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Quality Assurance

They say ‘Quality’ is conspicuous only in its absence.
Quality Assurance in the laboratory is intended to ensure reliability of laboratory tests.
And ‘reliability is our policy’.

In Laboratory practice Quality directly translates into achieving the following objectives:

Objective 1- Accuracy- This refers to “the closeness of the estimated value to that considered to be true”. In other words our method of obtaining a result should give a value equal to that of the true result of the sample.

Objective 2- Precision- This refers to “the reproducibility of a result, whether accurate or inaccurate”. In other words the method we use for testing should be so constant that every time the same sample is evaluated by our method the result should be exactly the same.

Inaccuracy and/or imprecision occurs as a result of improper standards or reagents, incorrect instrument calibration or poor technique.
Precision can be controlled by replicate tests, check tests on previously measured specimens and statistical evaluation of results.
Accuracy can, as a rule, be checked only by the use of reference materials which have been assayed by independent methods of known precision.
……………knowing this the following are the four ways in which we assure quality

  1. Internal Quality Control-
    Requires checking precision internally and performing statistical analysis (day to day, week to week, month to month). For that we purchase control materials from Ortho diagnostics division of Johnson & Johnson’s and Avena diagnostics.
  2. External Quality Control-
    Requires the objective evaluation by an outside agency of the performance by a number of laboratories on material which is supplied specially for the purpose. For this we subscribe to various EQAS (external quality assurance scheme) programs including……

    • BIORAD laboratories, USA for Biochemical tests and hormones.
    • IRCH – AIIMS (Eqas) for Hematological parameters
    • UK-NEQAS for Immunocytochemistry & Histopathology. Univ. Coll. London Hospital, London, U.K. http://www.ukneqas.org.uk/
  3. Proficiency Surveillance-
    Requires critical supervision of all aspects of the laboratory and its workflow. This includes the qualification of the doctors, the qualification of staff, sample collection protocol, labeling, delivery & storage of samples and last but not the least workflow management.
  4. Standardization- Well we are the first in Uttaranchal to get Standardized (ISO 9001-2000). This includes materials as well as methods.