FINAL BRIDGE FAR-Part13-5-Sole-Source-JA_ACC Blood Donor Testing (KO Reviewed_Changed_Approved)_Redacted.pdf

Control No: 20-RHCO-C-96 Contractor: Creative Testing Solutions

Program/Equipment: Blood Donor 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: FDA required Blood Donor Testing Services for specimens submitted by Robertson Blood Center, Ft Hood, Texas, and Ft Leonard Wood, Blood Donor Center, Ft Leonard Wood, Missouri.

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

Amount: $1,542,340.00

Prepared by: Karan E. Quiles DSN: 725-6744 Contract Specialist Date: 18 February 2020 Email: karan.e.quiles.civ@mail.mil

Contracting Officer: Randall P. Cummins DSN: 556-1660 Contracting Officer Date: 18 February 2020 Email: randall.p.cummins.civ@mail.mil

Technical: LTC Jenifer Marin DSN: NA Chief Blood Services Date: 18 February 2020 Email: jennifer.marin.mil@mail.mil

Requirements: LTC Jenifer Marin DSN: NA Chief Blood Services Date: 18 February 2020 Email: jennifer.marin.mil@mail.mil

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

mailto:karan.e.quiles.civ@mail.mil mailto:randall.p.cummins.civ@mail.mil mailto:jennifer.marin.mil@mail.mil mailto:jennifer.marin.mil@mail.mil

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: Bridge Contract to continue services on Firm Fixed Price contract for Non-Personal Services for the following requirement: FDA required Blood Donor Testing Services for specimens submitted by Robertson Blood Center, Ft Hood, Texas, and Ft Leonard Wood, Blood Donor Center, Ft Leonard Wood, Missouri. The Government projects award for 01 April 2020 and fiscal year 2020. This action will be accomplished for this acquisition through the use of an FFP contract funded with Defense Health Program (DHP) Operation and Maintenance (O&M) 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).

3. Description of Supplies/Services: Services include the contractor providing all required facilities, personnel, services, transportation, materials, equipment, and supplies required to provide testing for HBsAg, Anti-HBc, Anti-HCV, Anti-HTLV I/II, Anti-HIV ½, STS (syphilis), ABO/Rh, ABSC, NAT pooled testing for HIV/HCV/HBV, individual donor testing for West Nile Virus, Babesiosis and Chagas (T. cruzi), Babesia (IDS), Babesia (pooled) CMV testing and additionally the screening for cytomegaolovirus must be complete for blood donor specimens for unique labeling requirements for specimens submitted by Robertson Blood Center, Ft Hood, Texas, and Ft Leonard Wood, Blood Donor Center, Ft Leonard Wood, Missouri. The period of performance is 01 April 2020 - 30 September 2020 for six (6) months and the potential six (6) month extension ending on 31 March 2021. FY20 funds are available in the amount of $771,170.00. The potential six (6) month extension $771,170.00 is subject to availability of FY21 funds. Total estimated dollar amount is $1,542,340.00. Please note that the following tests must be added per the end user which are currently not on the extension. Per and MFR from LTC Jennifer Marin, Chief Blood Services: “Babesia will be a required test for all blood donor products by the FDA starting on 1 April 2020. If the Babesia testing requirements cannot be met the donor centers (Robertson Blood donor center and Fort Leonard Wood Blood Donor Center) will need to shut down all further operations and collections until this condition can be met. The impact of collections would be 730 units monthly. We will not be able to support the Army Blood Program quota’s for overseas shipments or support to local MTF’S. For the local MTF’S to purchase additional blood products the cost is $229.00 per unit. Units cannot be purchased from a civilian blood donor center for the overseas quota mission.”

Period of Performance: 01 April 2020 to 30 September 2020 Total Value: $771,170.00 FAR Clause 52.217-8 option: 01 October 2020 to 31 March 2021 Value: $771,170.00 Total: $1,542,340.00

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

☒ Other: FAR Subpart 13.5: Bridge requirement due to an ongoing GAO protest.

5. Reason for Authority Cited:

Bridge Contract Basic: W81K0014C0088 is currently in place for these Non-Personal Services at Robertson Blood Center, Ft Hood, Texas, and Ft Leonard Wood, Blood Donor Center, Ft Leonard Wood, Missouri, the contract included FAR Clause 52.217-8 – Option to Extend Services. FAR Clause 52.217-8 has been executed through 31 March 2020.

The purpose of this sole-source bridge contract is to allow time for the Pre-Award GAO Level protest to be resolved and allow time for the new awardee to properly establish protocols with the Blood Centers in order that appropriate FDA procedures are followed for all blood donor products.

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 Bridge contract is required to ensure continuation of these mission critical services until the follow-on FFP contract can be made effective. This FFP was solicited as full and open and due to two (2) Pre-Award GAO level protests the requirement has not been awarded. The first protest was received 26 August 2019 and the second protest was received 30 December 2019. This bridge contract will allow the Government the time to complete any further corrective action for the Pre-Award GAO Level protest.

If the blood donor testing requirements cannot be met the donor centers (Robertson Blood donor center and Fort Leonard Wood Blood Donor Center) will need to shut down all further operations and collections until this condition can be met per FDA guidelines.

The impact of collections would be that we will not be able to support the Army Blood Program quota’s for overseas shipments or support to local MTF’S. Units cannot be purchased from a civilian blood donor center for the mission. Creative Testing Solutions, the incumbent contractor, is the only responsible source that can prevent an unacceptable interruption in the required mission critical contract services because only Creative Testing Solutions has all of the required facilities, personnel, services, transportation, materials, equipment, and supplies already in place to be able to provide the required services by the 1 Apr 20 deadline. A sole source Bridge contract with Creative Testing Solutions is required to ensure continuation of these FDA mandated mission critical services until the follow-on FFP contract can be made effective. Creative Testing Solutions is already established as the current vendor and would not have to establish proper protocols with the Blood Centers in order that appropriate FDA procedures are followed for all blood donor products.

6. Efforts to Obtain Competition: “In accordance with FAR 5.202(a)(2), this action will not be synopsized.” Based on the need, and the ongoing protest, the required start date for the new interim contract must be 01 April 2020. There are multiple vendors who could perform the required services. The requirement was solicited and two vendors provided an offer to the solicitation. However, due to the ongoing pre-award GAO protest all actions on the requirement has ceased.

a. Effective Competition: Creative Testing Solutions is the only vendor capable of meeting the Government’s requirement for a 01 April 2020 start date.

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. 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. The requirement was solicited and two vendors have provided an offer to the solicitation. However, due to the pre-award GAO protest and all actions on the requirement has ceased.

10. Other Facts:

a. Procurement History

W81K0014C0088 (FFP):

(1) Total dollar value to date to include the six month extension of services due to the Pre-Award GAO Level protest is $5,407,971.23 (01 October 2014 – 31 March 2020).

(2). Competitive Status of these actions: FFP, full and open.

(3). Authority previously cite if less than full and open competition was used: N/A.

Program/Equipment: Blood Donor 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. N/A

(5) The purpose of this sole-source bridge J&A is to allow time for the Pre-Award GAO Level protest to be resolved. If there is a lapse in service the Robertson Blood donor center and Fort Leonard Wood Blood Donor Center will need to shut down all further operations and collections.

(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

b. Other facts. The Performance Work Statement (PWS) for this contract is essentially the same as the PWS for the current contract and may include changes to points of contact, and those required by law or regulation.

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: LTC Jennifer Marin Date:

Title: Chief Blood Services Signature:

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.

Typed Name: LTC Jennifer Marin Date:

Title: Chief Blood Services 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.

This determination will be made using the following: ☒ other: based on pricing that is currently in place

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: Randall P. Cummins Date:

Title: Contracting Officer Signature:

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

Typed Name: Randall P. Cummins Date:

Title: Contracting Officer Signature:

Approval

Based on the foregoing justification, I hereby approve the procurement of Blood Donor Testing 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.

Amount: $1,542,340.00

Liza J. Esmond Date:

Command Advocate for Competition S gnature: