JA -20-RHCO-C-61 - Govt Sci Source.pdf

Control No: 20-RHCO-C-61 Contractor: Government Scientific Source, Inc.

Program/Equipment: QFT Gold Plus Assays

Version –March 2017 FOR OFFICIAL USE ONLY

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 obtain QuantiFERON TB Gold Plus Reference Lab Pack and the QuantiFERON TB Gold Plus Tubes compatible with the Government –owned QFT Gold Plus Assay System for the purpose of Immunology testing.

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

Amount: $2,002,656.00

Base Period (1 October 2020 – 30 September 2021): $400,531.20 Option 1 (1 October 2021 – 30 September 2022): $400,531.20 Option 2 (1 October 2022 – 30 September 2023): $400,531.20 Option 3 (1 October 2023 – 30 September 2024): $400,531.20 Option 4 (1 October 2024 – 30 September 2025): $400,531.20

Prepared by: Medina Woodson DSN: 389-8525

Contract Specialist Date: 8 Sept 2020 Email: Medina.L.Woodson.civ@mail.mil

Contracting Officer: Michelle Bartkowski DSN: 389-8655

Contracting Officer Date: 8 Sept 2020 Email: Michelle.M.Bartkowski.civ@mail.mil

Technical: CPT Daniel B. Pederson DSN: 429-3168

OIC, Bacteriology Date: 8 Sept 2020 Department of Pathology and Area Laboratory Services Brooke Army Medical Center Email: Daniel.B.Pederson.civ@mail.mil

Requirements: CPT Daniel B. Pederson DSN: 429-3168

OIC, Bacteriology Date: 8 Sept 2020 Department of Pathology and Area Laboratory Services

Email: Daniel.B.Pederson.civ@mail.mil

Version –March 2017 FOR OFFICIAL USE ONLY

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

Program Manager:

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

DSN: 429-1817

Signature: CYBULSKI.ROBER Digitally signed by

T.JOHN.JR.123980

CYBULSKI.ROBERT.JOHN.JR.1

239805490 Date: 2020.09.10 11:36:37 -05'00'

Legal Counsel:

Typed Name: Eugene Smith

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

DSN: 471-5804

Signature:

Command Advocate for Competition:

Typed Name: Liza Esmond

Director, Procurement and Acquisition Management US Army Health Contracting Activity

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 sole source, firm-fixed-price purchase order with Government Scientific Source, Inc. The Government projects award for September 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 follow-on to purchase order W81K00-18-P-0141. This purchase order was solicited via full and open competition, on a “brand name or equal” basis, as market research indicated there was a significant probability of receiving at least two (2) offers.

However, when the solicitation closed, only one offer was received from Government Scientific Source, Inc.

3. Description of Supplies/Services: The Government’s requirement is to obtain QuantiFERON TB Gold Plus Reference Lab Pack and the QuantiFERON TB Gold Plus Tubes compatible with the Government–owned, Qiagen-manufactured QFT Gold Plus Assay System. This request is for Mycobacterium Tuberculosis (TB) reagents, consumables and reference controls for the purpose of in-house testing by the Department of Pathology and Area Laboratory Services (DPALS) Immunology Section at the Brooke Army Medical Center (BAMC), JBSA Fort Sam Houston, Texas. The QFT-Plus Reagent is an in vitro diagnostic aid for detection of Mycobacterium tuberculosis infection (including disease) and is intended for use in conjunction with risk assessment, radiography, and other medical and diagnostic evaluations.

The reagents will be utilized to screen Department of Defense personnel for latent TB infection. Therefore, it is imperative that the laboratory has the ability to perform this diagnostic function for the identification of the above item for patient treatment. If the contract is not awarded, the Immunology Section will be unable to offer these diagnostic tests for the treatment regimens required by health care providers within BAMC and from outlying facilities. The below table identifies the estimated quantities for the base period; the quantities and estimated pricing remain consistent for the option periods.

Catalog # Items Quantity Price 622832 QuantiFERON TB Gold Plus Reference Lab Pack 72 $369,896.40 622536 QuantiFERON TB Gold Plus Tubes 60 $30,634.80 Estimated Total $400,531.20

Base Period: 1 October 2020 to 30 September 2021 Value: $400,531.20 Option Period 1: 1 October 2021 to 30 September 2022 Value: $400,531.20 Option Period 2: 1 October 2022 to 30 September 2023 Value: $400,531.20 Option Period 3: 1 October 2023 to 30 September 2024 Value: $400,531.20 Option Period 4: 1 October 2024 to 30 September 2025 Value: $400,531.20

Total: $2,002,656.00

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 17July 2020 with a response due date of 29 July 2020, in order to find companies (small and other-than-small) that could provide that could provide reagents to conduct risk assessments, radiography, and other medical and diagnostic evaluations to detect Mycobacterium tuberculosis infection or disease. Further, the Source Sought Notice advised that interested vendors must indicate their offered reagents’ compatibility with the Government-owned QFT Gold Plus Assaay System. Only one (1) response was received, from Government Scientific Source, Inc, a small business and the incumbent.

Government Scientific Source submitted a capability statement providing information on reagents, preservation and packing, quality control, and delivery schedule requirements for the QFT Gold Plus Assays acquisition.

Qiagen, the manufacturer of the equipment and the only-known compatible testing reagents for that equipment, stated on an email dated 31 July 2020 that their company only offers the reagents through their small business distribution partners. Further, Qiagen also stated that Government Scientific Source, Inc. is currently their only distributor that maintains all certifications that are required in order to do business with the Government.

b. Alternatives. The only other known vendor that carries the compatible QFT Gold

Plus Assays is the manufacturer, Qiagen. As stated above the manufacturer prefers to satisfy this requirement by utilizing their distributor, Government

Scientific Source, Inc, rather than performing the requirement themselves.

A second alternative is the Department of Defense-wide contract with Laboratory Corporation of America. However, this 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 on 17 July 2020 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 reagents 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 March - July 2020. As discussed above, there were no other contractors identified that could meet the entirety of BAMC’s requirement

9. Interested Sources: Other than Government Scientific Source, Inc. no other sources can provide the QFT Gold Plus Assays that maintain all the security certifications and other prerequisites that is required while working with the Government.

10. Other Facts:

a. Procurement History:

(1) Contract W81K00-18-P-0141 was issued with a base period of 05 February

2018 – 30 September 2020 plus two (2) twelve-month option periods through 30 September 2020.

(2) Competitive Status – Issued on a full and open basis.

(3) Authority previously cited if less than full and open competition was used –

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 – The follow-on purchase order W81K00-18-P-0141 was solicited on a full and open basis, based on the market research conducted and that Contracting Officer’s personal knowledge of laboratory testing requirements. However, during the time of proposal submissions, only one offer was received, from Government

Scientific Source, Inc. The manufacturer, Qiagen, stated that the requested reagents are only offered to the federal Government, through one distributor, Government Scientific Source, Inc.

(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. –N/A.

(End of page)

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: CPT Daniel B. Pederson Date:

Department of Pathology and Area Laboratory Services, EL.B.1376437716

Digitally signed by

PEDERSON.DANIEL.B.1376437

Date: 2020.09.09 19:55:55 -05'00'

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: CPT Daniel B. Pederson Date:

Department of Pathology and Area Laboratory Services, EL.B.1376437716

Digitally signed by

PEDERSON.DANIEL.B.1376437

Date: 2020.09.09 19:56:06 -05'00'

PEDERSON.DANI

PEDERSON.DANI

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 based 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: Michelle Bartkowski Date:

Title: Contracting Officer Signature:

BARTKOWSKI.MIC Digitally signed by

HELLE.M.10194726 BARTKOWSKI.MICHELLE.M.101

78 Date: 2020.09.10 15:03:23 -05'00'

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

Typed Name: Michelle Bartkowski Date:

Title: Contracting Officer Signature:

BARTKOWSKI.MIC Digitally signed by

HELLE.M.10194726 BARTKOWSKI.MICHELLE.M.101

78 Date: 2020.09.10 15:03:38 -05'00'

9472678

9472678

Approval

Based on the foregoing justification, I hereby approve the procurement of QFT Gold Plus Assays from Government Scientific Source, Inc., for Brooke Army Medical Center on a sole source basis, in the amount of $3,000,000.00, 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.

Liza Esmond Date:

Command Advocate for Competition Signature: