SP 1103 W81K02-20-Q-0138 JA 21-RHCO-P-55 rev 16SEP redacted.pdf

Control Number: 21 RHCO P 55

Version – September 2018 FOR OFFICIAL USE ONLY

JUSTIFICATION REVIEW DOCUMENT

FAR SUBPART 13.5 SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS –

SOLE SOURCE JUSTIFICATION AND APPROVAL

Program/Equipment: Madigan Army Medical Center (MAMC), Department of Pathology, Joint Base Lewis McChord, Tacoma, WA, is requesting to lease a BioFire Film Array Torch analyzer with syndromic panels.

Authority: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.5

Amount: The estimated value of this requirement is $2,183,464.23 (base + 4 Options).

Prepared by: Scott Barr Contract Specialist Email: scott.a.barr.civ@mail.mil

Contracting Officer: Larry A. Bradbury Contracting Officer Larry.a.bradbury2.civ@mail.mil

Technical Representative: William C Gibson Supervisor, Core Microbiology william.c.gibson26.civ@mail.mil

Requirements Representative: Kurt H. Jerke LTC, Chief Microbiology kurt.h.jerke.mil@mail.mil

Reviews: I have reviewed this justification and find it adequate to support other than Full and Open Competition.

Contracting Officer:

Typed Name: Larry A. Bradbury Signature:

Digitally signed by

BRADBURY.LARR BRADBURY.LARRY.A.1164241951

Y.A.1164241951 Date: 2020.09.11 09:38:39 07'00'

Program Manager:

Typed Name: LTC Kurt H. Jerke Signature:

Digitally signed by

BELL.DAVID.L 04BELL.DAVID.L.11162404

Legal Counsel:

Typed Name: David L. Bell Signature:

Command Advocate for Competition:

Typed Name: Liza J Esmond Signature:

.1116240404 Date: 2020.09.11 15:31:18 05'00'

ESMOND.LIZA

.J.1016102195

Digitally signed by

ESMOND.LIZA.J.1016102195

Date: 2020.09.17 07:26:41 -05'00'

FAR Subpart 13.5 Simplified Procedures for Certain Commercial Items – Sole Source Justification and Approval

1. Contracting Activity: Joint Base Lewis McChord Health Contracting Branch (JBLM-HCB), Lacey, WA 98503

2. Description of Action: Madigan Army Medical Center (MAMC), Department of Pathology requests a new Firm Fixed Price contract. Proposed contract will start 1OCT2020 and be funded with FY21 DHP funds when they become available.

3. Description of Supplies/Services: This requirement is for a lease of a BioFire Film Array Torch analyzer with syndromic panels. Period of Performance: 1OCT2020 – 30SEP2021, plus four (4) one-year option periods (if exercised). Estimated total value is $2,183,464.23

Period of Performance (PoP) Value

Base 1 Oct 2020 to 30 Sept 2021 $403,126.70

Option Year 1 1 Oct 2021 to 30 Sept 2022 $419,251.77

Option Year 2 1 Oct 2022 to 30 Sept 2023 $436,021.84

Option Year 3 1 Oct 2023 to 30 Sept 2024 $453,462.56

Option Year 4 1 Oct 2024 to 30 Sept 2025 $471,601.36

(Estimate)Total 2,183,464.23

Vendor: BIOFIRE DIAGNOSTICS, LLC

4. Authority Cited: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.501(a)(1)(ii), sole source (including brand name).

5. Reason for Authority Cited:

MAMC is requesting a follow on contract for a lease of a BioFire Film Array Torch analyzer with syndromic panels.

The analyzer is a Polymerase Chain Reaction (PCR) technology analyzer from BioFire Diagnostics. BioFire is currently the only known manufacture of an analyzer that can complete all of the tests required by MAMC’s laboratory. They are also the only source that has an FDA approved assay for the detection of pathogens associated with meningitis and encephalitis from cerebral spinal fluid (CSF). There are other manufacturers that offer CSF PCR testing but they are limited to single targets such as enterovirus or Herpes simplex virus only. BioFire Film Array Torch analyzer is the only multiplex platform that offers multiple targets simultaneously. The BioFire Torch Film Array Torch analyzer is the instrument which provides results in approximately 1.5 hours as opposed to conventional identification of pathogens which takes 1-3 days. This allows physicians to start treatment immediately versus waiting one or more days.

6. Efforts to Obtain Competition:

The Contracting Officer shall publish the notices required by FAR 5.201 and any bids or proposals received shall be considered” as required by AFARS 5153.303-5

a. A Sources Sought Notice was posted to www.betaSAM.gov on 23JUL2020 with a closing date of 29JUL2020. One company, Essnova Solutions, Inc, responded. A review of the company indicates that they are a reseller of equipment and do not manufacture items. An email to BioFire confirmed that they only sell directly and do not use distributors. Based upon this information, Essnova, is not considered a source of possible competition. See Memorandum for Record located within the PCF system.

b. Effective Competition: In the future, Joint Base Lewis McChord Health Contracting Branch along with the Department of Pathology will continue to perform market research to monitor any changes in the status of this requirement. As technology becomes available, research will be performed to consider other possible sources that may meet or exceed this current requirement.

c. Subcontracting competition: A Determination and Findings of No Subcontracting has been signed. There are no subcontracting opportunities due to quality and control aspects of the products. Therefore, the Contracting Officer has determined that no subcontracting possibilities exist for this requirement and that determination has been approved one level above the Contracting Officer as required by FAR 19.705-2(c).

7. Actions to Increase Competition: No action on the part of this office will decrease this type of barrier to competition available. JBLM-HCB as well as the Department of Pathology will continuously monitor any changes in this requirement. As technology becomes available, research will be performed to consider other possible sources that may meet or exceed the current requirements.

8. Market Research: Market research conducted in the past 12 months has shown that BioFire Diagnostics is the only source that is able to meet the Government’s requirements. They are currently the only manufacturer that has an FDA approved assay for the detection of pathogens associated with meningitis and encephalitis from cerebral spinal fluid. Additional market research was conducted using numerous sources.

a. FAR 8.002(a)(1)(i) through FAR 8.002(a)(iv), which addresses supplies (including Federal Prison Industries and Ability One), are not applicable and will not be considered.

b. A review of FAR 8.002(a)(1)(v) was conducted and consideration to General Service Administration (GSA) and/or Federal Supply Schedules (FSS). Required supplies are partially available through FSS Schedules (V797D- 30085).

c. FAR 8.003, Use of Other Mandatory Sources does not apply.

d. FAR 8.004, Use of Other Sources, and FAR 12.1, Acquisition of Commercial Items, Google search conducted with keywords “Polymerase chain reaction analyzer” did show other vendors are available on the open market.

However, only BioFire had an analyzer that the ability to detect pathogens associated with meningitis and encephalitis from Cerebral Spinal Fluid; therefore, a sole source contract will be awarded.

e. A Dynamic Small Business Search was conducted with keyword “PCR Analyzer”, with NAICS Code: 334516” results from this search did not identify contractors that can provide the same or equal supplies outlined by the requiring activity.

f. Joint Base Lewis-McChord Health Contracting Branch will continuously monitor any changes in this requirement along with the Department of Pathology, Madigan Army Medical Center, Joint Base Lewis-McChord, WA.

9. Interested Sources: To date, only BioFire and no other sources have written to express interest in the acquisition.

10. Other Facts:

a. Procurement History

(1) Contract numbers and dates of the last several contracts for this same requirement: The current contract, W81K02-17-F-0062 was for a 12 month base period of 1OCT17 – 20SEP18 plus two 12-month options.

(2) The competitive status of these actions: The current contract was posted to GSA eBuy and solicited as Full and Open. The solicitation was sent to 18 possible sources. Only one responded, BioFire Diagnostics.

(3) The authority cited if less than Full and Open competition: N/A

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results.

N/A

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources.

Only one vendor responded out of 18 from the previous action. Additionally it has been documented in recent journals that BioFire is the only company that has FDA approved molecular tests available for cerebrospinal fluid.

(6) An explanation of any unusual patterns that may be revealed by the history. N/A

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes. N/A

11. Technical Certification: I certify 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.

Typed Name: William Gibson

Title: Supervisor Microbiology Signature:

12. Requirements Certification: I certify 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.

Typed Name: LTC Kurt H. Jerke Title: Chief Microbiology Signature:

13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable. The basis for this determination will be price analysis in accordance with FAR 15.404-10(b). Certified cost or pricing data is not required per FAR 15.403-1(b)(3) because the products being acquired are considered commercial.

Typed Name: Larry A Bradbury BRADBURY.LARR Digitally signed by

Title: Contracting Officer Signature: Y.A.1164241951

BRADBURY.LARRY.A.1164241951

Date: 2020.09.11 09:39:25 07'00'

14. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Typed Name: Larry A Bradbury BRADBURY.LARR Digitally signed by

Title: Contracting Officer Signature: Y.A.1164241951 BRADBURY.LARRY.A.1164241951 Date: 2020.09.11 09:39:25 07'00'

Approval Based on the foregoing justification, I hereby approve the procurement to lease a BioFire Film Array Torch analyzer with syndromic panels on an other than full and open competition basis pursuant to the authority of the Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.5, subject to availability of funds, and provided that the services or supplies herein described have otherwise been authorized for acquisition.

Typed name: Liza J Esmond Command Advocate for Competition Signature:

ESMOND.LIZA.J.

1016102195

Digitally signed by

ESMOND.LIZA.J.1016102195

Date: 2020.09.17 07:27:02 -05'00'