Attachment-1-SOW-Checklist.xlsx
XLSX spreadsheet 12 KB Posted
- Solicitation number
- HT940626QE091
- Issued by
-
Defense Health Agency
About this file
This is a Statement of Work (SOW) checklist for an Indefinite Delivery, Indefinite Quantity (IDIQ) Firm Fixed Price supply contract for chemistry analyzer supplies at U.S. Naval Hospital Sigonella. The Defense Health Agency is procuring materials necessary to support two Vitros 7600 chemistry and immunochemistry analyzers used for critical care testing including cardiac markers, liver enzymes, kidney function, and BHCG testing. The contract will run from September 1, 2026 through September 30, 2031 with an optional six-month extension period.
Key operational requirements include: delivery within four days of order placement via email or phone; proper temperature-controlled shipping and storage at three specified temperature ranges (18°C, 2-8°C, and ambient); minimum six-month shelf life at time of acceptance; identical manufacturer lot numbers for each batch with lot sequestration; FDA approval for all items; and technical support availability during regular working hours (0830-1300 CET Monday-Friday). For new tests added to the contract, contractors must perform on-site instrument validation including precision testing, linearity, carryover, correlation and sensitivity studies on both analyzers per established protocol, with technical support for method verification studies to meet CLIA and CAP regulatory requirements. Payment will be processed through the Wide Area Workflow (WAWF) website. This IDIQ FFP contract does not obligate any funds; the Government is obligated only upon issuance of authorized delivery orders while meeting minimum quantity requirements. The Defense Health Agency Contracting Activity is authorized to place delivery orders under this contract.
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Other files
| File | Type | Posted |
|---|---|---|
| Quality Assurance Surveillance Plan.docx | DOCX document | |
| HT940626QE091.pdf | ||
| Unit Pricing Sheet (Euros).docx | DOCX document | |
| SOW VITROS SUPPLIES IDIQ - Final.docx | DOCX document |
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Text version
MEC Checklist
| Attachment 1 - SOW Checklist | ||||||
| RFQ #: | RFQ1787669 | |||||
| Number | Document | PWS Section | Description | Offeror Confirms the PWS Section Can be Met (Answer "YES" or "NO" | Comments: If the vendor cannot meet the SOW section please explain why in this column. | |
| 1 | SOW | 1.1.1 | The proposed action is for a Indefinite Delivery, Indefinite Quantity (IDIQ) contract 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. | |||
| 2 | SOW | 1.1.4 | Ordering Period: 01 September 2026 – 30 September 2031 | |||
| 3 | SOW | 1.1.4.1 | Number of Option Periods: Optional 6 month extension | |||
| 4 | SOW | 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. | |||
| 5 | SOW | 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: (1) 18 degrees Celsius, (2) 2 to 8 degrees Celsius, and (3) Ambient temperature | |||
| 6 | SOW | 2.4 | The manufacturer lot numbers shall be identical for each batch of reagents; lot sequestration is required | |||
| 7 | SOW | 2.5 | The minimum shelf life of all items at the time of acceptance by the U.S. Government is six months. | |||
| 8 | SOW | 2.7 | The contractor must have technical support specialists available for assistance during regular | |||
| working hours, 0830-1300 (CET) Monday through Friday, excluding holidays. | ||||||
| 9 | SOW | 2.8 | Items provided must be FDA approved. | |||
| 10 | SOW | 2.9 | Validation of Tests | |||
| 11 | SOW | 2.9 (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. | |||
| 12 | SOW | 2.9 (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. | |||
| 13 | SOW | 2.10 | Invoices will be submitted and paid utilizing the Wide Area Workflow (WAWF) website. | |||
| 14 | SOW | 3.0 | 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. | |||
| 15 | SOW | 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. | |||
| 16 | SOW | 3.7 | The following office is hereby authorized to place delivery orders under this IDIQ FFP contract: Defense Health Agency Contracting Activity. |
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