Redacted JA Sole Source FAR Part 13.5_ Blood Products and Components_APPROVED.pdf

CUI//SP-SSEL

Control Number: 25-MRCO-W-136

CUI//SP-SSEL

(Source Selection Information - See FAR 2.101 and 3.104-4)

1 JUN 2023

Justification Review Document

For Sole Source - FAR Part 13.501* (*Format follows FAR 6.303-2, but modified to reflect FAR subpart 13.5 procedures)

Program/Equipment: The Department of Pathology and Area Laboratory Services (DPALS) requires a modification to increase the quantity on two (2) Sub-CLINs for the red blood cells – leukocyte-reduced and the single donor plasma – frozen to allow the Blood and Transfusion Laboratory to supply critical life-saving blood products and components in support of the DPALS trauma mission at the Brooke Army Medical Center (BAMC), JBSA Fort Sam Houston, TX 78234

Authority: 41 United States Code 3304(a)(1) as implemented in Federal Acquisition Regulation 6.302-1 “Only one responsible source and no other supplies or services will satisfy agency requirements”.

Amount: The estimated value of this modification effort is $266,960.00 for all remaining options.

Prepared by:

Medina Woodson Date: 1 April 2025 Contract Specialist medina.l.wooson.civ@health.mil

Contracting Officer:

Salameya Paulouskaya Date: 1 April 2025 Contracting Officer:

salameya.paulouskaya2.civ@health.mil

Technical Representative:

MAJ Jacquelyn Messenger , PHD Date: 1 April 2025 BAMC Chief, Blood Services (210) 916-1180

DPALS, BAMC

Jacquelyn.m.messenger.mil@health.mil mailto:medina.l.wooson.civ@health.mil mailto:salameya.paulouskaya2.civ@health.mil mailto:Jacquelyn.m.messenger.mil@health.mil

CUI//SP-SSEL Control Number: 25-MRCO-W-136

2 JUN 2023

Requirements Representative:

Mr. Arnel Rivera Date: 1 April 2025 Budget Analyst (210) 916-4835

DPALS, BAMC

arnel.rivera.civ@health.mil

Reviews

I have reviewed this justification and find it adequate to support other than full and open competition.

YOON.FRANK.1238380 Digitally signed by

YOON.FRANK.1238380274

Da te : 20 25 .04 .2 9 10 :35 :56 -04'00'

Mr. Frank Yoon Date: see digital signature Associate General Counsel Contract Law MTF Support Branch Defense Health Agency frank.yoon.civ@health.mil mailto:arnel.rivera.civ@health.mil mailto:frank.yoon.civ@health.mil

3 JUN 2023

Sole Source Justification and Approval Under

FAR 13.501

1. Contracting Activity: Medical Readiness Contracting Office, West (MRCO-W),3551 Roger Brooke Drive, JBSA Fort Sam Houston, Texas 78234.

2. Description of Action: DPALS at BAMC requests existing contract W81K00-23-D-0009, a firm-fixed-price indefinite delivery indefinite quantity (IDIQ) awarded to South Texas Blood and Tissue Center be modified to add additional red blood cells – leukocyte-reduced and single donor plasma – frozen products to Sub-CLINS 0001AA and 0002AA. The Government projects issuance of this modification by 15 June 2025. FY25 Defense Health Program funds have been appropriated by Congress and are available for obligation. An acquisition plan is not required because this modification is not a new contract request.

Name of Proposed Contractor and Address:

South Texas Blood and Tissue Center (STBTC) 6211 W Interstate 10 San Antonio, Texas 78201-2023 CAGE Number: 082Q3 UEI: Number: J4UKR8JY4L54

3. Description of Supplies/Services: The Government’s requirement is to modify the current contract W81K00-23-D-0009 issued to STBTC, for additional red blood cells – leukocyte-reduced and single donor plasma – frozen products to keep up with the growing demand. The clinical need for these types of blood products has increased above the predicted usage due to increased trauma and new clinical practices at BAMC. This is a modification that will increase blood products that are higher than originally projected this current period that began on 01 October 2024 and throughout the end of the ordering period, i.e., 30 September 2028.

This contract is currently in place to ensure DPALS Blood Services has the blood products available to support trauma, hematology/oncology patients, and in-patient care requirements.

CLINS Blood Products Additional

Quantity Unit Price Price

0001AA Red Blood Cells, Leukocyte- Reduced

800 $295.00 $236,000.00

0002AA Single Donor Plasma, Frozen 360 $86.00 $30,960.00

Total $266,960.00

4 JUN 2023

Delivery Date of Requirement: A five (5) year ordering period from 01 October 2023 to 30 September 2028

NOTE: As a supply contract, FAR 52.217-8 is not available for use.

4. Authority Cited: FAR 13.501(a)(1)(ii): sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

5. Reason for Authority Cited: The Government has a current need in the Department of Pathology, Transfusion Services, BAMC to receive blood products in short-fuse emergency situations to accommodate the potential variety of patients to include active duty, retirees, beneficiaries, and civilians. STBTC is the only facility that can deliver STAT orders within one hour of request, as soon as possible (ASAP) orders within 4 hours of request, routine blood orders within 24 hours of request, and can meet BAMC’s inventory demands on a consistent schedule. Blood is needed to sustain our patient population and trauma patients at BAMC.

STBTC is the only FDA approved blood product distributor to BAMC, located in San Antonio, Texas, with the collection capacity to meet BAMC’s extensive and unique inventory requirements.

6. Efforts to Obtain Competition: The current market research began on 3 April 2025 and the methods consisted of a sources source notice that was posted on 15 April 2025 with the response date of 22 April 2025. The only response was received from Bright Labs Diagnostics on 17 April 2025. DPALS technical evaluator reviewed Bright Labs Diagnostics capability statement and determined that this vendor did not meet the requirements for this action via email on 22 April 2025. In addition, DPALS personnel in conjunction with contracting personnel conducted the market research via internet searches, the Defense Health Agency Medical Logistics Bulletin, Electronic Cataloging (ECAT) and General Service Administration (GSA) Federal Supply Schedule (FSS) for any new local blood and blood product suppliers in San Antonio area that can meet the requirements for this contract. DPALS market research concluded that STBTC was still the only vendor capable of meeting the Government’s timeline requirements for this contract. Since the solicitation of this contract, the potential vendor status has remained unchanged. South Texas Blood and Tissue Center is the only blood and blood product supplier in the San Antonio metro area that can meet the STAT and ASAP deadline times required by the MTF. Additionally, the closest medical treatment facility outside of San Antonio that sustains a blood product inventory is St. David’s South Austin Medical Center, Austin Texas (70 miles, 1+hr. trip). The American Red Cross is the blood supplier for the Austin metro area (75 miles, 1+ hr. trip), delivering within a 40-mile radius of Austin. Blood product delivery inquiries to the American Red Cross, Austin confirmed that they cannot meet the delivery time requirements.

7. Actions to Increase Competition: Based on the results of the current market research that was conducted on 3-22 April 2025, competition is not anticipated for this requirement. The Government will continue to assess the market for new entrants. The Medical Readiness Contracting Office – West will continue to evaluate the capabilities of other vendor’s products and re-procure the products that provides the best value to the Government and are FDA approved.

8. Market Research: The market research began on 3 April 2025 for any new local blood and blood product suppliers in the San Antonio area that can meet the requirements for this contract. A Sources Sought Notice was posted to https://sam.gov, the official GPE, on 15

5 JUN 2023

April 2025 with a response due date of 22 April 2025 in order to find companies (small and other-than-small) that could provide the red blood cells – leukocyte-reduced and the single donor plasma – frozen. The only response was received from Bright Labs Diagnostics on 17 April 2025. Based on DPALS technical review of Bright Labs Diagnostics capability statement on 22 April 2025, it has been determined by DPALS that this vendor does not meets the requirements for this effort. The market research was conducted by DPALS personnel in conjunction with the contracting personnel to determine the likelihood of other blood and blood product suppliers that are able to provide for the complete requirement. The methods used included internet searches, a review of the College of American Pathologists’ website, Internet, ECAT, and GSA FSS. DPALS confirmed that both GSA and ECAT did not include all the blood products and components required for this action. Efforts were made to contact Carter Blood care and the American Red Cross to see if they would be able to provide the required products and services. The vendors indicated that they had the required blood, blood products, and services, however they could not meet the required one hour delivery timeline. Previous actions were reviewed and found that only one vendor is consistently capable of providing the Blood Products within one hour. The additional blood products are estimated at $266,960.00 which requires the lead time of up to 120 days.

Therefore, re-competing and awarding the additional supplies under a stand-alone contract will cause the unnecessary delays and increase the risk of failure of mission-essential services which would endanger patient safety.

9. Interested Sources: An SBA Dynamic small business search and Quick Market search was conducted using NAICS “621991” and a keyword “Blood”. The contract specialist also reviewed the Defense Logistics Agency, Medical Master Catalog and Electronic Catalog (ECAT) platforms and the requested items are currently not available. The search resulted in six (6) small business vendors that were unable to provide the blood products, components and services that can meet BAMC’S inventory demands and time schedule. Based on the Customer’s knowledge and expertise, it has been determined that STBTC is the only facility that can deliver STAT orders within one hour of request, as soon as possible (ASAP) orders within 4 hours of request, routine blood orders within 24 hours of request, and can meet BAMC’s inventory demands on a consistent schedule. The Contracting Officer shall publish the notices required by FAR 5.201 and 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.

10. Other Facts:

a. Procurement history.

(1) Contract numbers and dates of all awarded contracts for the same requirements:

W81K00-23-D-0009, IDIQ Contract was awarded to STBTC on 26 September 2023 with a five year ordering period from 01 October 2023 to 30 September 2028.

W81K00-18-P-0426 was awarded to STBTC on 17 July 2018 with a base period from 01 October 2018 to 30 September 2019 plus four (4) twelve (12) month option periods from 1 October 2019 thru 30 September 2023.

W81K00-17-P-0762 was awarded to STBTC on 29 September 2017 for the period of

6 JUN 2023

performance from 01 October 2017 to 30 September 2018.

(2) Competitive status:

W81K00-18-P-0426, full and open competitive acquisition W81K00-17-P-0762, full and open competitive acquisition

(3) Authority previously cited if less than full and open competition was used - N/A

7 JUN 2023

(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 – DPALS has solicited the last two acquisitions listed above as full and open and the only technically acceptable vendor has always been STBTC. STBTC is the only FDA approved blood product distributor to BAMC, located in San Antonio, Texas, with the collection capacity to meet BAMC’s extensive and unique inventory requirements. STBTC is the only facility that can deliver STAT orders within one hour of request, as soon as possible (ASAP) orders within 4 hours of request, routine blood orders within 24 hours of request, and can meet BAMC’s inventory demands on a consistent schedule.

(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. STBTC does not have any known local distributors or other authorized local vendors that could provide the blood products, components and services that can meet BAMC’S inventory demands and time schedule.

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.

MAJ Jacquelyn Messenger, PHD Date: see digital signature BAMC Chief, Blood Services

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.

RIVERA.ARNEL.12 Dig ita lly s ign ed by RIVERA.ARNEL.1267968450

67968450 Date : 2025.04.28 14:00:48 -05'00'

Mr. Arnel Rivera Date: see digital signature

MESSENGER.JACQUELY Digitally signed by

N.MARIE.1083904867

MESSENGER.JACQUELYN.MARIE.1083904867

Date: 2025.04.25 11:55:22 -05'00'

8 JUN 2023

Budget Analyst, DPALS

9 JUN 2023

13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost to the

Government for this contract action will be fair and reasonable. A price analysis will be conducted to compare the proposed prices to contracts within MRCO-W for the same or similar requirements. Certified cost or pricing data is not required, in accordance with FAR 15.403- 1(b)(3). I certify that this justification is accurate and complete to the best of my knowledge and belief.

PAULOUSKAY Digitally signed by

PAULOUSKAYA.SALAME

A.SALAMEYA.1 YA.1246035373

246035373 Date: 2025.04.29 09:28:40 -05'00'

Salameya Paulouskaya Date: see digital signature Contracting Officer

14. Contracting Officer Certification:

I certify that this justification is accurate and complete to the best of my knowledge and belief.

PAULOUSKAY

A.SALAMEYA.

1246035373

Digitally signed by

PAULOUSKAYA.SALAM

EYA.1246035373

Date: 2025.04.29 09:28:57 -05'00'

Salameya Paulouskaya Date: see digital signature

10 JUN 2023

Approval

Based on the foregoing justification, I hereby approve the procurement of the red blood cells – leukocyte-reduced and the single donor plasma – frozen to supply critical life-saving blood products and components testing in support of the Department of Pathology and Area Laboratory Services, for the estimated dollar value of $266,960.00, on an other than full and open competition basis pursuant to the authority of 41 U.S.C. 1901 as implemented by FAR 13.501, subject to availability of funds, and provided that the supplies herein described have otherwise been authorized for acquisition.

PAULOUSKAYA.

SALAMEYA.124

6035373

Digitally signed by

PAULOUSKAYA.SALAMEYA.

1246035373 Date: 2025.04.29 09:29:13 -05'00'

Salameya Paulouskaya

Date: see digital signature