JOFOC.pdf

OFOC SOP Revision 09 Page 1 of 6 Original Date: 03/22/11 Revision 09 Date: 04/17/2020

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: VA241-20-AP-2602

Contracting Activity: Department of Veterans Affairs, VISN 1, VA Connecticut Healthcare System, 950 Campbell Street, West Haven CT 06516

PR-IFCAP #s: 402-21-1-7455-0007, 405-20-4-7455-0418, 523-20-4-7455-0258, 608-20-4-7455-0070, 20-4-7455-1912, 689-20-4-7455-1941

Nature and/or Description of the Action Being Processed: This request is for a one-year Blanket Purchase Agreement (BPA) for Biofire Reagents and Supplies. A BPA is the best option for this requirement. It allows each individual Healthcare System in the VISN to order as needed and provide funding specific to their site. Indefinite Delivery Indefinite Quantity contracts are more restrictive in nature and would not fit for this requirement because of required delivery dates, and or quantities.

This

$998,402.80 for the period 8/19/20 through 8/18/21. The reagents and consumables procured from Biofire Diagnostics Incorporated are required products for the Film Array Respiratory Pathogen PCR testing equipment that is used at all VISN 1 Healthcare System Sites.

The sites listed will order the product as needed.

VA Healthcare System, 1400 VFW Parkway, West Roxbury, MA 02132 VA Healthcare System, 163 Veterans Drive, White River Junction, VT 05009 VA Healthcare System, 1 VA Center, Augusta, ME 04330 VA Healthcare System, 718 Smyth Road, Manchester, NH 03104 VA Providence Healthcare System, 830 Chalkstone Avenue, Providence, RI 02908-4799 VA Healthcare System, 950 Campbell Avenue, West Haven, CT 06516 VA Healthcare System, 555 Willard Avenue, Newington, CT 06111

The Film Array Respiratory Pathogen PCR sensitivity, specificity and reliability make it the respiratory virus test of choice. The Film Array Respiratory Pathogen Panel PCR tests for 20 respiratory viruses and bacteria. The Film Array instrument integrates sample preparation, amplification, detection and analysis into one system that requires 2 minutes of hands-on time and has a total run time of about 1 hour. All the reagents needed are included in the kit. Other test kits being purchased are the BCID (Blood Culture ID), GI Panel, Pneumo panel, Pneumo Panel and ME Panel.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: All Healthcare System sites in the VISN will be able to order as needed for their individual site. The below are ONLY estimates. In doing so, each individual laboratory site participating may order products via Electronic Data Interchange (EDI), telephone, facsimile or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and referencing the PO# and any special instructions. Volumes are estimated quantity derived from the previous history and anticipated volumes, but the government does not guarantee volumes as listed; they are estimates only.

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Revision 09 Date: 04/17/2020

Part Number Description- Reagent kits VISN 1 Est. Qty.

Annual

423738 Biofire RP 2.1 panel w/ Covid 30 tests/kit

RFIT-ASY-0129 Film Array RP2.0 tests 30 test/kit 27 RFIT-ASY-0124 Film Array RP panels 30 tests/kit 1 RFIT-ASY-0126 Film Array BCID Panel 30 tests/kit 43 RFIT_ASY_0147 Film Array BCID2 panel 30 tests/kit 1 RFIT-ASY-0116 Film Array GI Panel 30 tests/kit 34 RFIT-ASY-0118 Film Array ME panel 30 tests/kit 1 RFIT- ASY-0144 Film Array Pneumo Panel 30 tests/kit 1

RP-FLM-ASY-

Kit-Verification panel for RP panel 30 tests/kit

GI-FLM1-ASY-

Kit-Verification panel for GI FLM1-ASY- 013030 tests/kit

423640 BCID2 Verification Kit 1 423642 BCID2 verification kit (live organism) 1 FLM1-ASY-0145 ME Verification kit -FLM1-ASY-0145 1 FLM1 -ASY-0150 Pneumo Verification Kit- FLM1-ASY-

Estimated cost of this agreement: $998,402.80, Period of Performance: 8/19/20-8/18/21.

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;

FAR13.5 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): In accordance to FAR 6.302-1. The reagents and supplies are specific to the manufacturer and will only work on their testing equipment. Biofire Diagnostics Incorporated provided a sole source proprietary letter for the reagents specific to their equipment, and confirmed they had no distributors. No other company can provide their reagents. The reagents are FDA approved, and have gone through a 4 – 6-month

OFOC SOP Revision 09 Page 3 of 6

Revision 09 Date: 04/17/2020 validation process that verifies test results. Products listed in section 3 of this document. Additional market research was conducted as will be discussed in section 8 of this document. The Film Array assay’s sensitivity, specificity and reliability make it the respiratory virus test of choice. All the reagents needed are included in the kit. The Film Array multiplex PCR platform is easy to use and detects and differentiates 20 viral and bacterial pathogens. This testing is already in use in the Virology Lab (Reference Lab for VISN 1 Labs) at VACT and these assay kits and quality controls are required in order to provide a continuum of service for VISN 1 veterans. This testing has already been validated and implemented so no further cost would be incurred. This request is to ensure that the kits are available, provide ease of ordering, and fair pricing for the VISN 1 Labs so that this service continues without interruption. The same reasoning applies to the other reagent kits listed in section 3 of this document.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: As indicated above, Biofire Diagnostics Incorporated is the only provider for reagents and consumables to their Film Array Testing System. No other company reagents will work on their equipment. Market Research was conducted to verify Biofire’s assertion. Request for information (RFI) was sent to all (6) contractors on the Vendor Information Page (VIP) pursuant to NAICS 325413 (In-Vitro Diagnostic Substance Manufacturing). No responses were received by the vendors listed on VIP. Request for Information (RFI) was sent to (10) contractors under Federal Schedule 65 VII: 555-6. Received responses from the following vendors; Accelerate Diagnostics Inc (SB) and AvMedical LLC (SDVOSB). They were not able to provide the reagents and supplies needed.

Biofire Diagnostics Incorporated did not respond to the GSA RFI notice because the person that handles the requests no longer works at the company per Mr. Jim Otty, Territory Sales Manager for Biofire Diagnostics Inc. The RFI was sent directly to him for reply. Per Mr. Otty, the products are available only through his company. Mr. Ethan Suttles, Account Corporate Director for Biofire provided a response, and a breakdown of products that were open market and on Federal Schedule.

A Sources Sought Notice was posted on SAM.Beta.gov. Received one response from Accumen (Large Business). They indicated they could provide the reagents and supplies. Unfortunately, they had to rescind their offer. They did not look thoroughly at the announcement and its attachments as indicated in section 3 of this document.

Name of Offeror Name and Address of Building

Biofire Diagnostics Inc. 515 Colorow Drive, Salt Lake City, UT 84108-1248

These Respiratory panels are in current use at all VISN 1 sites. The inclusion of Covid-19 on this platform gives the lab greater capacity and flexibility to perform testing that provides valuable information for the treatment of veteran patients. The volume of testing is expected to rise significantly in the coming months, as shown from VA leadership’s geographical analysis of increased positive testing results in Florida, New York and New Jersey. Their analysis projects an increase in people testing positive along the East Coast and New England as the pandemic progresses. Providing VISN1 labs greater flexibility to perform these tests quickly and on site is crucial to respond and serve veteran patient needs.

Additional research was conducted, this is a follow-on to reagents and supplies currently being used at all the VISN 1 Healthcare System Sites. Searches of the following; Vendor Information Page (VIP), General Services Administration (GSA), Federal Procurement Data System (FPDS), SAM.Beta.gov, FedDataCheck, Internet. In search the Vendor Information Page (VIP) using NAICS 325413, six contractors (6) were found. A Request for Information was sent to all. No responses were received.

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Revision 09 Date: 04/17/2020

GSA RFI was posted, and sent to the following vendors under schedule 65 VII 555-6; Accelerate Diagnostics Inc 36F79718D0391, Fisher Healthcare 36F79718D0395, Luminex Corporation 36F79719D0244, 4MD Medical Solutions LLC 36F79720D0019, Avkare V797D-30052, Biofire Diagnostics, LLC V797D-30085, Abbott Laboratories V797D-40222, Volu-Sol V797D-50405, Biopool US, INC. DBA Trinity Biotec V797D-70113, Cardinal Health 200 LLC V797P-2210D. Received responses from Accelerate Diagnostics Inc. (SB) and AvMedical LLC (SDVOSB). They could not provide the products. Biofire did not respond due to their contact person for GSA no longer working for the company. An e-mail was sent directly to Mr. Otty due to several of the products being found on their GSA Schedule.

Searched the Federal Procurement Data System (FPDS) for NAICS and Reagents. Several companies were found that sold equipment and reagents. Unfortunately, they were specific to their companies, and could not be used interdependently. Example, the Abbott M2000 uses assay testing chemical specific to its equipment and would not work on the Film Array & Torch Systems.

Sources Sought Notice responses; Biofire Diagnostics LLC and Accumen. Biofire was able to provide all the products listed. Initially, Accumen claimed that they could until they took another look at what the reagents needed to be tested on. At which time, they declined to participate in any future requests.

Accumen (Large) 2111 E. Highland Avenue, Suite 145 Phoenix, AZ 85016 Eric Jurinic, Vice-President – Corporate Supply Chain Mobile: 312.848.5453

FedDataCheck report was pulled on Biofire Diagnostics Inc. It showed a history of providing not only equipment to the VA, but also the reagents for it. Internet search was conducted for Accumen and Abbott. Both companies were national and offered similar products pursuant to their individual company. However, their products were not interchangeable in use.

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

Reasonable: The reagents and consumables are required for testing on the Film Array System for all VISN 1 stations. The initial BPA had a ceiling of 5 million over 5-years, which included equipment and reagent costs. At this time, only reagents are required. Nine (9) items are open market, and five (5) are on schedule. The estimated cost to change out equipment and outsource would far exceed the amount indicated. Additionally, the transition from one contractor to another would take a minimal of 4 – 6 months, and cause patient delays in testing. We are still in the grip of COVID, and with flu season starting in the next several months. In addition, Biofire’s is providing a 20% discount on several of the high-volume items used, and 5% off the GSA Schedule pricing for items (V797D- 30085). VISN 1 Network Consolidated Laboratory has coordinated with all site managers to determine their expected usage for 1-year of reagents and consumables at a cost of $998,402.80.

Additionally, most of the equipment is owned by the sites, or rented. Because of the ordering capacity of a VISN BPA, the pricing is better than individual site purchasing of the products. All product will be ordered as needed per VA Healthcare System Sites, and invoices certified by point of contact Laboratory Managers.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: As the subject matter experts (SME), the Program Director

OFOC SOP Revision 09 Page 5 of 6

Revision 09 Date: 04/17/2020 for VISN 1 Network Consolidation Laboratories with coordination from the doctors agree to the following. Biofire Diagnostics are FDA cleared/approved for patient testing. These reagents are for continued continuity and standardization within the VISN 1 laboratories. The sites listed under this agreement either own or currently have rental equipment for this testing. VISN 1 has other PCR technology vendors already in use but those are for single analyte testing. Manufacturer Biofire Diagnostics is the sole distributor for these kits and this testing has already been validated .

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: Per Sole Source letter provided on July 13, 2020 by Ethan Suttles, Corporate Account Director for Biofire Diagnostics Incorporated, the reagents and supplies are proprietary to Biofire Diagnostics Incorporated, and their equipment and products.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Accumen initially wanted to participate but rescinded their offer after thoroughly reading the Sources Sought Notice.

They realize they could not provide the specific reagents necessary. Biofire Diagnostics Incorporated responded that they could provide all the products listed in section 3 of this document.

Biofire Diagnostics LLC (Large Business) 515 Colorow Drive Salt Lake City, UT 84108-1248

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 one year Blanket Purchase Agreement that gives the service time to assess new products for respiratory testing, and the equipment associated. We will continue to keep an eye on the market, in case other competitors become FDA approved and offer an advantage to VA in pricing or capability. As for now, Biofire is the sole manufacturer and distributor of the Biofire Film Array reagents and supplies, that is FDA approved. If the service does, consider changing contractor’s after next year, the following factors will be addressed by the service; transition of equipment & reagents, validation, training of staff, time, cost, and disruption/delays in patient care.

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.

David McElwee Date Program Support for VISN 1 Network Consolidated Laboratories 940 Belmont Street, Brockton MA 02301

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.

David G.

McElwee 142454

Digitally signed by David G. McElwee 142454 Date: 2020.07.29 09:55:59 -04'00'

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Revision 09 Date: 04/17/2020

Julie Lemire Date Contracting Officer, Network Contracting Office 1 718 Smyth Road, Manchester, NH 03104

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

Linda J. Ward Date Branch Chief – Network Contracting Office 1, Supply Team - South

718 Smyth Road, Manchester, NH 03104

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 recommend approval (if over $68 million) or approve ($700K to $68 million) for other than full and open competition.

Joseph P. Maletta Date Executive Director, Regional Procurement Office - East (RPO-E) Veterans Health Administration

Julie A. Lemire 149432 Digitally signed by Julie A. Lemire 149432 Date: 2020.07.29 10:51:00 -04'00'

Linda J. Ward 155235 Digitally signed by Linda J. Ward 155235 Date: 2020.07.29 12:05:17 -04'00'

Jordan, Curtis M.

(RPO)

Digitally signed by Jordan, Curtis

M. (RPO)

Date: 2020.08.10 12:26:37 -06'00'