JA 21-RHCO-C-60_Viral Load Testing.pdf

Control No: 20-RHCO-C-60

Contractor: Roche Diagnostics Corporation

Program/Equipment: Viral Load Testing

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’ requirement is to establish a cost-per-test arrangement for the testing of four viral load assays: Hepatitis B Viral Load (HBV), Hepatitis C Viral Load (HCV), Human Immunodeficiency Virus Type 1 Viral Load (HIV-1) and Cytomegalovirus Viral Load (CMV).

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

Amount: $1,872,816.60

Base Period (1 October 2020 – 30 September 2021): $374,563.32 Option 1 (1 October 2021 – 30 September 2022): $374,563.32 Option 2 (1 October 2022 – 30 September 2023): $374,563.32 Option 3 (1 October 2023 – 30 September 2024): $374,563.32 Option 4 (1 October 2024 – 30 September 2025): $374,563.32

Prepared by: Medina Woodson DSN: 389-8525

Contract Specialist Date: 9 Sept 2020 Email: Medina.L.Woodson.civ@mail.mil

Contracting Officer: Michelle Bartkowski DSN: 389-8655

Contracting Officer Date: 9 Sept 2020 Email: Michelle.M.Bartkowski.civ@mail.mil

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

OIC, Bacteriology Date: 9 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: 9 Sept 2020 Department of Pathology and Area Laboratory Services Brooke Army Medical Center Email: Daniel.B.Pederson.civ@mail.mil mailto:Medina.L.Woodson.civ@mail.mil mailto:Michelle.M.Bartkowski.civ@mail.mil mailto:Daniel.B.Pederson.civ@mail.mil mailto: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 11:37:24 -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:

SMITH.EUGEN

Digitally signed by

SMITH.EUGENE.J.1058759950

E.J.1058759950 Date: 2020.09.14 15:06:49 -05'00'

Command Advocate for Competition:

Typed Name: Liza Esmond

Director, Procurement and Acquisition Management US Army Health Contracting Activity

DSN: 471-4093

Signature:

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 Roche Diagnostics Corporation. 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 contract W81K00-20-P-0009 with Roche Diagnostics, which was issued on a short-term basis while the long-term acquisition strategy was being determined. The BAMC laboratory is the sole evaluation site for the United States Air Force and Army for testing and treatment of service members with known HIV infections.

3. Description of Supplies/Services: The Government’s requirement is to establish a Cost-Per-Test agreement for four (4) viral load assays: Hepatitis B Viral Load (HBV), Hepatitis C Viral Load (HCV), Human Immunodeficiency Virus Type 1 Viral Load (HIV-

1) and Cytomegalovirus Viral Load (CMV) for use with contractor-owned equipment/instrumentation. The purpose of this requirement is to support the viral load testing for patients under treatment or to determine the disease status for the viral infections caused by HBV, HCV, HIV-1 and CMV. It is imperative that the laboratory has the ability to perform this diagnostic function for the identification of the above viral load assays for patient treatment. If the contract is not awarded, the molecular microbiology section will be unable to offer these diagnostic tests for the treatment regimens required by health care providers within BAMC and from outlying facilities.

In order to perform this testing, reagents, consumables, and controls are required. The below annual estimates (quantities and price) are based on the platform currently in use to perform this testing.

Assays / Reagents Annual Kits (96 tests per kit)

Price Annual Total

Hepatitis B 20 $4,398.37 $87,974.40

Hepatitis C 20 $4,134.36 $82,694.40

Human Immunodeficiency Virus – Type 1

28 $4,131.18 $115,664.64

Cytomegalovirus 14 $3,281.21 $45,937.92

Total $332,271.36

Consumables Annual Kits Price Annual Total

Amplification Plate 11 $297.44 $3,271.84

Pipette Tips 41 $236.01 $9,676.41

Processing Plate 21 $45.56 $956.76

Lysis Reagent 7 $261.95 $1,833.65

MGP Reagent 17 $55.79 $948.43

Specimen Diluent 8 $93.17 $745.36

Wash Reagents 28 $33.39 $934.92

Total $18,367.37

Controls Annual Kits (96 tests per kit) Price Annual Total

CMV RMC IVD 7 $480.00 $3,360.00

NHP Negative Control Kit 21 $88.79 $1,864.59

HBV/HCV/HIV Control Kit 34 $550.00 $18,700.00

Total $23,924.59

Category Annual Total

Reagents / Assays $332.271.36

Consumables $18,367.37

Controls $23,924.59

Annual Total $374,563.32

Base Period (1 October 2020 – 30 September 2021): $374,563.32

Option 1 (1 October 2021 – 30 September 2022): $374,563.32

Option 2 (1 October 2022 – 30 September 2023): $374,563.32

Option 3 (1 October 2023 – 30 September 2024): $374,563.32

Option 4 (1 October 2024 – 30 September 2025): $374,563.32

Five-Year Total $1,872,816.60

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 posted to https://beta.sam.gov, the official

Government Point of Entry, on 17 June 2020 with a response due date of 29 June 2020 in order to find companies (small and other-than-small) that could provide the equipment/instrument, reagents, consumables and controls to conduct all four types of viral load testing. Only one response, from Roche Diagnostics Corporation, was received before the response date. Roche submitted a capability statement providing information on their unique features for the equipment, reagents, testing and training requirement for the new viral load acquisition.

b. Alternatives. The BAMC laboratory is the sole evaluation site for known Air

Force and Army service members with HIV infections. Further, while the Department of Defense-wide reference laboratory testing contract is a potential vehicle, it is both more efficient and cost effective to retain this testing in house.

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 posted and only one response was received by a large business, Roche Diagnostics Corporation 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 the viral load reagents and instrumentation 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 notice, 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 DPALS personnel exhausted all efforts with no success in researching and locating other Department of Defense hospitals that conduct the same testing in-house.

A Small Dynamic Business Search (DSBS) with the keyword “viral load” was used with the NAICS Code 325413 for the molecular testing and the results found no small businesses that offered the viral load reagents. The other methods used included internet searches to include a review of the College of American Pathologists’ website.

This outreach occurred in March – July 2020. As discussed above, there were no other contractors identified that could meet the entirety of BAMC’s requirement. Therefore, https://beta.sam.gov/ the Contracting Officer has determined that there is no justification for a small business set aside and is recommending a sole source award to Roche Diagnostics, a large business.

9. Interested Sources: Other than Roche Diagnostics Corporation, no other sources that can provide all four (4) viral load reagents with the equipment/instrumentation have written to express interest in the acquisition.

10. Other Facts:

a. Procurement History:

(1) Contract W81K00-20-P-0009 was issued with a base period of

19 December 2019 – 30 September 2020.

(2) Competitive Status – Non competitive.

(3) Authority previously cited if less than full and open competition was used on previous acquisition: FAR 13.106-1(b)(1) – For purchases not exceeding the simplified acquisition threshold (SAT), only one source reasonably available, urgency, exclusive licensing agreements, brand name, or industrial mobilization. NOTE: The value of contract W81K00-20-P-0009 is under the simplified acquisition threshold.

(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 – A notice of intent to sole source that contract, along with the final justification, were posted, with no response from industry on either occasion.

(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. – No changes.

(End of page)

PEDERSON.DANI

PEDERSON.DANI

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: Digitally signed by

PEDERSON.DANIEL.B.1376437

Signature:

Department of Pathology and Area Laboratory Services, Brooke Army Medical Center

EL.B.1376437716 716

Date: 2020.09.09 19:50:30 -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: Digitally signed by

PEDERSON.DANIEL.B.1376437

Signature:

Department of Pathology and Area Laboratory Services, Brooke Army Medical Center

EL.B.1376437716

Date: 2020.09.09 19:50:58 -05'00'

9472678

9472678

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: BARTKOWSKI.MIC Digitally signed by

Title: Contracting Officer Signature: HELLE.M.10194726

BARTKOWSKI.MICHELLE.M.101

78 Date: 2020.09.10 14:52:20 -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:

BARTKOWSKI.MIC Digitally signed by

Title: Contracting Officer Signature: HELLE.M.10194726

BARTKOWSKI.MICHELLE.M.101

78 Date: 2020.09.10 14:53:28 -05'00'

Approval

Based on the foregoing justification, I hereby approve the procurement of a Viral Load Cost-per-Test agreement with Roche Diagnostics Corporation for Brooke Army Medical Center on a sole source basis, in the amount of $2,500,000.00, 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: