JA Sole Source FAR Part 13.5 - Blood Blood Products - ALL SIGNED - FINAL (REDACTED)_Redacted.pdf

CUI//SP-SSEL

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, Transfusion Services at Carl R. Darnall Army Medical Center (CRDAMC) Fort Cavazos, Texas 76544 will need to order blood and blood products to maintain an established inventory level to support the mission requirements of the Department of Pathology. This mission involves providing blood and blood products when patients are bleeding, present with emergent blood needs, or need special tested blood products.

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 including all options.

Prepared by: Title:

Date: Email:

Contracting Officer:

Date: Email:

Technical Representative:

Title: Date Reviewed:

Controlled by: USAHCA Controlled by: MRCO-W CUI Category (ies): General Procurement & Acquisitions Limited Dissemination Control: FED

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

SEP 2021

CUI//SP‐SSEL

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

2 3 SEP 2021

Date:

Reviews

Command Advocate for Competition

Typed Name: DSN:

Date:

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

Legal Counsel

Typed Name: DSN:

Signature:

3 3 SEP 2021

Sole Source Justification and Approval Under FAR 13.501

1. Contracting Activity: Medical Readiness Contracting Office - West

2. Description of Action: This is a follow-on firm-fixed priced procurement using Defense Health Program FY24 funds.

3. Description of Supplies/Services: The Department of Pathology, Transfusion Services at Carl R. Darnall Army Medical Center (CRDAMC) Fort Cavazos, Texas 76544 will need to order blood and blood products to maintain an established inventory level to support the mission requirements of the Department of Pathology. This mission involves providing blood and blood products when patients are bleeding, present with emergent blood needs, or need special tested blood products.

The blood products needed and the estimated volume of each are indicated below: Based on a Biweekly (every 2 weeks) delivery:

RBC O Positive: 7 units RBC O Negative: 4 units RBC B Positive: 1-2 units RBC B Negative: 1-2 units RBC A Positive: 4 units RBC A Negative: 1-2 units Neonatal unit (Fresh, CMV neg, HgB S neg) 1 unit Cold-stored platelet: 1 unit

Additional blood products may be ordered directly as needed including Low Titer O Whole Blood, room temperature apheresis platelet, cold-stored apheresis platelet, red blood cell unit that will be used for neonatal transfusions (fresh, CMV negative, Hemoglobin S negative), red blood cells of any specified type and Rh status, fresh frozen plasma of any specified type, liquid plasma of any specified type, and cryoprecipitate. All additional reference testing and any product ordered outside of agreed upon weekly shipments will not be rotated out and will be paid for based on an established price list.

Base Period: 1 October 2023 to 30 September 2024 Value:

Option Period 1: 1 October 2024 to 30 September 2025 Value:

Option Period 2: 1 October 2023 to 30 September 2024 Value:

Option Period 3: 1 October 2024 to 30 September 2025 Value:

Option Period 4: 1 October 2025 to 30 September 2026 Value:

4 3 SEP 2021

Total:

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, CRDAMC to provide Blood Products to accommodate the potential variety of patients to include active duty, retirees and civilians. Blood is needed to sustain our patient populations, especially Trauma patients, Cancer patients, and Neonatal Intensive Care patients in the ER, OR, MSP, NICU, L&D, PEDS, and ICU. Carter Bloodcare is the only FDA approved blood product distributor to Fort Cavazos, located in Waco and Bedford Texas, with a constant blood product inventory review process. Carter Bloodcare is the only facility that will deliver and rotate CRDAMC’s stock on a consistent schedule.

6. Efforts to Obtain Competition: A Sources Sought notice for Blood Products was posted with the minimum requirements to https://SAM.gov from 30 March 2023 through 5 April 2023. There were no responses to the sources sought.

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

An SBA Dynamic small business search and Quick Market search was conducted using key words “621991” and Blood. There were several potential vendors that provide blood products, but once you delve into the vendors, the majority only offer supplies associated with blood and blood products but do not provide blood, that is required per the procurement. Additionally, in researching the few vendors that do provide blood, no vendor other than Carter Bloodcare, would be able to provide blood locally, and be able to meet emergent situations, such as mass casualties and other critical emergent care.

Additionally, the American Red Cross was contacted, however they do not supply (sell) blood to medical treatment facilities. The closest medical treatment facility to Fort Cavazos, is Brooke Army Medical Center in San Antonio, Texas (162 miles or a 2.5-3.5 hr. one way trip). Their blood product supplier will not deliver outside of a 50-mile radius of the metro San Antonio area.

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

5 3 SEP 2021

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 with the minimum requirements to https://SAM.gov from 30 March 2023 through 5 April 2023. There were no responses to the sources sought.

An SBA Dynamic small business search and Quick Market search was conducted using key words “621991” and Blood.

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

Previous actions were reviewed and found that one vendor is consistently capable of providing the Blood Products.

9. Interested Sources: Sources Sought produced no results, as there were no responses to the sources sought. Carter Bloodcare 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 Carter Bloodcare that could provide the entirety of the Government’s requested requirement at this current time.

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

a. Procurement history:

Contract number: W81K00-22-P-0217 Carter Bloodcare Total awarded amount:

Delivery Period: 1 October 2022 - 30 September 2023 Source Selection Method: Sole Source, FAR 13.106-1(b)(1) Paragraph 7 Summary: Only one source available in required delivery radius that was FDA approved. Market will continue to be surveilled for new entrants.

Contract number: W81K00-19-P-0273 Carter Bloodcare Contract type: Firm Fixed Price Total awarded amount:

Control Number: 23-RHCO-C-355

CUI//SP‐SSEL

6 3 SEP 2021

Delivery Period: 1 October 2019 - 30 September 2022 Source Selection Method: Solicitation 32 days, on FBO, unrestricted, with one bid received from Carter Bloodcare Circumstance Change: Requirement was issued as Full and open and only one bid was received.

Previous requirements listed below were also solicited (since 2013) with only one vendor providing a response.

The following contracts were competed with same results: only one vendor responding – Carter Bloodcare:

Contract number: W81K00-17-P-0707 Contract number: W81K00-15-P-0604 Contract number: W81K00-14-P-0953 Contract number: W81K00-13-C-0029

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.

Requirements Representative:

Title:

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.

J

7 3 SEP 2021

Approval

Based on the foregoing justification, I hereby approve the procurement of Blood Products being procured for including all options 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 and property herein described have otherwise been authorized for acquisition.