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  CAP Supplier Guidelines

 

 

 

The Purchasing Department is responsible for directing CAP suppliers and for the formation of supplier agreements. The Purchasing Department works with CAP departments and committees to identify suppliers who will best serve the College by demonstrating their ability to provide quality products and timely services at a competitive cost. It is critical to the success of this effort that suppliers view the Purchasing Department as their focal point at the College. All agreements made for the provision of new products or services, or for modifications of previously agreed upon products or services, must be documented by the Purchasing Department. Any agreement or commitment made outside of the CAP Purchasing Department may not be binding.

POTENTIAL PROFICIENCY TESTING SUPPLIERS:

The College of American Pathologists is a non-profit provider of CMS-approved Proficiency Testing (PT). PT is required for laboratories performing clinical testing. Having CAP PT available for testing methods and assays allows our common customers to easily meet CMS requirements for PT. If PT is not available through a PT provider such as the College, our common laboratory customers must create their own scheme to meet CMS PT requirements.

Potential new suppliers and materials will be evaluated based on business and technical information provided by the potential supplier, proposed products costs, and other product specific concerns. Organizations interested in becoming a PT material supplier to the CAP should provide the following information:

  1. Background of your organization and list of key contacts
  2. A list of at least (3) customers that have received similar products/materials, who can be contacted by CAP as references
  3. Disclosure of any business ties that are or could be related to the outcome of the provision of material to the CAP
  4. A current annual report or financial statement from an independent auditor
  5. Timelines for development/formulation
  6. Availability, if produced in a commercial form or if material would be custom manufactured for the College
  7. Package insert or comparable information, if a custom formulation for the CAP, should include:
    1. Handling instructions
    2. Storage and stability information (both open and closed vial)
    3. Shipping information (bulk and kit)
  8. Data on potential materials that demonstrate commutability across platforms
  9. Disclosure of any known instrument/kit incompatibilities
  10. Suggested method for target verification

The College has multiple means to qualify materials. Potential suppliers are expected to provide qualification (evaluation/pilot) materials free of charge.

General Proficiency Testing Purchase Terms and Conditions include, but are not limited to, the following:

  1. All information provided by the College in connection with the provision of this product/material must be kept confidential by the supplier and should not be shared with any other entity without the express written consent of the College of American Pathologists
  2. The College reserves the right to accept or reject any or all proposals for any reason whatsoever and will not be responsible for any charges incurred by the respondents for replying to this inquiry.
  3. The material shall meet all mutually agreed upon specifications.
  4. All operations are to be performed following current Good Manufacturing Procedures (GMP) guidelines and the supplier must ensure that all other regulatory requirements are satisfied.
  5. All shipments made FOB destination
  6. Appropriate handling of “protected health information” (“PHI”)
  7. Standard of care; indemnification
  8. The supplier shall maintain an insurance policy with limits of liability of at least one million dollars ($1,000,000) per claim and three million dollars ($3,000,000) in the annual aggregate for general, premises, and product liability, with an umbrella limit not less than one million aggregate. Such policy shall name CAP as an additional insured under this policy to provide protection against all potential liability arising in connection with performance of any of Supplier’s obligations.
  9. Supplier Warranties including but not limited to:
    1. materials performing as sample specimens on the testing equipment reasonably expected to be used by participants in the PT Programs in a manner that is suitable for a proficiency testing program
    2. facilitate the CAP’s preparation of handling instructions and warning statements
    3. all human source blood products incorporated into any PT Programs will be obtained from donors who are screened and tested and found negative for viral markers
    4. ensure that none of the materials used in the CAP PT Program are on the list of Select Agents as established by the Centers for Disease Control and Prevention and that all materials used are tested and free of any agent rated as BioSafety Level 3 or greater
    5. It owns all patent rights, technology, and information needed to produce, provide, package, and ship the samples, test materials and related services
  10. Liquidated damages for failure to meet specifications
  11. Liquidated damages relating to delays in shipping
  12. Supplier may not sell or distribute for resale or otherwise dispose of any lot of material custom manufactured and/or custom labeled for the CAP but not needed by the CAP
  13. Provide Certificates of Analysis (COA) and Material Safety Data Sheets (MSDS)
  14. CAP owns all data generated in connection with its PT Programs
  15. The College will not be responsible for any charges incurred by the respondents for replying to this inquiry.

If you require any additional information, please contact the Purchasing Department

 

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