scholarly journals LabRS: A Rosetta stone for retrospective standardization of clinical laboratory test results

2017 ◽  
Vol 25 (2) ◽  
pp. 121-126 ◽  
Author(s):  
Ronald George Hauser ◽  
Douglas B Quine ◽  
Alex Ryder
Keyword(s):  
Laboratory Tests ◽  
Standardized Test ◽  
Clinical Laboratory ◽  
Secondary Data ◽  
The United States ◽  
Test Results ◽  
Original Result ◽  
Clinical Laboratories ◽  
Laboratory Test Results ◽  
Standardization Process

Abstract Objective Clinical laboratories in the United States do not have an explicit result standard to report the 7 billion laboratory tests results they produce each year. The absence of standardized test results creates inefficiencies and ambiguities for secondary data users. We developed and tested a tool to standardize the results of laboratory tests in a large, multicenter clinical data warehouse. Methods Laboratory records, each of which consisted of a laboratory result and a test identifier, from 27 diverse facilities were captured from 2000 through 2015. Each record underwent a standardization process to convert the original result into a format amenable to secondary data analysis. The standardization process included the correction of typos, normalization of categorical results, separation of inequalities from numbers, and conversion of numbers represented by words (eg, “million”) to numerals. Quality control included expert review. Results We obtained 1.266 × 109 laboratory records and standardized 1.252 × 109 records (98.9%). Of the unique unstandardized records (78.887 × 103), most appeared <5 times (96%, eg, typos), did not have a test identifier (47%), or belonged to an esoteric test with <100 results (2%). Overall, these 3 reasons accounted for nearly all unstandardized results (98%). Conclusion Current results suggest that the tool is both scalable and generalizable among diverse clinical laboratories. Based on observed trends, the tool will require ongoing maintenance to stay current with new tests and result formats. Future work to develop and implement an explicit standard for test results would reduce the need to retrospectively standardize test results.

scholarly journals Verification of reference intervals in routine clinical laboratories: practical challenges and recommendations

2018 ◽  
Vol 0 (0) ◽  
Author(s):  
Yesim Ozarda ◽  
Victoria Higgins ◽  
Khosrow Adeli
Keyword(s):  
Clinical Laboratory ◽  
Local Population ◽  
Age Groups ◽  
External Source ◽  
Reference Intervals ◽  
Laboratory Method ◽  
Test Results ◽  
Multicenter Studies ◽  
Clinical Laboratories ◽  
Laboratory Test Results

Abstract Reference intervals (RIs) are fundamental tools used by healthcare and laboratory professionals to interpret patient laboratory test results, ideally enabling differentiation of healthy and unhealthy individuals. Under optimal conditions, a laboratory should perform its own RI study to establish RIs specific for its method and local population. However, the process of developing RIs is often beyond the capabilities of an individual laboratory due to the complex, expensive and time-consuming process to develop them. Therefore, a laboratory can alternatively verify RIs established by an external source. Common RIs can be established by large, multicenter studies and can subsequently be received by local laboratories using various verification procedures. The standard approach to verify RIs recommended by the Clinical Laboratory Standards Institute (CLSI) EP28-A3c guideline for routine clinical laboratories is to collect and analyze a minimum of 20 samples from healthy subjects from the local population. Alternatively, “data mining” techniques using large amounts of patient test results can be used to verify RIs, considering both the laboratory method and local population. Although procedures for verifying RIs in the literature and guidelines are clear in theory, gaps remain for the implementation of these procedures in routine clinical laboratories. Pediatric and geriatric age-groups also continue to pose additional challenges in respect of acquiring and verifying RIs. In this article, we review the current guidelines/approaches and challenges to RI verification and provide a practical guide for routine implementation in clinical laboratories.

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

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 1782. Real-World HIV Diagnostic Testing Patterns in the United States

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S656-S656
Author(s):  
James Karichu ◽  
Mindy Cheng ◽  
Pedro Rodriguez ◽  
Nicole Robinson ◽  
Chakkarin Burudpakdee ◽  
...  
Keyword(s):  
Real World ◽  
Index Date ◽  
Clinical Laboratory ◽  
The United States ◽  
Fourth Generation ◽  
Test Results ◽  
Confirmatory Testing ◽  
Confirmatory Tests ◽  
Testing Patterns ◽  
Hiv 1

Abstract Background Current HIV diagnostic laboratory testing guidelines from the US Centers for Disease Control and Prevention (CDC) recommend a sequence of tests for detection, differentiation, and confirmation of HIV-1 and HIV-2 diagnosis. There is a gap in knowledge about real-world implementation of the testing algorithm. The aim of this study was to characterize the population that underwent HIV antibody differentiation and confirmatory testing and to describe subsequent testing patterns from a large US clinical laboratory database. Methods Patients who received one or more HIV-1/2 antibody differentiation test (BioRad Geenius™ HIV 1/2 Supplemental Assay [Geenius]) in the Quest Diagnostics laboratory database between January 1, 2017 and December 31, 2017 were selected into the study; earliest test date was index date. Geenius tests, HIV-1 qualitative RNA (Aptima HIV-1 RNA Qualitative Assay [Aptima]), and HIV-2 DNA/RNA confirmatory tests subsequent to index date were captured. Study measures included pt demographic characteristics, testing frequency and sequencing, and test results. For patients with >1 Geenius test in 2017, concordance between index and subsequent test results was assessed. Results There were 26,319 unique patients identified who received ≥1 HIV antibody differentiation result from the Geenius assay. Mean age was 40.7 ± 14.3 years, 66.4% were male, and 42.5% were from southern states. Among the study population, there were 28,954 Geenius, 7,234 Aptima, and 298 HIV-2 DNA/RNA confirmatory tests. 26.4% of Geenius test results were discordant with the initial positive fourth-generation HIV screening results and required subsequent confirmatory testing. In terms of sequencing, the CDC-recommended HIV diagnostic algorithm was followed 74% of the time after screening. 8.5% of patients had >1 Geenius test in 2017; 11.2% of the retests returned different results compared with the first test. Conclusion The CDC recommended algorithm for HIV diagnosis is complex for laboratories to implement and currently available assays do not support testing efficiency. To mitigate observed inefficiencies and reduce the laboratory burden of HIV testing, a more accurate and reliable approach for HIV differentiation and confirmatory testing is needed. Disclosures All authors: No reported disclosures.

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.

Achievements in High Specific-Speed Water Turbines

1934 ◽  
Vol 128 (1) ◽  
pp. 361-407
Author(s):  
A. A. Fulton
Keyword(s):  
Stainless Steel ◽  
Laboratory Tests ◽  
Steady Increase ◽  
Test Results ◽  
Suction Tube ◽  
Generating Sets ◽  
Laboratory Test Results ◽  
Water Turbine ◽  
Specific Speed ◽  
Water Turbines

The steady increase in the capacity of generating sets created a demand for the high specific-speed turbine which was met by several experimenters. “Specific speed” is the speed at which a turbine will run under unit head when developing unit power, and nowadays a “high specific-speed” water turbine denotes one having a runner of the propeller type and a specific speed between 100 and 230 r.p.m. Difficulties were encountered in the development of propeller turbines, especially in connexion with cavitation. Laboratory tests and the use of visual study methods have played an important part in the solution of these difficulties. The method of fixing suction head in conjunction with laboratory test results is explained, and a comparison is made between the various forms of suction tube in use. Much work has been done to overcome the effects of localized cavitation, and stainless steel has been found to be very effective, especially when runners are cast entirely of that material. A method of operation has been developed to dispense with the use of inlet sluice gates in large machines. Several methods in use for operating the movable runner blades are described. The introduction of the high specific-speed turbine has led to a large increase in the number of automatic stations. The great size attained by these turbines has entailed the construction of equally large generators, the development of which has had its own problems.

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.

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