A.02 USAHCA Sole Source Justification under 13.501 RHCO-A 335 21-R-003 LJE Redacted 051121.pdf

(See FAR 2.101 and 3.104-4)

(March 2021)

Sole Source Justification and Approval Under FAR 13.501

1. Contracting Activity: Regional Health Contracting Office-Atlantic, Gordon Health Contracting Branch, Fort Gordon, Georgia.

2. Description of Action: Approval is requested for a six month non-personal services firm-fixed price (FFP) bridge contract for Blood Donor Testing Services in support of the Dwight D. Eisenhower Army Medical Center (DDEAMC), Kendrick Memorial Blood Donor Center (KMBDC), Fort Gordon, GA. The period of performance will be 01 April 2021 to 30 September 2021. FY21 DHP funds will be used to fund the requirement.

3. Description of Supplies/Services: This requirement is for Blood Donor Testing Services to support the DDEAMC, KMBDC, Fort Gordon. The current contract will expire on 31 March 2021. The Contractor shall be Food and Drug Administration (FDA) licensed for blood donor testing and provide the full range of blood donor testing currently required by the FDA. The contractor will provide whole blood panel, Cytomegalavirus, Zika and Babesia testing. This includes routine blood donor testing panels and repeat testing, as well as confirmation testing. All blood donor laboratory testing shall be executed in accordance with standard industry practices. The Contractor must have a sample surge capacity of at least 1,000 samples per day to accommodate any unforeseen mission requirements or contingency missions that would require an upsurge in blood and blood product requirement. The total estimated value of this requirement for a six month period is $570,975.00. FAR 52.217-8, “Option to Extend Services” will be included in this requirement. If the Option to Extend is exercise the total contract value will be $856,462.50.

4. Authority Cited: 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

5. Reason for Authority Cited: Qualtex, the current contractor provides FDA approved tests for whole blood panel, Cytomegalavirus, Zika and Babesia testing. Infectious disease testing of volunteer donor blood is mandated by US Statue (21 CFR, parts 601, 606, 610 and 630). Only facilities licensed by the FDA are authorized to peform infectious disease testing of donor blood. Only blood, blood products and components which have received infectious disease testing may be distributed and transfused into patients. Qualtex, the current contractor, is licensed by the FDA to provide all of tests required to manufacture blood and blood products (including whole blood panel, Cytomegalavirus, Zika and Babesia testing). The blood donor tests must be FDA approved. Qualtex also provides the same testing for the Martin Army Community Hospital, Fort Benning, Georgia. Volunteer blood donations that have been tested for infectious diseases are the only source of blood products available for transfusion (s).

DDEAMC must maintain a consistent supply of blood and blood products in its hospital

Blood Donor Testing Services blood bank inventory for emergent and non-emergent patient care services. Without the testing services provided under this contract, the KMBDC would not be able to supply any blood to DDEAMC and the Armed Services Blood Program. And without any blood products, DDEAMC would not be able to perform any surgical or operative services, as well as emergency and labor and delivery care. This would shut down DDEAMC. The hospital cannot operate inpatient or critical care services without having an inventory of blood products. KMBDC also provides blood to the Armed Services Blood Program which is used to transfuse military servicemembers and patients in austere locations across the globe and other MTFs. The infectious disease testing provided under this contact cannot be performed by just any clinical laboratory (including the DoD reference laboratory, LabCorp), special FDA liscening requirements for manufacturing blood products preclude just any laboratory form obtaining this capability because blood products are transfused directly into patients and the risk for a fatal transfusion reaction is significant.

6. Efforts to Obtain Competition: Market Research on the General Schedule Administration (GSA) Advantage website show that there are other vendors that provide blood donor testing. Due to time constraints the contracting staff will not have time to get the long term contract in place by 31 March 2021.

a. Effective competition. Based on the results of the market research, there is no effective competition anticipated for this acquisition.

b. Subcontracting competition. There are no subcontracting possibilities for this requirement. A subcontracting plan is required.

7. Actions to Increase Competition: There are no actions being taken to increase competition for the bridge contract.

8. Market Research: Market research was conducted in accordance with FAR Part 10 to identify qualified sources. Attempts to locate a suitable source were made through internet searches to include the Small Business Administration’s Small Business Dynamic Search engines, EZSearch and previous contract . SBA Dynamic Search was made using NAICS 621991 Blood and Organ Banks and keywords zika and cytomegalavirus revealed 0 small businesses. A third search using the same NAICS and keyword test revealed 16 small businesses. Among the 16 same businesses, however, none of their profiles stated they provide zika and cytomegalovirus tests. An EZSearch search using the same NAICS and keyword zika for awards within the past three years revealed two profiles: American National Red Cross and Qualtex.

Blood Donor Testing Services

9. Interested Sources: To date, no other sources have written to express an interest.

The notices required by FAR 5.201 will be published, and any bids or proposals received shall be considered.

10. Other Facts: None

a. Procurement history.

(1) The current contract was competed and expires on 31 March 2021.

(2) The competitive status of the action: This action was competed as Unrestricted.

(3) Authority previously cited if less than full and open competition was used. N/A, previous requirement was competed Unrestricted.

(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. There are no changes in circumstances that caused the contracting office to limit sources. The follow-on requirement cannot be completed timely due to the timelines that the complete Acquisition Requirement Package (ARP) was received. On 02 October 2020, the Contracting Officer notified the customer via email that the current contract would expire on 31 March 2021. After no response was received, a reminder was sent again to the customer on 13 October 2020, the customer made assurances that the ARP was forthcoming. On 19 January 2021, the Contracting Officer sent another reminder that the ARP had not been received. On 03 March 2021, the Branch Chief sent another message alerting the customer that the required documentation, specifically the Purchase Request (PR) had not been received by contracting. The PR was not received until 09 March 2021, and the RSCA was not signed unitl 18 March 2021. The bridge contract will allow contracting personnel time to complete the required documentation needed to award a long-term contract.. The long term follow-on procurement will be for a 12 month base period and four 12 month option periods.

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys. None.