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4040 McEwen Rd. Suite 350. Dallas. TX 75244

972-503-3215 * fax 972-503-3219 * info@nw 14.esrd.net *

RECOMMENDED CRITERIA AND STANDARDS FOR DIALYSIS

QUALITY ASSESSMENT & PERFORMANCE IMPROVEMENT (QAPI) PROGRAM

I.Quality Assessment & Performance Improvement (QAPI) Program Structure

A. The facility operates a QAPI Program that includes:

1.Quality Planning: Governing Body Issues. This is the activity of developing the products and processes required to meet customers needs.

2.Quality Control: Data Management and Analysis. This consists of evaluating actual performance, comparing performance with goals and acting on the difference.

3.Quality Improvement: Identification of Opportunities for and Plans for Improvement. This is the process of continuously striving to improve.

B. The Governing Body:

1.Establishes the Quality Mission of the facility

2.Conducts quality planning

3. Allots sufficient time and resources to support an active Quality Assessment & Performance Improvement (QAPI) Program

4. Reviews the activities of the Quality Assessment & Performance Improvement (QAPI) Program

  1. at least quarterly
  2. provides guidance
  3. provides resources
  4. revises goals
  5. monitors improvement projects

C. The program systematically:

1. Provides ongoing review of key elements of care utilizing:

  1. comparative data
  2. trend data

2. Identifies areas where performance measures or outcomes indicate an opportunity for or need for improvement

3. Establishes interdisciplinary Improvement Team(s) who know the process to:

a. study and understand variation from desired outcomes

b. create and implement an improvement plan

c. evaluate success of the plan

d. conduct monitoring and improvement activities until:

  1. goals are achieved
  2. data demonstrates that improvements have been made
  3. data demonstrates that improvements are maintained

D. Meetings are conducted:

  1. Monthly at a minimum by the Quality Assessment & Performance Improvement (QAPI) Committee, an interdisciplinary “Core Team” which includes the following:
  1. Medical Director
  2. Head Nurse/Director of Nursing
  3. Administrator
  4. Technical Services Representative/Chief Technician
  5. Social Worker
  6. Dietitian
  7. PD Nurse ( if applicable)
  8. Charge Nurse (Optional)
  9. Vascular Access Coordinator (Optional)
  10. Patient Care Technician (Optional)
  1. By Improvement Teams
  2. Separately from Patient Plan of Care Conference
  3. Written minutes reflect conclusion of monitoring, evaluation and problem solving activities and include actions and dates of review until final resolution occurs.
  4. Clinical indicator goals and results should be segregated by modality
  5. Elements specific to the various modalities offered should be recorded in sections by modality
  6. Appropriate team members such as the PD Nurse must be present for that portion of the QAPI meeting
  1. Quality Indicators
  1. The facility establishes and monitors key/important aspects of care that:
  1. Have acceptable levels of performance that are consistent with current professional knowledge
  2. Include at a minimum the on-going monitoring of the Quality Indicators for key aspects of patient care and facility operations
  3. Identify areas where performance measures or outcomes indicate an opportunity for improvement
  4. Are identified, measured, analyzed, and tracked for variation from desired outcomes on a monthly basis

B. When goal is not achieved

  1. Create and implement improvement plan(s)
  2. Evaluate the implementation of the improvement plan(s)
  3. Continue monitoring and improvement activities until resolution of the improvement plan

C. Key Aspect of Care: Hemodialysis Water Quality

1. Primary Monitoring Elements

  1. Chemical contaminants analysis, bacteriological, and endotoxin cultures
  2. Chloramine
  3. Total Chlorine
  4. Product Water Bacteria
  5. Dialysate Bacteria
  6. Product Water Endotoxin
  7. Dialysate Endotoxin
  8. Audits of water treatment practicesincluding actions when acceptable parameters are not met
  9. Audits of comprehensive water treatment logs
  10. Dialysate and Acid mixing parameters, if applicable
  11. Other indicators of water quality specific to facility water treatment process

2. Recommended Reference(s) for Facility Standard Development

  1. Association for the Advancement of Medical Instrumentation (AAMI) Standards and Recommended Practices (RD52:2004)
  2. Centers for Medicare & Medicaid Services (CMS) Conditions for Coverage & Measures Assessment Tool (MAT)
  3. Texas Department of State Health Services (DSHS) End Stage Renal Disease Facilities Licensing Rules
  4. Corporate policy and procedures (if applicable)

D. Key Aspect of Care: Dialysis and Other Medical Equipment Quality

1. Primary Monitoring Elements

  1. Routine preventive maintenance
  2. Equipment failure & repair
  3. Equipment testing including all equipment such as pH meter, conductivity meter, others
  4. Audits of equipment maintenance logs

2. Recommended Reference(s) for Facility Standard Development

  1. Association for the Advancement of Medical Instrumentation (AAMI) Standards and Recommended Practices (ANSI/AAMI RD52:2004)
  2. Texas DSHS End Stage Renal Disease Facilities Licensing Rules
  3. CMS Conditions for Coverage & Measures Assessment Tool (MAT)
  4. National Fire Protection Association (NFPA 99: Standard for Health Care Facilities)
  1. Manufacturers Recommendations
  2. Corporate policy and procedures (if applicable)

E. Key Aspect of Care: Hemodialyzer Reuse Program

1. Primary Monitoring Elements

  1. Dialyzer performance measures/effectiveness (Total Cell Volume)
  2. Dialyzer labeling
  3. Sterilization
  4. Evaluation and reporting of adverse outcomes
  5. Audits of reuse logs
  6. Review and response to reuse complaint log

2. Recommended Reference(s) for Facility Standard Development

  1. Association for the Advancement of Medical Instrumentation (AAMI) Standards and Recommended Practices (3rd edition, ANSI/AAMI RD47:2002 and RD47:2002/AL:2003)
  2. CMS Conditions for Coverage & Measures Assessment Tool (MAT)
  3. Texas DSHS End Stage Renal Disease Facilities Licensing Rules
  4. Manufacturers Recommendations
  5. Corporate policy and procedures (if applicable)

F. Key Aspect of Care: Infection Control Practices

1. Primary Monitoring Elements

  1. Infection control practice audits, monitoring, and analysis
  2. Patients: Washing vascular access, holding sites, visitation in treatment area
  3. Personnel: Hand washing, Personal Protective Equipment, Standard Precautions
  4. Hepatitis B Isolation Room Procedures and Equipment
  5. Audits of blood splatter
  6. Dialysis chairs
  7. B/P cuffs, stethoscopes
  8. Dialysis station area
  9. Immunizations Surveillance (Hepatitis B, Influenza, Pneumococcal)
  10. Surveillance Program
  11. Infections
  12. Episodes Sepsis
  13. Drug Resistant organisms (MRSA, VRE)
  14. Peritonitis rate, if applicable
  15. Vascular access infections
  16. Tracking, trending and analysis of infections, organisms and antibiotics
  17. Pyrogenic reactions
  18. Dialyzer, water, machine, and dialysate cultures
  19. Audits of logs

2. Recommended Reference(s) for Facility Standard Development

  1. Centers for Disease Control (CDC): Recommendations for Placement of Intravascular Catheters in Adults and Children, Parts I-IV; and Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters, in Adult and Pediatric Patients (MMWR Vol. 51, No. RR10, pp. 16 – 18, August 9, 2002)
  2. Centers for Disease Control (CDC): Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients (MMWR Vol. 50, No. RR05, April 27, 2001)
  3. Centers for Disease Control (CDC) National Surveillance of Dialysis-Associated Diseases in the United States Annual Report
  4. Association for the Advancement of Medical Instrumentation (AAMI) Standards and Recommended Practices
  5. University of Michigan Kidney Epidemiology and Cost Center (UMKECC), Dialysis Facility Report (DFR) TABLE 2: Hospitalization Summary for Medicare Dialysis Patients
  6. Texas DSHS End Stage Renal Disease Facilities Licensing Rules
  7. CMS Conditions for Coverage & Measures Assessment Tool (MAT)
  8. Occupational Safety and Health Administration, Occupational Exposure to Blood borne Pathogens Standard
  9. Corporate policy and procedures (if applicable)

G. Key Aspect of Care: Adverse Occurrence Reports (AORs)/ Adverse Events (AE)

1. Primary Monitoring Elements

  1. Adverse Occurrence Reporting (AORs)/AE reports
  2. Texas DSHS informed/submission of “Report to the Director” for reportable incidents (
  3. Incidence rates
  4. Ambulance Transfers from facility to hospital
  5. Track, trend, analyze to decrease frequency through prevention, early identification and root cause analysis

2. Recommended Reference(s) for Facility Standard Development

  1. Texas DSHS End Stage Renal Disease Facilities Licensing Rules
  2. CMS Conditions for Coverage & Measures Assessment Tool (MAT)
  3. Network # 14 website - Professionals/Quality Improvement & Regulations
  4. Corporate risk management reports and statistics (if applicable)
  5. NW 14 APO forms and tracking tools

H. Key Aspect of Care: Patient Mortality

1. Primary Monitoring Elements

  1. Complete death review for each death with determination of co-morbidities
  2. Mortality Rate
  3. CMS-2746 Form – ESRD Death Notification completion and submission

2. Recommended Reference(s) for Facility Standard Development

  1. United States Renal Data Service Annual Report (USRDS), Reference Tables
  2. University of Michigan Kidney Epidemiology and Cost Center (UMKECC), Dialysis Facility Report (DFR) TABLE 1: Mortality Summary for All Dialysis Patients, TABLE 2: Hospitalization Summary for Medicare Dialysis Patients, TABLE 8: Summaries for All Dialysis Patients Treated as of December 31 of Each Year, TABLE 9: Comorbidities Reported on Medicare Claims for Medicare Dialysis Patients Treated as of December 31 of Each Year, TABLE 10: How Patients Were Assigned to This Facility and End of Year Patient Status.
  3. ESRD Network 14, CMS-2746 Form – ESRD Death Notification
  4. Corporate risk management reports and statistics (if applicable)
  5. Texas DSHS End Stage Renal Disease Facilities Licensing Rules
  6. CMS Conditions for Coverage & Measures Assessment Tool (MAT)

I. Key Aspect of Care: Hospitalizations

1. Primary Monitoring Elements

  1. Each hospitalization
  2. Rate
  3. Track and trend for length of stay, admission diagnosis

2.Recommended Reference(s) for Facility Standard Development:

  1. United States Renal Data Service Annual Report (USRDS), Reference Tables
  2. University of Michigan Kidney Epidemiology and Cost Center (UMKECC), Dialysis Facility Report (DFR) TABLE 2: Hospitalization Summary for Medicare Dialysis Patients
  3. Corporate risk management reports and statistics (if applicable)
  4. Texas DSHS End Stage Renal Disease Facilities Licensing Rules
  5. CMS Conditions for Coverage & Measures Assessment Tool (MAT)

J. Key Aspect of Care: Complaints and Suggestions

1. Primary Monitoring Elements

  1. Complaints, Grievances and Suggestions
  2. Patient and family satisfaction evaluation
  3. Staff satisfaction
  4. CAHPS In-Center Hemodialysis Survey
  5. Involuntary Discharge
  6. Analyze for opportunities for improvement and trends

2. Recommended Reference(s) for Facility Standard Development

  1. Corporate Aggregate Patient Satisfaction Survey Data (if applicable)
  2. Consumer Assessment of Healthcare Providers and Systems(CAHPS In-Center Hemodialysis Survey) (
  3. Dialysis Facility Compare Web site (
  4. Texas DSHS End Stage Renal Disease Facilities Licensing Rules
  5. CMS Conditions for Coverage & Measures Assessment Tool (MAT)

K. Key Aspect of Care: Staffing

1. Primary Monitoring Elements

  1. Orientation and training
  2. Competency
  3. Licensing and certification
  4. Workload/ratios

2. Recommended Reference(s) for Facility Standard Development:

  1. Texas DSHS End Stage Renal Disease Facilities Licensing Rules
  2. CMS Conditions for Coverage
  3. Corporate policy & procedures (if applicable)
  4. State Licensing Boards

K. Key Aspect of Care: Safety/Risk Management

1. Primary Monitoring Elements

  1. Fire/Hurricane/Disaster Preparedness
  2. Hazardous waste disposal
  3. Personnel protection/health monitoring
  4. EMSystem updates monthly and participation in drills

2. Recommended Reference(s) for Facility Standard Development

  1. Network #14 Website: Disaster Planning (
  2. Texas Emergency ESRD Coalition (TEEC) (
  3. Network #14 EMSystems (
  4. Kidney Community Emergency Response Coalition (KCER) (
  5. The National Forum of ESRD Networks Disaster Planning:

(

  1. National Fire Protection Association (NFPA: Life Safety Code, 2000 Edition)
  2. Texas DSHS End Stage Renal Disease Facilities Licensing Rules
  3. CMS Conditions for Coverage & Measures Assessment Tool (MAT)
  4. Centers for Disease Control (CDC): Recommendations for Placement of Intravascular Catheters in Adults and Children, Parts I-IV; and Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters, in Adult and Pediatric Patients (MMWR Vol. 51, No. RR10, pp. 16 – 18, August 9, 2002)
  5. Centers for Disease Control (CDC): Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients (MMWR Vol. 50, No. RR05, April 27, 2001)
  6. Centers for Disease Control (CDC): Immunization Reciommendations
  7. Occupational Safety and Health Administration, Occupational Exposure to Bloodborne Pathogens Standard
  8. Occupational Safety and Health Administration, Hazard Communication Standard

L. Key Aspect of Care: Medical Records

1. Primary Monitoring Elements

a.Hard copy medical records

b. Electronic Health Records

2. Recommended Reference(s) for Facility Standard Development

  1. Texas DSHS End Stage Renal Disease Facilities Licensing Rules
  2. CMS Conditions for Coverage & Measures Assessment Tool (MAT)
  3. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule (
  4. The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) (
  5. Forum of ESRD Network Medical Record Model (

M. Key Aspect of Care: Clinical Outcomes

1. Primary Monitoring Elements

  1. Laboratory Core Indicators (for all Modalities – Hemodialysis, Peritoneal Dialysis, Home Hemodialysis, and Frequent Home Hemodialysis)
  2. Adequacy of dialysis
  3. Nutritional Status
  4. Bone- Mineral Metabolism
  5. Anemia Management (with Erythropoietin Stimulating Agents (ESAs) & without ESAs)
  1. Hospitalization rates (causes)
  2. Vascular access
  3. Types
  4. Evaluation of complications, causes
  5. Stenosis monitoring for AVG and AVF
  6. Patency Rates

2.Recommended Reference(s) for Facility Standard Development

  1. Network #14 MRB Cutpoints and Fistula First information/reports
  2. University of Michigan Kidney Epidemiology and Cost Center (UMKECC), Dialysis Facility Report (DFR) TABLE 2: Hospitalization Summary for Medicare Dialysis Patients, TABLE 5: Facility Modality, Hemoglobin, and Urea Reduction Ratio for Medicare Dialysis Patients, TABLE 6: Vascular Access Information(CMS Fistula First), TABLE 7: Characteristics of New Dialysis Patients, TABLE 8: Summaries for All Dialysis Patients Treated as of December 31 of Each Year, TABLE 9: Comorbidities Reported on Medicare Claims for Medicare Dialysis Patients Treated as of December 31 of Each Year
  3. Fistula First National Breakthrough Initiative (FFBI) –
  4. Texas DSHS End Stage Renal Disease Facilities Licensing Rules
  5. CMS Conditions for Coverage & Measures Assessment Tool (MAT)
  6. National Kidney Foundation (NKF) Kidney Disease Outcomes Quality Initiative (K/DOQI Practice Guidelines & Recommendations) (
  7. National Kidney Foundation (NKF) Kidney Disease: Improving Global Outcomes (K/DIGO Practice Guidelines & Recommendations) (
  8. United States Renal Data System (USRDS) Annual Report, Reference Tables
  9. Corporate Patient Outcome Data and Statistics (if applicable)

N. Key Aspect of Care: Patient Functional Status & Quality of Life

1. Primary Monitoring Elements

  1. Vocational Rehabilitation and Physical Rehabilitation referrals as indicated
  2. Kidney Disease Quality of Life (KDQOL-36)
  3. Patient Plan(s) of Care
  4. Patient Education & Training:
  1. Dialysis Experience
  2. Treatment Options
  3. Self-Care
  4. Infection Prevention
  5. Quality of Life
  6. Rehabilitation

e. End of Life care

i. Advanced Care Plan

ii. Advanced Directives

2. Recommended Reference for Facility Standard Development

  1. Kidney Disease Quality of Life (KDQOL-36) (
  2. Texas DSHS End Stage Renal Disease Facilities Licensing Rules
  3. CMS Conditions for Coverage & Measures Assessment Tool (MAT)
  4. Kidney School (
  5. American Association of Kidney patients (AAKP) (
  6. Renal Physicians Association (RPA) (
  7. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (
  8. National Kidney Foundation (NKF) (
  9. Life Options Rehabilitation Activity Report
  10. National Kidney End of Life Coalition (

O. Key Aspect of Care: Kidney Transplant Option Education

1. Primary Monitoring Elements

  1. Patient education
  2. Patient referral
  3. Standardized Transplant Ratio
  4. Comparative Waitlist data
  5. Candidacy or reason for non-referral reviewed

2. Recommended Reference for Facility Standard Development

  1. University of Michigan Kidney Epidemiology and Cost Center (UMKECC), Dialysis Facility Report (DFR) TABLE 3: Transplantation Summary for Dialysis Patients under Age 70, TABLE 4: Waitlist Summary for Dialysis Patients under Age 70 Treated as of December 31st of Each Year
  2. Texas DSHS End Stage Renal Disease Facilities Licensing Rules
  3. CMS Conditions for Coverage & Measures Assessment Tool (MAT)
  4. Contact local transplant centers for individual requirements for each program
  5. United Network of Organ Sharing (UNOS)
  6. Corporate Data and Statistics (if applicable)
  7. NW 14 Guidelines for Timely Transplant Referral
  8. NW 14 Transplant Criteria Book

P. Key Aspect of Care: Review Alerts/Faxes/Announcements

1. Primary Monitoring Elements

  1. Review alerts in QAPI
  2. Implement appropriate action as described and document

2. Recommended Reference for Facility Standard Development

  1. Network # 14 Alerts
  2. Texas Department of State Health Services (DSHS)
  3. Centers for Medicare & Medicaid Services (CMS)
  4. United States Food and Drug Administration (FDA)
  5. Centers for Disease Control and Prevention (CDC)
  6. Manufacturers

Supporting Quality Care

QI Department Revised April 14, 2011