JA - Blood Analyzer (current)1_Redacted.pdf

Sole Source (Including Brand Name) Justification - Simplified Procedures for Certain Commercial Items

CONTROLLED UNCLASSIFIED INFORMATION

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I. Contracting Activity.

The Contracting Activity is 60th Contracting Squadron, Travis Air Force Base, CA, 94533.

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

The proposed action is for a sole source, firm-fixed-price new purchase order with with Ortho-Clinical Diagnostics, Inc.

This acquisition is for an Automated Immunohematology (Blood Bank) analyzer and Reagents, in accordance with the Performance Work Statement (PWS). The Government projects award for 1 April 2023.

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

The 60th Medical Group (60 MDG), Transfusion Services Department at David Grant Medical Center has a requirement for Automated Immunohematology (Blood Bank) analyzer laboratory testing which includes: reagents, quality control materials, and consumable supplies, parts and accessories, equipment, instrumentation training, maintenance, and calibration services at frequencies specified in the manufacturer's service and operations manuals, with any required intervening repair service requirements.

The Period of Performance (POP) is 1 April 2023- 31 March 2024 and Option Year One (1) 1 April 2024-31 March 2025.

The current contractor, Ortho-Clinical Diagnostics, Inc., is the incumbent vendor and no action is required. Services will resume as currently performed.

The appropriation is FY23 O&M Funds

The requirement includes the following CLINS:

CLIN Item Quantity 0001 Bloodbank Analyzer and Reagents 1 Lot (IAW all items listed in the PWS) 1001 Bloodbank Analyzer and Reagents 1 Lot (IAW all items listed in the PWS)

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

AFFARS 5313.501- 10 U.S.C. 2302b, Implementation of Simplified Acquisition Procedures (41 U.S.C. 1901)

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

Ortho-Clinical Diagnostics, Inc. has the existing Blood Analyzer and Reagents Contract, FA442720C0005, which expires 31 March 2023. The Ortho Clinical Diagnostics analyzer meets all the technical requirements of providing an automated blood bank analyzer that is able to perform laboratory testing and connect to the lab information system.

It has been approved by the Defense Health Agency for an Authorization To Operate to interface with the Department of Defense's new electronic health record, MHS-Genesis. Additionally, it is the only blood bank analyzer that is on the Defense Health Agency's approved list of medical devices. The Ortho Vision is currently being utilized at David Grant Medical Center and is connected to MHS-Genesis.

Automated analyzers not interfaced with the laboratory information system will require manual entry of results, which increases the safety risks of clerical errors. Manual entry of results also require second verification prior to reporting, which increases the turn-around-time for reporting results to providers and cause delays in patient care. Disapproving

Sole Source (Including Brand Name) Justification - Simplified Procedures for Certain Commercial Items

CONTROLLED UNCLASSIFIED INFORMATION

April 2021 CONTROLLED UNCLASSIFIED INFORMATION Page 4 of 4April 2021 CONTROLLED UNCLASSIFIED INFORMATION Page 4 of 4

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 agency will continue to monitor DHA Approved ATO and equipment list for additional vendors.

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.

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.