SOLICITATION NOTICE
A -- Patient Safety Monitoring of International Laboratories
- Notice Date
- 12/2/2003
- Notice Type
- Solicitation Notice
- 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
- RFP-NIAID-DAIDS-04-30
- Response Due
- 12/15/2003
- Archive Date
- 12/30/2003
- 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
- The Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID) has a requirement for 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. The Government contemplates awarding one contract for accomplishing the tasks outlined in the Work Statement. It is anticipated that this contract will have a five year performance period. RFP-NIH-NIAID-DAID-04-30 will be available electronically on or about December 15, 2003, and may be accessed through the NIAID Contract Management Program (CMP) Home Page by using the following electronic address and instructions: NIAID/CMP Home Page (via the WWW): Use http://www.niaid.nih.gov/contract to access the NIAID/CMP Home Page. Once at the NIAID/CMP Home Page, click on the ?RFPs? link and then click on ?RFP NIH-NIAID-DAIDS-04-30.? Responses to this RFP will be due on or about March 15, 2004. Any responsible offeror may submit a proposal for consideration by the Government. This advertisement does not commit the Government to award a contract. No collect calls will be accepted. P.O.C. Glynis Fisher, Contract Specialist, DHHS, NIH, NIAID, DEA, CMP, email:gfisher@niaid.nih.gov 301-496-3699 (Fax) 301-480-5253. 6700 Rockledge Drive, Rm 2230 MSC7612 20892-7612 (FedEx ? 20817-7612)
- Place of Performance
- Address: To Be Determined
- Zip Code: TBD
- Country: TBD
- Zip Code: TBD
- Record
- SN00479497-W 20031204/031202211721 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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