Single_Source_Justification_HEMATOLOGY_SYSTEMS.pdf

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Single Source Justification (Simplified Acquisition)

Security Marking (select from the drop-down list) March 2018 Page 1 of 2

Is this aBridge Action as defined in the AFBridge ActionReduction Plan? Yes No

Contracting Activity: 31CONS/LGCB

Project/Program Name: Beckman Coulter/2EA TN, DXH 600HEMATOLOGYSYSTEM.S/N AZ03633 AND AZ18754 Instance number 21787277and 25264392

The services includes preventive maintenance based on the manufacturer's annual schedule, all mechanical and electromechanical parts, labor, travel cost, per diem expenses for the technician, emergency calls and materials which are in contract with the current reagents, maintenance kits, calibration, and all parts which need replacement periodically during normal preventive maintenance performance or emergency repair.

(A) ACTION: Request approval to award a sole source contract to UNIMED s.r.l. Pordenone Italy. For a preventive maintenance contract for 2 EA TN, DXH 600 HEMATOLOGY SYSTEM. S/N AZ03633 AND AZ18754 Instance number 21787277 and 25264392 equipment associated with the 31 Medical Group Laboratory Department.

10 U.S.C. 2304(c)(1), as implemented by FAR 6.302-1(a)(2)(iii)(A&B), Only One Responsible Source and No Other Supplies or Services will Satisfy Agency Requirements. The Hematology system at Aviano Air base medical clinic is manufactured by Unimed, and according to U.S. Food and Drug Administration (FDA) Code of Federal Regulations (CFR) 42 - Section 493.1254 Standard:

Maintenance and Function Checks state, "Function checks must be within the manufacturer's established limits before patient testing is conducted."Due to the unique nature of Unimed blood Hematology system and the necessity to maintain updated engineering revisions for the machine only one responsible source will satisfy the Agency requirement. Unimed SRL is the only authorized representative of Beckman Coulter in the Friuli region to repair and maintain Beckman equipment., at 31 MDG, Aviano Air Base, Italy.

CONTRACTOR OR PRODUCT UNIQUE QUALIFICATIONS: UNIMED srl is the sole provider for the 31 MDG, Hematology system. Noncompetitors sell the same model, only UNIMED can provide spare parts for Beckman Coulter and install in the Hematology to work in Laboratory Department, and provide OEM parts for required schedule service and unscheduled service

Search for alternate sources wasconducted via Internet search engines, no othersources provide theability to provide services, required scheduled maintenance and technical support that is required.Contacted Unimed,the manufacturer of the equipment to inquire the possibility of an authorized third party contractors that may beable to provide theservices required.The representativestated that thereare no other known authorized reseller of theservices that the 31st MDGrequires.Replacing the current system by purchasing new equipment cannot be justified due to theadditional costs that would be incurred with such

Section A: General Contract Information

SectionB: Description of theSupplies/ServicesRequired

SectionC: Justification for Soliciting from a Single Source or Brand Name

Section D: Effortsto Obtain Competition

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Single Source Justification (Simplified Acquisition)

Security Marking (select from the drop-down list) March 2018 Page 2 of 2 an acquisition, therefore, asolesource is necessary to Unimed for theservices required.

UNIMED SRL is the sole company that can certify the TN DXH Hematology System , service and repairs that is operated at the 31 MDG Laboratory Department.

Currently thereare no known service providers on the market capable of performing the requested service functions, as described by theStatement of Work (SOW). Market research was performed and no third party companies were identified with theability to provide the preventive maintenance/emergency repair of the Hematology system. In the future 31st MDGwould have to purchasea new blood culture analyzer that is not proprietary in nature, due to the warranty and preventive maintenance there may be no future solutions to 100% preclude future singlesource awards.The Government does not have in it's possession sufficient, accurate data or funding to purchase new equipment that provides this type of service.Future barriers still may exist based on the proprietary nature of design, manufacturing, production and processdata.The maintenance fullfills the needs of the Government.The purchase of thisservice contract is necessary to meet the requirements of the Government to provide blood culture analysis for the patients of the 31st Medical Clinic. It ensures the Hematology system is properly calibrated and can provide reliable diagnostic results. It also ensures that the 31st MDGis in compliance with Accreditation Association for Ambulatory Health Carestandards. As the customer seeks to replace the Hematology system in the future, every attempt will be made to compete the requirement by focusing not only on the replacement of the blood culture analyzer system but the follow-on preventive maintenance/calibration, extended warranty and proprietary nature of the system.Reviewing the proprietary nature of the requirement prior to acquisition of the new system may reduce the future singlesource justification.

I have determined, in accordance with FAR13.106-1(b)(1), that the circumstances of this contract action deem only a singlesource is reasonably available.

Date

08-Nov-2018

Typed Name and Rank/Grade of Contracting Officer

Megan Baer,Contracting Officer

Signature of Contracting Officer BAER.MEGAN.FRENCH.1014 Digitallysigned by

BAER.MEGAN.FRENCH.1014698627

698627 Date: 2018.11.08 10:44:01 +01'00'

SectionE: Steps to Preclude FutureSingle Source or Brand NameAwards

Section F: Contracting Officer's Determination