P03_Limiting_Sources_Justification_HCA_SIGNED.pdf

VHAPM Part 808.405-6 Limiting Sources Page 1 of 5 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: VA252-18-AP-2788

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

Network (VISN) 12, Great Lakes Acquisition Center (GLAC) on behalf of VISN 12 Pathology & Laboratory Medicine Service (PLMS) for locations throughout the VISN.

Various purchase requests.

2. Description of Action: This acquisition is conducted under the authority of the Multiple- Award Schedule Program (41 U.S.C. 251 and 40 U.S.C. 501). This is a limited sources justification to establish a new firm-fixed price Blanket Purchase Agreement (BPA) against FSS contract V797D-30085 with Biofire Diagnostics, LLC for reagent pouches and ancillary supplies to support the Film Array instruments purchased for the PLMS locations at Edward Hines Jr. VA Hospital, Hines, IL, James Lovell Federal Health Care Center, North Chicago, IL, Clement J. Zablocki VA Hospital, Milwaukee, WI, William Middleton VA Hospital, Madison, and Illiana Health Care Center, Danville, IL. The contractor’s schedule expiration date is 2/14/2023.

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, UT 84018-1214

Phone: 801-736-6354 x1348

3. Description of Supplies or Services:

The estimated value of the proposed action is $ 1,583,136.00

VISN 12 PLMS requires reagent pouches and ancillary supplies to support ten (10) purchased Film Array instruments. This will provide PLMS laboratories with the ability to conduct automated multiplex polymerase chain reaction (PCR) for rapid identification of microorganisms in patient blood cultures and respiratory, gastrointestinal, and cerebrospinal fluid samples via Food and Drug Administration (FDA) approved panels. Estimated annual values are the following:

Base period: $281,078.40 Option period 1: $298,852.80

VHAPM Part 808.405-6 Limiting Sources Page 2 of 5

Revision 01 Eff Date: 04/23/2018

Option period 2: $316,627.20 Option period 3: $334,401.60 Option period 4: $352,176.00

Estimated total for base and all option periods: $1,583,136.00

(4) IDENTIFY THE AUTHORITY AND SUPPORTING RATIONALE (see 8.405- 6(a)(1)(i)(A), (B), and (C) or 8.405-6(b)), AND IF APPLICABLE, A DEMONSTRATION

OF THE PROPOSED CONTRACTOR’S UNIQUE QUALIFICATIONS TO PROVIDE

THE REQUIRED SUPPLY OR SERVICE.

An urgent and compelling need exists, and following the ordering procedures would result in unacceptable delays.

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;

Biofire is the only known FDA approved testing platform with FDA approved panels that detect bacteria, viruses, parasites, yeast and antimicrobial resistance genes via multiplex utilizing patient samples in nasopharyngeal swab, positive blood culture, stool in cary-blair, and cerebrospinal fluid (CSF). Multiplexing allows for multiple analytes to be run simultaneously in one run of the instrument to identify if any of the system detectable pathogens are present, producing a result typically in 60-90 minutes. This reduction in testing time by the Biofire platform utilizing multiplexing allows for faster diagnosis and subsequent treatment of potentially life-threatening pathogens.

Biofire offers Respiratory panels that detect 20 viral and bacterial pathogens, Blood Culture panels that detect 27 targets, three of which are antibiotic resistance genes, Gastrointestinal panels that detect 22 pathogens, and Meningitis/Encephalitis panels that detects 14 targets. With the addition of meningitis and encephalitis panels, the system available from Biofire offers a comprehensive system with testing capabilities for a broad array of common pathogens all in one system decreasing the need for multiple, separate systems at the facilities. There is no other platform with all the above capabilities.

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.

Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition. The proprietary data is: (If FAR 8.405-6(a)(2)iii before posting. Do not include specific proprietary data. Only mention the type of equipment, procedure, etc. to show that proprietary supplies or services are being procured.)

VHAPM Part 808.405-6 Limiting Sources Page 3 of 5

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. Describe the equipment/function you have now and how the new item/service must coordinate, connect, or interface with the existing system.

Film Array instruments have been purchased at the facilities. In order for the purchased Biofire instruments to function, reagent pouches and ancillary supplies compatible with the platform are required. Biofire Diagnostics is the sole provider of reagents and ancillary supplies compatible with the platform.

(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:

Reagent pouch prices were established to be fair and reasonable by the NAC Contracting Officer. Additionally, Biofire Diagnostics will provide reagent pouches at a discount of 8% below the negotiated NAC FSS price.

(6) DESCRIBE THE MARKET RESEARCH CONDUCTED AMONG SCHEDULE

HOLDERS AND THE RESULTS OR A STATEMENT OF THE REASON MARKET

RESEARCH WAS NOT CONDUCTED:

In accordance with the Vets First Contracting Program, 38 U.S.C. 8127 & 8128 Implementation Policy and Procedures, a search was conducted on the Vendor Information Pages using NAICS 334516 and yielded 84 results. A search of keyword pathogen yielded 10 contractors, however, the contractors capabilities statements do not include information on their ability to provide the required type of testing. A search using NAICS 334516 and pathogen yielded no result.

Additional searches on VIP for keywords PCR, multiplex, polymerase, and syndromic either yielded no responses or no capabilities in contractors yielded. A search on Dynamic Small Business Search (DSBS) for NAICS 334516 and pathogen, PCR, syndromic separately did not yield results of contractors with capabilities to provide the required testing. A search of UNICOR and Ability-One did not yield capabilities. A search on GSA did not yield capabilities. There are no known sources on NAC FSS, namely schedule 66III. A general search on the internet yielded contractors with some capabilities but no contractors yielded panels for positive blood culture, respiratory, gastrointestinal, and meningitis/encephalitis. Some competitive contractors have one or two of the required testing panels but do not currently possess the capability to provide blood culture, respiratory, gastrointestinal, and meningitis/encephalitis.

Sources sought notice 9350 for instruments, supplies, and service captured as a cost per reportable result was posted to Federal Business Opportunities (FBO) on January 25, 2018 to assist in gathering information on possible sources of supply. It returned one response from industry, however, upon discussion with the end users and the contractor it was determined the panels are not FDA approved. Without FDA approved panels, results from a contractor’s system

VHAPM Part 808.405-6 Limiting Sources Page 4 of 5

Revision 01 Eff Date: 04/23/2018 would have to be offered for non-clinical purposes and could not be used in clinical diagnosis or patient management, therefore, this system did not meet the minimum requirements of VISN 12.

No other open market or schedule contractors have been identified with capabilities to provide reagent pouches and ancillary supplies for the Film Array instruments purchased from Biofire Diagnostics in September 2018.

(7) ANY OTHER FACTS SUPPORTING THE JUSTIFICATION:

None.

(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:

There are no known actions the agency can take to remove or overcome barriers to competition.

This will be dependent on other contractors to develop a competitive comprehensive system that meets the VISN 12 testing needs upon the end of the useable life of the current instruments.

(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.)

DONNA WRAY DATE

BUSINESS MANAGER

PLMS

(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.

JESSICA RASMUSSEN DATE

CONTRACTING OFFICER

NCO 12

jessica l. Rasmussen 303871

Digitally signed by jessica l. Rasmussen 303871 Date: 2018.11.15 08:37:33 -06'00'

Donna M.

Wray 394473

Digitally signed by Donna M.

Wray 394473 Date: 2018.11.15 13:13:37 -06'00'

VHAPM Part 808.405-6 Limiting Sources Page 5 of 5

b. Contracting Officer’s Manager

RICKY BOND DATE

OPERATIONS DIVISION MANAGER

NCO 12

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

PAUL LAURO DATE

NCO 12 DIRECTOR OF CONTRACTING

HIGHER LEVEL APPROVAL (Required for orders over $700,000):

d. VHA SAO HCA REVIEW AND APPROVAL (over $700,000 to $68 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.

TERRY L. SPITZMILLER DATE

ACTING EXECUTIVE DIRECTOR, SAO CENTRAL REGION

Ricky Bond 321819 Digitally signed by Ricky Bond 321819 Date: 2018.11.16 10:02:59 -06'00'

11/19/2108

Diane M Brazale 348123

Digitally signed by Diane M Brazale 348123 Date: 2018.11.16 14:49:57 -06'00'

TERRY L.

SPITZMILLER

394683

Digitally signed by

TERRY L. SPITZMILLER

394683 Date: 2018.11.19 09:47:52 -05'00'

N12-19-08 VISN 12 MULTIPLEX PCR SUPPLIES print copy