Performance criteria of the post-analytical phase

Author(s):  
Kenneth Sikaris

AbstractQuality in healthcare is ideally at an optimal benchmark, but must be at least above the minimal standards for care. While laboratory quality is ideally judged in clinical terms, laboratory medicine has also used biological variations and state-of-the-art criteria when, as is often the case, clinical outcome studies or clinical consensus are not available. The post-analytical phase involves taking quality technical results and providing the means for clinical interpretation in the report. 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. Reference intervals may have greater clinical value if they are both optimised to account for physiological individuality, as well as if they are harmonised through professional consensus. Clinical decision limits are generally superior to reference intervals as a basis for interpretation because they address the specific clinical concern in any patient. 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. Most profoundly critically abnormal results should to be acted upon to minimise the risk of mortality. The three steps in quality report interpretation, (i) describing the abnormal data, (ii) interpreting the clinical information within that data and (iii) providing knowledge for clinical follow-up, highlight that the quality of all laboratory testing is reflected in its impact on clinical management and improving patient outcomes.

2017 ◽  
Vol 5 (1) ◽  
pp. 122
Author(s):  
Assist. Prof. Dr. Demokaan DEMİREL

The distinctive quality of the new social structure is that information becomes the only factor of production. In today's organizations, public administrators are directly responsible for applying information to administrative processes. In addition to his managerial responsibilities, a knowledge based organization requires every employee to take responsibility for achieving efficiency. This has increased the importance of information systems in the decision-making process. Information systems consist of computer and communication technology, data base management and model management and include activity processing system, management information system, decision support systems, senior management information system, expert systems and office automation systems. Information systems in the health sector aim at the management and provision of preventive and curative health services. The use of information systems in healthcare has the benefits of increasing service quality, shortening treatment processes, maximizing efficiency of the time, labour and medical devices. The use of information systems for clinical decision making and reducing medical errors in the healthcare industry dates back to the 1960s. Clinical information systems involve processing, storing and re-accessing information that supports patient care in a hospital. Clinical information systems are systems that are directly or indirectly related to patient care. These systems include electronic health/patient records, clinical decision support systems, nurse information systems, patient tracking systems, tele-medicine, case mix and smart card applications. Diagnosis-treatment systems are information-based systems used in the diagnosis and treatment of diseases. It consists of laboratory information systems, picture archiving and communication system, pharmacy information system, radiology information system, nuclear medicine information system. This study aims to evaluate the effectiveness of health information system applications in Turkey. The first part of the study focuses on the concept of information systems and the types of information systems in organization structures. In the second part, clinical information systems and applications for diagnosis-treatment systems in Turkey are examined. Finally, the study evaluates applications in the health sector qualitatively from the new organizational structure, which is formed by information systems.


2021 ◽  
pp. 1-6
Author(s):  
Ben Kang ◽  
Hyun Seok Lee ◽  
Seong Woo Jeon ◽  
Soo Yeun Park ◽  
Gyu Seog Choi ◽  
...  

BACKGROUND: Colorectal cancer (CRC) is one of the leading causes of mortality and morbidity in the world. It is characterized by different pathways of carcinogenesis and is a heterogeneous disease with diverse molecular landscapes that reflect histopathological and clinical information. Changes in the DNA methylation status of colon epithelial cells have been identified as critical components in CRC development and appear to be emerging biomarkers for the early detection and prognosis of CRC. OBJECTIVE: To explore the underlying disease mechanisms and identify more effective biomarkers of CRC. METHODS: We compared the levels and frequencies of DNA methylation in 11 genes (Alu, APC, DAPK, MGMT, MLH1, MINT1, MINT2, MINT3, p16, RGS6, and TFPI2) in colorectal cancer and its precursor adenomatous polyp with normal tissue of healthy subjects using pyrosequencing and then evaluated the clinical value of these genes. RESULTS: Aberrant methylation of Alu, MGMT, MINT2, and TFPI2 genes was progressively accumulated during the normal-adenoma-carcinoma progression. Additionally, CGI methylation occurred either as an adenoma-associated event for APC, MLH1, MINT1, MINT31, p16, and RGS6 or a tumor-associated event for DAPK. Moreover, relatively high levels and frequencies of DAPK, MGMT, and TFPI2 methylation were detected in the peritumoral nonmalignant mucosa of cancer patients in a field-cancerization manner, as compared to normal mucosa from healthy subjects. CONCLUSION: This study identified several biomarkers associated with the initiation and progression of CRC. As novel findings, they may have important clinical implications for CRC diagnostic and prognostic applications. Further large-scale studies are needed to confirm these findings.


Author(s):  
Mary Kathryn Bohn ◽  
Siobhan Wilson ◽  
Alexandra Hall ◽  
Khosrow Adeli

Abstract Objectives The Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) has developed an extensive database of reference intervals (RIs) for several biomarkers on various analytical systems. In this study, pediatric RIs were verified for key immunoassays on the Abbott Alinity system based on the analysis of healthy children samples and comparison to comprehensive RIs previously established for Abbott ARCHITECT assays. Methods Analytical performance of Alinity immunoassays was first assessed. Subsequently, 100 serum samples from healthy children recruited with informed consent were analyzed for 16 Alinity immunoassays. The percentage of test results falling within published CALIPER ARCHITECT reference and confidence limits was determined. If ≥ 90% of test results fell within the confidence limits, they were considered verified based on CLSI guidelines. If <90% of test results fell within the confidence limits, additional samples were analyzed and new Alinity RIs were established. Results Of the 16 immunoassays assessed, 13 met the criteria for verification with test results from ≥ 90% of healthy serum samples falling within the published ARCHITECT confidence limits. New CALIPER RIs were established for free thyroxine and prolactin on the Alinity system. Estradiol required special considerations in early life. Conclusions Our data demonstrate excellent concordance between ARCHITECT and Alinity immunoassays, as well as the robustness of previously established CALIPER RIs for most immunoassays, eliminating the need for de novo RI studies for most parameters. Availability of pediatric RIs for immunoassays on the Alinity system will assist clinical laboratories using this new platform and contribute to improved clinical decision-making.


2020 ◽  
Vol 29 (01) ◽  
pp. 104-114
Author(s):  
Ursula H. Hübner ◽  
Nicole Egbert ◽  
Georg Schulte

Objective: The more people there are who use clinical information systems (CIS) beyond their traditional intramural confines, the more promising the benefits are, and the more daunting the risks will be. This review thus explores the areas of ethical debates prompted by CIS conceptualized as smart systems reaching out to patients and citizens. Furthermore, it investigates the ethical competencies and education needed to use these systems appropriately. Methods: A literature review covering ethics topics in combination with clinical and health information systems, clinical decision support, health information exchange, and various mobile devices and media was performed searching the MEDLINE database for articles from 2016 to 2019 with a focus on 2018 and 2019. A second search combined these keywords with education. Results: By far, most of the discourses were dominated by privacy, confidentiality, and informed consent issues. Intertwined with confidentiality and clear boundaries, the provider-patient relationship has gained much attention. The opacity of algorithms and the lack of explicability of the results pose a further challenge. The necessity of sociotechnical ethics education was underpinned in many studies including advocating education for providers and patients alike. However, only a few publications expanded on ethical competencies. In the publications found, empirical research designs were employed to capture the stakeholders’ attitudes, but not to evaluate specific implementations. Conclusion: Despite the broad discourses, ethical values have not yet found their firm place in empirically rigorous health technology evaluation studies. Similarly, sociotechnical ethics competencies obviously need detailed specifications. These two gaps set the stage for further research at the junction of clinical information systems and ethics.


2019 ◽  
Vol 50 (3) ◽  
pp. 273-278
Author(s):  
Mengli Lu ◽  
Liying Lv

Abstract Objective To analyze the performance characteristics, stability, and clinical value of lipoprotein-associated phospholipase A2 (Lp-PLA2) using an enzymatic kinetic method. Methods The performance characteristics included reference intervals, precision, and accuracy. We assessed Lp-PLA2 stability by comparing Lp-PLA2 changes under different conditions. Lp-PLA2 was determined in the following groups: control individuals, patients with coronary heart disease (CHD), patients of different lipid subgroups within CHD, and patients with high total cholesterol (TC). Also, correlations between Lp-PLA2 and traditional cardiovascular risk factors were assessed. Results The mean (SD) reference interval of serum Lp-PLA2 activity was 451 (113) U per L with sex differences. Inter- and intra-assay precision revealed coefficients of variance (CVs) of 1.81% to 2.63% and 1.43% to 1.77%. The average bias was 0.33%. Lp-PLA2 activity was stable. In the CHD group, high-lipid subgroups, and high-TC group, Lp-PLA2 was elevated, and correlation was observed between Lp-PLA2 and traditional risk factors. Conclusion Lp-PLA2 activity has important clinical value in CHD.


2019 ◽  
Vol 58 (1) ◽  
pp. 77-84 ◽  
Author(s):  
Giuseppe Lippi ◽  
Gian Luca Salvagno ◽  
Matteo Gelati ◽  
Mairi Pucci ◽  
Claudia Lo Cascio ◽  
...  

Abstract Background This two-center study was designed to verify comparability of procalcitonin (PCT) values among 10 different commercial immunoassays. Methods A total number of 176 routine lithium-heparin plasma samples were divided in identical aliquots and simultaneously analyzed with 10 different PCT immunoassays, including Kryptor BRAHMS PCT sensitive, Abbott Architect BRAHMS PCT, Beckman Coulter Access PCT (on Access and DXI), BioMérieux Vidas BRAHMS PCT, Diasorin Liaison BRAHMS PCT, Fujirebio Lumipulse G BRAHMS PCT, Roche BRAHMS PCT (on Cobas E801), Diazyme PCT (on Roche Cobas C702) and SNIBE Maglumi PCT. Results Highly significant correlation was always found across multiple comparisons, with correlation coefficients comprised between 0.918 and 0.997 (all p < 0.001). Bland and Altman plots analysis revealed highly variable bias among immunoassays, ranging between ±0.2% and ±38.6%. Diazyme PCT on Roche Cobas C702 and SNIBE Maglumi PCT displayed the larger overestimation, whilst PCT values were underestimated by Cobas BRAHAMS PCT. The agreement was always >80% (all p < 0.001), but varied largely across multiple comparisons, ranging between 90%–99% at 0.1 μg/L, 81%–99% at 0.25 μg/L, 83%–100% at 0.5 μg/L, 94%–100% at 2.0 μg/L and 90%–99% at 10 μg/L, respectively. The larger disagreement was observed comparing Diazyme PCT and Maglumi PCT with the other methods. Conclusions Although we found acceptable correlation among 10 commercial PCT immunoassays, the limited agreement at clinical decision thresholds remains a major issue, especially at lower end of PCT concentration, thus potentially contributing to jeopardize the clinical value of this biomarker.


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.


2014 ◽  
Vol 128 (1) ◽  
pp. 49-52
Author(s):  
A Qureishi ◽  
G Garas ◽  
J Shah ◽  
J Birchall

AbstractBackground:Radiologists require accurate clinical information to formulate reports. This is particularly relevant to computed tomography of the temporal bone, in which previous surgery can mimic disease.Objectives:The information provided with temporal bone computed tomography scan requests was evaluated. The study aimed to minimise inappropriate requests and improve the clinical value of reports.Method:A two-cycle prospective audit was undertaken using a proforma designed on the basis of national guidelines. Following the first cycle (in which the requests and reports of 100 scans were evaluated), new guidelines and training were implemented. A follow-up audit (of 50 scans) was then performed.Results:Following intervention, the percentage of clinically relevant reports increased from 52 to 94 (p < 0.01), whilst unnecessary or inappropriate scan requests decreased from 11 to 2 per cent (p < 0.05).Conclusion:Optimising the clinical value of temporal bone computed tomography scan requests will have positive implications for patient care, time management and cost. The quality of the clinical information provided can have a significant impact on the clinical value of radiology reports, and can mean that unnecessary irradiation is avoided.


2020 ◽  
Vol 4 (14) ◽  
pp. 3295-3301
Author(s):  
Joaquin Martinez-Lopez ◽  
Sandy W. Wong ◽  
Nina Shah ◽  
Natasha Bahri ◽  
Kaili Zhou ◽  
...  

Abstract Few clinical studies have reported results of measurable residual disease (MRD) assessments performed as part of routine practice. Herein we present our single-institution experience assessing MRD in 234 multiple myeloma (MM) patients (newly diagnosed [NDMM = 159] and relapsed [RRMM = 75]). We describe the impact of depth, duration, and direction of response on prognosis. MRD assessments were performed by next-generation sequencing of immunoglobulin genes with a sensitivity of 10−6. Those achieving MRD negativity at 10−6, as well as 10−5, had superior median progression-free survival (PFS). In the NDMM cohort, 40% of the patients achieved MRD negativity at 10−6 and 59% at 10−5. Median PFS in the NDMM cohort was superior in those achieving MRD at 10−5 vs &lt;10−5 (PFS: 87 months vs 32 months; P &lt; .001). In the RRMM cohort, 36% achieved MRD negativity at 10−6 and 47% at 10−5. Median PFS was superior for the RRMM achieving MRD at 10−5 vs &lt;10−5 (PFS: 42 months vs 17 months; P &lt; .01). Serial MRD monitoring identified 3 categories of NDMM patients: (A) patients with ≥3 MRD 10−6 negative samples, (B) patients with detectable but continuously declining clonal numbers, and (C) patients with stable or increasing clonal number (≥1 log). PFS was superior in groups A and B vs C (median PFS not reached [NR], NR, 55 respectively; P &lt; .001). This retrospective evaluation of MRD used as part of clinical care validates MRD as an important prognostic marker in NDMM and RRMM and supports its use as an endpoint in future clinical trials as well as for clinical decision making.


1998 ◽  
Vol 44 (4) ◽  
pp. 749-759 ◽  
Author(s):  
Xavier Bossuyt ◽  
Gilberte Schiettekatte ◽  
Ann Bogaerts ◽  
Norbert Blanckaert

Abstract We compared the automated Paragon 2000 clinical capillary zone electrophoresis (CZE) system with two manual methods, agarose electrophoresis (AGE) and cellulose acetate electrophoresis (CAE). Reference intervals in healthy adults were determined for each method. When compared with AGE and CAE, CZE gave substantially higher reference values for the α1-globulin fraction. With CZE, within-run precision for fraction quantitation was between 0.5% (albumin) and 4.1% (α1-globulin). Total precision was between 0.8% (albumin) and 5.3% (β-globulin). Data obtained from CZE showed poor linear correlation with results obtained by AGE but good linear correlation with data from CAE. Analysis of serum from patients with inter alia inflammation, nephrotic syndrome, or polyclonal gammopathy showed that clinical information obtained by CZE is comparable with information obtained by AGE and CAE. We conclude that CZE offers a clinically reliable alternative to AGE and CAE and has the advantages of automation, higher precision, and faster turnaround time.


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