• Testing related to safety and/or relevant to subject well being

• Testing performed in-house is supported.

• Only human specimens.

Research testing in the Clinical Pathology Core laboratories [Gray 5]

• Specific tests have been designated – all clinically validated and FDA cleared; many with critical value specifications

• These tests are listed on new Research requisitions – laboratory staff cannot make “safety” judgments

• No batches, complex processing or specimen returns – CRC is working on processing support

Testing related to subject safety

Requirements:

• MRN to identify subjects

• EPIC registration

• EPIC Study Visit

• Acceptable specimen type only – CLIA compliant processing and testing only

• Research requisition with each visit

Only in-house testing

Investigator Options:

• CRC/LabCorp – • Mayo Medical laboratories• Quest Diagnostics• ATUP Laboratories

Issues:

• Cost – research discount must be negotiated – no formula as billing is direct fro the reference laboratory

• Except for LabCorp, investigators must set up user accounts

Animal specimens are appropriately processed and tested by the Center for Comparative Medicine Veterinary Clinical Pathology Laboratory

Only human specimens

Questions/Discussion