Coagulation Analyzers at USNH Naples

Background
The Defense Health Agency intends to award a sole source contract to Dasit Spa La Fata, located at Via Merendi 22, Cornaredo 20010, for the provision of coagulation analyzers and related services in support of the Naval Medical Center Portsmouth, Virginia.

This contract aims to ensure that the U.S. Naval Hospital Naples, Italy has the capability to perform routine and STAT coagulation studies consistently and without interruption. The goal is to provide a reliable, fully automated analyzer system supported by a comprehensive service and supply agreement, ensuring maximum operational uptime and diagnostic accuracy.

Work Details
The contractor shall provide one (1) primary coagulation analyzer system and one (1) identical back-up analyzer system with the following specifications:
- **Automation**: Fully automated sample processing.
- **Access**: Random and STAT access capabilities.
- **Functionality**: Features on-board dilutions.
- **Volume**: Suitable for a mid-volume laboratory performing routine coagulation analysis.
- **Maintenance**: Virtually maintenance-free with no routine user maintenance of internal components.
- **Test Menu**: Must perform at least the following tests:
- Prothrombin Time / International Normalized Ratio (PT/INR)
- Activated Partial Thromboplastin Time (aPTT)
- Fibrinogen
- D-Dimer

Additional requirements include:
- Throughput of up to 100 results per hour with over 40 on-board coagulation tests.
- Customized patient reports with Laboratory Information System (LIS) interfacing capability.
- On-site maintenance services from 8:00 am to 4:00 pm local time, Monday through Friday.
- Provision of all reagents, calibrators, quality control materials, and consumables for both analyzers on a quarterly basis. Specific consumable quantities include:
- Prothrombin Time (PT)/INR: 600 tests
- Activated Partial Thromboplastin Time (aPTT): 600 tests
- D-Dimer: 300 tests
- Fibrinogen: 150 tests
- All products must be FDA-compliant and meet USNH Laboratory quality control standards.

Period of Performance
The anticipated period of performance for this contract is twelve (12) months.

Place of Performance
U.S. Naval Hospital Naples, Italy.

Bidder Requirements
The contractor must be able to obtain an Authorization to Operate (ATO) for the analyzer systems. All reagents and supplies must be FDA-compliant. The contractor is responsible for de-installation of current equipment and installation of new equipment. Emergency service calls must be available 24/7/365 with specific response times outlined.