Atch2_Limiting_Sources_Justification_OVER_SAT - PJ.pdf

Attachment 2: Request for Limited Sources Justification Format >SAT

VHAPG Part 808.405-6 Limiting Sources Page 1 of 5 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C248-26-AP-0325

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C248-26-AP-0325

(1) Contracting Activity: Department of Veterans Affairs, Veterans Health Administration, Regional Procurement Office East, Network Contracting Office 08 (NCO 08) on behalf of James A. Haley Veterans’ Hospital located at 13000 Bruce B Downs Blvd, Tampa, FL 33612.

2237: 673-26-1-023-0020

(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). The action being reviewed and approved will be awarded as a new requirement for a single award Federal Supply Schedule (FSS) Blanket Purchase Agreement (BPA).

The Contractor shall provide FDA-approved, Brand Specific Qiagen reagents for performing PCR and RE-

PCR testing JAK2 Gene Expression and Pathogen Detection testing on government-owned instrumentation for the James A. Haley Veterans’ Hospital (JAHVH), Tampa, Florida. All work is to be performed in accordance with the guidelines established by Federal, State and local ordinances, with the

FDA and manufacturer's guidelines, and with all terms, conditions, provisions, schedules and specifications provided herein.

This will be a new base +4 option year contract. to include all reagents and all consumables (including, but not limited to, all reagents, controls and calibrators) necessary produce a JAK2 Gene Expression and

Pathogen Detection test result (CPT) using the government-owned QIAGEN QIAgility® System, including the QIAcuity digital PCR, EZ2® Connect MDx, and Rotor-Gene® Q MDx System.

This Cost Per Test requirement is not IT related. FITARA Approval does not apply to this procurement.

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

Name of Proposed Contractor: FRANKLIN YOUNG INTERNATIONAL, INC.

Street Address: 1042 N. MOUNTAIN AVE, SUITE 310

City, State, Zip: UPLAND, CA 91786

Phone: 301--395-8369 (Direct Sales Rep) or 909-931-5012 https://www.acquisition.gov/far/part-8#FAR_8_405_6 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.gpo.gov/fdsys/pkg/USCODE-2011-title40/pdf/USCODE-2011-title40-subtitleI-chap5-subchapI-sec501.pdf

VHAPG Part 808.405-6 Limiting Sources Page 2 of 5 Revision: 01 Effective Date: 09/01/2024

(3) Description of Supplies or Services:

The estimated value of the proposed action is $470,073.51

The contractor is required to provide all reagents and all consumables (including, but not limited to, all reagents, controls and calibrators) necessary produce a JAK2 Gene Expression and

Pathogen Detection test result (CPT) using the government-owned QIAGEN QIAgility® System, including the QIAcuity digital PCR, EZ2® Connect MDx, and Rotor-Gene® Q MDx System.

Estimated Annual Total: 700 tests

(Qty is based on historical annual reported test volumes)

Manufacturer Part Number / Description Qty

2927-673633 ipsogen JAK2 RGQ PCR Kit (24) 30

2927-951034 EZ1&2 DNA Blood 200 µl Kit (48) 15

2927-981005 PCR TUBES, 0.2 ML (1000) 5

2927-981103 STRIP TUBES AND CAPS, 0.1 ML (250) 5

2927-981400 ROTOR-DISC OTV KIT 2

2927-990512 50 L CONDUCTIVE FILTERED TIPS 10

2927-990522 200 L CONDUCTIVE FILTERED TIPS 5

2927-990550 TIP DISPOSAL BOX 1

Period of Performance:

Base Yr: 10/01/2025 – 09/30/2026

Option Yr 1: 10/01/2026 – 09/30/2027

Option Yr 2: 10/01/2027 – 09/30/2028

Option Yr 3: 10/01/2028 – 09/30/2029

Option Yr 4: 10/01/2029 – 09/30/2030

(4) Identify the Authority and Supporting Rationale Authority of the Multiple Award Schedule Program, Title III of the Federal Property and Administrative Services Act of 1949 (41 USC 251, et seq.); Title 40 USC 501, Services for Executive Agencies; and Section 803 of the National Defense Authorization Act of 2002 (PL 107-107) and implemented by FAR 8.405-6. Mark the applicable exception:

VHAPG Part 808.405-6 Limiting Sources Page 3 of 5 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C248-26-AP-0325

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. The highly specialized Qiagen reagents and equipment is manufactured by Qiagen LLC (Qiagen). Qiagen has authorized Franklin Young International Inc (Franklin Young) as the only SDVOSB that can provide all necessary OEM parts and perform the necessary repairs due to patents and other intellectual property rights. Any repairs or services on these systems must be compatible in all aspects with the existing system, and any improper repairs can cause critical impairment to the entire system, thus risking patient care at Tampa and Bay Pines HCS.

These products are provided by Franklin Young under GSA/FSS Contract GS-07F-0636W, as confirmed within their sole source email received on 9/3/2025.

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 “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.

(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:

GSA has already determined the prices of supplies and fixed-price, under schedule contracts, to be fair and reasonable. Therefore, ordering activities are not required to make a separate determination of fair and reasonable pricing, except for a price evaluation as required by 8.405- 2(d). By placing an order against a schedule contract using the procedures in 8.405, the ordering activity has concluded that the order represents the best value (as defined in FAR 2.101) and results in the lowest overall cost alternative (considering price, special features, administrative costs, etc.) to meet the Government’s needs.

The necessary items to fulfil the needs of James A. Haley are found currently offered with the GSA schedule holder as identified above. These prices have already been determined fair and reasonable.

https://www.acquisition.gov/far/part-8#FAR_8_405_6 https://www.acquisition.gov/far/part-8#FAR_8_405_6

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Franklin Young is the only authorized SDVOSB distributor of the equipment and reagents required to fulfill the needs under GSA contract GS-07F-0636W. A signed Qiagen Letter of Authorization is available and filed in the contract file.

(6) Describe the Market Research Conducted:

Market Research was conducted in accordance with (IAW) FAR Part 10 and revealed that Qiagen is the original equipment manufacturer (OEM). Although Qiagen provided a Sole Source letter stating its authorization to Franklin Young for Qiagen reagents for performing PCR and RE-PCR testing JAK2 Gene Expression and Pathogen Detection, the agency posted a Special Notice as an Intent to Sole Source (RFI # 36C24825Q1195) on Contract Opportunities, 9/5/2025 to encourage other vendors capable to provide the requirements and to respond with the authorization to supply Qiagen equipment or reagents. In response to the Intent to Sole Source, zero vendors replied with capability.

The SBA DSBS database was searched to find possible sources able to provide the reagents and equipment. There are 297 potential SDVOSB or VOSB concerns listed under NAICS code 334516.

Searches were also conducted on GSA, NAC, SBA, SAM, and FPDS. However, based on the Qiagen SDVOSB authorization to Franklin Young, none of the vendors are authorized distributors to provide Qiagen products.

The Contracting Officer has determined that the most advantageous acquisition strategy for the Government is to award a sole source award to Franklin Young for a 12-month base period and four (4) Option Years.

(7) Any Other Facts Supporting the Justification:

QIAGEN, LLC is the OEM and sole source for the only, proprietary, FDA cleared automated

QIAgility® System, including the QIAcuity digital PCR, EZ2® Connect MDx, and Rotor-Gene® Q

MDx Systems and all reagents, and consumables used for processing of patient results on these instruments.

Upon contact with Diane Banchero, Qiagen (Large Business), it was discovered they have one authorized SDVOSB distributor, Franklin Young. Contact with rep, David Cook, revealed Qiagen product supply distribution is on a valid GSA Contract (GS-07F-0636W) with Franklin Young.

A copy of the Qiagen Sole Source letter is filed in the electronic file briefcase.

(8) 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:

Currently, only one SDVOSB has access to provide the necessary products for this highly specialized equipment that are currently in place at the Tampa and Bay Pines VAMC. A post-award notice will also be publicized to the contract opportunities website.

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(9) 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 source justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.

SIGNATURE DATE

Renae Slaughter Medical Technologist Path & Lab

Bay Pines

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.

Todd Pappas DATE

Contracting Officer, North VISN Team NCO 8

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.

SIGNATURE DATE

Paul Jarret Senior Contracting Officer, North VISN Team https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM2/VHAPM_Part_806.3.aspx https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM2/VHAPM_Part_806.3.aspx