Laboratory Operations. Consultant, together with the Laboratory Director, shall manage and oversee all of the Laboratory’s clinical and operational activities, including, without limit, ensuring that: (i) the Laboratory’s testing systems are appropriate and provide quality services in all aspects of test performance (i.e., pre-analytic, analytic, and post-analytic phases of testing); (ii) the Laboratory’s physical and environmental conditions are adequate and appropriate for the testing performed; (iii) the environment for personnel is safe from physical, chemical, and biological hazards and that biohazard and safety requirements are followed; (iv) a general supervisor for high complexity testing is available to provide day-to-day supervision of all testing personnel and reporting of test results while providing on-site supervision for specific minimally qualified testing personnel when performing such high complexity testing; (v) sufficient numbers of appropriately qualified Laboratory Personnel (defined below) are employed at the Laboratory; (vi) new assay procedures are reviewed, included in the appropriate procedure manual, and followed by Technical Personnel (defined below); (vii) all assays are appropriately performed in accordance with Consultant and Company’s procedures and a weekly testing schedule to be agreed upon by the Parties (which schedules shall be designed, to the extent practicable, to maximize the efficiency of the performance of the Test Services (as defined below)); and (viii) if requested by Company, all Laboratory Personnel’s responsibilities and duties are specified in written standard operating procedures. Consultant shall provide training of the Technical Personnel on all methods and procedures of all tests performed by the Laboratory, including, without limit, the EsoGuard assay (collectively, the “Test Services”), as well as provide ongoing support to the Laboratory Personnel, as needed. Consultant will periodically monitor quality and efficiency and conduct periodic reviews to make recommendations to Company relating to the Test Services.
Laboratory Operations. H-16/Item 1 “Increase in Laboratory Area: During Phase III, laboratory area would increase by 7% and chemical usage would presumably increase by a similar percent—with no additional significant impact.” 5I-32 H-16/Item 2 “Increase in Production Area: Occupied area would increase during Phases II and III to four and one-half times the present level, and the quantity of chemicals in use would increase proportionately.” 5I-32 H-16/Item 3 “Use of Ammonia: In lieu of increased use of CFC’s, a new refrigeration system using ammonia is proposed. While CFC’s pose a cumulative risk to the environment through destruction of the ozone layer, in the event of a release, ammonia would pose a greater acute hazard to workers, emergency responders, and the public, and would also pose a hazard to the environment.” 5I-33 Bayer will implement an Emergency Preparedness Program. Same as above. Bayer will obtain a certified Risk Management Prevention Program for the Ammonia Refrigeration System. H-16/Item 4 “Release of Ammonia: A risk of releasing ammonia during delivery and operation would exist. Workers and emergency responders could be exposed to hazardous conditions, and the environment and the public could be exposed to a cloud of ammonia vapor.” 5I-34 Same as above. H-17/Item 1 “Job Training: Of the 380 jobs created over the 30-year project period, an estimated 58% would require some college education and another 17% require completion of high school. Even with continuation of the First Source Employment agreement between the City and Bayer/Cutter, many applicants referred by the City would not be qualified for the new positions.” 5J-4 H-17/Item 2 “Construction Jobs: The approximately 200 temporary construction jobs would not necessarily be filled by Berkeley residents.” 5J-4 H-17/Item 3 “Construction Job Training: To fill the temporary construction jobs, some Berkeley residents would need training.” 5J-4 & 5J-5 Bayer will design and implement a Biotech Academy at Berkeley High School and a Biotech Career Institute at a local community college. Bayer has agreed that all recruitment for new and replacement construction employees will first be sought via the Construction section of the City’s First Source Employment Program, in accordance with union policy and procedures. Bayer will establish a goal of hiring one (1) out of every five (5) workers in the total construction work force from First Source throughout the life of the Development Agreement. First Source was disconti...
Laboratory Operations. Develop and oversee the implementation of strategies, policies, procedures and best practice initiatives to optimize performance and ensure the quality of the Corporation’s laboratory operations Conduct internal assessment of laboratory workflows, personnel training and processes as a basis for same Assure that policies and procedures are appropriately interpreted, understood and implemented by laboratory operations personnel Establish defined reporting metrics for measure the operating and quality performance of the Corporation’s laboratory operations Establish a culture of continuous operational improvement
Laboratory Operations a. The contractor shall annually perform approximately 15,000 inorganic, organic and radionuclide analyses. This number of analyses includes analyses for blanks, calibrations, equipment checks and actual samples analyzed. The sample analyses shall be performed on approximately 2,000 intermediate to high level radioactive and/or hazardous samples received from multiple locations and entities on the Hanford site. Samples received into the hot cell may be 300 Rad/hr, with a significant part of that from gamma radiation. Those high rad samples are diluted so that they can be analyzed in a ventilation hood. See Attachment 1, Required Laboratory Processes and Analyses, for the specific required capabilities. The following estimated work shall be performed in accordance with the rules and regulations under the American Recovery and Reinvestment Act of 2009, Pub. L. 1115 (Recovery Act). ARRA PROJECTS TOTAL ESTIMATED NUMBER OF ARRA SAMPLES K East Reactor (M013) 50 Balance of Site (RL 40 ARRA) 180 PFP Demo (RL 11 ARRA) 296
b. Analysis results shall be reported to meet customer's specified needs. Different methodologies for Required Data Reporting are as follows:
i. Full Data Package including raw data, Data Summary Reports with Method Detection Limits (MDL) and qualifiers, Quality Assurance (QA) data.
ii. Summary Data Package including Data Summary Reports with MDL
iii. Summary Data Package with QA and Data Upload including Data Summary Reports with MDL, QA qualifiers, and defined electronic deliverables
c. Sample analysis shall be performed by the Contractor’s trained and qualified workforce in accordance with approved procedures, using appropriate test and handling equipment provided by DOE (see Section C.3 below). The currently installed Laboratory Information and Management System (LIMS) shall be used for sample tracking, records and data gathering and reporting.
d. Future capabilities are expected to change little. Monthly work loads are expected to vary widely from 15% utilization to 125% utilization. Utilization in this case relates to the amount of time that analytical personnel are engaged in hands-on sample analysis work.
e. The Contractor shall plan analytical work using priorities from Customers, receive samples which are usually highly radioactive, prepare them for analysis, record and track all sample and related waste materials, perform the analyses using necessary quality control and quality assurance, report the results and archive material as requi...
