quality assurance st

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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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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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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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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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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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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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_States


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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)


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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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