P03 JOFOC - Ventana apw 01102024.pdf

Attachment 7: Request for Sole Source Justification Format >SAT Ventana Reagents CLE

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DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C250-23-AP-0994

1. Contracting Activity: The Department of Veterans Affairs, Veterans Integrated Service

Network (VISN) 10, Louis Stokes Cleveland Veterans Affairs Medical Center (CLE VAMC) Network Contracting Office (NCO) 10.

Transaction: 541-24-2-775-0415

2. Nature and/or Description of the Action Being Processed: Network Contract Office (NCO)

10 intends to award a new, firm fixed price, one year contract for a Roche, Ventana reagents. The request is for reagents, bulks, kits, and consumables for the Pathology and Laboratory Medicine Service (PLMS) Ventana BenchMark Ultra and BenchMark Special Stain equipment. Roche Diagnostics Corp. reagents, bulks, kits, and consumables are needed for malignancy testing.

This procurement is 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.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The request is for reagents, bulks, kits, and consumables for the Roche Diagnostics Corp. Ventana BenchMark Ultra and BenchMark Special Stain equipment.:

(a) Description of Supplies:

These reagents are proprietary in nature as they are uniquely made for only Roche systems.

Material Pricing Group Material Description Material

BenchMark Special Stains Cleaning Kit 09476580001

US Companion Diagnos ASSY, Kit Pack, Pathway C-Kit 05278317001

US IHC ANCILLARIES AMPLIFICATION KIT, CE 05266114001

BLUING REAGENT 05266769001

ENDOGENOUS BIOTIN BLOCKING KIT, CE 05266092001

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HEMATOXYLIN 05266726001

KIT PACK, EBAR (US/EUROPE) 05248850001

Label, Blank, Flap, 540 Roll 05247829001

PROTEASE 1 05266688001

Ventana Antibody Diluent with Casein 06440002001

US IHC ANTIBODY BREA CONFIRM ANTI-KI-67 (30-9) RABBIT

MONOCLO

05278384001

US IHC ANTIBODY HV CINtec HISTOLOGY (50) 06680003001

VENTANA H. PYLORI (SP48) PAB 06425607001

VENTANA ROS1 (SP384) Rb Mono Primary Ab

08404160001

US IHC ANTIBODY ROUT anti-CD30 (Ber-H2) 07007841001

Anti-CEA (TF-3H8-1) PAB 05266947001

Anti-CHROMOGRANIN A (LK2H10) PAB 05267056001

Anti-Keratin, Pan (AE1/AE3 & PCK26) PAB 05267145001 anti-p40 (BC28) Mouse Monoclonal PAB 07394420001

Arginase-1 (SP156) PAb, Cell Marque 06732348001

CD31 (JC70) PAb, Cell Marque 05463475001

CD117(EP10) Rabbit Monoclonal PAB 08763909001

CD-138 (B-A38) PAb, Cell Marque 05269083001

CDX-2 (EPR2764Y) PAb, Cell Marque 05463491001

CEA (CEA31) PAb, Cell Marque 06433316001

Cell Marque, Cytokeratin 19 05269440001

CELL MARQUE, MUSCLE SPECIFIC ACTIN 05267161001

Cell Marque, PSA (ER-PR8) 05269334001

CONFIRM anti-ALK1 (ALK01) 05278147001

CONFIRM anti-CD3 (2GV6) Rabbit Monoclona

05278422001

CONFIRM anti-CD15 (MMA) PAB, IVD 05266904001

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CONFIRM anti-CD20 (L26) PAB 05267099001

CONFIRM anti-CD34 (QBEnd/10) Primary Ant 05278210001

CONFIRM anti-CD45 (LCA) (RP2/18) PAB 05266912001

Confirm anti-CD56 (123C3) mAB 05878519001

CONFIRM anti-CD68 (KP-1) Primary Antibod 05278252001

CONFIRM anti-Desmin (DE-R-11) PAb 05267005001

CONFIRM anti-Keratin (34E12) Mouse Mono 05479266001

CONFIRM anti-Melanosome (HMB45) Mouse M

05479282001

CONFIRM anti-S100 (polyclonal) PAB 05267072001

CONFIRM anti-Synaptophysin (SP11) Rabbit 05479304001

CONFIRM anti-Thyroid transcription fact 05479312001

CONFIRM Anti-Vimentin (V9) Primary Antib 05278139001

CONFIRM Calretinin (SP65) RbmAb 05992184001

CONFIRM Cytokeratin 20 Rabbit Mono 05587760001

CONFIRM Cytokeratin7 RabbitMono 05986818001

CONFIRM EMA (E29) Mouse mAb 05878900001

CONFIRM MART-1/melan A (A103) Primary An

05278350001

CONFIRM Neg. Contr. Rabbit Ig 05266238001

Cytokeratin 5/6 (D5/16B4) 06478441001

Cytokeratin (CAM 5.2) PAB 06478425001

Cytokeratin8&18(B22.1&B23.1),Cell Marque 05269776001

DOG-1 (SP31) PAb, Cell Marque 06433189001

Epithelial Related Antigen (MOC-31) PAB 06374409001

FITC ANTI-C1Q PRIMARY ANTIBODY 05267994001

FITC ANTI-C3 PRIMARY ANTIBODY 05267978001

FITC ANTI-FIBRINOGEN PRIMARY ANTIBODY 05267960001

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FITC ANTI-IGG PRIMARY ANTIBODY 05267919001

FITC ANTI-IGM PRIMARY ANTIBODY 05267935001

FITC ANTI-KAPPA PRIMARY ANTIBODY 05267943001

FITC ANTI-LAMBDA PRIMARY ANTIBODY 05267951001

GATA3 (L50-823) PAb, Cell Marque 07107749001

Hepatocyte Spec Ant(OCH1E5),Cell Marque 05269792001

Napsin A (Polyclonal) 05973805001

NEXES REAGENT, VENTANA, FITC ANTI-IGA 05267927001

PAX8 (EP331) PAb, Cell Marque 08313431001

PAX8 (MRQ-50) PAb, Cell Marque 06523927001

SATB2 (EP281) PAb, Cell Marque 08313415001

TTF-1 (SP141) PAB 06640613001

VENTANA anti-CD10 (SP67) 05857856001

VENTANA Anti-E Cadherin (36) 05905290001

VENTANA ANTI-P63 (4A4) 05867061001

WT1 (6F-H2) PAb, Cell Marque 05435706001

US IHC DETECTION iView DAB Detection Kit 05266157001

ULTRAVIEW UNIVERSAL AP RED DETECTION

KIT

05269814001 ultraView Universal DAB Detection Kit 05269806001

US IHC PREP KITS ASSY, Prep Kit, BM, BM XT, BM LT 05250935001

NEXES REAGENT DISPENSER CARD OPTION 3 05271860001

NEXES REAGENT DISPENSER CARD, OPTION

05271878001

Prep Kit 1, (100) BM, BM XT 05273617001

Prep Kit 3, BenchMark 05273633001

Prep Kit 5, BenchMark 05273650001

Prep Kit 26, BenchMark 05273889001

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Prep Kit 30 (250), BM, BM XT, BM LT 05276608001

Prep Kit 30, BenchMark 05273935001

US IHC/ISH BULKS 10X EZ PREP SOLUTION, 2L 05279771001

Benchmark ULTRA CC1 05424569001

BenchMark Ultra LCS 05424534001

Reaction Buffer Concentrate (10X) 05353955001

US INSTRUMENTS & SER BenchMark Special Stains Full System 06657389001

BENCHMARK ULTRA FULL SYSTEM PTO 05842689001

US SS ANCL & BULKS ALCIAN BLUE FOR PAS 05279194001

BENCHMARK SPECIAL STAINS WASH II 08309817001

BMK SPEC STAINS DEPAR SOLUTION (10X) 06523102001

BMK SPEC STAINS LIQUID COVERSLIP 06523072001

BMK SPEC STAINS WASH SOLUTION (10X) 06523099001

DIASTASE KIT 05279208001

SPECIAL STAINS CLEAN PLUS 06649327001

SPECIAL STAINS CLEANING KIT 05279313001

US SS COMPLEX STAINS Jones Staining Kit 05279348001

Reticulum II Staining Kit 05279399001

SPECIAL STAINS GMS II STAIN KIT PACK 05412749001

US SS SIMPLE STAINS AFB III Staining Kit 05279437001

ALC BLUE STAINING KIT PH2.5 05279186001

BenchMark Special Stain AFB Staining Kit 08432503001

Congo Red Staining Kit 05279429001

GIEMSA STAINING KIT 05279224001

MUCICARMINE STAINING KIT 05279275001

PAS STAINING KIT 05279291001

TRICHROME STAINING KIT 06521908001

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(b) ESTIMATED DOLLAR VALUE: $639,348.03

(c) REQUIRED DELIVERY DATE: Base with four (4) option years:

4. Statutory Authority Permitting Other than Full and Open Competition:

(X) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

FAR 13.5 Simplified Procedures for Certain Commercial Items: The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(2).

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition

Requires the Use of the Authority Cited Above (applicability of authority): Per FAR 11.105 Items peculiar to one manufacturer and 12.4-Unique Requirements Regarding Terms and Conditions for Commercial Items, Roche Diagnostics Corp., is uniquely qualified to provide the reagents, bulks, kits, and consumables based on the following:

Roche Diagnostics Corp. is the only source that can provide the specific reagents, bulks, kits, and consumables for the Ventana BenchMark Ultra and BenchMark Special Stain equipment currently in use by the PLMS at the CLE VAMC to perform malignancy testing. The reagents, bulks, kits, and consumables are specific to the equipment used and alternate contractors cannot provide acceptable reagent systems. The reagents, bulks, kits, and consumables are only available through Roche Diagnostics Corp. The contractor was selected based on the availability of the reagents, bulks, kits, and consumables that meet the specific parameters of the equipment (chemical and antibody make-up, configuration, size, shape, etc.). This ensures that the highest standard of accuracy and validation is maintained, as required by the College of American Pathologists (CAP) and The Joint Commission (TJC). This presents a compelling need to continue this procurement with Roche Diagnostics Corp.

• The reagents, bulks, kits, and consumables are proprietary to Roche Diagnostics Corp.;

• Roche Diagnostics Corp. has no VA distributors for the reagents, bulks, kits, and consumables;

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• The Ventana BenchMark Ultra and BenchMark Special Stain equipment is only compatible with Roche Diagnostics Corp. cartridges, in which currently PLMS uses;

• The Ventana BenchMark Ultra & BenchMark Special Stains can be connected through a single intuitive user interface;

• Automated IHC/ISH platform manages STAT requests with no impact to in-process slides;

• Exceptional throughput – 90 slides per 8-hour shift;

• Individual slide heaters which eliminate need to batch runs;

Accordingly, Roche Diagnostics Corp. is the only firm capable of providing the reagents, bulks, kits, and consumables described in Section three (3) above without the Veterans 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: Roche products are proprietary and has no distributors.

Rocheis the only responsible source to provide the reagents, test kits, and matierial needed for patient care.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The CO will use a comparison of the proposed prices to historical prices paid for the same/similar items and a comparison of the proposed price to the IGCE, as well as any of the other price analysis techniques identified in FAR 13.106-3(a)(2)(ii), as necessary, to determine the price to be fair and reasonable.

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

Reasons Market Research Was Not Conducted: Per FAR 10 Market Research, market research was conducted by the Contracting Officer and the service to identify available sources to meet the requirements as follows:

VetCert, OEM, Sources Sought, MSPV, DSBS, SAM.gov, National Contracts, Interagency Contract Directory, GSA, NAC, FSS, ECAT, CM, BIC, FPDS and the Internet were reviewed with the following results:

In accordance with January 9, 2023, advisory for VetCert usage, VetCert was queried, as required, using NAICS 334516. The search provided 114 results. The SDVOSB and VOSB vendors in the market research were contacted to see if they can provide or are able to provide comparable equipment to no avail. Veteran Small Business Certification (sba.gov)

The OEM, Roche, was contacted to receive a list of authorized distributors, with a concentration on SDVOSB and VOSB authorized distributors and to determine in what country(ies) the reagents are manufactured. The reagents are manufactured in America.

The OEM contact, Christina Frederick, stated that Roche, is the manufacturer of the beds, and currently do not use distributors for leasing their beds.

https://veterans.certify.sba.gov/

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A search was conducted in the Medical Surgical Prime Vendor (MSPV) Contracts:

Equipment Home (dla.mil) which resulted in no results.

A search was conducted in Small Business Administration (SBA) Dynamic Small Business Search (DSBS) SBA - SBA Search Results under NAICS CODE 334516 and key words Ventana.

A search was conducted on SAM SAM.gov | Search under key words Ventana with all Roche as the result.

A search was conducted on National Strategic Source Listing Medical/Surgical Prime Vendor (MSPV) Program - Office of Procurement, Acquisition and Logistics (OPAL) (va.gov) which resulted in no results.

A search was conducted on the Interagency Contract Directory Interagency Contract Directory Portal with key words Ventana which resulted in no results.

A search was conducted on GSA eLibrary Search Results (gsaadvantage.gov) with key words Ventana which resulted with Roche.

A search was conducted on the National Acquisition Center VA National Acquisition Center Contract Catalog Search Tool which resulted in no results.

A search was conducted in Federal Procurement Data System (FPDS) FPDS-NG ezSearch with key words Ventana with several results showing Roche.

A search was conducted on Electronic Catalog (ECAT) DMMonline (dla.mil) with key words Ventana which resulted in no results.

A search was conducted on Category Management (CM) Quick Decisions Dashboard Equipment Home (dla.mil) with key words Ventana which resulted in no results.

IAW MB Memorandum M-19-13 Category Management: Making Smarter Use of Common Contract Solutions and Practices, this requirement cannot be satisfied through Best in Class contracting (BIC).

A search was conducted in The U.S. Food & Drug Administration (FDA) Search | FDA with key words Ventana which resulted in no results.

A search of the internet Ventana - Search (bing.com), with “Ventana” located only Roche, Inc. as the contractor.

2. Results of Market Research:

https://www.medical.dla.mil/Portal/Equipment/EquipmentOverview.aspx https://dsbs.sba.gov/search/dsp_profilelist.cfm?RequestTimeout=180 https://sam.gov/search/?page=1&pageSize=25&sort=-modifiedDate&sfm%5BsimpleSearch%5D%5BkeywordRadio%5D=ALL&sfm%5BsimpleSearch%5D%5BkeywordTags%5D%5B0%5D%5Bkey%5D=%22CEPHEID%20REAGENTS%22&sfm%5BsimpleSearch%5D%5BkeywordTags%5D%5B0%5D%5Bvalue%5D=%22CEPHEID%20REAGENTS%22&sfm%5Bstatus%5D%5Bis_active%5D=true https://www.va.gov/opal/sac/mspv.asp https://www.va.gov/opal/sac/mspv.asp https://www.contractdirectory.gov/contractdirectory/error.html https://www.contractdirectory.gov/contractdirectory/error.html https://www.gsaadvantage.gov/advantage/ws/search/advantage_search?q=0:8envella%20beds&db=0&searchType=0 https://www.vendorportal.ecms.va.gov/NAC/MedSurg/List?cboContractNumbers=&cboBPAContractNumbers=&cbo_fss_schedule_number=&cboContractorName=&cboBOAContractNumbers=&cbo_Contract_Types=&cbo_SIN_Number=&cbo_SIN_Description=&cbo_SIN_Id=&txtCriteriams=CEPHEID+REAGENTS&Sort=1&Count=20&search=Search https://www.vendorportal.ecms.va.gov/NAC/MedSurg/List?cboContractNumbers=&cboBPAContractNumbers=&cbo_fss_schedule_number=&cboContractorName=&cboBOAContractNumbers=&cbo_Contract_Types=&cbo_SIN_Number=&cbo_SIN_Description=&cbo_SIN_Id=&txtCriteriams=CEPHEID+REAGENTS&Sort=1&Count=20&search=Search https://www.fpds.gov/ezsearch/search.do?indexName=awardfull&templateName=1.5.3&s=FPDS.GOV&q=envella+beds https://www.medical.dla.mil/SSO/login.sfcc?certorform&TYPE=16777344&REALM=-SM-WAM%20Application%20Component%20%5b07%3a39%3a17%3a7421%5d&SMAUTHREASON=0&METHOD=GET&SMAGENTNAME=-SM-M4vg6BFFvica%2bSuDCMp6A9PSR6TZXW%2fx2%2fsrCg9%2fbYTd6CFIeUz6XcRmT6h3NiCy&TARGET=-SM-https%3a%2f%2fwww%2emedical%2edla%2emil%2fWAM%2fhome%2findex https://www.medical.dla.mil/Portal/Equipment/EquipmentOverview.aspx https://www.fda.gov/search?s=easyfit+trend+max https://www.bing.com/search?q=envella+beds&cvid=60dd660c0d6445d4a9ec5969926b4ce7&gs_lcrp=EgZjaHJvbWUyBggAEEUYOTIGCAEQRRg8MgYIAhBFGDwyBggDEEUYPNIBCDY2MjZqMGo0qAIAsAIA&FORM=ANAB01&PC=U531

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The NMR does apply to NAICS 334516, and SBA has not provided a class waiver for NAICS 334516 Ventana.

There are no Buy American Act (BAA) and a Trade Agreement Act (TAA) issue to be concerned with. This system is currently made in America.

Based on the market research conducted, no two or more VetCert verified and capable SDVOSBs or VOSBs were identified and appeared capable of performing the requirement. The VA Rule of Two and SBA Rule of Two cannot be met.

FITARA is not needed for this requirement, it is not IT related.

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

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

Roche Diagnostics

Elizabeth Burden

(317) 627-3717 elizabeth.burden@roche.com

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: Due to the technical risks, compatibility requirements of the existing equipment, and proprietary rights of Roche, there are no ways to eliminate the restriction of this requirement. If a future requirement for the same solution is identified, a full and open competition after exclusion of sources, shall be promoted amongst Roche resellers if there are subsequent acquisitions.

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13. 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.

For Rosado Mayra Laboratory Manager/Assistant Chief of P&LMS Louis Stokes Cleveland VAMC NCO 10

14. 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.

Rachelle J. Hamer Contracting Officer Network Contracting Office (NCO) 10

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.

Adam P. Weber Branch Chief – Supply Team 1 Network Contracting Office (NCO) 10 https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx