Four elements-t he accredit at ion organization, the regulatory agency, the consensus standards-writing organizations and the laboratory communityare all needed to assure the
Establishmentof accreditation programs for environmental labs William E. Oatess OA Laboratories, lnc. Indianapolis, Ind. 46239 The environmental laboratory, generally considered to be a laboratory engaged in the analyses of air and/or waterborne pollutants, is a species not easy to define. Even at the conference on the National Accreditation Program for Environmental Laboratories, held at Williamsburg, Virginia, March 3, 1978, there seemed to be a reluctance to define the environmental laboratory. T h e present-day environmental laboratory is quite often an outgrowth of the commercial laboratory, which was often a referee between buyer and seller. The commercial laboratory, for example, usually produces services on behalf of a buyer or seller, checking for conformance to purchase specifications and yielding an opinion. From this type of commercial laboratory has sprung the environmental lab, where the seller may be an industry that has to produce conformance data for a government regulatory agency or a buyer. There is also another source of the environmental lab-the laboratory that analyzed water. Ten years ago, the water lab was the most basic laboratory setup. At that time, there were not that many different tests that had to be performed in order to operate a competent and capable water-testing 1124
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@ 1978 American Chemical Society
laboratory. But with the advent of EPA’s water %regulations,the number of measured parameters shot up from the usual six or eight to more than 100 that the EPA lists for N P D E S permit monitoring requirement. In just a relatively short period of time, the independent water-analysis laboratory has realized the need for rapid capital expansion to meet these requirements. So, the chemist who started out in one of the most basic areas of laboratory testing-water analysis-now finds a need to prepare to enter into a sophisticated field that requires a much greater capital investment. H e must now expand his capabilities and his marketplace. These a r e economic pressures that he must meet if he is going to survive in business. From a need to expand capabilities in one area-water-has emerged an environmental lab that does a variety of tests. These tests are all done with the same type of equipment or the same piece of equipment. For example, the atomic absorption spectrophotometer, which performs reliably in analyzing trace metals in water, can be used to determine the presence and amount of lead in paint; or lead in air, blood, metals and alloys. Thus, the resulting environmental laboratory may typically perform 200 different chemistries. This broad range is needed to support its investment in capital equipment. Incentives for self-regulation The economic pressures for survival give some additional characteristics to the environmental lab. For example, the commercial laboratory field is not formally regulated, although it may at times be regulated by trade associations. Generally speaking, the regulatory pressure on the commercial lab is coming from its clientele: the industry that uses it to produce supportive data on the products it is selling; or the buyer of a product who desires assurance that he is getting what he requires. Both user and producer put pressure upon the laboratory to do creditable testing. In the case of the environmental lab, which is no longer producing data for a buyer in the usual sense, but is producing it ultimately for a regulatory agency, the same motivation for the highest quality or the most reliable data obtainable is not present. The cost of obtaining compliance data is not looked upon as a selling factor, but simply an overhead. It is a nuisance item in the cost of doing business, and the buyer seeks to obtain the data as cheaply as possible. It also happens that the cheapest work that a buyer
can obtain, may also be the most advantageous. Where corners are cut to lower costs, tests are likely not to show pollutants that may be present, or to show them in lesser concentrations than are actually present. Consciously or unconsciously, industry seems to be aware of this. As an example, consider the perishable nature of many environmental samples, or the special hindling that is required to obtain and transport a representative sample. There are also special digestion techniques to obtain reliable “total recoverable values.” A sample that is transported in a soft plastic container may not yield as high a value for oil and grease as it would if it had been transported in glass. O r if the sample sits on the bench for a few days before the analysis is performed, the result is likely to be lower owing to biological degradation of the sample. It is very unlikely that the ultimate user of this compliance data, the regulatory agency, will be interested in knowing any more about the data than whether or not they exceed predeter mined limits. For this reason, the environmental laboratory does not have the pressure for self-regulation that is present in the buyer/seller relationship of the commercial laboratory. The first thought of the environmental lab that has long been established in its field, and has built up a considerable amount of overhead in operation, equipment and personnel, is one of self-preservation. This lab is always apprehensive of the newcomer who, in his desire to get his share of the business, may offer to d o the work for less than the going rate. The mortality rate of environmental laboratories is very high. The lowpriced competitor does not enhance his chance for long-term survival. Probably half of the laboratories that came into the business six months ago, are already out of business. In three more years, 75% of them will be out of business, and in five years, 95% of them will be out of business. These laboratories may not have totally disappeared from the scene; they may have merely changed their mode of operation in order to survive; that is, they may have shifted to product sales or have been acquired by larger companies.
There are some things we need to look a t when we consider laboratory accreditation. For example, what is the most workable program? What is to be achieved in the long run? What is the nature of the approach? Let’s proceed to look at the pressures that are at play in this field. First of all, over the course of time, there will be more dollars spent on capital improvement of industrial operations than there will be in monitoring these operations. This capital improvement will call for better quality data which, in turn, will force improvement in testing laboratories. The laboratories
Accreditation Several trade organizations, professional societies and government regulatory agencies have recognized the problems inherent to a testing laboratory, and several organizations are working toward laboratory accreditation. Volume 12, Number 10, October 1978
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AA spectrophotometry. This technician is analyzing acid-digested samples f o r iron and copper f o r NPDES permit compliance testing
will have more incentive to upgrade their own operations, to improve their ability to produce more answers in less time, with less man-hour effort and with more reliability. There is always the competitive pressure to do this more economically than your competition. Upgrading a laboratory means adding more automated equipment and computerization. The cost of equipment is less than the cost of people for a given output. But this does not mean that chemists become obsolete. The more sophisticated testing that has to be done, the lower limits that have to be achieved, and the greater reliability of the results all call for more knowledgeable people to operate the equipment. At the same time, the automated operation of the equipment leaves
more time for the chemist to improve techniques, methodology, qualitycontrol procedures, and reporting procedures. The use of automated equipment also more readily allows sophisticated quality-control procedures to be used at less expense than their use in the manual operations would permit. This also facilitates a better recordkeeping system for the laboratory. Improved performance One purpose of laboratory accreditation should be to improve the performance of the laboratory. This requires the close monitoring of performance. With laboratory accreditation, a regulatory agency can be assured of receiving data of a stated reliability from reporting agencies or industries.
Preparing samples. This technician pipettes samples of unleaded gasoline into solution in order to analyze f o r lead leoels by AA spectrophotometry 1126
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The documentation can be computergenerated from the automated equipment. If a regulatory agency requires documentation, the economic pressures of staying in business will force laboratories to provide this documentation. The documentation of reliability permits the person at the bench level to monitor his performance. It gives management a tool with which to monitor the performance of its own organization and also provide such documentation to the regulatory agencies. It is the task of the professional organizations to generate the criteria documents, the methodology, the methods of documentation or validation of data. But, ultimately, the testing laboratories themselves must provide reliable information to regulatory agencies. The validation of data and the proper reporting of test results are management functions of the laboratory. Problems environmental labs face In my opinion, a very significant amount of compliance reporting comes from the commercial environmental laboratory. This area of business consists almost exclusively of small businesses-individual proprietorships, partnerships or closely-held corporations. These organizations have generally not enjoyed the best relationships with government agencies. They cannot afford to provide a full-time representative to deal with governmental matters, to express their needs to the government, to attend pre-proposal conferences or to be fully apprised of government regulations that may affect their welfare. If independent laboratories attempt to obtain government contracts for research and development services or analytical services which they see advertised in Commerce Business Daily, they often find that many of the more desirable projects are already in the process of being negotiated or negotiations are anticipated with a firm that is named by the time the public notice appears. These laboratories also find that some notices are given on such a short time frame, that without prior knowledge of the project, an intelligent response cannot be submitted. If the environmental laboratories do obtain a copy of the Request for Proposal (RFP), they often discover that they are faced with reams of “boiler plate” material that has very little, if anything, to do with the project to be performed, or the R F P requests information that seems not justified,
pertinent or possible to determine. For example, there is no justification for requesting information on the costaccounting procedures used to arrive at competitively bid per item costs, nor is there a logical way that a total fixed cost can be submitted on an indefinite quantit!. Technical people are not ordinarily trained in business management nor are business managers trained in technical subjects. It is not unlikely to find the technical scope of work completely out of phase with a businesslike cost-effective approach to the project. These situ.ations are often accompanied by a statement to the effect that in the event that the analytical procedures required by the scope of work are in conflict with procedures that are commonly used in the field and that may be published in the Federal Register, the procedures referenced in the scope of work will take precedence. I n other words, the instruction may require that the accepted procedures be disregarded in favor of the tentative or suggested procedures. These circumstances do not tend to enhance government/small business relationships. There is a credibility gap between business, and government regulatory agencies, and a workable laboratory accreditation program is not likely to result solely from government efforts. From management to accreditation The accreditation program has to include the area of business management because the motivating force is economic pressure:. The accreditation program has to come from within the business community affected by such a program. It is also within this business community that an unusual mix of technical and business management experience can be tapped. Many of the laboratory services are performed either i n compliance with reporting regulations or to provide information that ma.y be utilized in establishing a compliance condition. I n either case, the regulations generate the nced for laboratory services. I f the regulatory agencies are content to accept whatever data they receive wJithout qualification, economic pressure will force the environmental laboratory to generate data as cheaply as possible in order to remain competitive. This situation would generally tend to inhibit the use of the best approaches to the validation of data. I f the regulatory agencies are not content to accept data without qualification, but require that the report contain documentation of validity or
reliability according to a specified set of criteria, a mandated program of laboratory accreditation is in effect. T h e accreditation program would be voluntary, but compliance with specified criteria for the submission of some data would be mandatory. The A S T M Standard D 3614-77, Criteria for Laboratories Engaged in Sampling and Analysis of Atmospheres and Emissions, was developed to provide criteria by which one may know the features of organization, facilities, resources and operations that affect the reliability and credibility of the data generated. This standard also presents recommendations for the correction of unacceptable performance. The standard is predicated upon the analytical performance and those features that tend to enhance the quality of performance. Although there are several good sources of information available for the statistical treatment of data, this A S T M standard deals with the statistical generation of precision and accuracy statements in a rudimentary fashion. There are several reasons for this approach. The quality-control program should not be confused with a standardization program that might be used in the development of a new methodology. Whereas the new methodology should contain statements of precision and accuracy to describe how well a method performs, the quality-control program and the quality-assurance program only need to indicate whether or not a method is performing within predetermined limits of acceptability. The typical environmental sample is only capable of providing an estimate of the character of a heterogeneous mass that is in constant motion. The true values of the constituents are not known. For this reason, I prefer to describe the quality of the data in terms of repeatability and percent recovery or bias. The matrix of the sample may be very complex and variable. The level of quality control required may vary from 10- 100%. A duplicate analysis or some verification may be performed on every tenth sample or upon all samples. The report may consist of as little information as a single value or result. Thia is not the recommended way of evaluating an environment, but it may be necessary to generate some information. Conventional statistical analysis requires that sets of data be generated in order to allow evaluation for reliability. But sets of data are not always available or possible. ASTM Standard D 3614-77 provides a technique for
developing a statement of reliability on a single value. This technique is so simple that it may be applied routinely in the day-to-day operations of laboratories that are too small to have a statistician on staff. Components of a program My general concept of an accreditation program consists of an organization that represents all interested parties. This organization develops consensus criteria for acceptable statements of reliability-the means for generating the supporting data and assurance programs for the documentation of the program. It is the function of the regulatory agency to require that these criteria be utilized by the reporting agency, and to establish a means of assuring the capability of the laboratory to perform reliably by the use of standard reference materials and unknown or blind samples. The program may be elementary, but it is applicable to the format of computerized systems. The computer can be used to compare the stored rew l t s of replicate samples and reference materials and to generate “precision and accuracy” or “repeatability and percent recovery” statements automatically on every analysis that is performed. It can also generate a signal when preset limits for acceptability are exceeded. With the development of the relatively low cost minicomputer systems, the manual reduction and reporting of data is becoming too expensive for a laboratory, especially when the cost of man-hours is compared to the cost of equipment. The cost of operating a quality-assurance program has been estimated to add from 10-40% to the cost of operating a laboratory. AIthough there is no way to compare this cost with the cost of the errors that may go undetected, it would be reasonable to expect that the cost of a quality-assurance program is significantly reduced with automated analyses and computerized data-processing and report generation.
William E. Oatess is president and laboratory director of O A Laboratories, Inc. (Indianapolis, I n d . ) . Mr. Oatess is a Fellow of the American Society f o r Testing and Materials and has receiced its Award of Merit. Coordinated by LRE Volume 12, Number 10, October 1978
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