- Email: [email protected]
CAP inspection and the microbiology laboratory
19.
20.
21.
22.
23.
disease outbreaks and in tracing the transmission of antibiotic resistance. Clin. Microbiol. Rev. 1:228-243. Wachsmuth, K. 1986. Molecular epidemiology of bacterial infections: examples of methodology and of investigations of outbreaks. Rev. Infect. Dis. 8:682-692. Schaberg, D. R., L. S. Tompkins, and S. Falkow. 1981. Use of agarose gel electrophoresis of plasmid deoxyribonucleic acid to fingerprint gram-negative bacilli. J. Clin. Microbiol. 13:1105-1108. Schaberg, D. R., and M. Zervos. 1986. Plasmid analysis in the study of the epidemiology of nosocomial grampositive cocci. Rev. Infect. Dis. 8:705-712. John, J. E., and J. A. Twitty. 1986. Plasmids as epidemiologic markers in nosocomial gram-negative bacilli: experience at a university and review of the literature. Rev. Infect, Dis. 8:693704. Tompkins, L. S. et al. 1986. Cloned, random chromosomal sequences as probes to identify Salmonella species. J. Infect. Dis. 154:156-162.
28.
29.
30.
31.
32.
24. Mulligan, M. E. et al. 1988. Immunoblots, antimicrobial resistance, and bacteriophage typing of oxacillin-resistant Staphylococcus aureus. J. Clin. Microbiol. 26:2395-2401.
33.
25. Bjorvatn, B,, and B. E. Kristiansen. 1985. Molecular epidemiology of bacterial infections. Clin. Lab. Med. 5:437-445.
34.
26. Tenover, F. C. 1985. Plasmid fingerprinting: a tool for bacterial strain identification and surveillance for nosocomial and community acquired infections. Clin. Lab. Med. 5:413-436. 27. Archer, G. L., N. Vishniavsky, and H. G. Stiver. 1982. Plasmid pattern
35.
analysis of Staphylococcus epidermidis isolates from patients with prosthetic valve endocarditis. Infect. Immun. 35:627-632. Plesiat, P., B. Alkholof, and Y. Michael-Briand. 1988. Prevalence and profiles of plasmids in Pseudomonas aeruginosa. Eur. J. Clin. Microbiol. Infect. Dis. 7:261-264. John, J. J. Jr., and W. F. McNeill. 1981. Characteristics of Serratia marcescens containing a plasmid coding for gentamicin resistance in nosocomial infections. J. Infect. Dis. 143:810-817. Gillespie, M. T., J. W. May, and R. W. Skurray. 1984. Antibiotic susceptibilities and plasmid profiles of nosocomial methicillin-resistant Staphylococcus aureus: a retrospective study. J. Med. Microbiol. 17:295-310. Locksley, R. M. et al. 1982. Multiply antibiotic resistant Staphylococcus aureus: introduction, transmission, and evolution of nosocomial infection. Ann. Intern. Med. 97:317-324. Maher, W. E., M. F. Para, and J. F. Plouffe. 1987. Subtyping of Legionella pneumophila serogroup l isolates by monoclonal antibody and plasmid techniques. J. Clin. Microbiol. 25:22812284. Pfaller, M. et al. 1989. Application of molecular and immunologic techniques to study the epidemiology of Legionella pneumophila serogroup 1. Diagn. Microbiol. Infect. Dis. (in press). Archer, G. L. et al. 1984. Plasmidpattern analysis for the differentiation of infecting from non-infecting Staphylococcus epidermidis. J. Infect. Dis. 149:913-920. Parisi, J. T., and D. W. Hecht. 1980. Plasmid profiles in epidemiologic studies of infections by Staphylococcus epidermidis. J. Infect. Dis. 141:637643.
36. Hawkey, P. M. 1987. Molecular methods for the investigation of bacterial cross-infection. J. Hosp. Infect. 9:211-218. 37. Tompkins, L. S. 1985. DNA methods in clinical microbiology, p. 1023-1028. In E. H. Lennette et al. (ed.), Manual of clinical microbiology, 4th ed. American Society for Microbiology, Washington, DC. 38. Archer, G. L., D. R. Dietrick, and J. L. Johnston. 1985. Molecular epidemiology of transmissible gentamicin resistance among coagulase-negative staphylococci in a cardiac surgery unit. J. Infect. Dis. 151:243-251. 39. Sadowski, P. L. et al. 1979. Physical characterization of ten R plasmids obtained from an outbreak of nosocomial Klebsiella pneumoniae infections. Antimicrob. Agents Chemother. 15:616624. 40. Kado, C. I., and S. T. Liu. 1981. Rapid procedure for detection and isolation of large and small plasmids. J. Bacteriol. 145:1365-1373. 41. Holmes, D. S., and M. Quigley. 1981. A rapid boiling method for the preparation of bacterial plasmids. Anal. Biochem. 114:193-197. 42. Birnboim, H. C., and J. Doly. 1979. A rapid alkaline extraction procedure for screening recombinant plasmid DNA. Nucleic Acids Res. 7:15131523. 43. Takahashi, S., and Y. Nagano. 1984. Rapid procedure of isolation of plasmid DNA and application to epidemiological analysis. J. Clin. Microbiol. 20:608-613. 44. Maniatis, T., E. F. Fritsch, and J. Sambrook. 1982. Molecular cloning: a laboratory manual. Cold Spring Harbor Laboratory, Cold Spring Harbor, NY.
Editorial CAP Inspection and the Microbiology Laboratory James D. MacLowry, M.D. Microbiology Resource Committee College of American Pathologists Skokie, IL 60077-1034 The directors o f clinical laboratories in general, and microbiology laboratories in particular, spend considerable
Clinical Microbiology Newsletter 11:18, 1989
administrative effort trying to find new ways to make their operations more efficient and relevant. On the other hand, external regulatory agencies require that laboratories expend considerable resources adhering to specific guidelines o f practice. Many questions are raised about the need, usefulness, and appropriateness o f certain aspects o f these operational guidelines. In this editorial I will comment about certain requirements of the Commission on
© 1989 Elsevier Science Publishing Co., Inc.
Laboratory Accreditation of the College o f American Pathologists (CAP) as found in their inspection checklist for laboratory accreditation. For many clinical laboratories, accreditation under the CAP inspection and accreditation requirement suffices. The process consists o f several different activities, including an on-site inspection every other year by a team of CAP-designated inspectors, alternateyear self-inspection using the CAP in-
0196-4399/89/$0.00 + 02.20
141
spection and accreditation checklist, and enrollment in appropriate proficiency test programs. Other accreditation requirements are not relevant to this discussion. Struggling with the process of responding to the checklist items is sometimes puzzling, as some items are so specific while others are so general. It may be helpful to review part of the process by which these items are derived. The CAP laboratory accreditation process has been in existence for many years, even before the specific mandate of the Clinical Laboratory Improvement Act of 1967. Originally, the program was designed to bring uniformity to certain aspects of laboratory practice and to set goals to help the laboratory function at a high level of competence. At first, accreditation had an extremely useful educational function but, with the passage of specific federal and state legislation, the guidelines gradually took on a regulatory aspect that had not been envisioned. At present, the CAP Commission on Laboratory Accreditation works closely with federal agencies to ensure that the checklist items conform with regulatory expectations and that they are at least as stringent as the requirements in the regulations. Therefore, a number of constraints are placed on that Commission in terms of how far it can move without jeopardizing the accreditation process as viewed by federal agencies. Some states have their own accreditation process, which may be different from the CAP program. Generally, however, the inspection and accreditation checklist serves as a reasonable guide for a clinical laboratory standard of practice. The above comments notwith-
standing, a conscious effort has been made to prevent checklist items from becoming a specific standard of practice in all laboratory areas. The accreditation program involves thousands of laboratories of different sizes, geographic locations, and expertise. The checklist must remain sufficiently general so that some functions common to all laboratories can be considered, but at the same time ensure that practices appropriate for a large city hospital are not imposed on a small rural hospital. For these reasons, certain items of the checklist are very specific in areas that might be considered trivial or simply bookkeeping, but for procedures such as blood culture techniques, they are fairly general. An attempt is made not to favor one technique or manufacturer over another unless there is unequivocal agreement that a certain standardization is appropriate. For example, in the area of antimicrobial susceptibility testing, there is agreement that the standards promulgated by the National Committee for Clinical Laboratory Standards are appropriate for clinical practice; therefore, a number of questions relate to use of these standards. However, the checklist is not designed to evaluate every aspect of a standard method. General laboratory activities are evaluated, especially in regard to adequate documentation of laboratory functions, without being specific as to what those functions should be. Each individual has a preferred way of performing a particular diagnostic procedure, but all those varieties of artistry and creativity cannot be included in such a document. Reasonable questions can be raised, however, when a specific technique is
used and the accreditation guidelines appear to be biased against it. How should a laboratory director proceed under those circumstances? At least two options are available and both of them should be explored. The first is to document the performance of a specific method in the laboratory. For example, if laboratories are able to document that less frequent testing of quality-control specimens or less frequent testing of staining reagents is a good standard of practice in that laboratory, then the documentation can be forwarded to the original inspector when these deficiencies are noted for the laboratory. Another mechanism that should be considered is to communicate directly with the Commission on Laboratory Accreditation and request feedback from the appropriate CAP scientific resource committee as to the appropriateness of a procedure. Usually, questions in the area of microbiology are referred to the Microbiology Resource Committee, one of whose functions is to serve as a scientific adviser and reference for the inspection committee. The Microbiology Resource Committee may then make a recommendation to the Commission on Laboratory Accreditation that a specific checklist item be changed or modified. If such a modification can be shown to be scientifically sound and not in conflict with regulatory demands, then the change is usually made. Many thoughtful and co_n_st~ctive changes have been made to the checklist by individuals responding to the accreditation process in this way. The CAP welcomes this type of scientific input because, if it benefits one laboratory, it may benefit others as well.
A 43-year-old man on hemodialysis for chronic renal failure secondary to hypertension presented to the hospital with a 4-day history of fever, nausea, vomiting, and diarrhea. The patient was in mild distress, and physical examination revealed a pulse and blood pressure of 76 beats per minute and 165/90 mm Hg, respectively, a temper-
ature of 101.5°F, hyperactive bowel sounds, and poor dentition. Laboratory data revealed a white blood cell count of 9,400/mm 3 (63% polymorphonuclear leukocytes, 17% band cells, 8% lymphocytes, 8% monocytes, 1% eosinophils, and 3% atypical lymphocytes; occasional toxic granulations were noted), and metabolic findings were
Case Report
Kingella kingae Bacteremia Mary C. O'Connor, M.D. Robert E. Sperry, M.D. Cynthia A. Burdick, BSMT, ASCP Christopher J. Papasian, Ph.D. Veterans Administration Medical Center
Kansas City, MO 64128
142 IIIIIJIL
.........
0196-4399/89/$0.00 + 02.20
© 1989 Elsevier Science Publishing Co., Inc.
Clinical Microbiology Newsletter 11:18, 1989
20.
21.
22.
23.
disease outbreaks and in tracing the transmission of antibiotic resistance. Clin. Microbiol. Rev. 1:228-243. Wachsmuth, K. 1986. Molecular epidemiology of bacterial infections: examples of methodology and of investigations of outbreaks. Rev. Infect. Dis. 8:682-692. Schaberg, D. R., L. S. Tompkins, and S. Falkow. 1981. Use of agarose gel electrophoresis of plasmid deoxyribonucleic acid to fingerprint gram-negative bacilli. J. Clin. Microbiol. 13:1105-1108. Schaberg, D. R., and M. Zervos. 1986. Plasmid analysis in the study of the epidemiology of nosocomial grampositive cocci. Rev. Infect. Dis. 8:705-712. John, J. E., and J. A. Twitty. 1986. Plasmids as epidemiologic markers in nosocomial gram-negative bacilli: experience at a university and review of the literature. Rev. Infect, Dis. 8:693704. Tompkins, L. S. et al. 1986. Cloned, random chromosomal sequences as probes to identify Salmonella species. J. Infect. Dis. 154:156-162.
28.
29.
30.
31.
32.
24. Mulligan, M. E. et al. 1988. Immunoblots, antimicrobial resistance, and bacteriophage typing of oxacillin-resistant Staphylococcus aureus. J. Clin. Microbiol. 26:2395-2401.
33.
25. Bjorvatn, B,, and B. E. Kristiansen. 1985. Molecular epidemiology of bacterial infections. Clin. Lab. Med. 5:437-445.
34.
26. Tenover, F. C. 1985. Plasmid fingerprinting: a tool for bacterial strain identification and surveillance for nosocomial and community acquired infections. Clin. Lab. Med. 5:413-436. 27. Archer, G. L., N. Vishniavsky, and H. G. Stiver. 1982. Plasmid pattern
35.
analysis of Staphylococcus epidermidis isolates from patients with prosthetic valve endocarditis. Infect. Immun. 35:627-632. Plesiat, P., B. Alkholof, and Y. Michael-Briand. 1988. Prevalence and profiles of plasmids in Pseudomonas aeruginosa. Eur. J. Clin. Microbiol. Infect. Dis. 7:261-264. John, J. J. Jr., and W. F. McNeill. 1981. Characteristics of Serratia marcescens containing a plasmid coding for gentamicin resistance in nosocomial infections. J. Infect. Dis. 143:810-817. Gillespie, M. T., J. W. May, and R. W. Skurray. 1984. Antibiotic susceptibilities and plasmid profiles of nosocomial methicillin-resistant Staphylococcus aureus: a retrospective study. J. Med. Microbiol. 17:295-310. Locksley, R. M. et al. 1982. Multiply antibiotic resistant Staphylococcus aureus: introduction, transmission, and evolution of nosocomial infection. Ann. Intern. Med. 97:317-324. Maher, W. E., M. F. Para, and J. F. Plouffe. 1987. Subtyping of Legionella pneumophila serogroup l isolates by monoclonal antibody and plasmid techniques. J. Clin. Microbiol. 25:22812284. Pfaller, M. et al. 1989. Application of molecular and immunologic techniques to study the epidemiology of Legionella pneumophila serogroup 1. Diagn. Microbiol. Infect. Dis. (in press). Archer, G. L. et al. 1984. Plasmidpattern analysis for the differentiation of infecting from non-infecting Staphylococcus epidermidis. J. Infect. Dis. 149:913-920. Parisi, J. T., and D. W. Hecht. 1980. Plasmid profiles in epidemiologic studies of infections by Staphylococcus epidermidis. J. Infect. Dis. 141:637643.
36. Hawkey, P. M. 1987. Molecular methods for the investigation of bacterial cross-infection. J. Hosp. Infect. 9:211-218. 37. Tompkins, L. S. 1985. DNA methods in clinical microbiology, p. 1023-1028. In E. H. Lennette et al. (ed.), Manual of clinical microbiology, 4th ed. American Society for Microbiology, Washington, DC. 38. Archer, G. L., D. R. Dietrick, and J. L. Johnston. 1985. Molecular epidemiology of transmissible gentamicin resistance among coagulase-negative staphylococci in a cardiac surgery unit. J. Infect. Dis. 151:243-251. 39. Sadowski, P. L. et al. 1979. Physical characterization of ten R plasmids obtained from an outbreak of nosocomial Klebsiella pneumoniae infections. Antimicrob. Agents Chemother. 15:616624. 40. Kado, C. I., and S. T. Liu. 1981. Rapid procedure for detection and isolation of large and small plasmids. J. Bacteriol. 145:1365-1373. 41. Holmes, D. S., and M. Quigley. 1981. A rapid boiling method for the preparation of bacterial plasmids. Anal. Biochem. 114:193-197. 42. Birnboim, H. C., and J. Doly. 1979. A rapid alkaline extraction procedure for screening recombinant plasmid DNA. Nucleic Acids Res. 7:15131523. 43. Takahashi, S., and Y. Nagano. 1984. Rapid procedure of isolation of plasmid DNA and application to epidemiological analysis. J. Clin. Microbiol. 20:608-613. 44. Maniatis, T., E. F. Fritsch, and J. Sambrook. 1982. Molecular cloning: a laboratory manual. Cold Spring Harbor Laboratory, Cold Spring Harbor, NY.
Editorial CAP Inspection and the Microbiology Laboratory James D. MacLowry, M.D. Microbiology Resource Committee College of American Pathologists Skokie, IL 60077-1034 The directors o f clinical laboratories in general, and microbiology laboratories in particular, spend considerable
Clinical Microbiology Newsletter 11:18, 1989
administrative effort trying to find new ways to make their operations more efficient and relevant. On the other hand, external regulatory agencies require that laboratories expend considerable resources adhering to specific guidelines o f practice. Many questions are raised about the need, usefulness, and appropriateness o f certain aspects o f these operational guidelines. In this editorial I will comment about certain requirements of the Commission on
© 1989 Elsevier Science Publishing Co., Inc.
Laboratory Accreditation of the College o f American Pathologists (CAP) as found in their inspection checklist for laboratory accreditation. For many clinical laboratories, accreditation under the CAP inspection and accreditation requirement suffices. The process consists o f several different activities, including an on-site inspection every other year by a team of CAP-designated inspectors, alternateyear self-inspection using the CAP in-
0196-4399/89/$0.00 + 02.20
141
spection and accreditation checklist, and enrollment in appropriate proficiency test programs. Other accreditation requirements are not relevant to this discussion. Struggling with the process of responding to the checklist items is sometimes puzzling, as some items are so specific while others are so general. It may be helpful to review part of the process by which these items are derived. The CAP laboratory accreditation process has been in existence for many years, even before the specific mandate of the Clinical Laboratory Improvement Act of 1967. Originally, the program was designed to bring uniformity to certain aspects of laboratory practice and to set goals to help the laboratory function at a high level of competence. At first, accreditation had an extremely useful educational function but, with the passage of specific federal and state legislation, the guidelines gradually took on a regulatory aspect that had not been envisioned. At present, the CAP Commission on Laboratory Accreditation works closely with federal agencies to ensure that the checklist items conform with regulatory expectations and that they are at least as stringent as the requirements in the regulations. Therefore, a number of constraints are placed on that Commission in terms of how far it can move without jeopardizing the accreditation process as viewed by federal agencies. Some states have their own accreditation process, which may be different from the CAP program. Generally, however, the inspection and accreditation checklist serves as a reasonable guide for a clinical laboratory standard of practice. The above comments notwith-
standing, a conscious effort has been made to prevent checklist items from becoming a specific standard of practice in all laboratory areas. The accreditation program involves thousands of laboratories of different sizes, geographic locations, and expertise. The checklist must remain sufficiently general so that some functions common to all laboratories can be considered, but at the same time ensure that practices appropriate for a large city hospital are not imposed on a small rural hospital. For these reasons, certain items of the checklist are very specific in areas that might be considered trivial or simply bookkeeping, but for procedures such as blood culture techniques, they are fairly general. An attempt is made not to favor one technique or manufacturer over another unless there is unequivocal agreement that a certain standardization is appropriate. For example, in the area of antimicrobial susceptibility testing, there is agreement that the standards promulgated by the National Committee for Clinical Laboratory Standards are appropriate for clinical practice; therefore, a number of questions relate to use of these standards. However, the checklist is not designed to evaluate every aspect of a standard method. General laboratory activities are evaluated, especially in regard to adequate documentation of laboratory functions, without being specific as to what those functions should be. Each individual has a preferred way of performing a particular diagnostic procedure, but all those varieties of artistry and creativity cannot be included in such a document. Reasonable questions can be raised, however, when a specific technique is
used and the accreditation guidelines appear to be biased against it. How should a laboratory director proceed under those circumstances? At least two options are available and both of them should be explored. The first is to document the performance of a specific method in the laboratory. For example, if laboratories are able to document that less frequent testing of quality-control specimens or less frequent testing of staining reagents is a good standard of practice in that laboratory, then the documentation can be forwarded to the original inspector when these deficiencies are noted for the laboratory. Another mechanism that should be considered is to communicate directly with the Commission on Laboratory Accreditation and request feedback from the appropriate CAP scientific resource committee as to the appropriateness of a procedure. Usually, questions in the area of microbiology are referred to the Microbiology Resource Committee, one of whose functions is to serve as a scientific adviser and reference for the inspection committee. The Microbiology Resource Committee may then make a recommendation to the Commission on Laboratory Accreditation that a specific checklist item be changed or modified. If such a modification can be shown to be scientifically sound and not in conflict with regulatory demands, then the change is usually made. Many thoughtful and co_n_st~ctive changes have been made to the checklist by individuals responding to the accreditation process in this way. The CAP welcomes this type of scientific input because, if it benefits one laboratory, it may benefit others as well.
A 43-year-old man on hemodialysis for chronic renal failure secondary to hypertension presented to the hospital with a 4-day history of fever, nausea, vomiting, and diarrhea. The patient was in mild distress, and physical examination revealed a pulse and blood pressure of 76 beats per minute and 165/90 mm Hg, respectively, a temper-
ature of 101.5°F, hyperactive bowel sounds, and poor dentition. Laboratory data revealed a white blood cell count of 9,400/mm 3 (63% polymorphonuclear leukocytes, 17% band cells, 8% lymphocytes, 8% monocytes, 1% eosinophils, and 3% atypical lymphocytes; occasional toxic granulations were noted), and metabolic findings were
Case Report
Kingella kingae Bacteremia Mary C. O'Connor, M.D. Robert E. Sperry, M.D. Cynthia A. Burdick, BSMT, ASCP Christopher J. Papasian, Ph.D. Veterans Administration Medical Center
Kansas City, MO 64128
142 IIIIIJIL
.........
0196-4399/89/$0.00 + 02.20
© 1989 Elsevier Science Publishing Co., Inc.
Clinical Microbiology Newsletter 11:18, 1989