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