This document discusses quality control procedures for clinical biochemistry testing. It recommends: - Using Grade I/II water for reconstituting reference materials and reagents. - Performing hormone stimulation tests under medical supervision in a hospital lab. - Running a minimum of one control level once daily if less than 25 patient samples are tested, and two control levels once daily if between 25-75 patient samples are tested. For more than 75 patient samples, two control levels should be run twice daily. - For blood gas measurements, running one control every eight hours and one with each patient sample unless the instrument automatically calibrates at predefined intervals.

1. Clinical Biochemistry Changes
NABL 112 Issue 4
Dr. Jayesh Warade

2. 5.3 Laboratory equipment, reagents and consumables
• A microbial count is not required as long as Grade water
I/II is used for reconstitution of reference material and
reagents.

3. 5.4 Pre-examination processes
• Hormone stimulation tests – precautions Hormone
stimulation for these tests is to be done under the
supervision of a medical doctor in a hospital-based
laboratory where emergency services are available for
immediate handling of any adverse reactions if and when
they occur

4. Ensuring quality of examination results
• The laboratory shall include a
minimum of one level QC at least once
a day.
• However, where the number of patient
samples analysed for any parameter
exceeds 25 per day, the laboratory
shall employ 2 levels of QC at least
once a day for such parameters.
• Further, if the number of patient
samples analysed for any parameter
exceeds 75 per day, the laboratory
shall employ 2 levels of QC at least
twice a day at appropriate intervals.
• Two levels of QC
shall be included at
least once on the day
of performing the test
irrespective of the
size of the laboratory.
• If the laboratory is
operational 24X7, two
level controls shall be
run in the peak hour
subsequently one
level every 8 hours.

5. Ensuring quality of examination results
• For blood gas measurements at least one control shall be
assayed every eight hours. In addition one control should
be run with each patient sample unless the instrument
automatically calibrates itself at predefined intervals.

6. Ensuring quality of examination results
• The laboratory shall employ suitable reference material traceable
to International Standards for calibration of measuring systems
and methods.
• Traceability certificates for calibrators shall be obtained from kit
suppliers and appropriately documented.
• Alternate methods shall be employed for verifying accuracy of
results of those tests for which calibration and control materials
are not available.

7. Ensuring quality of examination results
• For blood gas measurements at least one control shall be
assayed every eight hours.
• In addition one control should be run with each patient
sample unless the instrument automatically calibrates
itself at predefined intervals.

8. 5.8 Reporting of results
• Wherever relevant, reports should have an interpretation.