P03_Signed_FAR6_JA_Over_SAT_BD Affirm Reagents.pdf

VHAPM Part 808.405-6 Limiting Sources Request for Limited Sources Justification Format >SAT

VHAPM Part 808.405-6 Limiting Sources Page 1 of 4

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C248-22-AP-1729

(1) Contracting Activity: Department of Veterans Affairs, VISN-8, Orlando Medical Center

PR # 675-22-1-2223-0023

(2) Description of Action: This acquisition is conducted under the authority of the

MultipleAward Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501). BD Affirm test kits can be purchased directly from the OEM Becton Dickinson or via GSA schedules.

Order against: FSS Contract Number: GS-07F-195DA

Name of Proposed Contractor: Becton Dickinson and Co. (Large Business)

Street Address: 2350 Qume Dr.

City, State, Zip: San Jose, CA 95131-1812 Phone: 619-895-

Order against: FSS Contract Number: GS-07F-0636W

Name of Proposed Contractor: Frankling Young Intl Inc (SDVOSB)

Street Address: 1042 N Mountain Ave. Ste 310

City, State, Zip: Upland, CA 91786-3695 Phone: 909-931-

Order against: FSS Contract Number: 36F78718D0395

Name of Proposed Contractor: Fisher Scientific Co. LLC (Large Business)

Street Address: 11450 Compau Center Dr. West

City, State, Zip: Houston, TX 77070

Phone: 1-800-640-0640

(3) Description of Supplies or Services:

The estimated value of the proposed action is $ 265,694.00

Becton Dickinson is the OEM of direct specimen DNA Probe tests for vaginitis testing, including test kits, specimen transport kits, and a "single swap" service. The supplies required are the BD

Affirm VPIII 24 Test kits, and the BD Affirm VPIII ATTS Transport Kits, and the swap service for the BD Microprobe Processor.

VHAPM Part 808.405-6 Limiting Sources Page 2 of 4

Base Year (02.15.2022 – 02.14.2023) item distribution on a standing order:

Option Year 1: 02.15.2023 – 02.14.2024

Option Year 2: 02.15.2024 – 02.14.2025

Option Year 3: 02.15.2025 – 02.14.2026

Option Year 4: 02.15.2026 – 02.14.2027

Projecting:

• 54 BD Affirm VPIII 24Test kits

• 16 BD Affirm ATT System 100 collection kits

• 1 BD Microprobe Processor Service (as needed)

(4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required 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;

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: Becton Dickinson- (BD Diagnostics) manufactures the only direct specimen DNA

Probe Test for Candida albicans, Gardnerella vaginalis and Trichomonas vaginalis. The diagnostic test instrument, the BD Affirm VPIII, differentiates and identifies 3 vaginitis pathogens from a single patient sample.

These are “direct replacements” parts/components for existing equipment.

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

Reagent and Equipment Service Agreement to continue providing direct specimen DNA

Probe Testing for Candida species, Gardnerella vaginalis and Trichomonas vaginalis, VHAPM Part 808.405-6 Limiting Sources Page 3 of 4 utilizing test equipment (BD Microprobe Processor (120V) currently owned by the laboratory.

(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:

Market research confirms there is No confidence 2 or more quotes will be received from capable SDVOSBs, VOSB, or Small Businesses at a fair and reasonable price. It is in the best interest of the government to solicit as unrestricted.

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

Market research was performed using Vendor Information Pages (VIP), Strategic Acquisition Center (SAC) contract search tool, General Service Administration (GSA) E-Buy, Federal Procurement Data System (FPDS), and ECMS.

A request for information was submitted to all businesses under NAICS 325413, 334516, and

GSA Source 65 VII Category 555-2 and 555-6.

(7) This is a Sole Source Requirement. Market research confirms there is No Authorized

SDVOSBs/VOSBs or Small Business to distribute product. It is in the best interest of the government to award procurement directly to the OEM-Distributor.

(8) Any Other Facts Supporting the Justification:

Orlando VA Healthcare System Lake Nona currently owns test equipment: BD Microprobe Processor (120V)) - Only BD test reagents are compatible with the existing test equipment.

(9) A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made: Continue market research for future purchases and seek competition.

(10) Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.

Anthony Roche 1375141 Digitally signed by Anthony Roche 1375141 Date: 2021.03.03 15:16:36 -05'00'

SIGNATURE DATE

VHAPM Part 808.405-6 Limiting Sources Page 4 of 4

Anthony Roche Laboratory Manager Pathology & Laboratory Medicine

NAME TITLE SERVICE LINE/SECTION

Orlando VA Medical Center

FACILITY

(10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Digitally signed by Patricia E. Brown

Patricia E. Brown 329998 329998Date: 2021.03.04 04:43:42 -05'00'

CONTRACTING OFFICER/DESIGNEE’S SIGNATURE

Patricia E. Brown Contracting Officer NCO-8 Orlando Commodities Team

NAME AND TITLE FACILITY/NCO/PCO

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding

$700K):I certify the justification meets requirements for other than full and open competition.

SIGNATURE DATE

Marie E. Smith Branch Chief

NAME

NCO 08 Orlando Commodities Branch Chief