8 quality assurance management

Quality control

monitors activities related to the examination (analytic) phase of testing.

focused on fulfilling quality requirements.

running known control materials with patient samples

required for accreditation

detect, evaluate, and correct errors

QUANTITATIVE EXAMINATION

Measure the quantity of an analyte present in the sample

The measurement produces numeric value as an end-point, expressed in a particular unit of measurement

QUALITATIVE EXAMINATIONS

Tests that determine the presence or absence of a substance or evaluate cellular characteristics such as morphology.

• Type of Results

  • Results are not numerical.

  • Reported using descriptive terms, including:

    • Positive / Negative

    • Reactive / Nonreactive

    • Normal / Abnormal

    • Growth / No growth

SEMIQUANTITATIVE EXAMINATIONS

Tests similar to qualitative examinations because results are not given as exact numerical values.

• Results provide an estimate of the amount of a substance present rather than just presence or absence.

• Type of Results

  • Reported using descriptive or graded terms such as:

    • Trace amount

    • Moderate amount

    • 1+, 2+, 3+

ISO 15189

The laboratory shall establish, document,

implement, and maintain a quality

management system and continually

improve its effectiveness in accordance with

the requirements of ___ _____