P03 Attachment 1 FAR 13.5 Sole Source Justification - Over SAT_Redacted.pdf

Effective Date: 02/01/2022 Page 1 of 6

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN

COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C261-23-AP-5924 JOFOC Tracking Number: FY24 – NCO 21 – 798

1. Contracting Activity: Department of Veterans Affairs, Regional Procurement Office West

(RPOW), Network Contracting Office (NCO) 21, on behalf of the Veterans Integrated Service Network (VISN) 21, VA Northern California Health Care System (VANCHCS) located at 10535 Hospital Way, Mather, CA 95655-4200.

Purchase Request: 612-24-1-113-0020

2. Nature and/or Description of the Action Being Processed:

This requirement is for a new, firm-fixed-price Indefinite Delivery Indefinite Quantity (IDIQ) contract for five one-year ordering periods, that provides blood bank reagents and products for in vitro immunohematology testing of human blood utilizing ID-MTS gel card technology and manual testing on a Cost per Test (CPT) basis under FAR Part 13.

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

Blood bank analyzers and gel card reagents are required for medical providers and laboratories to conduct Antibody Identification Testing for various blood related treatments to include testing, typing, and blood transfusions. VANCHCS currently owns an Ortho ID-MTS Blood Bank Analyzer Machine which utilizes an advanced and proprietary gel technology. The Ortho Analyzer machine, gel cards and applicable consumables are manufactured by Ortho and FDA Certified. Items of this type must be FDA approved for patient use to maintain safety and effectiveness.

ID-MTS Reagents MTS A/B/D Group (5 x 20) / MTS081115 MTS A/B/D Mono & Reverse Grp Card (5x20) / MTS 080515 MTS Anti-lgG-C3D Card (1 x 20) / MTS084014 MTS Anti lgG Card (5 x 20) / MTS084024 MTS Monoclonal Rh Phenotype Card (1 x 20) / MTS080024

ID-MTS Consumables MTS Diluent 2 (5 x 100mL) / MTS9230 MTS Diluent 2 Plus (5 x 100mL) / MTS9330 ORTHO 7% BSA (12 x 5 mL) / 6844285 OV Dilution Trays 916-well tray - 180/ box) / 6904591

OV Evaporation Caps for Reagent Red Cells- 10 mL (25/ box) / 6843005

Effective Date: 02/01/2022 Page 2 of 6

Traditional Reagents (Mather) 0.8% Affirmagen (2 x 20 mL) / 719201 0.8% RESOLVE Panel A (11 x 3 mL) / 6902317 0.8% RESOLVE Panel B (11 x 3 mL) / 6902318 0.8% Suriscreen (3 x 10 mL) / 6902316 Affirmagen (2 x 10 mL) / 719210 Alba Q Chek simulated whole Blood Controls (1 kit) / Z498 Anti-A BioClone (15 x 10 mL) / 711220 Anti-B BioClone (15 x 10 mL) / 711320 Anti-C BioClone (1 x 5 mL) / 713080 Anti-c BioClone (1 x 5 mL) / 714080 Anti-D BioClone (15 x 10 mL) / 717380 Anti-E BioClone (1 x 5 mL) / 713180 Anti-e BioClone (1 x 5 mL) / 714180 Anti-Jka BioClone (1 x 3 mL) / 721380 Anti-Jkb BioClone (1 x 3 mL) / 721480 ORTHO A2 Cells (1 x 10 mL) / 719310 ORTHO Anti-Fya (1 x 3 mL) / 715130 ORTHO Anti-Fyb (1 x 3 mL) / 725230 ORTHO Anti-IgG (Rabbit) Green (1 x 10 mL) / 716760 ORTHO Anti-Kell (1 x 5 mL) / 715150 ORTHO Anti-s (1 x 3 mL) / 721830 ORTHO Anti-S (1 x 3 mL) / 723030 ORTHO Bovine Albumin Solution (15 x 10 mL) / 718280 ORTHO Confidence System (1 Kit) / 6902096 ORTHO Coombs Control (1 x 10 mL) / 719810 ANTI-A1 LECTIN (1 x 3 mL) / 711830 Surgiscreen (3 x 10 mL) / 719100

Traditional Reagents (Martinez) 0.8% Suriscreen (3 x 10 mL) / 6902316 Affirmagen (2 x 10 mL) / 719210 ORTHO Coombs Control (1 x 10 mL) / 719810 ORTHO Confidence System (1 Kit) / 6902096 Surgiscreen (3 x 10 mL) / 719100

Traditional Reagents (Stockton) 0.8% Suriscreen (3 x 10 mL) / 6902316 Affirmagen (2 x 10 mL) / 719210 ORTHO Coombs Control (1 x 10 mL) / 719810 ORTHO Confidence System (1 Kit) / 6902096 Surgiscreen (3 x 10 mL) / 719100

Effective Date: 02/01/2022 Page 3 of 6

The estimated value of the proposed action is $698,517.15.

Ordering Period 1 March 1, 2024, to February 28, 2025 Ordering Period 2 March 1, 2025, to February 28, 2026 Ordering Period 3 March 1, 2026, to February 28, 2027 Ordering Period 4 March 1, 2027, to February 29, 2028 Ordering Period 5 March 1, 2028, to February 28, 2029

The proposed IDIQ ceiling is

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

Blood bank analyzers and gel card reagents are required for medical providers and laboratories to conduct Antibody Identification Testing for various blood related treatments to include testing, typing, and blood transfusions. VANCHCS currently owns an Ortho ID-MTS Blood Bank Analyzer Machine which utilizes an advanced and proprietary gel technology. The Ortho Analyzer machine, gel cards and applicable consumables are manufactured by Ortho and FDA Certified. Items of this type must be FDA approved for patient use to maintain safety and effectiveness.

( ) 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):

Ortho-Clinical Diagnostic Gel Cards are made specifically for the facility-owned Ortho ID-MTS Analyzer that is currently installed at VANCHCS. Ortho systems and reagents are FDA approved to work in unison to provide patient results. Ortho-Clinical Diagnostics, Inc. is the sole source manufacturer and supplier of reagents and supplies for the proprietary ID-Micro Typing System Gel technology reagent products. Competing the requirement would result in a duplication of cost that is not expected to be recovered from competition if the facility is forced to replace existing equipment that is estimated to cost approximately .

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

Based on Market Research, there are no Small Businesses capable of performing or providing the requirement. Ortho-Clinical Diagnostics, Inc. is the OEM, and sole authorized provider of the

Effective Date: 02/01/2022 Page 4 of 6 products. They are the only source compatible with existing VANCHCS equipment, FDA Approved, and capable of providing this proprietary product. Ortho-Clinical Diagnostics, Inc. is a Large Business.

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

The requirement has not been previously acquired at the VANCHCS; however, it has been procured numerous times throughout the VA and at other government agencies. The facility already owns the analyzer machine required for use with the products needed with this procurement. Replacing existing equipment would result in a duplication of cost and effort and as such, a sole source award to the OEM represents the best value to the government at this time. The contractor is a Large Business and currently has an FSS Contract (V797-D-60637) in place to provide the ID-MTS Reagents needed for this procurement. Traditional Reagents are offered via the open market. There are five (5) other contractors, all Large Businesses, with FSS Contracts in place to provide Category 605-2A High Maintenance/Complexity Analyzers; however only Ortho-Clinical Diagnostics, Inc. is capable of providing reagents and consumables compatible with the VANCHCS owned blood bank analyzer machine. The Contracting Oficer will determine price fair and reasonableness by comparing quoted prices to previous purchase of similar items and to items included on the vendor’s VA NAC FSS.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

The VA Northern California Health Care System requires Blood Bank Gel Cards and consumables compatible with the existing facility owned Ortho Vision Blood Bank Analyzer Machine. The North American Industry Classification System (NAICS) Code is 334516 – Analytical Laboratory Instrument Manufacturing. The Product Service Code (PSC) is 6630 – Chemical Analysis Instruments.

The Trade Agreement Act applies to this procurement. According to the existing FSS Contract, Clinical Reagents and Gel Cards are manufactured in the United States of America.

A Veteran Small Business Certification (VetCert) search utilizing NAICS code 334516 yielded 199 service-disabled veteran-owned small business (SDVOSB)/ veteran-owned small business (VOSB) matches. However, there are no SD/VOSBs capable of providing the supplies.

A search of the SBA’s Dynamic Small Business Search (DSBS) utilizing NAICS 334516 and keywords Blood Bank Gel Card yielded 0 results.

A query of GSA’s eLibrary utilizing category 66 III – Clinical Hemotology Analyzers and SIN 605- 2A – High Maintenance/Complexity Analyzers revealed 6 Large Businesses with active contracts.

A query of the Department of Veterans Affairs (VA) National Acquisition Center (NAC) catalog using SIN 605-2A – High Maintenance/Complexity Analyzers showed the same six Large Businesses as listed with GSA.

A search of the Federal Procurement Data System (FPDS) with keywords Gel Cards yielded 94 results; with the most recent (36C24724F0005) being from 01 October 2023. This Delivery Order was completed by the Department of Veterans Affairs, NCO 7, in the amount of $83,768.44 and awarded to Ortho-Clinical Diagnostics, Inc., a Large Business. Of the 94 results returned by FPDS, 92 awards were made to Ortho-Clinical Diagnostics directly and 2 were made to Ortho’s parent company, Johnson and Johnson.

This was originally solicited on GSA, however, it was discovered that Traditional Reagents are offered via the open market while ID-MTS Reagents are offered via an FSS Contract. The majority of

Effective Date: 02/01/2022 Page 5 of 6 the procurement will be for Traditional Reagents available on the open market and the minority for ID-MTS Reagents on the FSS Contact, therefore the procurement will be completed via FAR Part 13.

Given the market research completed and the proprietary nature of the Ortho Blood Bank Analyzer system (machine, reagents, and gel cards, and other consumables); there is no reason to believe that there are any other compatible and FDA approved products on the market and capable of fulfilling this requirement regardless of procurement method.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition

All items under this requirement must be FDA approved to work in unison with the facility-owned equipment. Ortho-Clinical Diagnostics is the OEM, sole distributor, and provider for these products.

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

Ortho-Clinical Diagnostics, Inc. (JG5JF2JQJ121) 1001 Us Highway 202 Raritan, New Jersey 08869-1424 United States

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:

In the future, if another vendor is authorized to supply the products and/or an FDA approved alternative, their qualifications will be evaluated. The market will be assessed at least yearly, before the exercise of any option years, to determine if other vendors can provide the required items.

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

Laboratory Manager Pathology & Laboratory Medical Service VANCHSC, Sacramento Medical Center

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.

Amanda J. Hildreth DATE Contracting Officer Network Contracting Office (NCO) 21

Effective Date: 02/01/2022 Page 6 of 6

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.

Nicholas Kluch DATE Acting Director of Contracting Network Contracting Office (NCO) 21

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve it for other than full and open competition.

Date

Executive Director Regional Procurement Office West Head of Contracting Activity (HCA)