scholarly journals Management of post-analytical processes in the clinical laboratory according to ISO 15189:2012. Considerations about the management of clinical samples, ensuring quality of post-analytical processes, and laboratory information management

Author(s):  
Mᵃ Libòria López Yeste ◽  
Antonia R. Pons Mas ◽  
Leonor Guiñón Muñoz ◽  
Silvia Izquierdo Álvarez ◽  
Fernando Marqués García ◽  
...  

Abstract ISO 15189:2012 establishes the requirements for clinical sample management, ensuring quality of process and laboratory information management. The accreditation authority, ENAC in Spain, established the requirements for the authorized use of the label in reports issued by accredited laboratories. These recommendations are applicable to the postanalytical processes and the professionals involved. The Standard requires laboratories to define and document the duration and conditions of sample retention. Laboratories are also required to design an internal quality control scheme to verify whether postanalytical activities attain the expected standards. Information management requirements are also established and laboratories are required to design a contingency plan to ensure the communication of laboratory results. Instructions are finally provided about the correct use of the accreditation label in laboratory reports. A range of nations and scientific societies support that clinical laboratories should be required to obtain accreditation. With ISO 15189 being the most specific standard for demonstrating technical performance, a clear understanding of its requirements is essential for proper implementation.

2018 ◽  
Vol 10 (1) ◽  
Author(s):  
Rita Sembajwe ◽  
Tendai Shamu ◽  
Fortunate Machingura ◽  
Henry Chidawanyika

Objective: Understand the challenges that exist in the Zimbabwe health systems, that could be addressed through the integration of a Laboratory Information Management System (LIMS).Understand key aspects for consideration when selecting and adapting a LIMS in a resource limited setting.Showcase improvements in laboratory information management processes following adoption of a LIMS.Introduction: Zimbabwe's National Health Laboratory Services faces multiple challenges related to inadequate financial support and skilled human resources, insufficient infrastructure, and inefficient tracking of clinical samples collected by health facilities. The slow turnaround time and poor management of the sample testing process, as well as delivery of results remain critical challenges. Compounding these problems further is a manual system for tracking large volumes of samples. This laborious and time-consuming process is inefficient for management of high amounts of incoming medical samples, frequently resulting in incomplete and inaccurate data. Additionally, health facilities are unable to monitor clinical samples and results in transit, leading to misplaced samples and missing results. Furthermore, although the laboratory service runs on a tiered network system - with lower level laboratories referring surveillance samples to higher level laboratories, processing of samples is not fulfilled promptly. The solutions to these challenges are divergent - sometimes even pointing in different directions. To this end, the Zimbabwe Ministry of Health and Child Care (MoHCC) has identified and integrated a LIMS to improve tracking of samples from the time of collection through results delivery.Methods: Our methods included an environmental needs assessment, user requirement analysis, followed by a LIMS customization and integration. The overarching aim has been to integrate the electronic open source BIKA LIMS into Zimbabwe’s national health information systems (HIS), to improve laboratory information management.The user requirements gathering exercise, included focus group discussion meetings with potential LIMS users, and direct observations, to guide the establishment of LIMS specifications. The needs assessment focused on the system functionality. Specifically, it investigated those aspects that would improve the ability: to track clinical samples such as creating and activating an ‘alerting’ capability when results are not reported within the set turnaround time; for users to see lists and counts of clinical samples at various testing levels; to uniquely identify samples received in the laboratories. Guided by these requirements, an environmental scan of off-the-shelf and open source LIMS platforms was conducted to identify a few options for the Zimbabwe context. Primary factors for shortlisting included: an existing community of practice for support; interoperability; customizability and configurability; and local awareness of the platform. In a LIMS national user’s meeting, involving relevant levels of the health system (Laboratories, Central, Provincial and District hospitals), a review of LIMS platform options was performed to narrow down selections. It evaluated the extent to which the user requirements (Workflow, equipment interface, result management, inter-operable, quality control, and stock management) were being met. Based on the evaluation, a single system (LIMS) was selected, adopted and adapted for use at six representative laboratories, including Zimbabwe’s National Microbiology Reference Laboratory.On-Site classroom and desk-side training, for knowledge transfer to local LIMS users, characterised the implementation phase. Local champions were identified from laboratory technicians and equipped to offer first line support. Both on-site and remote support was provided to LIMS users. The monitoring phase is ongoing, using interview guides and LIMS user meetings to understand challenges and ways to improve the system.Results: A LIMS was successfully customized and integrated into Zimbabwe’s national health information system infrastracture in six regional laboratories, to improve overall laboratory information management, timeliness of reporting and quality control. Since its full implementation between 2013 and 2017, average turnaround time for results improved significantly from 10 to 21 days in 2013 to only 3 days in 2017. Data quality improved; the number of untested clinical samples reduced from an average of 6 in 100 in 2013, to average of less or equal to 1 in 100, in 2017 . Also, there have been observed improvements in Zimbabwe's laboratory information management workflow and results reporting. High user satisfaction and increased LIMS use have led to the demand for LIMS expansion to additional laboratories. The LIMS has also managed to reduce the time required to produce disease notification reports.Conclusions: LIMS are proving to be an effective method for tracking samples and laboratory results in low resource settings like Zimbabwe. LIMS has provided an efficient way for record, store, and track timely reporting of laboratory data, allowing for improved quality of data. Overall, LIMS has increased efficiency in laboratory workflow and introduced the ability to adequately track samples from time of collection.


2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Selman Repišti ◽  
Nikolina Jovanović ◽  
Martina Rojnić Kuzman ◽  
Sara Medved ◽  
Stefan Jerotić ◽  
...  

AbstractObjectiveThe primary objective of this paper is to present a short measure of perceptions on the impact of the COVID-19 pandemic on quality of life, along with analysis of its reliability and validity in non-clinical and clinical samples.MethodsThe scale was named The COV19 – Impact on Quality of Life (COV19-QoL) and it consists of six items presented in the form of a 5-point Likert scale. The items (i.e. statements) cover main areas of quality of life with regard to mental health. The scale was administered to 1346 participants from the general population in Croatia (the non-clinical sample) and 201 patients with severe mental illness recruited from four European countries (Bosnia and Herzegovina, Montenegro, North Macedonia and Serbia), constituting the clinical sample. The clinical sample was part of the randomised controlled trial IMPULSE funded by the European Commission. Data on age and gender were collected for both samples, along with psychiatric diagnoses collected for the clinical sample.ResultsMain findings included a high internal consistency of the scale and a moderate to strong positive correlation among participants’ scores on different items. Principal component analysis yielded one latent component. The correlation between participants’ age and their results on COV19-QoL was negligible. Participants’ perceived quality of life was the most impacted domain, whereas mental health, personal safety and levels of depression were the least impacted domains by the pandemic.DiscussionThe COV19-QoL is a reliable and valid scale which can be used to explore the impact of COVID-19 on quality of life. The scale can be successfully used by researchers and clinicians interested in the impact of the pandemic on people experiencing various pre-existing mental health issues (e.g. anxiety, mood and personality disorders) as well as those without such issues.


2022 ◽  
pp. 215-229
Author(s):  
Antonia Mourtzikou ◽  
Marilena Stamouli ◽  
Georgia Kalliora ◽  
Ioanna Petraki ◽  
Christina Seitopoulou ◽  
...  

The use of quality indicators (QIs) and risk assessment are valuable tools for maintaining the quality of laboratory tests. Both are requirements of ISO 15189: 2012 and are usually based on standard statistical and empirical data. In this chapter, the authors focus on evaluating clinical laboratory quality indicators in the era of the COVID-19 pandemic. The goal is to pose and discuss, based on the authors' experience, the quality evaluation and risk assessment through the collection, study, and analysis of quality indicators covering the pre-analytical, analytical, and post-analytical phases of the laboratory testing process. QIs were evaluated using the Six Sigma method. Moreover, FMEA risk analysis was performed, and the degree of risk priority was assessed using the Pareto method. The results show that in the analytical phase, the laboratory's performance is satisfactory, while the pre-and post-analytical phases need further preventive/corrective actions.


Molecules ◽  
2020 ◽  
Vol 25 (22) ◽  
pp. 5370 ◽  
Author(s):  
Wencan Jiang ◽  
Gongwei Sun ◽  
Wenbin Cui ◽  
Shasha Men ◽  
Miao Jing ◽  
...  

Background: Element-tagged immunoassay coupled with inductively coupled plasma mass spectrometry (ICP-MS) detection has the potential to revolutionize immunoassay analysis for multiplex detection. However, a further study referring to the standard evaluation and clinical sample verification is needed to ensure its reliability for simultaneous analysis in clinical laboratories. Methods: Carcinoembryonic antigen (CEA) and α-fetoprotein (AFP) were chosen for the duplex immunoassay. The performance of the assay was evaluated according to guidelines from the Clinical and Laboratory Standards Institute (CLSI). Moreover, reference intervals (RIs) of CEA and AFP were established. At last, 329 clinical samples were analyzed by the proposed method and results were compared with those obtained with electrochemiluminescent immunoassay (ECLIA) method. Results: The measurement range of the assay was 2–940 ng/mL for CEA and 1.5–1000 ng/mL for AFP, with a detection limit of 0.94 ng/mL and 0.34 ng/mL, respectively. The inter-assay and intra-assay imprecision were all less than 6.58% and 10.62%, respectively. The RI of CEA and AFP was 0–3.84 ng/mL and 0–9.94 ng/mL, respectively. Regarding to clinical sample detection, no significant difference was observed between the proposed duplex assay and the ECLIA method. Conclusions: The ICP-MS-based duplex immunoassay was successfully developed and the analytical performance fully proved clinical applicability. Well, this could be different with other analytes.


2020 ◽  
Vol 58 (6) ◽  
pp. 873-882 ◽  
Author(s):  
Wencan Jiang ◽  
Gongwei Sun ◽  
Xinyu Wen ◽  
Shasha Men ◽  
Wenbin Cui ◽  
...  

AbstractIntroductionElement-tagged immunoassay coupled with inductively coupled plasma-mass spectrometry (ICP-MS) detection has the potential to revolutionize immunoassay analysis in clinical detection; however, a systematic evaluation with the standard guidelines of the assay is needed to ensure its performance meets the requirements of the clinical laboratory.MethodsCarcinoembryonic antigen (CEA) was chosen for analysis using the proposed method. A systematic evaluation of the proposed assay was carried out according to the Clinical and Laboratory Standards Institute (CLSI). The 469 clinical samples were analyzed using the new method and compared with the electrochemiluminescent immunoassay (ECLIA) method.ResultsThe measurement range of the assay was 1–900 ng/mL, with a detection limit of 0.83 ng/mL. The inter-assay and intra-assay imprecision were 4.67% and 5.38% with high concentration samples, and 9.27% and 17.64% with low concentration samples, respectively. The cross-reactivity (%) for different antigens was less than 0.05%, and the recovery was between 94% and 108%. Percentage deviation of all the dilutions was less than 12.5% during linearity estimation. The interference bias caused by different substances was less than 10%. The reference interval of the assay was 0–4.442 ng/mL. Comparison with the commercial ECLIA method for clinical sample detection, the proposed method showed a correlation of 0.9878 and no significant differences between the methods were observed (p = 0.6666).ConclusionsThe ICP-MS based immunoassay was successfully developed, and the analytical performance of the assay met the requirements of the CLSI, which fully proved the clinical transferability and application of the new method.


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