Policy Statement and Program Objectives:
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 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.
Laboratory Director/Supervisor: A program associate 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 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. 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.
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. Graduate students’ access and use of the CAL will be constrained by the training criteria and the absolute requirement of following standard operating procedures (SOP).
Sample Receipt and Handling:
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.
Safety & Training:
Knowledge of basic safe laboratory procedures. Knowledge of whereabouts and operation of safety equipment. Understanding of basic laboratory first aid. Working knowledge of principles of analysis preformed (can be learned on the job).
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.
Technical Support Personnel: Are required to participate in monthly training session conducted by laboratory personnel.
Procurement Practices and Costs:
Due to the analytical nature of the laboratory, quality of both equipment and reagents is exceedingly important. Every effort will be made to use the highest available grade of reagent suited for each analysis. Where critical and practical, reagent purity will be tested. The reagent inventory will track usage and age of reagents to ensure disposal of chemicals after their expiration date. Technical support personnel are responsible for keeping current inventory database. The laboratory manager is responsible for procurement of consumables, both chemical and supply (lab coats, bench pads, etc.). Available equipment funds will be used at the discretion of Lab Director/Lab Supervisor.
Cost of analysis will be based on cost of consumable materials, equipment maintenance, quality control program, and laboratory overhead.
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.
Inter- and intralaboratory testing: On a routine basis test samples will be submitted to CAL and two suitable independent laboratories for analysis. Results will be compared for reproducibility and accuracy. Significant differences between laboratories will result in reevaluation of procedure, analyst, and equipment to assure discrepancies are not due to CAL procedures and analysis.
Equipment Maintenance: All pertinent equipment will be entered in the CAL inventory. Included in this database will be any certification of initial instrument performance, purchase date, service technician, and a preventative maintenance (PM) schedule. The analyst in charge of equipment is responsible for PM and any other required servicing. The Lab Supervisor is responsible for ensuring completion of PM.
Facility Maintenance: Cal personnel will be responsible for the appearance of the lab in general. General laboratory cleanliness is addressed within the safety guidelines. Users as a whole are responsible for observing and reporting failures in general facility infrastructure.
Limited access: Limiting access to previously trained personnel should enhance safety, equipment life and function, and result in greater quality.
Yearly program revision and update: At years end, CAL Lab Supervisor will present suggested program revisions and analytical updates to CEPS Faculty and Administration for consideration.
Reagents and Solutions:
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.
Expiration Dates: Compounds with no practical expiration date (e.g. NaCl) will be labeled N/A
.Storage Conditions: Special storage conditions as listed on stock containers will be carried to reagent flasks or working solutions (e.g. refrigerate, protect from light).
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.
Laboratory Notebook: All entries will be made with indelible ink.
- Notebook pages will be numbered and used sequentially.
- Each entry set will include date, SOP #, analyst, sample number, standards, and results.
- Modification of raw data will be as follows: a single line will be drawn through value/item such that original is still legible. The new value/item will be written next to the original with a date, reason for change, and analyst initials.
Storage and Archiving: All raw data, SOP’s, protocols, and final reports will be retained. All samples will be returned to originating PI, Primary storage will be electronic. CAL will retain a hard copy for 3 years after which time the PI hardcopy becomes the only hardcopy available. CAL will retain an electronic copy for as long as capacity exists.
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 manufacturer’s recommendations and laboratory experiences.
Test-examination of equipment for compliance with performance specifications.
Calibration-comparison with measurement standard or instrument with known accuracy.
Standardization-comparison with a standard of known value (e.g. available from NIST).
Equipment will be calibrated and tested based on instrument type:
• ph meter before each use
• HPLC detector monthly
• HPLC system yearly.
Written records will be maintained of all inspections, maintenance testing, calibrations and(or) standardizing operations.
These records will include:
-name of equipment
-name of manufacturer, and model or type
-date equipment received into laboratory
-condition when received (new/used)
-details of checks for compliance with calibration or test standard specs.
-current location in laboratory
-details of maintenance carried out
-history of any damage, malfunction, modification or repair.