SOW VITROS SUPPLIES IDIQ - Final.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:

LIST of Required Supplies

Estradiol Reagent

FSH Reagent

1.1.2 Background: The requirement is for an 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 Periods:

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 understand that the person is contractor support personnel.

1.4 Start-Up Period

It is intended to make award of the resultant contract in time to allow up to fifteen (15) days start-up period in advance of the actual commencement of the performance period. The contractor shall make all necessary preparations, during this start-up period, to assume full responsibility for contract performance as of the contract start date. It is noted that invoices by the contractor will begin as of the commencement of supplies delivered and no reimbursement will be paid by the Government for efforts expended during the start-up period.

1.5 Task Orders

1.5.1 Task orders may be placed by any warranted contracting officer serving at the Defense Health Agency.

1.5.2 Task orders against this contract may be placed by mail, facsimile, or through electronic commerce, including email in accordance with the terms and conditions of the contract.

1.5.3 The period of performance of any task order shall be one year or less in duration.

2.0 SPECIFIC TASKS

2.1 The contractor must be able to delivery supplies 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, 0830-1300 (CET) Monday through Friday, excluding holidays.

2.8 Items provided must be FDA approved.

2.9 Validation of New Tests:

(a) 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.

(b) Contractors 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 Ordering Terms

Pursuant to FAR 16.5, the Contractor agrees to the following terms of the proposed Indefinite Delivery Indefinite Quantity (IDIQ) Firm Fixed Price (FFP) contract exclusively with the Defense Health Agency (DHA).

Exact item descriptions available through this IDIQ FFP contract are specified within the SOW, List of Required Supplies. Exact quantities and delivery requirements are not known in advance and may vary considerably per order. All delivery orders placed against this IDIQ FFP contract are subject to the terms and conditions set forth within or as noted below:

3.1. In accordance with FAR 16.505(a)(6), orders placed under indefinite delivery contracts must contain the following information:

(i) Date of order

(ii) Contract number and order number (iii)For supplies and services, contract item number and description, quantity, and unit price or estimated cost or fee

(iv) Delivery or performance schedule

(v) Place of delivery or performance (including consignee)

(vi) Any packaging, packing, and shipping instructions

(vii) Accounting and appropriation data

(viii) Method of payment and payment office, if not specified in the contract (see FAR 32.1110 (e)).

3.2. Special clauses shall be included, when required, on a delivery order basis and agreed to with contractor.

3.3. Warranty Terms: All products shall be covered by the standard commercial warranty of the contractor.

3.4. Delivery and Mark For Terms: Delivery shall be F.O.B. Destination within the continental United States, or as stated in each order. The Mark For Instructions shall be included in each order.

3.5. This IDIQ FFP contract does not obligate any funds. The Government is obligated only to the extent that an authorized delivery order is issued, while also meeting the minimum quantity as state within this IDIQ FFP.

3.6. This IDIQ FFP contract expires 30 September 2031, unless terminated in accordance with FAR 52.212-4.

3.7. The following office is hereby authorized to place delivery orders under this IDIQ FFP contract:

Defense Health Agency Contracting Office 7700 Arlington Blvd Falls Church, VA 22042

3.8. Maximum Order Limitations:

a. Maximum Order Limitation: The total ordering limit for all delivery orders under this IDIQ over the period of performance is $------ (will be added upon award). This IDIQ has a $1000 guaranteed minimum per FAR 16.504.

3.9. Delivery orders shall be placed against this IDIQ contract via electronic mail, facsimile, or paper.

3.10. Invoicing and Shipping Instructions – The following invoicing instructions will appear on each delivery order:

a. The delivery order written from this IDIQ FFP contract will be paid via Wide Area Workflow (WAWF). See each delivery order for invoicing.

b. Important Payment Information: In accordance with FAR Clause 52.232-25, entitled “Prompt Payment”, the contractor shall provide evidence of shipment with their invoice in order for the invoice to be considered proper. The evidence of shipment must include the signature of a Government representative authorized to sign and accept the delivery. Invoices submitted without evidence of shipment shall be considered to be improper within the meaning of FAR 52.232-25 and will be returned for correction and resubmittal.

4.0 POINTS OF CONTACT

4.1 Points of Contact:

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

AUTHORIZED CHANGES ONLY BY THE CONTRACTING OFFICER

a. Except as specified in paragraph (b) below, no order, statement, or conduct of Government personnel who visit the contractor’s facilities or in any other manner communicates with contractor personnel during the performance of this contract shall constitute a change under the “Changes” clause of this contract.

b. The contractor shall not comply with any order, direction, or request of Government personnel unless it is issued in writing and signed by the Contracting Officer or is pursuant to specific authority otherwise included as part of this contract.

c. The Contracting Officer is the only person authorized to approve changes in any of the requirements of this contract and notwithstanding provisions contained elsewhere in this contract, the said authority remains solely the Contracting Officer’s. In the event the contractor effects any changes at the direction of any person other than the Contracting Officer, the change will be considered to have been made without authority, and no adjustment will be made in the contract price to cover any increase in charges incurred as a result thereof.

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