Post on 16-Jan-2016
NEW ADVANCES IN QUALITY NEW ADVANCES IN QUALITY ASSURANCE INCLUDING ASSURANCE INCLUDING MOLECULAR PATHOLOGYMOLECULAR PATHOLOGY
Kenneth D. McClatchey, MDKenneth D. McClatchey, MD
Professor & Chairman of PathologyProfessor & Chairman of Pathology
Helen M. & Raymond M. Galvin Helen M. & Raymond M. Galvin ProfessorProfessor
WORLDWIDE QUALITY WORLDWIDE QUALITY TRENDSTRENDS
1960
1970
1980
1990
2000
QC
QA
CQI
QI
CUSTOMERVALUE
PERFORMANCEASSESSMENT
COST MGMT.
INDUSTRIALECONOMY
SERVICEECONOMY
FEE FORSERVICE
MANAGEDCARE
CAPITATION(BUNDLED PAYMENT)
LOCALEQAS
REGIONALEQAS
INTL.EQAS
LOCALGUIDELINES
REGIONALGUIDELINES
NATIONALGUIDELINES
INTL.STANDARDS
LABREGISTRATION
REGIONALACCREDITATION
NATIONALACCREDITATION
INTL.ACCREDITATIONQUALTY SYS.
MGMT
THE CLINICAL LABORATORY IS THE CLINICAL LABORATORY IS A:A:
MEDICAL MEDICAL
POLITICALPOLITICAL
ECONOMICECONOMIC
SOCIAL ENVIRONMENTSOCIAL ENVIRONMENT
QUALITY BUILDING QUALITY BUILDING BLOCKSBLOCKS
AccreditationInternal and External
Quality Assessment
Quality System Management
QUALITY CONTROL
STANDARDIZEDPERSONNEL
STANDARDIZEDPROCEDURES
STANDARDIZEDENVIRONMENT
APPLYING QUALITY SYSTEM ESSENTIALSAPPLYING QUALITY SYSTEM ESSENTIALS TO THE LABORATORY PATH OF WORKFLOW TO THE LABORATORY PATH OF WORKFLOW QUALITY SYSTEMQUALITY SYSTEM Information Management Information Management ESSENTIALS ESSENTIALS organizationorganization preanalytical -- analytical -- preanalytical -- analytical --
postanalyticalpostanalytical WorkflowWorkflow
QUALITYQUALITYMake sure you know the Make sure you know the
difference between:difference between: Quality ControlQuality Control Quality AssuranceQuality Assurance Quality SystemQuality System
QUALITY SYSTEMQUALITY SYSTEM looks at looks at a process in an indepth a process in an indepth fashion -- preanalytic, fashion -- preanalytic, analytic, postanalytic.analytic, postanalytic.
QUALITY SYSTEM QUALITY SYSTEM ESSENTIALSESSENTIALS
OrganizationOrganization EquipmentEquipment Purchasing & InventoryPurchasing & Inventory Process ControlProcess Control Documents & RecordsDocuments & Records Occurrence ManagementOccurrence Management Internal AssessmentInternal Assessment Process ImprovementProcess Improvement Service & SatisfactionService & Satisfaction
THE ULTIMATE ARBITER ON THE ULTIMATE ARBITER ON LABORATORY QUALITY IS THE LABORATORY QUALITY IS THE
“CUSTOMER”“CUSTOMER”
SERVICE QUALITY SERVICE QUALITY CHARACTERISTICSCHARACTERISTICS
Cost EffectivenessCost Effectiveness SecuritySecurity CompetenceCompetence ReliabilityReliability AccuracyAccuracy AccessibilityAccessibility ComfortComfort CourtesyCourtesy
SERVICE QUALITY SERVICE QUALITY CHARACTERISTICSCHARACTERISTICS
CredibilityCredibility DependabilityDependability EffectivenessEffectiveness FlexibilityFlexibility HonestyHonesty PromptnessPromptness Responsiveness Responsiveness
Other Aspects of the Other Aspects of the Quality Process Quality Process Include:Include:
External Quality Assessment External Quality Assessment SchemesSchemes
AccreditationAccreditation
Benefits of a Quality Benefits of a Quality SystemSystem
Dependable process inputDependable process input Informed, competent Informed, competent
management management decision makingdecision making Control of quality costsControl of quality costs Increased productivity Increased productivity Reduced wasteReduced waste
Aging Boom is at Hand A Baby Aging Boom is at Hand A Baby Boomer Will Turn 50 Every:Boomer Will Turn 50 Every:
8.4 Seconds in 19968.4 Seconds in 1996 6.8 Seconds in 20016.8 Seconds in 2001
POPULATION >65 ACCOUNTS POPULATION >65 ACCOUNTS FOR:FOR:
40% of: hospital admissions40% of: hospital admissions
hospital inpatient hospital inpatient daysdays
hospital care hospital care expensesexpenses
Under the Banner of Quality Major Under the Banner of Quality Major Changes Have Occurred in Laboratories Changes Have Occurred in Laboratories
WorldwideWorldwide
Cost ContainmentCost Containment ConsolidationConsolidation
SPECIFIC ISSUES SPECIFIC ISSUES ASSOCIATED WITH COST ASSOCIATED WITH COST
CONTAINMENTCONTAINMENT
Labor distributionLabor distribution Laboratory organizationLaboratory organization Equipment acquisition tacticsEquipment acquisition tactics
IMPACTIMPACTFewer 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
ISSUES ASSOCIATED WITH ISSUES ASSOCIATED WITH LABORATORY LABORATORY
CONSOLIDATIONCONSOLIDATION
“Strength in size”
corporate laboratories combine
hospital laboratories combine
affects both pathology and laboratory medicine
15189 - International Standard on Quality Management in the Clinical Laboratory
CEN ISO WHO
NATIONAL STANDARDS ORGANIZATIONS
REGIONAL STANDARDS ORGANIZATIONS
Typical Quality Typical Quality Improvement Improvement
Accreditation QuestionsAccreditation Questions
Is there a documented Quality Is there a documented Quality Improvement Plan?Improvement Plan?
Does the Quality Improvement Does the Quality Improvement program cover all aspects of the program cover all aspects of the laboratory?laboratory?
Are actions taken when opportunities Are actions taken when opportunities are identified?are identified?
Do Quality indicators measure -- Do Quality indicators measure -- preanalytical, analytical and post-preanalytical, analytical and post-analytical variablesanalytical variables
Typical Molecular Typical Molecular Laboratory Accreditation Laboratory Accreditation
IssuesIssues Is there a system for timely correction Is there a system for timely correction
of errors?of errors? Is turnaround time monitored?Is turnaround time monitored? Is there evidence of investigation of Is there evidence of investigation of
discrepancies between molecular discrepancies between molecular laboratory results and other laboratory results and other laboratory findings? laboratory findings?
Are statistics on molecular laboratory Are statistics on molecular laboratory results such as percentages of normal results such as percentages of normal and abnormal findings maintained?and abnormal findings maintained?
Laboratory Discipline Most Laboratory Discipline Most Involved in Molecular Involved in Molecular
TestingTesting
HematopathologyHematopathology Microbiology/VirologyMicrobiology/Virology CytologyCytology