J&A_Redacted.pdf

Justification and Approval (J&A) for Other Than Full and Open Competition

FOR OFFICIAL USE ONLY

March 2018 FOR OFFICIAL USE ONLY Page 1 of 3

NOTE: If a Justification and Approval was approved for the preceding acquisition, a copy of the approved J&A for the predecessor action must be included in the staff package for approval of the instant J&A. This applies to all J&A staff packages that are submitted for review and approval at a level above the contracting officer. The predecessor J&A will be used as a reference document by the approving official.

Is this a new or amended J&A Document? New Amended ( Prior to Award Only! )

Is this a Bridge Action as defined in the AF Bridge Action Reduction Plan? Yes No

Funding level for this acquisition:

Contracting Activity: 81st Contracting Squadron, Keesler AFB, MS

Purchase Request / Local ID Number: F2J4PC9164AW01

Program / Project (and PE, if applicable): Coagulation Equipment Lease & Reagents

Program Type (PEO or Other Contracting): Other Contracting (Operational)

Authority: 6.302-1 – 10 USC 2304(c)(1), Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

Estimated Contract Cost (including options): J&A Type: Class Individual

COORDINATION (AFFARS 5306.304(a) )

Date TRENT J. TATE, Col, USAF

81 MDTS/CC

DSN: 591-4475, COM: 228-376-4475

Signature

Date

01 Aug 2019

Contracting Officer

DEITRE L. BROWNE

81 CONS

DSN: 597-1833 COM: 228-377-1833

Signature

APPROVAL (AFFARS 5306.304(a) )

Date

01 Aug 2019

Contracting Officer

DEITRE L. BROWNE

81 CONS

DSN: 597-1833 COM: 228-377-1833

Signature

TATE.TRENT.J.1113593

Digitally signed by

TATE.TRENT.J.1113593012

Date: 2019.08.01 12:39:46 -05'00'

BROWNE.DEITRE.L

YNN.1174194110

Digitally signed by

BROWNE.DEITRE.LYNN.11741941

Date: 2019.08.01 14:17:08 -05'00'

BROWNE.DEITRE.L

YNN.1174194110

Digitally signed by

BROWNE.DEITRE.LYNN.11741941

Date: 2019.08.01 14:17:26 -05'00'

March 2018 FOR OFFICIAL USE ONLY Page 2 of 3

I. Contracting Activity.

Justification for Other Than Full and Open Competition 81st Contracting Squadron / LGCB (AETC) Keesler AFB, Biloxi, MS

II. Nature and/or description of the action being processed.

This action will be accomplished by issuing a firm fixed price contract to Diagnostica Stago, Inc., Five Century Drive, Parsippany, NJ 07054. The estimated total cost is for a 12-month base period and four 12-month option periods.

III. Description of supplies/services required to meet agency needs.

The 81 MDTS requests sole source procurement from Diagnostica Stago, Inc. to provide a lease of coagulation equipment to include two analyzers, reagents, training, business hours equipment services/ maintenance (to include 24/7 phone technical support), and other applicable supplies for testing. The fully automated analyzer must be capable of performing Prothrombin time (PT) assays, Activated Partial Thrombin time (aPTT or PTT) assays, d-dimer assays, and fibrinogen assays.

Annual estimated quantities: 8000 PT assays, 5500 aPTT or PTT assays, 600 d-dimer assays, and 150 fibrinogen assays.

IV. Statutory authority permitting other than full and open competition.

10 USC 2304(c)(1) as implemented by FAR 6.302-1 Only One Responsible Source and No Other Supplies or Services will Satisfy Agency Requirements.

V. Demonstration that the contractor's unique qualifications or nature of the acquisition requires the use of the authority cited above (applicability of authority).

Diagnostica Stago, Inc is the only company that can provide this service. While there may be many other companies capable of providing coagulation testing services, Diagnostica Stago, Inc, is the only vendor that can provide analyzers that use an electromechanical method for testing. Using this methodology eliminates re-draws of hemolyzed specimens, which is one of the top reasons for blood re-collection.

VI. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable.

A Sources Sought Synopsis was issued on 18 Jun 19; number: FA301019-SS-Coagulation; titled: Coagulation Equipment Lease. The sources sought closed on 10 Jul 19 with three responses received.

Responses were received from Diagostica Stago, Inc., Siemens Healthcare Diagnostics (Siemens), and Werfen USA, LLC (Werfen).

Neither Siemens nor Werfen offered the electromechanical methodology for testing. Both Siemens and Werfen use optical methods for testing. Optical methods have been known for interferences from lipemia, icterus, and hemolysis. These interferences do not occur with the electromechanical method. Roughly 2% of all patient samples are hemolyzed. Use of the electromechanical method prevents the re-drawing of samples which results

March 2018 FOR OFFICIAL USE ONLY Page 3 of 3 in patient discomfort, delay in patient care, longer hospital stays, and an increase in used resources due to re-collection of specimens.

VII. Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

As per FAR 6.303-2(b)(7), the Contracting Officer will determine the anticipated cost to be considered fair and reasonable using price analysis techniques and procedures listed in FAR 15.404-1(b)(2).

VIII. Description of the market research conducted and the results, or a statement of the reasons market research was not conducted.

As described in Section VI above, market research, in accordance with FAR Part 10, was conducted by posting a sources sought synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties.

IX. Any other facts supporting the use of Other Than Full and Open Competition.

None

X. List of any sources that expressed, in writing, an interest in the acquisition.

See block VI above.

XI. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before making subsequent acquisitions for the supplies or services required.

The 81 MDTS will continue to do market research to determine whether other vendors can meet future requests.

Current market research shows there is no other supplier on the market that can meet the requirement. If additional manufacturers, with comparable analyzers/reagents, offer coagulation analyzer equipment meeting all requirements, they will be considered viable options.

XII. Certification by the Contracting Officer.

As evidenced by my signature above, I have determined this document to be both accurate and complete to the best of my knowledge and belief.

XIII. Certification by the technical/requirements personnel.

As evidenced by my (our) signature(s) above, I (we) certify that any supporting data contained herein, which is my (our) responsibility, is both accurate and complete.