Preforma Layout3

LABORATORY REQUIREMENTS

•Staffing • Lab Director (PhD or MD) • Lab Manager (provided by Labnet, LLC) • Lab techs- 2 •Requirements • Space 1000 sq feet • Equipment (depends on volume, assume 2000 samples) • Sample prep- tables, computers, scanners, agitators, pipettes, refrigerator, freezer, water bath, hood. • LCMS- Schimadzu 8050 (fast positive and negative injections) nitrogen generator, UPS, generator, Software • Data Analysis- LIS

•Regulatory • CLIA or COLA • High Complexity • SOPs and Proficiency Testing • Validation Protocols • QA/QC protocols

•Timeline • Contracting 1mos • Ordering and Validating LCMS- 3 mos • Method Development and Validation- 1 mos • Training and Troubleshooting- 1 mos •Total 6 mos

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