SOW - STX Cepheid Reagents.pdf

STATEMENT OF WORK

Scope: The South Texas Veterans Health Care System (STVHCS) has a need for brand name reagents kits for the Leased Cepheid Gene Xpert Infinity’s located in the Microbiology Laboratory of Pathology & Laboratory Medicine Service at Audie L. Murphy VA Hospital. The GeneXpert system can only be used with the GeneXpert cartridge.

Technical Requirements:

• The vendor must be an authorized distributor of the following reagents and able to provide ready-to-use brand name reagents that are compatible with the following instrumentation: Cepheid GeneXpert Infinity. (Authorized distributor should have a letter with Cepheid Company Letterhead showing they are authorized)

• Vendor must provide confirmation of order within 24 hours as order request is received.

• The vendor must provide tracking information and provide an estimated delivery time.

• Standard 2-day shipping is provided as a courtesy to the VA. Next day delivery available at an additional cost to end user. The following reagents are required as needed:

Item # Description/Part Number* Qty Unit

1 3C057N Mini Tip Flocked SWAB W/UTM W/OBEADS 50 PCS 30 EA

2 SWAB/G-50 COLLECTION KIT, XPER SWAB, US CE IVD, 50 80 EA

3 URINE/A-50 Collection Kit A, Urine 50 200 EA

4 480 CFA ESWAB, LIQUID AMIES, FLOCKED, COPAN,480CFA 36 EA

5 GXSACOMP-10 KIT, SA COMP, 10-TEST, GX, IVD 100 EA

6 GXCT/NG-10 KIT, CT/NG-10 1080 EA

7 XPRSFLU-10 KIT, XPRESS, FLU, US-IVD, 10 TESTS 375 EA

8 GXMTB/RIF-US-10, KIT, MTB, IVD, 10 TESTS 50 EA

9 GXCDIFF/EPI-10 KIT, CDIFF/EPI, GX, IVD, 10-TEST 120 EA

10 GXMRSA/SA-BC-10 KIT, MRSA/SA BC, 10 TESTS, GX, IVD 30 EA

11 GXCARBAR-10, KIT, CARBA-R, IVD, GX 100 EA

12 XPRSMVP-10, KIT, XPRESS, MVP, US-IVD, 10 TESTS 240 EA

13 XPRSTREPA-10, KIT, XPRESS, STREPA, US-IVD, 10 TESTS 140 EA

14 GX MRSA-NXG-10, KIT, 10 TEST, MRSA NXG, IVD, GX 288 EA

Contractor shall deliver reagents when end user places orders against the contract/PO, unless end user provides contractor with a shipping schedule to load with the contract. These items shall be of the highest quality, to ensure precision and accuracy. Expiration date must be clearly marked on 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.

Special handling for emergency orders of supplies: If the supplies are found to be defective and unsuitable for use with the GeneXpert Infinity 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 Core Laboratory equipment for one week (under normal government test load volume). If additional requests for emergency supply delivery are required, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery.

Location: These reagents and supplies will be used in the Microbiology Laboratory located in the Pathology and Laboratory Medicine Service’s in San Antonio Laboratories of the STVHCS.

Period of Performance: Base + 4 Option Years

Deliverables/Supplies: As needed reagents/supplies for the Cepheid Gene Xpert Infinity located in the STVHCS Microbiology Laboratory.

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.

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) and VHA Directive 1106.

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.].

(End of Statement of Work)