P03 - LIMITING SOURCES JUSTIFICATION (FAR PART 13 OVER SAT).pdf

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

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: 36C263-23-AP-2426

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 23 (NCO23) in support of VISN 23 Labs

2. Nature and/or Description of the Action Being Processed: This procurement is for a new contract in accordance with FAR 13.5 (Simplified Procedures for Certain Commercial Items) and specifically FAR 13.501( Special Documentation Requirements). This contract will establish a firm fixed price 5 year IDIQ contract between VISN 23 and Diasorin for the purchase of reagents and consumables that are compatible with the government’s DiaSorin Liaison XL equipment. This equipment requires usage of the original equipment manufacturer (OEM) name brand reagents and consumables to support VISN 23 labs. The expected award date will be by August 1, 2023.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: Diasorin Reagents are required to properly perform clinical laboratory tests that include infectious disease, tumor markers, gastrointestinal disease, hepatitis and retroviruses, metabolic disorders, and endocrine testing.

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

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): DiaSorin is the original equipment manufacturer (OEM) for the government’s system, as well as compatible reagents and consumables that are processed on the proprietary DiaSorin Liaison XL. VISN 23 Pathology and Laboratory Division requires reagents and consumables for this essential, highly specialized equipment which can only be provided by DiaSorin, a large business.

DiaSorin does not possess authorized distributors for this requirement. DiaSorin is the only firm capable of providing the consumables in statement of work, as well as ensuring that the Veteran Health Administration does not experience a substantial duplication of cost.

The duplication of cost cannot be expected to be recovered through competition and unacceptable delays in fulfilling this requirement:

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a. Only One Responsible Source – VISN 23 has standardized testing on the DiaSorin Liaison XL brand of analyzers (owned). Items are proprietary to the analyzers that these reagents will be used on. “Or Equal” items will simply not work with this brand of analyzers nor would they be approved by regulatory agencies such as the CLIA, Joint Commission, FDA or the College of American Pathologists (CAP).

• Reference: Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24):7164 [42CFR493.1252] Sec. 493.1252 Standard: Test systems, equipment, instruments, reagents, materials, and supplies

• Reference: Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24):7164 [42CFR493.2]

• Reference: Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24):7164 [42CFR493.1255(a)]Sec. 493.1255 Standard: Calibration and calibration verification procedures

• Reference: Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24):7164 [42CFR4931253] Sec. 493.1253 Standard: Establishment and verification of performance specifications

• Reference VHA Handbook 1106.01, Paragraph 7, Subparagraph g(5), October 6, 2008.

• Reference: College of American Pathologists Anatomic Pathology All Common Checklist, COM.1060, Sept. 2012

Reference: Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24):7164 [42CFR493.15]

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: The Contracting Officer Representative (COR) conducted market research to determine the availability of sources for the proposed requirement. Acquisition history was reviewed. DiaSorin confirmed they do not posses authorized distributors and are the sole proprietor. An intent to sole source, along with the SOW, was posted to SAM on June 26, 2023 and closed on July 6,2023 and the Government did not received any responses.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The price will be determine fair and reasonable through multiple ways. The total amount was referenced from the previous contract awarded to VISN 23 and the amount was slightly higher than the current amount. Market research was conducted using and FPDS search first for the Government as a whole and secondly for the VA, the proposed prices that Diasoren has given VISN 23 is within an acceptable range to determing the price is fair and reasonable.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted: A keyword and a NAICS search was conducted on VIP and no

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

VIP listed contractors reurned through the keyword and 41 from the NAICS search. The rule of two would not be able to be met for this requirement, this was determined by the issue of a intent to sole source. Diasorin is consider a large business and the value of the contract is expected to be over $183,000, in accordance with FAR 25.1101(c)(1) the Trade Agreement Act (52.225-5) and Trade Agreement Certificate (52.225-6) will apply.

As described in Section 6 above, market research, in accordance with FAR Part 10, was 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: None

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

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: This is a highly specialized market, with very high barrier of entry. Therefore it will have limitations on the amount of business that will be able to offer the full suite of products the Government will need.

The Government will continue to monitor the market place for changes and new entrants.

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

Date

Rachel Pike Lead Medical Technologist Minneapolis VA Medical Facility

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

a. 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.

Shavokie Gibson Date Contracting Officer Network Contracting Office 23 (NCO 23)

SHAVOKIE

GIBSON

Digitally signed by

SHAVOKIE GIBSON 7/3/23

RACHEL PIKE

Digitally signed by RACHEL

PIKE

Date: 2023.07.05 08:11:56 -05'00'

07/05/2023

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

b. 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.

Jahaun Stafford Date Supply Service Team 1 Branch Chief

Network Contracting Office 23 (NCO 23)

07/09/2023