P03 36C241-21-AP-2084 - LSJ - BioFire Diagnostics Reagents - Signed.pdf

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C241-21-AP-2083

(1) Contracting Activity: Department of Veterans Affairs, Regional Procurement Office East, Network Contracting Officer 1 (New England) on behalf of VISN 1 Network Consolidated Laboratory (NCL) for all VISN 1 Medical Centers.

(2) Description of Action: This acquisition is conducted under the authority of the Multiple-Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501).

This request is for a 5-year firm-fixed price BPA with a performance period of 8/18/21 through 8/17/26 and will have yearly funded Task Orders. This is a follow-on to BPA # 36C24120N0957, current FSS# V797D-30085 expiring 8/17/2021.

Order against: FSS Contract Number: _V797D-30085__

Name of Proposed Contractor: BioFire Diagnostics LLC.

Street Address: 515 Colorow Drive

City, State, Zip: Salt Lake City, Utah 84108

Phone: 801-736-6354

(3) Description of Supplies or Services:

The estimated value of the proposed action is $6,365,161

The reagent/consumable items procured from BioFire Diagnostics LLC are required products for the Film Array Respiratory Pathogen PCR testing, including but not limited to SARS-CoV2, in the following VISN 1 sites: VA Boston, VA White River Junction, VA Togus, VA Manchester, VA West Haven and VA Newington. The Film Array Respiratory Pathogen PCR sensitivity, specificity and reliability make it the respiratory virus test of choice. The FilmArray Respiratory Pathogen Panel PCR tests for 22 respiratory viruses and bacteria. The FilmArray instrument integrates sample preparation, amplification, detection and analysis into one system that requires only 2 minutes of hands-on time and has a total run time of about 45 minutes. All the reagents needed are included in the kit. Other test kits being purchased are the BCID (Blood Culture ID), Gastrointestinal Panel, Pneumonia panel, and Meningitis/Encephalitis Panel.

Item Material Number Est. Annual Qty.

in Kits

BIOFIRE FILMARRAY RP2.1 Panel, 30 Tests (De Novo) 423742 223 RP2.1 Start-Up Verification Kit 423743 1 Film Array BCID Panel 30 tests/kit RFIT-ASY-0126 31 BIOFIRE FILMARRAY Blood Culture Panel BCID2, 30 Tests RFIT-ASY-0147 11 BCID2 Verification Kit 423640 4 BCID2 Verification Kit (Live Organism) 423642 4 BIOFIRE FILMARRAY Gastrointestinal Panel, 30 Tests RFIT-ASY-0116 61 GI Verification Kit FLM1-ASY-0130 3 BIOFIRE FILMARRAY Meningitis/Encephalitis Panel Tests RFIT-ASY-0118 1 ME Verification Kit FLM1-ASY-0145 1 BIOFIRE FILMARRAY Pneumo Panel, 30 Tests RFIT-ASY-0144 1 Pneumo Verification Kit FLM1-ASY-0150 1

(4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

FAR 8.405-6(a)(1)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized.

This is a sole source request for FDA approved reagents to perform required patient testing on our VA owned BioFire instruments, contract numbers 36C24120P0567 awarded on 5/8/2020 for instruments.

Contract# 36C24120N0957 awarded on 8/17/2020 for reagents and 36C24120P0946 awarded on 8/27/2020 for more instruments for the VISN.

BioFire Diagnostics’ reagents 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 already own the equipment for this testing. VISN 1 has other PCR technology vendors already in use but those are for single analyte testing. BioFire provides respiratory panel results that have up to 22 viruses and bacteria it can identify at once. Emergency Departments at sites benefit greatly from the ability to gain this information in under an hour. These results are critical to the ability of providers to make real time decisions regarding how to treat our Veterans. Manufacturer BioFire Diagnostics is the sole distributor for these kits and this testing has been validated.

FAR 8.405-6(a)(1)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.

FAR 8.405-6(b): Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition. The proprietary data is:

These are “direct replacements” parts/components for existing equipment.

The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing.

(5) Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination:

The VISN 1 participating sites own BioFire Torch equipment purchased via contracts 36C24120P0946 and 36C24120P0567 to increase testing capacity for respiratory pathogens and SARS-CoV-2 during the COVID-19 pandemic. The reagents and supplies are specific to the manufacturer and will only work on their testing equipment. BioFire Diagnostics Incorporated provided a proprietary letter for the reagents.

The BioFire 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 22 viral and bacterial pathogens.

This testing is already in use in VISN 1 Laboratories and these assay kits and quality controls are required to provide a continuum of service for VISN 1 veterans.

This testing has already been validated per clinical laboratory regulatory requirements 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 all the reagent kits listed in section 3.

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted.

Technical Market Research was conducted when the instruments were initially purchased, and validation studies have already been performed on the instrumentation associated with these reagents and supplies. Any duplication of this process would incur a large expense by the government as well as tech time, etc. to adopt any other method. BioFire is the sole source for BioFire reagents. Reagents from other vendors are not interchangeable and cannot be used with BioFire equipment. Substitutions are not allowed.

(7) Any Other Facts Supporting the Justification:

This testing is currently in place at VISN 1 Laboratories. No other equipment would be required to continue with this same methodology. The results are reliable and accurate, and the clinicians are satisfied with this method. The COVID-19 pandemic has not ended, therefor there is a need to continue uninterrupted, timely respiratory pathogen testing, to include SARS-CoV-2, for symptomatic patients presenting to our facilities for care. The Network Consolidated Laboratory will be requesting a BPA agreement with option years based on the Federal Supply Schedule contract with BioFire Diagnostics, V797D-30085.

(8) A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made:

A review of the technology and methodology will be performed prior to the end of this agreement to determine if any other system or method would be more beneficial to the Government for their patients.

(9) 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. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. (This signature is the requestor’s supervisor, fund control point official, chief of service or someone with responsibility and accountability.)

SIGNATURE DATE

NAME TITLE SERVICE LINE/SECTION

FACILITY

(10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

CONTRACTING OFFICER/DESIGNEE’S SIGNATURE DATE

Julie Lemire Contracting Officer Manchester VAMC

NAME AND TITLE FACILITY/NCO/PCO

Janet Lane NCL Program Director PLMS

VISN 1

Janet L. Lane 150483 Digitally signed by Janet L. Lane 150483 Date: 2021.05.24 11:39:20 -04'00'

Julie A. Lemire 149432 Digitally signed by Julie A. Lemire 149432 Date: 2021.05.26 07:36:46 -04'00'

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $750K):

I certify the justification meets requirements for other than full and open competition.

SIGNATURE DATE

Tammy Fox

NAME

HIGHER LEVEL APPROVAL (Required for orders over $750,000):

c. VHA RPO HCA Review and Approval (over $750,000 to $75 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for restricting consideration of the Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.

NAME

Joseph Maletta Executive Director DATE VHA Head of Contracting Activity (HCA)

Tammy A Fox 706200

Digitally signed by Tammy A Fox 706200 Date: 2021.06.01 12:30:18 -04'00'

JOSEPH MALETTA

1347841

Digitally signed by JOSEPH

MALETTA 1347841

Date: 2021.06.01 15:51:02 -04'00'