Table 3.

Study benchmarks

Benchmark	Assessment	Benchmark met?	Corrective Action Taken
Patient was properly enrolled	Patient was enrolled and eligible	4/5 patients.	One patient did not have Cobas testing prior to enrollment; this patient had tissue sent out after enrollment which was subjected to Cobas testing, eventually meeting eligibility with a BRAF mutation indicated. Evaluation of protocol-specific and institutional SOPs. Modifications were made to streamline the procedure and add clarification. Increased training of responsible personnel was made.
	Consent form was properly filled out and signed	5/5 patients	Not applicable
Blood/tissue samples were properly handled and shipped to their destination	Tissue and blood was obtained from the patient.	5/5 patients	Not applicable
	100% of samples shipped	5/5 patients	Not applicable
	Courier delivered 100% of samples	5/5 patients	Not applicable
	Sample handling procedures were adequately followed	5/5 patients	Not applicable
Tissue samples (following shipment) show acceptable pathological qualification of tumor content	Tumor content was adequate in 80% of samples to provide sufficient quantity/quality to proceed with analyte extraction (≥ 25% tumor nuclei)	4/5 patients	Guidelines for determining biopsy-able status of patients’ tumor were addressed and modified. A protocol amendment was prepared to allow an extra tissue core to be obtained to ensure proper pathology review, if one was needed.
Tissue/blood samples yield suitable DNA/RNA for sequencing	Sample quantity was adequate for obtaining molecular analytes for defined laboratory protocols.	5/5 patients	Not applicable.
	Sample DNA/RNA quality was adequate for defined laboratory protocols	4/5 patients	Optimal quantity of tissue for RNA/DNA analyses was not obtained from first patient because internal threads on collection tube resulted in damaged tissue. Cryovials with internal threads were replaced with vials with external threads.
Tumor samples yield assignment of molecular alterations deemed druggable to receive an assigned individualized treatment decision from the tumor board	Sample quantity, quality, and generation of molecular information performed in a timely fashion to integrate data in support of identifying druggable targets and associated therapy.	3/5 patients	Processing and communication issues led to delays in the genomic analyses for two patients, resulting in exceeding the 5-week target timeframe. A meeting between clinical and scientific investigators was held to discuss issues contributing to the delays. Utilization of project management application software was instituted to track the status of the analyses at each stage of collection, processing, shipping, and analysis.