Fluid Management In End Stage Renal Disease (ESRD)
Fluid Management InEnd Stage Renal Disease (ESRD) PatientsJennie D. Pike, ND, MBA, RNExecutive Director, HSAG: ESRD Network 15June 16, 20161
Objectives Review of Regulations – Part 494 Conditionsfor Coverage (CfCs) for ESRD Facilities ESRD CORE Survey Patient Assessment – Fluid Status Ultrafiltration – Current Thinking Post-Dialysis Weight – Current Thinking Quality Assessment and PerformanceImprovement (QAPI) – Fluid Management Review of Citations – Arizona and National2
Centers for Medicare & MedicaidServices (CMS)Part 494 - Conditions for Coverage forEnd Stage Renal Disease Facilities3
PART 494 - Conditions for Coverage forESRD Facilities The Federal Register - published continuously since March 14, 1936.Provides the only complete history of the regulations of the federalgovernment with the text of all changes. Orders from federal agencies or the Executive Branch - not effective untilpublished in the Federal Register. In 1937 - amended to create the Code of Federal Regulations, a set ofpaperback books that arrange effective regulations from the Federal Registerby subject. The Code of Federal Regulations (CFR) annual edition - codification of thegeneral and permanent rules published in the Federal Register by thedepartments and agencies of the Federal Government produced by the Officeof the Federal Register (OFR) and the Government Publishing Office. 42 CFR Part 494 Conditions for Coverage for ESRD facilities - Posting Date:October 3, ads/esrdfinalrule0415.pdf
PART 494 - Conditions for Coverage forESRD Facilities Conditions for Coverage (CfCs) & Conditions of Participations (CoPs) - healthcare organizations must meet in order to begin and continue participating inthe Medicare and Medicaid programs. Providers and Suppliers of health services - comply with minimum healthand safety standards. “Conditions of Participation” (“CoPs”) or “Conditionsfor Coverage” (“CfCs”), depending on the type of Medicare-participatingentity. “CoPs” – Hospitals, Home Health Agencies, Community Mental HealthCenters, Transplant Centers “CfCs” – End-Stage Renal Disease Facilities, Ambulatory Surgical Centers,Portable X-Ray, Rural Health nloads/esrdfinalrule0415.pdf
PART 494 - Conditions for Coverage for ESRDFacilities (cont.) End Stage Renal Disease Facilities (42 C.F.R. Part 494) 16 Conditions, V Tags 100 – 773 (635 tags or regulations) Conditions:Compliance with Federal, State, and Local laws and regulationsInfection ControlWater and Dialysate QualityPatients’ RightsPatient AssessmentPatient Plan of CareCare at HomeQuality Assessment and Performance ImprovementResponsibilities of Medical AndRegulations/Downloads/esrdpgmguidance.pdf6
PART 494 - Conditions for Coverage forESRD Facilities (cont.)Standards: Fluid Assessment, Target Weight, Ultrafiltration,Fluid Management Condition: Patient Assessment– V503 -(2) Evaluation of the appropriateness of the dialysisprescription– V504 - Blood pressure, and fluid management needs– V509 - 6) Evaluation of nutritional status by a dietitian(references V504)– V520 - (2) At least monthly for unstable patients including, butnot limited to, patients with the following:i.ii.iii.iv.7Extended or frequent hospitalizations;Marked deterioration in health status;Significant change in psychosocial needs; orConcurrent poor nutritional status, unmanaged anemia andinadequate nloads/esrdpgmguidance.pdf
PART 494 - Conditions for Coverage forESRD Facilities (cont.) Condition: Patient Plan of Care– V543 - The plan of care must address, but not be limited to, the following: (1)Dose of dialysis. The interdisciplinary team must provide the necessary careand services to manage the patient's volume status; and– V544 - Achieve and sustain the prescribed dose of dialysis to meet ahemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of atleast 1.7 or meet an alternative equivalent professionally-accepted clinicalpractice standard for adequacy of dialysis.– V559 - (3) If the expected outcome is not achieved, the interdisciplinary teammust adjust the patient’s plan of care to achieve the specified goals. When apatient is unable to achieve the desired outcomes, the team must:i.ii.iii.Adjust the plan of care to reflect the patient's current condition;Document in the record the reasons why the patient was unable to achieve the goals;andImplement plan of care changes to address the issues identified in paragraph (b)(3)(ii)of this sectionV545, V547, V549, ds/esrdpgmguidance.pdf
PART 494 - Conditions for Coverage forESRD Facilities (cont.) Condition: Care at Home– V584, and more Condition: Quality Assessment and Performance Improvement– V629 - (i) Adequacy of dialysis.– V640 - The facility must immediately correct any identified problems thatthreaten the health and safety of patients. Condition: Responsibilities of the Medical Director– V715 - (2) Ensure that:i.9All policies and procedures relative to patient admissions, patient care, infectioncontrol, and safety are adhered to by all individuals who treat patients in thefacility, including attending physicians and nonphysician providers; /esrdpgmguidance.pdf
ESRD CORE Survey10
ESRD CORE Survey ESRD Core Survey Field Manual Version 1.8 effectivedate: 09/29/2015 Measures Assessment Tool (MAT) - Version 2.4 Fiscal Year 2016 (10/01/15-9/30/16) ESRD CORESurvey Data Worksheet Fiscal Year 2016 (10/01/15-9/30/16) ESRD CORESurvey Data Worksheet– III. Clinical Outcomes Thresholds s/dialysis.html11
Measures Assessment Tool (MAT)12
MAT (continued)13
ESRD CORE Survey Data dialysis.html
CMS Survey and Certification (S&C) ds/Survey-and-Cert-Letter-16-03.pdf
ESRD CORE Survey Data lations/dialysis.html
ESRD CORE Survey Data dialysis.html
Patient Assessment – Fluid StatusUltrafiltration – Current ThinkingPost-Dialysis Weight – Current Thinking18
Patient Assessment – Fluid StatusWhat is meant by Dry Weight in a hemodialysispatient? The lowest weight tolerated without developing lowblood pressure Often difficult to determine Depends on:1.2.3.Intracellular fluid - how much water is held in the body’s cellsExtracellular fluid - water outside of cells in tissues and bodyspaces such as the chest and abdomenBody sodium - may affect fluid between compartments,weight gain between dialysis treatments, and the success offluid removal during hemodialysisEli. A. Friedman, MD., American Association of Kidney n-a-hemodialysis-patient.html19
Patient Assessment – Fluid Status (continued) No standardization of estimating dry weight Estimation of "dry weight" is determined clinically as “thelowest weight where the patient is normotensive, takes eithera minimum or no blood pressure medications, does notexperience cramps, and has no edema” Does not necessarily add up to a patient being "dry," or"euvolemic" (at a state of normal body fluid volume)CNNT Lead Article - Fluid Management in Hemodialysis: TheOngoing Challenge Elaine Go, NP, MSN, ge20
Patient Assessment – Fluid Status (continued)Definitions: Estimated Dry Weight: The standard HD prescriptiontargets fluid removal to a clinically derived estimate ofdry weight. Dry weight is currently defined as the lowestweight a patient can tolerate without the developmentof symptoms or hypotension (1). Since physiologic dryweight is that weight resulting from normal renalfunction, vascular permeability, serum proteinconcentration, and body volume regulation, dry weight inHD should theoretically be lower than physiologic toprophylax interdialytic weight gains.Assessment of Dry Weight in Hemodialysis - An 92.full21
Patient Assessment – Fluid Status (continued)Definitions: Third-spacing: Shift of fluid from the intravascular space to anonfunctional space (e.g., abdomen or thorax).Medical Dictionary for the Health Professions and Nursing Farlex 2012 Euvolemic: Having appropriate hydration. Synonym:normovolemicMedical Dictionary 2009 Farlex and Partners22
Patient Assessment – Fluid Status (continued) Adherence to treatment prescription Accurate pre- and post-treatment weights Accurate monitoring of patients’ symptomsand adjustments made Reporting of patients’ symptoms Adjustments to Estimated Dry Weight Staff knowledge of policies, maximum fluidremoval23
Ultrafiltration – Current ThinkingDefinition Ultrafiltration: A type of filtration, sometimesconducted under pressure, through filterswith very small pores, such as those used byan artificial kidney. It can separate largemolecules from smaller molecules in bodyfluids.Mosby's Medical Dictionary, 9th edition. 2009, Elsevier.24
Ultrafiltration – Current Thinking (continued)National Quality Forum - NQF-Endorsed Measuresfor Renal Conditions, 2015 TECHNICAL REPORT,December 2015 2701 Avoidance of Utilization of High Ultrafiltration Rate ( 13 ml/kg/hour) (Kidney Care Quality Alliance): Endorsed– Description: Percentage of adult in-center hemodialysis patientsin the facility whose average ultrafiltration rate (UFR) is 13ml/kg/hour– Measure Type: Intermediate Clinical Outcome– Level of Analysis: Facility– Setting of Care: Other– Data Source: Electronic Clinical Data A newly submitted measure specified at the facility level25
Ultrafiltration – Current Thinking (continued) Measure intended to assess the percentage of adult incenter hemodialysis patients whose averageultrafiltration rate (UFR) is 13 ml/kg per hour. Time component in the numerator considered a criticalelement Rather than dictating the UFR remain 13, the lengthof the session component of the measure allowsjudicious use of UFR rates above 13 as long as thepatient is dialyzed for more than 240 minutes. Can the measure eventually be implemented intoCROWNWeb?26
Ultrafiltration – Current Thinking (continued) Numerator Statement: Number of patients* from thedenominator whose average UFR 13 ml/kg/hour whoreceive an average of 240 minutes per treatmentduring the calculation period.***To address the fact that patients may contribute varying amounts oftime to the annual denominator population, results will be reportedusing a “patient-month” construction.** The calculation period is defined as the same week that themonthly Kt/V is drawn. Denominator Statement: Number of adult in-centerhemodialysis patients in an outpatient dialysis facilityundergoing chronic maintenance hemodialysis duringthe calculation period.27
Ultrafiltration – Current Thinking (continued) Exclusions: The following patients are excluded from thedenominator population1. Patients 18 years of age (implicit in denominator definition)2. Home dialysis patients (implicit in denominator definition.3. Patients in a facility 30 days4. Patients with 4 hemodialysis treatments during the calculationperiod5. Patients with 7 hemodialysis treatments in the facility duringthe reporting month6. Patients without a completed CMS Medical Evidence Form(Form CMS-2728) in the reporting month7. Kidney transplant recipients with a functioning graft8. Facilities treating 25 adult in-center hemodialysis patientsduring the reporting month28
Ultrafiltration – Current Thinking (continued) Measure is based on one Kidney DiseaseOutcomes Quality Initiative (KDOQI) clinicalguideline and a systematic review of theevidence (guidelines for hemodialysisadequacy: Achievement of optimal “dry”weight) Measure excludes four or more treatmentsper month (three maximum submissions forcompliance) Data source for this measure is CROWNWeb29
Ultrafiltration – Current Thinking (continued) Committee expressed concerns that CROWNWebcurrently only collects one data point and would need tobe expanded to the three submissions during the weekthat the monthly Kt/V is drawn in order to monitor thismeasure Developer reassured Committee regarding conversationswith CMS about adding the two extra data points sobatch submitters could batch them together to form thethree needed data points and all other facilities wouldhave to manually enter the additional two in the mannerthey currently manually enter the one data point30
Ultrafiltration – Current Thinking (continued) The National Kidney Foundation (NKF) notes that fluidmanagement is one of the most important aspects ofhemodialysis and including fluid managementmeasure(s) in the ESRD Quality Incentive Program isimportant Increasing time can achieve fluid removal and bloodpressure control goals that can be tailored to theindividual patient. Including the time of at least fourhours also protects against the risk of trying to satisfythe measure by meeting the UFR of 13ml/kg in theshortest amount of time, which may increase risks offluid overload and intra-dialytic hypotension.31Flythe, Jennifer E., et al. Rapid Fluid Removal During Dialysis is Associated With Cardiovascular Morbidity andMortality. Kidney Int. 2011;79(2):250-257.
Ultrafiltration – Current Thinking (continued) The NKF KDOQI hemodialysis adequacy draft guidelines(publication pending), do not include a target for UFRand instead recommend individualizing UFR targets forthe patient. This is because the supporting evidence fora specific target is limited. One study (not cited in theevidence for this measure) suggests an increased riskfor individuals with heart failure with a UFR between10–14 ml/h/kg, but improvements in outcomes forindividuals without heart failure with a UFR in thatrange (1). However, NKF believes the 13 ml/kg targetfor a quality measure of UFR has the most consensusamong experts.32Flythe, Jennifer E., et al. Rapid Fluid Removal During Dialysis is Associated With Cardiovascular Morbidity andMortality. Kidney Int. 2011;79(2):250-257.
Ultrafiltration – Current Thinking (continued) Implementing the measure is not without challenges.Successfully meeting the measure will requirepatient participation and adherence to the dialysisprescription and fluid restrictions. Accordingly,regulators will need to monitor for inappropriatepatient discharges that may result from facilitiestrying cherry-pick compliant patients.33Flythe, Jennifer E., et al. Rapid Fluid Removal During Dialysis is Associated With Cardiovascular Morbidity andMortality. Kidney Int. 2011;79(2):250-257.
Post-Dialysis Weight – Current ThinkingNational Quality Forum - NQF-Endorsed Measures forRenal Conditions, 2015 TECHNICAL REPORT, December2015 2702 Post-Dialysis Weight Above or Below Target Weight(Kidney Care Quality Alliance): Not Endorsed– Description: Percentage of patients with an average postdialysis weight 1 kg above or below the prescribed targetweight– Measure Type: Intermediate Clinical Outcome– Level of Analysis: Facility– Setting of Care: Other– Data Source: Electronic Clinical Data A newly submitted measure specified at the facility level34
Post-Dialysis Weight – Current Thinking Measure complements and serves as a check andbalance to measure #2701 KDOQI Guideline was provided which states thatpatients should be ultrafiltered to a targetoptimal dry weight Committee saw a compelling need to havemeasures for volume. However, noted that giventhe arbitrary manner in which clinicians set thedry weight and given the lack of data, theevidence presented did not suffice. Committee did not reach consensus on overallsuitability for endorsement.35
Post-Dialysis Weight – Current Thinking(continued) The NKF has concerns with this measure (2702) dueto the imprecise ability and lack of evidence on bestpractices to determine a patient’s target dry-weight Potential that the target could be set above what isoptimal in order to meet the measure Change in one Kg or - is less significant in an obesepatient than an underweight one36
Post-Dialysis Weight – Current Thinking(continued) Concerns that efforts to challenge the dry weight;probing to lower targets to achieve optimal bloodpressure and fluid status might be confounded by thismeasure For patients who skip or shorten treatments, measurewill be problematic to achieve Dialysis facilities with patients who frequently miss andskip treatments would be adversely affected Accordingly, regulators will need to monitor forinappropriate patient discharges that may result fromfacilities trying to cherry-pick compliant patients37
Ultrafiltration ExamplesExample 1:Patient’s Estimated Dry Weight: 69 kgPre- Dialysis weight 73kgTreatment time 4 hours (240 minutes)Goal? Remove 4 Liters in 4 hoursExample 2:Patient’s Estimated Dry Weight: 69 kgPre- Dialysis weight 73kgTreatment time 4.5 hours (270 minutes)Goal? Remove 4 Liters in 4.5 hoursFormula for removal: 13 ml/kg/hr(This is not calculating 13 ml/kg/hr which is the preferable goal.This example uses 13 ml/kg/hr for ease of calculation.)Formula for removal: 13 ml/kg/hr(This is not calculating 13 ml/kg/hr which is the preferable goal.This example uses 13 ml/kg/hr for ease of calculation.)13 ml x 73 kg 949 ml/hr for 4 hours 3,796 ml or 3.8 liters13 ml x 73 kg 949 ml/hr for 4.5 hours 4,271 ml or 4.27 liters(This would not include removing saline rinse back or other fluidsadministered during the treatment)(This increase in treatment time would better meet the expectationof getting the patient to EDW using the formula and would alsoensure saline administered during treatment would be removed.Could even afford the ability to use an Ultrafiltration rate of 13ml/hr)This will not put the patient at the EDW of 69 kg, but keeps moreclosely with the expectation of ml/kg/hr removed.38
Example 3:Patient’s Estimated Dry Weight: 69 kgPre- Dialysis weight 73kgTreatment time 4.5 hours (270 minutes)Goal? Remove 4 Liters in 4.5 hoursExample 4:Patient’s Estimated Dry Weight: 69 kgPre- Dialysis weight 73kgTreatment time 4.5 hours (270 minutes)Goal? Remove 4 Liters in 4.5 hoursFormula for removal: 12 ml/kg/hr(This is not calculating 13 ml/kg/hr which is the preferable goal.This example uses 13 ml/kg/hr for ease of calculation.)Formula for removal: 12.5 ml/kg/hr12.5 ml x 73 kg 912.5 ml/hr for 4.5 hours 4106 ml or 4.1 liters(This would include removing saline rinse back or other fluidsadministered during the treatment and would meet the expectationof 13/ml/kg/hr)12 ml x 73 kg 876 ml/hr for 4.5 hours 3942 ml or 3.9 liters(This would not include removing saline rinse back or other fluidsadministered during the treatment)39
Ultrafiltration Examples:Example 5:Patient’s Estimated Dry Weight: 69 kgPre- Dialysis weight 73kgTreatment time 4 hours (240 minutes)Goal? Remove 4 Liters in 4 hoursFormula for removal: 14 ml/kg/hr – first hour(This is not calculating 13 ml/kg/hr which is the preferable goal. Thisexample uses 13 ml/kg/hr for ease of calculation.)14 ml x 73 kg 1022 ml/hr12.5 ml x 73 kg 912.5 ml/hr for 3 hours 2737 mlTotal 3760 ml over 4 hours(This would not include removing saline rinse back or other fluidsadministered during the treatment)This will not put the patient at the EDW of 69 kg, but would be an averageultrafiltration rate of 12.88 ml/hr which is 13 ml/hr40
Ultrafiltration Examples:Example using the patient’s EDW instead of the pre-treatment weight:Patient’s Estimated Dry Weight: 69 kgPre-Dialysis weight 73 kgExample 6:Patient’s Estimated Dry Weight: 69 kgPre- Dialysis weight: 73kgTreatment time 4 hours (240 minutes)Goal? Remove 4 Liters in 4 hours, plus rinse back. Remove total of 4500 ml or 4.5 litersFormula for removal using EDW: 13 ml/kg/hr13 ml/69 kg/4 hours 3,588 ml total can be removed in 4 hours (this would need to alsoinclude 500 ml rinse back so a total of 3,088 ml plus 500 ml rinse back 3580 ml).(This is not calculating 13 ml/kg/hr which is the preferable goal. This example uses 13ml/kg/hr for ease of calculation.)This will not put the patient at the EDW of 69 kg. A higher UFR would need to be used to get thepatient to the EDW during this 4 hour treatment.You might decide that using the patient’s EDW each treatment, instead of the pre-treatmentweight, is an easier way to determine how much fluid can be removed during a treatment,keeping the UFR 13 ml/kg/hr.41
Fluid Management – QualityAssessment and PerformanceImprovement (QAPI)42
Fluid Management – QAPIV626The dialysis facility must develop, implement, maintain, and evaluate an effective, data-driven,quality assessment and performance improvement program with participation by theprofessional members of the interdisciplinary team. The program must reflect the complexity ofthe dialysis facility’s organization and services (including those services provided underarrangement), and must focus on indicators related to improved health outcomes and theprevention and reduction of medical errors. The dialysis facility must maintain and demonstrateevidence of its quality improvement and performance improvement program for review by CMS.V628(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects ofperformance that the facility adopts or develops that reflect processes of care and facilityoperations. These performance components must influence or relate to the desired outcomes orbe the outcomes themselves. The program must include, but not be limited to, the following:V629(i) Adequacy of DialysisV634(vi) Medical injuries and medical errors Regulations/Downloads/esrdpgmguidance.pdf
Review of Citations – Arizona andNational44
ESRD Standard Surveys Conducted FY2015This table displays the total number of standard surveys conducted inthe Federal Fiscal Year 2015.45Source: PDQ 12/17/2015
Average # of Deficiencies per Standard HealthSurveys – ESRD FY 2015This table displays the average number of deficiencies inthe Federal Fiscal Year 2015 for standard surveys.46
ESRD Top Ten Citation Frequencies forStandard 47V0143V0407V0111V011547Tag DescriptionRegion IXRankingIC - WEAR GLOVES/HAND HYGIENEIC - CLEAN, DISINFECT SURFACES &EQUIPMENT/WRITTEN PROTOCOLSMANAGE VOLUME STATUSV0503V0401PE - EQUIPMENT MAINTENANCE MANUFACTURER'S DFUIC - ITEMS TAKEN TO STATIONDISPOSED/DEDICATED OR DISINFECTEDV0113V0122Tag DescriptionAPPROPRIATENESS OF DIALYSIS RXPE - SAFE, FUNCTIONAL, COMFORTABLEENVIRONMENTIC - CLEAN, DISINFECT SURFACES &EQUIPMENT/WRITTEN PROTOCOLSIC - WEAR GLOVES/HAND HYGIENEV0403PE - EQUIPMENT MAINTENANCE MANUFACTURER'S DFUIC - STAFF EDUCATION RECATHETERS/CATHETER CAREIC - ASEPTIC TECHNIQUES FOR IV MEDSV0726PE - HEMODIALYSIS PATIENTS IN VIEWDURING TREATMENTSIC - SANITARY ENVIRONMENTIC - WEAR GOWNS, SHIELDS/MASKS; STAFFNOT EAT/DRINK IN TX AREAV0111MEDICAL RECORDS - COMPLETE, ACCURATE,ACCESSIBLEPE - HEMODIALYSIS PATIENTS IN VIEW DURINGTREATMENTSIC - SANITARY ENVIRONMENTV0407V0504V0196ASSESS B/P & FLUID MANAGEMENT NEEDSCARBON ADSORPTION - MONITORING, TESTINGFREQUENCY
Top Ten Citation Frequencies for ComplaintSurveysNationalRankingTag DescriptionRegion IXRankingV0113IC - WEAR GLOVES/HAND HYGIENEV0772V0122IC - CLEAN, DISINFECT SURFACES &EQUIPMENT/WRITTEN PROTOCOLSMD RESP - ENSURE ALL ADHERE TO IC - SANITARY ENVIRONMENTPE - SAFE, FUNCTIONAL, COMFORTABLEENVIRONMENTINTERNAL GRIEVANCE PROCESS COMPONENTS& IMPLEMENTEDMANAGE VOLUME STATUSIC - ITEMS TAKEN TO STATIONDISPOSED/DEDICATED OR DISINFECTEDIC - WEAR GOWNS, SHIELDS/MASKS; STAFF NOTEAT/DRINK IN TX AREAMEDICAL RECORDS - COMPLETE, 0765V0767Tag DescriptionRESPONDS TO NW REQUESTS/WORKS TOWARDGOALSADM RESP FOR RELATIONSHIP WITH ESRD NWPE - SAFE, FUNCTIONAL, COMFORTABLEENVIRONMENTRESPECT & DIGNITYMD RESP - ENSURE ALL ADHERE TO P&PIC - ITEMS TAKEN TO STATIONDISPOSED/DEDICATED OR DISINFECTEDAPPROPRIATENESS OF DIALYSIS RXIC - SANITARY ENVIRONMENTINTERNAL GRIEVANCE PROCESS COMPONENTS &IMPLEMENTEDINVOLUNTARY DISCHARGE PROCESSREQUIREMENTS
Questions?Comments?49
Thank you!Jennie D. Pike, ND, MBA, RNPhone: 602.801.6547JPike@nw15.esrd.netThis material was prepared by HSAG: ESRD Network 15, under contract with the Centers for Medicare & Medicaid Services (CMS), an agency of the U.S. Department of Health and HumanServices. The contents presented do not necessarily reflect CMS policy nor imply endorsement by the U.S. Government. CO-ESRD-15G010-06102016-0150
Jun 16, 2016 · 1. Intracellular fluid - how much water is held in the body’s cells 2. Extracellular fluid - water outside of cells in tissues and body spaces such as the chest and abdomen 3. Body sodium - may affect fluid between compartments, weight gain between dialysis treatments, and the success of fluid removal during hemodialysis 19
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