SOLICITATION NOTICE
B -- Clinical Laboratory Improvement Amendments (CLIA) - certified biochemical and mitochondrial testing for patients
- Notice Date
- 9/1/2016
- Notice Type
- Presolicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- 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
- HHS-NIH-NHLBI-CSB-(HG)-2016-294-DM
- Archive Date
- 9/23/2016
- 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
- INTRODUCTION: THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR A PROPOSAL. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI) Office of Acquisition (OA) on behalf of the National Human Genome Research Institute, (NHGRI), Undiagnosed Diseases Program (UDP) intends to negotiate and award a purchase order on a noncompetitive sole source basis to Emory University School of Medicine, Department of Pharmacology, Rollins Lab Research Center, 1510 Clifton Road, Atlanta, Georgia 30322. Emory University will collaborate with NHGRI, NIH Undiagnosed Program provide cutting edge analysis of multiple tissues for congenital disorders of glycosylation. Procurement: • Genetic testing services for any published test found on the EGL website (www.geneticslab.emory.edu). • EGL working days are defined as Monday-Friday. • Results will be sent via facsimile to the NHGRI. Background : The NIH DIR-NHGRI- Undiagnosed Diseases program (UDP) protocol 76-HG-0238, Clinical Trial Number: NCT00369421 are connected to this testing, which began in 2008 as a vehicle for admitting patients with broader range of inborn errors of metabolism. Under this observational protocol study, 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 to continue collaborating with Emory University School of Medicine, Department of Genetics expertise in laboratory genetic services, a key component in current and future clinical study results. Period of Performance: Base Year: 12 Months Upon Award Option 1: 12 Months Option 2: 12 Months Purpose and Objectives : The purpose of this acquisition is provide cutting edge analysis of multiple tissues for congenital disorders of glycosyslation and highly specialized testing for Lysosomal storage disease WBC enzymology for NHGRI Undiagnosed Disease Program. Emory University School of Medicine, Department of Genetics provides biochemical testing for patients within the National Human Genome Research Institute (NHGRI), Undiagnosed Diseases Program (UDP). Specifically, this laboratory provides highly specialized and lysosomal storage disease testing and supports the research needs of the UDP by collaborating on clinically identified new and rare diseases. Contractor's Requirements as follows: • The Contractor shall provide cutting edge analysis of fibroblasts or fibroblast pellets for congenital disorders of glycosylation (CDG). • The Contractor shall provide specialized lysosomal screening for the 12 most common lysosomal disorders and confirmatory mutation analysis as needed. • The Contractor shall add new tests as available. • 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. • The Contractor shall provide unique services specific to complex CDGs and lysosomal disorders meet the program goals of the UDP. • The Contractor's shall turn-around-time for UDP to receive results will be 2-4 weeks. • The Government will be contacted if any patient results need to be evaluated urgently for impact on caring for patients in the UDP. • The Contractor shall supply faxed copies of all patient reports for the study file and medical record. 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. Technical Specifications/Standards/Methods : 1. The Contractor shall supply CLIA-certified test results with qualified interpretations. Special Handling or Handling Requirements : 1. The Contractor shall provide result reports in a secure HIPAA compliant manner. Government Responsibilities : 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 Government 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. Reporting Requirements and Deliverables : 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. Regulatory Authority : This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart 13.106-1(b) Soliciting from a single source and is not expected to exceed the simplified acquisition threshold, only one responsible source and no other supplies or services will satisfy agency requirements. This requirement is under the SAT of $150,000.00. Statutory Authority : This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. Closing Statement : Industry Classification (NAICS) Code is 541711, Research and Development in Biotechnology, with a business size standard of 1000. The acquisition is being conducted under FAR Part 13, simplified acquisition procedures, therefore the requirements of FAR Part 6 B Competitive Requirements are not applicable (FAR Part 6.001). The resultant Contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-89-1 (August 15, 2016). This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must be received by September 8, 2016 and must reference synopsis number HHS-NIH-NHLBI-CSB-(HG)-2016-294-DM, may be submitted to the National, Heart, Lung and Blood Institute, Office of Acquisition, COAC Services Branch, 6701 Rockledge Drive, Suite 6149, Bethesda, Maryland 20892-7902, Attention: Dorothy Maxwell, Contracting Officer. Response may be submitted electronically to maxwelld@mail.nih.gov. Faxes will not be accepted. Responses will only be accepted if dated and signed by an authorized company representative. "All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency."
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHS-NIH-NHLBI-CSB-(HG)-2016-294-DM/listing.html)
- Record
- SN04251390-W 20160903/160901235016-b4a2bf3a1dc077cc0fd400f3f6872765 (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 |