Redacted JA _STBTC_W81K00-23-D-0009_17 June 2024___All Signatures (1).pdf

CUI//SP-SSEL

Control Number: 24-RHCO-C-231

Justification and Approval

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 a modification to add the ability to purchase all potential specialty testing/service requirements. These changes will ensure critical blood product inventory levels are maintained to support BAMC’s Level 1 Trauma mission and allow flexibility to procure any unique special handling, products, services, and reference testing that may be necessary based on each patient’s specific clinical condition and treatment requirements.

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 $2,245,775.00 including all options.

Prepared by:

Medina Woodson Contract Specialist Email: medina.l.woodson.civ@health.mil

Contracting Officer:

Salameya Paulouskaya Email: salameya.paulouskaya2.civ@health.mil

Technical Representative:

MAJ Jacquelyn Messenger, PhD BAMC Chief, Blood Services Email: jacquelyn.m.messenger.mil@health.mil Date

Requirements Representative:

SSG Milagros Montalvo BAMC NCOIC, Transfusion Services Email: milagros.e.montalvo.mil@health.mil

CUI//SP-SSEL

(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 mailto:milagros.e.montalvo.mil@health.mil

CUI//SP- PROCURE

Reviews

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

Level Above Contracting Officer:

Ms. Jamie Brunner Date: see digital signature Deputy Chief of the Contracting Office

MRCO-W

Mr. Frank Yoon Date: see digital signature Legal Counsel Office of General Counsel Chief, Contract Law MTF Support Branch

DHA

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

Sole Source Justification and Approval

Under FAR 13.501

1. Contracting Activity: Medical Readiness Contracting Office – West (MRCO-W)

2. Description of Action: Brooke Army Medical Center Department of Pathology and Area Laboratory Services (DPALS) requests that the existing contract W81K00-23-D-0009, a firm-fixed-price through an Indefinite Delivery Indefinite Quantity (IDIQ) contract agreement issued to South Texas Blood and Tissue Center (STBTC), be modified to realign blood product quantities based on changing patient population requirements, and consolidate all available specialty products, testing, and services under one CLIN to accommodate any unforeseen unique patient requirements. The Government projects issuance of this modification by 30 June 2024.

FY24 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.

This action is a modification request under Federal Acquisition Regulation (FAR) 6.302-1, “Only one responsible source and no other supplies or services will satisfy agency requirements”, to the firm fixed price contract with South Texas Blood and Tissue Center (STBTC). This modification captures increased blood products at the Department of Pathology and Area Laboratory Services, Transfusion Services at Brooke Army Medical Center, JBSA Fort Sam Houston, TX. The original contract Statement of Work requires modification to show added blood products. Blood products and blood components are used to treat acute hemorrhage in trauma and surgical patients, prevent coagulopathy in oncology patients, and enable disease management through therapeutic plasma and red blood cell exchange. Due to each patient’s unique clinical condition, many require specialized products specific to their blood antigen phenotype to prevent a fatal transfusion reaction. The current contract does not contain a full array of the blood products available at the STBTC. Failure to provide the necessary products in the time required would result in increased mortality. In order to decrease the risk of customer’s mortality, these modifications must be implemented without the delay a competitive acquisition would incur.

The IDIQ W81K00-23-D-0009 was awarded as a sole source under Federal Acquisition Regulation 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items. The Contracting Officer issued solicitation W81K00-23-R-0026 on 6 September 2023. The redacted Justification & Approval was posted on SAM.gov on 5 September 2023, as required by FAR 13.501(a)(1) (iii). Contract W81K00-23-D- 0009 was awarded on 26 September 2023 with the ordering period of 1 October 2023 – 30 September 2028. No additional modifications have been completed.

Through market research and acquisition history, the services are commercially available.

However, to enter in another contract for the required services through the use of competitive procedures would delay the required blood products at BAMC and for its patients and families.

3. Description of Supplies/Services: The Government’s requirement is to modify the current Contract W81K00-23-D-0009 issued to STBTC, to keep up with the growing demand for blood products and unforeseeable specialty requirements that have increased above the predicted usage.

This is a modification that will increase blood products and services that are higher than originally projected this current period that began on 01 October 2023 and throughout the end of the ordering period, i.e., 30 September 2028. This contract is currently in place to ensure blood products are available to support trauma, hematology/oncology patients, and in-patient care requirements for DPALS Blood Services.

Blood and blood components are used to treat acute hemorrhage in trauma and surgical patients, prevent coagulopathy in oncology patients, and enable disease management through therapeutic plasma and red blood cell exchange. The availability of these critical lifesaving products is a crucial component of BAMC’s level I trauma mission. Blood products, including whole blood, single donor plasma, cryoprecipitate, platelet concentrate and other related products, are flexible and customizable. Depending on the receiving patient’s needs, additional testing, handling, or product modification may be required and are unpredictable. These requirements include, but are not limited to rare antigen typing, sickle cell screening, HLA typing, RBC genotyping, component washing, irradiation, and product splitting.

This modification is necessary to support providers growing demand in usage of blood products and services that are needed for their patients at BAMC. Blood product and service demand has increased above previous years usage due to the expanded operating rooms that were previously closed during COVID and a significant increase in the hematology/oncology patient load as services continue to expand. This demographic of patients requires higher quantities of blood products and additional specialty testing services that normally are not required for surgical or trauma patients. It is imperative to BAMC’s trauma mission and patient care that Blood Services has these products readily available for use when required. If this contract modification is not awarded, BAMC will be unable to obtain critical lifesaving blood products and services, negatively impacting BAMC’s trauma mission, and would be detrimental to patient outcomes.

The CLIN for this contract will be added accounting for 72 separate special handling, products, services, and testing requirements for a total cost of $ 2,245,775.00.

4. Authority Cited: South Texas Blood and Tissue Center is the only contractor who meets the Government immediate needs at this time due to time constraints. Moreover, South Texas Blood and Tissue Center is able to provide the extensive range of blood products on short notice and, hence, to satisfy the immediate needs for the additional blood products at the DPALS, BAMC, at Ft Sam Houston. TX.

5. Reason for Authority Cited: The contract for blood products and services under an IDIQ agreement that is already in place for BAMC Blood Services. This modification is to request to increase blood products and services that the demand is higher than originally projected, add additional services that may be required, and to decrease blood products and services that have a decrease in demand. The ordering period for this contract is from 01 October 2023 to 30 September 2028. The overall period of performance and delivery date will remain unchanged allowing Blood Services to continue to support BAMC’s trauma mission.

The Government’s need for blood products to accommodate a variety of patients to include active duty, retirees and civilians has increased since this contract was awarded. Blood is needed to sustain the patient populations at BAMC. STBTC is the only Food and Drug Administration (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 90 minutes of request, as soon as possible (ASAP) orders within 4 hours of request, routine blood orders within 24 hours of request, and meet BAMC’s inventory demands on a consistent schedule.

6. Efforts to Obtain Competition: Market research performed in November 2022 for this contract concluded that STBTC was the only vendor capable of meeting the Government’s requirements. 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. 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 market research that was 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:

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 for the award of the IDIQ Contract W81K00-23-D-0009. A response was received from only one (1) vendor, South Texas Blood, and Tissue (STBT) on 12 January 2023. STBT submitted a capability statement providing information on blood and blood products, reference testing and services offered. 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 guarantee to meet the required delivery timeline. Previous actions were reviewed and found that only one vendor is consistently capable of providing the Blood Products. The additional blood products are estimated at $2,245,775.00. 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.

http://sam.gov/

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.

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

a. Procurement history:

(1) Contract numbers and dates of all awarded contracts for these same requirements.

Contract number: W81K00-23-D-0009 Contractor: South Texas Blood and Tissue Center.

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: Sole Source 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 Total awarded amount: $ 5,917,725.00 Period of Performance: 01 October 2023 – 30 September 2028 Basis for fair and reasonable pricing: Proposed pricing was compared to the Independent Government Estimate (IGE), which was prepared prior to seeking formal proposals.

Contract number: W81K00-18-P-0426 Contractor: South Texas Blood and Tissue Center.

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

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

Contract number, W81K00-17-P-0762 Contractor: South Texas Blood and Tissue Center Description of requirement: Blood Products Contract Type: Fixed Price Method of procurement: Full and Open Number of Offerors: Two Period of Performance 25 April2018 - 30 September 2018 Value: $860,000.00

(2) Authority previously cited if less than full and open competition was used.

41 U.S.C. 1901 as implemented in FAR 13.501(a)(1)(ii).

(3) Sole source justification was prepared to support the procurement made before this one.

(4) There are various blood products to be added to the original contract Statement of Work. Due to the urgency of the required changes to be incorporated into the current contract, this will help avoid any lapse in delivery of various blood products to ensure the patients’ health risk is decreased.

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.

Date: see digital signature MAJ Jacquelyn Messenger Title: 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.

Date: see digital signature SSG Milagros Montalvo Contracting Officer Representative

13. 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). “When a commercial product or commercial service is being acquired”.

Date: 2024.06.17 12:35:26 -05'00'

Ms. 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.

Ms. Salameya Paulouskaya Date: see digital signature Contracting Officer

APPROVAL

Based on the foregoing justification, I hereby approve the procurement of additional blood products in support of Department of Pathology and Area Laboratory Services, Transfusion Services at Brooke Army Medical Center, JBSA Fort Sam Houston, TX for the estimated dollar value of $2,245,775.00, pursuant to 41 U.S.C. 3304(a)(1) as implemented in FAR 6.302-1, “Only one responsible source no other supplies or services will satisfy agency requirements”, and provided that the supplies and services herein described have otherwise been authorized for this acquisition.

ALVARENGA.KERRY.ANN-

N-MARIE.1185865882 MARIE.1185865882

Date: 2024.06.21 12:30:54 -05'00'

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