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.     

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.     

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.     

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.     

Low level of adherence to instructions for 24-hour urine collection among hospital outpatients

Introduction:

We hypothesized that patients are poorly informed about proper procedure for 24-hour urine specimen collection and its relevance in determination of biochemical analytes, despite availability of leaflets and webpage with instruction for collection. The aim of this survey was to question outpatients how well are they informed about procedure of 24-hour urine specimen collection.

Materials and methods:

The survey with 10 questions was done in outpatient laboratory of University Department of Chemistry, Medical School University Hospital Sestre Milosrdnice, Zagreb, Croatia. The study included 59 patients with collected 24-hour urine sample who have consented to participate in the survey.

Results:

Out of 59 participants, most of them (0.97) were older than 40 years. Internet was not recognized as a source of information (1/59). Almost one third of the patients have changed their drinking habits to collect more urine volume. Although most of the patients (0.60) were aware that the bottle of water is the best choice for the container, almost half of them were collected urine samples in the plastic soft drink bottle. Laboratory staff and physicians often have given information about proper collection procedure, but that information was insufficient.

Conclusions:

Patients are usually not aware of importance of proper preanalytical procedure for collecting urine specimen and how improper collection could affect results of requested tests. Education of outpatients, general practitioners and laboratory staff is needed in order to improve sample quality and trueness of results.     

Influence of method of specimen collection on various preanalytical sample quality indicators in EDTA blood collected for cell counting

Improving specimen quality as well as healthcare worker (HCW) safety poses significant concerns for today’s laboratories. With an increasing number of diagnostic tests requested, laboratory professionals are faced with challenges to reduce laboratory errors, improve the quality of laboratory results to assure accurate diagnosis and implement initiatives to ensure healthcare worker safety and minimize risk of exposure to bloodborne pathogens. A prior study conducted in 2008 reported that variations in blood collection methods for clinical chemistry assays may affect overall specimen quality. As a follow up, the current study assessed the quality of 22563 patient specimens for cell counting in EDTA blood collection tubes that were obtained with needle and syringe collection (open) using either disposable tubes or re-washed glass vials or with an evacuated blood collection system (closed). Based on the observations, the use of the evacuated blood collection system resulted in better preanalytical specimen quality as compared with needle and syringe collection. The findings also showed an approximately 70-fold reduction in the incidence of clotting as well as fewer instrument-generated flags using the evacuated collection system. In addition, the use of an evacuated collection system for venous blood collection demonstrated lesser chance of blood exposure to healthcare workers.     

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     

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     

Preanalytical considerations in blood gas analysis

Blood gas testing is a commonly ordered test in hospital settings, where the results almost always have the potential to dictate an immediate or urgent response. The preanalytical steps in testing, from choosing the correct tests to ensuring the specimen is introduced into the instrument correctly, must be perfectly coordinated to ensure that the patient receives appropriate and timely therapy in response to the analytical results. While many of the preanalytical steps in blood gas testing are common to all laboratory tests, such as accurate specimen labeling, some are unique to this testing because of the physicochemical properties of the analytes being measured. The common sources of preanalytical variation in blood gas testing are reviewed here.     

Effect of sample type,centrifugation and storage conditions on vitamin D concentration

Introduction:

Studies about vitamin D [25(OH)D] stability in plasma are limited and preanalytical variables such as tube type may affect results. We aimed to evaluate effect of storage conditions, sample type and some preanalytical variables on vitamin D concentration.

Materials and methods:

Blood samples from 15 healthy subjects were centrifuged at different temperatures and stored under different conditions. Serum and plasma 25(OH)D difference, effect of centrifugation temperature and common storage conditions were investigated.

Results:

There was no difference between serum and plasma vitamin D concentration. Centrifugation temperature had no impact on vitamin D concentration. 25(OH)D is stable under common storage conditions: 4 hours at room temperature, 24 hours at 2–8 °C, 7 days at −20 °C, 3 months at −80 °C.

Conclusion:

Vitamin D does not require any special storage conditions and refrigeration. Both serum and plasma can be used for measurement.     

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     

Preanalytical phase--a continuous challenge for laboratory professionals

Preanalytical phase is the most vulnerable part of the total testing process and is considered to be among the greatest challenges to the laboratory professionals. However, preanalytical activities, management of unsuitable specimens and reporting policies are not fully standardized, nor harmonized worldwide. Several standards related to blood sampling and sample transportation and handling are available, but compliance to those guidelines is low, especially outside the laboratory and if blood sampling is done without the direct supervision of the laboratory staff. Furthermore, for some most critical procedures within the preanalytical phase, internationally accepted guidelines and recommendations as well as related quality measures are unfortunately unavailable. There is large heterogeneity in the criteria for sample rejection, the different strategies by which unacceptable samples are managed, processed and test results reported worldwide. Management of unacceptable specimens warrants therefore immediate harmonization. Alongside the challenging and long road of patient safety, preanalytical phase offers room for improvement, and Editors at Biochemia Medica Journal definitely hope to continue providing a respective mean for reporting studies on different preanalytical phase topics. With pleasure and delight we invite potential future authors to submit their articles examining the quality of various preanalytical activities to Biochemia Medica. We will keep nurturing this topic as our prominent feature and by this we hope to be able to deliver valid evidence for some future guidelines and recommendations.     

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.     

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.     

E环境下馆藏书目数据的维护方法与技巧

维护馆藏编目数据,保证书目数据质量是图书馆编目人员的重要工作之一,E环境下图书馆维护馆藏编目数据具有重要意义,在海量的馆藏数据中运用系统查错、技巧查错、分编新书查重过程查错以及其它部门的协作查错等方法,查出错误,并根据书目数据出错情况不同,采取不同方法进行修错,达到维护馆藏书目数据的目的。     

Clinical biochemistry laboratory rejection rates due to various types of preanalytical errors

Introduction:

Preanalytical errors, along the process from the beginning of test requests to the admissions of the specimens to the laboratory, cause the rejection of samples. The aim of this study was to better explain the reasons of rejected samples, regarding to their rates in certain test groups in our laboratory.

Materials and methods:

This preliminary study was designed on the rejected samples in one-year period, based on the rates and types of inappropriateness. Test requests and blood samples of clinical chemistry, immunoassay, hematology, glycated hemoglobin, coagulation and erythrocyte sedimentation rate test units were evaluated. Types of inappropriateness were evaluated as follows: improperly labelled samples, hemolysed, clotted specimen, insufficient volume of specimen and total request errors.

Results:

A total of 5,183,582 test requests from 1,035,743 blood collection tubes were considered. The total rejection rate was 0.65 %. The rejection rate of coagulation group was significantly higher (2.28%) than the other test groups (P < 0.001) including insufficient volume of specimen error rate as 1.38%. Rejection rates of hemolysis, clotted specimen and insufficient volume of sample error were found to be 8%, 24% and 34%, respectively. Total request errors, particularly, for unintelligible requests were 32% of the total for inpatients.

Conclusions:

The errors were especially attributable to unintelligible requests of inappropriate test requests, improperly labelled samples for inpatients and blood drawing errors especially due to insufficient volume of specimens in a coagulation test group. Further studies should be performed after corrective and preventive actions to detect a possible decrease in rejecting samples.     

Contribution of the laboratory to a diagnosis process by sequential reflective testing: Paraprotein interference on a direct bilirubin assay

Errors in laboratory medicine occur in the preanalytical, analytical, and postanalytical phases. The errors are mostly detected in the preanalytical period. However, analytical errors are still an important source of error, despite their frequency is reduced significantly in years thanks to developments in laboratories. In this case, an analytical error was noticed during the verification of a patient’s results. The direct bilirubin of a 66-year-old male patient admitted to the emergency department was higher than the total bilirubin. The patient’s symptoms were fatigue and dyspnoea. Albumin and haemoglobin (Hb) concentrations of the patient were significantly low. After considering the patient’s demographics and laboratory results, the laboratory specialist suspected a paraproteinemia interference. Total protein was performed as a reflective test. The albumin/globulin ratio was reversed. Thereafter, serum protein electrophoresis (SPEP) and immunofixation electrophoresis (IFE) were performed as another reflective tests, respectively. SPEP and IFE results were in favour of monoclonal gammopathy. The patient was directed to a haematologist, underwent a bone marrow biopsy, and the result was reported as Waldenstrom’s macroglobulinemia with plasma cell differentiation expressing IgM-Kappa. The patient went on a chemotherapy protocol, and his condition has been improved in subsequent months. Detection of analytical errors is of great importance, like in our case, and may be used as a tool to identify patients who have not yet been diagnosed. The laboratory specialist must dominate the entire process of each test in the laboratory, be aware of the limitations of tests, and turn these disadvantages into advantages when necessary.     

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.     

Current status of the lateral flow immunoassay for the detection of SARS-CoV-2 in nasopharyngeal swabs

Early detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and diagnosis of coronavirus disease 2019 (COVID-19) are priorities during the pandemic. Symptomatic and suspected asymptomatic individuals should be tested for COVID-19 to confirm infection and to be excluded from social interactions. As molecular testing capacity is overloaded during the pandemic, rapid antigen tests, such as lateral flow immunoassays (LFIAs), can be a useful tool as they allow greater test availability and obtain results in a very short time. This short review aims to present the analytical properties of LFIAs in the detection of SARS-CoV-2 in nasopharyngeal swabs. Lateral flow immunoassay is a method that combines thin-layer chromatography and indirect immunochemical sandwich method and allows the detection of a specific SARS-CoV-2 antigen in nasopharyngeal swabs. Swab specimens should be adequately collected and tested as soon as possible. Users should pay attention to quality control and possible interferences. Antigen tests for SARS-CoV-2 show high sensitivity and specificity in cases with high viral loads, and should be used up to five days after the onset of the first symptoms of COVID-19. False positive results may be obtained when screening large populations with a low prevalence of COVID-19 infection, while false negative results may happen due to improper specimen collection or insufficient amount of antigen in the specimen. So as to achieve reliable results, a diagnostic accuracy study of a specific rapid antigen test should be performed.     

复值型数据Improper线性回归模型的估计(英文)

复随机变量称为"improper"随机变量,若它的"伪"协方差阵不为0,否则称为"proper"随机变量.研究了误差服从独立同分布的improper复高斯分布的线性回归模型.利用极大似然方法和2阶段最小二乘方法来估计回归系数.模拟表明,这2种方法与经典复版本的最小二乘法有不同之处,并将该方法用于实际风信号数据的处理.