Veterinary Clinical Pathology ISSN 0275-6382
EDITORIAL
“In theory there is no difference between theory and practice – in practice there is” (Yogi Berra) DOI:10.1111/vcp.12100
Two articles in this issue deliver guidelines for the assessment and evaluation of quality performance data in conventional and point-of-care settings – useful tools to merge theory and practice. Point-of-care testing (POCT) is a laboratory medicine discipline that is evolving rapidly in analytical scope and clinical application.1 Sophisticated technological advances, such as a miniaturization of analyzer size and refined analytical concepts have induced a shift of laboratory testing from the conventional reference laboratory to the point of care – the patient side.2 Additionally, new tests are being developed at a fast rate and the technology of existing tests is continuously improved.3 Clever marketing strategies by manufacturers, together with clients who demand expedient diagnosis and therapy have contributed to the wide distribution of point-ofcare laboratory analyzers (POCA) throughout veterinary clinics and practices. Small sample volumes required by POCAs add to their popularity. Thus POCT, performing laboratory tests outside the conventional reference laboratory, has become a common standard in veterinary medicine. Smart sales people promise infallible results produced within minutes by anyone who is able to read and follow the short instructions tagged on a “maintenance-free” device. In larger units, such as veterinary teaching hospitals, POCT is successfully applied in emergency case management and during night shifts. However, POCT-derived diagnoses are only useful if the results produced lead to immediate therapeutic decisions.1 In human medicine there is still a paucity of evidence supporting improved patient outcome with the use of POCT.1 However, some studies confirm the usefulness and safety of POCT for selected tests especially in remote areas.4 Laboratory testing has been centralized not only due to cost effectiveness, but also as a result of quality issues. POCT-technology brings laboratory testing into the clinician’s office, but without the expertise of a board certified clinical pathologist to assure adequate quality assessment prior to getting results back to the patient site. Test results obtained by non-specialists might lead to unsatisfactory results. Unnecessary repeat testing with increased costs might be the most harmless sequel – faulty clinical decisions with poten-
tially harmful consequences for the patient are the worst case scenario. Concerns regarding the quality of veterinary in-clinic testing have been expressed by veterinarians themselves in the published literature.5,6 Mitzner correctly observed that manufacturers of inhouse testing equipment have done a superior job of training their customers as to the use of their products, while the education concerning quality assessment has been neglected.5,7 Additionally, in veterinary curricula information on quality assessment is scant if not absent in many academic programs, especially in environments lacking veterinary clinical pathologist faculty. The lack of legal regulations for veterinary in-house testing requires the profession to develop a commitment to self-monitoring and quality control.8 Accuracy and reproducibility define the quality of a laboratory test result followed by timely availability and a reasonable price. POCT in veterinary medicine fulfills timely availability and at least partly the cost effectiveness, whereas up to now only one study investigated the quality of veterinary in house biochemistry testing.2 In 1996 the ASVCP Quality Assurance and Laboratory Standards Committee was founded to develop standards and further continuous quality improvements. The efforts of this committee resulted in a series of excellent guidelines available on the ASVCP website. The core elements of these guidelines are published as scientific articles so that their generation becomes traceable for the professional community. I wish to thank everybody who contributed to these guidelines. This material does not only provide accessible and easy to follow material for anyone involved in laboratory testing, but it is also a meaningful political statement. It not only demonstrates the profession’s commitment to continuous quality improvement, but also shows that the clinical pathologist specialist cannot be superseded by POCT. In countries where clinical pathology was not already a firmly established and well recognized discipline, the advent of in-house testing systems interfered with its recognition as an indispensable area for specialization in modern veterinary medicine. Marketing campaigns for in-house testing dispatched the message that lab testing is easy as child’s play – everybody can do it! As a result the necessity for
Vet Clin Pathol 42/4 (2013) 399–400 ©2013 American Society for Veterinary Clinical Pathology
399
Editorial
running a core laboratory under the guidance of a board-certified laboratory specialist has been disregarded in some institutions in times of financial constraints. POCA are purchased and operated by individual hospital units and with only limited input, if any, by a clinical pathology specialist. The quality assessment guidelines for POCT published in this issue set a benchmark for quality improvement in this delicate area and clearly demonstrate that POCT should be performed under the guidance or at least consulting power of a clinical pathologist trained in quality assessment. Analytical performance characteristics should be judged against objective quality specifications.9,10 Ideally quality specifications should be derived objectively from an analysis of medical needs.9 In human medicine an abundance of data regarding biologic variance components are available, whereas the data base in veterinary medicine is under construction. Desirable performance criteria for imprecision and bias have been defined as CVA < 0.5 CVi and BA < 0.250 (CVi2 + CVG2)1/2, where CVA is the analytical variance, BA the analytical bias, CVi the intraindividual variance and CVG the inter-individual or group variance.9 Optimal and minimal performance goals have been designed for many analytes in routine testing, whereas desired performance goals for defined clinical situations are scarce. So far, only few data are available in the veterinary literature.11 Interestingly, the industry does not appear to use professionally set quality specifications in either development or marketing considerations.9 This issue of Veterinary Clinical Pathology contains guidelines on how to assess the overall analytical error (TEobs) and provides recommendations regarding quality specifications for selected analytes in veterinary medicine. Performance failure can be caused by a multitude of factors such as declining mechanical/optical instrument performance, deterioration of reagents, faulty calibrators or quality control material, or deficient operation due to training deficits of operating personnel. But quality assurance measures are limited when, despite appropriate training, maintenance of equipment, and state of the art handling of calibrators and reagents, the desired total error cannot be achieved. Immediate change of methodology or equipment may not be feasible. However, it is important to begin to take the necessary steps to observe the total error. A growing body of evidence will hopefully put some pressure on manufacturers to meet quality demands defined by the profession. Performance specifications might also vary between different users, such as the pharmaceutical industry, general practitioners and specialists. The proposed guidelines are ambitious
400
and represent an excellent starting point. Technical progress and an increasing body of data investigating variance components in veterinary species and specific disease entities will require current updates. Ilse Schwendenwein Dr. med. vet., Diplomate ECVCP (European Specialist) Ass. Prof. and Head of Clinical Pathology Unit Department of Pathobiology University of Veterinary Medicine Vienna, Austria
References 1. Luppa PB, M€ uller C, Schlichtiger A, Schlebusch H. Point-of-care testing (POCT): current techniques and future perspectives. TrAC, Trends Anal Chem. 2011;30:887–898. 2. Rishniw M, Pion PD, Maher T. The quality of veterinary in-clinic and reference laboratory biochemical testing. Vet Clin Pathol. 2012;41:92–109. 3. Bossuyt PM, Reitsma JB, Bruns DE, et al.; STARD Group. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. Vet Clin Pathol. 2007;36:8–12. 4. Bubner TK, Laurence CO, Gialamas A, et al. Effectiveness of point-of-care testing for therapeutic control of chronic conditions: results from the PoCT in General Practice Trial. Med J Aust. 2009;190:624–626. 5. Mitzner BT. It’s time for in-house quality assurance. J Am Anim Hosp Assoc. 2002;38:12–13. 6. Freeman K, Evans E, Lester S. Quality control for inhospital veterinary laboratory testing. J Am Vet Med Assoc. 1999;215:928–929. 7. Lester S, Harr KE, Rishniw M, Pion P. Current quality assurance concepts and considerations for quality control of in-clinic biochemistry testing. J Am Vet Med Assoc. 2012;242:182–192. 8. Flatland B, Freeman KP, Friedrichs KR, et al. ASVCP quality assurance guidelines: control of general analytical factors in veterinary laboratories. Vet Clin Pathol. 2010;39:264–277. 9. Fraser CG, Hyltoft Petersen P. Analytical performance characteristics should be judged against objective quality specifications. Clin Chem. 1999;45:321–323. 10. Kjelgaard-Hansen M, Jensen AL. Subjectivity in defining quality specifications for quality control and test validation. Vet Clin Pathol. 2010;39:134–135. 11. Farr AJ, Freeman KP. Quality control validation, application of sigma metrics, and performance comparison between two biochemistry analyzers in a commercial veterinary laboratory. J Vet Diagn Invest. 2008;20:536– 544.
Vet Clin Pathol 42/4 (2013) 399–400 ©2013 American Society for Veterinary Clinical Pathology
EDITORIAL
“In theory there is no difference between theory and practice – in practice there is” (Yogi Berra) DOI:10.1111/vcp.12100
Two articles in this issue deliver guidelines for the assessment and evaluation of quality performance data in conventional and point-of-care settings – useful tools to merge theory and practice. Point-of-care testing (POCT) is a laboratory medicine discipline that is evolving rapidly in analytical scope and clinical application.1 Sophisticated technological advances, such as a miniaturization of analyzer size and refined analytical concepts have induced a shift of laboratory testing from the conventional reference laboratory to the point of care – the patient side.2 Additionally, new tests are being developed at a fast rate and the technology of existing tests is continuously improved.3 Clever marketing strategies by manufacturers, together with clients who demand expedient diagnosis and therapy have contributed to the wide distribution of point-ofcare laboratory analyzers (POCA) throughout veterinary clinics and practices. Small sample volumes required by POCAs add to their popularity. Thus POCT, performing laboratory tests outside the conventional reference laboratory, has become a common standard in veterinary medicine. Smart sales people promise infallible results produced within minutes by anyone who is able to read and follow the short instructions tagged on a “maintenance-free” device. In larger units, such as veterinary teaching hospitals, POCT is successfully applied in emergency case management and during night shifts. However, POCT-derived diagnoses are only useful if the results produced lead to immediate therapeutic decisions.1 In human medicine there is still a paucity of evidence supporting improved patient outcome with the use of POCT.1 However, some studies confirm the usefulness and safety of POCT for selected tests especially in remote areas.4 Laboratory testing has been centralized not only due to cost effectiveness, but also as a result of quality issues. POCT-technology brings laboratory testing into the clinician’s office, but without the expertise of a board certified clinical pathologist to assure adequate quality assessment prior to getting results back to the patient site. Test results obtained by non-specialists might lead to unsatisfactory results. Unnecessary repeat testing with increased costs might be the most harmless sequel – faulty clinical decisions with poten-
tially harmful consequences for the patient are the worst case scenario. Concerns regarding the quality of veterinary in-clinic testing have been expressed by veterinarians themselves in the published literature.5,6 Mitzner correctly observed that manufacturers of inhouse testing equipment have done a superior job of training their customers as to the use of their products, while the education concerning quality assessment has been neglected.5,7 Additionally, in veterinary curricula information on quality assessment is scant if not absent in many academic programs, especially in environments lacking veterinary clinical pathologist faculty. The lack of legal regulations for veterinary in-house testing requires the profession to develop a commitment to self-monitoring and quality control.8 Accuracy and reproducibility define the quality of a laboratory test result followed by timely availability and a reasonable price. POCT in veterinary medicine fulfills timely availability and at least partly the cost effectiveness, whereas up to now only one study investigated the quality of veterinary in house biochemistry testing.2 In 1996 the ASVCP Quality Assurance and Laboratory Standards Committee was founded to develop standards and further continuous quality improvements. The efforts of this committee resulted in a series of excellent guidelines available on the ASVCP website. The core elements of these guidelines are published as scientific articles so that their generation becomes traceable for the professional community. I wish to thank everybody who contributed to these guidelines. This material does not only provide accessible and easy to follow material for anyone involved in laboratory testing, but it is also a meaningful political statement. It not only demonstrates the profession’s commitment to continuous quality improvement, but also shows that the clinical pathologist specialist cannot be superseded by POCT. In countries where clinical pathology was not already a firmly established and well recognized discipline, the advent of in-house testing systems interfered with its recognition as an indispensable area for specialization in modern veterinary medicine. Marketing campaigns for in-house testing dispatched the message that lab testing is easy as child’s play – everybody can do it! As a result the necessity for
Vet Clin Pathol 42/4 (2013) 399–400 ©2013 American Society for Veterinary Clinical Pathology
399
Editorial
running a core laboratory under the guidance of a board-certified laboratory specialist has been disregarded in some institutions in times of financial constraints. POCA are purchased and operated by individual hospital units and with only limited input, if any, by a clinical pathology specialist. The quality assessment guidelines for POCT published in this issue set a benchmark for quality improvement in this delicate area and clearly demonstrate that POCT should be performed under the guidance or at least consulting power of a clinical pathologist trained in quality assessment. Analytical performance characteristics should be judged against objective quality specifications.9,10 Ideally quality specifications should be derived objectively from an analysis of medical needs.9 In human medicine an abundance of data regarding biologic variance components are available, whereas the data base in veterinary medicine is under construction. Desirable performance criteria for imprecision and bias have been defined as CVA < 0.5 CVi and BA < 0.250 (CVi2 + CVG2)1/2, where CVA is the analytical variance, BA the analytical bias, CVi the intraindividual variance and CVG the inter-individual or group variance.9 Optimal and minimal performance goals have been designed for many analytes in routine testing, whereas desired performance goals for defined clinical situations are scarce. So far, only few data are available in the veterinary literature.11 Interestingly, the industry does not appear to use professionally set quality specifications in either development or marketing considerations.9 This issue of Veterinary Clinical Pathology contains guidelines on how to assess the overall analytical error (TEobs) and provides recommendations regarding quality specifications for selected analytes in veterinary medicine. Performance failure can be caused by a multitude of factors such as declining mechanical/optical instrument performance, deterioration of reagents, faulty calibrators or quality control material, or deficient operation due to training deficits of operating personnel. But quality assurance measures are limited when, despite appropriate training, maintenance of equipment, and state of the art handling of calibrators and reagents, the desired total error cannot be achieved. Immediate change of methodology or equipment may not be feasible. However, it is important to begin to take the necessary steps to observe the total error. A growing body of evidence will hopefully put some pressure on manufacturers to meet quality demands defined by the profession. Performance specifications might also vary between different users, such as the pharmaceutical industry, general practitioners and specialists. The proposed guidelines are ambitious
400
and represent an excellent starting point. Technical progress and an increasing body of data investigating variance components in veterinary species and specific disease entities will require current updates. Ilse Schwendenwein Dr. med. vet., Diplomate ECVCP (European Specialist) Ass. Prof. and Head of Clinical Pathology Unit Department of Pathobiology University of Veterinary Medicine Vienna, Austria
References 1. Luppa PB, M€ uller C, Schlichtiger A, Schlebusch H. Point-of-care testing (POCT): current techniques and future perspectives. TrAC, Trends Anal Chem. 2011;30:887–898. 2. Rishniw M, Pion PD, Maher T. The quality of veterinary in-clinic and reference laboratory biochemical testing. Vet Clin Pathol. 2012;41:92–109. 3. Bossuyt PM, Reitsma JB, Bruns DE, et al.; STARD Group. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. Vet Clin Pathol. 2007;36:8–12. 4. Bubner TK, Laurence CO, Gialamas A, et al. Effectiveness of point-of-care testing for therapeutic control of chronic conditions: results from the PoCT in General Practice Trial. Med J Aust. 2009;190:624–626. 5. Mitzner BT. It’s time for in-house quality assurance. J Am Anim Hosp Assoc. 2002;38:12–13. 6. Freeman K, Evans E, Lester S. Quality control for inhospital veterinary laboratory testing. J Am Vet Med Assoc. 1999;215:928–929. 7. Lester S, Harr KE, Rishniw M, Pion P. Current quality assurance concepts and considerations for quality control of in-clinic biochemistry testing. J Am Vet Med Assoc. 2012;242:182–192. 8. Flatland B, Freeman KP, Friedrichs KR, et al. ASVCP quality assurance guidelines: control of general analytical factors in veterinary laboratories. Vet Clin Pathol. 2010;39:264–277. 9. Fraser CG, Hyltoft Petersen P. Analytical performance characteristics should be judged against objective quality specifications. Clin Chem. 1999;45:321–323. 10. Kjelgaard-Hansen M, Jensen AL. Subjectivity in defining quality specifications for quality control and test validation. Vet Clin Pathol. 2010;39:134–135. 11. Farr AJ, Freeman KP. Quality control validation, application of sigma metrics, and performance comparison between two biochemistry analyzers in a commercial veterinary laboratory. J Vet Diagn Invest. 2008;20:536– 544.
Vet Clin Pathol 42/4 (2013) 399–400 ©2013 American Society for Veterinary Clinical Pathology
