SPECIAL NOTICE
B -- Continued Cell Line Re-Establishment, Maintenance, Storage, Expansion, and Distribution
- Notice Date
- 8/6/2009
- Notice Type
- Special Notice
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 00HCVKHD-2009-73420
- Archive Date
- 8/14/2009
- Point of Contact
- Linda M Young, Phone: (770) 488-2655
- E-Mail Address
-
lml3@cdc.gov
(lml3@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- The Centers for Disease Control and Prevention intends to issue a sole source purchase order to Coriell Institute for Medical Research, 403 Haddon Avenue, Camden, NJ 08103, for the continued cell-line re-establishment, maintenance, storage, expansion, and distribution for original set of cells containing human genetic mutations. The statement of work is as follows: Statement of Work A. Project Identification This project requires the re-establishment, maintenance, storage, expansion, and distribution of cell lines, cells and products containing mutations associated with genetic diseases of public health importance. The cells, cell lines and products derived from them will be distributed for use of positive controls for human genetics testing, for quality assurance purposes, performance evaluation, proficiency testing, and for research and development. Preparation, packaging, shipping and storing of cell lines and products derived from them will be the responsibility of the contractor. B. Purpose of Contract As part of a continuing initiative for improving the quality of genetics testing, the Centers for Disease Control and Prevention (CDC) established a collection of stably transformed cell lines for use as positive control materials through CDC Contract #220-2000-10050, entitled, "Develop and Pilot Test a Process to Collect Positive Samples and the Establishment of Stably Transformed Cell Lines Suitable for Use in Performance Evaluation and Quality Assurance of Human Molecular Genetics Testing." The intent of that project was to establish stably transformed cell lines from residual blood samples containing mutations associated with diseases of public health importance which could serve as a permanent resource for positive control materials in human molecular genetics testing. The project was successfully completed, and a unique set of 41 cell lines was established. These cell lines contain mutations associated with genetic diseases (other than cancer). These cell lines were collected and established through elaborate protocols which satisfied IRB requirements of many genetic testing techniques, and were pilot tested by laboratories normally performing genetic testing. Thus, this collection is the most well-characterized set of cell lines containing mutations associated with genetic diseases in the world. The collection is rate and virtually irreplaceable. The purpose of the current project is to re-establish distribution stocks of each cell line from original seed stocks provided by CDC, stores the cell lines and stocks, maintain them, expand them, to prepare positive control products from the distribution stocks, and distribute these positive control materials assurance, and research and development. Sufficient distribution stock will initially be prepared to permit the contractor to return five vials of each cell line to the CDC as soon as the distribution stock is established. Positive control materials will be distributed at nominal cost to laboratories performing genetic testing, to organization providing proficiency testing and performance evaluation, to researchers and developers of genetic testing methods, and for any other quality assurance purposes. The cells and products will be offered to clients according to reasonable pricing structures established as customary by the contractor and agreed upon by CDC. The costs should be reasonable for most laboratories and entities involved with quality assurance. With this contract, the CDC will be paying for the storage and maintenance of the cell lines, expanding the original seed stock cell lines as necessary to maintain a permanent and consistent distribution stock as a resource of positive controls, and for administration of the contract. The initial cell lines will be provided by CDC. Upon establishment of the distribution stock culture from each original seed stock cell line, the contractor will return any remaining quantity of each original sample and give vials of distribution stock culture to CDC shipped to a site designated by CDC. The contractor is expected to recover the costs of expanding cell lines for distribution, extracting positive control products if necessary, reference testing, packaging and distributing cell lines through charging the recipients a reasonable fee for cells and products. The goals of the contact are: • To provide a permanent and consistent source of well-characterized positive control materials for human genetics testing, research and development, and for quality assurance. • To provide cells, cell lines and products derived from them to laboratories, organizations concerned with proficiency testing and performance evaluation, and organizations performing genetics research and development at a nominal cost as established through normal pricing structures of the cell repository and agreed upon by CDC. • To establish, store, maintain and expand, and distribute transformed distribution stock cell lines (and products derived from them such as DNA and other materials) containing mutations associated with diseases of public health importance including, but not limited to, Cystic fibrosis, alpha-thalassemia, hemochromatosis, achondroplasis, Connexin 26, Factor V Leiden, Fragile X Syndrome, Muenke Syndrome, Huntington Disease, Sickle Cell hemoglobin Disease, and coagulation disorders associated with genetic mutations. • To maintain quality system standards in all phases of the project sufficient to ensure the integrity of the cell lines, distribution stocks, and products derived from them according to ISO 9001; 2000- certification standards. C. Background and Need The deficiency of positive control material for molecular genetic testing has been identified as the "issue of utmost urgency" for clinical genetic testing during a previous CDC project, #200-98-0011. Molecular genetic testing is becoming an increasingly important component of routine healthcare as genetic co-factors for disease risk are discovered. The availability of positive control material for performance evaluation and quality assurance (PE/QA) of existing tests, and for the development and validation of new tests is critical to health-care and to public health. Through CDC project #200-2000-10050 cell lines containing mutations associated with diseases of public health importance (other than cancer) were established and pilot-tested as positive control materials. The pilot testing was successful. CDC now seeks to have these cell lines (and products derived from them) expanded and distributed as positive controls. D. Period of Performance The period of performance is an initial contract of 12 months plus four subsequent 12-month option years, for a period of performance not to exceed 5 years. E. Establishment of Distribution Stock Cell Lines One initial seed stock sample of each cell line was provided by CDC Expansion under contract number 200-2004-09670. The contactor shall: Establish distribution stock cell lines from the original seed stock samples provided by CDC to be used as permanent source for providing cell lines and products derived from them as positive controls for human genetic testing, for quality assurance purposes, and for research and development. This shall be done using protocols established by the cell repository and proven successful. As some of the samples are rare ISO 9001; 2000 quality assurance measures should be used at all phases of the process. Cell lines and products should be stored to maintain integrity and inventoried using ISO 9001; 2000- certificated standards. The contractor will be responsible for distribution of cells, cell lines and products using customary reasonable pricing structure agreed upon by CDC. The contractor shall return original samples (if any remains) and five vials of each distribution stock culture is established. Original vials and distribution stock samples shall be returned to CDC immediately if the project is discontinued. F. Maintenance and Storage of Cell Lines The contractor shall: Store and maintain the transformed cell lines (seek stock and distribution stocks) and products derived from them using established successful procedures and equipment consistent with permanently maintaining a permanent resource to be used and expanded for producing positive control materials. The cell lines and stocks should be labeled, stored, and readily identifiable as the CDC collection. Storage conditions should be consistent with ISO 9001; 2000 standards. CDC shall have access to all cell lines at no cost to CDC. G. Advertisement and Distribution of Cell Lines and Products Derived from them as Positive Control Materials The contractor shall: a. Expand the seed stock cell lines to make distribution stocks, expand and prepare positive control products from the distribution stocks, and distribute the cells, cell lines, and positive control materials at nominal costs to clients using reasonable customary pricing agreed upon by CDC. The contractor shall recover the costs of performing this work through fees assessed when distributing the cell lines and products. The contractor shall advertise the availability of the positive control materials (cell lines, cells and products derived from them) to the public and to those likely to need these materials for genetic testing, quality assurance and research and development. The products should be advertised and labeled as the CDC collection using the contractor's website and through such methods as catalogs, brochures, advertisements and announcements at professional meetings. Additionally, the shipment of all cell and products must meet regulations governing interstate shipment of etiologic agents (49 CFR Parts 100-177), IATA regulations for international shipments, and ISO 9001; 2000 standards. b. Maintain shipment records on samples which are shipped by the contractor to the clients. Contractor shall provide copies of these shipment records to CDC with the quarterly report. Each sample will be shipped with information regarding the degree to which the cell line (or product) was verified and the degree to which the presence of the target mutation was verified. The clients shall be given adequate information to make decisions regarding the appropriate use of the cell lines or products derived from them for quality assurance or for research and development. Examples of this labeling will be provided to the government for approval. H. Reporting a. The contractor shall submit two copies of a quarterly letter-type report briefly describing progress of the project, the shipment records for the quarter, and any problems encountered by the tenth day of every third month following contract award performance, as specified in the schedule of deliverables. These reports shall briefly describe project status, problems foreseen and suggestions for resolution. The report shall be sent to the CDC Project Officer. In addition to the quarterly reports, the contractor shall report significantly impact the progress of the work as these problems are encountered. b. The contractor shall submit two copies of annual report summarizing project activities to the CDC Project Officer. I. Returning Cell Lines to CDC The contractor shall: Return the remainder of each original seed stock sample and five viable vials of each distribution stock cell line in the CDC collections to the CDC as soon as the distribution stock culture for positive controls has been established. The original seed stock samples and file vials of each distribution stock culture will be returned immediately if the project is discontinued, or upon request of the CDC. Contractor may also keep samples of each distribution stock cell line and products for further distribution in accordance with established procedures mutually agreeable to CDC and the contractor. CDC believes that this requirement is met by only one provider. This procurement will be processed under the authority of FAR 6.302-1 and 6.302-2. Only one responsible source and no other sources will satisfy agency requirements. No solicitation is being issued. Interested persons may identify their interest and capability to respond to this requirement. This procurement is not set-aside for small business. For contractual questions contact Linda M. Young.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/00HCVKHD-2009-73420/listing.html)
- Place of Performance
- Address: 403 Haddon Avenue, Camden, New Jersey, 08103, United States
- Zip Code: 08103
- Zip Code: 08103
- Record
- SN01902752-W 20090808/090807001447-9c3e1038ed462fc748062607cc8fa721 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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