Brand Name or Equal Technical Services from Quo Data (the makers of ProLab Plus software package licensed by FDA) to incorporate ISO Standards and Methods to FDA's Proficiency Testing Program

The goal of this effort is to provide Proficiency Testing and Inter-Laboratory Evaluation programs based on the ISO Standards. During a performance term of a base and one option period of twelve (12) months each, the Contractor shall independently furnish all of the necessary personnel, equipment, services, and otherwise do all things required, or incident to, to completing the work. Analysis should be performed by means of the Method Validation /PT software package ProLAB Plus A and InterVal Plus. Task Requirements A. To successfully perform, the personnel for this effort: Must have long-term experience in validation and standardization of methods and in the conduct, analysis and interpretation of collaborative studies. Must have Publications in peer-reviewed journals on statistical methods for validation of both quantitative and qualitative methods. Must have expertise in international standards of such as ISO 13528, 16140, 5725, Guide 34 and similar. Shall ensure that personnel for this effort are qualified and trained. B. Scope Tasks: The contractor is capable of performing to complete the following tasks: Task 1 - Provide technical guidance regarding understanding various PT & MV statistical principles which are beyond the scope of technical service normally provided with the software license. Task 2 - Advice and assist in implementation, incorporation and use of various quantitative statistical techniques in accordance with ISO 5725-2, NWIP/ISO 5725-3, NWIP/ISO 5725-5, ISO 16140-2, CD/ISO 16140-4, CD/ISO 16140-5, ISO 13528. Also, statistical analysis by means of newest statistical procedures, e.g. Kernel density estimation methods, sample comprehensive analysis and other appropriate for food chemical and microbiological proficiency testing. Task 3 - Advice and assist in Statistical analysis of qualitative data in accordance with ISO 16140-2, CD/ISO 16140-4, CD/ISO 16140-5. Also, statistical analysis by means of newest statistical procedures. Task 4 - Elaborate and develop statistical techniques in assessing equivalence and/or differences among analytical methods based on PT data. Task 5 - Provide statistical consult with respect calculation of measurement uncertainty and Analysis of components of measurement uncertainty with respect microbiological analysis of foods. Task 6 - Preparation of comprehensive report with charts, reports and interpretation in close cooperation with FDA. Provide detailed explanation/reasoning of used statistical methods with respect to biological, biochemical, chemical and physico-chemical interpretation of results. Task 7 -Assist in design, implementation and analysis of PT and MV schemes utilizing factorial design approach and dealing with binary qualitative tests utilizing advanced statistical methods such as Legit and Probit. Task 8 - Determination of the statistical limits based on the historical and appropriate data (rather than the arbitrary values used presently) and modification of the statistical criteria applied to proficiency testing program. Task 9 - Assist in design, conduct and publish proficiency testing data using statistical techniques for chemical and microbiological agents in foods and feeds matrices. Guidance on the future direction of the proficiency test program (types and composition of the food PT) samples to be used in the proficiency testing program. Task 10 - Assist in developing protocols for evaluation and of analytical methods used in FDA's milk program as described in Pasteurized Milk Ordinance-Evaluation of Milk Laboratories. Task 11 - Recommendations for the standardization of the methods used in proficiency testing program Tasks 1 - 11 shall be completed during the base and option periods. Deliverables The Contractor shall provide monthly oral and written status reports (Microsoft Office format) via email to the Project Officer. The reports shall include the work that has been accomplished, the activities planned for the next period, and any barriers to success. The Contractor shall provide all written reports in electronic format with read/write capability using Microsoft Office applications to the Project Officer. The Contractor shall be available to discuss with the Project Officer any current or anticipated problems. The Contractor shall also meet with the Project Officer to discuss the ISO accreditation requirement for statistical design and data analysis. The Contractor shall provide to the Project Officer via email, publication of manuscript (Microsoft Office format) on proficiency testing performance of US food and dairy laboratories in analysis of pathogens, heavy metals and quality indicators in foods using FDA PT data and software packages such as ProLab Plus and InterVal Plus. All deliverables are required for the base and option period, if exercised.