Bacteriology, Virology, Parasitology, Mycology, and Mycobacteriology
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.
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.
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.
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.
