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Laboratory Certificates

Apr 28, 2020: US CAP Inspections Suspended Until Further Notice
The College of American Pathologists (CAP) has suspended all inspections except Immediate Jeopardy/Complaint inspections (and associated follow-up revisit inspections) until further notice. Read more here.
What is the purpose of this Laboratory Certificate Library?

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.

Why aren't there certificates of all the laboratories performing testing for DAIDS-funded studies?

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.​

Who keeps track of which certificates are needed?

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.

How do I download a laboratory certificate?

To download a laboratory certificate:

  1. Click the double arrows next to the Institution to view a list of available certificates. 
  2. Click on the Document Name to download the certificate.

Why is the lab address on the certificate different from the lab address in the lab processing chart (LPC)?

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.

What if I have more questions?

If you have any questions or if you represent a laboratory and you would like to upload your certificates, please click on Contact Us and send an email to the HANC Laboratory Project Manager.

SelectedAdvanced BioMedical Labs
NormalAdvion BioServices, Inc.
NormalBiomedical Research Institute
NormalBoston Medical Center
NormalChildren's Hospital Los Angeles
NormalChildren's Hospital of Philadelphia
NormalHarvard University
NormalLurie Children's Hospital
NormalMonogram Biosciences Inc
NormalPHPT IRD Chiang Mai
NormalQuest Diagnostics
NormalRush University
NormalStanford University
NormalState University of New York, Buffalo
NormalUniversity of Alabama, Birmingham
NormalUniversity of California San Diego
NormalUniversity of California San Francisco
NormalUniversity of California, Davis
NormalUniversity of Cape Town
NormalUniversity of Colorado
NormalUniversity of Colorado Hospital Authority
NormalUniversity of Massachusetts
NormalUniversity of Nebraska Medical Center
NormalUniversity of North Carolina
NormalUniversity of Pittsburgh
NormalUniversity of Washington
Advanced BioMedical Labs-Clinical-CLIA_CMS-CURRENT3/12/2021
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