post analytical phase of laboratory testing

Harmonization: The Sample, the Measurement, and Report. Ann Clin Biochem. Although there are no universal guidelines on maximal permissible sample dilution, our recommendation is that the laboratory define and examine the dilution protocol based on the measurement procedure and define the range of reporting results, including the AMR and maximum dilution that can be used for each test, as well as the method for which dilution is applicable. Clin Chem Lab Med. Promoting clinical and laboratory interaction by harmonization. Laboratories should conform to recommendations of the CCMB and CSMBLM and to internal policies and regulations of the healthcare facilities where the laboratories operate. 2017;24:27785. Accessed June 6th 2018. Automated selection and reporting of test results does not affect routine laboratory work, nor does it affect confirmation criteria for steps preceding automated selection. Ann Clin Biochem. Review of Medical Errors in Laboratory Diagnostics and Where We Are Lab respond: a tool for autoverication. Accessed December 26th 2018. Process improvement and operational efficiency through test result autoverification. Approved Guideline, Third Edition. (In Croatian), Official Journal of the Republic of Croatia. Carraro P, Plebani M. Errors in a stat laboratory: types and frequencies 10 years later. https://doi.org/10.1016/j.ebiom.2017.09.024. Therefore, laboratories must define carefully who can access patient data for what purpose, and the data must be protected from alteration, premature destruction or unauthorised use (81). 2015 May;53(6):919-24. doi: 10.1515/cclm-2014-1268. https://doi.org/10.1515/cclm-2011-0611. These minimum storage periods vary with the type of document. As another example, free thyroxine (fT4) is performed if thyroid-stimulating hormone (TSH) results are outside the reference interval. The requesting physician may request testing of a new sample but cannot cancel the laboratory request. Critical limits may even be defined for specific departments or clinical units. These recommendations are based on CCMB regulations and recommendations, the International Organization for Standardization (ISO) 15189:2012 (Medical laboratories - Requirements for quality and competence), other national recommendations of the CSMBLM, laws and policies of the Republic of Croatia and recent literature (7). As well as providing quality data and interpretation, the knowledge of laboratory experts can be used to provide targeted procedural knowledge in a patient report. In an MBL, however, data are usually stored on a computer or shared storage platform (server) within the laboratory. If no reference interval is available, the reference interval should be clearly indicated. Management of critical- and significant-risk results, 1st Edition. Copyright: 2018, Croatian Society of Medical Biochemistry. If additional procedures give unacceptable results, the laboratory test report is released (Procedure 2) without the unacceptable (controversial) result, together with an explanation in the Comments area about why the test results are invalid and what further procedures are recommended (Procedure 3). In summary, the exploratory analysis consists of Features type identification, Identification of missing values, outliers and possibly other errors (often caused by humans), Identification of interconnections/relationships between individual features, and Selection of useful features. Automated or semi-automated selection and reporting of test results is the recommended procedure. If reference intervals have not been determined for specific age groups, such intervals should not be interpolated or extrapolated from data from other age groups in the absence of studies based on the relevant analytical method. Reflex testing and especially reflective testing are recommended as a useful way to improve diagnosis and treatment. Recommended actions when the delta check exceeds the laboratory-specified limits include: a) reviewing clinical data (clinical diagnosis, therapeutic interventions, contacting a physician); b) retesting the current and previous sample (if available), including primary tubes and aliquots; c) checking for the presence of haemolysis, lipemia, icterus, clot or error in tube labelling of the previous and current sample, including primary tubes and aliquots; and. 2016;26:516. [Arhiviranje laboratorijske dokumentacije Povjerenstva za struna pitanja.] These analytes have little day-to-day variation, low RCV and low index of individuality. Every error in the algorithm should be tested before introducing automated selection and reporting of test results into the routine. All results flagged by an analyser have to be confirmed by retesting, regardless of their position within or beyond the AMR. In other words, the post-analytical phase allows us to monitor performance of the analytical phase. Minimum recommended quality indicators for the post-analytical phase are: turnaround time (TAT), percentage of incorrect (revoked) laboratory test reports, and notification of critical results. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. Additional guidelines defining the interaction between the two laboratories can be found in the CCMB Recommendations for Sampling in a Collaborative (Referral) Laboratory (48). Reference intervals are commonly used as a basis for data interpretation; however, laboratories vary in the reference intervals they use, even when analysis is similar. Criteria can vary, but the one most often used is the RCV (see sections 1.2 and 1.2.11.2.1.). The https:// ensures that you are connecting to the Disclaimer. Turnaround time (TAT) is defined as the time interval that starts from the time when the laboratory receives the sample until the time the test results for that sample are validated and released (86). Managing the Pre- and Post-analytical Phases of the Total Testing government site. Such experts are mandated by regulations concerning the medical biochemistry profession to hold masters degrees or specialisations in medical biochemistry and laboratory medicine, they must have passed the relevant board certification exam, and they must possess a valid license to practise from the Croatian Chamber of Medical Biochemists (CCMB). The highest percentage of errors are made during the preanalytical stage, i.e., around 62% . Recommended actions are presented in Recommendation 5 (36). Niu A, Yan X, Wang L, Min Y, Hu C. Utility and necessity of repeat testing of critical values in the clinical chemistry laboratory. Limits for critical results can also be included in the LIS, facilitating their rapid interpretation. LABORATORY TESTING. Results: The frequency and types of errors in the pre-analytical, analytical, and post-analytical phases were assessed in this study. *CVA from long-term internal quality control data, Example 1. The analytical phase shows the lowest rate of errors in the whole Total Testing Process (TTP) (Pansini 2003). 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. Post-Analytical Phase - an overview | ScienceDirect Topics (PDF) Managing the Pre- and Post-analytical Phases of the Total Testing Accessed November 30th 2018. Available at: http://www.hkmb.hr/povjerenstva/strucna-pitanja/strucna-pitanja-2012-2014/. Automated selection and reporting of test results simplifies post-analytical laboratory work, shortens TAT, and helps ensure that results are confirmed based on the same objective rules, without risk of inter-individual variation such as among laboratory personnel. Available at: https://www.kiggs-studie.de/deutsch/home.html. An official website of the United States government. The laboratory should record policies and procedures about releasing reports, including details about who releases reports and to whom. Available at: https://www.rcpath.org/uploads/assets/uploaded/97364ab3-b679-43ab-8afb47be199e1d3c.pdf. An example of such an analyte is alkaline phosphatase or mean corpuscular volume (MCV). Accessed January 15th 2018. Before the introduction of reflective and/or reflex testing in routine laboratory work, agreement must be reached within the laboratory and with physicians, as well as in alignment with accepted clinical guidelines, about which tests are to be included in these algorithms. Accessed November 30th 2018. Label at the top of 2 sheets with the heading, "Pre-analytical." Repeat this labeling for "Analytical" and "Post Analytical" so that you create 2 sets of 3 Since 1 January 2005, all medical biochemistry laboratories (MBLs) in Croatia are required to use the recommended analytical methods from this CCMB document as a prerequisite for using the recommended reference intervals (16). 2009;131:41831. 2015;5:812. College of American Pathologists. The daily processes in a laboratory generate substantial amounts of data, mostly in electronic form, that must be catalogued and archived to ensure credibility and quality of test results. Document C28-A3 of the Clinical and Laboratory Standards Institute (CLSI) recommends the use of acceptable reference intervals regardless of their origin, which may come from the test reagent manufacturers, multi-centre studies, recommendations of regulatory bodies, medical literature and prevailing practice (11-13). Original results that are later revised should be retained on a cumulative laboratory test report and must be clearly labelled as such. https://doi.org/10.3346/jkms.1990.5.4.189, Park SH, Kim SY, Lee W, Chun S, Min WK. Laboratory turnaround time. Closing the loop in medical diagnostic laboratory testing phases (In Croatian), Official Journal of the Republic of Croatia. Postanalytical variables occur after a test result is generated. Only laboratory personnel with masters degrees and/or with a completed specialisation in medical biochemistry and laboratory medicine have the necessary competencies to confirm test results and decide whether to release them after review and any additional procedures. Clinical decision limits are generally superior to reference intervals as a basis for interpretation because they address the specific clinical concern in any patient. For example, a test for direct (conjugated) bilirubin is performed if a test for total bilirubin gives a result higher than the upper limit of the reference interval. (In Croatian). 2009;47:135560. Results outside the AMR cannot be confirmed or released during automated selection and reporting of test results (53). Reference change value). Analytical performance specifications for EQA schemes - need for harmonisation. J Mass Spectrom Adv Clin Lab. Organisations must at all times know where and for what purpose information may be used. The role of External Quality Assessment Schemes in monitoring and improving the standardization process. Post-Analytical Phase - an overview | ScienceDirect Topics https://doi.org/10.1373/clinchem.2005.054395, Onelv L, Gustafsson E, Grnlund E, Andersson H, Hellberg G, Jrnberg I, et al. This site needs JavaScript to work properly. Many analysers feature automatic sample dilution (auto dilution) for this purpose; if not, laboratory personnel should manually dilute the sample and multiply the results by the dilution factor in order to obtain results for the original sample, if applicable to the method. All test results that are not confirmed and released immediately upon analysis as part of the automated selection and reporting of test results must be evaluated through two mutually independent activities: review and confirmation of test results. Laboratories and their home medical institutions may also define additional regulations. [Preporuka za kritine vrijednosti laboratorijskih nalaza i nainu izvjetavanja Povjerenstva za struna pitanja]. Available at: https://narodne-novine.nn.hr/clanci/sluzbeni/2015_08_90_1757.html. Accessed May 24th 2018. J Korean Med Sci. 2000;46:18117. Primary samples must be stored after analyses to ensure their availability for re-testing or additional testing. A laboratory expert is authorised to revoke an entire laboratory test report, part of the report or only a specific test result on the report. After review of the results of tests and any additional procedures, the decision is made whether to release the test results. https://doi.org/10.1373/clinchem.2004.036301, Fraser CG, Stevenson HP, Kennedy IMG. Results are sent to the required individual in a timely . If a difference between two measurements is suspected to be due to patient or sample miss-identification, evaluation of results and any further actions should take into account all the patients existing samples. The laboratory must define and examine the dilution protocol according to the measurement procedure. When a laboratory test report must be changed, the change should be clearly indicated and explained to the user. Clin Chem. Please enable it to take advantage of the complete set of features! Only authorised personnel can report critical results. Laboratories should define their own limits beyond which delta check values are considered significant; these limits should be defined according to the patient population, type of laboratory test and existing clinical recommendations. It is recommended that the review of test results include the testing of the difference between two consecutive results (delta check) whenever a predetermined result exists, because any difference between successive results that exceeds the defined limits may indicate (a) a significant change in the patients clinical condition, or (b) a problem with the sample. Monitoring of turnaround time can be expressed in terms of percentage of tests not performed within a given time (86). The index of individuality can estimate the usefulness of the reference interval as described in the next chapter (1.2.1. Accessed February 25th 2018. Laboratory test results cannot be released without reference intervals (14). Accessed December 26th 2018. Reasons for the revocation should be explained to the medical professional who received the report and used it for decision-making. The most important attributes of the laboratory test report are the use of recommended, standardised language and syntax and the presence of all administrative and patient identification data, measurement results and confirmation data. 2022 Jun 4;25:12-18. doi: 10.1016/j.jmsacl.2022.06.002. MeSH Successful implementation of harmonization in laboratory testing requires input by all stakeholders, including the clinical laboratory community, diagnostics industry, clinicians, professional societies, IT providers, consumer advocate groups and governmental bodies. McCune JS, Quinones CM, Ritchie J, Carpenter PA, van Maarseveen E, Yeh RF, Anasetti C, Boelens JJ, Hamerschlak N, Hassan M, Kang HJ, Kanda Y, Paci A, Perales MA, Shaw PJ, Seewaldt VL, Savani BN, Hsieh A, Poon B, Mohty M, Pulsipher MA, Pasquini M, Dupuis LL. Considering analytical influences alone, test methodologies affect the magnitude of false positive and false negative results. When semi-automated selection and reporting of test results is established, laboratory staff must initiate it by selecting the automated selection function and enabling the confirmation and release of test results as long as results are available for all tests on the sample. In the Remarks column of part 3, the appropriate reference interval and diagnostic values are indicated together with their sources, which should be consistent with the recommendations of CCMB and CSMBLM. Monitoring of quality indicators in daily laboratory work is recommended. The frequency of laboratory errors during the post-analytical phase is lower than the frequency of errors during the pre-analytical phase, yet the post-analytical phase accounts for nearly one quarter of the entire laboratory process (1-6). Sensitivity and specificity profiles influence choices for screening and confirmatory tests. It can be calculated in terms of the percentage of manually transcribed results that were incorrectly transcribed, in terms of the percentage of results released by the LIS that were incorrect, or in terms of the percentage of released reports that were incorrectly released (5). Clin Chem Lab Med. These data can be stored in the LIS. The modified report should indicate the date and time of the change, as well as the name of the person responsible for the change. Unauthorized use of these marks is strictly prohibited. Clin Chem Lab Med. Download .nbib In most cases, patient medical records are stored in the HIS, and these data are merged into a single electronic health card (EHC). It is also possible to modify the delta check formula to take into account how much time elapsed between the consecutive test results (29-32). These procedures should ensure the protection of the reports themselves as well as the privacy of patient data. Laboratories should establish rules for repeat testing. Employees are required to maintain the confidentiality of this information. [Laboratorijska dijagnostika eerne bolesti u trudnoi, Standardni laboratorijski postupak, izdanje 2.] If a physician requests the release of results for only a subset of requested tests, the laboratory test report should be considered incomplete and provisional. The difference from the previous result is calculated as a delta percent change and compared with RCV limits. Minimum recommended quality indicators for the post-analytical phase are discussed below (85). Autoverification in a core clinical chemistry laboratory at an academic medical center. Clin Chem Lab Med. Harmonization of Clinical Laboratory Information - Current and Future Strategies. The post- analytical phase is the last phase of the TTP. The Delta Check in Action: Causes and consequences of discrepant laboratory results Available at: http://www.arup.utah.edu/media/deltaChecks/Straseski%20DeltaCheck.pdf. It is recommended that each laboratory set rules for repeating certain results. https://doi.org/10.1080/00365513.2016.1200135, Krasowski MD, Davis SR, Drees D, Morris C, Kulhavy J, Crone C, et al. PDF The detection and prevention of errors in Clinical laboratory - IJSRP Each laboratory must define delta check criteria based on its patient population. On the basis of clinical information and previous test results, they may request retesting or resampling. Several types of software can accommodate automated selection and reporting results in routines: LIS after appropriate upgrade (49, 51, 52), and. Introduction The role of the clinical laboratory is essentially to provide therapists with patient data and test results for use in clinical assessment and decision making. It may be useful for detecting the most frequent causes of erroneous reports (83). Journal ID (nlm-ta): Biochem Med (Zagreb), Abbreviated Title: Biochem. The interaction between these laboratories should be specified in a contract, including the methods for reporting and transferring results (i.e. This chapter provides a brief description of these events, as well as guidance for preventing or minimizing post-analytical issues. 1. This indicator can be expressed as the average time required for reporting, or as the number or proportion of critical results reported within a defined period of time (84). In addition, the verbal communication of critical results must always be followed by a written or electronic report. Performance criteria of the post-analytical phase The percentage all laboratory test reports that are incorrect is another essential quality indicator in the post-analytical phase. Accessed December 26th 2018. 2013;8:e80663. Federal government websites often end in .gov or .mil. In any case, it must always be possible for reports to be printed out and, for example, supplied to the patient upon request or mailed to his or her home address. . Retesting prolongs turnaround time (TAT) and increases laboratory costs. 2021 Nov;100:108095. doi: 10.1016/j.intimp.2021.108095. Each laboratory determines the authority and degree of responsibility of each member of personnel in accordance with that persons documented competencies. Measuring and Unambiguous and clearly defined criteria and rules must be assured in order to prevent the release of incorrect laboratory reports. Such validation can help guide improvement of the initial algorithm for automated selection and reporting of test results. For example, test results will not be confirmed or release during automated selection and reporting of test results if the albumin concentration is higher than the total protein concentration. Quality in healthcare is ideally at an optimal benchmark, but must be at least above the minimal standards for care. This is an Open Access article distributed under the terms of the Creative Commons Attribution (http://creativecommons.org/licenses/by/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. (Zagreb), Publisher: Croatian Society of Medical Biochemistry and Laboratory Medicine. Repeat testing is recommended only when results are flagged by the analyser, regardless of their position within or beyond the AMR. Glucose concentration, 4.6 mmol/L, Serum indices: haemolysis 2, icterus 0, lipemia 0, Example 2. 2019 Sep;25(9):1890-1897. doi: 10.1016/j.bbmt.2019.05.021. In the post-analytical phase of the testing process, results are released to the . Bookshelf Available at: http://www.hkmb.hr/dokumenta/arhiva/arhivirane-obavijesti-2011/sadrzaj-laboratorijskog-nalaza/. Preanalytical phase comprises of test selection, patient identification, collection of the sample, handling of the sample, sorting out, pipetting and centrifugation ( 2, 3 ). 4. Accessed December 26th 2018. Post-Analytical Phase Errors | Download Table - ResearchGate Croatian and European Union (EU) legislation permit documentation to be archived in paper or electronic form. EN ISO 15189 - Medical laboratories - Requirements for quality and competence. https://doi.org/10.1309/LM5AM4IIXC4OIETD, Vermeer HJ, Thomassen E, de Jonge N. Automated processing of serum indices used for interference detection by the laboratory information system. However, this information should be recorded in the LIS. The legend of sample types is adapted to the type(s) of sample actually used. Key points of critical result reporting are present in Recommendation 14. Since the number of samples included in the validation process is not predetermined, each laboratory should decide how many samples will be included in the validation of the algorithm for automated selection and reporting of test results. 2017;27:15376. The recommendations are intended for laboratory experts who are responsible for timely and accurate release of laboratory test results. 2010;47:2237. Exceptions are components of complete blood count and acid-base balance values. Badrick T, Gay S, McCaughey EJ, Georgiou A. Biochem Med (Zagreb). Document AUTO 10-A. Accessed June 6th 2018. 7. Pre-analytical pitfalls: Missing and mislabeled specimens External Quality Assessment beyond the analytical phase: an Australian perspective. This definition process includes specifying how results are reported, within what time frame they must be reported, and which laboratory personnel are responsible for reporting them. The laboratory is obliged to archive revoked or modified laboratory test reports (46). 2016;54:190111. Toll AD, Liu JM, Gulati G, Behling EM, Kocher WD. Epub 2019 May 25. 1990;5:18995. Clinical and Laboratory Standard Institute (CLSI). 2017;54:358413. A laboratory test report can be revoked or changed at any time for objective reasons that must be documented and archived. Clin Biochem. Tate JR, Johnson R, Barth J, Panteghini M. Clin Chim Acta. Bookshelf https://doi.org/10.1309/LMMY883OKBZQQBKU. (in Croatian), Radii Biljak V, Honovi L, Matica J, Krei B, imi Vojak S. The role of laboratory testing in detection and classification of chronic kidney disease: national recommendations. Appendix 6 describes minimum sample storage conditions for traceability purposes (69-72). Clinical and Laboratory Standard Institute (CLSI). 6. Available at: http://www.hkmb.hr/dokumenti/2014/HKMB%20PPSP%203%20ispravak%20JM%2021_02_14.pdf. Available at: http://acb.org.uk/docs/default-source/committees/scientific/guidelines/acb/best-practice-when-providing-interpretative-comments-for-laboratory-medicine---final.pdf?sfvrsn=2. Clin Biochem. 2014;34:18797. National Library of Medicine Harmonization of critical result management in laboratory medicine. https://doi.org/10.1093/ajcp/aqx083, Schifman RB, Talbert M, Souers RJ. Available at: https://narodne-novine.nn.hr/clanci/sluzbeni/2009_03_39_881.html. Evaluation of Lab Respond, a new automated validation system for clinical laboratory test results. Sikaris K. Performance criteria of the post-analytical phase. 2017 Nov;38(3):107-114. 3. It is necessary to document all that is done during validation (e.g. Available at: https://narodne-novine.nn.hr/clanci/sluzbeni/2013_07_94_2123.html. Pre-Analytical, Analytical, & Post-Analytical Phases of Lab Testing in 2022 These experts are authorised to evaluate and release laboratory test results (9, 10). It has been suggested that up to 70% of all medical decisions are based on some kind of pathology and/or laboratory result. Accreditation bodies such as the Joint Commission International (JCI) and the College of American Pathologists (CAP) now require clear and effective procedures for patient/sample identification and communication of critical results. https://doi.org/10.3343/alm.2014.34.3.187, Vasikaran S, Sikaris K, Kilpatrick E, French J, Badrick T, Osypiw J, et al. https://doi.org/10.1515/cclm-2016-0709, Kardum Paro MM. Reflective testing is a non-automated procedure in which laboratory experts add additional tests and/or comments to the original request, after consideration of a wide range of information, including previously obtained laboratory results, clinical information, and demographic data. This is particularly important for the oral glucose tolerance test in pregnancy, glomerular filtration rate (eGFR-CKD-EPI), albumin and creatinine ratio in urine, protein ratio and urine creatinine (87, 88). 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. Harmonization of laboratory testing - Current achievements and future CHILDx. Accessed February 25th 2018. Harmonization of Busulfan Plasma Exposure Unit (BPEU): A Community-Initiated Consensus Statement. Epub 2013 Sep 5. Clin Chim Acta. It ties together the analytical quality achieved, the context of the patient, the perceived ability of the physicians, to interpret and utilize the laboratory information. EJIFCC. [Uredba o gospodarenju komunalnim otpadom.] Minimum archiving conditions of laboratory documentation according to CCMB recommendations is described in Appendix 7. It comprises all steps that begin with the verification and review of the results, passing to the communication of the results and their interpretation by the attending clinician (Smith, et al., 2013). These flags may occur because of insufficient sample volume, bubbles in the sample, or technical faults during analysis. Monitoring quality indicators in daily work can reduce laboratory errors and risk to patient safety by identifying problems in all phases of laboratory process, allowing their correction (66, 83). All corrections in laboratory test reports should be documented; preserving evidence about the initial results. PMC Accessibility Besides using RCV to define delta check criteria, the maximum permissible time between two measurements should be specified. Clin Chem. Pre-analytical errors: their impact and how to minimize them Processing of results for transcription onto report forms 2. Hawkins RC. Med. 2014 May 15;432:44-8. doi: 10.1016/j.cca.2013.07.033. Disclaimer. The recommended interval between measurements is 2-5 days, though laboratories should define an acceptable interval based on their own population. glucose, creatinine) or for a class of tests (i.e. [Opa uredba o zatiti podataka - Uredba (EU) 2016/679.] 2002;7:45560. Analytical Phase - Quality Assurance for Laboratory This is the first step in the post-analytical phase of laboratory work. The channels can include intercom, e-mail, fax, or other forms of communication that allow the information to be given to a predefined person within a predefined time. Available at: https://narodne-novine.nn.hr/clanci/sluzbeni/1996_04_27_539.html.
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