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ABSTRACTS FROM THE CURRENT LITERATURE.

None of us can read all the medical literature, even that that pertains particularly to medical technology. Presented below are short abstracts from current literature presented with the hope that they will answer some of your questions and lead you to a better understanding of what is happening. You are encouraged to send copies of articles you have found in journals or on the Internet to AMT and we will abstract them for an upcoming issue. We encourage and welcome future contributors from readers of this journal. Please send your abstracts to Editor, Journal of Continuing Education Topics & Issues, 10700 W. Higgins Rd., Suite 150, Rosemont, IL 60018.

The following abstracts were contributed by David Plaut, Plano, TX, who is AMT's book reviewer and a frequent speaker at AMT annual conventions.

Your hospital librarian or your public librarian can help obtain copies of the full text of these articles.

According to official data, 60-70% of clinical decisions about hospitalization and discharge are based on laboratory results. I have collected a number of articles relating to our work in the clinical laboratory. Most of these focus on laboratory errors and test utilization. I have chosen these topics as they are important in all areas of the laboratory and are currently of some interest in our efforts to reduce errors and expenses to both the institutions and the patients. Each of these shortened abstracts is available as a complete, free copy of the article. Some of the articles referenced here as 'See also' are not available free. The sequence is chronological beginning with the most recent article I picked. If you want the entire list of those I selected to study in more detail, send me an email (davidsplaut@gmail.com) and I will send it to you.

1. Every day, analytical and bio-analytical chemists make sustained efforts to improve the sensitivity, specificity, robustness, and reproducibility of their methods. Nevertheless, all efforts from the analysts are in vain if the sample quality is poor, i.e. if preanalytical errors are made by the partner sample collection and handling during delivery to the laboratory. Preanalytical risks and errors are more common than usually thought. This focuses on the preanalytical phase of liquid chromatography-mass spectrometry-driven metabolomics analysis of body fluids. Several important preanalytical factors that may seriously affect the profile of the investigated metabolome (the complete set of small-molecule chemicals found within a biological sample (e.g. serum, blood, urine, tissue) from body fluids), including factors before sample collection, blood drawing, subsequent handling of the whole blood (transportation), processing of plasma and serum, and inadequate conditions for sample storage, are discussed. In addition, a detailed description of latent effects on the stability of the blood metabolome and a suggestion for a practical procedure to circumvent risks in the preanalytical phase will be given. Anal Bioanal Chem. 2015 Jul;407(17):4879-92 Effects of pre-analytical processes on blood samples used in metabolomics studies. Yin P, Lehmann R, Xu G. (See also these two other articles: Preanalytical aspects and sample quality assessment in metabolomics studies of human blood.Clin Chem. 2013 Preanalytical aspects and sample quality assessment in metabolomics studies of human blood. Yin P, Peter A, Franken H, Zhao X, Neukamm SS, Rosenbaum L, Lucio M, Zell A, Haring HU, Xu G, et al. Clin Chem. 2013 May; 59(5):833-45. Quality markers addressing preanalytical variations of blood and plasma processing identified by broad and targeted metabolite profiling. Lin Z, Zhang Z, Lu H, Jin Y, Yi L, et al. Biomed Chromatogr. 2014 Sep; 28(9):1235-45.

2. To rapidly obtain outpatient results, we use plasma separation tubes (PST) for chemistry analysis. If lactate dehydrogenase measurement is required, serum separation tubes (SST) are used. There has been no evaluation of hemolysis with these tubes. We compared the hemolytic index (HI) obtained by using PST and SST and applied this for choosing appropriate tubes for clinical laboratories. The HI of specimens obtained from outpatients and scored from 0 to 10. HI was classified by sample tube type, and significant hemolysis was defined as a HI of 2 or more. For significant hemolysis cases, medical records were ed to identify the causes. Among 171,519 specimens, significant hemolysis was observed in 0.66% of specimens (0.68% of PST specimens, 0.46% of SST specimens). The mean HI in PST was 0.18 (SD: 0.43) and that in SST was 0.14 (SD: 0.37). The proportion of significant hemolysis was significantly higher in PST than in SST (P=0.001). The cause of significant hemolysis was identified as chemotherapy and prosthetic valve in 48% of specimens. Complex sampling errors may have caused significant hemolysis in the remaining 52% of specimens. The incidence of hemolysis was slightly higher for PST than SST, although both were <1%. PST are thought to be more useful than SST in outpatient testing because of rapid turnaround time, greater sample volume, and less risk of random errors due to fibrin strands. Ann Lab Med. 2015 Mar;35(2):194-7. Comparison of red blood cell hemolysis using plasma and serum separation tubes for outpatient specimens. Ko DH, Won D, Jeong TD, et al.

3. 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. Clin Chem Lab Med. 2015 May; 53(6):943-8. Performance criteria and quality indicators for the pre-analytical phase. Plebani M, Sciacovelli L, Aita A, et al. See also: Quality indicators to detect pre-analytical errors in laboratory testing. Clin Chim Acta. 2014 Quality indicators to detect pre-analytical errors in laboratory testing. Clin Chim Acta. 2014 May 15; 432:44-8. Epub 2013 Sep 5. Harmonization of pre-analytical quality indicators. Biochem Med (Zagreb). 2014 Clin Chem Lab Med. 2013.

4. Preanalytical control and monitoring continue to be an important issue for clinical laboratory professionals. The aim of the study was to evaluate a monitoring system of preanalytical errors regarding not suitable samples for analysis, based on different indicators; to compare such indicators in different phlebotomy centers; and finally to evaluate a single synthetic preanalytical indicator that may be included in the balanced scorecard management system (BSC). We collected individual and global preanalytical errors in hematology, coagulation, chemistry, and urine samples analysis. We also analyzed a synthetic indicator that represents the sum of all types of preanalytical errors, expressed in a sigma level. We studied the evolution of those indicators over time and compared indicator results by way of the comparison of proportions and Chi-square. There was a decrease in the number of errors along the years (P<0.001). This pattern was confirmed in primary care patients, inpatients and outpatients. In blood samples, fewer errors occurred in outpatients, followed by inpatients. The authors presented a practical and effective methodology to monitor unsuitable sample preanalytical errors. The synthetic indicator results summarize overall preanalytical sample errors, and can be used as part of BSC management system. Biochem Med (Zagreb). 2015;25(1):4956. Ten years of preanalytical monitoring and control: Synthetic Balanced Score Card Indicator. Salinas M, Lopez-Garrigos M, Flores E, et al.

5. An observational study was conducted in 12 European countries to assess the level of compliance with the CLSI H3-A6 guidelines. A structured checklist including 29 items was created to assess the compliance of European phlebotomy procedures with the CLSI H3-A6 guideline. A risk occurrence chart of individual phlebotomy steps was created from the observed error frequency and severity of harm of each guideline key issue. The severity of errors occurring during phlebotomy was graded using the risk occurrence chart. Twelve European countries participated with a median of 33 (18-36) audits per country, and a total of 336 audits. The median error rate for the total phlebotomy procedure was 27 % (11-44), indicating a low overall compliance with the recommended CLSI guideline. Patient identification and test tube labeling were identified as the key guideline issues with the highest combination of probability and potential risk of harm. Administrative staff did not adhere to patient identification procedures during phlebotomy, whereas physicians did not adhere to test tube labeling policy. The level of compliance of phlebotomy procedures with the CLSI H3-A6 guidelines in 12 European countries was found to be unacceptably low. The most critical steps in need of immediate attention in the investigated countries are patient identification and tube labeling. Clin Chem Lab Med. 2014 Dec 23. pii: /j/cclm.ahead-of-print/cclm-2014-1053/cclm-2014-1053.xml. Compliance of blood sampling procedures with the CLSI H3-A6 guidelines. Simundic AM, Church S, Cornes MP, et al. See also: Clin Chem Lab Med. 2014Continuing professional development crediting system for specialists in laboratory medicine within 28 EFLM national societies. Biochem Med (Zagreb). 2013 Klin Lab Diagn. 2014 Croatian Society of Medical Biochemistry and Laboratory Medicine: national recommendations for venous blood sampling. Biochem Med (Zagreb). 2013 Preanalytical quality improvement: in quality we trust. Clin Chem Lab Med. 2013.

6. Point-of-care testing (POCT) is one of the formidable concept introduce in the field of critical care settings to deliver decentralized, patient-centric health care to the patients. Rapid provision of blood measurements, particularly blood gases and electrolytes, may turn into improved clinical outcomes. Studies shows that POCT carries the advantages of providing reduced therapeutic turnaround time (TTAT), shorter door-to-clinical-decision time, rapid data availability, reduced preanalytic and postanalytic testing errors, self-contained user-friendly instruments, small sample volume requirements, and frequent serial whole-blood testing. However, still there is a noticeable debate that exists among the laboratorians, clinicians, and administrators over concerns regarding analyzer inaccuracy, imprecision and performance (interfering substances), poorly trained non-laboratorians, high cost of tests, operator-dependent quality of testing, and difficulty in integrating test results with hospital information system. The authors found that POCT of blood gases and selected electrolytes may not entirely replace centralized laboratory testing but may change the clinical practice of emergency and critical care physicians. Point of care blood gases with electrolytes and lactates in adult emergencies. Kapoor D, Srivastava M, Singh P. Int J Crit Illn Inj Sci. 2014 Jul; 4(3):216-22. See also: The clinical effectiveness and cost-effectiveness of home-based, nurseled health promotion for older people: a systematic. Health Technol Assess. 2012, Health Technol Assess. 2010. Systematic and modeling of the cost-effectiveness of cardiac magnetic resonance imaging compared with current existing testing pathways in ischaemic cardiomyopathy. Health Technol Assess. 2014. The clinical effectiveness and cost-effectiveness of bariatric (weight loss) surgery for obesity: a systematic and economic evaluation. Health Technol Assess. 2009. Non-invasive diagnostic assessment tools for the detection of liver fibrosis in patients with suspected alcohol-related liver disease: a systematic and economic evaluation. Health Technol Assess. 2012.

7. Five main themes emerged from the data in this study: (i) the usual method for communicating results differed between practices; (ii) clinical impact of results and patient characteristics such as anxiety level or health literacy influenced methods by which patients received their test result; (iii) which staff member had responsibility for the task was frequently unclear; (iv) barriers to communicating results existed, including there being no system or failsafe in place to determine whether results were returned to a practice or patient; (v) staff envisaged problems with a variety of test result communication methods discussed, including use of modern technologies, such as SMS messaging or online access.

Communication of test results is a complex yet core primary care activity necessitating flexibility by both patients and staff. Dealing with the results from increasing the volume of tests is resource intensive and pressure on practice staff can be eased by greater utilization of electronic communication. Current systems appear vulnerable due to a lack of a routine method for tracing delayed or missing results. Instead, practices only become aware of missing results following queries from patients. The creation of a test communication protocol for dissemination among patients and staff would help ensure both groups are aware of their roles and responsibilities. Fam Pract. 2014 Oct; 31(5):592-7. Test result communication in primary care: clinical and office staff perspectives. Litchfield IJ, Bentham LM, Lilford RJ, et al. See also: Patient perspectives on test result communication in primary care: a qualitative study. Patient perspectives on test result communication in primary care: a qualitative study. Br J Gen Pract. 2015 Mar; 65(632):e133-40. Quality and safety issues highlighted by patients in the handling of laboratory test results by general practices--a qualitative study. See also: BMC Health Serv Res. 2014 Test result communication in primary care: a survey of current practice. BMJ Qual Saf. 2015 Mobile phone messaging for communicating results of medical investigations. Cochrane Database Syst Rev. 2012.

8. Evaluating possible conditions that could lead to errors and outlining the necessary steps to detect and prevent errors before they cause patient harm is an important part of laboratory testing. This can be achieved through the practice of risk management. EP23-A is a new guideline from the CLSI that introduces risk management principles to the clinical laboratory. This guideline borrows concepts from the manufacturing industry and encourages laboratories to develop risk management plans that address the specific risks inherent to each lab. Once the risks have been identified, the laboratory must implement control processes and continuously monitor and modify them to make certain that risk is maintained at a clinically acceptable level. This summarizes the principles of risk management in the clinical laboratory and describes various quality control activities employed by the laboratory to achieve the goal of reporting valid, accurate and reliable test results. Risk management in the clinical laboratory. Njoroge SW, Nichols JH, Ann Lab Med. 2014 Jul; 34(4):274-8. See also Laboratory quality control based on risk management. Ann Saudi Med. 2011, Errors in clinical laboratories or errors in laboratory medicine? Clin Chem Lab Med. 2006, An error management system in a veterinary clinical laboratory. J Vet Diagn Invest. 2012, Perspectives on quality control, risk management, and analytical quality management. Clin Lab Med. 2013

9. A total of 303,866 samples, 2,430,928 tests were received for analysis. The total number of errors was 153,148 (6.3%) (116,392 for inpatients and 36,756 for outpatients). Analysis of the results revealed that about 65.09% of the errors occur across preanalytical phase, whereas 23.2% and 11.68% are related to analytical and postanalytical phase, respectively. N Am J Med Sci. 2014 May;6(5):224-8. See also: Types and Frequency of Errors during Different Phases of Testing At a Clinical Medical Laboratory of a Teaching Hospital in Tehran, Iran. Abdollahi A, Saffar H, Saffar H.
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Title Annotation:Effects of pre-analytical processes on blood samples used in metabolomics studies, Comparison of red blood cell hemolysis using plasma and serum separation tubes for outpatient specimens, Performance criteria and quality indicators for the pre-analytical phase
Publication:Journal of Continuing Education Topics & Issues
Date:Aug 1, 2015
Words:2530
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