scholarly journals Electronic tools in clinical laboratory diagnostics: key examples, limitations, and value in laboratory medicine

2021 ◽  
Vol 45 (6) ◽  
pp. 319-324
Author(s):  
Mary Kathryn Bohn ◽  
Giulia F. Fabiano ◽  
Khosrow Adeli
Keyword(s):  
Clinical Laboratory ◽  
Laboratory Data ◽  
Reference Intervals ◽  
Medical Laboratory ◽  
Laboratory Diagnostics ◽  
Evidence Based ◽  
Complex Data ◽  
Clinical Implementation ◽  
Patient Centered ◽  
Diagnostic Management

Abstract Electronic tools in clinical laboratory diagnostics can assist laboratory professionals, clinicians, and patients in medical diagnostic management and laboratory test interpretation. With increasing implementation of electronic health records (EHRs) and laboratory information systems worldwide, there is increasing demand for well-designed and evidence-based electronic resources. Both complex data-driven and simple interpretative electronic healthcare tools are currently available to improve the integration of clinical and laboratory information towards a more patient-centered approach to medicine. Several studies have reported positive clinical impact of electronic healthcare tool implementation in clinical laboratory diagnostics, including in the management of neonatal bilirubinemia, cardiac disease, and nutritional status. As patients have increasing access to their medical laboratory data, it is essential that accessible electronic healthcare tools are evidence-based and user-friendly for individuals of varying digital and medical literacy. Indeed, studies suggest electronic healthcare tool development processes significantly lack the involvement of relevant healthcare professionals and often present misinformation, including erroneous calculation algorithms or inappropriate interpretative recommendations. The current review provides an overview of the utility of available electronic healthcare tools in clinical laboratory diagnostics and critically reviews potential limitations and benefits of their clinical implementation. The Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) online database is also detailed as an example of a pediatric diagnostic tool with widespread global impact.

Organization of the work of the medical laboratory service in accordance with the requirements of the standard GOST ISO 15189–2015 «Medical laboratories. Particular requirements for quality and competence»

2020 ◽  
pp. 15-22
Author(s):  
Elena Vitalievna Perminova
Keyword(s):  
Clinical Laboratory ◽  
Medical Laboratory ◽  
Laboratory Research ◽  
Laboratory Diagnostics ◽  
Clinical Diagnostic Laboratory ◽  
Diagnostic Laboratory ◽  
Iso 15189 ◽  
Laboratory Service ◽  
Medical Laboratories

Clinical laboratory diagnostics is a medical specialty, which is based on in vitro diagnostic studies of biomaterial obtained from an individual. At the present stage, there are three main types of organization of the laboratory research process — a laboratory service as part of a medical and preventive institution, a centralized laboratory where biomaterials are delivered for research from various healthcare institutions, as well as mobile laboratories that allow conducting the research directly at the patient’s bedside. This discipline involves the use of a wide variety of diagnostic research methods and the use of a huge number of specific techniques. Their list should include carrying out hematological, microbiological, virological, immunological, serological, parasitic, and biochemical studies. Also, when organizing laboratory diagnostic activities, a number of other studies (cytological, histological, toxicological, genetic, molecular biological, etc.) are provided. A laboratory report is formulated after obtaining clinical data and comparing them with the obtained test results. The quality of laboratory tests is ensured through the systematic implementation of internal laboratory control, as well as participation in a national program for external quality assessment. The activities of the clinical diagnostic laboratory should be organized in accordance with the requirements of the standard GOST R ISO 15189–2015 «Medical laboratories. Particular requirements for quality and competence», which is based on the provisions of two more fundamental standards — ISO 9001 and ISO 17025, and adds a number of special requirements related to medical laboratories.

Response to the editor: Limitations of the Hoffmann method for establishing reference intervals using clinical laboratory data

2019 ◽  
Vol 70 ◽  
pp. 51
Author(s):  
Ying Zhang ◽  
Weibo Ma ◽  
Guocheng Wang ◽  
Yaqi Lv ◽  
Yaguang Peng ◽  
...  
Keyword(s):  
Clinical Laboratory ◽  
Laboratory Data ◽  
Reference Intervals

A multi-stage Gaussian transformation algorithm for clinical laboratory data.

1982 ◽  
Vol 28 (8) ◽  
pp. 1735-1741 ◽  
Author(s):  
J C Boyd ◽  
D A Lacher
Keyword(s):  
Mean Squared Error ◽  
Clinical Laboratory ◽  
Statistical Tests ◽  
Random Noise ◽  
Laboratory Data ◽  
Reference Interval ◽  
Reference Intervals ◽  
Distributed Data ◽  
Multi Stage ◽  
Positive Coefficients

Abstract We have developed a multi-stage computer algorithm to transform non-normally distributed data to a normal distribution. This transformation is of value for calculation of laboratory reference intervals and for normalization of clinical laboratory variates before applying statistical procedures in which underlying data normality is assumed. The algorithm is able to normalize most laboratory data distributions with either negative or positive coefficients of skewness or kurtosis. Stepwise, a logarithmic transform removes asymmetry (skewness), then a Z-score transform and power function transform remove residual peakedness or flatness (kurtosis). Powerful statistical tests of data normality in the procedure help the user evaluate both the necessity for and the success of the data transformation. Erroneous assessments of data normality caused by rounded laboratory test values have been minimized by introducing computer-generated random noise into the data values. Reference interval endpoints that were estimated parametrically (mean +/- 2 SD) by using successfully transformed data were found to have a smaller root-mean-squared error than those estimated by the non-parametric percentile technique.

scholarly journals THE PROFESSIONAL STANDARD OF A SPECIALIST IN CLINICAL LABORATORY MEDICINE AND ITS EVALUATION BY MEDICAL LABORATORY STAFF

2017 ◽  
Vol 25 (3) ◽  
pp. 63-68
Author(s):  
P. N. Zolotaryov
Keyword(s):  
Higher Education ◽  
Clinical Laboratory ◽  
Laboratory Medicine ◽  
Study Data ◽  
Medical Laboratory ◽  
Laboratory Research ◽  
Laboratory Diagnostics ◽  
Professional Standard ◽  
Laboratory Staff ◽  
Wide Range

The issue of improving the personnel service in clinical laboratory diagnostics is topical, since specialists, having modern knowledge in laboratory research, can not stay aside from active participation during their appointment and interpretation. Training of specialists of this level requires revision of the regulatory framework, namely, the development of professional standards for specialists in clinical laboratory medicine. The survey involved 83 specialists with higher education working in clinical diagnostic laboratories of various forms of ownership in the Samara Region (Russia). In the course of the study, data were obtained reflecting the readiness to perform a number of generalized labor functions of the professional standard. Prior to the evaluation of the criterion of attention paid to the labor function in each group of respondents, we expected to obtain values of 9-10 units. However, in the course of the study, we found that this indicator in various groups of respondents fluctuated in a wide range. We believe that the training of professional stuff with higher education in laboratory medicine should be implemented in parallel with the introduction of the professional standard.

Pediatric reference intervals for alkaline phosphatase

2017 ◽  
Vol 55 (1) ◽  
pp. 102-110 ◽  
Author(s):  
Jakob Zierk ◽  
Farhad Arzideh ◽  
Rainer Haeckel ◽  
Holger Cario ◽  
Michael C. Frühwald ◽  
...  
Keyword(s):  
Alkaline Phosphatase ◽  
Phosphatase Activity ◽  
Alkaline Phosphatase Activity ◽  
Clinical Laboratory ◽  
Clinical Care ◽  
Tertiary Care ◽  
Laboratory Data ◽  
Reference Intervals ◽  
Photometric Method ◽  
Laboratory Service

Abstract Background: Interpretation of alkaline phosphatase activity in children is challenging due to extensive changes with growth and puberty leading to distinct sex- and age-specific dynamics. Continuous percentile charts from birth to adulthood allow accurate consideration of these dynamics and seem reasonable for an analyte as closely linked to growth as alkaline phosphatase. However, the ethical and practical challenges unique to pediatric reference intervals have restricted the creation of such percentile charts, resulting in limitations when clinical decisions are based on alkaline phosphatase activity. Methods: We applied an indirect method to generate percentile charts for alkaline phosphatase activity using clinical laboratory data collected during the clinical care of patients. A total of 361,405 samples from 124,440 patients from six German tertiary care centers and one German laboratory service provider measured between January 2004 and June 2015 were analyzed. Measurement of alkaline phosphatase activity was performed on Roche Cobas analyzers using the IFCC’s photometric method. Results: We created percentile charts for alkaline phosphatase activity in girls and boys from birth to 18 years which can be used as reference intervals. Additionally, data tables of age- and sex-specific percentile values allow the incorporation of these results into laboratory information systems. Conclusions: The percentile charts provided enable the appropriate differential diagnosis of changes in alkaline phosphatase activity due to disease and changes due to physiological development. After local validation, integration of the provided percentile charts into result reporting facilitates precise assessment of alkaline phosphatase dynamics in pediatrics.

A new predictive indicator for development of pressure ulcers in bedridden patients based on common laboratory tests results

2008 ◽  
Vol 61 (4) ◽  
pp. 514-518 ◽  
Author(s):  
N Hatanaka ◽  
Y Yamamoto ◽  
K Ichihara ◽  
S Mastuo ◽  
Y Nakamura ◽  
...  
Keyword(s):  
Laboratory Tests ◽  
Pressure Ulcers ◽  
Proportional Hazards Model ◽  
Cox Regression ◽  
Clinical Laboratory ◽  
Laboratory Data ◽  
Clinical Implementation ◽  
Clinical Tool ◽  
Braden Scale ◽  
Hospitalised Patients

Background:Various scales have been devised to predict development of pressure ulcers on the basis of clinical and laboratory data, such as the Braden Scale (Braden score), which is used to monitor activity and skin conditions of bedridden patients. However, none of these scales facilitates clinically reliable prediction.Aims:To develop a clinical laboratory data-based predictive equation for the development of pressure ulcers.Methods:Subjects were 149 hospitalised patients with respiratory disorders who were monitored for the development of pressure ulcers over a 3-month period. The proportional hazards model (Cox regression) was used to analyse the results of 12 basic laboratory tests on the day of hospitalisation in comparison with Braden score.Results:Pressure ulcers developed in 38 patients within the study period. A Cox regression model consisting solely of Braden scale items showed that none of these items contributed to significantly predicting pressure ulcers. Rather, a combination of haemoglobin (Hb), C-reactive protein (CRP), albumin (Alb), age, and gender produced the best model for prediction. Using the set of explanatory variables, we created a new indicator based on a multiple logistic regression equation. The new indicator showed high sensitivity (0.73) and specificity (0.70), and its diagnostic power was higher than that of Alb, Hb, CRP, or the Braden score alone.Conclusions:The new indicator may become a more useful clinical tool for predicting presser ulcers than Braden score. The new indicator warrants verification studies to facilitate its clinical implementation in the future.

scholarly journals Immunotherapy Monitoring with Immune Checkpoint Inhibitors Based on [18F]FDG PET/CT in Metastatic Melanomas and Lung Cancer

2021 ◽  
Vol 10 (21) ◽  
pp. 5160
Author(s):  
Egesta Lopci
Keyword(s):  
Large Scale ◽  
Clinical Laboratory ◽  
Scale Validation ◽  
Checkpoint Inhibitors ◽  
Laboratory Data ◽  
Major Change ◽  
New Drugs ◽  
Response Criteria ◽  
Clinical Implementation ◽  
Pet Ct

Immunotherapy with checkpoint inhibitors has prompted a major change not only in cancer treatment but also in medical imaging. In parallel with the implementation of new drugs modulating the immune system, new response criteria have been developed, aiming to overcome clinical drawbacks related to the new, unusual, patterns of response characterizing both solid tumors and lymphoma during the course of immunotherapy. The acknowledgement of pseudo-progression, hyper-progression, immune-dissociated response and so forth, has become mandatory for all imagers dealing with this clinical scenario. A long list of acronyms, i.e., irRC, iRECIST, irRECIST, imRECIST, PECRIT, PERCIMT, imPERCIST, iPERCIST, depicts the enormous effort made by radiology and nuclear medicine physicians in the last decade to optimize imaging parameters for better prediction of clinical benefit in immunotherapy regimens. Quite frequently, a combination of clinical-laboratory data with imaging findings has been tested, proving the ability to stratify patients into various risk groups. The next steps necessarily require a large scale validation of the most robust criteria, as well as the clinical implementation of immune-targeting tracers for immuno-PET or the exploitation of radiomics and artificial intelligence as complementary tools during the course of immunotherapy administration. For the present review article, a summary of PET/CT role for immunotherapy monitoring will be provided. By scrolling into various cancer types and applied response criteria, the reader will obtain necessary information for better understanding the potentials and limitations of the modality in the clinical setting.

Algorithm on age partitioning for estimation of reference intervals using clinical laboratory database exemplified with plasma creatinine

2018 ◽  
Vol 56 (9) ◽  
pp. 1514-1523 ◽  
Author(s):  
Xiaoxia Peng ◽  
Yaqi Lv ◽  
Guoshuang Feng ◽  
Yaguang Peng ◽  
Qiliang Li ◽  
...  
Keyword(s):  
Decision Tree ◽  
Serum Creatinine ◽  
Clinical Laboratory ◽  
Statistical Tests ◽  
Laboratory Data ◽  
Reference Intervals ◽  
The Difference ◽  
Decision Tree Method ◽  
Methodological Considerations ◽  
Tree Method

Abstract Background: We describe an algorithm to determine age-partitioned reference intervals (RIs) exemplified for creatinine using data collection from the clinical laboratory database. Methods: The data were acquired from the test results of creatinine of 164,710 outpatients aged <18 years in Beijing Children’s Hospital laboratories’ databases between January 2016 and December 2016. The tendency of serum creatinine with age was examined visually using box plot by gender first. The age subgroup was divided automatically by the decision tree method. Subsequently, the statistical tests of the difference between subgroups were performed by Harris-Boyd and Lahti methods. Results: A total of 136,546 samples after data cleaning were analyzed to explore the partition of age group for serum creatinine from birth to 17 years old. The suggested age partitioning of RIs for creatinine by the decision tree method were for eight subgroups. The difference between age subgroups was demonstrated to be statistically significant by Harris-Boyd and Lahti methods. In addition, the results of age partitioning for RIs estimation were similar to the suggested age partitioning by the Canadian Laboratory Initiative in Pediatric Reference Intervals study. Lastly, a suggested algorithm was developed to provide potential methodological considerations on age partitioning for RIs estimation. Conclusions: Appropriate age partitioning is very important for establishing more accurate RIs. The procedure to explore the age partitioning using clinical laboratory data was developed and evaluated in this study, and will provide more opinions for designing research on establishment of RIs.

Pediatric Reference Intervals for Ten Coagulation Assays.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 2988-2988 ◽  
Author(s):  
Michele M. Flanders ◽  
Ronda A. Crist ◽  
William M. Roberts ◽  
George M. Rodgers
Keyword(s):  
Lower Limit ◽  
Reference Values ◽  
Laboratory Tests ◽  
Clinical Laboratory ◽  
Protein S ◽  
Reference Intervals ◽  
Health Improvement ◽  
Laboratory Diagnostics ◽  
Healthy Children ◽  
Coagulation Proteins

Abstract There is a lack of reliable pediatric reference intervals for many clinical laboratory tests. In 2002, the Children’s Health Improvement through Laboratory Diagnostics (CHILDx) organization initiated a project to collect blood and urine samples from healthy children 7 – 17 years of age with the goal of establishing reference intervals for many laboratory tests. The purpose of the present study was to determine pediatric reference intervals for ten coagulation proteins associated with common bleeding and thrombotic disorders. All assays were functional except for vonWillebrand factor antigen. All were measured according to manufacturer specifications and standard methods using the STA-R coagulation analyzer (Diagnostica Stago), with the exception of the ristocetin cofactor assay, which was performed on the BCS (Dade Behring). Samples used to establish adult reference intervals were purchased from George King Bio-Medical, Precision Biologic, and also drawn in-house. At each age of life, 62 individuals (31 girls/31 boys) were drawn for a minimum of 124 individuals for each age group. Reference intervals were established based on a nonparametric method (NCCLS C28-A). RESULTS: 1. Although pediatric PTT values do not differ from adult values, the mean pediatric PT values are about 1 sec longer, 2. Pediatric FIX levels trend upward until ages 16-17 when adult levels are reached, 3. FVIII, FXI, RCF and vWFAg demonstrate higher reference values in younger ages, 4. The lower limit of pediatric AT levels is significantly higher than adults, 5. The lower limit of pediatric protein C levels is significantly lower than adults, however, this difference is not seen for protein S levels. In conclusion, a number of significant differences between pediatric and adult reference intervals have been found supporting the use of these newer reference intervals. Age N PT PTT F VIII F IX F XI 7–9 186 13.1–15.4* 27–38 78–199* 71–138* 70–138 10–11 124 12.9–15.5* 27–38 83–226* 72–159* 63–137 12–13 124 13.1–15.2* 27–38 74–205* 73–152* 65–130* 14–15 124 12.9–15.4* 26–35 69–241* 80–162 57–125* 16–17 121 12.6–15.9* 26–35 63–225* 85–175 64–160 Adult 125 12.3–14.4 26–38 56–190 78–184 56–153 Age AT RCF VWF Ag PC PS-Male PS-Female * The t-test of the means, F-test of the SD, or both is statistically different (p&lt; 0.05) from adult reference values. 7–9 96–135* 51–172* 62–176 71–143* 64–141 58–154 10–11 92–134* 61–195* 61–201* 76–146* 68–150 68–140* 12–13 92–128* 47–183* 61–186* 68–162* 65–143 60–150 14–15 95–135* 50–215* 57–204* 69–170* 66–149 53–147* 16–17 94–131* 47–206* 51–211 70–170* 75–157* 51–150* Adult 76–128 44–195 51–185 83–168 66–143 57–131

scholarly journals Use of The WISN Method to Assess the Health Workforce Requirements for the High-volume Clinical Biochemical Laboratories

2021 ◽  
Author(s):  
Sanja Stankovic ◽  
Milena Santric Milicevic
Keyword(s):  
Health Service ◽  
Clinical Laboratory ◽  
High Volume ◽  
Working Time ◽  
Medical Laboratory ◽  
Laboratory Diagnostics ◽  
Laboratory Staff ◽  
Service Activities ◽  
Laboratory Workers ◽  
Workforce Shortages

Abstract Background: The clinical laboratory services, as an essential part of health care, require appropriate staff capacity to assure satisfaction and improve outcomes for both patients and clinical staff. This study aimed to apply the Workload Indicators of Staffing Need (WISN) method for estimating required laboratory staff requirements for the high-volume clinical biochemical laboratories. Methods: In 2019, we applied the WISN method in all 13 laboratories within the Center for Medical Biochemistry of the University Clinical Centre of Serbia (CMB UCCS). A review of annual routinely collected statistics, laboratory processes observations, and structured interviews with lab staff helped identify their health service and additional activities and duration of these activities. The study outcomes were WISN based staff requirements, WISN ratio and difference, and a recommendation on the new staffing standards for two priority laboratory workers (medical biochemists and medical laboratory technicians).Results: Medical biochemists' and laboratory technicians' annual available working time in 2019 was 1508 and 1347 working hours, respectively, for the workload of 1,848,889 samples. In general, the staff has four health service, eight support, and 15 additional individual activities. Health service activities per sample can take from 1.2 to 12.6 min. Medical biochemists and medical laboratory technicians spend almost 70% and more than 80% of their available working time, undertaking health service activities. The WISN method revealed laboratory workforce shortages in the CMB (i.e., current 40 medical biochemists and 180 medical laboratory technicians as opposed to required 48 medical biochemists and 206 medical laboratory technicians). Workforce maldistribution regarding the laboratory workload contributes to a moderate-high workload pressure of medical biochemists in five and medical laboratory technicians in nine organizational units.Conclusions: The WISN method showed mainly a laboratory workforce shortages and workload pressure in the CMB UCCS. WISN is a simple, easy-to-use method that can help decision-makers and policymakers prioritize the recruitment and equitable allocation of laboratory workers, optimize their utilization, and develop normative guidelines in the field of clinical laboratory diagnostics. WISN estimates require periodic reviews.

Sign in / Sign up

Export Citation Format

Share Document