NOI Coag Analyzers.docx

The Defense Health Agency intends to award a sole source contract under the authority of 41 U.S.C. 1901, to Dasit Spa La Fata, Via Merendi 22, Cornaredo 20010 for the performance of the described requirement in support of the Naval Medical Center Portsmouth, Virginia. The requirement intends to provide coagulation analyzer, identical back-up analyzer, reagents and consumables at the U.S. Naval Hospital Naples, Italy.

USNH Naples requires consistent and uninterrupted capability to perform routine and STAT coagulation studies. To meet this mission-critical need, a reliable, fully automated analyzer system supported by a comprehensive service and supply agreement is necessary. The lease agreement shall include full-risk maintenance, staff training, and quality support services. The ultimate goal is to ensure maximum operational uptime and diagnostic accuracy for the required coagulation test menu.

The contractor shall provide one (1) primary analyzer system and one (1) back-up analyzer system (identical to the primary analyzer system) as described below:

Primary Analyzer System The contractor shall provide one (1) new, fully automated coagulation analyzer that meets the following minimum 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: Must be virtually maintenance-free, with no routine user maintenance of internal components.

· Test Menu: The primary analyzer system must be capable of performing, at a minimum, the following tests:

· Prothrombin Time / International Normalized Ratio (PT/INR)

· Activated Partial Thromboplastin Time (aPTT)

· Fibrinogen

· D-Dimer

Technical Requirements:

The Coagulation Analyzer Instrument must:

1) Utilize sample cup technology that keeps precision in evaluation and analyses of coagulation profiles.

2) Minimize interference from hemolysis, lipedema, and bilirubin

3) Have a throughput of up to 100 results per hour, with 40 plus on-board coagulation testing.

4) Provide customized patient reports and the option for positive patient identification, facilitating Laboratory Information System (LIS) interfacing capability.

5) Facilitate sorting, managing, and manipulating of patient reports up to 5,000.

6) Be able to interface with the existing Laboratory Information System (LIS) and MHS Genesis.

7) On-site maintenance services must be performed from 8:00 am to 4:00 pm local time, Monday through Friday, excluding holidays.

8) Any emergency service should be scheduled by the next business day after notification to the contractor is given.

9) Preventative Maintenance (PM) per manufacturer’s specifications including travel, labor, and non-consumable parts.

10) On-site training provided annually as necessary and at no extra cost to the Government.

11) Perform correlation, precision, linearity and all other studies required during installation of system.

12) The manufacturer Lot Numbers need to be identical for each batch of reagents.

13) All products MUST be covered by the Application Support Service and Testing in order to cover any post sale products failure and issues. If any problem occurs with the products, a Product Specialist is required on-site to fix the problem and/or replace the product immediately and no later than eight (8) working hours after the product service call is opened.

14) Shall have the capability to process tests manually, STAT, and automatic.

15) Shall be capable of processing the primary tube with a positive sample identification system (PSID via barcode reader).

The contractor will be required to enroll USNH Naples in a recognized External Quality Assessment (EQA) Program for Hemostasis testing (e.g., CAP or equivalent) as part of the service agreement.

The contractor shall provide all reagents, calibrators, quality control materials, and consumables required to perform the specified test menu. The quantities must be sufficient to support the operational, calibration, and quality control requirements for both the primary and backup analyzers. Supplies shall be delivered on a quarterly basis according to a mutually agreed-upon schedule.

The contractor shall provide consumables which include calibrators, reagent, quality controls and materials to perform daily, weekly, monthly, quarterly and annual maintenance to perform annually:

Consumables:

Prothrombin Time (PT)/INR: 600 tests Activated Partial Thromboplastin Time (aPTT): 600 tests D-Dimer: 300 tests Fibrinogen: 150 tests

Number of consumables should also account for performing QC every eight (8) hours which accounts for approximately 1,080 runs per year. The amount must put into account a buffer of 10-15% extra to account for QC failures and troubleshooting 1,188 – 1,242 runs.

All reagents and supplies must be FDA-compliant and meet all USNH Laboratory quality control standards for the specified equipment.

The analyzers must interface with MHS Genesis.

All items must be refrigerated. Due to the fragility of the products, minimum handling is suggested. The manufacturer’s lot numbers shall be identical for each batch of reagents and controls delivered each quarter throughout the year.

The contractor is responsible for the de-installation and removal of current equipment and installation and set-up of the new equipment.

Both analyzers must fit in a 213 cm x 88 cm space.

The contractor must adhere to the following mandatory requirements for all deliveries:

• All refrigerated items must arrive at the delivery site within a temperature range of 2 – 10 degrees Celsius.

• The Contractor shall replace, at no cost to the Government, any products that fail to meet the specified temperature criteria upon receipt.

The analyzers shall operate at an electrical voltage of 220V.

The contractor shall provide a "full-risk" maintenance contract, inclusive of all parts, labor, and travel, for the duration of the contract.

· Preventive Maintenance: The contractor shall perform all manufacturer-recommended preventive maintenance at scheduled intervals.

· Emergency Repair and After-Hours Support:

· Availability: The contractor shall provide (via an English-speaking service technician) a method for placing emergency service calls 24 hours per day, 7 days per week, 365 days per year (24/7/365), including all U.S. Federal and local Italian holidays which includes:

Epiphany: 06 January Easter Sunday: Day Varies Easter Monday: Day after easter Sunday Liberation Day: 25 April Labor Day: 01 May Republic Day: 02 June Assumption of May: 15 August All Saints Day: 01 November Immaculate Conception: 08 December St. Stephens Day: 26 December

· Initial Response: A qualified technician must provide an initial telephonic or remote response to begin troubleshooting within two (2) hours of an emergency service call being placed.

· On-Site Response: If the issue cannot be resolved remotely, a qualified Field Service Engineer must arrive on-site at USNH Naples within 48 hours of the initial service call placement.

· Cost: All after-hours, weekend, and holiday service, including all associated travel, labor, and parts, shall be included in the contract price at no additional cost to the Government.

· Application Support: The contractor shall provide ongoing application support services for all products and test procedures.

On-site operator training shall be provided upon installation and annually thereafter for all designated laboratory personnel.

The contractor must be able to obtain an Authorization to Operate (ATO) for the analyzer systems.

The period of performance for this contract is anticipated to be twelve (12) months.

This notice of intent is not a request for competitive proposals and no solicitation document exists for the requirement. Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data and cost information, in sufficient detail and with convincing evidence that clearly demonstrates the capability to perform the required work. Capability statements shall not exceed 1 (8.5 x 11 inch) page using a font size no smaller than 10-point. All capability statements received by the due date of this notice will be considered by the Government. A request for documentation or additional information will not be considered as an affirmative response. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source contract.

Capability statements are due by 1:00 PM Eastern Time, 19 June 2026. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following address: laura.l.powers10.civ@health.mil