Master List Information for Manufacturers
A master list appears on CAP PT kit instructions or result forms. The list consists of methods, manufacturers, instruments, reagents, or kits used by participants in their laboratories. Each master list item is assigned a reporting code; participants report the code on their PT result forms. We use the codes to compile PT data, calculate statistics, and at times grade by peer group. Manufacturers should request any code additions, changes, or deletions for their products.
How do I submit a master list request for additions/changes/deletions?
- Use the product addition form if you want to add a product.
- Use the product deletion form if you want to remove a discontinued product.
- Use the product name change form if you want to update the product name (eg, rebranding, buyout, etc.).
- Use the product reformulation form if you are introducing an updated version of an existing product (eg, reagent restandardization or recalibration), and you can demonstrate a significant performance difference between the current and updated products.
What are the minimum requirements to process an MLC request?
- Complete all required fields on the appropriate master list change form.
- For master list additions, include the reagent/kit package insert (instructions for use) or instrument specification sheet.
- For product updates (eg, reformulation, recalibration), provide package inserts for BOTH the current and new product.
- For multiconstituent analyzers, provide a test menu.
- See the section regarding compatibility testing.
- Master list requests must be received with ALL required documentation in order to begin processing.
The master list is any list of methods, manufacturers, instruments, reagents, kits, etc, used by participants in their laboratories. Collecting this data facilitates grading on our Surveys programs.
If I only have a few of the required documents, should I still submit a request?
- No. We will not accept your request until you submit all required documents.
Can I submit a request early, before my product is on the market?
- No. The proficiency testing master lists are used solely for data collection. We will not list products that are not being used in the field. You are welcome to submit your request up to 6 months prior to your product launch date, provided you have all of the required information. Draft copies of product inserts are acceptable.
What is required to verify compatibility of my product with CAP PT?
Manufacturers must verify the compatibility of their instruments, reagents, or kits with appropriate CAP PT specimen materials on an ongoing basis for the benefit of our mutual customers. Compatibility can be demonstrated as follows:
- Perform in-house testing of CAP PT specimen materials. (PREFERRED)
- Manufacturers can purchase CAP PT Surveys or additional specimen material. For information on PT ordering and pricing, call the customer contact center at 800-323-4040 (domestic), 001-847-832-7000 (international), or email email@example.com.
- If you purchase additional specimen material in lieu of the full Survey, please request a copy of the participant summary in order to perform compatibility assessment.
- Detailed PT program information can be found in the Surveys catalog on the Catalog & Shipping Information page.
- After testing the appropriate Survey specimens, you can submit your results to the CAP for evaluation. Alternatively, you can perform an in-house evaluation based on participant results for those specimens.
- When testing CAP PT material, note if there are any special testing instructions for customers, and include that information when submitting the master list request.
- A given analyte may be offered on multiple CAP PT Surveys; however, the material composition may be different. If the specimen material is the same as that for the Survey you tested, we will include the other Survey(s) in your request. If the specimen material has a different composition, we will ask you to test the Survey(s) to verify compatibility.
- Demonstrate substantial equivalence with another product already on the PT master lists.
- If your instrument or kit has the same analytical platform or formulation as an existing product, please specify the name of that product in your request.
- Attest that customers are performing CAP PT using your product, with no reported issues.
- We will review our data. If we cannot verify a statistically significant number of users, we may ask you to perform in-house testing before we will process your request.
What happens after I submit my request?
- Requests will be processed in a timely manner; it may take longer to process requests involving many products (eg, buyout or rebranding scenarios) or PT modules.
- For ship date, refer to the Catalogs & Shipping Information page.
Requests for changes to the master lists must be submitted by a manufacturer. Send requests as early as possible to allow time for processing prior to upcoming mailings. The master lists are finalized approximately 16 weeks before the program ship date.
How can I contact the CAP if I have a question?
- Please email us at firstname.lastname@example.org.
- PT customers whose products or methods do not appear on the master lists should contact their manufacturer and ask them to submit a request to the CAP.