SPECIAL NOTICE
B -- Laboratory Testing Services
- Notice Date
- 2/2/2015
- Notice Type
- Special Notice
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Clinical Center/Office of Purchasing & Contracts, 6707 Democracy Blvd, Suite 106, MSC 5480, Bethesda, Maryland, 20892-5480
- ZIP Code
- 20892-5480
- Solicitation Number
- 15-004036
- Archive Date
- 2/17/2015
- Point of Contact
- Monifa Coleman, Phone: 3015945914
- E-Mail Address
-
Monifa.Coleman@nih.gov
(Monifa.Coleman@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The Department of Health and Human Services (DHHS), the National Institutes of Health (NIH), the Clinical Center (CC), in the Office of Purchasing and Contracts (OPC) has a need to continue existing genetic analysis laboratory services related to congential adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency, where patients are being seen under the Natural History Study of Patients with Excess Androgens, Protocol number: 06-CH-0011 which is currently being provided by Laboratory Corporation in accordance with FAR 13.106-1(b). A major goal of this study is to evaluate genetic causes associated with certain clinical conditions. NIH/CC needs to provide results to patients, thus NIH/CC needs to use a Clinical Laboratory Improvement Amendments (CLIA) certified lab. This requires sending blood to a CLIA certified commercial laboratory. Laboratory Corporation is a CLIA-certified laboratory that is currently offering and has offered genetic testing that screens for the 12 most common mutations. This identifies approximately 95 percent of mutations causing CAH. Therefore, the need to assure continuity of protocol content, prior samples, and data control, the NIH/CC/OPC intends to sole source the requirement for the required laboratory services. Government responsibilities, NIH/CC will be responsible for obtaining blood specimens from patients under an Internal Review Board (IRB) approved protocol and will be responsible for interpreting clinical implications of results. Reporting requirements of the laboratory shall provide a written report of the genetic analysis performed. Program management and control requirements for the laboratory shall be CLIA certified. Blood and/or DNA will be shipped from NIH/CC to Laboratory Corporation according to the NIH/CC regulations and via courier- per company standards. It is NIH/CC/OPC's intent to sole source the requirement to: Laboratory Corporation of America 358 S. Main Street, Ste. 458 Burlington, NC 27215-5837 The NAICS code is: 621511. It is anticipated that one purchase order will be issued for a 1 year base period and 2 one year option periods. This is not a Request for Quote. Sources interested in this requirement must provide a statement of capabilities in sufficient detail to determine if the requirements of this synopsis can be met. Responses must be in writing and must be received within fifteen (15) calendar days from the date of this notice. A determination by the Government not to compete the proposed contract based on responses from this notice is soley within the discretion of the Government. Information received will be considered soley for the purpose of determining whether to conduct a competitive procurement. No phone calls will be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/CCOPC/15-004036/listing.html)
- Place of Performance
- Address: 9000 Rockvill Pike, Bethesday, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03630346-W 20150204/150202234435-d829cd29ce1e3d12ac7a3b4698cf9415 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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