Redacted JA.docx

J&A No. 21-00009

JUSTIFICATION AND APPROVAL

FOR USE OF OTHER THAN FULL AND OPEN COMPETITION

1. Contracting Activity.

This justification is executed by the Naval Medical Logistics Command (NMLC), Fort Detrick, MD, on behalf of the Navy to meet Naval Medical Center Portsmouth, VA (NMCP) requirements.

2. Description of the Action Being Approved.

Award of a contract on a sole source basis to provide blood products and reference laboratory testing for NMCP. The Government intends on awarding a Blanket Purchase Agreement (BPA). The proposed source is the American National Red Cross (ARC) (CAGE: 7D348), 431 18th Street, Washington, DC 20006-5310. The ARC’s Mid-Atlantic Region office is located in Richmond, VA.

3. Description of Supplies/Services.

NMCP has a requirement for blood products and reference laboratory testing. Blood products needed include packed red blood cells, apheresis platelets, fresh frozen plasma, cryoprecipitate, etc. Products are required on both a standard and emergent basis. Reference laboratory services include antibody identification, antibody screenings, Rh typing, etc. Testing is required on both a standard and emergent basis. The Contractor shall provide test results via reports and consult with NMCP on test results, as needed.

Blood products and related services must be delivered timely and products must be free of defects in accordance with federal and industry standards per Food and Drug Administration (FDA) regulations and AABB standards. In addition, the Contractor shall comply with continuous Current Good Manufacturing Practices (CGMP) as outlined by the International Society for Pharmaceutical Engineering (ISPE).

The BPA will include a three-year ordering period from 01 October 2021 through 30 September 2024.

DHP Fiscal Year 22 Operation & Maintenance funds will be used to fund the first order. The total value of this BPA is estimated at $1,500,000.00.

The ARC is currently providing the required products/services under Contract N6264517D5035, which has an ordering period that ends on 30 September 2022. It is anticipated that the maximum contract value will be reached by 30 September 2021.

4. Statutory Authority Permitting Other Than Full and Open Competition.

The statutory exception permitting other than full and open competition for this acquisition is 10 U.S.C. 2304(c)(1), One source or limited sources.

The procedures in FAR Part 13 will be used in accordance with 41 U.S.C. 1901.

5. Rationale Justifying Use of Cited Statutory Authority.

The ARC is the only blood/blood product distribution service within a reasonable distance to NMCP that can provide products on an as needed basis in a timely manner ranging from routine requests of 2 hours to STAT requests of 1 hour. Additionally, the ARC has reference laboratory services on-site to provide non-routine testing of complex patient samples 24 hours a day and 7 days a week. The ARC is able to screen units for complex patients and provide suitable blood products for transfusion to NMCP in a timely manner to support patient care. Additionally, the ARC supports a transfer program that allows the Government to recover costs on products that potentially would not be used by transferring them to an alternate facility before they expire.

6. Description of Efforts Made to Solicit Offers from as Many Offerors as Practicable.

No other sources have expressed an interest in this acquisition. A notice of intent to award a sole source contract to the ARC was posted to Contracting Opportunities section of the beta.sam.gov website for a period of 15 calendar days (23 November 2020 through 09 December 2020). No responses were received. Another notice of intent will be posted for 15 days in August 2021 to coincide with the changes made in this revised justification. No responses were received.

Market research was conducted in November 2020, including a search of the Internet to find blood banks, transfusion services, and blood centers accredited by the AABB. Several results were located for Virginia; however, all but one (ARC) were for medical centers or hospitals, not blood banks or organizations that provide blood products and reference laboratory testing for the commercial marketplace. Per the AABB’s website, ARC is the only AABB Accredited Immunohematology Reference Laboratory in Virginia. The required sources of supply, see FAR 8.002 and 8.004, were also searched with no sources located.

7. Determination of Fair and Reasonable Cost.

The Contracting Officer has determined the anticipated cost to the Government of the supplies/services covered by this J&A will be fair and reasonable.

8. Actions to Remove Barriers to Future Competition.

For the reasons set forth in Paragraph 5, NMLC has no plans at this time to compete future contacts for the types of supplies/services covered by this document. If another potential source emerges, NMLC will assess whether competition for future requirements is feasible.

CERTIFICATIONS AND APPROVAL

TECHNICAL/REQUIREMENTS CERTIFICATION

I certify that the facts and representations under my cognizance which are included in this Justification and its supporting acquisition planning documents, except as noted herein are complete and accurate to the best of my knowledge and belief.

Technical Cognizance

Contracting Officer’s Representative Requirements Cognizance

LEGAL SUFFICIENCY REVIEW

I have determined this Justification is legally sufficient.

Office of Counsel Code 00L Date

CONTRACTING OFFICER CERTIFICATION below $750,000

Contracting Officer Certification.

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

Contracting Officer

COMPETITION ADVOCATE/APPROVING OFFICIAL between $750,000 and $15 million

Upon the basis of the above Justification, I hereby approve, as Competition Advocate, the solicitation of the proposed procurements described herein using other than full and open competition, pursuant to the authority of 41 U.S.C. 1901.

Competition Advocate