SOURCES SOUGHT
Q -- HIV and Pathogen Diagnostic and Confirmatory Testing and Monitoring and Product Development and Evaluation Support
- Notice Date
- 7/15/2015
- Notice Type
- Sources Sought
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH-15-R-0070
- Response Due
- 7/21/2015
- Archive Date
- 9/13/2015
- Point of Contact
- Drew Green, 301-319-9279
- E-Mail Address
-
US Army Medical Research Acquisition Activity
(andrew.w.green17.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- Request for Information (RFI) for HIV Diagnostic Testing, Monitoring, Evaluation, and Assay Detection Development. 1.0 SUBJECT The Department of Laboratory Diagnosis and Monitoring, US Military HIV Research Program and WRAIR is conducting market research to obtain information from industry partners with knowledge and experience in HIV Diagnostic Testing, Monitoring, Evaluation, and Assay Detection Development. 2.0 CAUTION: This is an active requirement. Contractors are strictly prohibited from discussing this requirement with any member of the identified program office. All discussion shall be with the POC listed below. 3.0 DISCLAIMER This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kinds of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. All information received in response to this RFI that is marked proprietary will be handled accordingly. Responses to the RFI will not be returned. Performance on any potential award associated with this RFI may result in an Organizational Conflict of Interest arising from performing advisory or consulting support services. 4.0 RFI INSTRUCTIONS Interested parties are asked to respond to this RFI and submit a capability statement that supports the focus of this RFI. No written solicitation document is available at this time. Telephone requests will not be honored, and no bidders list shall be maintained. Potential offerors are requested to direct all questions via email to the Point of Contact listed below in item 6.0. The format for the capability statement shall be 12-point font; and not exceed 4 pages total, including tables, graphics and appendices. All responses should be complete. Through this RFI the Government is looking for capability statements addressing the following requirements: Conduct clinical screening and confirmatory diagnosis, clinical monitoring and therapeutic monitoring for HIV, pathogens of Military or U.S. National interests; Conducting clinical research to evaluate new/novel products for Pre-Market Application to the U.S. Food and Drug Administration and/or execution in a clinical diagnostic settings; Conducting clinical research to develop, evaluate, validate Laboratory Developed Assays for detection, diagnosis and/or monitoring of pathogens of U.S. Military and/or National interest; Support knowledge product development, generating data and intervention/prevention strategies; Provide diagnostic support with multiple partners and collaborators, to include the FDA, for vaccine/therapeutic/cure clinical trials of pathogens of U.S. Military and/or US importance. Your capabilities statements should also consider the following in your responses: Laboratory personnel have at least 5 years documented competency/expertise in quality assurance management and maintenance/compliance with all College of American Pathologist (CAP), US Health and Human Services, Clinical Laboratory Improvement Amendment (CLIA), and DoD Clinical Laboratory Improvement Program (CLIP) regulatory requirements for clinical diagnostic testing/monitoring for HIV, HCV, HBV, Sexually Transmitted Infections, and Leishmania in a CAP accredited laboratory; Laboratory personnel have documented competency/expertise in use of Laboratory Information Management System; administrative system management of Master Control software for document control per CAP/CLIA/CLIP regulatory requirements; administration of Refrigeration ambient/cold chain thermo sensor monitoring per CAP/CLIA/CLIP regulatory requirements; Laboratory personnel have documented competency/expertise in preparation for CAP re-accreditation inspections for CAP accredited laboratories conducting Clinical Diagnosis and Monitoring for HIV and Sexually Transmitted Infections; and, Clinical Diagnosis for Leishmania species; Laboratory personnel Health Insurance Portability Accountability Act (HIPAA) certified; Laboratory personnel have documented competency/expertise in quality assurance management of US FDA Pre-Market Application Clinical Trail documentation; documentation in support of vaccine and therapeutic trials for HIV, Leishmania, and pathogens of US Military and National interest. 5.0 ATTACHED PWS See attached PWS. The incumbent contractor is The Henry M. Jackson Foundation. Potential offerors may provide questions or comments regarding the draft PWS. However, it should be noted that the PWS is ONLY a draft document. Set-asides have not been determined. A solicitation time frame has not been determined. 6.0 CONTACT INFORMATION Following is the Point of Contact for this RFI: andrew.w.green17.civ@mail.mil
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH-15-R-0070/listing.html)
- Place of Performance
- Address: Walter Reed Army Institute of Research 503 Robert Grant Ave Silver Spring MD
- Zip Code: 20910-7500
- Zip Code: 20910-7500
- Record
- SN03797733-W 20150717/150715235457-529df5ef8f6b1e5334c3fc527ef608d3 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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