scholarly journals The roadmap for harmonization: status of the International Consortium for Harmonization of Clinical Laboratory Results

2018 ◽  
Vol 56 (10) ◽  
pp. 1667-1672 ◽  
Author(s):  
Gary L. Myers ◽  
W. Greg Miller
Keyword(s):  
Clinical Laboratory ◽  
Technical Committee ◽  
Laboratory Measurement ◽  
Test Results ◽  
International Consortium ◽  
Information Portal ◽  
Resource Center ◽  
Regulatory Processes ◽  
Laboratory Test Results ◽  
Laboratory Results

Abstract The International Consortium for Harmonization of Clinical Laboratory Results (ICHCLR) was established to fulfill recommendations identified by an international conference convened to review the available infrastructure and challenges in achieving harmonization of results among different measurement procedures. The specific objectives of the ICHCLR are to: prioritize measurands by medical importance, coordinate the work of different organizations, and stimulate development of technical and regulatory processes to achieve harmonization. Central to these objectives is the website “www.harmonization.net” developed by the ICHCLR as an information portal designed to provide a resource center for global activities to harmonize and standardize results from clinical laboratory measurement procedures. Priorities based on medical impact are provided for measurands for which harmonization is needed or work to implement harmonization is incomplete or inactive. By making information available regarding harmonization activities in progress or planned, coordination of work to harmonize laboratory measurement procedures will minimize duplication of effort and optimize the use of limited resources. A toolbox of technical procedures developed by ICHCLR to be considered when developing a process to achieve harmonization for a measurand is presented. The ICHCLR initiated a proposal to ISO Technical Committee 212 for a harmonization protocol as the basis for calibration traceability when there are no other higher order reference system components available. The ICHCLR offers a unique service to prioritize measurands in need of harmonization and to provide a centralized approach to organize global efforts to achieve harmonization of clinical laboratory test results.

Herbal Remedies: Effects on Clinical Laboratory Tests

2006 ◽  
Vol 130 (4) ◽  
pp. 521-528 ◽  
Author(s):  
Amitava Dasgupta ◽  
David W. Bernard
Keyword(s):  
Chinese Medicine ◽  
Laboratory Test ◽  
Alternative Medicine ◽  
Clinical Laboratory ◽  
Herbal Remedies ◽  
Test Results ◽  
Abnormal Laboratory ◽  
St John's Wort ◽  
Laboratory Test Results ◽  
Laboratory Results

AbstractContext.—Complementary and alternative medicine (herbal medicines) can affect laboratory test results by several mechanisms.Objective.—In this review, published reports on effects of herbal remedies on abnormal laboratory test results are summarized and commented on.Data Sources.—All published reports between 1980 and 2005 with the key words herbal remedies or alternative medicine and clinical laboratory test, clinical chemistry test, or drug-herb interaction were searched through Medline. The authors' own publications were also included. Important results were then synthesized.Data Synthesis.—Falsely elevated or falsely lowered digoxin levels may be encountered in a patient taking digoxin and the Chinese medicine Chan Su or Dan Shen, owing to direct interference of a component of Chinese medicine with the antibody used in an immunoassay. St John's wort, a popular herbal antidepressant, increases clearance of many drugs, and abnormally low cyclosporine, digoxin, theophylline, or protease inhibitor concentrations may be observed in a patient taking any of these drugs in combination with St John's wort. Abnormal laboratory results may also be encountered owing to altered pathophysiology. Kava-kava, chaparral, and germander cause liver toxicity, and elevated alanine aminotransferase, aspartate aminotransferase, and bilirubin concentrations may be observed in a healthy individual taking such herbal products. An herbal product may be contaminated with a Western drug, and an unexpected drug level (such as phenytoin in a patient who never took phenytoin but took a Chinese herb) may confuse the laboratory staff and the clinician.Conclusions.—Use of alternative medicines may significantly alter laboratory results, and communication among pathologists, clinical laboratory scientists, and physicians providing care to the patient is important in interpreting these results.

scholarly journals Roadmap for Harmonization of Clinical Laboratory Measurement Procedures

2011 ◽  
Vol 57 (8) ◽  
pp. 1108-1117 ◽  
Author(s):  
W Greg Miller ◽  
Gary L Myers ◽  
Mary Lou Gantzer ◽  
Stephen E Kahn ◽  
E Ralf Schönbrunner ◽  
...  
Keyword(s):  
Reference Materials ◽  
Systematic Approach ◽  
Clinical Laboratory ◽  
Clinical Sample ◽  
Clinical Importance ◽  
Disease Diagnosis ◽  
Laboratory Measurement ◽  
Pure Substance ◽  
Test Results ◽  
Laboratory Test Results

Abstract Results between different clinical laboratory measurement procedures (CLMP) should be equivalent, within clinically meaningful limits, to enable optimal use of clinical guidelines for disease diagnosis and patient management. When laboratory test results are neither standardized nor harmonized, a different numeric result may be obtained for the same clinical sample. Unfortunately, some guidelines are based on test results from a specific laboratory measurement procedure without consideration of the possibility or likelihood of differences between various procedures. When this happens, aggregation of data from different clinical research investigations and development of appropriate clinical practice guidelines will be flawed. A lack of recognition that results are neither standardized nor harmonized may lead to erroneous clinical, financial, regulatory, or technical decisions. Standardization of CLMPs has been accomplished for several measurands for which primary (pure substance) reference materials exist and/or reference measurement procedures (RMPs) have been developed. However, the harmonization of clinical laboratory procedures for measurands that do not have RMPs has been problematic owing to inadequate definition of the measurand, inadequate analytical specificity for the measurand, inadequate attention to the commutability of reference materials, and lack of a systematic approach for harmonization. To address these problems, an infrastructure must be developed to enable a systematic approach for identification and prioritization of measurands to be harmonized on the basis of clinical importance and technical feasibility, and for management of the technical implementation of a harmonization process for a specific measurand.

scholarly journals Utilisation of laboratory test results for patient management by clinicians at two large referral hospitals in Zambia

2020 ◽  
Author(s):  
Sabe Mwape ◽  
Victor Daka ◽  
Scott Matafwali ◽  
Kapambwe Mwape ◽  
Jay Sikalima ◽  
...  
Keyword(s):  
Teaching Hospital ◽  
Laboratory Tests ◽  
Patient Management ◽  
Medical Laboratory ◽  
Test Results ◽  
Cross Sectional ◽  
Childrens Hospital ◽  
Laboratory Test Results ◽  
Laboratory Results ◽  
Referral Hospitals

Background Medical laboratory diagnosis is a critical component of patient management in the healthcare setup. Despite the availability of laboratory tests, clinicians may not utilise them to make clinical decisions. We investigated utilsation of laboratory tests for patient management among clinicians at Ndola Teaching Hospital (NTH) and Arthur Davison Childrens Hospital (ADCH), two large referral hospitals in the Copperbelt Province, Ndola, Zambia. Method We conducted a descriptive cross-sectional study among clinicians. The study deployed self-administered questionnaires to evaluate clinician utilisation, querying and confidence in laboratory results. Additional data on demographics and possible laboratory improvements were also obtained. Data were entered in Microsoft excel and exported to SPSS version 16 for statistical analysis. Results Of the 80 clinicians interviewed, 96.2% (77) reported using laboratory tests and their results in patient management. 77.5% (62) of the clinicians indicated they always used laboratory results to influence their patient management decisions. Of the selected laboratory tests, clinicians were more confident in using haemoglobin test results (91.2%). There was no statistically significant association between the clinicians gender or qualification and use of test results in patient management. Conclusion Our findings show that despite the majority querying laboratory results, most of the clinicians use laboratory results for patient management. There is need for interactions between the laboratory and clinical area to assure clinician confidence in laboratory results. Key words: utilisation, clinicians, laboratory tests, Ndola Teaching Hospital, Arthur Davison Childrens Hospital

scholarly journals Knowledge and attitudes of Saudi medical laboratory professionals concerning non-pathological factors influencing test results

2021 ◽  
Vol 3 (3) ◽  
pp. 234-240
Author(s):  
Mohammed Makkawi ◽  
Keyword(s):  
Health Management ◽  
Healthcare Services ◽  
Medical Laboratory ◽  
Test Results ◽  
Medical Decisions ◽  
Knowledge And Attitudes ◽  
Laboratory Test Results ◽  
Laboratory Results ◽  
Patient Health ◽  
Medical Laboratory Professionals

Introduction: Successful medical decisions are highly reliant on medical laboratory results; as such, laboratory results are essential to patient health management, and errors in those results may lead to serious complications and death. The aim of the present study was to assess the knowledge of medical laboratory practitioners in Saudi Arabia regarding factors that may influence medical laboratory testing results and the correct actions for troubleshooting. Methods: A total of 256 practitioners participated, representing diverse qualifications and various healthcare sectors. The study utilized a pretested questionnaire comprised of three sections: socio-demographic characteristics, knowledge, and attitudes. Results: The responses demonstrated participants to possess outstanding knowledge of factors that may affect laboratory test results, including biological and pathological factors, diet, and personal habits. Furthermore, participants demonstrated satisfactory attitudes toward such factors. Conclusions: Thus, this study reveals a magnificent image concerning Saudi practitioners’ knowledge and capacity for suitable actions given unexpected test results, and hence their ability to provide correct healthcare services. This constitutes an acceptable overview, particularly as a first pass; nonetheless, more studies on larger cohorts remain required.

Terminology of cardiac troponin assays and data censoring

2017 ◽  
Vol 55 (11) ◽  
Author(s):  
Petr Jarolim
Keyword(s):  
Laboratory Test ◽  
Cardiac Troponin ◽  
Clinical Laboratory ◽  
Clinical Information ◽  
Reference Population ◽  
Test Results ◽  
Clinical Laboratory Test ◽  
Laboratory Test Results ◽  
Data Censoring ◽  
Selection Of

AbstractWe discuss the sensitivity terminology of cardiac troponin assays and its dependence on the selection of the reference population. In addition, the need for reasonable censoring of clinical laboratory test results is contrasted with potential loss of valuable clinical information.

scholarly journals European views on patients directly obtaining their laboratory test results

2015 ◽  
Vol 53 (12) ◽  
Author(s):  
Ian D. Watson ◽  
Joanna Siodmiak ◽  
Wytze P. Oosterhuis ◽  
Joel Corberand ◽  
Per E. Jorgensen ◽  
...  
Keyword(s):  
Information Technologies ◽  
Clinical Chemistry ◽  
Information Age ◽  
Negative Attitude ◽  
Laboratory Medicine ◽  
European Federation ◽  
Test Results ◽  
Laboratory Test Results ◽  
Laboratory Results ◽  
Changing Practices

AbstractMedicine is a highly professionalized endeavour, by tradition centred on the authority of physicians. Better education and the advent of the information age cater for increased demands on society in general and on health care in particular to enable people to make informed decisions regarding themselves. Participation in medical decisions requires informed knowledge which is hard to obtain without substantial and time consuming professional help.We performed a survey amongst the member organizations of European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) in order to investigate the recognition and preparedness of providing help to patients in interpreting their laboratory results.Out of 40 EFLM Member Societies, 27 sent their responses to the survey. In most cases the first line delivery of laboratory results to physicians is by computer link (63%). Patients receive their laboratory results on demand from their physician in 60% of cases. However, 34% of laboratory specialists showed a negative attitude for delivering laboratory results to patients. Yet, in 48% of countries 1–5 patients per day ask a laboratory specialist about the significance of laboratory results outside the reference range. When patients are informed about the purpose of laboratory testing, they seek information primarily from their physician, followed by the internet and the Specialist in Laboratory Medicine.Changing practices increasingly enabling patient access to their records are on the increase facilitated by recent innovations in information technologies. Successful transfer of some of the responsibilities of physicians, demands a mutual triangular dialogue between the patient, their physician and laboratory medicine.

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