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Mario Plebani - One of the best experts on this subject based on the ideXlab platform.

  • performance criteria and quality indicators for the post analytical Phase
    Clinical Chemistry and Laboratory Medicine, 2015
    Co-Authors: Laura Sciacovelli, Elisa Piva, Ada Aita, Michela Pelloso, Maria Laura Chiozza, Andrea Padoan, Giorgia Antonelli, Mario Plebani
    Abstract:

    The definition, implementation and monitoring of valuable analytical quality specifications have played a fundamental role in improving the quality of laboratory services and reducing the rates of analytical errors. However, a body of evidence has been accumulated on the relevance of the extra-analytical Phases, namely the pre-analytical steps, their vulnerability and impact on the overall quality of the laboratory information. The identification and establishment of valueable quality indicators (QIs) represents a promising strategy for collecting data on quality in the total testing process (TTP) and, particularly, for detecting any mistakes made in the individual steps of the pre-analytical Phase, thus providing useful information for quality improvement projects. The consensus achieved on the developed list of harmonized QIs is a premise for the further step: the identification of achievable and realistic performance targets based on the knowledge of the state-of-the-art. Data collected by several clinical laboratories worldwide allow the classification of performances for available QIs into three levels: optimum, desirable and minimum, in agreement with the widely accepted proposal for analytical quality specifications.

  • biological variation and reference change values an essential piece of the puzzle of laboratory testing
    Clinical Chemistry and Laboratory Medicine, 2012
    Co-Authors: Mario Plebani, Giuseppe Lippi
    Abstract:

    The biological variability of analytes assessed in clinical laboratories is pivotal to understand several issues related to the quality of laboratory information throughout all steps of the testing process (Figure 1 ). In the pre-analytical Phase, the knowledge of predictable biological cyclical biorhythms is required for appropriate collection of specimens at times pertinent to the clinical questions. Daily, monthly and seasonal rhythms have been broadly described and all play a critical role for addressing proper sample collection but also for interpreting test results (1, 2) . This is the typical case of serum cortisol in Cushing’s disease, as it is widely recognized that the 24 h cortisol secretory pattern is characterized by a lack of normal circadian variation (3) . In the analytical Phase, appreciation of biological variation represents precious information for setting reliable quality specifi cations (4, 5) . This principle, originally proposed by Cotlove et al. (6) , has been thoroughly investigated by Fraser and Harris (7) and fi nally endorsed by the 1999 International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), the International Union of Pure and Applied Chemistry (IUPAC) and the World Health Organization (WHO) “ Stockholm Conference Hierarchy ” (8) . Although quality specifi cations based on how analytical quality affects medical decision-making are at the top of the hierarchy, this approach is diffi cult to apply because few tests are used in single, well-defi ned clinical situations and with standardized medical strategies that are directly related to the test results. Conversely, data on biological variation and related analytical quality specifi cations are available for a large number of laboratory tests (9) . Finally, in the Post-Analytical Phase, knowledge of underlying biological variation of quantities examined in medical laboratories plays a central role in understanding the proper generation and application of traditional populationbased reference values (10) . In a seminal article published in 2004 in this Journal , Fraser (11) emphasized how the awareness of the biological changes that occur over the life span is a necessary prerequisite for deciding whether stratifi cation of reference values according to age, gender, race and other demographical variables is likely to be necessary. Moreover, studies carried out over the last three decades on inherent random biological variation have provided signifi cant insights into serious intrinsic problems associated with conventional population-based reference values, thus supporting the need for revising the concept of reference values (12) . Quantitative data on withinand between-subject components of biological variation have revealed that most quantities of interest in laboratory medicine are characterized by a marked individuality and a quantitative measure is the index of individuality (II), originally proposed by Harris (13) in 1981. Individuality provides an indisputable argument for the more appropriate use of individual-specifi c reference values, especially when monitoring individuals over time. The acknowledgment that changes in serial results of an individual may originate from clinical improvement or deterioration of health status, but might also be due to the three inherent sources of variation (pre-analytical, analytical and within-subject biological variation), led Harris and Yasaka (14) to develop and introduce the concept of reference change values (RCV). In this issue, we are delighted to publish an article on reference change values, written by the most widely recognized expert in this fi eld, Callum G. Fraser (15) . Although the concept of RCV is simple and its calculation extremely straightforward because clinical laboratories are aware of their analytical coeffi cient of variation (CVA) and within-subject biological variation (CVI) estimates are available for a large number of analytes, some drawbacks and problems have been raised by Cooper et al. (4) to explain the unwarranted delay in its application in clinical laboratory practice. The great value of this paper, along with an outstanding ability to summarize and ease the comprehension of the body of knowledge gathered so far on this

  • errors in clinical laboratories or errors in laboratory medicine
    Clinical Chemistry and Laboratory Medicine, 2006
    Co-Authors: Mario Plebani
    Abstract:

    Laboratory testing is a highly complex process and, although laboratory services are relatively safe, they are not as safe as they could or should be. Clinical laboratories have long focused their attention on quality control methods and quality assessment programs dealing with analytical aspects of testing. However, a growing body of evidence accumulated in recent decades demonstrates that quality in clinical laboratories cannot be assured by merely focusing on purely analytical aspects. The more recent surveys on errors in laboratory medicine conclude that in the delivery of laboratory testing, mistakes occur more frequently before (pre-analytical) and after (Post-Analytical) the test has been performed. Most errors are due to pre-analytical factors (46–68.2% of total errors), while a high error rate (18.5–47% of total errors) has also been found in the Post-Analytical Phase. Errors due to analytical problems have been significantly reduced over time, but there is evidence that, particularly for immunoassays, interference may have a serious impact on patients. A description of the most frequent and risky pre-, intra- and Post-Analytical errors and advice on practical steps for measuring and reducing the risk of errors is therefore given in the present paper. Many mistakes in the Total Testing Process are called ‘‘laboratory errors’’, although these may be due to poor communication, action taken by others involved in the testing process (e.g., physicians, nurses and phlebotomists), or poorly designed processes, all of which are beyond the laboratory’s control. Likewise, there is evidence that laboratory information is only partially utilized. A recent document from the International Organization for Standardization (ISO) recommends a new, broader definition of the term ‘‘laboratory error’’ and a classification of errors according to different criteria. In a modern approach to total quality, centered on patients’ needs and satisfaction, the risk of errors and mistakes in pre- and post-examination steps must be minimized to guarantee the total quality of laboratory services.

  • error budget calculations in laboratory medicine linking the concepts of biological variation and allowable medical errors
    Clinica Chimica Acta, 2003
    Co-Authors: A K Stroobants, H M J Goldschmidt, Mario Plebani
    Abstract:

    Background: Random, systematic and sporadic errors, which unfortunately are not uncommon in laboratory medicine, can have a considerable impact on the well being of patients. Although somewhat difficult to attain, our main goal should be to prevent all possible errors. A good insight on error-prone steps in the laboratory process is essential to achieving a structured system for error reduction. Methods: Here, the process of laboratory medicine is divided into Phases, and for each Phase, an error frequency is presented. While error frequencies in the laboratory (pre-analytical to Post-Analytical) have been reported elsewhere, we also include them in the present paper. In order to investigate error frequencies in the pre-pre- and post-Post-Analytical Phases, clinicians were asked to carefully answer questions concerning their ordering strategies for laboratory investigation and their interpretation of results. Results: In the present study, the overall error rate in laboratory medicine was found to be 20.0%. The error percentages in the pre-pre- and post-Post-Analytical Phase were about 12.0% and 5.0%, respectively. This indicates that, also on the clinical side, error reduction is desirable, especially in the requesting of laboratory investigation. Error reduction can be achieved through process redesigning by, for example, applying the Hazard Analysis and Critical Control Points approach. The error budget that clinicians might spend, based upon critical differences, is 26.9%. For the same test set and production circumstances, the overall biological variation is 7.9%. Clinicians thus take the error rates into account in their practical, daily use, and the ultimate achievable in laboratory medicine is biological variation. Conclusions: Several currently available software applications can aid error reduction in clinical chemistry. Both laboratory consultants and the use of information and communication technology are essential tools in optimizing the efficiency of laboratory medicine.

Veerle Lejon - One of the best experts on this subject based on the ideXlab platform.

  • external quality assessment of reading and interpretation of malaria rapid diagnostic tests among 1849 end users in the democratic republic of the congo through short message service sms
    PLOS ONE, 2013
    Co-Authors: Pierre Mukadi, Albert Lukuka, Joel Mbatshi, John Otshudiema, Jeanjacques Muyembe, Philippe Gillet, Jan Jacobs, Jozefien Buyze, Veerle Lejon
    Abstract:

    Background Although malaria rapid diagnostic tests (RDT) are simple to perform, they remain subject to errors, mainly related to the Post-Analytical Phase. We organized the first large scale SMS based external quality assessment (EQA) on correct reading and interpretation of photographs of a three-band malaria RDT among laboratory health workers in the Democratic Republic of the Congo (DR Congo). Methods and Findings High resolution EQA photographs of 10 RDT results together with a questionnaire were distributed to health facilities in 9 out of 11 provinces in DR Congo. Each laboratory health worker answered the EQA by Short Message Service (SMS). Filled-in questionnaires from each health facility were sent back to Kinshasa. A total of 1849 laboratory health workers in 1014 health facilities participated. Most frequent errors in RDT reading were i) failure to recognize invalid (13.2–32.5% ) or negative test results (9.8–12.8%), (ii) overlooking faint test lines (4.1–31.2%) and (iii) incorrect identification of the malaria species (12.1–17.4%). No uniform strategy for diagnosis of malaria at the health facility was present. Stock outs of RDTs occurred frequently. Half of the health facilities had not received an RDT training. Only two thirds used the RDT recommended by the National Malaria Control Program. Performance of RDT reading was positively associated with training and the technical level of health facility. Facilities with RDT positivity rates >50% and located in Eastern DR Congo performed worse. Conclusions Our study confirmed that errors in reading and interpretation of malaria RDTs are widespread and highlighted the problem of stock outs of RDTs. Adequate training of end-users in the application of malaria RDTs associated with regular EQAs is recommended.

Jan Jacobs - One of the best experts on this subject based on the ideXlab platform.

  • external quality assessment of reading and interpretation of malaria rapid diagnostic tests among 1849 end users in the democratic republic of the congo through short message service sms
    PLOS ONE, 2013
    Co-Authors: Pierre Mukadi, Albert Lukuka, Joel Mbatshi, John Otshudiema, Jeanjacques Muyembe, Philippe Gillet, Jan Jacobs, Jozefien Buyze, Veerle Lejon
    Abstract:

    Background Although malaria rapid diagnostic tests (RDT) are simple to perform, they remain subject to errors, mainly related to the Post-Analytical Phase. We organized the first large scale SMS based external quality assessment (EQA) on correct reading and interpretation of photographs of a three-band malaria RDT among laboratory health workers in the Democratic Republic of the Congo (DR Congo). Methods and Findings High resolution EQA photographs of 10 RDT results together with a questionnaire were distributed to health facilities in 9 out of 11 provinces in DR Congo. Each laboratory health worker answered the EQA by Short Message Service (SMS). Filled-in questionnaires from each health facility were sent back to Kinshasa. A total of 1849 laboratory health workers in 1014 health facilities participated. Most frequent errors in RDT reading were i) failure to recognize invalid (13.2–32.5% ) or negative test results (9.8–12.8%), (ii) overlooking faint test lines (4.1–31.2%) and (iii) incorrect identification of the malaria species (12.1–17.4%). No uniform strategy for diagnosis of malaria at the health facility was present. Stock outs of RDTs occurred frequently. Half of the health facilities had not received an RDT training. Only two thirds used the RDT recommended by the National Malaria Control Program. Performance of RDT reading was positively associated with training and the technical level of health facility. Facilities with RDT positivity rates >50% and located in Eastern DR Congo performed worse. Conclusions Our study confirmed that errors in reading and interpretation of malaria RDTs are widespread and highlighted the problem of stock outs of RDTs. Adequate training of end-users in the application of malaria RDTs associated with regular EQAs is recommended.

  • sms based external quality assessment of reading and interpretation of malaria rapid diagnostic tests preliminary results among more than 2000 end users in the democratic republic of the congo
    Malaria Journal, 2012
    Co-Authors: Pierre Mukadi, Veerle Leion, Albert Lukuka, Joel Mbatshi, John Otshudiema, Jeanjacques Muyembe, Philippe Gillet, Jan Jacobs
    Abstract:

    Background Rapid diagnostic tests (RDT) are increasingly replacing microscopy for diagnosis of malaria in endemic settings. Although RDTs are simple and robust, errors in the post analytical Phase i.e. in reading and interpretation of the RDT result, are not uncommon. In the Democratic Republic of the Congo (DRC) malaria is endemic, and malaria RDTs have been introduced since 2010. In JuneJuly 2012, an external quality assessment (EQA) addressing correct reading and interpretation of the three band malaria RDT recommended by the National Malaria Control Programme was organized among end-users in DRC.

Pierre Mukadi - One of the best experts on this subject based on the ideXlab platform.

  • external quality assessment of reading and interpretation of malaria rapid diagnostic tests among 1849 end users in the democratic republic of the congo through short message service sms
    PLOS ONE, 2013
    Co-Authors: Pierre Mukadi, Albert Lukuka, Joel Mbatshi, John Otshudiema, Jeanjacques Muyembe, Philippe Gillet, Jan Jacobs, Jozefien Buyze, Veerle Lejon
    Abstract:

    Background Although malaria rapid diagnostic tests (RDT) are simple to perform, they remain subject to errors, mainly related to the Post-Analytical Phase. We organized the first large scale SMS based external quality assessment (EQA) on correct reading and interpretation of photographs of a three-band malaria RDT among laboratory health workers in the Democratic Republic of the Congo (DR Congo). Methods and Findings High resolution EQA photographs of 10 RDT results together with a questionnaire were distributed to health facilities in 9 out of 11 provinces in DR Congo. Each laboratory health worker answered the EQA by Short Message Service (SMS). Filled-in questionnaires from each health facility were sent back to Kinshasa. A total of 1849 laboratory health workers in 1014 health facilities participated. Most frequent errors in RDT reading were i) failure to recognize invalid (13.2–32.5% ) or negative test results (9.8–12.8%), (ii) overlooking faint test lines (4.1–31.2%) and (iii) incorrect identification of the malaria species (12.1–17.4%). No uniform strategy for diagnosis of malaria at the health facility was present. Stock outs of RDTs occurred frequently. Half of the health facilities had not received an RDT training. Only two thirds used the RDT recommended by the National Malaria Control Program. Performance of RDT reading was positively associated with training and the technical level of health facility. Facilities with RDT positivity rates >50% and located in Eastern DR Congo performed worse. Conclusions Our study confirmed that errors in reading and interpretation of malaria RDTs are widespread and highlighted the problem of stock outs of RDTs. Adequate training of end-users in the application of malaria RDTs associated with regular EQAs is recommended.

  • sms based external quality assessment of reading and interpretation of malaria rapid diagnostic tests preliminary results among more than 2000 end users in the democratic republic of the congo
    Malaria Journal, 2012
    Co-Authors: Pierre Mukadi, Veerle Leion, Albert Lukuka, Joel Mbatshi, John Otshudiema, Jeanjacques Muyembe, Philippe Gillet, Jan Jacobs
    Abstract:

    Background Rapid diagnostic tests (RDT) are increasingly replacing microscopy for diagnosis of malaria in endemic settings. Although RDTs are simple and robust, errors in the post analytical Phase i.e. in reading and interpretation of the RDT result, are not uncommon. In the Democratic Republic of the Congo (DRC) malaria is endemic, and malaria RDTs have been introduced since 2010. In JuneJuly 2012, an external quality assessment (EQA) addressing correct reading and interpretation of the three band malaria RDT recommended by the National Malaria Control Programme was organized among end-users in DRC.

Albert Lukuka - One of the best experts on this subject based on the ideXlab platform.

  • external quality assessment of reading and interpretation of malaria rapid diagnostic tests among 1849 end users in the democratic republic of the congo through short message service sms
    PLOS ONE, 2013
    Co-Authors: Pierre Mukadi, Albert Lukuka, Joel Mbatshi, John Otshudiema, Jeanjacques Muyembe, Philippe Gillet, Jan Jacobs, Jozefien Buyze, Veerle Lejon
    Abstract:

    Background Although malaria rapid diagnostic tests (RDT) are simple to perform, they remain subject to errors, mainly related to the Post-Analytical Phase. We organized the first large scale SMS based external quality assessment (EQA) on correct reading and interpretation of photographs of a three-band malaria RDT among laboratory health workers in the Democratic Republic of the Congo (DR Congo). Methods and Findings High resolution EQA photographs of 10 RDT results together with a questionnaire were distributed to health facilities in 9 out of 11 provinces in DR Congo. Each laboratory health worker answered the EQA by Short Message Service (SMS). Filled-in questionnaires from each health facility were sent back to Kinshasa. A total of 1849 laboratory health workers in 1014 health facilities participated. Most frequent errors in RDT reading were i) failure to recognize invalid (13.2–32.5% ) or negative test results (9.8–12.8%), (ii) overlooking faint test lines (4.1–31.2%) and (iii) incorrect identification of the malaria species (12.1–17.4%). No uniform strategy for diagnosis of malaria at the health facility was present. Stock outs of RDTs occurred frequently. Half of the health facilities had not received an RDT training. Only two thirds used the RDT recommended by the National Malaria Control Program. Performance of RDT reading was positively associated with training and the technical level of health facility. Facilities with RDT positivity rates >50% and located in Eastern DR Congo performed worse. Conclusions Our study confirmed that errors in reading and interpretation of malaria RDTs are widespread and highlighted the problem of stock outs of RDTs. Adequate training of end-users in the application of malaria RDTs associated with regular EQAs is recommended.

  • sms based external quality assessment of reading and interpretation of malaria rapid diagnostic tests preliminary results among more than 2000 end users in the democratic republic of the congo
    Malaria Journal, 2012
    Co-Authors: Pierre Mukadi, Veerle Leion, Albert Lukuka, Joel Mbatshi, John Otshudiema, Jeanjacques Muyembe, Philippe Gillet, Jan Jacobs
    Abstract:

    Background Rapid diagnostic tests (RDT) are increasingly replacing microscopy for diagnosis of malaria in endemic settings. Although RDTs are simple and robust, errors in the post analytical Phase i.e. in reading and interpretation of the RDT result, are not uncommon. In the Democratic Republic of the Congo (DRC) malaria is endemic, and malaria RDTs have been introduced since 2010. In JuneJuly 2012, an external quality assessment (EQA) addressing correct reading and interpretation of the three band malaria RDT recommended by the National Malaria Control Programme was organized among end-users in DRC.