It is essential that both, computer-based and paper-based information systems are considered, as well as all scenarios where information is received, generated or reported. Performance of tests in the laboratory is rigorously controlled, with quality control procedures in place that markedly reduce errors in the analytic phase of testing. Into some of them can continually be loaded the specimens and all supplies, including reagents. This work is licensed under the Creative Commons Attribution 4.0 International License. The photometric and immunoassay analytical automations can share the majority of these properties and differ in measurement principles and modes. Management of post-analytical processes in the clinical laboratory It was after the coupling of instrument and electronic automation by means of LIS that attention was directed to automation of the pre- and post-analytic laboratory work phases. There are three phases in any sample testing procedure. This resultant automation can be considered as partial or task-targeted automation [23]. Am J Clin Pathol 2006;125:76570.10.1309/3J5P9VJRUP4U5RU5Search in Google Scholar, 9. Your purchase has been completed. Some authors have introduced the "pre-pre-" and "post-post-" analytical phases to identify activities associated with the initial selection of tests and with the interpretation by clinicians respectively, to differentiate them for the pure collection/transport activities (pre-analytical phase) and reporting (post-analytical phase) [ 3, 4 ]. Instructions are finally provided about the correct use of the accreditation label in laboratory reports. Primary or secondary tubes with conventional sizes (16*100 mm and 13*100 mm) are transported to proper localization by means of this transporter in racks or as individual tubes. Durner J. Available from: Aarsand, AK, Sandberg, S. How to achieve harmonisation of laboratory testing The complete picture. The contingency plan must consider different scenarios and clearly define the actions to be taken and the professional responsible for each action [17]. The specimen caps or stoppers are removed by a device and discarded into a waste. Some of these vendors, such as Abbott Diagnostics, Beckman Coulter, Roche Diagnostics, and Siemens Healthcare Diagnostics, have become more prominent than the others. Analytical Phase - an overview | ScienceDirect Topics Armbruster DA, Overcash DR, Reyes J. Lpez Yeste M, Pons Mas A, Guin Muoz L, Izquierdo lvarez S, Garca F, Blanco Font A, Pascual Gmez N, Snchez Gancedo L, Garca lvarez A, Bernabeu Andreu F, Chueca Rodrguez M, lvarez Domnguez L. Management of post-analytical processes in the clinical laboratory according to ISO 15189:2012. Just after understanding the pre- analytic errors have a large impact on the test results, the efforts were directed to the automation of the pre-analytic phase, which meant an extra-analytical automation, and the door was expanded out of the testing phase. The modern analyzers use positive displacement pipettes, capable of pipetting of various or fixed volumes of both samples and reagents. "Automation in the clinical laboratory: integration of several analytical and intralaboratory pre- and post-analytical systems". It is in the phase that the attention was directed to the pre- and post-analytic activities of the laboratory work flow after instrument and electronic automations. Clin Biochem Rev 2014;35:14353.Search in Google Scholar, 31. The wider the sizes, the better. Beastall, GH. However, the most important component of automated systems have been the microprocessor and computer [18]. Verboeket van de Venne, WPHG, Aakre, KM, Watine, J, Oosterhuis, WP. Interface to workstations or automated analyzers. In such event, prior to the delivery of results, customers will be informed of such circumstance and its associated consequences and give consent. Oxford: Elsevier, 2013.Search in Google Scholar, 27. CAP Today 2003;17:336.Search in Google Scholar, 13. Their tube capacity may differ depending on the vendor. With regard to laboratory reports, all methods of delivery must be considered (electronic systems, paper, electronic mail or smartphone) to establish the appropriate security measures (dissociated information, encryption, among others). J Lab Autom 2012;17:46980. For further information about the use of the ENAC label, see the CEA-ENAC-01 document. The risk assessment identifies and . PDF The detection and prevention of errors in Clinical laboratory - IJSRP laboratory analyzers) and external (i.e. Klinik laboratuvarlarda toplam otomasyon uygulanmasnda yksek kalitede hizmeti srdrmek iin devaml ve yksek kalitede mteri hizmetleri gerektirmesi gibi maliyeti etkileyen tartmal durumlardan dolay baz zorluklar vardr. Thanks to the laboratory automation, there has been a reduction in the variability of results and analytic errors, and a significant improvement in the quality of laboratory test results has been caused by the improved reproducibility, which provides the support to clinicians to improve the diagnosis and treatment of patients [16]. Evaluation of the postanalytical process must include the activities carried out both, in the laboratory (post-analytical phase) and out of the laboratory (post-postanalytical phase). Clinical laboratories increasingly devote more efforts to improve their methodological and communication skills to help physicians in the interpretation of test results. Automation in the clinical laboratory. PubMed, 36. These are traditionally called post-postanalytical phase/process errors [7], [8], [9]. Ferraro S, Braga F, Panteghini M. Laboratory medicine in the new healthcare environment. First of all, a workflow and a workload analysis must be made for the present semi-automated laboratory. Flexible scope: accredited tests are shown in the list of accredited tests classified by categories. Auditing is also intended to verify whether this process satisfies users needs and requirements. Boyd JC, Felder RA. https://doi.org/10.1016/j.labcli.2009.12.001.Search in Google Scholar, 18. Sciacovelli, L, Aita, A, Padoan, A, Pelloso, M, Antonelli, G, Piva, E, et al.. If a bidirectional interface with LIS is available in the laboratory, some tasks may become automated [23]. PubMed, 15. Oxford: Elsevier, 2013. In contrast, in sequential analyzers, the samples are tested sequentially, and the results are reported at that order. The throughput of AutoAnalyzer was 150 samples per hour, and repertoire 20 analytes. Clin Lab 2008;54:42338. In many cases, the analyzer design and functionality should thus be considered carefully, The availability technical service and logistic, Real time, local service availability is more important. Laboratorios clnicosRequisitos particulares para la calidad y la competencia. PubMed, 14. One should take into consideration that the more on-line connected the analytical systems, the more complicated and problematic the total laboratory automation. However, not all systems can decap hemograds, rubber stoppers, or screw caps. For instance, multiple samples are tested in a series in batch analyzers. Consequently, stand-alone pre- and/or post-analytical systems have become supplementary for automated analyzers in clinical laboratories. Automation and expert systems in a core clinical chemistry. Entidad Nacional de Acreditacin. Thus, the reference intervals and medical decision limits are all the same for all analyzers, Inter- and intra-assay coefficients of variations or precision check are important, No sample-to-sample or reagent-to-reagent carryover must be provided, Either in aliquoter or in analyzers, clot detection must be executed, Detection of sample integrity or hemolytic-icteric-lipemic (HIL) indices determination, Ability to handle small sample volumes; the lower the sampling volume, the better in general, Open channel are used for extra or out-of-menu tests, This means periodical/preventive maintenance, the maintenance intervals, and the duration of a maintenance or downtime. For procedures not clearly defined by CCMB, our recommendations have been formulated based on the literature specified. Rosenfeld L. A golden age of clinical chemistry: 19481960. MO: Elsevier Saunders, St. Louis, 2012:46984. It is concerned with achieving appropriate levels in matters such Laboratories are also required to design an internal quality control scheme to verify whether postanalytical activities attain the expected standards. Tatsumi N, Okuda K, Tsuda I. Clin Chem Lab Med 2016;54:52333.10.1515/cclm-2015-0803Search in Google Scholar Mean time to critical result notification. The workflow of the laboratory can be improved using refrigerated stockyard with automatic retrieval. The latter comprises all laboratory work flows such as sample transfer to the laboratory, accepting a clinical specimen into the laboratory, pre-testing processes, testing, and post-testing processes [17]. J Pathol Inform 2014;5:13. Clin Chem Lab Med 2012;50:124952. In 2011, the National Quality Forum added 2 new laboratory-related errors to its list of serious . https://doi.org/10.1515/cclm-2016-0929.Search in Google Scholar In a wider perspective, the laboratory automation may be associated with improvements in analytical methods, TAT, specimen handling (including centrifugation, retrieval, dilution, and rerun), throughput, cost, middleware, laboratory safety, and instrument downtime and service [14]. PubMed, 13. access to facilities, location of computers, automatic screen lock, to name a few). The post-analytic phase is the final phase of the laboratory process. PubMed, 21. Multiple linear bar code readers may be preferred, How many aliquots can be made from a single primary tube if needed? However, the specimens can repeatedly be identified by one of two options: multiple linear bar code readers and radiofrequency identification. The ultimate phase of clinical laboratory automation is the instruction of integrated pre- and post-analytical systems, with the other naming being integrated or modular automation systems and total laboratory automation. Immunoassays & co.: past, present, future? In cases where the literature does not provide a clear . Activities performed by external suppliers: Accredited activity performed by an external accredited laboratory: clearly identify the activities performed by an external laboratory. In cases where the literature does not provide a clear . PDF Quality assurance in analytical laboratories - International Union of The label is always associated with the name or trademark of the accredited organization and should appear at least on the first page of the report. Clinical chemistry laboratory automation in the 21st century Amat Victoria curam (Victory loves careful preparation). Performance criteria and quality indicators for the post-analytical phase. Zaninotto M, Plebani M. The hospital central laboratory: automation, integration and clinical usefulness. The laboratories should use automation provided that it is only necessary and appropriate. This phase culminates in the production of a final value, result, or in the case of histology, a diagnostic pathology report. However, the aliquot number, aliquot tube type, and label involvement must be considered carefully, which may not be suitable for every laboratory. CAP Today 2003;17:336. Middleton S, Mountain P. Process control and on-line optimization. CLIA and Quality Assurance In order for us to define the quality indicators and to evaluate the improvements thanks to the laboratory automation, we should use solid metrics, and it is only with this way that we objectively evaluate the pre- and post-automation performance characteristics and its effectiveness. Clin Chem 2002;48:175160. & Nurcan, K. (2017). All procedures for the post-analytical phase are an integral part of ISO 15189:2012, thereby allowing rigorous quality control of post-analytical laboratory work . 42 (Issue 1), pp. Competing interests: Authors state no conflict of interest. Maclin E, Young DS. MO: Elsevier Saunders, St. Louis, 2012:46984.10.1016/B978-1-4160-6164-9.00019-6Search in Google Scholar, 24. Washington, DC: AACC Press, 2002. Several systems can make aliquots for offline analyzers. Does the aliquoting module have a secondary tube-capping, labeling, and sorting capacity for off-line analyzers? The characteristics of the contingency plan are detailed in Figure4. Clin Chem Lab Med 2010;48:9117.10.1515/CCLM.2010.192Search in Google Scholar A clinical laboratory may have several, multiple automated systems, and moving from the present situation to the laboratory automation is generally difficult task [14]. Some systems can detect the clot and physical property of the specimen (serum indices) here. Blood Clot Identification Procedures in Clinical Laboratory - PubMed Turk J Biochem 2015;40(S1). At least three major vendors in market offer this unit (See, Most systems contain a decapper unit. When use is not feasible (visualization on a web portal). Am J Clin Pathol 2006;125:76570. Sources of pre-analytical, analytical and post-analytical errors in the Despite the high number of errors that occur throughout the postanalytical process and the fact that it is a requirement of ISO 15189 (5.6.3), EQAPs are not yet fully developed. Special emphasis is placed on the communication of results, laboratory information management and risk management. These requirements are becoming increasingly questionable because of cost apprehensions. Automation in the clinical laboratory: integration of several analytical and intralaboratory pre- and post-analytical systems, Downloaded on 9.7.2023 from https://www.degruyter.com/document/doi/10.1515/tjb-2016-0234/html?lang=en, Classical and Ancient Near Eastern Studies, Library and Information Science, Book Studies, Flow cytometric detection of endothelial progenitor cells (EPC) in acute coronary syndrome, Evaluation of prolidase activity in uremic bone disease, The independent relationship between hemoglobin A, Association of missense substitution of A49T and V89L in the SRD5A2 gene with prostate cancer in Turkish patients, Delays in reporting critical values from clinical laboratories to responsible healthcare staff, Re-determining the cut-off points of FIB-4 for patients monoinfected with chronic hepatitis B virus infection, Approach to pre-analytical errors in a public health laboratory, Serum proPSA as a marker for reducing repeated prostate biopsy numbers, NT-proBNP levels in -thalassemia major patients without cardiac hemosiderosis, Comparison of high sensitive and conventional troponin assays in diagnosis of acute myocardial infarction, Assessment of macroprolactinemia rate in a training and research hospital from Turkey, Evaluation of the first Turkish in vitro diagnostic symposium. All procedures for the post-analytical phase are an integral part of ISO 15189:2012, thereby allowing rigorous quality control of post-analytical laboratory work . Plebani, M. Errors in clinical laboratories or errors in laboratory medicine? The automation system needs smooth, perfect, and fault-free integration and interaction between software programs. Post-Analytical Phase - an overview | ScienceDirect Topics PDF Laboratory Quality Standards - World Health Organization Post-analytical laboratory work: national recommendations from the Durner J. Turkish Journal of Biochemistry, Vol. As mentioned earlier, analytical automation is the fast-developing area of clinical laboratory automation, and new automated analytical platforms are day-to-day being developed such as molecular diagnostic, immunostainer, and microbiological platforms. Sarkozi L, Simson E, Ramanathan L. The effects of total laboratory automation on the management of a clinical chemistry laboratory. (Invited speaker abstract of 27th National Biochemistry Congress). PubMed, 16. In: ENAC, editor, CEA-ENAC. Protocolo para el estudio de la estabilidad de las magnitudes biolgicas. PubMed, 26. Critical results reported out of time with respect to the total number of reported results. In: Ward-Cook KM, Lehmann CA, Schoeff LE, Williams RH, Editors. Comisin de calidad extraanaltica. However, it has been suggested that the laboratories with workloads of 100010,000 specimens per day design the complex laboratory systems, which involves a track for connecting the analyzers [28]. Conflict of interest: The authors declare that there is no conflict of interest. As the automated instruments have been evolved, the test throughput of analyzers in the clinical laboratory has increased extensively. Laboratory automation: communications with automated clinical laboratory systems, instruments, devices, and information systems. (Invited speaker abstract of 27th National Biochemistry Congress).Search in Google Scholar, 11. PubMed In order to evaluate the cost effectiveness of the laboratory automation implementation, it has been suggested that a commitment to automate be formed from technologists, supervisors, information services, and hospital and department administration [14]. Olsen K. The first 110 years of laboratory automation: technologies, applications, and the creative scientist. Management of post-analytical processes in the clinical laboratory Sarkozi L, Simson E, Ramanathan L. The effects of total laboratory automation on the management of a clinical chemistry laboratory. Laboratory accreditation organizations recommend that each laboratory determine TATs for each test (form both stat and routine analytes) and the number of process failures for a given period, all of which can be followed and evaluated by means of information technology. Laboratory Accreditation Board of the Spanish Society of Laboratory Medicine (SEQCML). A range of nations and scientific societies support that clinical laboratories should be required to obtain accreditation. The currently-used laboratory instruments are designed for stand-alone operation and are of workstation concept. Several advantages of laboratory automation include the standardization of testing, reducing the duration of sample handling steps, improvements in TAT, and eliminating the potential human errors, all of which improve patient care and provide a high-quality service. Preanalytical phase comprises of test selection, patient identification, collection of the sample, handling of the sample, sorting out, pipetting and centrifugation ( 2, 3 ). Clinical Laboratory - StatPearls - NCBI Bookshelf Depending on the system configuration, the analyzers having direct physical connections are called on-line analyzers, which can make sampling either directly from the conveyor belt or by taking the sample into the analyzer and pipetting it. Management of post-analytical processes in the clinical laboratory according to ISO 15189:2012. 10 Quality improvement initiatives must . Management of post-analytical processes in the clinical laboratory J Lab Autom 2012;17:46980.10.1177/2211068212455631Search in Google Scholar Adding value to laboratory medicine: a professional responsibility. Sasaki M, Kageoka T, Ogura K, Kataoka H, Ueta T, Sugihara S. Total laboratory automation in Japan: past, present, and the future. Situations that may arise include a failure of the HIS or/and LIS or the interruption of communication between the HIS and LIS. the laboratory staff focuses on detecting and eliminating the analytical errors. Evaluation of needs and alternatives and development of a plan. Wiwanitkit V. Types and frequency of preanalytical mistakes in the first Thai ISO 9002: 1994 certified clinical laboratory, a 6-month monitoring. Protocolo para el estudio de la estabilidad de las magnitudes biolgicas. Paul Wallace, Elaine McCulloch, in Encyclopedia of Virology (Fourth Edition), 2021. Meanwhile, a coupling occurred between clinical chemistry and immunoassay within a single workstation such as Dimension Vista [25]. PubMed IFCC WG-LEPS: MQI-KP - revision 1 January 2017. The control module can coordinate both the analyzer and robotic system operations. Holland LL, Smith LL, Blick KE. A selected history and future of immunoassay development and applications in clinical chemistry. The role of total laboratory automation in a consolidated laboratory network. Klinik laboratuvar otomasyonu: eitli analitik ve laboratuvar ii pre- ve post-analitik sistemlerin entegrasyonu, Ebubekir, Bakan, Nurinnisa, Ozturk and Nurcan, Kilic-Baygutalp.