Source documentation is key in our business. So is precision. Confirming key results at Stanford Hospital and Clinics is part of our due diligence. All diseases diagnosed based off histological sections, morphological assessment of fine needle aspirates, bone marrow aspirates, or peripheral blood must have such diagnoses confirmed by a Medical Staff member with Pathology privileges at Stanford.

Therapy for clinical trials cannot be initiated prior that step. The exception – requiring detailed documentation by study principal investigator – is mandated urgent therapy.  If the pathology specimens cannot be obtained because they have been destroyed, no longer exist, or have been irrevocably lost or cannot be obtained through reasonable efforts, this should be documented in the medical record.

This recommendation (and exceptions) are part of the Rules and Regulations of medical staff bylaws available at Stanford governing documents homepage.