SSJ Stago - Eglin Coagulation Analyzer - Redacted.pdf

Controlled Unclassified Information - Source Selection Information – See FAR 2.101 and 3.104

Controlled Unclassified Information - Source Selection Information – See FAR 2.101 and 3.104

(November 18, 2024)

Justification for Soliciting from a Single Source Federal Acquisition Regulation (FAR) Subpart 8.405-6(a)(1)(i)(B) – Only one source capable of providing the supplies/services required at the level of quality required because the supplies/services are unique and highly specialized.

1. Identification of the agency and contracting activity: The Defense Health Agency (DHA), Healthcare Contracting Division - South (HCD-S).

2. Nature and/or Description of Action being approved: HCD-S intends to negotiate and award a new, firm fixed price order on a sole source basis to Diagnostica Stago Inc., Five Century Drive, Parsippany, NJ 07054, for the purchase of leasing two (2) Stago Compact Max 3 analyzers, supply of reagents/consumables on a scheduled drop-ship basis and service and support for the analyzers. The laboratory currently uses Diagnostica Stago Compact Max 2 analyzers under task order FA2823-20-F-0128. The task order period of performance ends on 31 January 2025.

3. Description of Supplies/Services required to meet the agency’s needs: The 96th Medical Group at the Eglin Hospital laboratory department is seeking lease of two (2) Diagnostica Stago Compact Max 3 analyzers, capable of performing a maximum of 3500 PT assays, 3000 PTT and aPTT assays, 600 D-dimer assays, 250 Fibrinogen assays, and 150 Heparin assays annually. The contractor shall provide all, equipment, installation, training, maintenance, supplies (including all reagents, calibrators, consumable parts, software upgrades and accessories), and non -personal services necessary to deliver, install, and maintain the analyzers as defined in the PWS necessary for a table-top clinical coagulation analyzer. Services required include 2 table-top analyzers, each no larger than 68” width, 36” high, 34” deep, including the operating system. Additionally, the instrument must have a valid, or ability to obtain, the DoD Information Assurance Certification and Accreditation Process (ATO-ATC or DHA RMS), ability to connect to the GENESIS Health Care System, and approval by the Food and Drug Administration. This justification is written to procure these supplies with a total estimated amount of Period of performance starts 1 February 2025 to 31 January 2026, with four (4) option periods.

4. This acquisition is conducted under the authority of FAR 8.405-6(a)(1)(i)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized.

5. Rationale Justifying Use of the Regulatory Authority Cited:

Diagnostica Stago is the only U.S. based company research has shown that offers a Viscosity- Based (Mechanical) Detection System, as opposed to the optical based systems readily available.

This system consistently delivers accurate results immediately. There is exclusive technology standardized on all Stago systems, insensitive to analytical interferences from haemolysis, icteric and lipemic samples for clotting assays, maximum precision for weak clot detection. It also has maximum precision for weak clot detection. With the other available technology, photo optical

Controlled Unclassified Information - Source Selection Information – See FAR 2.101 and 3.104 method, erroneously prolonged coagulation studies can occur with any sample turbidity, leading to inaccurate patient results. These specifications, including higher accuracy and lower analytical inferences are required for the services to meet MTF’s mission requirements.

Stago Compact Max 3 analyzers function the same way as the current Stago Compact Max 2 analyzers. This will allow for sustained operations without the need for training of technicians, versus having to utilize resources and time to train all technicians.

6. Anticipated cost to the Government will be fair and reasonable: Price analysis techniques, outlined in FAR 15.404-1(b), will be conducted to ensure the Government receives fair and reasonable prices in accordance with FAR 8.404(d). Additionally, IAW FAR 8.405-3, discounts will be sought prior to the establishment of the order.

7. Description of the market research conducted among schedule holders and the results, or a statement of the reason market research was not conducted:

Market research was conducted by reviewing mandatory sources, suggested sources, past historical data and SAM.gov. No sources, other than the Diagnostica Stago coagulation analyzers, were found that could meet the Government’s requirement of a viscosity-based detection system. During market research, it was discovered that Diagnostica Stago has a FSS schedule (36F9718D0351) with the Department of Veteran’s Affairs that can meet the Government’s needs.

A review of the DHA Systems CSTAR Website, found the Diagnostica Stago Compact Max analyzers have an active ATO for Eglin AFB through 24 May 2026. Additionally, CSTAR listed five coagulation analyzers produced by Werfen (ACL TOP 350, ACL TOP 550, ACL TOP 750, ACL TOP 750 CTS, ACL TOP 750) and two analyzers produced by Siemens Healthineers (Sysmex CS 2500, Sysmex CS 5100) with active ATOs. A review of the Werfen and Siemens Healthineers Coagulation specifications shows the analyzers are optical based and do not have viscosity-based detection. A review of the College of American Pathologists CAP today publication lists coagulation analyzers produced by Diagnostica Stago, Werfen, Chrono-log Corp., Bio/Data Corp, HemoSonics LLC, LABiTEc Labor BioMedical Technologies and Siemens Healthineers. All but Diagnostica Stago use the optical based technology. Diagnostica Stago was the only provider using viscosity-based detection.

9. Efforts to Obtain Competition.

The 96th Medical Group at the Eglin Hospital laboratory and the DHA HCD-S will continue to survey and engage the market of any potential vendors that can provide viscosity-based detection coagulation analyzers and will consider competing future requirement if there are other vendors capable of meeting the requirements. In addition, review and due diligence will be conducted by the Government for any vendor submitting capability statements for coagulation analyzers, reagents, and consumables.

Controlled Unclassified Information - Source Selection Information – See FAR 2.101 and 3.104

COORDINATION:

10. Technical/Functional Representative: & Requirements Certification

I certify that the information provided in this justification, is accurate and complete to the best of my knowledge and belief.

11. Legal Review:

I have reviewed this justification and have no legal objections. (Note: All J&A’s must be reviewed by Office of General Counsel (OGC)/Legal Review.)

APPROVAL:

12. Contracting Officer: I certify that this justification is accurate and complete to the best of my knowledge and belief.