Quality Assurance in relation to

Medical Laboratory

Accreditation

Dr. T.A. Varkey

Medilab Specilaity Laboratories India Pvt. Ltd., Kochi,

Mobile: 9447031471

QUALITY

“ Quality is never an accident;

it is always the result of high intention,

sincere effort,

intelligent direction and skilful execution;

it represents the wise choice of many

alternatives.”

William A. Foster

QUALITY

The ISO 9000 definition of quality

is ―

the degree to which a set of

inherent characteristic fulfils

requirements.

Fundamentals of Measurement

QUALITY

ACCURACY PRECISION REPRO

DUCEBILITY RESOLUTION

Accuracy is the closeness of agreement

between the result of measurement and

the true value of the measurand

Precision is the closeness of agreement

between the results of successive

measurements of the same value of a

quantity carried out under identical

conditions at short intervals of time.

Resolution is the smallest difference

between indications of a displaying device

that can be meaning fully distinguished

Reproducibility is the closeness of

agreement between corrected results of

measurement of the same value of a

quantity when measurements are made

under different conditions

Precise but not Accurate

Accurate but not Precise

Precise and Accurate

Quality Assurance Quality Assurance encompasses all measures

taken to ensure the reliability of investigations to give the best patient care

Quality assurance includes the evaluation of patient preparation and specimen collection, as well as the pre analytical, analytical, and post analytical phases of laboratory testing.

Quality assurance measures are implemented to detect irregularities in analytical results

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The Quality Assurance Cycle

•Data and Lab

Management

•Safety

•Customer

Service

Patient/Client Prep

Sample Collection

Sample Receipt

and Accessioning

Sample Transport Quality Control

Record Keeping

Reporting Personnel Competency

Test Evaluations

Testing

Internal Quality Control( I.Q.C)

IQC is the action of detecting errors that would invalidate the medical usefulness of laboratory results. IQC enables the detection of Day-to Day performance problems and assures the precision of clinical laboratory tests. An IQC system requires results from two levels of quality control sera on 20 consecutive days. The mean and 2SD limits are established for each analyte at both levels. SD values are then plotted on a Levey Jennings chart and the SDI is used to observe the deviations from the mean.

External Quality Assessment( E.Q.A)

External quality assessment schemes

allow laboratories to monitor their

accuracy and compare performance with

other laboratories.

The laboratory is unaware of the

parameter values, this is known as „blind

analysis‟ of an EQA sample

Medical Laboratory Accreditation

• Credibility of test results is extremely important where diagnosis depends on these results. Laboratory results must be reliable.

• For the reliable test results, the data must be accurate, precise & reproducible.

Concept of Laboratory Accreditation

• This is possible only when the laboratories

performing these tests are competent.

• The concept of Laboratory Accreditation

was developed to provide a means for

third-party certification of the competence

of laboratories.

• Improve quality

• Demonstrate commitment to quality

• Comply with International Standards

• Harmonisation of working processes

• Control of Laboratory Services

• Rationalisation of Services

Why Accreditation

• Potential increase in business due to enhanced customer confidence and satisfaction

• Savings of time and money due to reduction or elimination of re-testing

• Better control of laboratory operations due to in-built Quality Assurance System and competent man-power

• Increased Confidence in test results and personnel performing work.

Formal recognition of competence of laboratory by Accreditation body has many advantages

Formal recognition of competence of laboratory by

Accreditation body has many advantages

• Customers can identify Accredited Laboratories from directory of Accredited Laboratories.

• Users of Accredited Laboratories enjoy greater access in Domestic and International market

• Improved medical tourism through reliable & acceptable Medicare as per International Standards

* NABL *

In India, laboratory accreditation scheme

is operated by the National Accreditation

Board for Test & Calibration Laboratories

(NABL), an autonomous society under the

Department of Science & Technology,

Govt. of India.

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