Association of Laboratory Science Education and Certification with Laboratory Errors: The Value of Education and Certification Study.

OBJECTIVES: With the exception of states that require licensure, there is no uniform requirement for certification or for education from the National Accrediting Agency for Clinical Laboratory Science (NAACLS) accredited laboratory science program for employment in a laboratory, under the Clinical Laboratory Improvement Amendments (CLIA) of 1988. The objective of the Value of Education and Certification (VEC) study was to determine if lack of NAACLS-accredited education and Medical Laboratory Technician (MLT)/Medical Laboratory Scientist (MLS) certification was associated with laboratory errors. METHODS: This cross-sectional study used personnel and testing/reporting error data from 739 laboratorians, involving five laboratory partners. RESULTS: MLS-certified individuals were 33% less likely to make errors (p=0.0473) and MLT-certified individuals were 71% less likely to make errors (p=0.0014) compared to those who were not certified. MLS-certified laboratorians were twice as likely to make testing/reporting errors compared to those who were MLT certified, which was significant (p=0.0238). Education level and accredited laboratory education were not associated with testing/reporting errors. CONCLUSION: Our data suggest that lack of MLS and MLT certification are independently associated with laboratory testing/reporting errors.

SBAR as a Standardized Communication Tool for Medical Laboratory Science Students.

OBJECTIVE: Laboratory professionals must communicate effectively on an interprofessional team. It is the responsibility of Medical Laboratory Science (MLS) programs to teach communication. The structured communication tool Situation, Background, Assessment, and Recommendation (SBAR) is one way to promote effective communication. METHODS: Students participated in a case-based simulation activity on the importance of teamwork/communication and the use of SBAR and completed a pre/post survey on communicating interprofessionally. RESULTS: Students reported increased confidence and competence with interprofessional communication after the activity with 4 of 5 questions demonstrating a statistically significant increase in scores post SBAR instruction. CONCLUSIONS: Our study demonstrates that SBAR is a suitable communication tool that can be used to increase our MLS students' confidence and competency in interprofessional communication. Educators should use this communication tool to empower MLS students to be effective members of the healthcare team.

General position of Croatian medical biochemistry laboratories on autovalidation: survey of the Working Group for Post-analytics of the Croatian Society of Medical Biochemistry and Laboratory Medicine.

INTRODUCTION: Autovalidation (AV) is an algorithm based on predefined rules designed, among others, to automate and standardize the postanalytical phase of laboratory work. The aim of this study was to examine the overall opinion of Croatian medical biochemistry laboratories regarding various aspects of AV. MATERIAL AND METHODS: This retrospective study is an analysis of the responses of a survey about AV comprised of 18 questions, as part of Module 10 ("Postanalytical phase of laboratory testing") of national External Quality Assessment program, administered by the Croatian Centre for Quality Assessment in Laboratory Medicine. Results were reported as percentages of total number of participants in survey or as proportions of observed data if the overall number of data was <100. RESULTS: 121 laboratories responded to the survey, of which 76% do not use AV, while 11% of laboratories use AV in routine laboratory work. 16/29 laboratories implemented semi-automated AV for general biochemistry (7/29), haematology (5/29), and coagulation (4/29) tests. Analytical measurement ranges, critical values, flags from analysers, interference indices and delta check were the most commonly used rules in the algorithm. 12/29 laboratories performed validation of AV with less than 500 samples (8/29). 7/13 laboratories report the percentage of AV being 20-50%, while 10/13 answered that introduction of AV significantly reduced turnaround time (TAT) (for 20 - 25%), especially for biochemistry tests. CONCLUSIONS: Despite of its numerous benefits (i.e. shorter TAT, less manual validation, standardization of the postanalytical phase), only a small number of Croatian laboratories use AV.

Statistical distributions commonly used in measurement uncertainty in laboratory medicine.

Uncertainty is an inseparable part of all types of measurement. Recently, the International Organization for Standardization (ISO) released a new standard (ISO 20914) on how to calculate measurement uncertainty (MU) in laboratory medicine. This standard can be regarded as the beginning of a new era in laboratory medicine. Measurement uncertainty comprises various components and is used to calculate the total uncertainty. All components must be expressed in standard deviation (SD) and then combined. However, the characteristics of these components are not the same; some are expressed as SD, while others are expressed as a ± b, such as the purity of the reagents. All non-SD variables must be transformed into SD, which requires a detailed knowledge of common statistical distributions used in the calculation of MU. Here, the main statistical distributions used in MU calculation are briefly summarized.

Roots of the total testing process.

Laboratory professionals can contribute to improvement of diagnosis in the context of the total testing process (TTP), a multidisciplinary framework complementary to the diagnostic process. While the testing process has been extensively characterized in the literature, needed is accurate identification of the source of the term "total testing process". This article clarifies first appearance of the term in the literature and supplies a formal definition.

The Journal of Molecular Diagnostics: 20 Years Defining Professional Practice.

This editorial highlights 20 years of JMD defining professional practice.

Post-analytical laboratory work: national recommendations from the Working Group for Post-analytics on behalf of the Croatian Society of Medical Biochemistry and Laboratory Medicine.

The post-analytical phase is the final phase of the total testing process and involves evaluation of laboratory test results; release of test results in a timely manner to appropriate individuals, particularly critical results; and modification, annotation or revocation of results as necessary to support clinical decision-making. Here we present a series of recommendations for post-analytical best practices, tailored to medical biochemistry laboratories in Croatia, which are intended to ensure alignment with national and international norms and guidelines. Implementation of the national recommendations is illustrated through several examples.

Documenting metrological traceability as intended by ISO 15189:2012: A consensus statement about the practice of the implementation and auditing of this norm element.

ISO15189:2012 requires medical laboratories to document metrological traceability of their results. While the ISO17511:2003 standard on metrological traceability in laboratory medicine requires the use of the highest available level in the traceability chain, it recognizes that for many measurands there is no reference above the manufacturer's selected measurement procedure and the manufacturer's working calibrator. Some immunoassays, although they intend to measure the same quantity and may even refer to the same reference material, unfortunately produce different results because of differences in analytical selectivity as manufacturers select different epitopes and antibodies for the same analyte. In other cases, the cause is the use of reference materials, which are not commutable. The uncertainty associated with the result is another important aspect in metrological traceability implementation. As the measurement uncertainty on the clinical samples is influenced by the uncertainty of all steps higher in the traceability chain, laboratories should be provided with adequate and appropriate information on the uncertainty of the value assignment to the commercial calibrators that they use. Although the between-lot variation in value assignment will manifest itself as part of the long-term imprecision as estimated by the end-user, information on worst-case to be expected lot-lot variation has to be communicated to the end-user by the IVD provider. When laboratories use ancillary equipment that potentially could have a critical contribution to the reported results, such equipment needs verification of its proper calibration and criticality to the result uncertainty could be assessed by an approach based on risk analysis, which is a key element of ISO15189:2012 anyway. This paper discusses how the requirement for metrological traceability as stated in ISO15189 should be met by the medical laboratory and how this should be assessed by accreditation bodies.

The importance of commutability in material used for quality control purposes.

External Quality Assessment (EQA) is an important part of laboratory quality assurance. Spiking of normal plasma is sometimes employed to mimic clinical samples. It is important that spiked material gives similar results to clinical samples (ie, is commutable) to ensure appropriate conclusions can be drawn from EQA exercises. We describe here data from UK National External Quality Assessment Scheme for Blood Coagulation (NEQAS BC) exercises where spiked samples were tested alongside samples from patients to explore commutability of artificial material. Normal plasma was spiked with unfractionated heparin (UFH), low molecular weight heparin (LMWH), Dabigatran or Rivaroxaban. Factor VIII (FVIII) deficient plasma was spiked with FVIII concentrate. Spiked samples and ex vivo patient material were sent to laboratories for testing. For LMWH, good agreement was seen between results for samples from patient plasma and plasma spiked with heparin. For UFH, APTT ratios differed between spiked and patient samples for the same drug concentration, with no correlation in ranking of reagents. Precision for patient and spiked material for Rivaroxaban and Dabigatran assays was comparable. However, the pattern of results for some Dabigatran assay kits differed between spiked and patient samples. For FVIII assays, results obtained with spiked and postinfusion samples gave comparable results. Spiked material is suitable for EQA if commutability is demonstrated. Our data show commutability for plasma spiked with Rivaroxaban, LWMH and some FVIII concentrates. For some tests, notably APTT for UFH, marked differences between patient and spiked samples indicate not all tests can be evaluated using artificial samples.

Clinical Laboratory Reference Intervals in Ethiopia: Current Status and Future Considerations: Review.

Background: Clinical laboratory reference intervals are derived from a sample of selected healthy population and they are used for disease diagnosis, management, and monitoring. International guidelines recommended that laboratories and manufacturers are supposed to establish their own RIs for a certain group of population. Therefore, the aim of this narrative review is to summarize the current status and to show future directions regarding reference intervals of clinical laboratory parameters among Ethiopian population. Methods: PubMed, Google Scholar, and Google databases were searched to access relevant reference interval studies in Ethiopia. Journal articles, guidelines, reports, and related documents published in English language were included without publication period restriction. Results: Fifteen studies were conducted to establish local reference intervals for hematology, immunology, and clinical chemistry parameters in Ethiopia from 1999 - 2018. The majority of those studies determined clinical laboratory reference intervals for adults only. Some other Ethiopian reference interval studies did not include the majority of routine hematology and clinical chemistry parameters. In addition, the studies we reviewed did not consider the cultural, ethnic, demographic, and geographical diversity of Ethiopian population. Conclusions: There is limited data regarding locally established reliable clinical laboratory reference intervals in Ethiopia though attempts are made. Therefore, further local reference interval studies should be undertaken considering the cultural, ethnic, demographical, and geographical diversity of the Ethiopian population.

The Observation and Analysis of Internal Quality Control of Cystatin C in China from 2014 to 2017.

BACKGROUND: This study observed and analyzed the internal quality control (IQC) of cystatin C (CysC) so that we can have overall knowledge about imprecision levels in Chinese medical laboratories. METHODS: Using the software developed by the National Center for Clinical Laboratories (NCCL), we can get the IQC information of CysC from 2014 to 2017. Then the proportion of laboratories meeting five quality specifications (pass rates) were calculated and the current CVs (coefficient of variation) were also compared among subgroups and years. RESULTS: We find that the current CVs between 2014 and 2017 show significant differences (p = 0.016) and the proportion of laboratories meeting the 1/3 TEa specification distributes randomly from 2014 to 2017 but all of them exceed 80 percent. When the optimum specification is applied, the pass rates all become very low and the distributions are wide spread (from 3.63% to 6.74%). Beckman, Roche, and Hitachi are mainstream analyzers, making up as much as 78% to 85% of all. We can see a significant difference of the pass rate between Beckman and Hitachi in 2014 (p = 0.005). The primary means of detecting CysC is particle-enhanced turbidimetric immunoassay (PETIA) which makes up 30.57% - 32.64% of detection methods. The good news is that the IQC practice has improved greatly from 2014 to 2017 in laboratories in China. CONCLUSIONS: Medical laboratories have made some progress in IQC from 2014 to 2017, but it is still not satisfactory. As a result, there is a long way to go to improve detection quality of laboratories in China.

[Medical biology in the face of the evolution of health care needs]. / Rapport des Académies nationales de médecine et de pharmacie sur la biologie médicale La biologie médicale face aux défis de l'évolution des besoins de santé.

Since the publication of the ordinance of January 13th 2010, ratified by the law of May 30th 2013, medical biology in France has undergone a massive restructuration with the emergence of groups of several hundred laboratories. This evolution, which leads to a considerable reduction in the number of structures, causes numerous problems related to increased industrialization and financialization, difficulties of accreditation and disappearance of the proximity link between the biologist and the prescriber or the patient. It also leads to a clear disaffection of students, especially medical students, for this specialty whose medical character has been clearly affirmed by the law. This report takes stock of the current situation of medical biology and makes recommendations to strengthen the role of the medical biologist in the health system and patients' care.