FAR-Part13-5-Sole-Source-JA_ACC COVID-19 Blood Donor Testing _Redacted.pdf

Control No: 21-RHCO-C-115 Contractor: Creative Testing Solutions

Program/Equipment: COVID-19 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: Request to add additional funds on the Firm Fixed Price contract, W81K00-20-P-0163, for Non-Personal Infectious Blood Testing Services. The additional funds are to be used to test the donated blood for Coronavirus Disease 2019 (COVID- 19).

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

Amount: $3,465,000.00

Prepared by: DSN:

Contract Specialist Date: 21 September 2020 Email:

Contracting Officer: DSN:

Contracting Officer Date: 21 September 2020 Email:

Technical: DSN: NA Date: 21 September 2020 Email:

Requirements: DSN: NA Date: 21 September 2020 Email:

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

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: Region Health Contracting Office-Central

2. Description of Action: The Army Blood Program requests a firm-fixed-price contract modification to contract W81K00-20-P-0163 with Creative Testing Solutions. Contract W81K0020P0163 was competed on the Government point of entry. The additional funding to add the tests for FY21 is subject to the availability of FY21 DHP-Defense Health Program Operations and Maintenance funds. The purpose of this modification is to add two additional tests in support of the COVID-19 response for contract W81K0020P0163 for Blood Donor Testing Services for Robertson Blood Center, Ft.

Hood, Texas, and Ft. Leonard Wood, Blood Donor Center, Ft. Leonard Wood, Missouri for the base year of 1 October 2020 through 30 September 2021 and the proposed follow on years of 1 October 2021 through 30 September 2025. The dollar increase for FY 21 will increase the total of the FY 21 contract value from $1,338,575.00 to $1,968,575.00. The original award for the proposed base and four options is for $7,615.832.50. The proposed additional testing for the pricing for the base and four years could increase the total by an approximate $3,150,000.00. The proposed additional testing for the pricing for the base and four years could increase the total from $7,615,832.50 to $10,765,832.50.

☒ 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).

3. Description of Supplies/Services: Due to COVID-19

Base Period: 10/01/2020 to 09/30/2021 Value: $630,000.00 Option Period 1: 10/01/2021 to 09/30/2021 Value: $630,000.00 Option Period 2: 10/01/2021 to 09/30/2021 Value: $630,000.00 Option Period 3: 10/01/2021 to 09/30/2021 Value: $630,000.00 Option Period 4: 10/01/2021 to 09/30/2021 Value: $630,000.00 Option Period 5: 10/01/2021 to 09/30/2021 Value: $630,000.00 FAR Clause 52.217-8 option: 10/01/2021 to 03/31/2026 Value: $315,000.00

Total $3,465,000.00

4. Authority Cited: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented in Federal Acquisition Regulation 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

Other: Presidential declared national emergency

5. Reason for Authority Cited:

Due to the current COVID-19 pandemic Carl R. Darnall Army Medical Center, Robertson Blood Bank, Fort Hood, Texas requested for additional tests to be added to the current contract. The additional items have been mandated by the Army Blood Program. At this time the current vendor is providing the testing on W81K0020P0059 and has done so without any interruptions. If another vendor is used the start-up times for the additional testing would result in failure of the Army Blood Program mandate because there is not enough time to competitively award a contract for these mission essential services and allow a new contractor to be ready for full performance on 1 October 2020 when the current contract expires. Only Creative Testing Solutions, the awardee of the recently competed and awarded contract, would be ready for full performance on 1 October 2020.

These Non-Personal Services are critical to the mission of the Armed Services Blood Program and specifically for this action the facilities of the Robertson Blood Center, Ft.

Hood, Texas, and Ft. Leonard Wood, Blood Donor Center. A sole source contract is required to ensure continuation of these mission critical services when the FY21 contract begins.

This testing must be performed by an entity that has the capacity to meet all FDA guidelines and unique labeling requirements for blood donor testing specimens submitted by Robertson Blood Center, Ft. Hood, Texas, and Ft. Leonard Wood, Blood Donor Center.

These additional tests provide testing whole blood (WB) donors for the presence of anti- SARS-CoV-2 antibodies to identify individuals who may have been exposed to the coronavirus without developing overt symptoms.

The testing comprises of a screening test that informs the lab if the patient has the COVID-19 Antibody or if they do not. If they have the COVID-19 antibody it reflexes (indicates that additional testing should be performed) to a second titer test. Based on the results of the titer test determines whether the donor product can be used to treat a patient with the COVID-19 Convalescent Plasma (CCP).

In consideration of the original contract requirements, industry was, and is, aware of the potential for fluctuations in differing types of testing regarding these types of services.

The required services under this contract are for FDA mandated procedures that are followed for all blood donor product testing services. Contract W81K0020P0163 was competed on the Government point of entry.

If the blood donor testing requirements cannot be met, the donor centers (Robertson Blood donor center and Fort Leonard Wood Blood Donor Center) will be out of compliance of the directive signed by COL Jason B. Corley, Director of the Army Blood Program that requires that these additional tests be conducted.

Program/Equipment: COVID-19 Testing

Version – March 2017 FOR OFFICIAL USE ONLY

6. Efforts to Obtain Competition: “In accordance with FAR 5.202(a)(2), this action will not be synopsized.” Based on the urgency and to reduce delays in patient care it’s in the best interest of the Government to add the additional tests to the upcoming FY21 contract and all proposed follow on years.

7. Actions to Increase Competition: For future actions, the Government will reassess the market for available items, including but not limited to, issuing a Sources Sought Notice to determine market availability for brand name, or equal requirements. When the current testing becomes obsolete or when equivalent testing services become available every effort shall be made to increase competition and therefore an evaluation shall also be made concerning pertinent services. CRDAMC and GLWACH in conjunction with MEDCOM will continue to evaluate the capabilities of other vendor's services in order to provide items that are the best value to the Government. The Government will continue to seek new resources that will satisfy these requirements through continued market research, requests for Statements of Capability, research on the World Wide Web and telephonic inquiries.

8. Market Research: Market Research was conducted and there are possible service providers in the market who currently provide similar services however, in this instance, award to any other vendor, rather than to Creative Testing Solutions would be detrimental to critical healthcare services with the Robertson Blood Center, Ft. Hood, Texas, and Ft. Leonard Wood, Blood Donor Center, Ft. Leonard Wood, Missouri;

resulting in unacceptable mission failure.

9. Interested Sources: There are multiple vendors who could perform the required services. However, in this instance, due to the current COVID-19 pandemic, there is not sufficient time to solicit the requirement, evaluate offers and make an award for the 1 October 2020 start date. Award to any other vendor, rather than to Creative Testing Solutions would be detrimental to critical healthcare services with the Robertson Blood Center, Ft. Hood, Texas, and Ft. Leonard Wood, Blood Donor Center, Ft. Leonard Wood, Missouri; resulting in unacceptable mission failure.

10. Other Facts:

Modification to the current contract W81K0020P0059 for the same requested tests was done on 10 July 2020.

a. Procurement History

(1) Contract numbers of the current award:

Bridge Contract: W81K0020P0059 13 July 2020 to 30 September 2020.

$1,236,968.79

(2) The competitive status of this action. Sole source due to a protest.

(3) Authority previously cited if less than full and open competition was used. FAR Subpart 13.5

Program/Equipment: COVID-19 Testing

Version – March 2017 FOR OFFICIAL USE ONLY

(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.

For future actions, the Government will reassess the market for available items, including but not limited to, issuing a Sources Sought Notice to determine market availability for brand name, or equal requirements. When the current testing becomes obsolete or when equivalent testing services become available every effort shall be made to increase competition and therefore an evaluation shall also be made concerning pertinent services. CRDAMC and GLWACH in conjunction with MEDCOM will continue to evaluate the capabilities of other vendor's services in order to provide items that are the best value to the Government. The Government will continue to seek new resources that will satisfy these requirements through continued market research, requests for Statements of Capability, research on the World Wide Web and telephonic inquiries.

(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. Due to the Presidential declared national emergency and the requirement mandated by the Director of the Army Blood Program.

(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. Bridge contract due to ongoing GAO protest.

Program/Equipment: COVID-19 Testing

Version – March 2017 FOR OFFICIAL USE ONLY

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: 22 September 2020 Title: Signature:

X Right-Click "Signature Setup"

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.

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.

This determination will be made using the following: other: pricing for current modification

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.

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

Program/Equipment: COVID-19 Testing

Version – March 2017 FOR OFFICIAL USE ONLY

Approval Based on the foregoing justification, I hereby approve the procurement of additional tests in the amount of $3,465,000.00 due to the COVID-19 crisis on a sole source 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.

Date:

Signature: