36C25719Q1171-002.pdf

Attachment 1 Statement of Work 36C25719Q1171 Page 1 of 3

STATEMENT OF WORK (SOW)

COST-PER-TEST PROGRAM

South Texas Veterans Health Care System

Background

The Cepheid Xpert C. difficile/Epi Assay is a qualitative in vitro diagnostic molecular test that is used for the rapid detection of toxin B gene sequences and for presumptive identification of 027/NAP1/BIstrains of toxigenic Clostridium difficile from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). Presumptive identification of 027/NAP1/BI strains of C. difficile is by detection of binary toxin (CDT) gene sequences and the single base pair deletion at nucleotide 117 in the tcdC gene. The test is performed on the Cepheid GeneXpert Infinity and GeneXpert DX systems and utilizes automated real-time polymerase chain reaction (PCR) to detect toxin gene sequences associated with toxin producing C. difficile. The Cepheid Xpert C. difficile/Epi Assay has a validated sensitivity of 98.7% and specificity of 90.86%.

The Cepheid Xpert MRSA Assay performed in the GeneXpert DX system is a qualitative in vitro diagnostic test designed for rapid detection of methicillin-resistant Staphylococcus aureus (MRSA) from nasal swabs in patients at risk from nasal colonization. The test utilizes automated real time polymerase chain reaction (PCR) to detect MRSA DNA. The Xpert MRSA Assay is intended to aid in the prevention and control of MRSA infections in healthcare settings. The Cepheid Xpert MRSA Assay has a validate sensitivity of 100% and a specificity of 95%.

Scope

The contractor will provide a Cost-Per-Test Program with a Cepheid GeneXpert Infintiy 48s, 32 Testing Site, Fully Automated System; GeneXpert IV, 2 Testing Site System with 6 color modules; 1 desktop computer, DX4.3 Software, Dx; Two Color Printers; UPS, Equipment Maintenance Services and Shipping, to include all attachments and accessories.

The contractor is required to provide a continuously stocked inventory of reagents/supplies and any other materials required to properly perform patient testing such that Microbiology Laboratory operations are not interrupted. These items shall be of the highest quality, to assure precision and accuracy. Expiration date must be clearly marked all supplies. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals determined at contract award.

Location:

Department of Veterans Affairs South Texas Veterans Health Care System Pathology & Laboratory Medicine Service 7400 Merton Minter San Antonio, TX 78229-4404

36C25719Q1171 Page 2 of 3

Monthly/Annual usage/test volumes determines the monthly rental rate. The contractor agrees to supply the reagents, collection devices and equipment maintenance services.

Deliverables/Supplies

Reagents/supplies will be requested on an as-needed basis.

Reagents/Consumable Supplies:

• Xpert C, difficile/Epi (120) - with a monthly minimum of 120 tests.

• Xpert MRSA, NxG (120) - with a monthly minimum of 960 tests.

• Ancillary Consumable Supplies: Twenty-two 50 pack, Collection Devices (Double

Swabs) per month

Tests performed over the minimum monthly amounts:

• Testing quantities over the minimum monthly quantities are not funded with the original request. Testing quantities over the minimum quantities must be funded through a contract modification, bilaterally with contractor and the Contracting Officer.

Special handling for emergency orders of supplies: If the supplies are found to be defective and unsuitable for use with the GeneXpert Infinity 48 or Gene Xpert IV Laboratory equipment, or the contractor has failed to comply with the requirements for routine supply delivery, the contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the contractor shall deliver to the government site in the most expeditious manner possible, without additional cost to the government, the necessary consumables in sufficient quantity as required to allow operation of the contractor’s Microbiology Laboratory equipment for one week (under normal government test load volume).

If additional requests for emergency supply delivery is required by the government, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery.

Government Inherent Functions:

Contractor shall not perform inherently governmental functions. This includes, but is not limited to, determination of agency policy, determination of Federal program priorities for budget requests, direction and control of government employees, selection or non-selection of individuals for Federal Government employment including the interviewing of individuals for employment, approval of position descriptions and performance standards for Federal employees, approving any contractual documents, approval of Federal licensing actions and inspections, and/or determination of budget policy, guidance, and strategy.

General Duties, Requirements, and Expectations:

1. Be professionally competent to handle required duties.

2. Work with staff to ensure safety measures are in place and documented.

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3. Services provided under the terms of this contract are required to be in compliance with the American Association of Blood Banks (AABB) and College of American Pathologists (CAP) accreditation policies and all applicable Federal, State and Government laws required by the Veteran’s Healthcare System.

Information Systems Officer, Information Protection:

The contractor will not have access to VA Desktop computers nor will they have access to online resources belonging to the government while conducting services. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody.

Privacy Officer:

The contractor will not have access to Patient Health Information (PHI) nor will they have the capability of accessing patient information during the services provided to the VA.

Records Manager:

There will be no federal records created, maintained, used or dispositioned with this contract; regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.].