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La qualita

in patologia molecolare

Aldo Scarpa, Rita T. Lawlor

Anatomia Patologica
Processo diagnostico in un caso di gastrite cronica

A B

C D
Esempio del processo diagnostico in un caso di
un tumore stromale gastrointestinale

A B

N T CG

del C

C D
Modern Pathology
Materials
RNA/DNA
Paraffin Needle aspirate

DNA, RNA, Proteins


"Quality is the result of accurate and
permanent controls and corrective actions"
"Quality is the parent, the source of all
subjects and objects." -

Robert Pirsig
(Zen and the Art of Motorcycle Maintenance)
Quality Management System
(QMS)

Quality Assurance Quality Control


QA QC
Quality Assurance
is the preventive medicine
to Quality Control

Quality Assurance makes sure you are doing the


right things, the right way

Quality Control makes sure the results of


what you've done are what you expected
Quality Management System
Quality Management System

QA

QA
Quality Management System

QC

QA

QA

QC
QC
Quality Assurance in Health Care

System design Performance monitoring


and resources and readjustment
Quality Assurance in Health Care

System design Performance monitoring


and resources and readjustment

Obtain information on performance

Interpret information
Readjustments
in the system Take appropriate action

Educational and
Motivational activities

Alterations in behaviour
(professionals, technicians, managers, etc.)
System design and resources

The process
surgeon
Tissue retrieval pathologists

Tissue transport technician


Tissue preparation
Tissue selection technician
Molecular extraction

PCR
qPCR Specialist
RT-PCR technician
Western Blot
IHC
FISH
pathologists
Interpretation
Skill and motivation
Quality Assurance for Resources
person
Skills / knowledge
Training
Standard operating procedures

equipment
Regular maintenance (calibration)
Continuous availability
Standard operating procedures
information
Data collection
Data registration
Standard operating procedures
Quality Assurance for Resources
person
Skills / knowledge
Training
Standard operating procedures

equipment
Regular maintenance (calibration)
Continuous availability
Standard operating procedures
information
Data collection
Data registration
Standard operating procedures
THE SOP OPERA
Patient

Protocol for
tissue colleciton
CLINICAL HISTOPATHOLOGY
INFORMATION INFORMATION TISSUE

MINIMAL
Protocol for tissue
DATA SHEET preparation

Procedure for
BASIC COLLECTION BIOBANK tissue use

Protocol for
tissue
conservation

FINAL PRODUCTS AND DATA END USERS


KRAS : Direct Sequencing

QCSteps
canofoccur
the
direct sequencing
at each step

Wherever any product


results during the
workflow process, QC
may be implemented
KRAS mutational analysis

The biological material


DNA extraction
PCR amplification
Analysis of mutations
1 H.E. 5 sections 20 m-thick

QC for Tissue
Microscopic examination
by pathologist
Manual microdissection

cancro normale

+ =
Laser microdissection

a a

b b

c c
KRAS mutational analysis

The biological material


DNA extraction
PCR amplification
Analysis of mutations
Control of DNA quality and PCR Amplifiability

Agarose Gel
Control of DNA quality and PCR Amplifiability

Gel virtuale da
analisi microfluidica

1 2 3 C
Elettroforesi capillare ss
KRAS mutational analysis

The biological material


DNA extraction
PCR amplification
Analysis of mutations
KRAS mutational analysis

The biological material


DNA extraction
PCR amplification
Analysis of mutations
Components of quality
Application of that
Science & Technology Science and
(what) Technology
(how)

Quality
(measures)

Effectiveness
Replicability
Efficiency
Optimality
Quality Management System
(QMS)
in Molecular Pathology
Quality Management System
(QMS)
in Molecular Pathology

Quality Assurance Quality Control


QA QC
Quality Management System
(QMS)
in Molecular Pathology

Quality Assurance Quality Control


QA QC

- Accuracy: ability to obtain .. - Internal QC every lab ..


- Precision: ability to produce . - External QC exchange of ..
- Analytical specificity: ability .
Quality Assurance in Health Care

System design Performance monitoring


and resources and readjustment

Obtain information on performance

Interpret information
Readjustments
in the system Take appropriate action

Educational and
Motivational activities

Alterations in behaviour
(professionals, technicians, managers)