P03 - LSJ - Over Sat - A1c Hemoglobin - 36C263-24-AP-0654 - MP - ds - FINAL_Redacted.pdf

Effective Date: 02/01/2022 Page 1 of 5

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C263-24-AP-0654

(1) Contracting Activity: Department of Veterans Affairs, Department of Veterans Affairs, Veterans Health Administration, Regional Procurement Office Central, Network Contracting Office (NCO) 23, Veterans Integrated Services Networks (VISN) 23 Medical Center Laboratories.

(2) Description of Action: This acquisition is conducted under the authority of the Multiple- Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501).

This action is a new requirement and requests approval for a VISN 23 Indefinite Delivery Indefinite Quantity (IDIQ) Sole Source Task Order.

Order against: VA NAC FSS Contract Number: V797D-40130 Expires 10/14/2024

Name of Proposed Contractor: Tosoh BioScience, Inc.

Street Address: 3600 Gantz RD

City, State, Zip: Gove City, Ohio 43123

Phone: (214) 662-5239

(3) Description of Supplies or Services:

The estimated value of the proposed action is

Period of Performance: 08/23/2024 08/22/2025

This action is for a cost-per-reportable result (CPRR) Indefinite Delivery Indefinite Quantity (IDIQ) for a hemoglobin A1c system. The CPRR IDIQ shall include costs covering: One (1) year equipment use, (2) all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories, and any other item required for the proper operation of the per patient reportable result price shall also encompass all costs associated with dilution;

repeat and confirmatory testing required producing a single patient reportable result. It shall

Effective Date: 02/01/2022 Page 2 of 5 also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI). (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and (4) training for Government personnel. Contractors shall provide delivery, installation, and removal of equipment at no additional charge.

(4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed supply or service.

FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

FAR 8.405-6(a)(1)(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;

Tosoh BioScience Inc. has a current VA National Acquisition Center (NAC) Schedule V797D- 40130 expiring 10/14/2024. No other companies were identified on the VA NAC with the capability to provide a cost-per-reportable result (CPRR) for a hemoglobin A1c system for VISN 23 Medical Centers.

FAR 8.405-6(a)(1)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.

FAR 8.405-6(b): Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition. The proprietary data is:

These are for existing equipment.

The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing.

Effective Date: 02/01/2022 Page 3 of 5

(5) Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination:

The VA NAC have already determined the prices of supplies/services under their Schedule contracts to be fair and reasonable. By placing a Task Order against a Schedule contract using the procedures in FAR 8.405, the Contracting Officer has concluded that the needs.

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted.

A Sources Sought (3626324Q0315) was posted to Contracting Opportunities (SAM.gov) from 02/06/2024 to 02/15/2024. This notice provided contractors the opportunity to submit a technical package, that provides clear and convincing evidence that they can meet the Government's requirement. The following contractors responded.

o US. Arkray, Inc.

o Biomerieux, Inc.

o Government Scientific Sources Inc.

o Branch Medical LLC.

Conducted a search on the VA National Acquisition Center (NAC) with the following results:

o Biomerieux Inc Listed, but Schedule does not have the requested service.

o Cardnel Health 200 Inc. Listed, but Schedule does not have the requested service.

o Tosoh BioScience Inc Listed with current contract V797D-40130 expiring

10/14/2024, has the requested service.

(7) Any Other Facts Supporting the Justification:

VISN 23 currently has contract number 36C26319D0095 expiring 08/22/2024 awarded to Tosoh BioScience Inc. All VISN 23 use Tosoh BioScience Inc CPRR and the quality lab results will be consistent with past practices of which both Veterans and Providers are accustomed.

Sole Source awarding to Tosoh BioScience Inc. would be a time and cost savings due to validation plans and implementation processes.

Effective Date: 02/01/2022 Page 5 of 5

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $750K):

I certify the justification meets requirements for other than full and open competition.

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