Laboratory accreditation %re is a need for coordination in the way environmental testing laboratories are approved
By John U! Lock Analytical testing of environmental samples is a growing business in communities throughout the United States. The results produced by testing laboratories are crucial to sound management decisions about drinking water, groundwater, wastewater, solid waste, toxic substances, and pesticides. EPA is in the process of developing standards and test methods, defining new levels of laboratory performance that must be obtained to meet the requirements of the environmental protection laws. This work is complicated because standards and test methods change continuously. In addition, decision making is further complicated because there is uncertainty attendant to the analytical data obtained by the laboratories. Those who are responsible for environmental monitoring must select qualified laboratories to do the work, and the data generated by these laboratories must be reliable.
Duplication in procedures Congress changes the law frequently; EPA creates new regulations yearly to comply. And even when laws don’t change, EPA changes regulations. This is a neverending process, and new parameters are added to the test method list often. In many cases, by the time state legislatures approve one list, a 332 Envimn. Sci. Technol.. MI. 21. No. 4.1987
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new one has been issued. The result is that state governments can be operating on the basis of as many as three different EPA requirements in many of these areas of testing. States that develop lists of approved testing laboratories are assisted in this task by EPA. For example, EPA has developed performance evaluation programs for water supply and water pollution studies in support of state and regional drinking-water and wastewater testing programs. Individual laboratories normally participate every six months. Laboratories that seek state a p proval must register with the state or regional offices responsible for preparing lists of approved laboratories. To retain approval, a laboratory must obtain test results within specified ranges on two sequential, semiannual performance evaluation samples. Some states have developed separate programs for performance evaluation, in
which approved laboratories must participate. In some states this approval is called laboratory certification, but the international terminology used is “laboratory accreditation.” Although EPA is recommending the performance evaluation approach as the basis for all testing approval processes, it has not attempted to coordinate the requirements of the different areas of environmental testing, such as those for drinking water and hazardous wastes. A fundamental question relates to whether EPAs guidance provides a reasonable model for a national laboratory approval system. W o aspects come into focus. The first concerns the need for efficiency of the system incorporating all environmental testing areas. The second relates to the adequacy of relying only on performance tests for judging laboratory competence. In practice, EPA and various state environmental departments list approved laboratories for narrowly defined fields of testing and testing procedures. Separate listing is granted for testing of drinking-water supplies, wastewater, groundwater, solid waste, and Superfund sites. And although the testing equipment and facilities may be the Same for all areas of water testing, each area is handled separately. There is little if any communication among a p provers. This gives rise to the current duplicative and confusing mixture of
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regulations, fees, and inspections. Although some states are attempting to arrive at comprehensive listing, approval of a laboratory by one state does not necessarily mean acceptance in another. Management at EPA headquarters implies that the only proof of a laboratory's competence is in a demonstration of its ability to obtain accurate test results. However, semiannual performance evaluations do not provide sound statistical evidence that a laboratory performs competently. Then, too, there is the question of whether laboratories must submit to separate performance evaluations for hundreds of parameters when we know the limited statistical significance of a semiti~ualperformance evaluation. The use of on-site assessment of laboratories conducted by members of the profession who examine laboratory operations and evaluate them against widely accepted criteria is frowned upon by some in EPA as a paper exercise.
Uniform national system needed It seems that a combination of techniques is needed to arrive at the most effective mechanism for approving laboratories. This would include on-site visits to laboratories to evaluate them against accreditation criteria, laboratory participation in performance testing, and establishment of sound quality
control procedures, including control charts in the laboratory. The American Association for L a b ratory Accreditation (AALA) has embarked on a prograin to accredit environmental laboratories based on this combination of techniques. The criteria found in the International Standards Organization's Guide 25 (I) have been adopted as the basis for accrediting testing laboratories. This document sets requirements for laboratory organization, quality control systems, staffing levels, testing and measurement equipment, calibration, items to be tested, records, and test reports. Check forms were developed to guide assessors to look for specific, correct performance on each of the EPA tests. The evaluation focuses on the particular testing equipment and process, rather than on the aspect of the environment being tested, because test processes often are comparable, whether for drinking water, wastewater, or solid waste. The laboratory procedure must reflect the level of accuracy required for each aspect of the environment. For example, the accuracy demanded for drinking-water testing may be much greater than that for solid waste. Performance testing is required for laboratories that seek accreditation to EPA specifications, and the results are viewed by assessors as a clue to
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satisfactory or unsatisfactory performance. Although the AALA program is well under way, much remains to be done. So far, eight laboratories in five states have been accredited by this method. EPA's Region VI and the state of New Mexico have accepted AALA accreditation as the basis for drinking-water testing certification. But there is a need for a more complete and integrated performance testing program based on private-sector capabilities, if possible, or based on EPA systems, if they can be expanded and made available to all potential participants. Specific procedures to be followed in the laboratory in developing quality control charts must be addressed and specified. More peer assessors are needed. Finally, federal and state regulatory officials need to focus on the use of such a national system for comprehensive accreditation in serving their needs.
Reference ( I ) "General Requirements for the Technical Competence of Laboratories." ISOIIEC Guide 25-1982; International Standards Organization: Geneva. Switzerland, 1982.
John W Locke is executive director of the AmericM Association for Laboratory Accreditation in Gaithersburg, Md.
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