Preanalytical requirements of urinalysis

Urine may be a waste product, but it contains an enormous amount of information. Well-standardized procedures for collection, transport, sample preparation and analysis should become the basis of an effective diagnostic strategy for urinalysis. As reproducibility of urinalysis has been greatly improved due to recent technological progress, preanalytical requirements of urinalysis have gained importance and have become stricter. Since the patients themselves often sample urine specimens, urinalysis is very susceptible to preanalytical issues. Various sampling methods and inappropriate specimen transport can cause important preanalytical errors. The use of preservatives may be helpful for particular analytes. Unfortunately, a universal preservative that allows a complete urinalysis does not (yet) exist. The preanalytical aspects are also of major importance for newer applications (e.g. metabolomics). The present review deals with the current preanalytical problems and requirements for the most common urinary analytes.     

Assessment of antinuclear antibodies (ANA): National recommendations on behalf of the Croatian society of medical biochemistry and laboratory medicine

Antinuclear antibodies (ANA) represent a family of autoantibodies targeting ubiquitous cellular constituents and are a hallmark of systemic inflammatory autoimmune rheumatic diseases named connective tissue diseases (CTD). The gold standard method for ANA determination is indirect immunofluorescence (IIF) on the human laryngeal epidermoid carcinoma cell line type 2 substrate (HEp-2), but with increasing demand for ANA testing, novel methods eased for automation emerged, which allows testing by staff less experienced in this specific field of laboratory diagnostic. In 2016 The working group (WG) for laboratory diagnostics of autoimmune diseases as part of the Committee for the Scientific Professional Development of the Croatian Society of Medical Biochemistry and Laboratory Medicine (CSMBLM) published the data of a survey regarding general practice in laboratory diagnostics of autoimmune diseases in Croatia. Results indicated high diversity in the performance of autoantibody testing as well as reporting of the results and indicated the need of creating recommendations for the assessment of ANA that would help harmonize diagnostics of systemic autoimmune rheumatic diseases in Croatia. This document encompasses twenty-seven recommendations for ANA testing created concerning indications for ANA testing, preanalytical, analytical, and postanalytical issues, including rational algorithm and quality control assurance. These recommendations are based on the relevant international recommendations and guidelines for the assessment of ANA testing and relevant literature search and should help to harmonize the approach in ANA testing and clarify differences in interpretation of the results obtained using different methods of determination.     

Lipemia: causes,interference mechanisms,detection and management

In the clinical laboratory setting, interferences can be a significant source of laboratory errors with potential to cause serious harm for the patient. After hemolysis, lipemia is the most frequent endogenous interference that can influence results of various laboratory methods by several mechanisms. The most common preanalytical cause of lipemic samples is inadequate time of blood sampling after the meal or parenteral administration of synthetic lipid emulsions. Although the best way of detecting the degree of lipemia is measuring lipemic index on analytical platforms, laboratory experts should be aware of its problems, like false positive results and lack of standardization between manufacturers. Unlike for other interferences, lipemia can be removed and measurement can be done in a clear sample. However, a protocol for removing lipids from the sample has to be chosen carefully, since it is dependent on the analytes that have to be determined. Investigation of lipemia interference is an obligation of manufacturers of laboratory reagents; however, several literature findings report lack of verification of the declared data. Moreover, the acceptance criteria currently used by the most manufacturers are not based on biological variation and need to be revised. Written procedures for detection of lipemia, removing lipemia interference and reporting results from lipemic samples should be available to laboratory staff in order to standardize the procedure, reduce errors and increase patient safety.     

The rise in preanalytical errors during COVID-19 pandemic

IntroductionThe COVID-19 pandemic has posed several challenges to clinical laboratories across the globe. Amidst the outbreak, errors occurring in the preanalytical phase of sample collection, transport and processing, can further lead to undesirable clinical consequences. Thus, this study was designed with the following objectives: (i) to determine and compare the blood specimen rejection rate of a clinical laboratory and (ii) to characterise and compare the types of preanalytical errors between the pre-pandemic and the pandemic phases.Materials and methodsThis retrospective study was carried out in a trauma-care hospital, presently converted to COVID-19 care centre. Data was collected from (i) pre-pandemic phase: 1^st October 2019 to 23^rd March 2020 and (ii) pandemic phase: 24^th March to 31^st October 2020. Blood specimen rejection rate was calculated as the proportion of blood collection tubes with preanalytical errors out of the total number received, expressed as percentage.ResultsTotal of 107,716 blood specimens were screened of which 43,396 (40.3%) were received during the pandemic. The blood specimen rejection rate during the pandemic was significantly higher than the pre-pandemic phase (3.0% versus 1.1%; P < 0.001). Clotted samples were the commonest source of preanalytical errors in both phases. There was a significant increase in the improperly labelled samples (P < 0.001) and samples with insufficient volume (P < 0.001), whereas, a significant decline in samples with inadequate sample-anticoagulant ratio and haemolysed samples (P < 0.001).ConclusionIn the ongoing pandemic, preanalytical errors and resultant blood specimen rejection rate in the clinical laboratory have significantly increased due to changed logistics. The study highlights the need for corrective steps at various levels to reduce preanalytical errors in order to optimise patient care and resource utilisation.     

Influence of blood specimen collection method on various preanalytical sample quality indicators

Preanalytical errors contribute to a large proportion of total laboratory errors. In order to achieve continuous laboratory improvement, it is important to focus on all phases of patient specimen testing i.e. preanalytical, analytical and post-analytical. With large variations in the way venous blood specimens are collected using diverse devices in the country, the effect of such practices on specimen quality is not known. The purpose of this study was to monitor fourteen specimen preanalytical quality indicators in order to compare the usage of evacuated blood collection devices with needle and syringe open collection using either disposable tubes or re-washed glass vials. The study involved 26638 patient specimens assessed over a period of 6 months. The results demonstrated that evacuated closed blood collection resulted in an approximate 100-fold reduction in the incidence of hemolysis in samples. Similarly, there was a 200-fold reduction in incidence of insufficient specimen quantity while using evacuated collection system. It was also found that incidence of specimen contamination, improper volume of sample collected, and specimen spillage was also lower when the evacuated collection system was used. Further, it was also observed that the facility with a laboratory information system demonstrated much lower specimen identification and related errors. The observed results clearly demonstrate that the usage of the evacuated blood collection system resulted in improvement of preanalytical specimen quality as compared to needle and syringe usage.     

History of the preanalytical phase: a personal view

In the 70ies of the last century, ther term “preanalytical phase” was introduced in the literature. This term describes all actions and aspects of the “brain to brain circle” of the medical laboratory diagnostic procedure happening before the analytical phase. The author describes his personal experiences in the early seventies and the following history of increasing awareness of this phase as the main cause of “laboratory errors”. This includes the definitions of influence and interference factors as well as the first publications in book, internet, CD-Rom and recent App form over the past 40 years. In addition, a short summary of previous developments as prerequesits of laboratory diagnostic actions is described from the middle age matula for urine collection to the blood collection tubes, anticoagulants and centrifuges. The short review gives a personal view on the possible causes of missing awareness of preanalytical causes of error and future aspects of new techniques in regulation of requests to introduction of quality assurance programs for preanalytical factors.     

Evaluation of Preanalytical Quality Indicators by Six Sigma and Pareto`s Principle

Preanalytical steps are the major sources of error in clinical laboratory. The analytical errors can be corrected by quality control procedures but there is a need for stringent quality checks in preanalytical area as these processes are done outside the laboratory. Sigma value depicts the performance of laboratory and its quality measures. Hence in the present study six sigma and Pareto principle was applied to preanalytical quality indicators to evaluate the clinical biochemistry laboratory performance. This observational study was carried out for a period of 1 year from November 2015–2016. A total of 1,44,208 samples and 54,265 test requisition forms were screened for preanalytical errors like missing patient information, sample collection details in forms and hemolysed, lipemic, inappropriate, insufficient samples and total number of errors were calculated and converted into defects per million and sigma scale. Pareto`s chart was drawn using total number of errors and cumulative percentage. In 75% test requisition forms diagnosis was not mentioned and sigma value of 0.9 was obtained and for other errors like sample receiving time, stat and type of sample sigma values were 2.9, 2.6, and 2.8 respectively. For insufficient sample and improper ratio of blood to anticoagulant sigma value was 4.3. Pareto`s chart depicts out of 80% of errors in requisition forms, 20% is contributed by missing information like diagnosis. The development of quality indicators, application of six sigma and Pareto`s principle are quality measures by which not only preanalytical, the total testing process can be improved.     

Croatian Society of Medical Biochemistry and Laboratory Medicine: national recommendations for venous blood sampling

Phlebotomy is one of the most complex medical procedures in the diagnosis, management and treatment of patients in healthcare. Since laboratory test results are the basis for a large proportion (60–80%) of medical decisions, any error in the phlebotomy process could have serious consequences. In order to minimize the possibility of errors, phlebotomy procedures should be standardised, well-documented and written instructions should be available at every workstation. Croatia is one of the few European countries that have national guidelines for phlebotomy, besides the universally used CLSI (Clinical Laboratory Standards Institute) H3-A6 Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; approved Standard-Sixth Edition (CLSI, 2007) and WHO (World Health Organization) guidelines on drawing blood: best practices in phlebotomy (WHO, 2010). However, the growing body of evidence in importance of preanalytical phase management resulted in a need for evidence based revision and expansion of existing recommendations.The Croatian Society for Medical Biochemistry and Laboratory Medicine, Working Group for the Preanalytical Phase issued this recommendation. This document is based on the CLSI guideline H3-A6, with significant differences and additional information.     

Pre and post analytical errors

Laboratory data illustrative of preanalytical errors such as the effect of improper storage of sample, the type and concentration of anticoagulant used for specimen collection, the lability of an improperly preserved sample, and the effect of infusion are presented. Strategies to detect preanalytical errors by delta checks are illustrated. Physiological variables such as the effect of age, sex, diet, smoking, menstrual cycle, pregnancy, and specimen collection variables such as posture, duration of tourniquet application, diurnal effects and exercise introducing preanalytical error are discussed. The types of post analytical errors ranging from improper entry of data to errors in strategies used for the interpretation of laboratory data are also highlighted.     

Ten years of preanalytical monitoring and control: Synthetic Balanced Score Card Indicator

Introduction

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 centres; and finally to evaluate a single synthetic preanalytical indicator that may be included in the balanced scorecard management system (BSC).

Materials and methods

We collected individual and global preanalytical errors in haematology, 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.

Results

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.

Conclusion

We present 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.Key words: Preanalytical phase, errors in laboratory medicine, balanced scorecard, patient safety     

Specimen rejection in laboratory medicine: Necessary for patient safety?

Introduction

The emergency laboratory in Hacettepe University Hospitals receives specimens from emergency departments (EDs), inpatient services and intensive care units (ICUs). The samples are accepted according to the rejection criteria of the laboratory. In this study, we aimed to evaluate the sample rejection ratios according to the types of pre-preanalytical errors and collection areas.

Materials and methods

The samples sent to the emergency laboratory were recorded during 12 months between January to December, 2013 in which 453,171 samples were received and 27,067 specimens were rejected.

Results

Rejection ratios was 2.5% for biochemistry tests, 3.2% for complete blood count (CBC), 9.8% for blood gases, 9.2% for urine analysis, 13.3% for coagulation tests, 12.8% for therapeutic drug monitoring, 3.5% for cardiac markers and 12% for hormone tests. The most frequent rejection reasons were fibrin clots (28%) and inadequate volume (9%) for biochemical tests. Clotted samples (35%) and inadequate volume (13%) were the major causes for coagulation tests, blood gas analyses and CBC. The ratio of rejected specimens was higher in the EDs (40%) compared to ICUs (30%) and inpatient services (28%). The highest rejection ratio was observed in neurology ICU (14%) among the ICUs and internal medicine inpatient service (10%) within inpatient clinics.

Conclusions

We detected an overall specimen rejection rate of 6% in emergency laboratory. By documentation of rejected samples and periodic training of healthcare personnel, we expect to decrease sample rejection ratios below 2%, improve total quality management of the emergency laboratory and promote patient safety.Key words: clinical laboratory services, total quality management, patient safety, preanalytical phase, preanalytical error     

The knowledge and understanding of preanalytical phase among biomedicine students at the University of Zagreb

Introduction

The educational program for health care personnel is important for reducing preanalytical errors and improving quality of laboratory test results. The aim of our study was to assess the level of knowledge on preanalytical phase in population of biomedicine students through a cross-sectional survey.

Materials and methods

A survey was sent to students on penultimate and final year of Faculty of Pharmacy and Biochemistry – study of medical biochemistry (FPB), Faculty of Veterinary Medicine (FVM) and School of Medicine (SM), University of Zagreb, Croatia, using the web tool SurveyMonkey. Survey was composed of demographics and 14 statements regarding the preanalytical phase of laboratory testing. Comparison of frequencies and proportions of correct answers was done with Fisher’s exact test and test of comparison of proportions, respectively.

Results

Study included 135 participants, median age 24 (23-40) years. Students from FPB had higher proportion of correct answers (86%) compared to students from other biomedical faculties 62%, P < 0.001. Students from FPB were more conscious of the importance of specimen mixing (P = 0.027), prevalence of preanalytical errors (P = 0.001), impact of hemolysis (P = 0.032) and lipemia interferences (P = 0.010), proper choice of anticoagulants (P = 0.001), transport conditions for ammonia sample (P < 0.001) and order of draw during blood specimen collection (P < 0.001), in comparison with students from SM and FVM.

Conclusions

Students from FPB are more conscious of the importance of preanalytical phase of testing in comparison with their colleagues from other biomedical faculties. No difference in knowledge between penultimate and final year of the same faculty was found.Key words: survey, education, preanalytical phase     

A sudden creatinine increase: A case report

Creatinine and estimated glomerular filtration rate (eGFR) are first-line laboratory parameters in the diagnosis of various renal diseases. In recent decades, cystatin C (cysC) has furthered the laboratory repertoire regarding renal status assessment and has been implemented in many clinical guidelines. Accordingly, with the establishment of cysC as a renal routine biomarker, further opportunities for assessing eGFR have been attained. Nevertheless, various limitations are still associated with cysC and creatinine analysis. Preanalytical errors could cause false results in both biomarkers. In our case, we were confronted with implausibly elevated creatinine levels due to preanalytical errors.     

Hemolysis from a nurses’ standpoint – survey from four Croatian hospitals

Introduction

Hemolysis can occur during sample collection, handling and transport. It is more frequent when the non-laboratory staff performs sampling. The aim of this study was to assess nurses’ knowledge on the causes of hemolysis and consequential impact on the laboratory tests results. Additionally, the differences in knowledge, related to work experience, professional degree and previous education about hemolysis were explored.

Materials and methods

An anonymus survey, containing 11 questions on demographics, causes of hemolysis, its impact on biochemical parameters and nurses’ attitude towards additional education in preanalytics, was conducted in four Croatian hospitals. The answers were compared by Chi-squared and Fischer exact test.

Results

In total, 562 survey results were collected. Majority of nurses declared familiarity with the term “hemolysis” (99.6%). There were 77% of correct answers regarding questions about the causes of hemolysis, but only 50% when it comes to questions about interference in biochemical tests. The percentage of correct answers about causes was significantly lower (P = 0.029) among more experienced nurses, and higher (P = 0.027) in those with higher professional degree, while influence of previous education was not significant. Also, higher percentage of correct answers about interferences was encountered in nurses with longer work experience (P = 0.039). More than 70% of nurses declared that additional education about preanalytical factors would be beneficial.

Conclusion

Croatian nurses are familiar with the definition of hemolysis, but a lack of knowledge about causes and influence on laboratory test results is evident. Nurses are eager to improve their knowledge in this field of preanalytical phase.Key words: hemolysis, nurses, survey, preanalytical phase