R -- PROFESSIONAL, ADMINISTRATIVE, AND MANAGEMENT SUPPORT SERVICES(ASSAY)

Notice Date

April 23, 2001

Contracting Office

National Cancer Institute, Research Contracts Branch, PSAS, 6120 Executive Blvd, EPS/Room 638, Bethesda, MD 20892-7227

ZIP Code

20892-7227

Solicitation Number

RFQ-NCI-10073

Response Due

May 22, 2001

Point of Contact

Cynthia Brown, Purchasing Agent, 301-402-4509, Gail Zois, Contracting Officer

Description

Combined synopsis/solicitation for services to perform assays for insulin-like growth factor 1 (IGF-1) and insulin-like growth factor binding protein 3 (IGFBP-3) in blood samples drawn from a sample of subjects participating in the PPT (Polyp Prevention Trial). The National Cancer Institute (NCI), Nutritional Epidemiology Branch (NEB), plans to procure the subject IGF-1 and IGFBP-3 Assays in accordance with the simplified acquisition procedures authorized in FAR Part 13. This announcement consitutes a combined synopsis/solicitation, and a separate written solicitation will not be issued. The solicitation includes all applicable provisions and clauses in effect through FAR FAC 97-22. The North American Industry Classification System #541380. However, this requirement is not set-aside for Small Businesses. BACKGROUND: The Polyp Prevention Trial (PPT) assessed the impact of a low-fat, high-fiber, high-fruit and vegetable, dietary intervention on recurrence of colorectal polyps in subjects with recently removed adenomas. Baseline investigators collected blood and assessed diet using a food frequency questionnaire for all subjects. After randomization into control and intervention groups, follow-up occurred annually for 4 years and included colonscopic screening for polyp recurrence along with repeat dietary assessment and blood collection. REQUIREMENT: The Contractor shall receive approximately 2,250 coded 0.5 ml serum samples from NEB investigators for IGF and IGFBP analysis. The Contractor will be blinded to any identifying information pertaining to the individuals from whom these specimens were derived. The Contractor shall perform IGF-1 assays as follows: (1) Use high and low controls (as provided in RIA kit) as well as in-house serum control; (2)Assay serum samples and controls in duplicate for IFG-1 using the Nichols IGF-1 kit with a modified acid ethanol cryoprecipitation extraction method -- confirm and report samples within acceptable ranges from each assay run; and (3) Typical intra-assay CV per batch should be under 10%. Inter-assay CV for an entire project should be a similar magnitude understanding that some inter-assay variability is inevitable given the changes in lot number of the isotopes and other reagents contained in the kits. The Contractor shall deliver the batch-specific written reports detailing the QC results within 7 days of completing the work on each batch. The Contractor shall receive 2,250 coded 0.5 ml serum samples to perform IGFBP-3 assays as follows: (1) IGFBP-3 shall be analyzed in duplicate using a DSL IRMA assay with 10ul samples. (2) Use high and low controls provided in the IGFBP-3 kit and report those values plus an in-house serum control as noted for the IGF-1 assay. (3) Confirm that CV for suplicate sets is less than 10%. If a sample has greater than 10% CV, re-assay and report. (4) Typical intra-assay CV per batch should be under 10%. Inter-assay CV for an entire project should be similar magnitude understanding that some inter-assay variability is inevitable given the changes in lot number for the isotopes contained in the kits. The contractor shall delivery the NEB investigators with a formal written report detailing the intra-assay CV for each duplicate set of tubes, and the degree to which control samples are in acceptable ranges for each batch. Also provide a final written report with inter-assay CV for the study; deliver the final writtren report with eight(8) months of specimen receipt, except in the case of unusual problems requring additional attention. These exceptions must be negotiated directly via telephone discussion with the NEB investigators. The Contractor will also provide the NEB investigator with an electronic report detailing the IGF-1 and IGFPB-3 assay results (averaging the duplicate samples) for each sample supplied to the Contractor. The Contractor batch reports (outlined above) will be subject to review and approval by the NEB investigators. Any deficiencies identified in these reports must be corrected prior to final approval.These evaluations will be performing in a ongoing fashion, as the sample testing proceeds in sequential batches as described. Provisions and Clauses: The solicitation incorporates the NCI REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENT OF OFFERORS OR QUOTERS (SIMPLIFIED ACQUISITIONS). The award document will incoroprate the requirements of the clause at FAR 52.213-4, TERMS AND CONDITIONS-SIMPLIFIED-ACQUISITIONS. Full text copies of these documents may be obtained from Cynthia Brown on (301) 402-4509 or by fax on (301) 402-4513. TECHNICAL EVALUATION CRITERIAL: The technical portion of quotations will receive paramount consideration in selecting a vendor. However, price will also be a significant factor in the event that two or more vendors are determined to be essentially equal following the evaluation of technical factors. In any event, the Government reserves the right to make award to the vendor whose offer provides the greatest overall value to the Government. The following technical evaluation criteria will be used by the Government when receiving the technical portion of the quotation. The criteria below are listed in order of relative importance with weights assigned for evaluation purposes: (1) Understanding and awareness fo the task required, and demonstrated competence in having successfully performed IGF-1 and IGFBP-3 assays. This will include demonstration of previous successful performance of these assays in the context of large epidemiologic studies and with high standards of quality control. (45%); (2) Specimen processing, tracking, and data analysis techniques that are reasonable, sound, proven, and timely, and which reflect both an awareness of potential methodological problems and the proposed solutions for handling them. The Contractor shall demonstrate its ability to track specimens accurately to avoid loss or mix-up. (23%); (3)An administrative framework satisfactory for maintaining quality control over the analytic tasks required, including Clinical Laboratory Improvement Act (CLIA) certification. (20%); (4) An overall approach that reflects clarity, conciseness, general responsiveness (including timely delivery of reports), and the ability to comply with the requirements of the Statement of Work. OFFERS: Offers must be submitted on an SF-18 that is signed by an authorized representative of the offeror and include a completed "Schedule of Offered Supplies/Services." The offer price must include all labor and facilities. Offers must be accompanied by a completed and signed NCI REPRESENTATIONS AND CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS OR QUOTERS (SIMPLIFIED ACQUISITIONS). Offers must also be accompanied by materisls demonstrating that the offer and offeror meet the foregoing requirements and evaluation criteria. Offers and related materials must be received in this office by 2:00 pm EST on May 22, 2001. No collect calls will be accepted.

Record

Loren Data Corp. 20010425/RSOL007.HTM (W-113 SN50J9H3)