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)