Attachment B-SOW.docx

STATEMENT OF WORK

Pathology & Laboratory Medicine Service, Fully Automated Single Gene Molecular System

1. Introduction: The Pathology and Laboratory Service requests purchase of an automated single gene molecular system and reagents necessary for the generation of single gene reportable patient results.

This piece of equipment is highly specialized and regulated molecular oncology instrument. It will be the cornerstone of the molecular laboratory and is essential to patient testing. System will perform single gene identification of KRAS, NRAS, BRAF, EGFR, and MSI.

2. Minimum Requirements:

a. The automated molecular system shall have the capability of being interfaced with Data Innovations middleware solution, Instrument Manager.

Meets the minimum requirement described above (y/n)?

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b. The system shall be capable of producing accurate and reproducible assays on formalin fixed paraffin embedded tissue.

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c. The system shall be a fully automated molecular system that requires less than two minutes of hands-on time per sample.

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d. The model being purchased shall be in current production as of the date the purchase is made. Remanufactured and discontinued models will not be accepted.

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e. If there is a newer instrument released during the duration of the contract, VA facility should be given opportunity to replace existing instrument with the newer instrument on the same contract.

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f. System shall be capable of performing the following:

1. KRAS

2. BRAF

3. EGFR

4. MSI

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g. Instrumentation shall provide the following MSI functionality:

1. Provide a result between in approximately 150 minutes.

2. Perform testing with no need to extract sample.

3. Perform MSI testing on approximately 1 slice of FFPE tissue section.

4. Eliminate need for batch testing.

5. Eliminate use of external quality control.

6. Qualitative detection of mutations in 7 novel MSI loci (ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A, and SULF2).

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f. Contractor shall:

1. Provide initial in-depth training for personnel operating the system.

2. Provide on-site validation support of the equipment

3. Define the actual hands on maintenance time required for daily, weekly, monthly, and as needed maintenance. Contractor is to include the analyzer time required to perform each maintenance task and list which tasks are user level and which tasks are service level.

4. Provide low cost service contract pricing after warranty period

5. Identify who will provide service on the instrument

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