The New ESRD Regulations From the Surveyors Perspective

Liza Ben Vaughn, RN

KDHE BCCHF

QI Coordinator

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

Resources for Standards Regulations and Guidelines

FDA, NKF, NQF, American Nephrology Nurses’ Association, Renal Physicians Association

Manufacturer’s Directions State Practice Acts MAT (Measures Assessment Tool)

Focused Basic Survey Process

Initials Complaints Relocations Change in service

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.

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

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

“FLASH SURVEY”

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

Observations and Tour

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

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.

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

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?

Medical Record Review~

How Will Surveyors Know the POC Is Implemented?

Physician’s orders Laboratory values IDT progress notes POC changes and updates Dialysis flow sheets

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.

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.

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

Hemodialysis Pre-treatment RecordSurveyors Look For:

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

information

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_____

Treatment Orders-examples

Dialyzer____DFR____BFR____Tx Time___

Dialysate______K_____Ca_____Bicarb____

Sodium Modeling_________ UF Profiling____

Dialysate temp______

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

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.

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.

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.

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.

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 orders…etc

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 orders…etc

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

notes…etc….

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

Patient Assessment and Patient Plan of Care

CFR 494.80 Patient Assessment The IDT must provide each patient an

individualized comprehensive assessment- V501There 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.

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

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.

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.

Staffing review continued:

If the facility “shares”the 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 patient’s 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.

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.

Positive Patient Outcome

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

Questions???

Liza Ben Vaughn, RN

Email- lbenvau@kdhe.state.ks.us

785-207-0203