SOURCES SOUGHT
A -- Maintenance of the NHLBI Biologic Specimen Repository
- Notice Date
- 8/21/2014
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except 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
- NHLBI-CSB-HB-2016-03-JT
- Archive Date
- 9/20/2014
- Point of Contact
- John Turner, Phone: 3014029787
- E-Mail Address
-
john.turner@nih.gov
(john.turner@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Maintenance of the NHLBI Biologic Specimen Repository Sources Sought Notice NHLBI-CSB-HB-2016-03-JT Contracting Office Address 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. RKL2/6148 MSC 7902, Bethesda, MD, 20892-7902, UNITED STATES Introduction 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. An organization that is not considered a small business under NAICS code 541712 should not submit a response to this notice. Background The National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH) conducts and supports epidemiological and clinical research in heart, lung and blood diseases and transfusion medicine. The NHLBI Biologic Specimen Repository (Biorepository), first funded in 1980, is a storage and management program for biospecimens collected on selected NHLBI clinical studies. The Biorepository was initially established to support the need for archival collections to address emerging blood-safety concerns. These collections have made several seminal contributions to public health, such as establishing the viral origin of the agent responsible for non-A, non-B hepatitis (HCV) and transfusion transmissibility of HIV. Towards the end of the 1990s the Biorepository mission was expanded to acquire biospecimens from studies with unique patient populations, such as the Honolulu Heart Program, A Case Controlled Etiologic Study of Sarcoidosis, and the Multicenter Hemophilia Cohort Study. These richly phenotyped biospecimens provide a return on the original study investment through their continued research use. Access to the biospecimens is provided through the Biologic Specimen and Data Repositories Information Coordinating Center (BioLINCC). BioLINCC, funded under contract HHSN268201400014C, maintains the clinical study datasets in the NHLBI Data Repository, links the study datasets in the Data Repository to their biospecimens in the Biorepository, and makes both resources available online through the BioLINCC website at www.biolincc.nhlbi.nih.gov. The management of the Biorepository follows the current National Cancer Institute (NCI, http://biospecimens.cancer.gov/bestpractices/) and International Society for Biological and Environmental Repositories (ISBER; (http://www.isber.org/?page=BPR) Best Practices. In addition, a five-year Business Plan is used to assist in long term planning. The Plan has three goals: 1) increase use; 2) acquire new collections with potential scientific utility; and 3) minimize infrastructure costs Plan activities are guided by a NHLBI trans-Division committee and coordinated by BioLINCC in collaboration with the Biorepository. Currently, 4.1 million vials from 66 clinical studies are housed in 163 mechanical freezers (28 upright; 123 chest) and 9 liquid nitrogen freezers. Contemporary study collection vials are labeled with barcoded labels that may include a study ID or a laboratory ID and the stored material type. Vial labels from older studies may be barcoded, printed or handwritten and may contain subject initials and other sensitive data. The biospecimen inventory is managed using the Biological Specimen Inventory System (BSI) software (http://www.bsisystems.com/). Each vial has a record in the BSI and BioLINCC maintains a direct link to the Biorepository BSI software to enable real-time searching for biospecimens within and across study collections. The number of new biospecimens that will be acquired during the contract is not known but the total inventory at the end of the contract is unlikely to exceed ten million samples. The current five-year contract with Precision Bioservices, Inc., (contract number HHSN268201400035C) will expire on April 30, 2016. Purpose and Objectives The objective of this contract is to meet the goals of the Business Plan in a cost-effective manner by implementing strategies to efficiently maintain, acquire and distribute quality and scientifically valuable biospecimens from NHLBI-funded clinical studies. Biospecimen material types include serum, plasma, whole blood, peripheral blood mononuclear cells, immortalized cell lines, tissue and other bodily fluids or substances such as bronchial lavage, urine, biopsy materials, whole blood spots dried on filter paper and embedded tissue blocks. The specimens have been collected over many years from carefully chosen subjects and reflect the history of the NHLBI epidemiology and clinical trials programs since 1965. Biospecimens are typically received as bulk relocations at the end of the clinical study. Some intermittent shipping from ongoing studies may occur as the need arises. Biospecimens that are limited in number and/or volume are divided into multiple vials or sections or expanded, depending on material type. Biospecimens are requested online through the BioLINCC program and Biorepository staff assist with the online review of each request and provide recommendations regarding the appropriateness of the material type and volume of material requested. Biorepository staff also assist in reviewing the suitability of collections for transfer to the Biorepository and in developing strategies to extend limited resources and reduce the number of vials identified as having low scientific utility. The procedures to acquire and distribute biospecimens are available online at www.biolincc.nhlbi.nih.gov in the BioLINCC Handbook. Project Requirements The contractor should be capable of housing, operating and managing the NHLBI Biorepository. Each specimen is unique and cannot be replaced if lost, damaged or contaminated. Therefore, it is essential that the specimens be stored and managed under optimal conditions to maintain their integrity and biological properties, which vary from specimen type to specimen type. Specifically, the Contractor will be required to: A. Follow all Federal, State and local requirements and current best practices for the collection, handling, preservation, storage, retrieval and distribution of biological material for scientific. This includes having, or applying to the Office for Human Research Protections at the Department of Health and Human Services for, Federalwide Assurance (http://www.hhs.gov/ohrp/assurances/assurances/update/index.html ) B. Provide and maintain a safe, secure and appropriately temperature-controlled physical environment that is equipped with fire, smoke, and mechanical failure alarms to house and maintain the NHLBI biospecimens. C. Provide a management team with demonstrated knowledge and experience in biorepository program and project management. Demonstrated experience must include: 1) managing a repository with over 2 million samples; 2) daily operation oversight; and 3) reporting on program performance. D. Provide trained staff and facilities to manage the biospecimen collections, including: 1) acquiring specimens intermittently or as a bulk relocation, including specimens with known blood borne or other potentially infectious pathogens; 2) storing specimens under optimal conditions to minimize loss, damage or contamination; 3) dividing specimens into aliquots; 4) sectioning frozen and fixed embedded tissue specimens; 5) preparing blinded panels of specimens; 6) processing frozen whole blood and blood derivatives; 7) expanding renewable biospecimens, such as immortalized cell lines and DNA; 8) retrieving and distributing specimens to qualified investigators including packaging, handling, and coordinating specimen shipments to domestic and international sites; 9) withdrawing and destroying specimens; and 10) and providing preprinted barcoded label sets. E. Provide staff with the appropriate expertise to 1) assist BioLINCC with the scientific review of biospecimen requests, promotion of Biorepository collections; 2) review new collection applications; 3) assist with the development, and implementation, of plans to maintain and operate the Biorepository in an efficient manner; and 4) assist NHLBI funded investigators with building and maintaining a biospecimen collection. F. Have the ability to adjust the number of staff, and expertise of staff, in a timely manner when fluctuations in work volume occur. G. Provide and maintain a secure, robust, validated web-based software system for biospecimen management that can be customized to meet the needs of the program. The software system must be able to seamlessly transfer data from the current Biorepository BSI software system at initiation of the contract and provide a direct transfer of data between the Biorepository software and the BSI system at BioLINCC throughout the contract. Information on the BSI software is available at http://www.bsisystems.com/. H. Provide and maintain efficient Quality Assurance (QA) and Quality Control (QC) Programs to meet the specific needs of the Biorepository. I. Ensure an orderly transition of the NHLBI Biorepository at contract initiation. J. Ensure an orderly transition of the NHLBI Biorepository at contract termination. K. Participate in meetings and teleconferences with the NHLBI, BioLINCC and NHLBI funded clinical study programs. Period of Performance The Government intends to award one (1) Indefinite Delivery/Indefinite Quantity contract for a period of five years with an approximate effective date of March 1, 2016. It is anticipated that an annual Task Order will be awarded to fully fund twelve-months of administrative effort to maintain the Biorepository infrastructure. Additional Task Orders to acquire, distribute and cull historic collections will be funded as needed over the five year period. Task Orders will be on a Cost-Reimbursement basis, expect when a Firm-Fixed-Price contract type is more appropriate. Place of Performance The Request for Proposal will contain a mandatory qualification criterion which restricts the facility to be located within the continental United States to accommodate the requirements for shipping of biological specimens to and from the facility. Capability Statement/Information Sought Small business concerns that believe they possess the capabilities necessary to undertake this work should submit complete documentation of their capabilities to the Contract Specialist. The capabilities statement shall specifically address each project requirement separately. Additionally, the capability statement must clearly convey information regarding the respondent's capabilities, including: (a) total number of employees (b) staff expertise, including their availability, experience, and formal and other training; (c) current in-house capability and capacity to perform the work; (d) prior completed projects of similar nature; (e) corporate experience and management capability; and (f) examples of prior completed Government contracts, references, and other related information. The capability statement must not exceed 15 single sided pages in length using a minimum 12-point font size. Interested small business organizations are required to identify their size standards in accordance with the Small Business Administration. The Government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone numbers of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. All capability statements sent in response to this Sources Sought Notice must be submitted electronically (via email) to John Turner, Contract Specialist, at john.turner@nih.gov in either MS Word or Adobe Portable Document Format (PDF), within 15 calendar days of the date of this announcement. All responses must be received by the specified due date and time in order to be considered. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. No proprietary, classified, confidential, or sensitive information should be included in your 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 review of the responses received, pre-solicitation and solicitation notices may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. The solicitation release date is pending. Original Point of Contact John Turner, Contract Specialist, NHLBI COAC Services Branch, Phone (301) 402-9787, Email: john.turner@nih.gov 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. RKL2/6148 MSC 7902, Bethesda, MD, 20892-7902, UNITED STATES
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