#06-5558 Accrd Manual V7 - COLA

CRITERIA FOR QUALITY LABORATORY PERFORMANCE>VirologyVI 1 EIf you perform viral identification in your laboratory, do you document the use of uninoculated cells or cell substratecontrols cultured simultaneously with patients’ specimens as a negative control?VI 2 RIf you perform viral identifications, do you maintain host systems to cover the full range of isolates necessaryto identify the clinical diseases for which you are offering laboratory services?VI 3 RIf you perform viral testing, are records maintained that describe the systems used and the reactions observed?IMMUNOLOGYSyphilis SerologySY 1 EDo all the equipment, glassware, reagents, and techniques conform to manufacturer’s specifications?Check for the requirements in the package insert of the kit you are using.SY 2 RAre appropriately-sized cards used for testing?Again, check the package insert for the size circle card which must be used.SY 3 RIs the speed of the rotator monitored each day of use?Check the manufacturer’s package insert to determine the speed of rotation required for test performance(this is generally defined as # of rotations/minute). It is important to regulate the speed of the rotator as therotation has an effect on the antibody/antigen reaction. Too rapid a rate could break up the antibody/antigenreaction, resulting in a false negative. Too slow a rate may inhibit the antibody and antigen from reactingdue to lack of adequate contact. This may also result in a false negative result. Be sure to document thischeck each day of testing.SY 4 EIs the needle used for testing calibrated regularly?Follow the manufacturer’s recommendation and record when this is performed. The method for doing thisshould be included in the procedure for this test.SY 5 RAre positive and negative controls being used in the same manner as patient specimens to ensure reactivity anduniform dosages for all test phases?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .FOR MORE INFORMATION CONTACT COLA PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org49