Laboratory medicine and clinical medicine are co-dependent components of medicine. Laboratory medicine functions most effectively when focused through a clinical lens. Me dical practice as a whole undergoes change. New drugs, treatments and changes in management strategies are introduced. New techniques, new technologies and new tests are developed. These changes may be either clinically or laboratory initiated, and so their introduction requires dialogue and interaction between clinical and laboratory medicine specialists. Treatment monitoring is integral to laboratory medicine, varying from direct drug measurement to monitoring cholesterol levels in response to treatment. The current trend to »personalised medicine« is an extension of this process with the development of companion diagnostics. Technological innovation forms part of modern laboratory practice. Introduction of new technology both facilitates standard laboratory approaches and permits introduction of new tests and testing strategies previously confined to the research laboratory only. The revolution in cardiac biomarker testing has been largely a laboratory led change. Flexibility in service provision in response to changing clinical practice or evolving technology provides a significant laboratory management challenge in the light of increasing expectations, shifts in population demographics and constraint in resource availability. Laboratory medicine practitioners are adept at meeting these challenges. One thing remains constant, that there will be a constant need laboratory medicine to meet the challenges of novel clinical challenges from infectious diseases to medical conditions developing from lifestyle and longevity.
Diagnostic blood samples collected by phlebotomy are the most common type of biological specimens drawn and sent to laboratory medicine facilities for being analyzed, thus supporting caring physicians in patient diagnosis, follow-up and/or therapeutic monitoring. Phlebotomy, a relatively invasive medical procedure, is indeed critical for the downstream procedures accomplished either in the analytical phase made in the laboratory or in the interpretive process done by the physicians. Diagnosis, man agement, treatment of patients and ultimately patient safety itself can be compromised by poor phlebotomy quality. We have read with interest a recent article where the authors addressed important aspects of venous blood collection for laboratory medicine analysis. The authors conducted a phlebotomy survey based on the Clinical and Laboratory Standard Institute (CLSI) H03-A6 document (presently replaced by the GP41-A6 document) in three government hospitals in Ethiopia to evaluate 120 professionals (101 non-laboratory professionals vs. 19 laboratory professionals) as regards the venous blood collection practice. The aim of this mini (non-systematic) review is to both take a cue from the above article and from current practices we had already observed in other laboratory settings, and discuss four questionable activities performed by health care professionals during venous blood collection. We refer to: i) diet restriction assessment; ii) puncture site cleansing; iii) timing of tourniquet removal and; iv) mixing specimen with additives.
Working in laboratories of clinical chemistry, we risk feeling that our personal contribution to quality is small and that statistical models and manufacturers play the major roles. It is seldom sufficiently acknowledged that personal knowledge, skills and common sense are crucial for quality assurance in the interest of patients. The employees, environment and procedures inherent to the laboratory including its interactions with the clients are crucial for the overall result of the total testing chain. As the measurement systems, reagents and procedures are gradually improved, work on the preanalytical, postanalytical and clinical phases is likely to pay the most substantial dividends in accomplishing further quality improvements. This means changing attitudes and behaviour, especially of the users of the laboratory. It requires understanding people and how to engage them in joint improvement processes. We need to use our knowledge and common sense expanded with new skills e.g. from the humanities, management, business and change sciences in order to bring this about together with the users of the laboratory.
Hemoglobin A1c, (HbA1c) which is the major constituent of glycated hemoglobin, has been used in the follow-up of retrospective glycemia for years and in the diagnosis of diabetes mellitus nowadays. Since the analytical performance of HbA1c should be high likewise all laboratory tests, various quality control measures are used. Sigma metrics is one of these measures and it is the combination of bias, precision and total allowable error that ensures a general evaluation of analytical quality. The aim of our study was to evaluate the analytical performance of Bio-Rad’s Variant Turbo II HbA1c analyzer according to sigma metrics. Sigma levels were calculated using the data obtained from two levels of internal and 12 external quality control materials (Bio-Rad) of Variant II Turbo HbA1c analyzer according to s= (TEa% - Bias%) / CV% formula. The mean sigma levels for low and high quality control materials were found to be 3.0 and 4.1, respectively. The annual mean analytical performance of Variant II Turbo HbA1c analyzer was found to be acceptable according to sigma metrics. In order to be sure of the difference in HbA1c results indicating the success or failure in treatment but not arise from analytical variation, it is thought that more stringent quality control measures should be applied to reach higher sigma levels.
Background: FTO, a gene recently discovered in genome-wide associated studies for type 2 diabetes mellitus (T2D), play an important role in the management of energy homeostasis, nucleic acid demethylation and regulation of body fat mass by lipolysis. The aim of this study was to analyze the association of FTO rs8050136 A>C genetic variant with clinical and biochemical parameters of T2D in the population of West Balkan region (Bosnians and Herzegovinians and Kosovars). Methods: The study included 638 patients with T2D and prediabetes and 360 healthy controls of both genders, aged from 40 to 65 years. Patients were recruited at the Clinical Centre University of Sarajevo, University Hospital of Clinical Centre in Banja Luka, General Hospital in Tesanj and Health Centre in Prizren. Genotyping of analyzed FTO polymorphism rs8050136 A>C was performed by qPCR allelic discrimination. Results: Genotype frequencies of the analyzed polymorphism were comparable between patients with T2D, prediabetic patients, and healthy population. Logistic regression analyses didn't show significant association of FTO rs8050136 A allele with increased risk of T2D. However, risk A allele was significantly associated with higher levels of HbA1c, insulin, HOMA-IR index, diastolic blood pressure, and inflammatory markers (fibrinogen and leukocytes) as well as showed tendency of association with increased values of obesity markers (BMI, waist and hip circumference). Conclusions: Results of our study showed a significant association of FTO genetic variant rs8050136 A>C with the major markers of insulin resistance, obesity and inflammation, opening new avenues for solving many unclear questions in the pathogenesis of T2D.