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CENTRAL
ANALYTICAL LAB OPERATING GUIDELINES |
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The Central Analytical Laboratory (CAL) and associated technical personnel exist to support the ongoing research of the Center of Excellence for Poultry Science (CEPS) members. In addition, the CAL will address requests from the poultry and allied industries and other departments in the University of Arkansas system. Thus, the CAL will primarily provide technical service for the CEPS. As an academic research facility, the CAL will provide technical services and educational opportunities in the context of that environment. The CAL will conduct standardized tests/analysis suited to the needs of CEPS faculty. In addition, personnel, laboratory space, and technical expertise will be accessible for nonstandard analysis as required by CEPS faculty. The facility will also have the capability for methods development and analytical research in a limited number of specialty areas. The goal of the CAL will be to provide highly accurate, reproducible results in a minimum amount of time, and to work with CEPS faculty to continually identify good analytical methods and developing research areas. The purpose of the following guidelines are to delineate the laboratory administrative organization and operating guidelines. This will include responsibilities of personnel, facility maintenance, analytical requirements, protocol of analysis, safety program, education program, quality control, costs and usage. Laboratory Administrative Organization: Director and Assistant Director for the Center. The Director and/or Assistant Director will provide budgeting and staffing levels to the Faculty Laboratory Director and Laboratory Supervisor. In addition, they are responsible for long-range laboratory planning and will assist in the description of program objectives. On a yearly basis, they will aid in program revision and update. Faculty Laboratory Director: A faculty member assigned by the Center Director will act as a direct liaison between the Center faculty and the CAL and provide major guidance for the CAL program. The Lab Director is responsible for decisions concerning capital equipment purchases and analytical methods to be used in the laboratory. The Lab Director is also responsible for quality control programs, laboratory testing (audit) programs, and overrsee continuing education and safety programs. Much of this will be done in concert with the Laboratory Supervisor. The Lab Director will act as an intermediate between Director/Faculty and laboratory personnel in the long-term planning of laboratory functions and aid the lab supervisor in staffing decisions. The guiding principle is to address as many CEPS faculty analytical requests as possible within the constraints of budget, personnel, and equipment. Laboratory Supervisor: Directs daily operation of laboratory. Budgets time and resources to analyses as needed. Coordinates methods development with faculty. Responsible for personnel management, equipment and facility maintenance programs, reporting of QC data, safety program, and coordinating the continuing education programs. Conducts yearly personnel reviews and evaluations. Will attend all Center faculty seminars to keep abreast of current research focus. Gives one seminar a year addressing new analytical technology applicable to CEPS faculty. Technical Support Personnel: Responsible for everyday operation of the CAL. Functions will include receipt of samples, sample preparation, conducting analysis, reporting of data, integrity fo quality control program, maintaining stock solutions/reagents, and equipment preventative maintenance. In addition, support personnel will participate in the continuing education process. As outlined in the policy statement, first priority will be given to analysis required for research projects conducted by CEPS faculty. Analysis will be performed by the CAL on a first-come, first-serve basis by trained, qualified personnel. Requests for analyses from sources outside CEPS will be addressed on an individual basis. As CEPS and the CAL are part of an academic institution, graduate and undergraduate students will have access and functional roles in the operation of the CAL. Their access and use of the CAL will be constrained by the training criteria and the absolute requirement of following standard operating procedures (SOP). All samples will be received in containers approved for the analyses
requested. Sample will be provided with appropriate documentation including
physical description, estimated sample weight, date of collection, storage
conditions, required completion date, faculty sponsor, contact person,
special instructions, and type of analysis requested. Failure to do
so may result in refusal of analysis request. Laboratory personnel will document sample with test number, title,
sample number, estimated completion, approximate cost, special instructions.
Samples will be processed for sampling per investigators instructions
or standard operating procedures for the particular analysis. Upon completion on analysis, data will be recorded in the CAL database. The database will include information on standards used and results obtained, date of analysis, protocol used, raw data, analyst, and any special notes. The CAL will provide the investigator with remaining sample and a hard or electronic copy of analytical results. In order to document training required prior to working in the CAL all personnel will attend a safety course before use of the laboratory. The CAL will maintain a current summary of training and experience and a job description for each individual conducting analysis in the laboratory. Safety, instrumentation, and continuing education programs will be required of all CAL personnel. Other users of CAL (graduate and undergraduate students and faculty) will be granted access upon completion of safety course and appropriate training on instrumentation.
Instrumentation: All users or potential users of equipment will receive training prior to their independent use of that equipment. This will include; operation of equipment, basic principles of analysis, and maintenance of equipment. Completion of training or proficiency will be conferred upon demonstration of reproducible results. All operators of equipment are subject to spot check of analytical technique. All users of CAL will be trained in the use of the CAL database and/or the laboratory information management system.
The quality control program will include Intra- and interlaboratory testing, yearly audit, continuing education, equipment maintenance, facility maintenance, limited access, reference standards, complaint mediation, and yearly program revision and update.
All reagents and solutions will be labeled to indicate identity, titer or concentration, storage requirements and expiration date. Solutions not meeting these requirements or out of date shall not be used. Only reagents meeting these requirements shall be stored in the CAL all others will be disposed of immediately. Stock chemical containers will be labeled with DATE OPENED. Mixed reagents or working solutions will have date made and analyst responsible listed.
. Raw data shall refer to any laboratory worksheets, records, and notes that are the results of original observations/activities. Examples include records of sample receipt, results of analytical methods either in hand written or computer generated form and instrument calibration. Transcription of data to a computer will not substitute for notebook values. Direct capture of data from the analytical instrument is considered raw data and as such either a hard copy or electronic copy will be archived. The electronic copy will be in non-corruptible form where possible.
It is the goal of the CAL to address as many of the different regulatory requirements as financially possible. To this end, where possible equipment will be selected for GLP compatibility. Where possible a record will be kept of tests performed to evaluate compliance with performance specifications. Equipment will be inspected, cleaned, tested, calibrated and maintained based on established schedules from manufacturers recommendations and laboratory experiences.
Written records will be maintained of all inspections, maintenance
testing, calibrations and(or) standardizing operations. |
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