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