SOURCES SOUGHT
Q -- Genetics Testing Services
- Notice Date
- 12/5/2012
- Notice Type
- Sources Sought
- NAICS
- 621111
— Offices of Physicians (except Mental Health Specialists)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-CSB-HG-2013-08-DLM
- Archive Date
- 12/26/2012
- Point of Contact
- Dorothy Maxwell, Phone: 301-435-0352
- E-Mail Address
-
maxwelld@mail.nih.gov
(maxwelld@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This Sources Sought Notice (SS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Heart, Lung, and Blood Institute (NHLBI). The purpose of this SS is to identify businesses that are interested in a study on "Genetic Testing Services" for Undiagnosed Diseases program (UDP), Clinical Trial Number: NCT00369421, Protocol Number: 76-HG-0238, providing biochemical and molecular testing for genetic syndromes, inborn errors of metabolism, and mitochondrial diseases for clinical and research programs. The NHLBI does not intend to award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted. As a result of this Sources Sought notice, the NHLBI may issue a Request for Quote (RFQ). THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NHLBI shall arise as a result of a response to this Sources Sought notice or the NHLBI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. The NHLBI is seeking capability statements from all eligible businesses, under the North American Industry Classification System (NAICS) code 621111, Office of Physicians (except Mental Health Specialists), with size standard of $10.0M Per Annum. BACKGROUND The National Human Genome Research Institute (NHGRI), Undiagnosed Disease Program (UDP) is a pilot program designed to address the needs of persons with debilitating medical conditions for which no diagnosis has been found despite an extensive workup. The goals of the UDP include finding accurate diagnoses and discovering new diseases that provide insight into human physiology and genetics. The UDP was established to evaluate participants who have undiagnosed medical conditions. UDP participants have generally received extensive diagnostic workups before traveling to the NIH and often have numerous and/or complex medical problems. The UDP program makes use of a diverse set of diagnostic and research techniques both to attempt to find a diagnosis and to generate research projects to advance medical knowledge. The DIR-NHGRI- Undiagnosed Diseases program (UDP) protocol 76-HG-0238, Clinical Trial Number: NCT00369421 are connected to this clinical testing, which began in 2008 as a vehicle for admitting patients with broader range of inborn errors of metabolism. Under this observational protocol study, patients with long-standing, complex undiagnosed diseases are admitted to the NIH Clinical Center for comprehensive evaluation to discover new genetic disorders and/or potential treatments. The UDP program has made 47 diagnoses, which is about 20% of the total number of patients seen in this protocol to date. Ongoing research continues to find diagnosis on the other patients who have been seen in the UDP to date. The Researchers in the Protocol study intend on diagnosing and treating certain inborn errors of metabolism. By doing this, researchers hope to expand their knowledge about these disorders and provide access to patients of interest for research, teaching, and clinical experience. Patients enrolled in this protocol have been referred with a known or suspected inborn error of metabolism, heritable disorder, or genetic predisposition. Patients participating in this study will be examined and treated on an outpatient basis, if practical. However, patients requiring specialized tests or treatments will be admitted to the NIH Clinical Center as necessary. Researchers will use only accepted medical procedures in diagnosing (medical history, physical examinations, X-ray studies, eye examinations, blood tests, and urine tests) and treating the patients involved in this study. Additional tests may be required on a case by case basis. UDP has a critical need for expertise in clinical and laboratory genetic services, a key component in current and future clinical study results. PURPOSE : The Contractor shall provide Clinical Laboratory Improvement Amendments (CLIA) - certified biochemical and mitochondrial testing for patients within the National Human Genome Research Institute (NHGRI), Undiagnosed Disease Program (UDP). CONTRACTOR REQUIREMENTS : A. Specific Tasks : 1. The Contractor shall provide cutting edge analysis of blood, urine and fibroblasts for congenital disorders of glycosylation (CDG). 2. The Contractor shall provide specialized lysosomal screening for the 12 most common lysosomal disorders and confirmatory mutation analysis as needed. 3. The Contractor shall add new tests as available 4. The Contractor shall provide a wide-range of tests as outlined in the attachment with family follow up as needed, as well as support the ongoing collaborative research expertise needed by the NHGRI, UDP. 5. The Contractor shall provide unique services specific to complex CDGs and lysosomal disorders meet the program goals of the UDP. 6. The Contractor's shall turn-around-time for UDP to receive results will be 2-4 weeks. 7. The Government will be contacted if any patient results need to be evaluated urgently for impact on caring for patients in the UDP. 8. The Contractor shall supply faxed copies of all patient reports for the study file and medical record. B. Desired Results/Functions/End Items : 1. CLIA-certified test results with qualified interpretations in a timely way given the requirements of the particular test the UDP Clinicians request. 2. Research collaborations will be conducted via Teleconferences, email communications, shared professional presentations, posters and publications. Grand Round presentations at the Contractor's location and the NIH Clinical Center may also occur. C. Technical Specifications/Standards/Methods : 1. The Contractor shall supply CLIA-certified test results with qualified interpretations. D. Special Handling or Handling Requirements : 1. The Contractor shall provide result reports in a secure HIPAA compliant manner. E. Government Responsibilities : The Government will provide to the Contractor : 1. The Government will not furnish any government property to the vendor 2. The Government will provide patient samples will include; isolated DNA, blood, urine, fibroblasts, skeletal muscle or liver tissue as the patient condition and evaluation warrants. 3. The Government will send all patient samples via Fed-Ex overnight to the Contractor for testing. 4. The Government will not furnish any facilities to be used by the vendor. The Governments will be responsible for reviewing and approving reports and similar matters generated: 1. Abnormal results will be provided via phone, with follow up fax, directly to the ordering Clinician who can plan appropriate follow up with other members of UDP caring for the patient/family impacted by the result(s). 2. All confirmed abnormal diagnostic test results will be released to the referring clinician and patient/family. F. Reporting Requirements and Deliverables : • Itemize all progress, management, financial and fiscal or other reporting requirements and the frequency of their generation, or specific dates when due. 1. The Government will receive all written results of patient samples within 2-4 weeks of the Contractor receiving the patient samples. 2. The Government will receive additional reports for any test added-on after the Contractor receives the original specimen. 3. The Government will receive additional reports for any parental or sibling testing done for the clarification of a new genetic disease. Program Management and Control Requirements : • Any internal management and control systems, either specified by the Government or to be developed by the contractor. Interested parties are expected to review this notice to familiarize yourself with the requirements of this project; failure to do so will be at your firm's own risk. Interested parties should submit a tailored capability statement for this requirement, not to exceed 20 single-sided pages (including all attachments, resumes, charts, etc.) presented in single-space and using a 12-point font size minimum, that clearly details the ability to perform the aspects of the notice described above and in the attached draft statement of work. All proprietary information should be marked as such. Statements should also include an indication of current certified business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern's name and address). Responses will be reviewed only by NIH personnel and will be held in a confidential manner. All capability Statements sent in response to this SOURCES SOUGHT notice must be submitted electronically (via email) to Dorothy Maxwell, Contract Specialist, at maxwelld@mail.nih.gov in either MS Word or Adobe Portable Document Format (PDF), December 11, 2012, 7:30 AM, EST. All responses must be received by the specified due date and time in order to be considered. Note: In order to receive an award from NIH/NHLBI, contractors must be registered and have a valid CCR and ORCA on-line at https://www.sam.gov/portal/public/SAM/.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-CSB-HG-2013-08-DLM/listing.html)
- Place of Performance
- Address: NIH, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02943024-W 20121207/121205234303-a054c5c67a0804c5dfd5a1e814515d90 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |