SOW VITROS SUPPLIES IDIQ - DRAFT.docx

Department of Defense Defense Health Agency Statement of Work

IDIQ VITROS SUPPLIES

04 JUNE 2026

U.S. NMRTC SIGONELLA

1.0 GENERAL INFORMATION

1.1 This is a non-personal Indefinite Delivery, Indefinite Quantity (IDIQ) supply contract to provide materials necessary for USNH Sigonella Laboratory’s two Vitros 7600 chemistry and immunochemistry analyzers.

1.1.1 Description of supplies/services/introduction: The requirement is for materials necessary for USNH Sigonella Laboratory’s two Vitros 7600 chemistry and immunochemistry analyzers. These supplies are used to perform critical care testing including cardiac markers, liver enzymes, kidney function and BHCG testing needed for emergent patient care and essential to hospital operation. Given the critical nature of the testing performed and that the products required strict temperature control, a local supplier is required to ensure product integrity. For this reason, an IDIQ Contract for 5 years is required. The estimated annual requirement for supplies and consumables required for the analyzers are listed below:

Estradiol Reagent

FSH Reagent

1.1.2 Background: The requirement is for a Indefinite Delivery, Indefinite Quantity (IDIQ) contract to provide materials necessary for USNH Sigonella Laboratory’s two Vitros 7600 chemistry and immunochemistry analyzers. These supplies are used to perform critical care testing including cardiac markers, liver enzymes, kidney function and BHCG testing needed for emergent patient care and essential to hospital operation. Given the critical nature of the testing performed and that the products required strict temperature control, a local supplier is required to ensure product integrity. Previous attempts at procuring these products via mandatory sources have been highly unsuccessful as not all products were available, products came in out of temperature and without lot sequestration.

1.1.3 Scope: The contractor shall materials necessary for USNH Sigonella Laboratory’s two Vitros XT7600 chemistry and immunochemistry analyzers.

1.1.4 Ordering Period: 01 September 2026 – 30 September 2031

1.2 Administrative specifications

1.2.1 Delivery Site: The Contractor shall deliver the supplies to the following address:

U.S. NMRTC Sigonella – NAS 1 Strada Statale 192 KM 15 Catania-Enna Sigonella, Sicily (Italy)

1.2.2 Delivery Schedule: For deliveries, the regular working hours of the U.S Government are 0830-1300 Monday through Friday, excluding holidays.

1.2.3 Recognized Italian holidays: Deliveries are not required on holidays.

Republic Day

1.3 Contractor Identification

1.3.1 The Contractor shall submit the required information to complete the U.S. NMRTC Sigonella Security Pass and ID form and get a base pass. Contractor personnel performing services in a contractor capacity in a government facility are required to possess and wear an identification badge that displays his or her name and the name of their company. Ensure all those with whom the person interacts in any face-to-face dealings while supporting the Government understands that the person is contractor support personnel.

2.0 SPECIFIC TASKS

2.1 The contractor must be able to schedule deliveries within 4 days of order placed by the laboratory department. Orders will be placed via email or phone on a need basis.

2.2 The items include frozen, refrigerated, and ambient temperature supplies which must be shipped and received at the required temperature. Below are required temperatures for items:

-18 degrees Celsius, this includes most chemistry slides and controls

- 2 to 8 degrees Celsius, this includes most immunochemistry reagents and calibrators

- Ambient temperature, this includes consumables such as filters and probes

2.3 Due to the fragility of the products, minimum handling is required.

2.4 The manufacturer lot numbers shall be identical for each batch of reagents; lot sequestration is required.

2.5 The minimum shelf life of all items at the time of acceptance by the U.S. Government is six months.

2.6 The supplier must be able to deliver within 4 days of request.

2.7 The contractor must have technical support specialists available for assistance during regular working hours.

2.8 Items provided must be FDA approved.

2.9 Validation of New Tests:

· For new tests added, contractors must perform on-site instrument validation including precision testing, linearity, carryover, correlation and sensitivity studies on both analyzers per U.S NMRTC Sigonella established protocol.

· Contractor must have Technical Support Specialists to assist in method verification studies, including the review of the protocol, sample requirements, and data analysis. Said method verification studies shall complete the necessary verifications required by CLIA and CAP regulatory agencies.

2.10 Invoices will be submitted and paid utilizing the Wide Area Workflow (WAWF) website.

3.0 POINTS OF CONTACT

3.1 Points of Contact:

TPOC - NMRTC Sigonella Laboratory Department Michela Mignosa Phone: +39 095564677 E-mail: michelina.mignosa.ln@health.mil image1.png