Transcript NEW ADVANCES IN QUALITY ASSURANCE INCLUDING MOLECULAR

NEW ADVANCES IN QUALITY
ASSURANCE INCLUDING
MOLECULAR PATHOLOGY
Kenneth D. McClatchey, MD
Professor & Chairman of Pathology
Helen M. & Raymond M. Galvin Professor
WORLDWIDE QUALITY
TRENDS
QC
1960
1990
FEE FOR
SERVICE
QA
1970 CQI
1980
INDUSTRIAL
ECONOMY
LOCAL
EQAS
SERVICE
ECONOMY
MANAGED
CARE
QI
NATIONAL
GUIDELINES
PERFORMANCE
ASSESSMENT
2000
QUALTY SYS.
MGMT
REGIONAL
ACCREDITATION
REGIONAL
EQAS
CAPITATION
(BUNDLED
PAYMENT)
LAB
REGISTRATION
REGIONAL
GUIDELINES
CUSTOMER
VALUE
COST
MGMT.
LOCAL
GUIDELINES
INTL.
EQAS
INTL.
STANDARDS
NATIONAL
ACCREDITATION
INTL.
ACCREDITATION
THE CLINICAL LABORATORY IS A:
MEDICAL
POLITICAL
ECONOMIC
SOCIAL ENVIRONMENT
QUALITY BUILDING BLOCKS
Accreditation
Internal and External
Quality Assessment
Quality System Management
QUALITY CONTROL
STANDARDIZED
PERSONNEL
STANDARDIZED
PROCEDURES
STANDARDIZED
ENVIRONMENT
APPLYING QUALITY SYSTEM ESSENTIALS
TO THE LABORATORY PATH OF WORKFLOW
QUALITY SYSTEM
Information Management
ESSENTIALS
organization
preanalytical -- analytical -- postanalytical
Workflow
QUALITY
Make sure you know the
difference between:
 Quality Control
 Quality Assurance
 Quality System
QUALITY SYSTEM looks at a
process in an indepth fashion -preanalytic, analytic, postanalytic.
QUALITY SYSTEM ESSENTIALS
 Organization
 Equipment
 Purchasing
& Inventory
 Process Control
 Documents & Records
 Occurrence Management
 Internal Assessment
 Process Improvement
 Service & Satisfaction
THE ULTIMATE ARBITER ON
LABORATORY QUALITY IS THE
“CUSTOMER”
SERVICE QUALITY
CHARACTERISTICS
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Cost Effectiveness
Security
Competence
Reliability
Accuracy
Accessibility
Comfort
Courtesy
SERVICE QUALITY
CHARACTERISTICS
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Credibility
Dependability
Effectiveness
Flexibility
Honesty
Promptness
Responsiveness
Other Aspects of the
Quality Process Include:
External Quality Assessment Schemes
 Accreditation

Benefits of a Quality System
 Dependable
process input
 Informed, competent management
decision making
 Control of quality costs
 Increased productivity
 Reduced waste
Aging Boom is at Hand A Baby
Boomer Will Turn 50 Every:
 8.4
Seconds in 1996
 6.8 Seconds in 2001
POPULATION >65 ACCOUNTS FOR:
40% of: hospital admissions
hospital inpatient days
hospital care expenses
Under the Banner of Quality Major Changes
Have Occurred in Laboratories Worldwide
 Cost
Containment
 Consolidation
SPECIFIC ISSUES ASSOCIATED
WITH COST CONTAINMENT
 Labor
distribution
 Laboratory organization
 Equipment acquisition tactics
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
ISSUES ASSOCIATED WITH
LABORATORY CONSOLIDATION
“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 Improvement
Accreditation Questions
 Is
there a documented Quality
Improvement Plan?
 Does the Quality Improvement program
cover all aspects of the laboratory?
 Are actions taken when opportunities
are identified?
 Do Quality indicators measure -preanalytical, analytical and postanalytical variables
Typical Molecular Laboratory
Accreditation Issues
 Is
there a system for timely correction of
errors?
 Is turnaround time monitored?
 Is there evidence of investigation of
discrepancies between molecular
laboratory results and other laboratory
findings?
 Are statistics on molecular laboratory
results such as percentages of normal
and abnormal findings maintained?
Laboratory Discipline Most
Involved in Molecular Testing
 Hematopathology
 Microbiology/Virology
 Cytology