How do I select the correct program module for Hematology?
Find your analyzer on the Hematology Instrument List on the Forms page, or the Hematology Analyzer Reference in the Program Guide. If still unsure, call or email AAB-MLE before submitting your order.
Why do some program modules only have 1 or 2 challenges, and others have 5 challenges?
This can depend on the method and the analyte. CMS requires 5 proficiency challenges for certain “regulated” analytes. CMS Regulated analytes are identified in a table on pages 3-22 of the AAB-MLE 2023 Catalog. Non-regulated analytes or methods may have fewer than 5 challenges. If your testing kit or method is waived, you can select the option with fewer challenges, as long as your state or other regulatory agency does not have more stringent requirements. It is ok to have more than the required number of challenges, but not less. Do not enroll in a waived module if you are using a non-waived test method. For some non-regulated analytes, AAB-MLE only offers 1 or 2 challenges. This is acceptable to CMS.
How do I know if my test is waived?
Common waived tests include urine dipstick, fecal occult blood, and urine pregnancy tests (urine hCG). The CPT code used for billing may have the modifier “QW” at the end to indicate the test is waived. However, some newly approved waived tests don’t require a QW modifier to be recognized as waived. If unsure, contact your test manufacturer’s technical support, or use the FDA’s searchable CLIA database at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm
If we are only doing waived tests, do we need to do proficiency testing?
Do we need to order extra PT for each instrument, or for each practitioner who performs microscopy, or other testing?
No. Proficiency testing is an external assessment of your testing facility as a whole, therefore, you only need one AAB-MLE account for each CLIA ID number, and only one set of PT results should be submitted for each account.