Intent to Sole Source Coagulation Analyzer System

INTENT TO SOLE SOURCE

The Airforce Life Cycle Management Center (AFLCMC/PZIBA) intends to award a sole-source, firm-fixed-price contract to Werfen USA LLC, located at 180 Hartwell RD, Bedford, Massachusetts 01730, United States. This proposed action is for the acquisition of Automated Coagulation Analyzer Systems for the 88th Medical Center at Wright-Patterson Airforce Base (WPAFB).

The Government intends to solicit and negotiate with only one source under the authority of RFO 6.103-1, “One responsible source. Agencies may contract without providing for full and open competition when the supplies or services required by the agency are available from only one responsible source and no other type of supplies or services will satisfy agency requirements.” The reason for lack of competition is as follows: Werfen is the sole-source provider and direct servicer of ACL TOP analyzers in the United States, with no authorized distributors. A Sources Sought on SAM.gov (FA860126Q0136SS) yielded one respondent which was deemed technically unacceptable for lacking direct Sarstedt tube compatibility, missing required 671 nm wavelength technology, and requiring extensive laboratory information system (LIS) integration and manual rewrites that risk critical patient care amid staffing shortages. Standardizing on Werfen eliminates technician retraining, avoids hospital-wide tube replacement, prevents costly sample re-draws via 671 nm HIL interference screening, offers ready-to-use reagents with fastest turnaround time, and ensures seamless LIS continuity. The Contracting Officer has determined that only one source is reasonably available: Werfen USA LLC.

This proposed procurement will be a Sole Source under North American Industry Classification System code (NAICS) 325412 – Pharmaceutical Preparation Manufacturing, with a size standard of 1300 employees.

The proposed source is Werfen USA LLC, 180 Hartwell RD. Bedford, Massachusetts 01730, United States.

This notice of intent is not a request for competitive quotations. However, all responsible sources may submit a capability statement, proposal, quotation, or exception to the intent to purchase on a sole source basis, which shall be considered by the Government if received within seven (7) days of this notice. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.

The Department of Defense (DoD) has determined the System for Award Management (SAM) to be the single DoD registration for contractors who conduct business or who are interested in conducting business with the DoD. Contractors must be registered in SAM prior to award for contracts issued after 29 May 2012. You may contact SAM at 866-606-8220. SAM website: www.SAM.gov.

The contact for this acquisition is Claire Hess and Dametria Walder. Any information should be e-mailed to claire.hess@us.af.mil and dametria.walder@us.af.mil no later than 1:00 pm Local (Wright-Patterson AFB) Time, Wednesday, 09 September 2026. Only inquiries/information received by this date will be considered.

Be advised that all correspondence sent via e-mail shall contain a subject line that reads “FA860126Q0136 Automated Coagulation Analyzer System.” Note that e-mail filters at Wright-Patterson AFB are designed to filter e-mails without subject lines or with suspicious subject lines or contents (i.e., .exe, or .zip files). Therefore, if this subject line is not included, the e-mail may not get through the e-mail filters. Also, be advised that .zip or .exe files are not allowable attachments and may be deleted by the e-mail filters at Wright-Patterson AFB. If sending attachments with e-mail ensure only .PDF, .doc, or .xls documents are sent. The e-mail filter may delete any other form of attachments.

Attachments:

1. Statement of Work


2. Redacted Sole Source Justification