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SECTION III: COLA CRITERIA FOR QUALITY LABORATORY PERFORMANCEIMPORTANT NOTEFrequently, ISI values differ frombatch to batch or lot to lot ofthromboplastin. When valueschange, the new value must beupdated and used in calculatingthe INR. This is critical foraccurate results.Specialty: CoagulationThere are specific requirements for Coagulation testing and theproper calculation of INR. Manual coagulation tests also havespecific requirements.COAGULATIONThe International Normalized Ratio (INR) is rapidly replacing the reporting of “seconds” for Prothrombin times. Correctlycalculated INR can allow the clinician to compare patient results from different laboratories more effectively. The use of theINR is becoming the “gold standard” for reporting of Prothrombin time results.The correct formula for calculating INR is: (A/B)CA = Patient Prothrombin Time in secondsB = Normal Patient Reference Mean in secondsC = Activity of the Thromobplastin as indicated by the ISI Value assigned by the manufacturer of the Thromboplastin> NOTE: Frequently ISI values differ from batch to batch or lot to lot of Thromboplastin. When values change, the newvalue must be updated and used in calculating the INR.3-64. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .© 2007 COLA FOR MORE INFORMATION CONTACT COLA PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org
SECTION III: COLA CRITERIA FOR QUALITY LABORATORY PERFORMANCE>When an International Normalized Ratio (INR) is reported: (CO 1-2)CO 1 EDoes the laboratory have a mechanism to ensure that the correct activity of the thromboplastin, as indicated bythe ISI, (corresponding to the current lot number of tissue thromboplastin in use) is used to calculate the INR?The ISI is the International Sensitivity Index value that is determined by the thromboplastin reagent manufacturer foryour particular instrument or method. The ISI is an indication of how sensitive the thromboplastin reagent is in relationto the standard set by the World Health Organization.> NOTE: Frequently ISI values differ from batch to batch or lot to lot of Thromboplastin. When values change, the newvalue must be updated and used in calculating the INR.Some coagulation instruments calculate the INR automatically, however the user must confirm that the reagent ISIvalue is updated in the analyzer whenever the lot number of thromboplastin changes.Some manufacturers will provide a chart to read the INR’s off of that are based upon the lot number of thromboplastinin use and its assigned ISI. The laboratory needs to define a process for ensuring the proper ISI is being used incalculations of patient INR’s. It is advisable to incorporate this into a routine quality assessment activity, such as partof a chart review process or overall review of coagulation testing.CO 2 EDoes the laboratory determine the normal patient reference range and mean, with each change in lot number ofthromboplastin reagent, and with any change in methodology?This range is method, instrument, and reagent specific. It is not acceptable to use the daily normal control value or themean of the normal control in place of your normal patient reference mean as the denominator in 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 lots of thromboplastinfor at least a year at your request. If you have not had a change in your test system in 12 months and don’tanticipate a change, it is suggested that you recalculate your normal patient range and mean. This can be done usingrecent values taken from unmedicated normal patients appropriate for a normal range study.In those coagulation instruments that calculate the INR automatically, the laboratory must confirm that its normalpatient 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 newvalue 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.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .© 2007 COLA FOR MORE INFORMATION CONTACT COLA PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org3-65
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COLA LABORATORYACCREDITATION MANUAL
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TABLE OF CONTENTS>I Introduction to
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SECTION V: APPENDIX>IN THIS SECTION
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