2.2 Clinical Chemistry

 

2.2.1 Monitoring

a. Internal monitoring should include the following.

i. Water quality (as specified by instrumentation and assays)

ii. Stability of electrical power (as specified by instrumentation).

iii. Temperatures of water bath, refrigerator, and freezer (recommended daily).  Large equipment may be wired to an alarm system to alert users when temperatures are out of a specified range.

iv. Regular calibration of analytical balances and pipettes (recommended annually).

v. Maintenance of up-to-date SOP manuals with dates of initial implementation, and revision number clearly stated should be available. A system should be in place in which only updated copies are used and obsolete versions are archived but not available for inadvertent use and circulation.

vi. Proper storage, handling and maintenance of inventory.

vii. Maintenance of a log containing procedural changes, problems with methods or instruments, and actions taken to resolve problems.  All entries should be clearly dated and signed by laboratory personnel.  This function may be performed by a metrology unit and maintained electronically for easy access during a regulatory or quality assurance inspection.

b. External monitoring – see General recommendations

i. Method Validation – see General recommendations

ii. Instrumentation – see General recommendations

iii. Personnel Knowledge – see General recommendations

iv. Quality Control – see General recommendations

v. Procedures Manual – see General recommendations

vi. Comparison of Tests – see General recommendations

vii. Identification of Out-sourced Tests – see General recommendations