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Q. Should I validate new reagent lot numbers for chemistry and hematology reagents? What should the acceptable criteria be? How much should the difference be?

A. The CAP checklist requirement COM.30450 addresses the checks of new reagent lots and shipments. New reagent lots must be checked against old reagent lots or with suitable reference materials before or concurrent with being placed in service. The CAP recommends the use of patient specimens, when possible, but will accept the use of other types of materials. Each laboratory is responsible for defining its own acceptability criteria to evaluate if the change in reagent lot will affect patient results. Laboratories may use tolerance limits (e.g. + or − %) based on precision studies performed by the laboratory or following manufacturers’ recommendations. The acceptability criteria need to be defined in laboratory policy.

• College of American Pathologists. COM. 30450 New reagent lot confirmation of acceptability. In: All Common Checklist. July 28, 2015.

Shelley Martire, MLS(ASCP), Laboratory Accreditation Program Technical Specialist
College of American Pathologists, Northfield, Ill.

Dr. Kiechle is medical director of clini­cal pathology, Memorial Healthcare, Hollywood, Fla. Use the reader service card to submit your inquiries, or address them to Sherrie Rice, CAP TODAY, 325 Wau­ke­gan Road, Northfield, IL 60093; srice@cap.org. Those questions that are of general interest will be answered.