Clinical Genetics Testing Services

Project Title: Clinical Genetics Testing Services Sources Sought Notice Number Department: HHS-NIH-NHLBI-CSB-(HG)-SBSS-2018-75N92018Q0010 Sources Sought Notice Number CAMS: HHS-NIH-NHLBI-CSB-(HG)-SBSS-2018- 75N92018Q0010 This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. A. Background: The National Institute of Health (NIH) is the nation's leading medical research agency and the primary Federal agency conducting, supporting and making medical discoveries that improve people's health and save lives. 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. 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. B. Purpose and Objectives: 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 Contractor shall provide Clinical Laboratory Improvement Amendments (CLIA) - certified biochemical and molecular genetic testing for patients within the National Human Genome Research Institute (NHGRI), Undiagnosed Disease Program (UDP). C. Procurement: - The Contractor shall provide cutting edge analysis of blood, urine and fibroblasts 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. D. Anticipated Period of Performance: Base Year: 12 Months Option 1: 12 Months Option 2: 12 Months Option 3: 12-Months Option 4: 12-Months E. Contractors Requirement: 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: 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 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. F. Reporting Requirements and Deliverables: MNG Laboratories supply CLIA certified test results with qualified interpretations in a timely way given the requirements of the particular test the UDP clinicians request. Billing will be prompt and include a 15% discount on all CLIA tests ordered through the UDP. Research collaborations will be ongoing as new disorders are identified or confirmed by MNG Laboratories. 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. G. Capability Statement /Information: Interested parties are expected to review this notice to familiarize itself with the requirements of this project. Failure to do so will be at your firm's own risk. The following information shall be included in the capability statement: 1. A general overview of the respondents' opinions about the difficulty and /or feasibility of the potential requirement, and any information regarding innovative ideas or concepts. 2. Information in sufficient details of the respondents' (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information. 3. The respondents' DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZone, etc) pursuant to the North American Industry Classification System (NAICS) code: 621511, Medical Laboratories, small business size standards $32.5M. 4. Any other information that may be helpful in developing or finalizing the requirements of the potential acquisition. 5. The capability statement shall not exceed 10 single-sided pages (including all attachments, resumes, charts, etc.) presented in single-space and using a 12-point font size minimum, in either Microsoft Word or Adobe Portable Document Format (PDF), with 8-1/2 by 11 inch paper size, and 1 inch top, bottom, left and right margins. 6. All proprietary information should be marked as such. Statements should also include an indication of current certified small 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. H. Closing Statement: Point of Contact: Dorothy Maxwell, Contracting Officer, NHLBI, Section 3, Branch B, OM/OA, Phone (301) 827-7729. Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Office of Acquisitions, 6701 Rockledge Drive, Rockledge 2, Room 6149, Bethesda, MD, 20892-7902, UNITED STATES Submission Instructions: (www.fedconnect.net) and reference the FedConnect Sources Sought Number HHSN26817HG00006R. The due date for receipt of statements is October 26, 2017, 7:30 a.m. Eastern Time. Vendors can register with FedConnect at https://www.fedconnect.net/FedConnect/default.htm. Please note that FedConnect is used by multiple federal agencies and therefore FedConnect assistance will be provided by Compusearch Software Systems, not the NHLBI OA. More information about registration requirements can be found by downloading the FedConnect Ready, Set, Go! Guide at https://www.fedconnect.net/fedconnect/Marketing/Documents/FedConnect_Ready_Set_Go.pdf. For assistance in registering or for other FedConnect technical questions please call the FedConnect Help Desk at (800) 899-6665 or email at support@fedconnect.net. Please use the Contracting Officer/ Contract Specialist contact information provided, should you require a waiver not to use FedConnect for submitting. All responses must be received by the specified due date and time in order to be considered. 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 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 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 notice or the NHLBI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. "Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s)."