Water laboratorv certification U
Adequate staff, funding, and training and consistent practices nationwide are needed
Arnold E. Greenberg California State Department of Health Services Berkeley, Calif. 94704 William J. Hausler, Jr. University of Iowa Iowa City,Iowa 52242 Water laboratory certification programs have had a long and productive history in some states-Iowa’s program was established in 1942, for example; California’s, in 1949. Passage of the Safe Drinking Water Act of 1974 has provided additional impetus to establishing and operating such programs. Most, if not all, states will soon have these programs to comply with Section 141.28 of the Interim Primary Drinking Water Regulations (1, 2 ) , which stipulates that for compliance purposes “samples may be considered only if they have been analyzed by a laboratory approved by the State.” It is our objective to examine two state programs and from this review to develop recommendations for further actions, on both state and national levels. Because tasting, smelling, and looking at a drinking water sample cannot determine the presence or concentration of undesirable constituents, laboratory testing is required to supplement the program of engineering management of water quality. Qualitative and quantitative assessment of most inorganic and organic substances, radionuclides, and microorganisms in drinking water requires testing by proven methods in laboratories that are adequately equipped and staffed by competent personnel. While acceptable analytical methods are available in such publications as “Standard Methods for the Examination of Water and Wastewater” ( 3 ) ,there is no assurance that labora520
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tories using these methods are using them correctly. Thus, the fundamental need is that the competence of laboratories doing drinking water analyses be consistently and demonstrably high. To this end, certification programs were developed and implemented.
California and Iowa In California, more than 600 water laboratories currently are approved under regulations of the Department of Health Services ( 4 ) . These regulations define water laboratories and the kinds of tests that they may perform. They require, in general terms, that: laboratory personnel are adequately trained to perform the tests; the physical facilities and equipment are adequate; analytical methods and record keeping are acceptable; the laboratory successfully analyzes appropriate performance evaluation samples; and an acceptable quality assurance program is documented. Specifics relating to these characteristics are available from the Environmental Protection Agency, whose criteria and procedures document (5)-while not binding except for certifying EPA, regional, and state laboratories-is used in California as well as in Iowa. Iowa, a classic rural state with a large number of relatively small municipal water supplies, has 3 1 laboratories participating in its program. These laboratories must meet the same general requirements as those in California. Key aspects of both programs include site visits to laboratories seeking approval or reapproval (triennially in California and biennially in Iowa), preapproval evaluation of the laboratory’s ability to analyze unknown samples, and regular check samples thereafter (annually for bacteriological testing and biennially for chemical testing). Critically important to the program is follow-up, by site visits or
correspondence, for apparent inadequate performance, for questions on analytical or quality-control problems, and in response to complaints by laboratory clients or field personnel of a health or environmental agency. Training of laboratory personnel, for example in special short-term training sessions, is another essential element of the program. A staff of eight professionals and a clerk deal with the California laboratories; because of the size of the state and the large number of laboratories, they are barely able to make the scheduled visits or provide the necessary training. Funding to s q p o r t this activity comes from the department’s budget, the State Water Resources Control Board, and the EPA Safe Drinking Water Grant to the state. The Iowa experience is markedly different. With 31 laboratories participating, only one certification officer is required. Furthermore, neither the Iowa Department of Environmental Quality (DEQ) nor the Iowa State Department of Health have a laboratory as an organizational component. Both agencies are required by statute to utilize the University Hygienic Laboratory, which is a public service component of the University of Iowa. In the Hygienic Laboratory contract with DEQ there are no funds to operate a laboratory certification program; the Hygienic Laboratory assesses each laboratory $100 for each site visit plus mileage and incidental travel costs. The average cost is approximately $165 per site visit.
Problem areas Despite the long history of the program in California, deficiencies in laboratory performance have been noted in the past (6-8). That similar, but fewer, deficiencies still exist is made clear by internal documents and
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@ 1981 American Chemical Society
the occasional complaints made by users of services of approved laboratories. Most commonly, these complaints deal with bacteriological testing and analyses for nitrates, both critical factors from the health and public notification points of view. Studies elsewhere have noted comparable laboratory deficiencies (9-11). Aside from specific details of laboratory methods, the most frequently observed difficulty in the approved laboratories is the concept of a formalized quality assurance program. First, there is the misconception that laboratory quality assurance (12 ) and drinking water quality assurance are synonymous. This is patently untrue, although good laboratory services do support the water quality program and can verify how good (or bad) the product water is. Second, there are the questions of what a water laboratory quality assurance program is and how to establish one in each laboratory. Although consultations from both states’ water laboratory consultants are available, laboratories initially have documented their activities inadequately. Last, there is the problem of financial burdens imposed by a satisfactory quality control and assurance program. As a rule of thumb, such activities should consume no less than 10% of staff time-a considerable burden for smaller laboratories. From the state’s point of view there are also serious problems, not the least of which is how to provide funding to set up and maintain a good program. In California, one professional staff member is required for 50-75 approved laboratories. This number will require modification based on geography (certainly the difference in size between California and Iowa exemplify this), climate, and the distribution of laboratories. Fortunately for California, more laboratories are located in urban areas than in remote, rural
ones. However, this exacerbates the problems associated with testing water supplies in areas distant from large metropolitan centers. In Iowa, the problem of geographic distribution is not significant because the state is almost square, the terrain is relatively uniform, and the certification officer works out of an office near the state’s geographic center. A second problem exists with performance-evaluation samples. If these are to be produced by the state, laboratory space and professional staff as well as supporting funds will be required. Preparing good unknown or check specimens is difficult and may not even be possible because of constituent instability. Bacteriological samples represent a special problem which has not been totally resolved. In California, each coliform reference sample is actually a set of three samples including a sterile water, a water in which large numbers of coliform bacteria are naturally or artificially present, and a water containing a spore-forming anaerobe that gives a positive result in the presumptive M P N test but does not confirm. This set is useful in providing a qualitative assessment of laboratory performance but it is of limited quantitative value. Although Iowa has had reasonable
success by preparing coliform proficiency test specimens using a wildstrain coliform bacterium prepared in nutrient stability broth (13), a good, stable, quantitative sample for coliform bacteria testing still must be developed. For some chemical constituents, commercial standards are available, but these tend to be costly and occasionally have been of poor quality. EPA has made some reference samples (drinking water contaminants, notably) available to the states, but its capacity for providing these also is limited by available funds. It is well known that when reference or audit samples come into a laboratory they are given high priority and special attention. This usually means that the sample measures the best performance a laboratory is capable of rather than the ordinary quality. To measure routine performance requires the use of unknown or blind performance samples. It is difficult to submit such samples; in the case of utilityowned laboratories, it’s essentially impossible. At best, blind samples may be presented through dummy clients to commercial laboratories, but at considerable cost and only with complex arrangements.
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Still another problem is administrative-legal. In many places, including California and Iowa, out-of-state laboratories may be more accessible or more desirable to a water utility requiring laboratory services than laboratories within the state. In California the regulations make no provision for approving out-of-state laboratories and no system of reciprocity exists. Thus, although there may be obvious advantages to the client and the state in using a laboratory in a neighboring state (or in the case of an investorowned utility there may be an outof-state corporate laboratory). a mechanism for reciprocal approval is not available. Because Iowa's program is not based on a state statute or regulation, it can be more flexible. Reciprocity is provided if, after contacting the state authority, it is determined that their procedures meet the EPA standards and include on-site surveys, audit samples, and other certification essentials. When a copy of the certification survey is provided to the Iowa certification officer, it is reviewed for compliance with the Iowa requirements and reciprocity is granted if all certification essentials are satisfactory. A last problem worth mentioning is the need of enough laboratories to meet the overall demands of the Safe Drinking Water Act regulations. While this is not directly a problem of laboratory quality assurance, a marked local paucity of laboratory capability may lead to the use of noncertified, substandard laboratories. This situation may be self-remedying; however, as the interim drinking water regulations continue to require more analyses and more sophisticated analytical techniques (as for example, trihalomethanes and other organic chemicals), the problem of laboratory capacity and the equitable geographic distribution of that capacity may become critical. Improved programs
Having indicated that there are serious problems existing in state water laboratory certification programs, it is appropriate to discuss means for improving the situation. What is needed first and foremost is a mechanism for certifying all laboratories at all levels, based on scope and volume of services. A program that may serve as a model in reaching this goal is the Clinical Laboratory Improvement Act of I961 (14). Second is the matter ofadequate funding to operate a regulatory program that is keyed to establishing competence in water laboratories. This 522
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need must be met by both state and federal governments. While the Safe Drinking Water Act clearly gives the responsibility for action to state government, it unfortunately does not provide sufficient funds for accomplishing this. Neither through grants to the state nor EPA internal support are enough funds provided. The states need enough support for personnel and travel, and EPA must be able to provide essential backup that crosses state lines. Funds for preparing, distributing, and evaluating reference samples to be used by all states in assessing certified laboratories within the states and training programs for both laboratory certifiers and the personnel of approved laboratories must be included. EPA offers some training courses, but only in Cincinnati; this does not meet the needs within individual states. It would be most advantageous to have EPA training within each state, or at a minimum within each EPA region. Unless EPA training is accessible at the local level, it will be used less and less as travel costs escalate. Certification by EPA of state laboratories (and consequently certification of local laboratories by the states) is handled on a regional basis. This leads to nonuniform practices nationwide and should be abandoned in favor of a single, consistent, state-certifying operation. As a corollary to this, EPA should develop an umbrella program which would make possible reciprocal certification among the states. Based on past experience, one of the EPA national laboratories in Cincinnati could well be the focus of this activity. If EPA undertakes the actions listed above it will be able to take over local laboratory certification in those states that do not have their own certification programs. This expanded service by EPA is necessary in nonprimacy states a s well as for those primacy states which have elected to provide all laboratory services but have not established a system for certifying local laboratories. I n summary, water laboratory certification is necessary to assure that all laboratories involved in water analysis are producing meaningful assessments of water quality and should be conducted by the states with federal assistance where necessary or appropriate. Adequate funding is essential for these programs as is sensitivity to local needs and local problems. While a good laboratory is an essential part of any water program, the laboratory is an adjunct to, never a substitute for, good engineering and field work.
References (1) "National Interim Primary Drinking Water Regulations"; EPA-S70/9-7h-003: U.S. EPA: 1976. ( 2 ) Federoi Rrgirar 1980,45,57332. (3) "Standard Methods for the Examination o l Water and Wartcwatcr": 14th ed; American Public Health Assmiation: Washington. D.C.. 1976. (4) California Administrative C d e . Titlc 22. Division 4. Chap. I S . Article 9. Sections 64481-64501, 1979. ( 5 ) "Manual for the Interim Certification o l Laboratories Involved in Analyzing Public Drinking Water Supplier": EPA h00/8-78008: US. EPA: 1978. (6) Greenberg. A. E. Public Health. Rep. 1961. 76,783. (7) Greenberg. A. E.: Mmkawitz. N.; Tamplin. B. R.: Thomas. J. J . Ant. Worrr Workr A.wx-. 1969.61.599. (8) Greenbcrg. A. E. "Water Laboratory Evaluation and Certification"; Proc. Amer. Water Works Arrm. Water Quality Technology Conlcrence: Dallas. Tcx.. Dec. 2-3. 1974. pp. X V I 1-6. (9) Smith. R. Water South Afrieo 1980, 6 . 37. ( I O ) Fuhs. G. W.; Daly, J. C."Environmental Laboratory Improvement Program in the State of New York: Experience and Results": Prcrented a t Amcr. Pub. Health Arsm. Annual Mce1ing:Oa. 22, 1980. ( 1 1 ) Marsh.J.L.;Gable,J.W.;Regnier,J.E. A ~ ILob. . 1980,i z ( 1 2 ) . 5s. (12) McClelland, N . I.: Delfina. J. J.: Grccnberg. A. E.; Morris, R. L."Waterand Wastcwater Analysis," In "Quality Arsurance Practiccs lor Health Laboratories": S. L. Inharn. Ed.; Amer. Pub. Hcalth Assoc.: Washington. D.C.. 1978. (13) Brdaky. M . H.: Ciebin. 6. W.: Schiemann. D.A. Appl. En?iron. Microbid. 1978.
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I 5 , AYl-AQI .... . ,.. (14) Clinical Laboratories Improvement Act 1967. Scaian s the Partnerships lor Health Amendments o l 1967. P.L. 90-174.
Arnold E. Greenkrg (1.) is assisront chief, Lahoratory Srn.ices Branch, ofrhe California Departiirenr ofHealth Sercices. H e is also a consulrant on water quality and analysis and wastewater trearment. and has published extensiveiy on these suhjectr. Mr. Greenberg is currently seruing as chairman of the American Public Health Association's commitreefor Standard Methodr for the Examination of Warer and Wastewater.
William 1. Hausler, Jr., ( 1 . )is director of the Uniuersity Hygienic Dlboratory at the University of Iowa. His current research interests include description of arboviruses in Iowa and health effects of environmental contaminants: he is also working to expand statewide continuing education programs for ciinical and environmental laboratories. Dr. Hausler holds a Ph.D. from the University of Kansas.
