Laboratory Certificate List

Each Clinical Research Site (CRS) is required to maintain copies of the necessary laboratory certificates of each laboratory that provides testing and/or patient result reporting. Laboratory certificates of those laboratories that perform testing and/or result reporting for a large number of CRSs are available here for download. ​This library of laboratory certificates is provided as a convenience for laboratories and CRSs.

View our Frequently Asked Questions.

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PPD-Central Research-Cert_Exemption-CURRENT
Expiration Date: 12/31/2099

Quest Diagnostics Baltimore - CLIA
Expiration Date: 10/19/2022

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Frequently Asked Questions

Please complete the certificate upload form to submit laboratory certificates.

For additional information, please contact HANC.

There are several reasons why not all the certificates are posted here:

  • The focus is on those laboratories that perform testing and/or patient result reporting for a large number of CRSs. Laboratories that perform testing only for a local CRS may post their certificates here, but they are not required to.
  • The Centers for Medicare & Medicaid Services (CMS) is a Federal agency which regulates all laboratory testing, except research, performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA) program.  The CMS has also granted the College of American Pathologists (CAP) authority to accredit clinical laboratories which meet specific proficiency standards. Some laboratories that are classified as a research-only organizations are not required to have CLIA or CAP certification. Additionally, some states require additional certification, and some don't.
  • Some labs haven't posted their certificates yet.​

It is ultimately the responsibility of the CRS to ensure it has copies of the necessary certificates for monitoring purposes. It is the responsibility of the laboratory to ensure that current certificates are posted.

To download a laboratory certificate, view the list above.

The lab address on the certificate might be different from the lab address on the LPC because oftentimes a generic, administrative address is used on the certificate while an LPC will list the lab's actual sample shipping address.

If you have any questions or if you represent a laboratory and you would like to upload your certificates, please contact the HANC Laboratory Project Manager.