Brain and Tissue Bank for Developmental Disorders

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 621991 in the North American Industry Classification System (NAICS), and the size standard for such requirements is $9 million. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)/NIH, seeks capability statements from interested and qualified potential sources to continue to provide a resource designed to receive, store, catalog, preserve, and distribute brain and tissue specimens to research investigators. The NICHD Brain and Tissue Bank was established to advance the research of developmental disabilities. Human autopsy and surgical tissues are retrieved from all over the United States and also from various International sites, including Canada. Over 300 disorders are represented. They include: diagnosed Down's Syndrome, other chromosomal defects, mitochondrial encephalopathies, phenylketonuria and other aminoacidopathies, maternal phenylketonuria, Rett syndrome, leukodystrophies, lysosomal disorders, unexplained forms of mental retardation, sudden infant death syndrome (SIDS), dyslexia, autism and other neurodevelopmental disorders. Specific tissues collected include the following: brain, spinal cord, cerebrospinal fluid, blood and serum, peripheral nerves, liver, kidney, pancreas, lungs, spleen, adrenal, skeletal muscles, heart, skin, thyroid, lymph nodes and gonads. The bank serves the critical purpose of collecting, preserving, and distributing human tissues to qualified scientific investigators who are dedicated to the improved understanding, care and treatment of developmental disabilities. NICHD anticipates that the tissue repository will periodically distribute portions of stored samples to recipients at the direction of the Government. In addition, the Institute anticipates that other, outside groups may wish to collaborate with the Brain and Tissue Bank on separate ancillary projects related to their NICHD-funded activities. NICHD is seeking information on the capabilities and limitations of organizations interested in providing the services described below. 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 of past projects that are similar to the NICHD Brain and Tissue Bank mission. Responses must indicate whether the project has concluded or ongoing, and the types of tissues and associated diagnosed disorders in sufficient detail to demonstrate: i. Expertise in developing a common protocol for use by clinicians and pathologists in the collection, storage and distribution of brain and other human postmortem and surgical/biopsy tissues for research purposes. ii. Expertise in developing a standardized protocol for dissecting different parts of the central nervous system, i.e. cerebrum, cerebellum, brain stem and spinal cord. iii. Expertise in developing standard forms and computerized inventory databases that are compatible to include the following: type of sample, amount, source, distribution, relevant family information, clinical histories & findings, post-morteum investigations, post-conceptional age, material history, neonatal history, cause of death, medication at the time of death and ethnicity. iv. Expertise in developing a mechanism to convey to the professional and lay public the existence of the brain bank and the need to obtain pre- and post-mortem tissues by contacting appropriate parent groups, professional societies and primary care providers. This includes developing and implementing a referral mechanism to obtain tissues in useful quantities for research purposes over a range of post-conceptional ages. v. Personnel with demonstrated ability and experience to manage a large long-term project such as this repository, including expertise in tissue storage management, community outreach recruitment and public awareness of the bank. They should demonstrate an ability to accurately and safely retrieve, inventory, process, store, retrieve and conduct processing services. vi. Ability to package and ship periodically up 5,000 specimens during the contract to designated recipients according to international, federal, state and local regulations. vii. Demonstrate ability and willingness to interact with advocacy groups to develop and perform separate ancillary projects related to the activities of the Brain and Tissue Bank. 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. This is to include sample receiving, processing, storing and shipping facilities, as well as office and computer space. There are currently 79,000 plus samples that are already part of the Brain and Tissue Bank. C. Service Capabilities: Demonstrate the capability to provide services in the following areas for studies of the size and breadth of those conducted: i. 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. Compliance with relevant tissue regulations for materials stored and distributed. ii. Tissue 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. iii. 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. iv. Accessibility: a. Ability to host site visit audits from NICHD for QC and regulatory compliance purposes; b. Facilities open and staffed to receive samples with appropriate and sufficient staff available for emergencies. Interested organizations that believe they possess the capabilities necessary to undertake this project should submit electronic copies in addition to four (4) hard copies of their capability statement, addressing the areas above. Please limit responses to fifteen (15) pages or less. 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 August 8, 2008. 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 4 HARD COPIES. See NUMBER NOTE 25. Responses should be no more than 15 pages. These pages exclude resumes. INQUIRIES Seena Mathews 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: 301-435-6963 Fax: 301-402-3676 E-mail: mathewss@mail.nih.gov OR Ross Kelley 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: 301-435-6960 Fax: 301-402-3676 E-mail: rk17a@nih.gov