#06-5558 Accrd Manual V7 - COLA

CRITERIA FOR QUALITY LABORATORY PERFORMANCECO 2 EDoes the laboratory determine the normal patient reference range and mean, with each change in lot numberof thromboplastin reagent, and with any change in methodology?This range is method, instrument, and reagent specific. It is not acceptable to use the daily normal controlvalue or the mean of the normal control in place of your normal patient reference mean as the denominatorin the INR calculations. You may not borrow a normal patient mean from any other facility.To minimize the impact of this requirement, many thromboplastin reagent manufacturers will sequester lotsof thromboplastin for at least a year at your request. If you have not had a change in your test system in 12months and don't anticipate a change, it is suggested that you recalculate your normal patient range andmean. This can be done using recent values taken from unmedicated normal patients appropriate for a normalrange study.In those coagulation instruments that calculate the INR automatically, the laboratory must confirm that itsnormal patient reference range/mean is updated in the analyzer with each new lot of thromboplastin.> NOTE: Frequently ISI values differ from batch to batch or lot to lot of Thromboplastin. When values change,the new value must be updated and used in calculating the INR.IF non-waived AUTOMATED COAGULATION TESTS ARE PERFORMED INCLUDING COAGULATION TESTING ON AFIBROMETER OR SIMILAR SEMI-AUTOMATED INSTRUMENT:CO 3 EAre two levels of controls run and documented at least every 8 hours of testing?CO 4 EAre two levels of controls run and documented with each change of reagents?This includes new reagent which is reconstituted and is the same lot number as the reagent previously used.If manual coagulation tests are performed (CO5- CO7):CO 5 EDoes each individual perform two levels of control each day before they perform patient tests and documentthe results?Manual coagulation test results may vary greatly among testing personnel. Each person should “control”their own technique. Laboratory records must show who performed the testing.CO 6 RAre two levels of controls run and documented each time there is a change of reagents?This includes new reagent which is reconstituted and is the same lot number as the reagent previously used.CO 7 EAre patient specimen and control materials tested in duplicate and the results of each test documented?38. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .FOR MORE INFORMATION CONTACT COLA PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org