Microbiology Enrollment Requirements
CLIA requires laboratories performing microbiology tests that are regulated for proficiency testing to test five regulated challenges per test event in each sub-specialty where regulated testing is performed. The five sub-specialties are Bacteriology, Mycobacteriology, Mycology, Parasitology, and Virology. All non-waived tests in a sub-specialty can be combined to meet the five-challenge requirement.
Challenges tested with waived methods (e.g., Rapid Group A Strep) cannot be included in the five regulated challenges. Furthermore, if one of your methods becomes waived or you change to a waived mid-year, you are responsible for ensuring you maintain five challenges per test event for the remaining non-waived tests in that sub-specialty.
Programs listed that have fewer than five samples are to be used as add-on options to other programs in the same sub-specialty.
Susceptibility testing counts as one challenge regardless of the number of drugs reported.
Urine colony count is not regulated test and cannot be included as one of the five challenges.
Frequently asked questions
What are the five Microbiology subspecialties that must meet the 5-sample requirements?
Bacteriology, Virology, Parasitology, Mycology, and Mycobacteriology
What are "add on" programs?
Add on programs are proficiency programs consisting of 2 or 3 samples, that can be combined with other programs in that subspeciality to meet CMS’s minimum requirement of 5 regulated challenges for each subspecialty tested, per event.
Each program that can be used as an add on program will be designated in the catalog description. If you have any questions or would like assistance with enrolling, please contact our Technical Support team at 800-333-0958 or TechSupport@api-pt.com.
If I perform waived testing, do I need to do proficiency testing?
This is dependent upon your regulatory agency, and their recommendations for how they would like you to show accuracy and reliability for each assay performed. Many laboratories find that proficiency testing is one of the easiest ways to accomplish this and can also be used to document competency of personnel performing testing. To ensure you are meeting regulatory requirements, we recommend reaching out to your individual accreditation agency to determine the best route for your facility.
Should I enroll in a two sample or five sample program?
This depends on several factors, namely whether you are performing waived or moderately complex testing, whether the analyte is regulated, and whether you are already meeting the minimum requirement of five regulated challenges per test event per subspecialty. Analytes that are considered regulated will be bolded in the catalog, and the Microbiology catalog is separated by subspecialty. As a note, only tests performed by a non-waived method can be counted towards the 5-sample requirement.
If you are performing waived testing, please consult with your accreditation agency to determine what enrollment is necessary or recommended.
If your testing is moderately/highly complex, you will need to ensure that you are meeting the minimum of five challenges for that subspecialty per event. If you are already meeting this, you can determine if you would prefer to enroll in a two sample program or a five sample program. Many of our laboratories choose a five sample program to be able to spread out the testing amongst their staff to ensure accuracy and document competency.
Is SARS-CoV-2 a regulated analyte and do I need 5 samples?
SARS PT is not considered a regulated analyte at this time, and therefore is not required to be reported to CMS, so 5 samples are not required. For all non-regulated analytes, CLIA states that it is the decision of the medical director to determine how to document accuracy and reliability. Since SARS remains an evolving situation, for agencies such as New York state who determine their own requirements, we recommend verifying their requirements with them directly.
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