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7/30/2019 QUALITY Assurance St
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Presented ByToheed Kausar
QUALITY CONTROL & QUALITYASSURANCE in
Molecular Laboratory
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Introduction
Molecular Pathology
In AKUH , Molecular Pathology section was
established in 1995 in Clinical Laboratory ,
performs DNA and RNA based testing to provide
diagnostic information to physicians and clinicians.
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Introduction
Molecular Pathology
Molecular
Virology
Molecular
Oncology
Molecular
Genetics
HLA
Testing
Molecular
Bacteriology
HCV PCR
QHCV
HCV
Genotyping
HBV PCR
QHBV
HBV
Genotyping
HDV PVRQHDV
HEV PCR
CMV PCR
HIV PCR
QHIV
Dengue IgM
CCHF PCR
HSV1 &2 PCR
H1N1 PCR
BCR PCR
QBCR
APL PCR
JAK2 mutation
FLT3 Mutation
NPM1
Mutation
Thalassemia PCR (CVS)
Thalassemia PCR
(Blood)
SMA PCR
DMD
Delta 508 Mutation
MTHFR Polymorphism
PCRQ-Pre
Q-post
HbE Mutation
HbD Mutation
HbS Mutation
DNA banking
IL28B by PCR
T. HLA Typing
HLA DR
HLA Typ minus
DR
HLA B27 PCR
AFB PCR
CTA
Molecular
ParasitologNaegleria
Sp by PCR
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Quality Assurance Quality assurance is the series of checks and
balances that ensure laboratory results areaccurate and reliable. The common componentsof the laboratory quality assurance program
include pre analytical (specimen collection, handling, and
storage),
analytical (instruments/equipment, reagents,
personnel) post-analytical (result reporting and
interpretation) procedures.
All quality assurance procedures must be written
and included in the laboratory procedure manualwith documentation of the performance of the
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Quality Control
Quality controlis an integral component of quality
assurance and is the aggregate of processes andtechniques to detect, reduce, and correct
deficiencies in an analytical process.
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QC & QA
Quality control is concerned with the end
product, while quality assurance isprocessoriented.
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Quality Management System(QMS)
in Molecular Pathology
Quality Assurance
QA
Quality Control
QC
- Accuracy:- Precision:
- Analytical specificity:
- Internal QC- External QC
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Quality Control in Molecular
Pathology
Controls are samples of known type or amountthat are treated like and run with patient
specimens.
Interpretation of test results always includes
inspection of controls and standards to verify
acceptable test performance.
With qualitative tests, a positive, negative,
internal and, in some cases, a sensitivity
control are required. The sensitivity control
defines the lower limit of detection for more
meaningful interpretation of negative results.
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QMS in Molecular Pathology
ObObjective (Sample Handling/Processing):
jecample Receiving):
1.To ensure specimen meets required quality
specifications.2. To maintain identification and traceability of
patient supplied products from time of its receipts
till its test results.
3. To ensure traceability of patients/physicianssupplied product at all processing and storage
level from receipt, till dispatch of results.
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QMS in Molecular Pathology Objective(Sample Handling/Processing):
To ensure that necessary check / tests are carried
out and documented to verify that specific
requirements for the document are met.
To document and maintain the records for all
inspection and testing.
To dispatch specimen to appropriate laboratory
sections for further processing. To ensure that approved procedure manual are
available for consultation.
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QMS in Molecular Pathology
Objective(Storage/Retention):
To ensure that all products from point of receipt until
dispatch of final product are controlled, properly
documented, handled safely, stored as per Specificrequirements to prevent from damage or
deterioration of products.
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QMS in Molecular Pathology
Instrument Maintenance:
Instruments used in the molecular laboratory
must be monitored and maintained for consistent
performance and accurate test results.
Reagents:
When reagents are replaced in a test method, the
new lot is ideally tested on a previously positive
and negative specimen as well as the runcontrols.
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QMS in Molecular Pathology
Reagents: Instructions on the preparation of reagents and the
quantities used in each assay are included in the
written laboratory protocol for each procedure.
Lot numbers and working stocks of probes and
primers used in amplification methods are
documented and matched to test performance in the
runs in which they were used.
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QMS in Molecular Pathology Chemical Safety: Volatile and flammable
reagents are stored in properly vented and
explosion-proof cabinets or refrigeration units.
Secondary or reinforced containers are required
for transport handling of dangerous chemicals.
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QMS in Molecular Pathology
OBJECTIVE (Result dispatch)
1. To ensure quality results.
2. To make certain that reports are released as
per contract.
3. To ensure documentation of verbal
communication of urgent results.
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Important Definitions
Analytic sensitivity:
lower limit of detection of the analyte(The t(14;18)
translocation test can detect 1 translocated cell
in 10,000 normal cells, an analytic sensitivity of
0.01%.)
Clinical sensitivity:
Ability of test result to predict a clinical condition
(95 of 100 patients with a gene mutation have adisease state, a clinical sensitivity of 95%.)
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Important Definitions
Analytic specificity:Ability to detect only theanalyte and not nonspecific targets.
(The Invader assay for factor V Leiden
successfully detected mutations in 18 positive
specimens while yielding negative results for30
normal specimens (no false positives.)
Clinical specificity: Disease-associated results
only in patients who actually have the disease
conditions. (1 of 100 normal specimens displayed
a gene mutation (1 false positive) a clinical
specificity of 99%.)
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Important Definations
Precision: Reproducibility of test results.
A quantitative method yields 99 results in
agreement out of 100 runs, a precision of 99%.
Analyte measurement: The range within which a
specimen may be measured directly (without
dilution or concentration). A qPCR HSV assay
yields reproducible linear results from 10 to 107
copies of HSV per 20 ul of CSF. Specimens
within this range are measured directly.
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Important Definitions
Analytic accuracy: Production of correct results.(
99 of 100 specimens with mutations in the BG gene
are detected by sequencing withno mutations
detected in normal specimens.)
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College of American Pathologist
(CAP)
College of American Pathologists is a medicalsociety serving more than 17,000 physician
members and more than 6,000 laboratories are
accredited by CAP throughout the world. It is the
worlds largest association composed exclusivelyof pathologists and is widely considered the
leader in laboratory quality assurance.
It is the best Laboratory Accreditation Program
which is useful for demonstrating and improvingquality. It certifies that the lab is committed to
quality patient care and achieving excellence.
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INTERNATIONAL ACREDITATIN
(JCIA)
The Joint Commission, formerly the Joint
Commission on Accreditation of Healthcare
Organizations (JCAHO), is a private sectorUnited
States-based not-for-profit organization. The Joint Commission operates accreditation
programs for a fee to subscriber hospitals and
otherhealth care organizations.
http://en.wikipedia.org/wiki/United_Stateshttp://en.wikipedia.org/wiki/United_Stateshttp://en.wikipedia.org/wiki/Health_carehttp://en.wikipedia.org/wiki/Health_carehttp://en.wikipedia.org/wiki/United_Stateshttp://en.wikipedia.org/wiki/United_States7/30/2019 QUALITY Assurance St
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JOINT COMISSION INTERNATIONALACREDITATIN (JCIA)
The company updates its accreditation standardsand expands patient safety goals on a yearly
basis, and posts them on its Web site for all
interested persons to review, making this
information and process transparent to allstakeholders ranging from institutions, to
practitioners, to patients and theiradvocates.
http://en.wikipedia.org/wiki/Transparency_(humanities)http://en.wikipedia.org/wiki/Advocacyhttp://en.wikipedia.org/wiki/Advocacyhttp://en.wikipedia.org/wiki/Transparency_(humanities)7/30/2019 QUALITY Assurance St
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INTERNATIONAL ORGANIZATION
FOR STANDARDIZATION (ISO)
TheInternational Organization for Standardization
(ISO) is a non-governmental organization based in
Geneva, Switzerland, that works to develop technical
standards for products and services all around the
world.
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Summary
Proper specimen handling is required foraccurate test results.
Specimens should be held and stored underconditions that will preserve nucleic acids.
Molecular test performance is monitored by theuse of quality controls. Instruments should be maintained and calibrated
for accurate detection and measurement ofanalytes.
Reagents are prepared, stored, and used asrecommended by manufacturers and/orlaboratory protocol.
Raw data should be documented and resultsclearly reported.
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