensed Practical Nurse, Employee D, who completed the document was conducted on 04/04/18 at which time Employee D stated the measurements documented on page 7 were the accurate measurements and she could not explain why she documented different measurements on page 1 of the document.  (CMS Ex. #1, p. 18).  Those measurements and descriptions were internally inconsistent in the same skin assessment.

When Resident #3 was readmitted on 03/23/18 she had an indwelling Foley catheter in place.  (CMS Ex. #1, p. 18; CMS Ex. #10, p. 45; *see*CMS Ex. #10, pp. 96, 99-100).  The medical record failed to document any physician orders for the use of the catheter and failed to document any provision for catheter care.  (CMS Ex. #1, p. 18).

Petitioner acknowledged there were some documentation errors and omissions acknowledged in Petitioner's detailed Declarations.  (PPHB, pp. 2, 3, and 6).

KE acknowledged Regina Barkley, RN failed to enter the order or document any treatment in the resident's records.  (P. Ex. #4, p. 13).

KE testified it was not necessary to document turning and repositioning because such documentation is not required by any rule, regulation, or law, rather it is the standard protocol at Petitioner and elsewhere in Florida.  (Id., pp. 14 and 15).

CC acknowledged a facility nurse inadvertently juxtaposed the right and left sides when describing the wounds.  The date for potential skin breakdown obviously had an incorrect date as the initial date was after the revision date.  It was clear the potential for skin breakdown was written on March 12, 2018 when all of the other care plan sections were completed.  (P. Ex. #7, p. 2).

RG's Declaration stated with respect to Resident #2, although the wounds were clearly outlined on the admission and on the Form 3008 there has been some confusion regarding whether these wounds were facility acquired.  The wound nurse at the time of survey had just assumed the responsibility of this position and may have made this assumption.  However, the documentation clearly showed that the wounds were present on admission.  (P. Ex. #9, p. 2).

**Page 35**

RG further stated Resident #2's care plan regarding potential for skin impairment date showed an initiation date of 04/12/2018, with a revision of 04/03/2018.  RG acknowledged this had to be a typo or input error.  According to RG, obviously, you cannot revise a care plan before it is initiated.  The date of initiation for these care plans - including this portion -- was not 04/12/18 as alleged, but was in fact 03/12/2018 with a revision of 04/03/18.  (P. Ex. #9, p. 3).

CMS has come forward with evidence – primarily the facility's own documents – establishing facts showing that the facility was not in substantial compliance with 42 C.F.R. §§ 483.20(f)(5) and 483.70(i)(l)-(5).  For its part, Petitioner has not come forward with any admissible evidence establishing a dispute over the objective facts.  Instead, it asks me to ignore irrefutable evidence in order to draw unreasonable inferences based on witness speculation.  Speculation and unsubstantiated assertions do not satisfy a party's burden to identify specific evidence demonstrating a material fact in dispute.  *Shah v. Azar*, 920 F.3d 987, 995-96 (5th Cir. 2019); *Pearsall Nursing & Rehab. Ctr. – N.*, DAB No. 2692 at 7 (2016).

I find and conclude with respect to Residents #1, #2, and #3, Petitioner was not in substantial compliance with 42 C.F.R. § 483.20(f)(5) and 42 C.F.R. § 483.70(i)(l)-(5) because Petitioner failed to maintain complete and accurately documented medical records, failed to timely document wound care orders and assessments, and failed to document catheter care.

**D. Petitioner was not in substantial compliance with 42 C.F.R. § 483.75(g)(2)(ii).**

Petitioner was not in substantial compliance with 42 C.F.R. § 483.75(g)(2)(ii) because Petitioner failed to develop and implement appropriate plans of action to address quality concerns related to the management of pressure ulcers and injuries.  (SS D/F867).

**42 C.F.R. § 483.75(g)(2)(ii)(Tag F867****-Quality Assessment and Assurance/Improvement****Plan) at a D level of scope and severity.**

Petitioner violated 42 C.F.R. § 483.75(g)(2)(ii)(Tag F867) which provides a facility must maintain a quality assessment and assurance committee.  The statute provides the facility committee must:

(ii) Develop and implement appropriate plans of action to correct identified quality deficiencies;

Petitioner failed to ensure implementation of a Quality Assessment Performance Improvement Plan (QAPIP) developed after Petitioner identified quality concerns related to the management of pressure wounds.

**Page 36**

On 04/04/18 the Petitioner's DON provided a notebook containing documents identified as a four point performance improvement program developed on 02/14/18, after review of the records of Resident #1 identified areas for improvement, including concerns related to documentation.  (CMS Ex. #1, pp. 18 to 19; CMS Ex. #19, p. 1).

Debra Ball, the AHCA surveyor, interviewed the DON who informed Ball there was a breakdown of these processes due, in part, to the DON being out on medical leave and resignation of the Petitioner's designated wound care nurse.  (CMS Ex. #15, p. 5).  Ball stated Petitioner initiated a PIP on 02/14/18, however she found the quality issues related to pressure ulcers continued after implementation of the plan.  (CMS Ex. #15, pp. 5 to 6).

KE argued while there was no new date put on the care plan, none was needed because the information was covered by other entries.  (P. Ex. #4, p. 10).  She further stated "...while, "[w]hile there were no official [emphasis added] 'skin checks' however there are 37 different times over a period of 13 days where documentation in the medical record (TAR) demonstrated that the nurses did skin checks" which she enumerates.  (Id., pp. 10-11).  KE opined "...if there was [sic] any abnormalities or open areas thought to be the beginning of a pressure ulcer/injury it would have been reported as it was on 02/07/18 . . . ."  (Id., p. 11).  Further, "[i]t is customary for nurses to report to the medical provider any abnormalities the patient may have."  (Id., p. 12).  I find KE's statements are speculative and inconsistent with the record as a whole, and are contradicted by other evidence within the record.

KE later admitted that Regina Barkley, RN ". . . failed to document but did the treatments . . . ."  (Id., p. 13).  I find and conclude that admission in and of itself supports CMS's allegations and rebuts the argument of Petitioner with respect to this violation.

KE further stated ". . . while the documentation may look like '[n]o treatment was initiated until 01/25/18', this is not true."  (Id., p. 14).  I find and conclude the statute does not permit documentation to merely "look like" but must in fact comply with the statute.

CC stated "[t]here is a facility nurse who inadvertently juxtaposed the right and left sides when describing the wounds . . . ."  (P. Ex. #7, p. 2).  CC later stated, "[t]he date for potential skin breakdown obviously had an incorrect date as the initial date was after the revision date."  (Id.)  CC testified staff provided appropriate care.  Nonetheless, Petitioner failed to comply with the regulations by accurately documenting information, a violation of this portion of the statute.

**Page 37**

I find and conclude Petitioner violated 42 C.F.R. § 483.75(g)(2)(ii) by failing to develop and implement appropriate plans of action to correct identified quality deficiencies.

X.  CONCLUSIONS

I find and conclude the evidentiary evidence and facts support a finding Petitioner violated 42 C.F.R. § 483.21(b)(1)(Tag F656 – Develop/Implement Comp. Care Plan) at a D level of scope and severity in that Petitioner failed to develop and implement a comprehensive care plan for use of an indwelling urinary catheter for Resident #3; and

I find and conclude the evidentiary facts support a finding Petitioner violated 42 C.F.R. § 483.25(b)(1)(Tag F686 – Treatment/Services to Prevent/Heal Pressure Ulcers) at a G level of scope and severity in that Petitioner failed to provide the necessary treatment and services to promote healing and prevent infection of resident wounds by failing to prevent the development of pressure wounds and failing to ensure pressure wounds were assessed when identified; failing to prevent the worsening of pressure wounds; failing to obtain wound care orders when pressure wounds were identified; failing to document weekly skin assessments in accordance with Petitioner's protocol; and failing to document the provision of wound care treatments in accordance with written physician orders; and

I find and conclude the evidentiary facts support a finding Petitioner violated 42 C.F.R. §§ 483.20(f)(5) and 483.70(i)(l)-(5)(Tag F842 – Resident Records) at a D level of scope and severity in that Petitioner failed to maintain complete and accurately documented resident medical records by failing to enter and implement physician wound care orders; failing to include appropriate wound care assessments in a timely manner; failing to include documentation of the provision of physician-ordered catheter care and by entering conflicting information in resident medical records; and

I find and conclude the evidentiary facts support a finding Petitioner violated 42 C.F.R. § 483.75(g)(2)(ii)(Tag F867-Quality Assessment and Assurance/Improvement Plan) at a D level of scope and severity in that Petitioner failed to ensure implementation of a Quality Assessment Performance Improvement Plan developed after they identified concerns related to the management of pressure wounds.

XI.  PENALTY

There being liability under the relevant statute, I must now determine the amount of penalty to impose.

**Page 38**

Petitioner, in its brief, stated it did not challenge the amount of the civil money penalty in this case but challenged the imposition of the civil money penalty.  (PPHB, pp. 1 to 2, and 7).  Petitioner argued the violations could not be proven.  I have found and concluded CMS has proven each of the allegations.

XII.  MITIGATION

Petitioner provided no evidence and/or testimony in support of mitigation so no mitigation of penalty is considered.

Having determined Petitioner was liable as set forth above, I find no reason to modify the civil money penalty imposed.

WHEREFORE, evidence having read and considered it be and is hereby ORDERED as follows:

1) Petitioner violated 42 C.F.R. § 483.2l(b)(1)(Tag F656 – Develop/Implement Comp. Care Plan) at a D level of scope and severity; and
2) Petitioner violated 42 C.F.R. § 483.25(b)(1)(Tag F686 – Treatment/Services to Prevent/Heal Pressure Ulcers) at a G level of scope and severity; and
3) Petitioner violated 42 C.F.R. §§ 483.20(f)(5) and 483.70(i)(1)-(5)(Tag F842 – Resident Records) at a D level of scope and severity; and
4) Petitioner violated 42 C.F.R. § 483.75(g)(2)(ii)(Tag F867-Quality Assessment and Assurance/Improvement Plan) at a D level of scope and severity; and
5) I affirm the assessment of a civil money penalty in the amount of $12,110.


          /s/
        Richard C. Goodwin

                      Administrative Law Judge
      1. See also Butz v. Economou, 438 U.S. 478 at 513, 98 S. Ct. 2894, 57 L. Ed. 2d 895 (1978); Marshall v. Jerrico, Inc., 446 U.S. 238 (1980); Federal Mar. Comm'n v. South Carolina State Ports Auth., 535 U.S. 743, 744 (2002). back to note 1
                      2. eFiled Document #1. back to note 2
                      3. eFiled Documents #2, #2a and #2b. back to note 3
                      4. eFiled Documents #4, #4a to #4x. back to note 4
                      5. eFiled Documents #7, #8, #8a to #8c, #9, #9a to #9c, #10, #11, #12, and #13, #13a and #13b.  Petitioner later filed replacement exhibits on December 7, 2018, that are eFiled Documents #21 to #25. back to note 5
                      6. eFiled Document #15. back to note 6
                      7. eFiled Document #16. back to note 7
                      8. eFiled Document #17. back to note 8
                      9. eFiled Document #18. back to note 9
                      10. eFiled Documents #28 and #29. back to note 10
                      11. APO, paragraph #9; eFiled Document #2. back to note 11
                      12. eFiled Document #30. back to note 12
                      13. eFiled Document #31. back to note 13
                      14. The change in condition document erroneously notes the date as 7-2017, instead of correct date of February 7, 2018.  (See CMS Ex. #8, pp. 36 to 56). back to note 14
                      15. "Unstageable" means the extent of the tissue damage and wound bed is obscured by slough (a layer or mass of dead tissue separated from surrounding living tissue, as in a wound, sore, or inflammation) or eschar (dead tissue that sheds or falls off from the skin).  (CMS Ex. #21, p. 4; see also CPHB FN #2). back to note 15
                      16. Partial thickness loss of dermis presenting as a shallow open ulcer with red pink wound bed, without slough.  May also present as an intact or open/ruptured serum filled blister.  (CMS Ex. #21, p. 3). back to note 16
                      17. The change in condition document erroneously notes the date as 7-2017, instead of correct date of February 7, 2018.  (See CMS Ex. #8, pp. 36 to 56). back to note 17
                      18. "Unstageable" means the extent of the tissue damage and wound bed is obscured by slough (a layer or mass of dead tissue separated from surrounding living tissue, as in a wound, sore, or inflammation) or eschar (dead tissue that sheds or falls off from the skin).  (CMS Ex. #21, p. 4; see also CPHB FN #2). back to note 18 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