Werfen final redacted_Redacted SSJ.pdf

DEPARTMENT HEALTH AGENCY

SOUTHEASTERN MARKEST CONTRACTING DIVISION

808 SCHREIDER STREET

FORT DETRICK, MD 21702

06 FEB 2024

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION SOLE

SOUCE JUSTIFICATION

I. CONTRACTING ACTIVITY

a. Requiring Activity: Naval Medical Center Camp Lejeune, NC Laboratory Department

100 Brewster Blvd.

Camp Lejeune, NC 28547

b. Procuring Activity: DHA Southeastern Markets Contracting Division 808 Schreider Street Fort Detrick, MD 21702

c. Purchase Request Number:

II. NATURE AND/OR DESCRIPTION OF THE ACTION BEING PROCESSED

The proposed action is the award of a service contract on a sole source basis for fully automated coagulation analyzers with consumable reagents, computer, monitor, software, printers and other required hardware necessary for full operation of the following test menu: Prothrombin Time, Activated Partial Thrombin Time, Fibrinogen, D-Dimer and Anti-Xa (LMWH and UFH) at Naval Medical Center Camp Lejeune (NMCCL), NC. The Government intends on awarding a Firm, Fixed-Price (FFP) contract. The proposed source is Werfen USA, LLC. (Werfen) (Cage Code:

22270), 180 Hartwell Rd, Bedford, MA 01730, United States of America.

The Contracting Officer and Contract Specialist with the Defense Health Agency (DHA)- Southeastern Healthcare Operation Division received this requirement during an internal transition November 2023. A complete package was received 13 February 2024. Werfen is the only contractor that can have the analyzers installed, calibrated and hospital staff trained on the operation of the analyze by the required delivery date. The installation and start up procedures can take up to several months to complete. Therefore, in order to avoid a lapse in service and support that would cause patient safety concerns for NMCCL a one (1) year sole source contract is needed to ensure these critical services continue while the full and open competitive action is awarded. Due to the timing of services being requested, partly due to the internal transition of workload at DHA; there is not enough time to procure a competitive award and have the equipment install and operational by 01 April 2024. Before completion of this contract's period of performance, the Contract Specialist will ensure the Government procures a competitive acquisition.

The current contract expires on 31 March 2024.

NMCCL FY24 Operation and Maintenance funds, in the amount of , will be used to fund the base year of this contract.

III. DESCRIPTION OF THE SUPPLIES/SERVICES REQUIRED

NMCCL has a requirement for a service contract for fully automated coagulation analyzers with consumable reagents, computer, monitor, software, printers and other required hardware necessary for full operation of the following test menu: Prothrombin Time, Activated Partial Thrombin Time, Fibrinogen, D-Dimer and Anti-Xa (LMWH and UFH).

IV. STATUTORY AUTHORITY

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.

V. APPLICABILITY OF AUTHORITY

Other supply cost per reportable result offered through GSA did not meet the requirements in accordance with the PWS. Werfen is the only contractor that can have the analyzers installed, calibrated and hospital staff trained on the operation of the analyzer by the required delivery date.

A small business set-aside determination is not appropriate for this acquisition, such determination is supported in this document. This requirement is sole source one (1) year contract to mitigate a lapse in service to support the mission. A lapse in service would impact patient care severely enough to necessitate shutting down inpatient services within the hospital. Sole source procurement to Werfen is recommended. The PALT for an open market procurement usually takes up to 9 months, including time to allow a potential new awardee to become fully operational, including the logistical process of creating, delivering, and installing the equipment.

VI. EFFORTS TO OBTAIN COMPETITION

At this time the sole source for Werfen USA, LLC is due to maintaining the current analyzers owned by this company and they are the sole manufacturers and distributors of the required consumables needed to perform patient testing at NMCCL. A Notice of Intent to sole source will be posted for 15 days on SAM.gov.

VII. ACTIONS TO INCREASE COMPETITION

A full and open competitive multi-year solicitation shall be prepared, solicitated, awarded and executed within the acquisition guidelines and the laboratory accreditation requirements. A lease vs purchase analysis was conducted for the original five-year solicitation and for the new multi-year solicitation and it was determined that a cost per test or cost per reportable award was more economical than purchasing the equipment and the consumables separately.

VIII. MARKET RESEARCH

The market research has concluded the requested supplies are available on the federal supply schedule under in the cost per reportable format that we are requesting. There are no other authorized distributors of Werfen consumable products. There were distributors found for the instrumentation in a refurbished statues but that does not meet the requirement needed of maintaining current instrumentation on a cost per test or cost per reportable status.

IX. OTHER FACTS

X. TECHNICAL/REQUIREMENTS PERSONNEL CERTIFICATION

I certify that any supporting data contained herein under my cognizant responsibility, which forms a basis for this justification, is both accurate and complete.

Requiring Activity:

XI. CONTRACTING OFFICER’S CERTIFICATION

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

Contracting Officer