P03 - Attachment 1 FAR 13.5 Sole Source Justification - Over SAT (36C246-24-AP-1088) - Redacted.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Request for Sole Source Justification >SAT-$7.5M under FAR13.5 (36C246-24-AP-1088)

Effective Date: 02/01/2022 Page 1 of 4

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR

CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID:_ 36C246-24-AP-1088

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO) 06, VISN 06, on behalf of the Durham VA Medical Center, 508 Fulton Street, Durham, NC 27705-3875. 2237 No. 558-24-2-044-0044.

2. Nature and/or Description of the Action Being Processed: This procurement is for the

Hologic ThinPrep Reagents and Supplies for Cytology testing in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items. The Durham Pathology and Laboratory will place an Open Market purchase order for a duration of five years to acquire Hologic ThinPrep supplies. These supplies will be used for sampling and testing on Hologic equipment, which follows the national standard procedure of operation for the cytology department This is a new requirement for an open market solicitation, and a new firm-fixed-price Blanket Purchase Agreement (BPA) is anticipated.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: Durham

Pathology and Laboratory Medicine Services (P&LMS) currently owns the ThinPrep 2000 Processor and the ThinPrep 5000 Auto Loader Processor Systems. During regular testing, Durham Pathology - Cytology will replenish its reagents and supplies. Hologic will continue to provide support for any necessary services on the equipment and promptly notify the service provider whenever a replacement is needed. The estimated period of performance for this requirement is 02/16/2024 – 02/15/2029. The total estimated price of the proposed action (including option years) is $309,285.00.

Durham VA Medical Center Product # Description Price/Kit Total Price

70471-001

ThinPrep UroCyte Microscope slides, 100 Slides per box

$ 52.00

$ 520.00

70472-001

ThinPrep UroCyte Filters, 100 Filters per box

$ 88.00

$ 616.00

ASY-15208

CytoLyt Solution Centrifuge Tubes, 80 Centrifuge Tubes per box, Pre-filled with 30 ml

$ 246.00

$ 246.00

70137-001

Laboratory Kit, 500 Filters and 500 Slides per Kit

$ 5,485.00

$ 38,395.00

70136-001

Physician’s Kit, 500 Vials, and 500 Broom-like Collection Devices per Kit

$ 1,225.00

$ 8,575.00

70136-002

Physician’s Kit, 500 Vials, and 500 Cytobrush/Plastic Spatula Collection Devices per Kit

$ 1,225.00

$ 7,350.00

Effective Date: 02/01/2022 Page 2 of 4

70205-001 Non-Gyn Filters, 100 Filters per box 7 $ 465.00 $ 3,255.00

ASY-14756

PreservCyt Solution Vials, 100 Vials per box, Pre-filled with 20ml

$ 134.00

$ 1,340.00

236004

CytoLyt Solution 32 oz Bottles, 4 per box

$ 145.00

$ 725.00

234004 PreservCyt Solution 32 oz Bottles, 4 per box

$ 145.00

$ 725.00

70372-001

ThinPrep Microscope Slides, 100 slides per box

$ 22.00

$ 110.00

$ 61,857.00

Base Year: 02/16/2023 – 02/15/2024 ($61,857.00) Option Year 1: 02/16/2024 – 02/15/2025 ($61,857.00) Option Year 2: 02/16/2025 – 02/15/2026 ($61,857.00) Option Year 3: 02/16/2026 – 02/15/2027 ($61,857.00) Option Year 4: 02/16/2027 – 02/15/2028 ($61,857.00)

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

(X) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability, or

Expert Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the

Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

The ThinPrep Pap Test is a liquid-based Pap test that is used for the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells, and all other cytologic categories as defined by the Bethesda system for reporting results of cervical cytology. It is intended as a replacement for the conventional method of Pap smears. The ThinPrep Pap Test is the first liquid-based Pap test with FDA approval/clearance for sample collection of Pap, HPV, chlamydia/gonorrhea, and trichomoniasis testing from the same vial. It offers patient comfort, clinician versatility, chain-of-custody verification, and improved cervical cancer detection with the ThinPrep Imaging System. The ThinPrep 2000 System is for use in screening for the presence of atypical cells, cervical cancer, or precursor lesions (LSIL, HSIL) and other cytologic categories as defined by the Bethesda System for Reporting Cervical Cytology.

Effective Date: 02/01/2022 Page 3 of 4

Digitally signed by BRITTNEY

JACKSON

JACKSON -05'00'

The Pap test is a screening test for cervical cancer and its precursors with an inherent false-negative rate.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: The Contract Specialist contacted the Original Equipment Manufacturer (OEM) Hologic, Inc. On 01/22/2024; OEM informed the CS that they do not have authorized distributors for the ThinPrep system or disposables. On 09/20/2023 Sources sought notification 36C24624Q0012 closed with no responses.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable: The CO anticipates that the price will be considered fair and reasonable based on a comparison of proposed prices with previous purchases. The CO will request additional discounts.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market Research was performed using SBA VetCert, VIP, NSSL, SCMC, NAC, GSA, FPDS-NG, and the Internet. A source sought notice (36C24624Q0012) was posted on 09/18/2023 and closed on 09/20/2023 with no responses. Hologic, Inc. Has provided the Contract Specialist documentation stating they have no authorized distributors or resellers. SBA VetCert on 01/31/2024 using NAICS 325413 resulted in 86 SDVOSB and VOSB vendors; further search using VIP, NAICS 325413, and keyword “ThinPrep” to narrow the search revealed no SDVOSB or VOSB vendors. Based on the market research conducted, no two or more SBA-verified and capable SDVOSBs or VOSBs were identified and appeared capable of performing the requirement. In addition, no small business in any of the other targeted socio-economic groups appeared to qualify for a set-aside or sole-source procurement.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: The Durham P&LMS is currently utilizing the Hologic equipment on-site. The equipment requires certain supplies, that only Hologic can provide. Hologic is the manufacturer of these supplies, and there are no comparable alternatives available.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: None.

11. 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: Currently, no actions can be taken to overcome barriers to competition.

12. 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, included in the justification, are accurate and complete to the best of my knowledge and belief.

Brittney Jackson Administrative Officer for P&LMS Durham VA Medical Center

JACKSON

Effective Date: 02/01/2022 Page 4 of 4

CHELLRY

Digitally signed by CHELLRY

WHITTIER

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contract Specialist Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Chellry Whittier Supply I

NCO-06

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

Cherisse A.

Hall 613334 Cherisse Hall Branch Chief, Supply I

NCO-06

Digitally signed by Cherisse A. Hall 613334 Date: 2024.02.07 13:10:37 -05'00'

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

$750K): I certify the justification meets requirements for other than full and open competition.

Digitally signed by KEESHIA

KEESHIA NEWMAN NEWMAN

Date: 2024.02.07 14:05:09 -05'00'

Keeshia Newman Division I Chief

NCO-06

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