The New ESRD Regulations From the Surveyors Perspective

1
The New ESRD Regulations From the Surveyors
Perspective

• Liza Ben Vaughn, RN
• KDHE BCCHF
• QI Coordinator

2
ESRD Survey Focus

• Protect Patient Safety and Improve Patient
  Outcomes
• Data is used to focus surveys
• Standards are incorporated into regulations
  (AAMI, CDC and NFPA)
• Multiple resources for Standards

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Resources for Standards

• Regulations and Guidelines
• FDA, NKF, NQF, American Nephrology Nurses
  Association, Renal Physicians Association
• Manufacturers Directions
• State Practice Acts
• MAT (Measures Assessment Tool)

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Focused Basic Survey Process

• Initials
• Complaints
• Relocations
• Change in service

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STAR

• Surveyor Technical Assistant for Renal Disease
• An automated survey guide
• Uses a wireless tablet PC
• Guides the surveyor through the process
• Roll out in some states. Kansas and Iowa are
  using STAR.

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Sixteen Survey Tasks

• Pre-survey
• Introductions
• Tour/Observations
• Entrance conference
• Patient sample selection
• Water treatment-Dialysis preparation
• Reprocessing-Reuse
• Machine operation-maintenance
• Home training department review

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• Patient interviews
• Medical record reviews
• Personnel interviews
• QAPI
• Personnel record reviews
• Decision Making
• Exit conference

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FLASH SURVEY

• Waiting room
• Patient restrooms
• Reuse room
• Water-Dialysate areas
• Home training area
• Treatment area
• Isolation

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Observations and Tour

• Ongoing throughout the survey
• Physical environment
• Infection control
• Patient Staff interaction
• Patient care delivery
• Staffing
• Medical record and logs in use

10
Patient Sample Selection

• Ten percent sample with a minimum of 5 and
  maximum of 15.
• Sample from ALL treatment modalities offered.
• Selection made from information provided by the
  facility and general observations.
• Cumulative lab reports, infection logs,
  hospitalization logs, vascular access
  information, pediatric patients, LTC facility
  patients, unstable patients are all used to
  select sampled patients.

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Patient Interviews

• Minimum of 5 patients
• Can be same as sampled or different.
• Done in treatment area, waiting room, in private
  or by phone
• STAR has a structured guide or may use custom
  questions

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Sample of Interview Questions

• How do you participate in your plan of care?
  (V541, V 556)
• How does your dialyzer look when your treatment
  is finished? V547)
• Do you have a problem with your blood pressure?
• Is your weight goal generally achieved?
• Have you had any problems while on dialysis such
  as itching, chills, fever?
• What happened? How did staff respond?

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Medical Record ReviewHow Will Surveyors Know
the POC Is Implemented?

• Physicians orders
• Laboratory values
• IDT progress notes
• POC changes and updates
• Dialysis flow sheets

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Medical Record Review

• FORMAT-electronic, manual or combination
• CONTENT-
• Consents, Medical Exam, Histories, Progress
  notes, Labs, Treatment orders, Dialysis treatment
  records, Patient educations, Patient Assessment,
  POC, Demographic Information, Anemia management
  records, plus information from other disciplines.

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Treatment Orders

• Peritoneal dialysis treatment orders contain the
  Number of Exchanges and Dialysate
  Concentration-Volume.
• Hemodialysis treatment orders contain- Treatment
  duration and frequency, BFR (Blood Flow Rate),
  Dialyzer, Dialysate Rx and flow rate, Target
  weight, Heparin dosing and other medications.

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Dialysis Treatment Records

• PD- contain flowsheets can be electronic or
  manual and are reviewed at least every 2 months.
• Hemodialysis-contain Pre-Treatment, During
  Treatment and After treatment information

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Hemodialysis Pre-treatment RecordSurveyors Look
For

• Water Treatment
• Dialysis machine
• Reprocessed dialyzer checks
• Dialysis orders
• Patient information-demographic information

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Machine Safety and Reprocessed Dialyzer Checks

• Machine assessment-conductivity
  machine____manual____
• pH____machine ____manual
• Alarm test
• Air detector on
• UF system
• Positive Presence Test___
• Negative Residual Test___
• Dialyzer ID___ Machine ID_____

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Treatment Orders-examples

• Dialyzer____DFR____BFR____Tx Time___
• Dialysate______K_____Ca_____Bicarb____
• Sodium Modeling_________ UF Profiling____
• Dialysate temp______

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Pre-Treatment, Post-Treatment Information

• Include B/P sit____stand___
• Weight_____ EDW___Wt gain__
• Wt loss___Wt removed_____
• Time on___time off____
• Assessment of patients GI, Cardiac, Edema,
  Mental, Mobility, and Access

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Hemodialysis Treatment Records

• Surveyors review orders, tx records and observe
  treatments to ensure all orders are followed
  pre-treatment, during treatment, and post
  treatment. Review for intradialytic patient and
  machine monitoring, medication and treatments
  administered. Heparin or anticoagulation are
  reviewed and compared with orders, observations,
  and interview information.

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Immunization Medical Record Documentation

• V 506, V 126, and V 127
• Record of testing and immunizations
• Documentation of immunity or acknowledgement of
  absence of immunity
• Documentation of further action planned if
  required.

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Medical Record Documentation for Access and
Adequacy

• If expected outcomes for dialysis access or
  adequacy are NOT achieved, there should be
  evidence of reassessment for that aspect of care.
• If the patient is not achieving the expected
  targets, there should be documentation of the
  reason WHY and a change in plan
• Adjust the plan and implement the changes.

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Medical Record Documentation for Access and
Adequacy

• May be in IDT assessments
• Plan of care
• Implementation of the care plan may be on
  flowsheets, progress notes, physician orders,
  etc.

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Medical Record Documentation for Anemia Management

• IDT assessments
• Plan of care with measurable goals and timelines
• Implementation of care plan
• flowsheets
• progress notes
• medication administration records
• physician ordersetc

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Medical Record Documentation for Nutrition

• IDT assessment
• Plan of care with measurable goals and timelines
• Implementation of care plan
• flowsheets
• progress notes
• medication administration records
• physician ordersetc

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Medical Record Documentation for Psychosocial

• V 730- Results of standardized survey of mental
  and physical assessment (chosen by social worker)
• Plan for psychosocial interventions (counseling
  and referral) to achieve and sustain appropriate
  psychosocial status
• Plan for other elements of care that may be
  influenced by psychosocial status
• IDT assessment
• POC with goals and timelines
• Implementation documentation in flowsheets,
  progress notesetc.

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Types of Medical Record Review

• Comprehensive-all components are reviewed
• Focused-review based on the rationale for
  sampling.
• Review areas of concern from survey or other
  records
• MAT will be used for reviews-see example

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Patient Assessment and Patient Plan of Care

• CFR 494.80 Patient Assessment
• The IDT must provide each patient an
  individualized comprehensive assessment- V501
• There are 14 assessment criteria- V502-515.
• Reassessment frequency criteria is defined at
  V515-520.
• Kelly gave examples of the IDT POC and its
  correlation with the PA.

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Staffing COP V 750

• 494.180 Governance-addresses the overall
  management of the facility. The GB must
  demonstrate
• Responsibility for the operation of the
  facility
• Fiscal management
• Staff Training and Coverage
• Medical Staff appointments and coverage
• QAPI

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Survey Process -Staffing

• V 757and V 758 require the GB to ensure adequate
  numbers of qualified personnel are present for
  the patient/staff ratio is appropriate and meets
  the needs of patients. The RN, social worker and
  dietitian members of the IDT are available to
  meet patient clinical needs.

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Staffing

• Surveyors consider patient acuity and care needs
  of patients, staff experience and areas of
  expertise. Staffing assignments and schedules
  reviewed to determine if there is a pattern of
  sufficient staff coverage to ensure safe patient
  care.

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Staffing review continued

• If the facility sharesthe social worker or
  dietitian with multiple clinics or requires
  professional staff to perform non-clinical tasks,
  it must NOT negatively impact the time available
  to provide clinical interventions require to
  achieve the goals identified in the patients
  POC. The facility CEO or administrator is
  RESPONSIBLE to assure professional support staff
  members have sufficient time available in the
  facility to meet the clinical needs of in-center
  and home dialysis patients.

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Surveyor Interviews With Professional Staff

• Interview Professional staff to determine their
  professional duties and number of non-clinical
  duties.
• Determine if non-clinical duties or tacks
  negatively impact the time available to provide
  clinical interventions and implementation of the
  plan of care.

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Positive Patient Outcome

• The renal community, CMS, state agency, and
  Network all work together to improve patient
  outcomes.

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Questions???

• Liza Ben Vaughn, RN
• Email- lbenvau_at_kdhe.state.ks.us
• 785-207-0203