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Master List Information for Manufacturers
Master lists are lists of methods, manufacturers, instruments, reagents, or kits used by customers in their laboratories. The master lists are on the CAP program kit instructions or result forms. Each master list item is assigned a reporting code; customers report the code on their Program result forms. The codes are used to compile Program data, calculate statistics, and, at times, grade by peer group. Manufacturers should request any code additions, changes, or deletions for their products.
What is the master list change (MLC) process?
The master list change process is a series of steps required for a manufacturer to follow to be listed on the CAP master lists. The steps are listed in order below:
- First, the manufacturer must complete compatibility testing. (For details see the section, What is required to verify the compatibility of my product with the CAP Program specimen materials?)
- Once compatibility testing is complete with acceptable results, the manufacturer submits a digital application form.
- The CAP MLC team reviews the request.
- If approved, the change will be implemented in the next mailing according to the CAP production timelines.
What is required to verify the compatibility of my product with CAP Program specimen materials?
Manufacturers must verify the compatibility of their instruments, reagents, or kits with CAP Program specimen materials for the benefit of our mutual customers through in-house testing.
- Manufacturers can purchase CAP Programs or additional specimen material.
Detailed Program information can be found in the Surveys catalog on the Catalog & Shipping Information page to determine the appropriate program for your product. For information on ordering and pricing, call the customer contact center at 800-323-4040, Option 1 or +1-847-832-7000, Option 1 (for customers outside the US), or email contactcenter@cap.org. - Manufacturers must test their product with the program specimens and verify compatibility on the Master List Application. We no longer accept compatibility from customers running CAP program material with acceptable results. Manufacturers must show compatibility by doing the testing themselves.
How do I submit an MLC request for additions, changes, and/or deletions?
The CAP uses an online form for MLC requests. PDF forms are not accepted. If you have more than one type of request (eg, two additions, three reformulations), you must submit a separate request for each change.
Use the online request form to fill out an MLC application. Select the appropriate application below, enter the required information, and click Submit. After you submit, you will receive an email confirming submission.
- Use the Product Addition section if you want to add a product.
- Use the Product Reformulation section if you are introducing an updated version of an existing product (eg, reagent re-standardization, calibration, or both) and you can demonstrate a significant performance difference between the current and updated products.
- Use the Product Name Change section if you want to update the product name (rebranding, buyout, etc).
- Use the Product Deletion section if you want to remove a discontinued product.
What is the timeline for MLC changes?
- The master lists are finalized approximately 16 weeks before the Program ship date. MLC requests should be submitted as early as possible for processing. More time is required to process requests involving many programs or analytes. For ship dates, refer to the Catalogs & Shipping Information page.
- Manufacturers should not submit requests earlier than 6 months prior to the product launch date, provided all the required information is available. We will not list products that are not being used in the field. Draft copies of product inserts are acceptable.
What are special testing instructions?
When testing CAP Program material, include any special testing instructions when submitting the MLC request. Special testing instructions are specific procedural steps that the manufacturer discovers during compatibility testing and recognizes as required for customers to obtain acceptable results. These will be included in the Kit Instructions for customers and are changes to the standard package insert procedures.
What compatibility steps do I take if significant changes to my product occur?
It is the manufacturer’s responsibility to continue to monitor compatibility. Additional compatibility testing is required if significant changes are made to assays or instruments.
How can I contact the CAP if I have a specific MLC question?
- Email masterlists@cap.org.
- 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.