The National Quality Assurance Guideline
(The National Quality Assurance Guideline proposed by the Korean Association of Quality Assurance for Clinical Laboratory)
The purpose of this document is to provide the guidelines to improve the quality assurance performance of the medical laboratories in Korea. This document has referred to the certified international quality assurance recommendations for global standardization of the medical laboratory testing.
1. Internal Quality Control
1.1. Quality control material
1.1.1 The QC material used must cover the analytical range of the testing system. Low /normal/ high, normal/abnormal, positive/negative, reactive/non-reactive controls as appropriate for the test must be used.
1.1.2 Controls independent of those produced by the manufacturer of the test or analyzer must be used. If independent commercial QC material is unavailable, the labs may obtain the QC material from any of the following The manufacturers of reagents or calibrator. However, in this case, information on production of QC material should be sought from manufacturer to determine the extent of independence from kit calibration process. This should include the source of QC material, traceability (including value assignment) and matrix matching. Patient pools
1.1.3 Laboratory should obtain control material to last for at least one year, where practical. This will help in long term monitoring of testing systems.
1.1.4 For most analytes, a minimum of two level of QC is recommended. Where possible the analyte concentrations should be at the clinically relevant levels.
1.2. QC Application
1.2.1 Frequency of control measurements: The QC samples should be analyzed at least once during the analytical run length. Manufacturers (of reagents & instruments) recommendation should be used only as guidelines
1.2.2 Location of control samples The location of QC sample should be such that it allows for reporting the QC before the patient sample It is advisable to keep the QC samples in between and at the end of the run to detect errors.
1.2.3 Setting control limits Acceptable ranges must be defined for the quality control material Values provided in the assay sheets should be used only as guidelines. The range should be calculated as +/- 2 SD
1.2.4 QC Analysis & Out of control situations Numerical QC should be presented graphically to assist in early detection of trends. The laboratory should have a system of long term monitoring of internal quality control results to assess method performance There must be documented evidence of review of internal quality control results. The lab should establish guidelines to respond to out of control situations. The actions should be documented
1.2.5 Interlaboratory participation Laboratory should actively participate in interlaboratory programs for the control materials where such programs are available.
1.2.6 Calibrators Where calibration of an assay is required appropriate material must be used as a calibrator. Record of the traceability certificate of the calibrator must be maintained. If the material selected is not intended for use as a calibrator, assigned calibrator values must be substantiated
2. External Quality Assurance / Proficiency Testing
2.1. Where available labs must participate in EQAS / PT programs
2.2. Program which includes laboratories in other countries / region should be preferred
2.3. The EQAS/PT program must be from an accredited provider.
2.4. Labs should submit data EQAS data regularly as per the submission dates specified by the
program organizers
2.5. EQAS performance should be reviewed and the evidence of review should be documented
2.6. The EQAS /PT samples should be treated a patient samples.