B01-Notice of Intent to Sole Source.pdf

Notice of Intent to Sole Source

Date: 7 March 2023

Contracting Office Address – US Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, MD 21702-5014

Subject: Notice of Intent to Sole Source –

Testing for Transfusion-Transmissible Diseases (TTD) in Blood Samples for Walter Reed Army Institute of Research (WRAIR)

Solicitation Number: HT942523Q0043

The United States Army Medical Research Acquisition Activity (USAMRAA) intends to negotiate on a sole source basis IAW FAR 6.302-1 with Qualtex Laboratories

The WRAIR aims to conduct biomedical research that is responsive to Department of Defense and US Army requirements and delivers life-saving products including knowledge, technology and medical material that sustain the combat effectiveness of the Warfighter.

This requirement is for commercial laboratory services to perform testing on malaria infected blood samples from human subjects received from OCONUS field sites located within Kenya, Ghana, Peru/Columbia, and Thailand/Cambodia. The contractor shall test samples for infection with HIV-1/2, HBV, HCV, HTLV-1/2, Syphilis, West Nile Virus, Chagas, and Zika utilizing tests that meet FDA guidelines for cGMP manufacturing of biologics for use in humans.

Due to cultural sensitivities in the regions from which the samples will be collected, the volume of blood samples collected will be smaller than what is typically collected for analyses of this nature. As a result, a vendor who can run screening panels on small volumes of blood is required. Qualtex Laboratories is the only source capable of providing these screening panels with the limited size of the samples available.

Objectives

This requirement is for commercial laboratory services to perform testing on malaria infected blood samples from human subjects received from OCONUS field sites located within Kenya, Ghana, Peru/Columbia, and Thailand/Cambodia. The contractor shall test samples for infection with HIV-1/2, HBV, HCV, HTLV-1/2, Syphilis, West Nile Virus, Chagas, and Zika utilizing tests that meet FDA guidelines for cGMP manufacturing of biologics for use in humans.

1.5.1 Quality Control Plan (QCP): The Contractor shall develop and maintain a QCP to ensure services are performed in accordance with (IAW) this PWS. The Contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The Contractor's QCP is the means by which it assures that the work provided complies with the requirements of the contract.

The Contractor’s Proposed QCP shall be submitted to the Contracting Officer (KO) through the Contracting Officer’s Representative (COR) for review within ten days after date of contract award

The Government will review and either notify the Contractor in writing of acceptance of the plan or return their comments to the Contractor within 30 days. If the Government has provided comments, the Contractor shall then have 30 days to submit a Final QCP. After receipt of the Final QCP, the Contractor may receive the Contracting Officer’s acceptance in writing. Any proposed changes to the accepted QCP are required to be resubmitted for acceptance by the Contracting Officer no later than 30 days prior to the anticipated change and before implementation by the Contractor. The timeline noted above will apply for review and acceptance for proposed changes. At a minimum, the QCP must include and answer the following to be acceptable:

(a) A chart showing the organizational structure and lines of authority, the names, qualifications, duties, responsibilities, and classification of each member of the Contractor's Quality Control Team;

(b) How the Contractor will monitor work to ensure performance complies with all deliverables

(etc. timelines, deadlines, and goals);

(c) How the Contractor will monitor work to ensure performance complies with all specifications and requirements of the contract, including the contract’s clauses;

(d) How the Contractor will monitor and ensure staff qualifications remain current and valid including Department of Defense (DoD) Contractor Personnel Office (DOCPER) processes/approvals throughout contract performance;

(e) How the Contractor will ensure all keys issued will remain controlled items (Paragraph 1.7

Key Control);

(f) How the Contractor will inventory and track maintenance of all Government Provided

Equipment / Materials;

(g) How the Contractor will identify, investigate, and correct any non-conforming performance and prevent similar deficiencies in the future; and

(h) How the Contractor will file and save all Quality Control related documents for the life of the contract plus 5 years.

1.5.1.1 An Analysis of Quality Control and Timeliness of Submittals (i.e., deliverables) shall be provided to the COR within 30 days upon completion of each option period or Task Order

1.5.1.2 The Contractor shall inform the COR of issues or potential issues that might affect the performance within 48 hours of identifying those issues. Verbal reports shall be followed up by written reports within two days

1.5.2 Quality Assurance: The Government will evaluate the Contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan is primarily focused on what the Government must do to ensure that the Contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the acceptable quality levels (performance thresholds).

THIS NOTICE OF INTENT IS NOT A REQUEST FOR COMPETITIVE QUOTATIONS.

Responsible, interested parties may identify their interest by submitting capability information, in writing, by 2:00 p.m. est. 21 March 2023 to Mr. Nathaniel Reus at Nathaniel.a.reus.civ@health.mil.

Supporting evidence must be furnished in suffici3nt detail to demonstrate the firm’s ability to provide the stated capability.

Responses will be evaluated; however, a determination by the Government not to compete the proposed procurement based upon responses to this notice is solely within the discretion of the Government. If no responses are received, USAMRAA will proceed with the sole source contract.

mailto:Nathaniel.a.reus.civ@health.mil