scholarly journals Total Testing Process, including standardisation, preanalytical process

2021 ◽  
Vol 59 (s1) ◽  
pp. s762-s788
2016 ◽  
Vol 5 (07) ◽  
pp. 4704
Author(s):  
Syed Riaz Mehdi* ◽  
Sharique Ahmad ◽  
Noorin Zaidi

Laboratory error is defined by ISO 22367 as “Failure of planned actions to be completed as intended or use a wrong plan to achieve an aim”. Lundeberg in 1981 outlined the concept of Total Testing Process (TTP) and Plebani elaborated it further and classified the whole testing process into five phases of Pre-Pre Analytic, Pre Analytic, Analytic, Post Analytic and Post - Post Analytic. The errors have to be identified and resolved in each phase of the process. The medical laboratories have to run Internal and External Quality Control programs and abide by the guidelines of ISO 15189 in order to be accredited by bodies like JCI, CAP or NABL. Active communication and regular interaction between the clinicians and the laboratory is recommended during Pre Analytic and Post Analytic phases of TTP in order to achieve the target of Best Laboratory Practices. 


Author(s):  
Pieter Vermeersch ◽  
Glynis Frans ◽  
Alexander von Meyer ◽  
Seán Costelloe ◽  
Giuseppe Lippi ◽  
...  

Abstract The International Organization for Standardization (ISO) 15189:2012 standard aims to improve quality in medical laboratories through standardization of all key elements in the total testing process, including the pre-analytical phase. It is hence essential that accreditation bodies, assessing laboratories against ISO15189:2012, pay sufficient attention to auditing pre-analytical activities. However, there are significant differences in how technical auditors interpret the pre-analytical requirements described in ISO15189:2012. In this consensus document, the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Pre-analytical Phase (WG-PRE) sets out to review pre-analytical requirements contained in ISO15189:2012 and provide guidance for laboratories on how to meet these requirements. The target audience for this consensus document is laboratory professionals who wish to improve the quality of the pre-analytical phase in their laboratory. For each of the ISO requirements described in ISO15189:2012, members of EFLM WG-PRE agreed by consensus on minimal recommendations and best-in-class solutions. The minimal consensus recommendation was defined as the minimal specification which laboratories should implement in their quality management system to adequately address the pre-analytical requirement described in ISO15189:2012. The best-in-class solution describes the current state-of-the-art in fulfilling a particular pre-analytical requirement in ISO15189:2012. We fully acknowledge that not every laboratory has the means to implement these best-in-class solutions, but we hope to challenge laboratories in critically evaluating and improving their current procedures by providing this expanded guidance.


2012 ◽  
Vol 31 (3) ◽  
pp. 174-183 ◽  
Author(s):  
Nada Majkić-Singh ◽  
Zorica Šumarac

Quality Indicators of the Pre-Analytical PhaseQuality indicatorsare tools that allow the quantification of quality in each of the segments of health care in comparison with selected criteria. They can be defined as an objective measure used to assess the critical health care segments such as, for instance, patient safety, effectiveness, impartiality, timeliness, efficiency, etc. In laboratory medicine it is possible to develop quality indicators or the measure of feasibility for any stage of the total testing process. The total process or cycle of investigation has traditionally been separated into three phases, the pre-analytical, analytical and post-analytical phase. Some authors also include a »pre-pre« and a »post-post« analytical phase, in a manner that allows to separate them from the activities of sample collection and transportation (pre-analytical phase) and reporting (post-analytical phase). In the year 2008 the IFCC formed within its Education and Management Division (EMD) a task force calledLaboratory Errors and Patient Safety (WG-LEPS)with the aim of promoting the investigation of errors in laboratory data, collecting data and developing a strategy to improve patient safety. This task force came up with the Model of Quality Indicators (MQI) for the total testing process (TTP) including the pre-, intra- and post-analytical phases of work. The pre-analytical phase includes a set of procedures that are difficult to define because they take place at different locations and at different times. Errors that occur at this stage often become obvious later in the analytical and post-analytical phases. For these reasons the identification of quality indicators is necessary in order to avoid potential errors in all the steps of the pre-analytical phase.


Author(s):  
Vanja Radišić Biljak ◽  
Ivana Lapić ◽  
Valentina Vidranski ◽  
Ivona Herceg ◽  
Franciska Tomić ◽  
...  

Abstract Objectives In 2019 The Croatian Working Group for Laboratory Hematology, on behalf of the Croatian Society of Medical Biochemistry and Laboratory Medicine, wanted to explore the background in field of laboratory hematology routine practice among Croatian laboratories in order to develop future strategies for producing national recommendations, if needed. Methods During April and May 2019, a comprehensive survey covering all main parts of the total testing process within the field of laboratory hematology among Croatian medical laboratories was conducted. The survey comprised 49 inquiries. Data was collected using Survey Monkey (Palo Alto, CA, USA). All collected data was anonymized. Results The response rate was 72%. There is still a substantial number of laboratories that have only three-part differential hematology analyzers (9%). Furthermore, a very high number of laboratories did not perform analyzer verification prior to implementation into routine work (31%). Out of those who have verified their analyzers, a diversity of guidelines and recommendations were used. Nearly 10% of the laboratories do not have a defined policy regarding specimen rejection. The majority of the participants perform internal quality control daily (83%), however, only 51% of respondents evaluate the agreement between different hematology analyzers on daily basis. Although more than 90% of Croatian laboratories have a defined policy regarding specimen rejection, only 61% of respondents continuously monitor quality indicators in routine practice. Conclusions The survey revealed substantial differences in all aspects of laboratory hematology practices among Croatian medical laboratories, indicating the need for universal recommendations at the national level.


2000 ◽  
Vol 124 (7) ◽  
pp. 1004-1010 ◽  
Author(s):  
Richard J. Zarbo

Abstract Objective.—To review tenets of basic quality assurance and identify opportunities for quality improvement in the laboratory assessment of prognostic factors. Design.—College of American Pathologists Q-Probes data obtained from hundreds of American laboratories throughout the 1990s are used to illustrate laboratory performance and practice opportunities in the preanalytic, analytic, and postanalytic phases of the total testing process. Results.—A wide range of performance deficiencies are documented, most in the preanalytic and postanalytic phases, and contributed by individuals outside and not under the control of the laboratory. In the analytic phase, the effectiveness of checklists on the content and completeness of reported diagnostic and prognostic data for breast and colon cancers is proven. Conclusions.—In the preanalytic phase, marked enhancements in quality would result from improvements in (1) patient and specimen identification, (2) adherence to patient-sampling and specimen-handling requirements, and (3) communication to the laboratory of the pertinent clinical context of the individual test. Once basic analytic quality control and laboratory quality assurance issues are resolved, a focus on standardization and enhancement of preanalytic and postanalytic communications and satisfaction of clinical expectations becomes the source of improved laboratory performance.


Author(s):  
Marilena Stamouli ◽  
Antonia Mourtzikou

The main role that clinical laboratories play in the detection, diagnosis, and treatment of diseases is clearly evident. Clinical laboratories need to sustain a commitment to quality and demonstrate a certifiable level of compliance. Many strategies are used to reduce laboratory errors, including internal QC procedures, external quality assessment programs, implementation of QIs and six-sigma methodology. All strategies should be consistent with the requirements of the international standard for medical laboratory accreditation and suitable for promoting corrective/preventive actions. They must promote total quality and patient safety and be consistent with the definition of a laboratory error. Harmonization process is in progress; however, further efforts must be made. Total quality management must be evaluated periodically. For a patient-centered approach, there is the need to assure that each and every step of the total testing process is correctly performed, that weaknesses are recognized, and that corrective and preventive actions are designed and implemented.


Author(s):  
Mario Plebani ◽  
Laura Sciacovelli ◽  
Ada Aita ◽  
Michela Pelloso ◽  
Maria Laura Chiozza

AbstractThe 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.


Author(s):  
Giuseppe Lippi ◽  
Giuseppe Banfi ◽  
Mauro Buttarello ◽  
Ferruccio Ceriotti ◽  
Massimo Daves ◽  
...  

AbstractA large body of evidence attests that quality programs developed around the analytical phase of the total testing process would only produce limited improvements, since the large majority of errors encountered in clinical laboratories still prevails within extra-analytical areas of testing, especially in manually intensive preanalytical processes. Most preanalytical errors result from system flaws and insufficient audit of the operators involved in specimen collection and handling responsibilities, leading to an unacceptable number of unsuitable specimens due to misidentification, in vitro hemolysis, clotting, inappropriate volume, wrong container or contamination from infusive routes. Detection and management of unsuitable samples are necessary to overcome this variability. The present document, issued by the Italian Inter-society SIBioC-SIMeL-CISMEL (Society of Clinical Biochemistry and Clinical Molecular Biology-Italian Society of Laboratory Medicine-Italian Committee for Standardization of Hematological and Laboratory Methods) Study Group on Extra-analytical Variability, reviews the major causes of unsuitable specimens in clinical laboratories, providing consensus recommendations for detection and management.Clin Chem Lab Med 2007;45:728–36.


2017 ◽  
Vol 37 (1) ◽  
pp. 187-205 ◽  
Author(s):  
Mario Plebani ◽  
Laura Sciacovelli ◽  
Ada Aita

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