6550--SOLE SOURCE NOTICE - Hologic Panther Supplies

Presolicitation Notice

Presolicitation Notice

Page 4 of 4

Presolicitation Notice

Presolicitation Notice

Page 1 of 4

This notice is in accordance with (IAW) Federal Acquisition Regulation (FAR) subpart 5.2.

The Department of Veterans Affairs (VA), Network Contracting Office (NCO) 09, hereby provides notice of its intent to award a sole source, firm-fixed price indefinite delivery contract for the product/service listed below to a large business, Hologic Inc., headquartered out of California. The contract is expected to be awarded under the authority of FAR subpart 13.5. A Sole Source Justification for Other Than Full and Open Competition has been prepared. The anticipated award date is no later than 3/1/2024.The contractor will provide the product/service listed below to the place of performance listed on the cover page of this notice.

This action is for recurrent Hologic Panther system reagents, controls, and consumables for James H. Quillen VA Medical Center s (JHQVAMC), Microbiology lab. The Panther Fusion analyzer was purchased and installed on 10/14/2021. The Executive Leadership Team (ELT) directed the laboratory to utilize this test platform to do COVID testing for employees, screen CLC staff, and Dom Staff. The Panther is a random access analyzer and will help Mountain Home manage surveillance COVID testing during outbreaks. JHQVAMC also intends to bring in-house testing for Quantitative HCV, and Chlamydia/Gonorrhoeae on the Hologic Panther System. Utilizing this testing platform for these purposes/intentions saves the government taxpayer money, improves testing turn-around time and physician diagnosis, and reduces Veteran patient inconvenience by lessening return visits for lab results and additional physician consultations, if required.

Listed below are the estimated volumes of reagents and consumables that are needed to support this requirement for one year.

Market research found no other vendors providing like product/service as the Panther system and its reagents, controls, and consumables are proprietary. Also, the Hologic Aptima COVID test kits are mandated by the Food & Drug Administration (FDA) to be used only on Hologic Panther system. Using other than Hologic COVID reagents, controls, consumables on the Hologic Panther system not only could damage the equipment but could lead to erroneous test results/analysis.

Product/Service Required:

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Estimated 1 year of COVID reagents and Consumables for the Panther System

Item #

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Description/Part Number*

Qty

Price

Extended Amount

1

PRD-06419

Aptima SARS-CoV-2 Assay,250-Test

60

2

PRD-06420

Aptima SARS-CoV-2 Assay Controls

65

3

PRD-06997

Hologic Direct Load Tube, 100/bag

135

4

PRD-03705

Aptima HV Quant Dx Assay Kit, 100-Test

10

5

PRD-03706

Aptima HCV Quant DX Control Kit

As needed

6

PRD-03707

Aptima HCV Quant DX Calibrator Kit

As needed

7

303096

Panther System Run Kit (Includes Product No. 303014, 303013,104772-02,902731 and 504405)

As needed

8

104772-02

MTUs (multi-tube units) (100 Tubes/case)

As needed

9

303013

Aptima Auto Detect (1000 tests)

As needed

10

303014

Aptima Assay Fluids (1000 tests)

As needed

11

504405

Waste Bin Covers (10/Ea)

As needed

12

902731

Waste Bin Bags (10/Ea)

As needed

13

CL0040

Spare Caps, TRC+Select 250 Kit

As needed

14

CL0041

Spare Caps, AMP&Probe 100&250 kit Enzyme 100 Kit

As needed

15

303085

Panther Advance Cleaning Solution

As needed

16

501616

Spare Caps, Enzyme 250 Kit

As needed

17

501604

Spare Caps, TCR, Aptima 2x50 kits

As needed

19

504415

Transport Tube Cap, 100/pack

As needed

20

PRD-03455

Panther Run Kit for Real Time Assays

As needed

21

PRD-03503

Aptima Specimen Diluent US

2

22

PRD-03654

Aptima Specimen Diluent Kit US

2

23

PRD-05576

Aptima Combo 2-100 test Kit

8

24

PRD-05571

Aptima Combo 2-250 test Kit

As needed

25

301040

Kit Aptima Combo 2 urine specimen collection

As needed

26

301041

Kit Aptima Combo 2 swab specimen collection

As needed

27

PRD-03546

Aptima Multitest Swab Collection

As Needed

28

301154C

Kit Aptima LPT-IVD sale bom

As needed

29

105575

Aptima Urine Collection Tubes

As needed

30

MTL-02093

500 Pack Pipet Trans Dispo 5ML

As needed

31

301110

Aptima CT/GT Control Kit (1 tray) IVD

As needed

32

PRD-03706

HCV Quant Assay Controls, Aptima, US IVD

As needed

33

PRD-03707

HCV Quant Assay Calibrator, Aptima, US IVD

As needed

34

FAB-18184

Specimen Aliquot Tube Pack

As needed

35

PRD-06952

Direct Load Capture CAP Collection Kit-FLOQ Swab

As needed

36

4339

Panther Fusion Specimen Lysis TUBE

150

37

15668

Kit, Penetrable Caps

2

This estimate is not a representation to an offeror or contractor that the estimated quantity will be required or ordered, or that conditions affecting requirements will be stable or normal.Â

All products are made in the USA

Estimated Value: $2,000.000.00 for a 3-year Ordering Period Indefinite Delivery Contract.

Period of Performance: As-Needed covering a 3-year period of performance with an anticipated end date of 9/30/2026.

NAICS code: 325413 In-Vitro Diagnostic Substance Manufacturing

SBA Small Business Size Standard: 1250 employees

PSC: 6550

THIS NOTICE OF INTENT IS NOT A SOLICITATION OR REQUEST FOR COMPETITIVE

QUOTES. However, interested parties may identify their interest and capability to respond to this requirement and may submit a bid, proposal, or quotation (as appropriate) that the agency shall consider within the given closing/due date of this notice.

A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. Information received will normally be considered solely for determining whether to conduct a competitive procurement. The Department of Veterans Affairs will NOT be responsible for any costs incurred by interested parties in responding to this notice of intent. Only written responses will be considered. All responses from responsible sources will be fully considered. As a result of analyzing responses to this notice of intent, the Government shall determine if a solicitation will be issued. Any prospective contractor must be registered in the System for Award Management (SAM) to be eligible for award and must submit a current authorized distributor letter from the manufacturer.

Interested parties are encouraged to furnish information by email only with RESPONSE TO NOTICE 36C24924Q0093 in the subject line. All documents submitted will not be returned. All interested parties shall submit clear and convincing documentation demonstrating their capabilities to satisfy the requirements listed above to the point of contact (POC) listed on the cover page of this notice and NO LATER THAN the given closing date and time on this notice. The capability documentation should include general information and technical background describing in detail the prospective contractor's capabilities like an authorized distributor/reseller letter from their source of supply if not a manufacturer that will demonstrate the ability to support this requirement.