The National Quality Assurance Guideline |
| (The National Quality Assurance Guideline
proposed by the Korean Association of Quality Assurance for Clinical Laboratory) |
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| SCOPE |
| 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. |
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| 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. |
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| 1.1.2.1 |
If independent commercial QC material is unavailable, the
labs may obtain the QC material from any of the following |
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| 1.1.2.1.1 |
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. |
| 1.1.2.1.2 |
Patient pools |
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| 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. |
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| 1.1.4.1 |
Where possible the analyte concentrations should be at the
clinically relevant levels. |
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| 1.2. QC Application |
| 1.2.1 |
Frequency of control measurements: |
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| 1.2.1.1 |
The QC samples should be analyzed at least once during the
analytical run length. |
| 1.2.1.2 |
Manufacturers (of reagents & instruments) recommendation
should be used only as guidelines |
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| 1.2.2 |
Location of control samples |
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| 1.2.2.1 |
The location of QC sample should be such that it allows for
reporting the QC before the patient sample |
| 1.2.2.2 |
It is advisable to keep the QC samples in between and at
the end of the run to detect errors. |
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| 1.2.3 |
Setting control limits |
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| 1.2.3.1 |
Acceptable ranges must be defined for the quality control
material |
| 1.2.3.2 |
Values provided in the assay sheets should be used only as
guidelines. |
| 1.2.3.3 |
The range should be calculated as +/- 2 SD |
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| 1.2.4 |
QC Analysis & Out of control situations |
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| 1.2.4.1 |
Numerical QC should be presented graphically to assist in
early detection of trends. |
| 1.2.4.2 |
The laboratory should have a system of long term monitoring
of internal quality control results to assess method performance |
| 1.2.4.3 |
There must be documented evidence of review of internal quality
control results. |
| 1.2.4.4 |
The lab should establish guidelines to respond to out of
control situations. The actions should be documented |
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| 1.2.5 |
Interlaboratory participation |
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| 1.2.5.1 |
Laboratory should actively participate in interlaboratory
programs for the control materials where such programs are available.
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| 1.2.6 |
Calibrators |
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| 1.2.6.1 |
Where calibration of an assay is required appropriate material
must be used as a calibrator. |
| 1.2.6.2 |
Record of the traceability certificate of the calibrator
must be maintained. |
| 1.2.6.3 |
If the material selected is not intended for use as a calibrator,
assigned calibrator values must be substantiated |
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| 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. |
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