FOOD AND DRUG ADMINISTRATION USA Tender

Background: proficiency Testing (pt) Programs Are An External Quality Control To Measure A Laboratory’s Proficiency. Fda Field Laboratories Must Maintain Iso 17025 Accreditation. According To Iso 17025 Requirements And Aoac Guidelines, Laboratories Are Required To Participate In Relevant And Available Proficiency Testing Provided By Accredited Proficiency Testing Providers Administering Acceptable Proficiency Testing Programs Which Are Conducted Yearly. objectives: the Food And Drug Administration (fda) / Office Of Regional Affairs/office Of regulatory Science (ors)/ Hfc-140 Has A Requirement For The Purchase Of Ors Food And Feed Laboratory Annual Proficiency Testing For The Following Three Programs: standard Microbiology pesticide Residue In Fruits And Vegetables nutrients In Infant Formula And Adult Nutritional’s scope: ors Requires Pt Services, From An Iso 17043-accredited Provider Whose Accreditation Scope Includes, At A Minimum: Microbiology In Foods, Pesticides In Foods, And Vitamins And Nutrients In Infant Formulas. The Selected Provider Must Conduct Accredited Proficiency Testing In All Three Programs Listed In This Statement Of Work (e.g. The Standard Microbiology Program, Pesticide Residue In Fruits And Vegetables, And Nutrients In Infant Formula And Adult Nutritionals) For Laboratories That Conduct Analyses In The Area Of Food Safety As Specified Below: standard Microbiology Program – Proficiency Testing In This Program Must Demonstrate Proficiency In Detection Of Pathogens (including Salmonella, E. Coli O157:h7, And Listeria), As Well As Quantifying E. Coli, Coagulase Positive Staphylococcus, Yeast And Mold, And Aerobic Organisms. The Selected Provider Must Provide Test Samples, Qualitative And Quantitative, At A Frequency Of Four Shipments Per Year To Each Lab. Evaluation Of O And H Antigens Is To Be Included For Salmonella And Identification Of Listeria Species. pesticide Residues In Fruits And Vegetables - Proficiency Testing In This Program Must Identify The Proficiency Of Laboratories That Conduct Analyses In The Area Of Food Safety That Test For Possible Pesticide Residues In Fruit And Vegetable Matrix. nutrients In Infant Formula And Adult Nutritionals - Proficiency Testing In This Program Must Identify The Proficiency Of Laboratories That Conduct Analyses In The Area Of Food Safety That Test For Vitamin A, Vitamins B1, B2, B3, B6, B12, B5 Pantothenic Acid, Vitamins D, D2, D3, Vitamin E, Vitamin K1, Fatty Acids, Iodine, Nucleotides (total), Chromium, Selenium And Molybdenum (utm) And Myo-inositol. pt Samples, Whose Expected Values Are To Be Unknown To The Labs, Are To Be Shipped To Identified Fda Labs By The Selected Provider. Labs Are To Analyze The Pt Samples And Return Their Results Electronically To The Selected Proficiency Provider. The Selected Provider Will Collect The Returned Results And Review Them To Determine Whether Each Participating Laboratory Passes Or Fails Established Performance Levels, A Performance Evaluation Will Then Be Issued To Both The Evaluated Lab And To Designated Project Officer. The Cost Of All Shipping And Handling Of Pt Test Materials Is To Be Included As Part Of The Total Contract Cost And Paid By The Selected Service Provider.