Redacted Justification and Approval_20-RHCO-C-353_BioFire.pdf

Control No: 20-RHCO-C-353 Contractor: BioFire Diagnostics

Program/Equipment: Reagent Testing Panels

Version –March 2017 FOR OFFICIAL USE ONLY

$4,553,541.00 $910,708.20 $910,708.20 $910,708.20 $910,708.20 $910,708.20

Medina Woodson

Email: Medina.L.Woodson.civ@mail.mil

Michelle Bartkowski Date: 22 June 2020

DSN: 389-8655

Contracting Officer Email: Michelle.M.Bartkowski.civ@mail.mi

CPT Daniel B. Pederson DSN: 429-3168 Date: 22 June 2020 OIC, Bacteriology

Daniel.B.Pederson.civ@mail.mi

Daniel B. Pederson CPT

Daniel.B.Pederson.civ@mail.mi

JUSTIFICATION REVIEW DOCUMENT

FAR SUBPART 13.5 SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS – SOLE SOURCE JUSTIFICATION AND APPROVAL

Program/Equipment: The Brooke Army Medical Center Department of Pathology and Area Laboratory Services seeks to establish a cost-per-test arrangement for the testing of four (4) pathogens: Respiratory Virus, Gastrointestinal, Meningitis, and Blood Culture Identification.

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

Amount:

Base Period (1 October 2020 – 30 September 2021):

Option 1 (1 October 2021 – 30 September 2022):

Option 2 (1 October 2022 – 30 September 2023):

Option 3 (1 October 2023 – 30 September 2024):

Option 4 (1 October 2024 – 30 September 2025):

Prepared by: DSN: 389-8525

Contract Specialist Date: 22 June 2020

Contracting Officer:

Technical:

Department of Pathology and Area Laboratory Services Brooke Army Medical Center

Requirements: DSN: 429-3168 OIC, Bacteriology Date: 22 June 2020 Department of Pathology and Area Laboratory Services Brooke Army Medical Center Email: l l l Email:

Version –March 2017 FOR OFFICIAL USE ONLY

LTC Robert Cybulski, Director, Microbiology Department of Pathology and Area Laboratory Services Brooke Army Medical Center

CYBULSKI.ROBER Digitally signed by

CYBULSKI.ROBERT.JOHN.JR.1 T.JOHN.JR.123980 239805490

5490 Date: 2020.06.25 08:54:11 -05'00'

Eugene Smith Contract Law Attorney Office of the Staff Judge Advocate US Army Medical Command

Liza Esmond Director, Procurement and Acquisition Management US Army Health Contracting Activity

Reviews: I have reviewed this justification and find it adequate to support a sole source contract action.

Program Manager:

Typed Name:

DSN: 429-1817

Signature:

Legal Counsel:

DSN: 471-5804

Special Advocate for Competition:

DSN: 471-4093

Version – March 2017 FOR OFFICIAL USE ONLY

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

1. Contracting Activity: Joint Base San Antonio Health Contracting Branch (JBSA HCB), Regional Health Contracting Office – Central (RHCO-C), US Army Health Contracting Activity, 3551 Roger Brooke Drive, JBSA Fort Sam Houston, Texas.

2. Description of Action: The Brooke Army Medical Center Department of Pathology and Area Laboratory Services requests a firm-fixed-price (utilizing a cost-per-test arrangement) contract with BioFire Diagnostics. The Government projects award for July 2020, with a start date of 1 October 2020, contingent upon the availability of FY21 Defense Health Program funds. An acquisition plan is not required because this procurement does not meet the threshold at Defense Federal Acquisition Regulation Supplement 207.103(d)(i)(B).

This action is a quasi-follow-on to contract W81K00-18-P-0098. That contract was not competed under authority 41 United States Code 1901 as implemented in FAR 13.501(a)(1)(ii). Paragraph, “Actions to Increase Competition” of the previous justification, stated: “As long as SAMMC (also known as BAMC) owns this equipment and BioFire does not have any authorized distributors, it is expected this requirement will continue to be solicited on a sole-source basis. However, the Government will continue to monitor the marketplace for any new entrants.” For this new requirement, BAMC wishes to move to a cost-per-test arrangement, wherein the contractor retains ownership of the equipment and the cost of the lease is embedded in the reagents. (The equipment utilized under the current contract will be moved to another facility.) See paragraph 6 below for details on how actions to increase competition for this new requirement were executed.

3. Description of Supplies/Services: The Government’s requirement is to obtain a Cost per Test (CPT) Agreement to establish a cost-per-test agreement for an identification system to provide rapid results for four pathogens: Respiratory Virus, Gastrointestinal, Meningitis, and Blood Culture Identification. This organism identification system will provide rapid results and cumulatively provide the identification of 80 different pathogens. By rapidly determining the correct pathogen, primary care providers are able to assign the correct treatment course for patients, thus saving time and eliminating unnecessary costs for the facility. This requirement includes reagents, instrument/equipment, consumables, controls, and any necessary services to conduct testing under a CPT Arrangement. The testing is performed in-house for the Department of Pathology and Area Laboratory Services (DPALS) at Brooke Army Medical Center (BAMC), Fort Sam Houston, Texas. The below table identifies the estimated quantities for the base period; these quantities and estimated pricing remain consistent for the option periods.

$3,803.30

$3,489.45

$509,655.60 $126.78

$116.32 $139,584.00

$910,708.20 Option Period 1: 1 October 2021 to 30 September 2022 Value: $910,708.20 Option Period 2: 1 October 2022 to 30 September 2023 Value: $910,708.20

$4,553.05

$5,750.33

$147.94 $146,460.60

$191.68 $115,008.00

$910,708.20

Option Period 3: 1 October 2023 to 30 September 2024 Value: $910,708.20 Option Period 4: 1 October 2024 to 30 September 2025 Value: $910,708.20

$4,553,541.00

Panel

Kit

Quantity

Kit Cost

Test

Quantity per Year

Test Unit Price

Total Item

Cost

Respiratory Panel (30 tests/kit)

4,020

Blood Culture Identification

1,200

Gastrointestinal

Meningitis Panel (30 tests/kit)

Estimated Total

Base Period: 1 October 2020 to 30 September 2021

Total:

4. Authority Cited: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.5: Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

5. Reason for Authority Cited:

a. A Sources Sought Notice was initially posted to https://beta.sam.gov, the official

Government Point of Entry, on 15 March 2020 with a response due date of 23 March 2020 in order to find companies (small and other-than-small) that could provide equipment/instruments and reagents to conduct Respiratory Virus, Gastrointestinal, Meningitis, and Blood Culture Identification, and COVID-19 (SARS-CoV-2) testing, including pathogens that were specifically listed.

Responses were received from three (3) companies: Luminex Corporation (small business), Qiagen (other-than-small business) and BioFire Diagnostics (other-than-small business). However, Luminex Corporation provided a Gastrointestinal panel that could only identify half of the organisms requested by the Government and a Meningitis panel that allowed for lab-developed tests but they were not Food and Drug Administration (FDA) approved. Qiagen responded to the Sources Sought Notice but only provided information on their Respiratory panel. Both

Value:

companies were specifically asked about the panels they did not list, and each confirmed they do not have those panels available. BioFire Diagnostics was the only vendor that responded with an affirmation they could provide all five (5) panels.

Subsequently, on 30 March 2020, DPALS informed the Contracting Officer that the COVID-19 panel was no longer required, as they were going to utilize another method to obtain those tests. The Contracting Officer re-issued the Sources Sought Notice, removing the COVID-19 requirement but leaving the remaining panels intact, via https://beta.sam.gov on 2 April 2020 with a response due date of 16 April 2020. No new responses from industry were received

b. Alternatives. There are known known alternatives to BioFire Diagnostics that would not result in mission failure; the Department of Defense-wide contract with Laboratory Corporation of America does not offer the complete Respiratory panel.

The remaining panels could be used, but would have a significant delay in obtaining test results. Brooke Army Medical Center provides healthcare services to Active Duty and Retired military members as well as their dependents, as mandated by statute. Part of those healthcare services involves performing laboratory tests in order for physicians to make a diagnosis and develop a treatment plan.

6. Efforts to Obtain Competition: No further efforts will be made to obtain competition.

The Contracting Officer shall publish the notices required by FAR 5.201. A Sources Sought Notice was already posted twice; upon finalization of this Justification and Approval document, a notice of intent to sole source will be posted to the GPE, with the final J&A to be published within 14 days of contract award.

7. Actions to Increase Competition: Should BAMC continue to have a need for these testing panels at the conclusion of the last option period, a sources sought notice will be posted to the GPE to determine if there are any new entrants to the marketplace.

8. Market Research: Prior to the posting of the sources sought notices, market research was conducted by DPALS personnel in conjunction with Contracting personnel to determine the likelihood of other laboratory testing companies being able to provide for the complete requirement. The methods used included internet searches, to include a review of the College of American Pathologists’ website. This outreach occurred in March and April 2020. As discussed above, there were no other contractors identified that could meet the entirety of BAMC’s requirement

9. Interested Sources: Other than BioFire Diagnostics, no other sources that can provide all four (4) testing panels have written to express interest in the acquisition.

Preliminary technical information submitted by Luminex Corporation and Qiagen, in response to the Sources Sought Notice was reviewed by the requiring activity who have advised that neither firm can meet the requirements in the RFP, as neither can provide all four (4) testing panels.

10. Other Facts:

a. Procurement History:

(1) Contract W81K00-18-P-0098 was issued with a base period of 19 December 2017 – 30 September 2018 plus two (2) twelve-month option periods through 30 September 2020.

(2) Contract W81K00-18-P-0098 was executed on a non-competitive basis and supported by a Justification and Approval.

(3) Contract W81K00-18-P-0098 was not competed under authority 41 United States Code 1901 as implemented in FAR 13.501(a)(1)(ii).

(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 – See paragraph 2 above.

(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 – N/A

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys. – 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. – See paragraph 2 above.

(End of page)

CPT Daniel B. Pederson Digitally signed by PEDERSON.DANI PEDERSON.DANIEL.B.1376437

EL.B.1376437716 716

Date: 2020.06.25 08:37:35 -05'00'

CPT Daniel B. Pederson Digitally signed by PEDERSON.DANI PEDERSON.DANIEL.B.1376437

EL.B.1376437716 716

Date: 2020.06.25 08:38:47 -05'00'

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: Date:

Title: OIC, Bacteriology Signature:

Department of Pathology and Area Laboratory Services,

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: Date:

Title: OIC, Bacteriology Signature:

Department of Pathology and Area Laboratory Services, Version – cost or price to the Government for this contract action will be fair and reasonable based

March 2017 FOR OFFICIAL USE ONLY

Michelle Bartkowski Date:

Title: Contracting Officer Signature:

BARTKOWSKI.MICHE

Digitally signed by

BARTKOWSKI.MICHELLE.M.1019

on the independent Government estimate and previous prices paid. As a part of this basis, certified cost or pricing data is not required because the item and/or services being acquired are considered commercial.

Typed Name:

Date: 2020.07.10 12:38:04 ‐05'00'

Name: Michelle Bartkowski Date:

Officer Signature:Contracting Title:

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

13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated

LLE.M.1019472678 472678

Typed

Liza Esmond Date:

Special Advocate for Competition Signature

Approval

Based on the foregoing justification, I hereby approve the procurement of BioFire Diagnostics testing panels under a cost-per-test arrangement for Brooke Army Medical Center on a sole source basis, not to exceed $5,000,000.00 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.