H -- Microbiological and Fat Testing and Analysis to Support USDA Meat Purchase Programs

USDA APHIS intends to issue a future solicitation for USDA AMS Commodity Procurement Branch for the procurement of meat testing services in accordance with the attached statement of work. In accordance with FAR Clause 15-202'Advisory Multi-Step Process, APHIS is utilizing this presolicitation notice to invite potential offerors to submit technical and past performance information that will allow the Government to pre-determine vendor capabilities and ultimately advise the offerors about their potential to be viable competitors in the upcoming solicitation. After review of the technical application information and any necessary follow-up communications and/or required site visits, each respondent will ultimately be advised in writing either that it will be invited to participate in the resultant acquisition or, based on the information submitted, that it is unlikely to be a viable competitor. Copies of the technical applications must be submitted (electronic submissions are allowed) to the Contracting Officers Representative (Duane Williams) with a courtesy copy submitted to the Contracting Officer listed below: Duane Williams, Chief Commodity Procurement Branch USDA, AMS, Livestock and Seed Program Stop 0253, Room 2610, S-Bldg, 1400 Independence Ave., SW Washington, DC 20250-0253 Electronic mail address: contact@example.gov Contracting Officer Address: USDA APHIS, Marketing and Regulatory Programs Minneapolis Business Site Attn: Larry Nelson Butler Square West 5th Floor 100 North 6th Street Minneapolis, MN 55403 Electronic mail address: contact@example.gov STATEMENT OF WORK: The Agricultural Marketing Service (AMS) of the Department of Agriculture procures a variety of meat and fish products that are distributed to participants in the National School Lunch Program and other Federal Food and Nutrition Programs. Boneless beef and boneless beef destined for ground beef suppliers under contract with AMS, must meet presence-only and quantification level microbiological requirements. In addition, the finished beef products must meet specified fat content requirements (target, upper and lower specification levels). The boneless beef and ground beef suppliers are required to meet statistical process control (SPC), centered process capability (Cpk/Cpu), requirements for the specified microbiological quantification levels and fat content. The need for timely and accurate laboratory sample results and analysis of the results is critical to AMS and to AMS suppliers. I. OBJECTIVE The purpose of this statement of work is to provide the requirements for laboratories wishing to enter into a service contract with AMS to conduct required microbiological and fat tests. All results and other information will be supplied simultaneously to AMS and AMS contracted boneless beef suppliers or suppliers of boneless beef destined for AMS contracted ground beef. Laboratories shall be a third party independent laboratory and not owned by companies that are or may be involved in meat procurement contracts with AMS. Laboratories will need to submit a detailed technical proposal addressing all of the AMS requirements listed below for review. After submission of a satisfactory technical proposal, the laboratory must successfully complete an onsite capability assessment by AMS to be eligible to receive an award under the service contract. II. APPLICABLE DOCUMENTS A. Official Methods of Analysis of AOAC INTERNATIONAL, Current Edition B. AMS Boneless Beef and Ground Beef Product Specifications (TRS-BB, May 2004; and TRS-GB 2004, May 2004) C. ISO/IEC 17025, - General Requirements for the Competence of Calibration and Testing Laboratories D. USDA/FSIS Microbiology Laboratory Guidebook (http://www.fsis.usda.gov/ophs/microlab/mlgbook.htm), Chapter 5.03 for Detection, Isolation, and Identification of Escherichia coli O157:H7 and O157:NM (Nonmotile) from Meat Products, Effective Date 10/25/02. III. ANALYTICAL TESTING REQUIREMENTS A. MICROBIOGICAL TESTING REQUIREMENTS 1. Sample Preparation, Analysis, and Test Results a) Sample Preparation - As described within their technical proposal, AMS contracted boneless beef suppliers and suppliers of boneless beef destined for AMS contracted ground beef will randomly select, prepare, and submit samples to a designated laboratory under contract with AMS. The laboratory will be responsible for supplying all materials, protocol and methods (including sample size, handling of reserve samples, etc.) for sample preparation and submission. b) Analysis - As specified within the applicable AMS specification, the laboratory will be required to analyze boneless beef samples for: Quantification levels of: (1) Standard plate counts, (2) Total coliforms, (3) Generic E. coli, Presence-only: (4) Salmonella (5) E. coli O157:H7 c) Test Methods - The microbial test for all microbes, except for E. coli O157:H7, will be in accordance with the applicable test methods listed in the Compendium of Methods for the Microbiological Examination of Foods (current edition), published by the American Public Health Association. The presence of E. coli O157:H7 will be determined using referenced test methods that are within or conform to the "USDA/FSIS Microbiology Laboratory Guidebook (http://www.fsis.usda.gov/ophs/microlab/mlgbook.htm), Chapter 5.03" for Detection, Isolation, and Identification of Escherichia coli O157:H7 and O157:NM (Nonmotile) from Meat Products, Effective Date 10/25/02. d) Test Results - Laboratories will simultaneously report results to both the boneless beef supplier and AMS. When the specification has SPC requirements, the laboratory will supply the results in SPC control charts and histograms. For presence-only specified organisms, the results shall be in control chart format. For microbial quantification level requirements, the control charts shall have statistically derived upper and lower control limits representing +/- 3 standard deviations of the process results and the histograms will be equipped to supply a process capability (Cpk/Cpu) value. All required charts are illustrated in APPENDIX A. 2. Specification Requirements - Boneless beef microbial presence-only and quantification level requirements will be specified within the applicable AMS purchase specifications. All applicable specifications will be made available to the laboratory by AMS. B. FAT TESTING REQUIREMENTS 1. Sample Preparation, Analysis, and Test Results a) Sample Preparation - The ground beef suppliers will select 4 individual sample units (selected after initial grinding or blending) to be analyzed for fat content from each production lot destined for USDA. The laboratory will be responsible for supplying all materials and methods (including sample unit size, handling of reserve samples, etc.) for sample preparation and submission. b) Analysis - As specified within the applicable AMS specification, the laboratory will be required to analyze ground beef samples for fat content using test methods that conform to the latest edition of the Association of Official Analytical Chemists (AOAC), Official Methods of Analysis, Chapter 41. c) Test Results - Laboratories will simultaneously report fat tests results to both the ground beef supplier and AMS. The laboratory will record and plot the results on variable data control charts and histograms. Control charts must have statistically derived upper and lower control limits (+/- 3 standard deviations from the mean) and histograms will be equipped to supply a process capability (Cpk/Cpu) value. All required charts are illustrated in Appendix A. 2. The requirements for target fat content, the upper and lower specification level limits, and sampling frequency are within the TRS-GB 2004, May 2004 specification for ground beef. C. DATA MANAGEMENT All results shall be available on a data spreadsheet format (compatible with Microsoft office products) and provided to an AMS, LS Program, Commodity Procurement Branch, representative on request for program analysis. All data is proprietary information and shall be confidential. IV. LABORATORY INFORMATION A. Company Technical Profile - Please address each of the following requirements by describing: 1. The analytical methods used to conduct each microbial and fat test as set forth within the ANALYTICAL TESTING REQUIREMENTS section. 2. How and on what medium are results recorded and documented; 3. The data analysis tools (SPC charting methods and software) used to compute process capability when specified within AMS specifications; 4. The materials necessary and procedures you will prescribe for the preparation, handling and shipping of samples to your laboratory. Please include capability to receive and analyze samples on weekends and holidays; 5. Time schedule that your laboratory will operate under for testing and reporting of submitted samples once received. Please specify time requirements for (1) negative, presumptive and confirmatory test results for organisms requiring presence-only reporting and (2) organisms requiring quantification; 6. How you will simultaneously notify the applicable ground beef or boneless beef supplier and AMS of the results of the required analyses, including SPC software used to generate all required charts (please attach examples of charts generated by the software), and copies of any forms; 7. The internal validation process you use to assure accurate analysis and reporting of results; and 8. How the data will be maintained as proprietary information that is kept confidential B. Accreditation The technical proposal shall include: 1. Documentation that the laboratory and methods used to perform analysis for AMS requirements, are ISO/IEC 17025 accredited by the American Association for Laboratory Accreditation (A2LA). 2. Documentation that all analytical procedures proposed are AOAC approved methodology. 3. Copies of any additional certifications granted by other internationally recognized accreditation and certification organizations. C. Past Performance The technical proposal shall provide past performance information, which demonstrates the laboratories ability to test and deliver microbial analyses in accordance with their stated delivery terms. The information includes: 1. Identification of the tests performed, test methods used, quantity (number of tests) for the year beginning January 1, 2003. 2. Average turn around time (number of days from mailing and delivering test results to customer) that will apply to the types of test performed stated in Section IV.A. 3. Recent and relevant contracts or agreements for the same or similar tests conducted for ground meat products and other references--including Contract Numbers (Purchase Orders), contacts with telephone numbers, and volume of sales (by types of tests). 4. Prior complaints and policy or action taken for complaint resolutions, previous late notification, and any other relevant information, and complaint and resolution processes. D. Conflict of Interest Statement The technical proposal shall declare that the laboratory has no financial or management affiliation with any company that is or may be involved in meat procurement contracts with AMS. V. APPLICATION REVIEW Please submit the complete technical application package directly to the Contractors Officer Representative at the following address: Duane Williams, Chief Commodity Procurement Branch USDA, AMS, Livestock and Seed Program Stop 0253, Room 2610, S-Bldg, 1400 Independence Ave., SW Washington, DC 20250-0253 Electronic mail address: contact@example.gov In addition, please submit a second copy of the technical application to the Contracting Officer at the following address: USDA APHIS, Marketing and Regulatory Programs Minneapolis Business Site Attn: Larry Nelson Butler Square West 5th Floor 100 North 6th Street Minneapolis, MN 55403 Electronic mail address: contact@example.gov Within 10 days of receipt, the Contracting Officer's technical representatives will review each technical proposal and report if it is adequate or not adequate: A. Adequate All items within the technical proposal clearly address all requirements listed within this statement of work. The laboratory will be notified that the application has been approved pending results of an onsite capability assessment. The applicant will then schedule a pre-award onsite capability assessment by the Livestock and Seed Program's, Audit Review and Compliance (ARC) Branch. B. Not Adequate - If all requirements are not clearly addressed, the laboratory will be notified of the deficiencies. The laboratory may submit a revised application proposal for further review. VI. ONSITE CAPABILITY ASSESSMENT AND REPORT A. Onsite Assessment 1. Onsite Audit - The onsite capability assessment consists of an onsite audit to determine the laboratory's ability to meet AMS requirements and the declarations made in the laboratory's approved technical proposal. The ARC Branch's onsite assessment will include facility, process, and quality control program evaluations. All costs associated with the onsite assessment will be paid for by the laboratory. 2. Evaluation - The audit will include, but is not limited to, a thorough evaluation of the laboratory facilities, equipment, and procedures referenced in the technical proposal. It will include a detailed review of purchasing, receiving, production, quality control, inventory and shipping records, and interviews with management and laboratory personnel. B. Onsite Assessment Report The ARC Branch will provide an onsite assessment report to the Contracting Officer for final determination. 1. Eligible - If all requirements are adequately addressed, the Contracting Officer will so notify the laboratory. 2. Ineligible - If the report demonstrates that the laboratory is inadequate, the Contracting Officer will notify the applicant that they are ineligible. They will have the opportunity to modify their procedures and/or technical proposal and resubmit for further consideration. Eligibility for further consideration will be dependent upon whether modifications demonstrate that the processes are capable of providing acceptable service to the USDA Meat Purchase Programs. C. Eligibility Maintenance AMS designated laboratories must have their technical proposal and supporting documents readily available for review by AMS agents. The records may be maintained as hard copy or electronic media. However, records maintained as electronic media will be made available in printed form immediately upon request by AMS or its agents. The AMS designated laboratories are subject to periodic onsite audits after they become eligible. The frequency of audits will be on a semi-annual basis. However, when deficiencies are detected, the Contracting Officer may request additional audits. Any changes to the approved procedures must be submitted to the Contracting Officer for approval prior to implementation. Any deviations to contractual requirements will be immediately reported to the Contracting Officer. The Contracting Officer will notify the laboratory regarding eligibility to be a designated laboratory.