FDA/CFSAN/OFS DFPST has a requirement of a ProLab Plus license (or the equivalent) to enable CFSAN’s Proficiency Testing (PT) program to analyze inter-laboratory studies data to evaluate the testing of milk, shellfish, and food and Food Emergency Response Network laboratories. Currently analyses do not meet scientific standards.  CFSAN’s Proficiency Testing program expanded recently and is seeking to acquire ISO accreditation. To fulfill our mandate CFSAN needs to expand the use of the statistical package to more users within the Proficiency Testing Team and specifically addresses ISO criteria.

Statistical evaluation of proficiency test data is essential to evaluate the data available and draw meaningful and accurate conclusions based on the participant data.  A proficiency testing program based on sound scientific principles includes:

•    types and composition of the food PT samples to be used in the proficiency testing program

•    determining the limits based on the historical data rather than the arbitrary values used presently

•    modifying the statistical criteria to include the new limits

The knowledge acquired in this program is critical in overall evaluations of analysts as well as analytical methodology. The PT programs evaluate and analyze the information provided by the participating laboratories such as quality control data for analytical determinations, method validation and analysis of proficiency test samples. Approximately 35 – 80 laboratories participate in the various proficiency testing programs.

The CFSAN's Proficiency Testing (PT) program has expanded over the past couple of years and the program is seeking to acquire International Standards Organization (ISO) accreditation. To achieve this accreditation, the PT program requires a statistical software package that specifically addresses ISO criteria. Statistical software will be essential in addressing the lab’s requirements and is required to fulfill CFSAN role in development of ISO accredited PT program.

The license for ProLab Plus has been is use for the past year and has proved to fulfill the PT Program requirements.   It has been determined that additional licenses are required for use by other scientists to fulfill ISO accreditation.

The Contractor shall provide ProLab Plus licenses (or the equivalent