Quality Control

Quality Control 1. The laboratory must be successfully participating in an acceptable proficiency testing program that will monitor the performance of all testing methodologies. Acceptable testing programs include the following: a. College of American Pathologists (CAP) b. American Association of Clinical Chemists (AACC) c. Centers for Disease Control (CDC) 2. Test methods used by the laboratory must be FDA cleared/approved and must be used according to the manufacturers’ directions. Documentation must be provided upon request for any appropriate and necessary test used by the laboratory that is not FDA cleared/approved. 3. The laboratorian must examine the quality and integrity of blood spots and must have a written procedure for rejection of those specimen judged to be unacceptable. 4. The laboratory must test a minimum of 40,000 specimens per year for each disorder. 5. Standard curves must be done with each assay of TSH and CAH. 6. Since interpretation of 17-OHP levels for CAH is weight dependent, a birth weight and current weight in grams must be documented for all specimen submitted for CAH testing. 7. Laboratories must be Medicare approved. 8. Hemoglobinopathies a. Control(s) containing AFSC must be included in each assay. b. All samples that are not normal (not FA or AF) must be sent to a recognized reference laboratory as liquid blood unless a diagnosis has been determined by DNA analysis or other valid means. c. If transfused, a repeat blood spot specimen or a liquid blood sample will be collected and tested between two and twelve weeks post last transfusion.