I.A.02 JA - Signed.pdf

Control No: 20-RHCO-C-415 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: The William Beaumont Army Medical Center (WBAMC) Blood Donor Center (BDC) at Fort Bliss, Texas requires a modification of existing Donor Testing Contract, W81K0018P0476, for the manufacturing of transfusable blood products. WBAMC must add COVID-19 antibody testing to each Standard Donor Panel, to be in compliance with Army Blood Program guidance, effective 05 June 2020 (see ABPL 2020-06-01). Modification will cover screening for anti-SARS-CoV-2 antibodies and quantitative measurement of COVID neutralizing antibodies when screening is positive. The government contemplates a performance period from 29 June 2020 – 31 August 2020. The entire contract will be competitively rebid, effective 01 September 2020.

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

Amount: Funding required for base 2 1/2-month modification period outlined below.

Performance Time Frame Total Cost

MOD 29 Jun 2020 – 31 Aug 2020 $141,750.00

Prepared by: CPT Annette Mott Comm. 915-742-6422 Chief, Blood Services Date: 06/10/2020 Email: Annette.m.mott.mil@mail.mil

Contracting Officer: Kristin Hermosillo DSN: 915-742-9581 Contracting Officer Date: 06/10/2020 Email: Kristin.s.hermosillo2.civ@mail.mil

Technical: CPT Annette Mott Comm. 915-742-6422 Chief, Blood Services Date: 06/10/2020 Email: Annette.m.mott.mil@mail.mil

Requirements: CPT Annette Mott Comm. 915-742-6422 Chief, Blood Services Date: 06/10/2020 Email: Annette.m.mott.mil@mail.mil

Program/Equipment: Blood Donor Testing

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: William Beaumont Army Center

2. Description of Action: William Beaumont Army Medical Center requests modification of current contract to add screening for anti-SARS-CoV-2 antibodies and quantitative measurement of COVID neutralizing antibodies when screening is positive. This is required to be in compliance with Army Blood Program guidance, effective 05 June 2020 (see ABPL 2020-06-01).

The Government projects award for 29 June 2020 and fiscal year FY20 Army funds will be used.

3. Description of Supplies/Services: WBAMC must add COVID-19 antibody testing to each Standard Donor Panel, to be in compliance with Army Blood Program guidance, effective 05 June 2020 (see ABPL 2020-06-01). Modification will cover screening for anti-SARS-CoV-2 antibodies and quantitative measurement of COVID neutralizing antibodies when screening is positive. The government contemplates a performance period from 29 June 2020 – 31 August 2020. The entire contract will be competitively rebid, effective 01 September 2020.

Period of Performance:

29 June 2020 to 31 August 2020 Value: $141,750.00

4. Authority Cited: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 (or 41 U.S.C.

1903 for Special Emergency Procurement) as implemented by FAR Subpart 13.5:

X Unusual and compelling urgency Exclusive licensing agreements Industrial mobilization

X Other: Army Blood Program is mandating screening of potential donors for COVID antibodies, and quantitative measurement (titer) of antibody levels in positive screens. See ABPL 2020-06-01.

5. Reason for Authority Cited:

Sole source is being pursued because Army Blood Program mandate is effective NLT 29 June 2020.

Modification of current contract for the remainder of period of performance is necessary as timeframe is too short to implement the processes of another vendor and to get new supplies and data-resulting system in place before effective date.

(b) Alternatives: If sole-sourced contract modification were not granted by 29 June 2020, mission could not be met. Army Blood Program requires this additional testing by 29 June 2020.

6. Efforts to Obtain Competition: Modification to contract W81K00-18-P-0476

7. Market Research: See attached Market Research document.

8. Other Facts:

Program/Equipment: Blood Donor Testing

Version – March 2017 FOR OFFICIAL USE ONLY

a. Procurement History:

W81K0018P0476 was competitively bid for Donor Testing. Creative Testing Solutions won this bid.

We are currently in option year one of four.

9. 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 Mott, Annette Date:

Title: Chief, Blood Services Signature:

X Right-Click "Signature Setup"

10. 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 Mott, Annette Date:

Title: Chief, Blood Services Signature:

X Right-Click "Signature Setup"

11. 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. Price is in line with previous test cost on current contract.

Typed Name: Kristin Hermosillo Date:

Title: Contracting Officer Signature:

X Right-Click "Signature Setup"

Annette Mott

Annette Mott

MOTT.ANNETTE.MA

RIE.1269489657

Digitally signed by

MOTT.ANNETTE.MARIE.1269489657

Date: 2020.06.16 14:02:35 -06'00'

MOTT.ANNETTE.M

ARIE.1269489657

Digitally signed by

MOTT.ANNETTE.MARIE.12694896

Date: 2020.06.16 14:02:59 -06'00'

6/24/2020

Program/Equipment: Blood Donor Testing

Version – March 2017 FOR OFFICIAL USE ONLY

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

Typed Name: Kristin Hermosillo Date:

Title: Contracting Officer Signature:

X Right-Click "Signature Setup"

6/24/2020