EDITORIALS
causally involved is small. Although reasons have been advanced for believing that this number may be greater,4 a number of observations suggest that hepatitis A virus,5 and rotaviruses and Norwalk type agents (Parvovirus-like) which cause nonbacterial gastroenteritis are the major enteric viruses causally involved in shellfish transmitted disease.6 The virologic dilemma represented involves the formidable technical difficulties encountered in working with those enteric viruses causally associated with shellfish transmitted enteric disease. Those enteric viruses (enteroviruses, adenoviruses, reoviruses) for which evidence of shellfish transmitted enteric disease is lacking are the only ones which can be studied conveniently in cell culture systems. Animal hosts, organ cultures or immunologically associated procedures are used to grow, recover or identify hepatitis A virus, rotaviruses and Norwalk type agents. However, the availability, costs, effectiveness and sensitivity of these latter procedures offer serious technical problems which preclude their routine use on the scale necessary for the health risk and indication studies needed. The Gerba, et al, article refers obliquely to a virus standard for assessing the viral quality of recreational water (and presumably shellfish growing water) and serving to help protect against virus health hazards transmitted by means of virus polluted water or shellfish. Even if the argument is made that the present recovery technology based upon work with enteroviruses, adenoviruses and reoviruses is adequate for establishing water or shellfish standards, (and this point is arguable), it must be kept in mind that the enteric viruses recovered would not be those currently linked causally to shellfish transmitted enteric disease. In effect such standards would be based upon the use of indirect indication of hepatitis and gastroenteritis viruses and the same questions raised about the relevancy of indirect coliform indication of virus could be raised about the effectiveness of indirect virus indication of other virus. Although technical limitations based upon current monitoring capabilities may exist, the need for a virus standard is clear. The philosophy expressed by Shuval7 on behalf of virus standards describes the shellfish situation well: "We have waited too long for research to provide the perfect virus monitoring technique-. Let us not wait for the best but try to apply today what can be considered good enough." Shellfish virology research needs to take some new directions. A vigorous, imaginative program which places pri-
mary emphasis upon those enteric virus pathogens and conditions actually involved in shellfish transmitted disease is needed. The initial key goal of such a program would be development of appropriate means for the detection of these particular pathogens, either by recovery in cell or organ cultures, or by immunologic-associated methods of adequate sensitivity and specificity. Designation of a standard method would follow and the health risks for both consumers of virus polluted shellfish, (and) those exposed to secondary infections, could be determined. An informed decision about an acceptable level of risk could then be made. The end result of such a program would be better protection of public health in general, and a possibility that the number of shellfishing waters approved for the taking of shellfish could be increased.
THEODORE G. METCALF Address reprint requests to Theodore G. Metcalf, Professor of Microbiology, University of New Hampshire, College of Liberal Arts, Spaulding Life Science Building, Durham, NH 03824.
REFERENCES 1. Gerba CP, Gayal SM, LaBelle RL, et al; Failure of indicator bacteria to reflect the occurrence of enterovirus in marine waters. Am J Public Health 69:1116-1119, 1979. 2. Berg G: The indicator system. In Indicators of Viruses in Water and Food (G Berg, ed), Ann Arbor Science, Ann Arbor, MI pp 1-
13, 1978. 3. Microbiology Panel. Risks, regulations and resources. In Water Quality and Health Significance of Bacterial Indicators of Pollution, Workshop Proceedings (WO Pipes, ed) Drexel University and National Science Foundation, pp 154-160, 1978. 4. Melnick JL: Viruses in water, an introduction. In Viruses in Water (G Berg, HL Bodily, EH Lennette, JL Melnick and TG Metcalf, eds). American Public Health Association, Washington, DC, pp 3-11, 1976. 5. NIAID Task Force Report. Viral diseases of the gastrointestinal system. Virology, volume 2, Acute Viral Infections. U.S. DHEW, No. (NIH)79-1832, pp 152-167, 1979. 6. Microorganisms Panel. Microorganisms. In Scientific Problems relating to Ocean Pollution, Workshop Proceedings (ED Goldberg, ed), U.S. Department of Commerce, pp 104-110, 1978. 7. Shuval HI: Water needs and usage, The increasing burden of enteroviruses on water quality. In Viruses in Water (G Berg, HL Bodily, EH Lennette, JL Melnick and TG Metcalf, eds), American Public Health Association, Washington, DC, pp 12-25, 1976.
New Approaches To Achieving Old Goals in Laboratory Improvement Programs Traditionally, laboratory improvement programs have included consideration of: 1) personnel qualifications (education, training, and experience), 2) quality control, and 3) proficiency testing. These three factors are included in both voluntary and regulatory programs for laboratory improvement. " 2 After almost 30 years of laboratory experience, of which at least 15 years have been in the laboratory improvement field, I am more convinced now than ever before that these factors are interdependent. If any one of the factors is 1094
dropped or relegated to a subordinate position, the program is not likely to be as effective as one which maintains all three factors in a balanced relationship. The Public Health Brief by Neimeister, et al,3 in this issue of the Journal, further supports this view. The close relationship between test performance and results is highlighted by these authors. Although the rest of this editorial is directed more toward proficiency testing than to personnel qualifications or quality control, I want to emphasize this factor interdependence. AJPH November 1979, Vol. 69, No. 11
EDITORIALS
Although the issue of personnel qualifications also creates controversy, proficiency testing is probably more controversial than any other aspect of laboratory improvement programs. Some people claim that proficiency testing has no place in a regulatory laboratory program and that, to be effective, it must be included only in voluntary programs. Others maintain that only on-site proficiency testing or "blind" proficiency testing provides any real measure of performance, regardless of whether the program is voluntary or regulatory. I believe that proficiency testing has been a useful tool ever since the 1930s when groundwork was first laid for nationwide proficiency testing at the early syphilis serology conferences.4 Later, 30 state, municipal, and private laboratories participated in an evaluation of syphilis serology testing.5 These early studies were the precursors of our existing proficiency testing programs. The term "laboratory improvement" implies the need for a baseline. Without a baseline, how can we prove that the time, effort, and manpower devoted to laboratory improvement have any impact? And yet, is it enough to measure something without doing something about the data that are generated? One of the easiest things for any of us and one of our most common faults is to continue to do the same things in the same way as we go about our day-to-day tasks. We sometimes forget that innovations and fresh perspectives do not require major discoveries that revolutionize an entire industry or field of study. Innovations may be developed from information available to us as we perform our daily tasks. The report by Neimeister, et al, is a good example of principle in action in the Commonwealth of Pennsylvania.3 The use of proficiency testing as part of a laboratory improvement program is not new, nor is the use of a checklist. For as far back as I can remember, inspectors have used checklists in assessing the quality control aspect of laboratory improvement performance. Even self-assessment checklists are not unique. Laboratory self-assessment at periodic intervals has been a part of the College of American Pathologists' accreditation program for many years. The potential effect of laboratory self-assessment on test performance has many interesting ramifications, not just for the laboratory, but for all aspects of medical care. Self-assessment can be used to identify as well as solve problems. As the authors of the Brief indicate, if a state agency reviews the results of the laboratory's self-evaluation, the findings can be used as a basis for providing direct assistance to a single laboratory or, if a problem proves to be widespread within a state, a statewide training effort can be initiated. A refinement of this approach could lead to the improvement of laboratory improvement programs per se. Most of us involved in one aspect or another of laboratory improvement have made many observations and developed many attitudes based on these observations, but few of us have taken the time (maybe we have not had the time) to analyze the data in our files for the answers to some very perplexing questions about the quality of laboratory work in our country. Too often quality control, proficiency testing, and personnel are regarded as independent entities in laboratory imAJPH November 1979, Vol. 69, No. 11
provement programs. In few, if any, programs has test performance in proficiency testing been evaluated objectively, with a review of the credentials of the personnel performing the tests; at least, such an approach to performance evaluation does not seem to have been documented. What about measuring performance and documenting the impact of supervision and direction on performance? Almost everyone has an opinion, but no one has produced the facts in a way that will help the scientific community to arrive at a consensus. Do laboratories with absentee directors perform as well as those with full-time or part-time directors? What is the minimal level of theoretical scientific knowledge (formal education) needed to perform the various tasks and to assume the technical and legal responsibilities for the operation of a laboratory? To what extent do breakdowns in quality control systems reflect the levels of competence of the laboratory staff to identify, much less correct, the factors leading to breakdowns in the system? The Center for Disease Control (CDC), Licensure and Proficiency Testing Division-in working with laboratories performing drug analyses under the National Institute for Drug Abuse (NIDA) program, the Indian Health Service, and Public Health Service clinic laboratories-has used onsite practices to assist these laboratories in improving their services. The CDC observations appear to support those of the Pennsylvania study. The Pennsylvania study is modest and almost oversimplified, yet it challenges all of us interested in laboratory improvement to take another look at what we are doing, not with the purpose of creating something new and elaborate but with the hope of developing more effective laboratory improvement programs by using the tools and the information already available to us.
CARL H. BLANK, DrPH
Address reprint requests to Carl H. Blank, DrPH, Chief, Examination and Documentation Branch, Licensure and Proficiency Testing Division, Bureau of Laboratories, DHEW, CDC, Atlanta, GA 30333.
REFERENCES
1. Code of Federal Regulations, Title 20, Chapter III, Subpart M,
Part 405 (Medicare). 2. Public Law 90-174, Section 5(a), 81 Statute 536 (Includes the Clinical Laboratories Improvement Act of 1967). 3. Neimeister RP, Wilf CZ, Cocklin JH, et al: The use of a technical questionnaire in the Pennsylvania laboratory improvement program, technical questionnaire in proficiency testing. Am J Public Health 69:1170-1172, 1979. 4. Committee on Evaluation of Serodiagnostic Tests: Report for 1938, USPHS, Washington, DC. 5. Parran T, Hazen HH, Sanford AH, et al: Efficiency of state and local laboratories in the performance of serodiagnostic tests for syphilis. Vener Dis Inf 18:4-11, 1937.
1095
causally involved is small. Although reasons have been advanced for believing that this number may be greater,4 a number of observations suggest that hepatitis A virus,5 and rotaviruses and Norwalk type agents (Parvovirus-like) which cause nonbacterial gastroenteritis are the major enteric viruses causally involved in shellfish transmitted disease.6 The virologic dilemma represented involves the formidable technical difficulties encountered in working with those enteric viruses causally associated with shellfish transmitted enteric disease. Those enteric viruses (enteroviruses, adenoviruses, reoviruses) for which evidence of shellfish transmitted enteric disease is lacking are the only ones which can be studied conveniently in cell culture systems. Animal hosts, organ cultures or immunologically associated procedures are used to grow, recover or identify hepatitis A virus, rotaviruses and Norwalk type agents. However, the availability, costs, effectiveness and sensitivity of these latter procedures offer serious technical problems which preclude their routine use on the scale necessary for the health risk and indication studies needed. The Gerba, et al, article refers obliquely to a virus standard for assessing the viral quality of recreational water (and presumably shellfish growing water) and serving to help protect against virus health hazards transmitted by means of virus polluted water or shellfish. Even if the argument is made that the present recovery technology based upon work with enteroviruses, adenoviruses and reoviruses is adequate for establishing water or shellfish standards, (and this point is arguable), it must be kept in mind that the enteric viruses recovered would not be those currently linked causally to shellfish transmitted enteric disease. In effect such standards would be based upon the use of indirect indication of hepatitis and gastroenteritis viruses and the same questions raised about the relevancy of indirect coliform indication of virus could be raised about the effectiveness of indirect virus indication of other virus. Although technical limitations based upon current monitoring capabilities may exist, the need for a virus standard is clear. The philosophy expressed by Shuval7 on behalf of virus standards describes the shellfish situation well: "We have waited too long for research to provide the perfect virus monitoring technique-. Let us not wait for the best but try to apply today what can be considered good enough." Shellfish virology research needs to take some new directions. A vigorous, imaginative program which places pri-
mary emphasis upon those enteric virus pathogens and conditions actually involved in shellfish transmitted disease is needed. The initial key goal of such a program would be development of appropriate means for the detection of these particular pathogens, either by recovery in cell or organ cultures, or by immunologic-associated methods of adequate sensitivity and specificity. Designation of a standard method would follow and the health risks for both consumers of virus polluted shellfish, (and) those exposed to secondary infections, could be determined. An informed decision about an acceptable level of risk could then be made. The end result of such a program would be better protection of public health in general, and a possibility that the number of shellfishing waters approved for the taking of shellfish could be increased.
THEODORE G. METCALF Address reprint requests to Theodore G. Metcalf, Professor of Microbiology, University of New Hampshire, College of Liberal Arts, Spaulding Life Science Building, Durham, NH 03824.
REFERENCES 1. Gerba CP, Gayal SM, LaBelle RL, et al; Failure of indicator bacteria to reflect the occurrence of enterovirus in marine waters. Am J Public Health 69:1116-1119, 1979. 2. Berg G: The indicator system. In Indicators of Viruses in Water and Food (G Berg, ed), Ann Arbor Science, Ann Arbor, MI pp 1-
13, 1978. 3. Microbiology Panel. Risks, regulations and resources. In Water Quality and Health Significance of Bacterial Indicators of Pollution, Workshop Proceedings (WO Pipes, ed) Drexel University and National Science Foundation, pp 154-160, 1978. 4. Melnick JL: Viruses in water, an introduction. In Viruses in Water (G Berg, HL Bodily, EH Lennette, JL Melnick and TG Metcalf, eds). American Public Health Association, Washington, DC, pp 3-11, 1976. 5. NIAID Task Force Report. Viral diseases of the gastrointestinal system. Virology, volume 2, Acute Viral Infections. U.S. DHEW, No. (NIH)79-1832, pp 152-167, 1979. 6. Microorganisms Panel. Microorganisms. In Scientific Problems relating to Ocean Pollution, Workshop Proceedings (ED Goldberg, ed), U.S. Department of Commerce, pp 104-110, 1978. 7. Shuval HI: Water needs and usage, The increasing burden of enteroviruses on water quality. In Viruses in Water (G Berg, HL Bodily, EH Lennette, JL Melnick and TG Metcalf, eds), American Public Health Association, Washington, DC, pp 12-25, 1976.
New Approaches To Achieving Old Goals in Laboratory Improvement Programs Traditionally, laboratory improvement programs have included consideration of: 1) personnel qualifications (education, training, and experience), 2) quality control, and 3) proficiency testing. These three factors are included in both voluntary and regulatory programs for laboratory improvement. " 2 After almost 30 years of laboratory experience, of which at least 15 years have been in the laboratory improvement field, I am more convinced now than ever before that these factors are interdependent. If any one of the factors is 1094
dropped or relegated to a subordinate position, the program is not likely to be as effective as one which maintains all three factors in a balanced relationship. The Public Health Brief by Neimeister, et al,3 in this issue of the Journal, further supports this view. The close relationship between test performance and results is highlighted by these authors. Although the rest of this editorial is directed more toward proficiency testing than to personnel qualifications or quality control, I want to emphasize this factor interdependence. AJPH November 1979, Vol. 69, No. 11
EDITORIALS
Although the issue of personnel qualifications also creates controversy, proficiency testing is probably more controversial than any other aspect of laboratory improvement programs. Some people claim that proficiency testing has no place in a regulatory laboratory program and that, to be effective, it must be included only in voluntary programs. Others maintain that only on-site proficiency testing or "blind" proficiency testing provides any real measure of performance, regardless of whether the program is voluntary or regulatory. I believe that proficiency testing has been a useful tool ever since the 1930s when groundwork was first laid for nationwide proficiency testing at the early syphilis serology conferences.4 Later, 30 state, municipal, and private laboratories participated in an evaluation of syphilis serology testing.5 These early studies were the precursors of our existing proficiency testing programs. The term "laboratory improvement" implies the need for a baseline. Without a baseline, how can we prove that the time, effort, and manpower devoted to laboratory improvement have any impact? And yet, is it enough to measure something without doing something about the data that are generated? One of the easiest things for any of us and one of our most common faults is to continue to do the same things in the same way as we go about our day-to-day tasks. We sometimes forget that innovations and fresh perspectives do not require major discoveries that revolutionize an entire industry or field of study. Innovations may be developed from information available to us as we perform our daily tasks. The report by Neimeister, et al, is a good example of principle in action in the Commonwealth of Pennsylvania.3 The use of proficiency testing as part of a laboratory improvement program is not new, nor is the use of a checklist. For as far back as I can remember, inspectors have used checklists in assessing the quality control aspect of laboratory improvement performance. Even self-assessment checklists are not unique. Laboratory self-assessment at periodic intervals has been a part of the College of American Pathologists' accreditation program for many years. The potential effect of laboratory self-assessment on test performance has many interesting ramifications, not just for the laboratory, but for all aspects of medical care. Self-assessment can be used to identify as well as solve problems. As the authors of the Brief indicate, if a state agency reviews the results of the laboratory's self-evaluation, the findings can be used as a basis for providing direct assistance to a single laboratory or, if a problem proves to be widespread within a state, a statewide training effort can be initiated. A refinement of this approach could lead to the improvement of laboratory improvement programs per se. Most of us involved in one aspect or another of laboratory improvement have made many observations and developed many attitudes based on these observations, but few of us have taken the time (maybe we have not had the time) to analyze the data in our files for the answers to some very perplexing questions about the quality of laboratory work in our country. Too often quality control, proficiency testing, and personnel are regarded as independent entities in laboratory imAJPH November 1979, Vol. 69, No. 11
provement programs. In few, if any, programs has test performance in proficiency testing been evaluated objectively, with a review of the credentials of the personnel performing the tests; at least, such an approach to performance evaluation does not seem to have been documented. What about measuring performance and documenting the impact of supervision and direction on performance? Almost everyone has an opinion, but no one has produced the facts in a way that will help the scientific community to arrive at a consensus. Do laboratories with absentee directors perform as well as those with full-time or part-time directors? What is the minimal level of theoretical scientific knowledge (formal education) needed to perform the various tasks and to assume the technical and legal responsibilities for the operation of a laboratory? To what extent do breakdowns in quality control systems reflect the levels of competence of the laboratory staff to identify, much less correct, the factors leading to breakdowns in the system? The Center for Disease Control (CDC), Licensure and Proficiency Testing Division-in working with laboratories performing drug analyses under the National Institute for Drug Abuse (NIDA) program, the Indian Health Service, and Public Health Service clinic laboratories-has used onsite practices to assist these laboratories in improving their services. The CDC observations appear to support those of the Pennsylvania study. The Pennsylvania study is modest and almost oversimplified, yet it challenges all of us interested in laboratory improvement to take another look at what we are doing, not with the purpose of creating something new and elaborate but with the hope of developing more effective laboratory improvement programs by using the tools and the information already available to us.
CARL H. BLANK, DrPH
Address reprint requests to Carl H. Blank, DrPH, Chief, Examination and Documentation Branch, Licensure and Proficiency Testing Division, Bureau of Laboratories, DHEW, CDC, Atlanta, GA 30333.
REFERENCES
1. Code of Federal Regulations, Title 20, Chapter III, Subpart M,
Part 405 (Medicare). 2. Public Law 90-174, Section 5(a), 81 Statute 536 (Includes the Clinical Laboratories Improvement Act of 1967). 3. Neimeister RP, Wilf CZ, Cocklin JH, et al: The use of a technical questionnaire in the Pennsylvania laboratory improvement program, technical questionnaire in proficiency testing. Am J Public Health 69:1170-1172, 1979. 4. Committee on Evaluation of Serodiagnostic Tests: Report for 1938, USPHS, Washington, DC. 5. Parran T, Hazen HH, Sanford AH, et al: Efficiency of state and local laboratories in the performance of serodiagnostic tests for syphilis. Vener Dis Inf 18:4-11, 1937.
1095
