SOW Cepheid GBS - CT-NG.pdf

Zuni PHS Indian Hospital

Project Name: GBS and GC/Chlamydia Cepheid GeneXpert

Statement of Work

A. Introduction and Background The Cepheid GeneXpert is a molecular diagnostic platform that uses RT-PCR test methodology which is currently the gold standard in testing. This instrument is already placed and in use at Zuni PHS Hospital. Purchase of analyzer is not needed. Among the analyzers capabilities is to perform Group B Strep (GBS) testing for prenatal patients and Chlamydia/Gonorrhea (CT/NG) testing for the general population which would require purchasing additional reagents.

B. Objectives The Cepheid GeneXpert requires Group B Reagents kits and controls to perform testing. Group B Strep is a bacterial organism that if left untreated in a prenatal patient cause cause severe health complications to the infant during/after child birth. Reagents and kits for Chlamydia/Gonorrhea are also required to perform testing.

Chlamydia and Gonorrhea are sexually transmitted diseases that if left untreated, can cause complications that can include infertility, pelvic inflammatory disease, pregnancy complications, and increased risk of HIV acquisition. The current method of GBS testing is a time-consuming process and not cost effective. Chlamydia and Gonorrhea are both test sent to a reference laboratory and take 3-4 days for results. Having the ability to perform these test will improve patient turn-around time care, prevent inappropriate use of antibiotics, along with preventing the spread of diseases in the community due to same day results and faster treatment.

C. Scope of Work SOW for this request will include:

• Cepheid GeneXpert – Continued use of Instrument that is already installed at ZSU.

• Starter Pak requirement for GC/CT and Strep B as a startup for validation of test.

• Vendor will provide the following for purchase of disposable items which include

- CT/NG Collection kits for Urine – 50 pk: COLLECTION KIT,URINE,CE-IVD,CT/NG,50

- CT/NG Cartridge Kits – 120 test per kit: XPERT CT/NG-120 US-IVD

- GBS Cartridge Kits – 10 test per kit : KIT,GBS LB,10-TESTS,GX,IVD

• Vendor allows ordering of reagents on an as needed basis

• Reagent kits shall have long expiration dates and not received expired

• Reagent kits shall be received in good condition, if reagents are received in unacceptable conditions, vendor agrees to replace kit at no cost.

• Reagent Kits shall be shipped in a timely matter with acceptable storage temperature of 2 °C – 28 °C

• Vendor provides easy ordering for Reagents.

• Vendor must be available for technical consultation and provide any product recalls or updates on a timely manner

Period of Performance

Request Base + 2 option years

Start End Base Year TBD/2022 TBD/2023 Option Year #1 TBD/2023 TBD/2024 Option Year #2 TBD/2024 TBD/2025

Place of Performance/Hours of Operation:

Zuni Indian Hospital Laboratory Department Route 301 North B Avenue Zuni, NM 87327

Hours of operation for installation will be M-F from 8:00 AM to 4:00 PM

Point of Contact:

Melinda Banteah – Microbiology Clinical Lab Scientist 505-782-7423 Angela Kanteena – Acting Supervisor – Clinical Lab Scientist 505-782-7421

COR: Angela Kanteena - Angela Kanteena@ihs.gov

Evaluation Factors:

To be considered for award of a contract under this solicitation, the offeror must comply with the following criteria. Failure to provide evidence of the following shall automatically disqualify an offeror from further consideration. The following responsibility factors will be used as a basis for the technical evaluation of offeror’s proposals. The contractor shall meet the technical requirements, possess the required experience and provide Point of Contacts for any government contracts and DUNS number for the following:

1. Technical Factors Each offeror shall include a Technical Approach narrative that details the offeror’s approach toward performing the required service. The narrative shall be specific and clearly demonstrate the Offeror’s understanding of and capability to meet all Government requirements. At minimum, the narrative shall address the following:

a. General Approach: Instrument is capable and delivering test results in accordance to CLIA guidelines.

b. Reagents and Calibrators are received with acceptable methods for testing.

c. Quality control performance are within specific requirements under CLIA guidelines.

d. Calls made to Vendor for troubleshooting equipment or reagents are done with out delays or interruptions of services.

e. Notification of any recalls or methods changes are communicated on a timely manner.

2. Timeliness and Scheduling’

a) Each Offeror must have ability deliver reagents and consumable on a timely basis.

b) Supplies received must be complete and have documentation provided for products received

3. Price

a) Fair and reasonable

b) Cost is accurate and timeliness on invoicing