36C25026D0039_1.docx

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

GENERAL INFORMATION

Network Contracting Office 10 Suite 210 3140 Govenors Place Blvd Kettering OH 45409-1337

POINT OF CONTACT*

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

AWARD INFORMATION

MODIFICATION NUMBER

LINE ITEM NUMBER

AWARDEE NAME*

CONTRACTOR’S UEI

HOLOGIC SALES AND SERVICE, LLC

Q1NBY5GKN9Z3

AWARDEE ADDRESS LINE 1*

AWARDEE ADDRESS LINE 2*

AWARDEE ADDRESS LINE 4*

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

Justification and Approval Notice Justification and Approval Notice

DESCRIPTION

Justification and Approval Notice

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C250-26-AP-0288

1. Contracting Activity: Department of Veterans Affairs, NCO 10, 24 Frank Lloyd Wright Dr., Ann Arbor, MI 48105, in support of the Lieutenant Colonel Charles S. Kettles VA Medical Center, 2215 Fuller Road, Ann Arbor, MI 48105. 2237: 506-26-2-1030-0011.

2. Nature and/or Description of the Action Being Processed: This is a new requirement in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.510 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. The action will be awarded as a Firm-Fixed Price IDIQ with a five-year ordering period. This is a Cost Per Test (CPT) contract to provide gyn and non-gyn specimen testing for the Pathology and Laboratory Medicine Services at the Ann Arbor VA.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The procurement is for a CPT contract to provide 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.

Period of Performance: 2/16/2026 – 2/15/2031

VA Ann Arbor Health care System

Total for 5-Year

23505

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):

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.

With that in mind, the salient characteristics for the liquid-based cytology processing instrument are as follows:

· Ability to process all types of ThinPrep collection vials.

· Available with: ThinPrep 5000, ThinPrep 5000 Autoloader, ThinPrep Genesis

· Not Available with: None

· Ability to read Cerebro labels and option to interface with LIS.

· Available with: ThinPrep 5000, ThinPrep 5000 Autoloader

· Note Available with: ThinPrep Genesis

· Automated batch processing to standardize processing of slides and allow more efficient use of technician time.

· Available with: ThinPrep 5000, ThinPrep 5000 Autoloader

· Not Available with: ThinPrep Genesis

· Dimensions allow instrument to fit in available laboratory space.

· Available with: ThinPrep 5000, ThinPrep Genesis

· Not Available with: ThinPrep 5000 Autoloader

All the instruments researched provide at least one of these characteristics, but the only instrument to provide all of them is the Hologic ThinPrep 5000 processor. For this reason, the recommendation is to select the ThinPrep 5000 Cytoprocessor for use.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: An intent to sole source will be posted to Contract Opportunities through SAM.gov advising industry of the pending acquisition and soliciting inquiries from interested parties.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Anticipated cost will be considered fair and reasonable in accordance with FAR 13.106-3(a)(2)(ii) based on comparison of proposed prices with prices found reasonable on previous purchases.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: SBA was searched with NAICS 334516 and SD/VOSB selected and 6 results were found. SBA was search with NAICS 334516 and keyword “cytoprocessor” and no results were found. GSA was searched under “cytoprocessor” with no results. GSA was also searched under “CT5000” and “Hologic” with no results. NAC was searched under “cytoprocessor” with no results. NAC was also searched under “CT5000” with no results. Searched SCMC with keyword “cytoprocessor” and 12 results were found from Becton Dickinson for VISN 10. Searched SCMC with keyword “CT5000” and no results were found. AddsUp was searched under “Cytoprocessor” and 2 results were found from Becton Dickinson. AddsUp was then searched under “CT5000 Hologic” and 110 result were found. When sorted by date, the most recent purchases have been from Hologic. NAICS 334516 has a waiver for some items; however, these products are only available through the manufacturer, Hologic Sales and Service, LLC, a large business. They have confirmed they have no distributors. Therefore, the VA Rule of Two and the SBA Rule of Two cannot be met. This equipment is made in the USA and the Buy America Act applies. As described in Section 6 above, market research, in accordance with FAR Part 10, will be conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: There are no other supporting facts.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Hologic Sales and Service, LLC 250 Campus Drive Marlborough, MA 01752

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: Should a requisition of this nature recur, the market will be surveyed.

Effective Date: 11/15/24 Page 6 of 6

REVISION: 01

Acquisition ID#: 36C250-26-AP-0288