Redacted _JA Sole Source_ Blood Blood Components.pdf

CUI//SP-SSEL

Control Number: 23-RHCO-C- 550

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: Department of Pathology and Area Laboratory Services (DPALS), Transfusion Services at Brooke Army Medical Center (BAMC), JBSA Fort Sam Houston, TX 78234 requires purchasing blood and blood products to maintain critical inventory levels necessary to support BAMC’s Level 1 Trauma mission. Blood and blood components are used to treat acute hemorrhage in trauma and surgical patient, prevent coagulopathy in oncology patients, and enable disease management through therapeutic plasma and red blood cell exchange. Failure to provide the necessary products in the time required would result in increased mortality.

Authority: The statutory authority permitting other than full and open competition is 41 United States Code 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.

Amount: The estimated value of this effort is $6,106,645.00 for a five (5) year ordering period.

Prepared by: Medina Woodson Title: Contract Specialist

Date: 29 August 2023 Email: medina.l.woodson.civ@health.mil

Contracting Officer: Salameya Paulouskaya

Date: 29 August 2023 Email: salameya.paulouskaya2.civ@health.mil

Technical Representative: MAJ Jacqueline Messenger

Title: BAMC Chief, Blood Services Email: jacquelyn.m.messenger.mil@health.mil

Date Reviewed: 29 August 2023

Controlled by: USAHCA Controlled by: MRCO-W CUI Category (ies): General Procurement & Acquisitions Limited Dissemination Control: FED ONLY POC: Medina Woodson, 210-539-8525

(Source Selection Information - See FAR 2.101 and 3.104-4) mailto:medina.l.woodson.civ@health.mil mailto:salameya.paulouskaya2.civ@health.mil mailto:jacquelyn.m.messenger.mil@health.mil

Control Number: 23-RHCO-C-353

Reviews

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

Legal Counsel

Julia P. Hatch 301-619-2150 Date: see digital signature

Command Advocate for Competition

Kerry A. Alvarenga DSN: 471-4093

Sole Source Justification and Approval Under FAR 13.501

1. Contracting Activity: Medical Readiness Contracting Office – West, US Army Health Contracting Activity, 3551 Roger Brooke Drive, JBSA Fort Sam Houston, Texas

2. Description of Action: Purchase blood and blood components, at a firm fixed price agreement for the Department of Pathology & Area Laboratory Services - Blood Services at Brooke Army Medical Center, Fort Sam Houston, TX. The Government projects award before 30 September 2023, with performance to start 1 October 2023; award will be subject to the availability of Defense Health Program, (DHP) FY24 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: Department of Pathology and Area Laboratory Services, Transfusion Services at Brooke Army Medical Center, JBSA Fort Sam Houston, TX 78234 requires the ability to purchase blood and blood products to maintain critical inventory levels necessary to support BAMC’s Level 1 Trauma mission. Blood and blood components are used to treat acute hemorrhage in trauma and surgical patient, prevent coagulopathy in oncology patients, and enable disease management through therapeutic plasma and red blood cell exchange. Blood products include whole blood, single donor plasma, cryoprecipitate, platelet concentrate and other related products. Blood and blood components are flexible and customizable. Depending on the receiving patient’s needs, additional testing or product modification may be required. These requirements include, but are not limited to rare antigen typing, sickle cell screening, Human Leukocyte Antigen (HLA) typing, genetic RBC phenotyping, component washing, irradiation, and product splitting.

The blood products needed and the estimated volume of each are indicated below:

Estimated Quantity: The estimated quantity of this effort is as below:

The Government’s requirement is to obtain blood and blood components manufactured in accordance with current Food and Drug Administration (FDA) guidance and current Association for the Advancement of Blood and Biotherapies (AABB) standards from an FDA licensed and AABB accredited facility. All blood products and components must be provided by a 24-hour courier service to the appropriate location at Brooke Army Medical Center (BAMC), JBSA - Fort Sam Houston, Texas: STAT orders must be delivered within one hour of request, as soon as possible (ASAP) orders must be delivered within 4 hours of request, and routine blood orders may be delivered within 24 hours of request. This requirement is needed NLT 1 October 2023.

Amount: The estimated value of this effort is $6,106,645.00 for a five (5) year ordering period.

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

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 provide blood products in order to accommodate the potential variety of patients to include active duty, retirees, beneficiaries, and civilians. Blood is needed to sustain our patient populations at BAMC. South Texas Blood & Tissue Center (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. Efforts to Obtain Competition: The Sources Sought Notice was posted to http://sam.gov (the Government’s Point of Entry) on 23 November 2022 with a response due date of 07 December 2022 in order to find companies (small and large) that could provide blood and blood products required for trauma support. A response was received from only one (1) vendor, STBTC on 12 January 2023. Efforts were made to contact Bloodworks (CAGE 44701), the American Red Cross (CAGE 1PZT5) and Carter Blood Care (CAGE 318U5) 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 cannot guarantee the required delivery timeline and do not support one (1) hour blood product requirements to medical treatment facilities in the San Antonio area.

Additional required notices in accordance with FAR 5.202 will be publicized.

A SBA Dynamic Small Business Search was conducted using the key words “Blood and Organ Banks” with the appropriate NAICS code “621991”. This search resulted in Veteran – 0, Service-Disabled Veteran - 0, HUBZone - 0, SDB – 0, 8a – 0, Woman or Women Owned - 0 for http://sam.gov/ all the categories listed. Reviewing the profile, no vendors were identified that could provide blood and blood components which are used in support of blood services.

Economic Group Number of Firms Found

Veteran 0

Service-Disabled Veteran 0

Currently 8(a) Certified 0

Currently HUBZone Certified 0

Currently SDB Certified 0

Woman or Women Owned 0

STBTC is the only blood and blood product supplier able to provide a 24-hour courier service to the appropriate location at BAMC, JBSA - Fort Sam Houston, Texas. Moreover, STBTC is the only blood and blood product supplier who can deliver STAT orders within one hour of request and is able to deliver as soon as possible (ASAP) orders within 4 hours of request, and routine blood orders within 24 hours of request. 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+hour trip). The American Red Cross is the blood supplier for the Austin metro area (75 miles, 1+ hour trip), delivering within a 40-mile radius of Austin. Blood product delivery inquiries to the American Red Cross, Austin confirmed they cannot meet the delivery time requirements.

7. Actions to Increase Competition: Based on market research conducted and the results of the Sources Sought Notice, 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: A sources sought notice for Blood Products was posted to https://SAM.gov from 23 November 2022 through 7 December 2022. There were no responses to the sources sought. A response was received from only one (1) vendor, STBTC on 12 January 2023. Efforts were made to contact Bloodworks (CAGE 44701), the American Red Cross (CAGE 1PZT5) and Carter Blood Care (CAGE 318U5) to see if they would be able to provide the required products and services. The vendors indicated they had the required blood, blood products, and services, however they cannot guarantee to meet the required delivery timeline and do not support one (1) hour blood product requirements to medical treatment facilities in the San Antonio area.

The contract specialist also reviewed the DLA, Medical Master Catalog and ECAT platforms and the requested items are currently not available.

9. Interested Sources: A sources sought notice for Blood Products was posted to https://SAM.gov from 23 November 2022 through 7 December 2022. There were no responses to the sources sought upon the response due date. After the close of the Sources Sought a response was received from STBTC on 12 January 2023. STBTC forwarded an updated pricelist, as they have written to express an interest in this requirement. As stated in paragraph 6 above, the notices required by FAR 5.201 have been published, and there are none other than STBTC that could provide the entirety of the Government’s requested requirement at this current time. Previous actions were reviewed and found that one vendor is consistently capable of providing the Blood Products.

10. Other Facts: The following facts support the use of other than full and open competition:

a. Procurement history:

Contract number, Contractor: W81K00-18-P-0426, STBTC. Description of requirement:

Blood and blood components manufactured in accordance with current FDA guidance/Code of Federal Regulations and current Association for the Advancement of Blood and Biotherapies (AABB) standards from an FDA licensed and AABB accredited facility.

Method of procurement: Full and Open Contract type: Firm-fixed Price Delivery requirements: All blood products and components must be provided by a 24- hour courier service to the appropriate location at Brooke Army Medical Center (BAMC), JBSA - Fort Sam Houston, Texas: STAT orders must be delivered within one hour of request, ASAP orders must be delivered within 4 hours of request, and routine blood orders may be delivered within 24 hours of request.

Number of Offerors: One (1) Total awarded amount: $4,591,785.00 Period of Performance: 01 October 2018 – 30 September 2023 Basis for fair and reasonable pricing: Proposed pricing was compared to the Independent Government Estimate (IGE), which was prepared prior to seeking formal proposals.

Reason for limitation: Historically only one source, SBTC had proposed on this action.

The following contract was competed with the same result: only one vendor responding – BAMC Blood Care (with the exception of W81K00-17-P-0762):

Contract number, Contractor: W81K00-17-P-0762 Description of requirement: STBTC Contract Type: Fixed Price Method of procurement: Full & Open Number of Offerors: Two (2) POP: 1 October 2018 - 30 September 2018

Value: $860,000.00 Note: there were two (2) quotes provided, from South Texas Blood & Tissue Center and Gulf Coast Blood Central. South Texas Blood quoted all items, to include meeting the statement of objectives, in response to the RFQ. Gulf Coast Blood Central did not provide a quote for three of the eighty-eight items listed; they did not submit evidence of Food and Drug Administration (FDA) approval; or evidence of accredited by the American Association of Blood Banks. As a result, South Texas Blood’s quote was therefore determined to be technically acceptable and Gulf Coast Blood Central, IAW FAR Clause 52.212-2, all or none basis, was found to be unacceptable.

Contract number, Contractor: W81K00-17-P-0108

Contract Type: Fixed Price Method of procurement: Full & Open Number of Offerors: One (1) POP: 1 January 2017 – 31 March 2017 Value: $150,000.00

Contract number, Contractor: W81K00-17-P-0504

Contract Type: Fixed Price Method of procurement: Full & Open Number of Offerors: One (1) POP: 1 July 2017 – 30 September 2017

Contract number, Contractor: W81K00-16-P-0573

Contract Type: Fixed Price Method of procurement: Full & Open Number of Offerors: One (1) POP: 23 November 2016 – 31 December 2016

Contract number, Contractor: W81K00-15-P-0874

Contract Type: Fixed Price Method of procurement: Full & Open Number of Offerors: One (1) POP: 24 November 2015 – 31 January 2016 Value: $273,000.00

11. Technical/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.

Signature:

MAJ Jacquelyn Messenger BAMC Chief, Blood Services

12. Fair and Reasonable Cost Determination/Contracting Officer Certification:

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.

Signature:

Salameya Paulouskaya Date: see digital signature Contracting Officer, MRCO-W

PAULOUSKAYA Digitally signed by

.SALAMEYA.12 A.1246035373

PAULOUSKAYA.SALAMEY

46035373 Date: 2023.09.05 10:31:59 -05'00'

Approval

Based on the foregoing justification, I hereby approve the procurement of Blood and blood components for the Department of Pathology, Transfusion Services, BAMC, from South Texas Blood & Tissue Center, in the total amount of $6,106,645.00 for a five (5) year ordering period of on 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.

Kerry A. Alvarenga Date: see digital signature Command Advocate for Competition