3. NEW ADVANCES IN QUALITY ASSURANCE INCLUDING MOLECULAR PATHOLOGY Kenneth D. McClatchey, MD Professor & Chairman of Pathology Helen M. & Raymond M. Galvin Professor

4. WORLDWIDE QUALITY TRENDS WORLDWIDE QUALITY TRENDS 1960 1970 1980 1990 2000 QC QA CQI QI CUSTOMER VALUE PERFORMANCE ASSESSMENT COST MGMT. INDUSTRIAL ECONOMY SERVICE ECONOMY FEE FOR SERVICE MANAGED CARE CAPITATION (BUNDLED PAYMENT) LOCAL EQAS REGIONAL EQAS INTL. EQAS LOCAL GUIDELINES REGIONAL GUIDELINES NATIONAL GUIDELINES INTL. STANDARDS LAB REGISTRATION REGIONAL ACCREDITATION NATIONAL ACCREDITATION INTL. ACCREDITATION QUALTY SYS. MGMT

5. THE CLINICAL LABORATORY IS A: MEDICAL POLITICAL POLITICAL ECONOMIC ECONOMIC SOCIAL ENVIRONMENT SOCIAL ENVIRONMENT

6. QUALITY BUILDING BLOCKS Accreditation Internal and External Quality Assessment Quality System Management QUALITY CONTROL STANDARDIZED PERSONNEL STANDARDIZED PROCEDURES STANDARDIZED ENVIRONMENT

7. APPLYING QUALITY SYSTEM ESSENTIALS TO THE LABORATORY PATH OF WORKFLOW QUALITY SYSTEM Information Management ESSENTIALS organization preanalytical -- analytical -- postanalytical Workflow

8. QUALITY Make sure you know the difference between: À Quality Control Á Quality Assurance  Quality System

9. QUALITY SYSTEM looks at a process in an indepth fashion -- preanalytic, analytic, postanalytic.

10. QUALITY SYSTEM ESSENTIALS u Organization u Equipment u Purchasing & Inventory u Process Control u Documents & Records u Occurrence Management u Internal Assessment u Process Improvement u Service & Satisfaction

11. THE ULTIMATE ARBITER ON LABORATORY QUALITY IS THE “CUSTOMER” SERVICE QUALITY CHARACTERISTICS u Cost Effectiveness u Security u Competence u Reliability u Accuracy u Accessibility u Comfort u Courtesy SERVICE QUALITY CHARACTERISTICS u Credibility u Dependability u Effectiveness u Flexibility u Honesty u Promptness u Responsiveness

12. Other Aspects of the Quality Process Include: À External Quality Assessment Schemes Á Accreditation

13. Benefits of a Quality System u Dependable process input u Informed, competent management decision making u Control of quality costs u Increased productivity u Reduced waste

14. Aging Boom is at Hand A Baby Boomer Will Turn 50 Every: u 8.4 Seconds in 1996 u 6.8 Seconds in 2001

15. POPULATION >65 ACCOUNTS FOR: 40% of: hospital admissions hospital inpatient days hospital inpatient days hospital care expenses hospital care expenses

16. Under the Banner of Quality Major Changes Have Occurred in Laboratories Worldwide u Cost Containment u Consolidation

17. SPECIFIC ISSUES ASSOCIATED WITH COST CONTAINMENT u Labor distribution u Laboratory organization u Equipment acquisition tactics

18. IMPACT Fewer hospitals -- thus fewer laboratories Smaller hospital laboratories Fewer MD specialists Larger reference laboratories Fewer PhD’s Fewer medical technologists Fewer medical laboratory technicians More of an emphasis on near patient testing

19. ISSUES ASSOCIATED WITH LABORATORY CONSOLIDATION “Strength in size” corporate laboratories combine hospital laboratories combine affects both pathology and laboratory medicine

20. 15189 - International Standard on Quality Management in the Clinical Laboratory CEN ISO WHO NATIONAL STANDARDS ORGANIZATIONS REGIONAL STANDARDS ORGANIZATIONS

21. Typical Quality Improvement Accreditation Questions u Is there a documented Quality Improvement Plan? u Does the Quality Improvement program cover all aspects of the laboratory? u Are actions taken when opportunities are identified? u Do Quality indicators measure -- preanalytical, analytical and post- analytical variables

22. Typical Molecular Laboratory Accreditation Issues u Is there a system for timely correction of errors? u Is turnaround time monitored? u Is there evidence of investigation of discrepancies between molecular laboratory results and other laboratory findings? u Are statistics on molecular laboratory results such as percentages of normal and abnormal findings maintained?

23. Laboratory Discipline Most Involved in Molecular Testing u Hematopathology u Microbiology/Virology u Cytology