Loren Data's SAM Daily™

FBO DAILY ISSUE OF OCTOBER 17, 2003 FBO #0689
SOURCES SOUGHT

R -- Patient Safety Monitoring of International Laboratories

Notice Date

10/15/2003
 

Notice Type

Sources Sought
 

Contracting Office

Department of Health and Human Services, National Institutes of Health, National Institutes of Allergy and Infectious Diseases, Contract Management Branch 6700 B Rockledge Room 2230 MSC7612, Bethesda, MD, 20892-7605
 

ZIP Code

20892-7605
 

Solicitation Number

NIAIDDAIDSRFC04-30
 

Response Due

10/27/2003
 

Archive Date

11/11/2003
 

Point of Contact

Glynis Fisher, Contract Specialist, Phone 301-496-3699, Fax 301-402-0972, - Barbara Shadrick, Senior Contracting Officer, Phone 301-496-7288, Fax 301-480-5253,
 

E-Mail Address

gfisher@niaid.nih.gov, bs92y@nih.gov
 

Description

THIS IS NOT A REQUEST FOR PROPOSALS AND DOES NOT COMMIT THE GOVERNMENT TO AWARD A CONTRACT NOW OR IN THE FUTURE. NO SOLICITATION IS AVAILABLE AT THIS TIME. BASED ON RESPONSES RECEIVED FROM THIS SOURCES SOUGHT, THIS ACQUISITION MAY BE SOLICITED AS A 100% SMALL BUSINESS SET-ASIDE, NAICS CODE 541710, WITH A SIZE STANDARD OF 500 EMPLOYEES. The Division of AIDS (DAIDS), of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), is seeking capability statements from qualified organizations to act as a contractor to provide a comprehensive program to ensure that clinical laboratories in developing countries around the world can reliably perform tests to monitor the safety and efficacy of preventive and therapeutic products as part of clinical HIV/AIDS trials sponsored by the NIAID. There is a need to evaluate laboratories' ability and readiness to routinely conduct activities according to Good Laboratory Practice standards; to train, implement and monitor general QA/QC for pre-analytical, analytical and post-analytical functions; to evaluate laboratories' ability to correctly perform required study-specific tests, provide troubleshooting and training when needed, and implement and monitor on-site QA/QC for these tests; to prepare laboratories for participation in external proficiency testing (PT) programs for these tests, monitor performance in such PT programs and assist when performance is poor; to ensure that study-specific tests are performed correctly and results are reported accurately; to design and implement tools to evaluate the ability of laboratories to perform required tests for which PT programs do not exist; and, only as an emergency, perform study-specific tests when laboratories are unable to do so and/or to verify test results. This will require presence in developing areas that are centers of HIV infection, such as Southern Africa, Asia and the Caribbean Islands. This will also require staff with medical technology/pathology background, expertise in training, knowledge of compliance with safety and ethics regulations, and knowledge of languages. Laboratories will require full or partial range of the services described above, depending on their initially-determined level of readiness to participate in NIAID studies. It is anticipated that in the first year of contract operations one medical technologist will stay up to one year in each of four (4) laboratories in Southern Africa, four (4) in Asia and two (2) in the Caribbean Islands. It is also anticipated that in the first year the contractor will conduct five (5) five-day visits for the purpose of assessment and/or trouble shooting to ten (10) laboratories in same regions as described above, and will conduct one regional three-day training workshop in each of these regions. The Government anticipates the need to provide services to additional laboratories during the course of the contract. This effort will require presence in developing areas that are centers of HIV infection, such as Southern Africa, Asia and the Caribbean Islands. This will also require staff with medical technology/pathology background, expertise in training, knowledge of compliance with safety and ethics regulations, and knowledge of languages. The prospective contractor must have a Principal Investigator and staff that have the experience and expertise to carry out a project of this size and complexity, must understand cultural sensitivity issues relevant to resource-constrained countries, and must have the flexibility to address emerging needs and expansion. The contractor must also have laboratory facilities where actual safety tests (e.g. hematology, chemistries) can be performed. Interested small business organizations that believe they possess the capabilities necessary to undertake this project should submit two (2) copies of their capability statement addressing the areas above, to be received no later than 3:30 PM local time on October 27, 2003, to the attention of Glynis Fisher at the address listed above. See Government-wide Numbered Note 22. NO COLLECT CALLS WILL BE ACCEPTED. FACSIMILE AND E-MAIL TRANSMISSIONS WILL BE ACCEPTED.
 

Place of Performance

Address: To Be Determined

Zip Code: TBD

Country: TBD
 

Record

SN00452500-W 20031017/031016073238 (fbodaily.com)
 

Source

FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

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