SOURCES SOUGHT
A -- National Children's Study Repository
- Notice Date
- 3/26/2007
- Notice Type
- Sources Sought
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch 6100 Executive Blvd., Suite 7A07, MSC7510, Bethesda, MD, 20892-7510, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- SS-NICHD-2008-07
- Response Due
- 4/13/2007
- Archive Date
- 4/28/2007
- Description
- This announcement is not a Request for Proposals (RFP) and does not commit the Government to award a contract now or in the future. No solicitation is available at this time. The purpose of this synopsis is to identify small business organizations with requisite qualifications to provide the services stated herein. Based on capability statements received in response to this Sources Sought Announcement this acquisition may be solicited as a 100% small business set-aside. All small business organizations (SB, SDB, WOSB, HUBZone, VOSB, and SDVOSB) are encouraged to respond to this notice. This requirement is assigned a code of 541710 in the North American Industry Classification System (NAICS), and the small business size standard for such requirements is 500 employees. The National Institute of Child Health and Human Development (NICHD)/NIH, seeks capability statements from interested and qualified potential sources to provide repository services for the National Children's Study. The support services being sought are related to the establishment and operation of a large repository to receive, store, process, and ship biological and environmental samples that will be collected throughout the study (as described below). It is anticipated that the repository will periodically distribute samples to laboratories at the direction of the Government. NICHD is seeking information on the capabilities and limitations of organizations interested in providing the services described below. BACKGROUND The Children?s Health Act of 2000 authorized the NICHD and a consortium of other Federal Agencies to ??plan, develop, and implement a prospective cohort study, from birth to adulthood, to ...incorporate behavioral, emotional, educational, and contextual consequences to enable a complete assessment of the physical, chemical, biological, and psychosocial environmental influences of children's well-being.? That study is now known as the National Children's Study (NCS). Investigators in the Department of Health and Human Services (DHHS), including the National Institute of Child Health and Human Development (NICHD), the National Institute of Environmental Health Sciences (NIEHS), the Centers for Disease Control and Prevention (CDC), and the U.S. Environmental Protection Agency (EPA), as well as at other Federal agencies, have begun to plan and implement this large study. The NCS will study the complex relationship between health and the environment for approximately 100,000 U.S. children and their families throughout the United States. Enrollment of subjects throughout the U.S. will begin before birth (and possibly before conception) and follow-up will continue at least until each child is 21 years of age. Study planners have identified the following child health areas as priorities for the NCS: pregnancy outcomes, neurodevelopment and behavior, injury, asthma, obesity, and physical development. As a result of the many study hypotheses being considered for the NCS, as well as the anticipation that other hypotheses will emerge during the course of the Study and afterward, millions of diverse biological specimens and environmental samples will be collected over the life of the project. Biological samples may include, but are not limited to, blood, urine, hair, nails, saliva, buccal cells, breast milk, placentas, umbilical cord, vaginal swabs, cord blood, and meconium. Environmental samples may include, but are not limited to, air sampling filters, water, bulk household dust (vacuum and floor wipes), mattress dust, floor mats, soil, and food. Additionally, prepared ampulated environmental samples, such as digestates or extracts, and residual environmental samples may be required to be stored. Plans for a repository for the Study are evolving. Concepts being considered include shipping all samples directly from field sampling technicians to a central receiving repository where they will be processed, aliquotted and stored. Periodically, at the direction of the government, the repository will send aliquots to the primary analytic and clinical laboratories. Alternatively, some samples may be shipped first to the primary analytic and clinical laboratories for analysis with remaining material sent to the main repository. The ability to store a fraction of the biological and of the environmental samples at a separate geographic location is required to mitigate the risk of sample loss in a disaster. Given the long-term nature of the study, it will be important to assess the long-term integrity and analyte stability of the various samples. The repository will contribute to the development of standard operating procedures (SOPs) to conduct these assessments and will store, process, and ship specimens as necessary to support these efforts. A support services contract is anticipated to be used for the National Children?s Study Sample Repository. The repository shall be located in facilities owned or operated by the contractor with specific space allocated for purpose of this contract. The successful offeror shall possess the following qualifications and meet the following requirements at the time of proposal submission. Organizations that submit capability statements in response to this notice will be evaluated against the following technical areas of experience and expertise: A. Repository Experience and Expertise. Provide names of projects and references (contract number, contract officer and technical representative), distinguishing previous experience from current projects. Response must include number of samples as well as duration and description of services provided, in sufficient detail to demonstrate: i. Extensive experience managing large biological and environmental sample repositories. ii. Experience in receiving, processing, and archiving biological samples (such as blood, urine, hair, nails, buccal cells, breast milk, meconium, cord blood, umbilical cords, tissues such as placenta). Types of processing to address include but are not limited to aliquotting samples and adding preservatives using an automated or robotics system, under BSL 2 conditions, and under appropriate temperature, light, and contamination-free environmental conditions. iii. Experience in handling and archiving environmental samples such as soil samples, air sampling filters, water, bulk household dust, prepared samples (ampulated extracts) and special samples (such as floor mats, food). iv. Capability to rapidly develop the capacity to receipt and store over 10 million samples during the first 5 years of the study. v. Capability to rapidly develop the capacity to aliquot as many as 1 million samples per year, under appropriate environmental conditions for future analyses of light sensitive compounds, pesticides, Polycyclic Aromatic Hydrocarbons, and metals, including the ability to aliquot specimens into multiple containers using a robotic aliquotting system. vi. Capability to handle room temperature, refrigerated, frozen, and liquid/vapor phase nitrogen frozen samples (e.g. 4-6 degrees C, -20 degrees C, -80 degrees C, and liquid/vapor phase nitrogen) in a space specifically dedicated to this study. vii. Capability to handle emergency situations resulting from electrical outages, changes in room temperature and humidity, freezer conditions, hardware and software failures of computer systems. viii. Capability for an automated tracking system to receipt, inventory, process and track samples. Discuss the ability of any automated system to provide sample receipt, processing and shipping information to the NCS Information Management System in an agreed upon file format. ix. Capability to support and adhere to health data exchange standards such as Logical Observation Identifiers Names and Codes (LOINC), HL7, Electronic Health Records Laboratory Results Reporting (HITSP/IS 01) and/or others. x. Additional capabilities required include: (a) Ability to do complex processing such as DNA and RNA extraction; (b) Extraction and cryopreservation of PBMCs; (c) Extraction of urine from disposable diapers. xi. Personnel with demonstrated ability and experience to manage a large long-term project such as this repository, including expertise in computerized sample and data management. xii. Personnel with demonstrated ability to accurately and safely receive, inventory, process, store, retrieve and aliquot samples, and to conduct processing services. xiii. Experience in maintaining and documenting appropriate quality assurance and quality control procedures for all repository activities. xiv. Ability to package and ship periodically up to 2 million specimens during the 5 year period to designated laboratories according to NCS procedures and federal, state and local regulations B. Facilities: Provide a brief description of the facilities and demonstrate the capability to provide appropriate climate controlled and contamination-free dedicated space for the repository needs over the life of the contract in two geographically separate locations to reduce the risk of sample loss in the event of a natural disaster. This is to include sample receiving, processing, storing and shipping facilities, as well as office and computer space. C. Service Capabilities: Demonstrate the capability to provide services in the following areas for a study of the size and breadth of the NCS: i. Project Management: a. Long-term services b. wide range of support, including secretarial, clerical, housekeeping, technical, telecommunications, computer support, security, and equipment maintenance; c. space for administrative activities as well as dedicated storage space. ii. Quality Assurance and Quality Control: a. Development of Quality Manual, evidence of compliance with ISO and other standards organizations; b. regular performance evaluation reviews; c. yearly and random facility inspections; d. specific QA/QC program for archived samples. iii. Receiving and Preparing Aliquots: Adequate qualified and trained personnel to receive, process, store and track between 460 and 6,500 samples per day, handle infectious and biohazardous materials, and aliquot samples using robotics and manually under BSL2 conditions; iv. Data Storage: a. Maintain and update a computerized tracking inventory control to document condition, status and location of all samples for the duration of the contract; b. backup of inventory control system. v. Shipping Samples: a. Ship under appropriate conditions, in appropriate containers, to the proscribed destination; b. Maintain adequate records on all shipments; c. verify arrival of all samples at destination; d. receive residual specimens from laboratories, add back to inventory and track. vi. Accessibility: a. Ability to host site visit audits for QC purposes. b. Facilities open and staffed to receive samples 365 days per year with appropriate and sufficient staff available for emergencies. Interested organizations that believe they possess the capabilities necessary to undertake this project should submit two hard(2) copies of their capability statement, addressing the areas above. Any proprietary information should be so marked. Written capability statements should be received by the Contracting Officer by no later than 4:00PM local time on April 13, 2007. Capability statements must identify the business status of the organization (i.e. educational institution, non-profit, large business, small business, 8 (a), or other corporate or non-corporate entity). NO COLLECT CALLS WILL BE ACCEPTED. RESPONDENTS MAY SUBMIT THEIR CAPABILITY STATEMENTS VIA E-MAIL IN ADDITION TO THE 2 HARD COPIES. See NUMBER NOTE 25. Responses should be no more than 15 pages. These pages exclude resumes. INQUIRIES Lisa K. Coleman Contracts Specialist National Institute of Child Health and Human Development 6100 Executive Boulevard, Suite 7A07, MSC 7510 Bethesda MD 20892-7510 Rockville, MD 20852 (for express/courier service) Telephone: 301-402-8552 Fax: 301-402-3676 E-mail: licoleman@niddk.nih.gov OR Elizabeth Osinski Contracting Officer National Institute of Child Health and Human Development 6100 Executive Boulevard, Suite 7A07, MSC 7510 Bethesda MD 20892-7510 Rockville, MD 20852 (for express/courier service) Telephone: 301-435-6947 Fax: 301-402-3676 E-mail: eo4343m@nih.gov
- Record
- SN01259073-W 20070328/070326220200 (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 |