CLINICAL LABORATORY QUALIFICATION

Synopsis: This is a Request for Information (RFI). This is NOT a solicitation for proposals, proposal abstracts, or quotations. This notice is for MARKET RESEARCH PURPOSES ONLY, and in no way obligates the United States Government to issue a solicitation or otherwise make a contract award. This notice is open to all interested parties. The Defense Threat Reduction Agency intends to execute a sole source contract to establish and support the Cooperative Biological Engagement Program's (CBEP) Clinical Laboratory "Qualification" Program in a partnership-like arrangement with a leader in the international clinical laboratory community that issues recognized international certifications that carry value, beyond the CBEP program, to CBEP's overseas clinical laboratory partners. This RFI is being issued to determine if there are other qualified sources. Background: CBEP aims to restructure its training program according to a measurable, goal-oriented framework that is internationally recognizable and endorsed, and to also enable CBEP management to objectively and clearly articulate intent and achievement of CBEP international training programs' goals. To this end, CBEP seeks support from an established, leading clinical laboratory certifying organization to create a goal-oriented training validation framework that defines criteria for trainees' achievement of "CBEP qualification(s)". The provider may also support the modification of a CBEP training curriculum around the established CBEP qualification framework (if/as needed). The provider should not only convey international reputation in the area of clinical laboratory, but also demonstrate experience in performing similar activities in low-resource international settings. The certification/qualification framework should set out measurable goals that can be presented as trainees' attainment of skills and competencies according to international standards. Goals, and milestones achieved toward these goals, should be marked by internationally endorsed "CBEP qualifications" that are defined objectively and consistently. Achievement of a CBEP Qualification should carry value beyond the CBEP program and in the international biomedical community; it should represent an apparent step toward an international achievement that trainees and partner country stakeholders may aspire to. Purpose and Objectives: The organization/provider should be unbiased to the greatest extent possible (ie, non-profit, not an existing CBEP training provider), and be recognized as a central and original source of the certification framework used. The goals set forth by this certification/qualification framework will also become the basis for DTRA management's metrics to evaluate clinical laboratory training progress and proficiencies achieved by training programs funded, and to support decision-making about when a given training program may be considered "complete", and/or gauge whether and when milestone goals are effectively met along the way. Provider will perform the following functions: - Establish CBEP qualification exam criteria and guidelines that are clearly within the framework of, and a step toward international certification by a leading certifying organization with an established reputation for global clinical laboratory excellence. - Develop tests for qualification achievement, including written/computer-based and hands-on laboratory practical components; provider will also be asked to administer some or all of these tests under their "name brand" as appreciated in the international clinical community - If/as appropriate, communicate to DTRA any additional support needs to administer tests that are not available by the provider (may include reagents, adequately established exam centers, qualified expert panels, etc.) - Endorse and brand these qualification criteria as the internationally recognized and endorsed entity, marked by "CBEP qualification" granted to trainees upon successfully passing qualifying exam(s) administered by provider. - Communicate and report progress of clinical laboratory training to DTRA management, according to established qualification criteria. - Modify and/or make recommendations to modify a CBEP training curriculum and/or country training program design that clearly trains to the qualification criteria established. Response Requirements: The U.S. Government invites sources to respond to this RFI that have the capability to meet these parameters and would have an interest to bid on a requirement of similar objectives. Responses shall be limited to five (5) pages including diagrams. Pages not included in the total page count are the cover page, the cover letter and the table of contents. Any and all information submitted in response to this notice is strictly voluntary and in no way obligates the U.S. Government to a monetary compensation or otherwise to make a contract award. The U.S. Government will not return any submitted data and information Submission Instructions: Responses shall be limited to five (5) 8X11 pages and shall: - Confirm source's ability and interest to meet purpose and objectives provided; - Demonstrate the ability to communicate and collaborate with DTRA regularly and easily. - Indicate whether or not your organization has an established certification program and framework that would be used for this effort and how certification criteria encompass the CBEP mission regarding clinical laboratory knowledge, skills and abilities - Describe your organization's experience in the international clinical lab community, including who your organization currently works with, your general global presence and who is certified by your organization. Disclaimer and Important Notes: This is a Request for Information. There is no solicitation available at this time. Requests for Solicitation and inquiries related to same will not receive a response. THIS NOTICE IS PUBLISHED FOR MARKET RESEARCH PURPOSES ONLY, AND IN NO WAY OBLIGATES THE GOVERNMENT TO ISSUE A SOLICITATION OR OTHERWISE MAKE A CONTRACT AWARD. Any and all information submitted in response to this synopsis is strictly voluntary. The Government will not pay for any information submitted in response to this notice and shall become the property of DTRA/SCC-WMD. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organizations qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. Confidentiality: No classified or confidential information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). Any proprietary information should be clearly marked.