FAQ – New Customers

Frequently Asked Questions

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?

Probably not. Although it’s a good way to ensure quality for all tests performed on your patients, PT is not required for waived tests under federal regulations (CMS/CLIA).  Your state or other regulatory agency may have stricter requirements, so check with them before changing or canceling your PT order.  State Agency contact list: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIASA.pdf

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.

Will AAB-MLE send our records to the CAP, COLA, or state/CLIA/CMS?

Yes. You must provide the CLIA number assigned to your facility. The CLIA number is the unique 10-character alpha-numeric code on your CLIA certificate that is utilized by your state and CMS to identify and track your laboratory. If you have an accrediting body such as CAP, COLA, or New York State, we must have the number assigned to your lab by that body to transmit your PT enrollment and scores to them.