36C25025Q0971.docx

Special Notice Special Notice

GENERAL INFORMATION

Ann Arbor Healthcare System Network Contracting Office 10 2215 Fuller Road Ann Arbor MI 48105

POINT OF CONTACT*

Contracting Officer Kellie Konopinski Kellie.Konopinski@va.gov 734-222-4330

ADDITIONAL INFORMATION

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DESCRIPTION

Notice of Intent to Sole Source Requirement

The Department of Veterans Affairs, VA Ann Arbor Healthcare System, NCO 10 Contracting Activity intends to negotiate a sole source contract under Simplified Acquisition Procedures and the authority of FAR 13.106-1(b)(2), Soliciting from a single source for the following items listed below. The associated NAICS code for this is 334516. The vendor will be Hologic Sales and Services, LLC, 250 Campus Drive, Marlborough, MA 01752.

Description of requirements:

The procurement is for one (1) standalone automated Cytology Processing and Papanicolaou nontoxic staining system, UPS (uninterrupted power supply), Printer, Toner, Parts, Service manual (technical and service manuals), Reagents, Consumable and Supplies, Shipping and Handling costs associated with receipt of reagents, Preventative and Emergency Repair Maintenance agreement including non-refurbished materials, labor, transportation necessary to perform maintenance/preventative maintenance, operator and Pathologists training, hardware and software and software updates to VA Ann Arbor Healthcare System.

For screening of cervical cancer, there are two liquid-based cytoprocessing methods that are widely used, SurePath and ThinPrep. Both have similar diagnostic capabilities but differ in specimen collection, preservation and processing methods. SurePath and ThinPrep, both use a cervical brush or a broom-like device to collect the exfoliated cells from the affected area, where most of the precancerous and cancerous lesions originate. But the transfer of cells into the liquid medium differs and thereby affects specimen composition.

With SurePath technology, after the collection, the device is detached and placed directly into the vial containing the preservative solution. There is minimal cell loss, but it also introduces contamination from which can potentially obscure cellular details and complicates interpretation. Whereas with ThinPrep technology, after the collection, the device is rinsed in the vial by swirling before discarding the brush. This cell transfer exhibits uniform monolayer cell distribution allowing clearer visualization of individual cellular morphology for better microscopic evaluation and reduces unwanted material.

Currently the Ann Arbor VA is using the SurePath Cytoprocessor in Cytology for gyn and non-gyn specimens. Moving forward the Ann Arbor VA is shifting to ThinPrep sample collection over SurePath sample collection given the industry standards and FDA requirements for HPV testing on expanded specimen types. Liquid-based cytology testing and HPV testing is standard of care for a variety of patients and in order to deliver optimal care to a wider array of situations.

HPV testing is FDA regulated and can only be performed on approved instrumentation, with approved protocols and reagents. HPV testing with current instrumentation can only be performed on cervical specimens when in SurePath fixative. ThinPrep fixative would allow for HPV testing for vaginal and anal specimens. Therefore, to continue and expand HPV testing in-house, the VA must transition to ThinPrep.

Making this shift will require proprietary equipment while also being mindful of technologist time, existing available resources as well as average workload. ThinPrep specimens are proprietary to the Hologic system and require a Hologic Cytoprocessor for slide preparation.

A firm fixed price 5-year ordering period IDIQ contract is anticipated and shall be awarded. It is the Government's belief that only the proposed candidate possesses the required capabilities to successfully meet this requirement. It is the Government's intention to solicit and negotiate with only this source.

This notice of intent is not a request for competitive proposals. It is not a solicitation or request for offers. No solicitation package is available. Any response to this notice must show clear and convincing evidence that competition would be advantageous to the Government. Responses must be received no later than 4:30 pm on Monday, September 29, 2025.

Kellie Konopinski Contracting Officer

(734) 222-4330 Kellie.Konopinski@va.gov

Special Notice