JUSTIFICATION_Redacted.pdf

Simplified Acquisition Procedures for Certain Commercial Items Sole Source Justification

Effective Date: 02/01/2022 Page 1 of 5

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR

CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID:

RPOW JOFOC Tracker:

1. Contracting Activity: Department of Veterans Affairs, Network Contract Office

(NCO) 21 on behalf of Veterans Integrated Service Network (VISN) 21, San Francisco VA Medical Center (VAMC), 4150 Clement Street, San Francisco, CA 94121-1563 2237:

2. Nature and/or Description of the Action Being Processed: This procurement is for reagents, consumable supplies and maintenance services of bioMerieux analyzers in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 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. This will be a five-year Indefinite Delivery / Indefinite Quantity, firm fixed price contract.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The estimated total value for five ordering periods is , with estimated for each year. IDIQ ceiling is estimated as .

Period of Performance:

Ordering Period 1 – 10/01/2025-09/30/2026 - Ordering Period 2 – 10/01/2026-09/30/2027 - Ordering Period 3 – 10/01/2027-09/30/2028 - Ordering Period 4 – 10/01/2028-09/30/2029 - Ordering Period 5 – 10/01/2029-09/30/2020 -

Supplies and services required as a part of this procurement are as follows with services being the minor element of estimated value.

4705396

FULL SERVICE AGREEMENT BTA VIRTUO

4705363 FULL SERVICE AGREEMENT BacT/ALERT 3D 0120

4705544 FULL SERVICE AGREEMENT VITEK 2 0060 1

4705505

REPAIR CENTER COVERAGE PREVI

COLOR V2

4705564 FULL SERVICE AGREEMENT VITEK MS 1

4705876 FULL SERVICE AGREEMENT MYLA PC 1

Effective Date: 02/01/2022 Page 2 of 5

259789 BACT/ALERT SA (PLASTIC) 100 BTLS 1

259790 BACT/ALERT SN (PLASTIC) 100 BTLS 1

414997 MYCO ANTIMICROBIAL KIT 100 BTLS 10

419744 BACT/ALERT MP 100 BTLS 10

21347 ANC TEST KIT VTK2 20CARDS 6

21341 GN TEST KIT VTK2 20CARDS 96

21346 NH TEST KIT VTK2 20CARDS 6

21342 GP TEST KIT VTK2 20CARDS 30

21343 YST TEST KIT VTK2 20CARDS 10

420915 AST-ST02 TEST KIT 20 CARDS 8

415670 AST-GP75 TEST KIT 20 CARDS 96

423331 AST-YS09 TEST KIT 20 CARDS 12

424703 AST-N809 TEST KIT 20 CARDS 120

29582 ACETONE SAFRANIN-A (NA) 20

29586 IODINE-B (NA) 20

29587 CRYSTAL VIOLET-C (NA) 20

412240 AMOXI/CLAV 2/1 XL 256 US S30 2

412274 CEFIXIME IX 256 US S30 1

412272 CEFEPIME PM 256 US S30 2

412250 AMPI/SULB 2/1 AB 256 US S30 6

412252 AMPICILLIN AM 256 US S30 1

412256 AZITHROMYCIN AZ 256 US S30 1

412262 BENZYLPENICIL PG 256 US S30 2

412258 AZTREONAM AT 256 US S30 1

412264 BENZYLPENICIL PG 32 US S30 2

412292 CEFTAZIDIME TZ 256 US S30 1

412302 CEFTRIAXONE TX 32 US S30 2

412310 CIPROFLOXACIN CI 32 US S30 2

412314 CLINDAMYCIN CM 256 US S30 1

412323 DAPTOMYCIN DPC 256 US S30 6

412373 IMIPENEM IP 32 US S30 1

412392 LEVOFLOXACIN LE 32 US S30 1

412407 MINOCYCLINE MC 256 US S30 4

412410 MOXIFLOXACIN MX 32 US S30 1

412431 OXACILLIN OX 256 US S30 2

412449 RIFAMPICIN RI 32 US S30 1

412470 TETRACYCLINE TC 256 US S30 1

412486 VANCOMYCIN VA 256 US S30 2

414445 CEFTOLOZANE/TAZO C/T US S30 4

419046 CEFTAZIDIM/AVIBACTAM US S30 4

421167 PIPERACILLIN/TAZOBACTAM (P/T) US S30 1

Effective Date: 02/01/2022 Page 3 of 5

424315 ETEST TIGECYCLINE TGC S30 US 1

412401 MEROPENEM MP 32 US S30 1

412331 ERTAPENEM ETP 32 US S30 1

424001 ETEST CEFTAROLINE CPT S30 US 1

423531 ETEST FOSFOMYCIN FO US S30 1

20100 API 20 E 25STRIPS 6

43841 CHROMID MRSA 20 PLT US 85

411071 VITEK MS-CHCA 11

410893 VITEK MS-DS 8

411072 VITEK MS-FA 6

411721 VITEK-MS SILICA ORANGE GEL 1

415680 VITEK MS MOULD KIT 4

415659 VITEK MS MYCOB/NOCARDIA KIT 2

421564

VITEK MS LIQUID MYCO SUPPLEMENTAL

KIT

421560

ETEST MEROPENEM/VABORBACTAM MEV

US S30

420927 IMIPENEM RELEBACTAM IPR US S30 1

A100760 SAMPLOK ADAPTER CAP 3 (X600) 1

A100722 SAFETY SUBCULTURE UNIT 2 (X288) 3

69285 UNSENSITIZED TUBES 1X2000 5

21219 ACCESSORY KIT VTK2 PIP/DIL 30

93059 DENSICHEK CALIBRATION STANDARD 3

V1200 SMALL DISPENSER 1 1

21255 KIT DENSICHEK PLUS STANDARDS 1

417820

VITEK 2 0.45% SODIUM CHLORIDE

DILUENT

423719 BTL, 0.45% SALINE SOLUTION 0.5LX18 4

414291 NOZZLE CLEANING SOL 500ML (NA) 10

423546 VITEK PICKME PEN 1

423551 VITEK PICKME NIBS (qty 1728) 2

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

Effective Date: 02/01/2022 Page 4 of 5

( ) 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):

The VITEK 2 system is a fully automated bacterial identification and susceptibility testing system that uses fluorescence-based technology. The VITEK 2 platform offers quality control testing solutions for fast and accurate microbial identification.

The supplies will include bioMerieux consumables which includes E-Test, test kits and various other supplies. The service will include VITEK MS Low usage, and a Virtuo (A Unit) Full-Service Plan. The VAMC owns the VitekMS, Virtuo, BacT/Alert and MYLA which are highly specialized systems manufactured by bioMerieux.

bioMerieux is the only vendor that can provide the required reagents and a service contract for our VA-owned equipment. Transition to any other reagents would require significant financial investment and significant duplication of costs for new analyzers and could result in less effective or consistent testing. Accordingly, bioMerieux is the only firm capable of providing the supplies and services described in Section III above without the Veteran’s Health Administration experiencing substantial duplication of cost that could not be expected to be recovered through competition.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: As only bioMerieux can provide the necessary supplies and services, this will be a non-competetive procurement.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Quoted prices will be reviewed against prices previously paid by the government, including a comparison of historical increase in cost year-over-year.

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

Statement of the Reasons Market Research Was Not Conducted: Initial market research was conducted with FPDS reviewed under 36C26124P0023 as a sole source to bioMerieux in the amount for supplies and services for existing equipment on 10/01/2023. Also reviewed was 36C26125P0029, a sole source to bioMerieux in the amount of , awarded on 10/01/2024 for the Las Vegas VA Medical Center. 36C26125P0005 was reviewed as the most recent San Francisco award, a sole source to Biomerieux in the amount of .

The NAC was reviewed with no significant results and an understanding that the elements of this requirement are not included on existing bioMerieux contracts.

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

There are no other facts.

Effective Date: 02/01/2022 Page 5 of 5

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

bioMerieux Inc, HCNVCMEG9NL6, Large Business

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: The agency will continue to conduct market research to identify opportunities for a competitive procurement in the future.

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.

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.

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.