Total Testing Process Research Articles

Practical Guidance for Clinical Microbiology Laboratories: Implementing a Quality Management System in the Medical Microbiology Laboratory

This document outlines a comprehensive practical approach to a laboratory quality management system (QMS) by describing how to operationalize the management and technical requirements described in the ISO 15189 international standard. It provides a crosswalk of the ISO requirements for quality and competence for medical laboratories to the 12 quality system essentials delineated by the Clinical and Laboratory Standards Institute. The quality principles are organized under three main categories: quality infrastructure, laboratory operations, and quality assurance and continual improvement. The roles and responsibilities to establish and sustain a QMS are outlined for microbiology laboratory staff, laboratory management personnel, and the institution's leadership. Examples and forms are included to assist in the real-world implementation of this system and to allow the adaptation of the system for each laboratory's unique environment. Errors and nonconforming events are acknowledged and embraced as an opportunity to improve the quality of the laboratory, a culture shift from blaming individuals. An effective QMS encourages "systems thinking" by providing a process to think globally of the effects of any type of change. Ultimately, a successful QMS is achieved when its principles are adopted as part of daily practice throughout the total testing process continuum.

How do we use the data from pre-analytical quality indicators and how should we?

It is impossible to imagine a modern medical laboratory without a structured quality management system in place. Nevertheless, this system usually focuses mostly on the analytical part of the total testing process (TTP), despite being aware of the fact that most errors occur in the pre- and post-analytical phases. There are many reasons possibly explaining this fact, one of them being that extra-analytical processes are hard to grasp, since they occur mostly outside of the laboratory and include many different parties. Despite these obstacles, it is mandatory to keep all steps of TTP, potentially influencing the analytical test result or their interpretation, under meticulous quality control and to improve them as much as possible, involving all health care workers contributing to sample quality. Additionally, it is necessary to collect and evaluate all data in a standardized manner, not only within one laboratory, but nationwide and internationally. This is a perquisite for valid data comparison over time (trend analysis) and benchmarking, the basis for threshold definition and continuous improvement. A widely accepted method to meet all these requirements is the concept of quality indicators (QIs). In this review, we provide an overview over this topic and we discuss an easy to use and freely available tool, aiming to aid laboratories in data collection and comparison: The QIs project of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Working Group on “Laboratory errors and patient safety” (WG-LEPS). Additionally, we provide practical suggestions on how to successfully implement QIs within any laboratory.

Local quality assurance of serum or plasma (HIL) indices

The presence of hemolysis (H), icterus (I) and lipaemia (L) in serum or plasma samples may be regarded as an important preanalytical drawback, since an abnormal concentration of these substances may derange the global quality and reliability of the total testing process. Although the assessment of sample quality before testing by means of the so-called HIL indices has become an essential part of routine practice in most clinical laboratories worldwide, no clear indications have been provided about the quality assurance of these measures. This article is hence aimed to provide an expert opinion about management of internal quality control (IQC) assessment for HIL indices. In summary, we support the use of in-house prepared IQC materials with at least two different levels for each interfering substances. IQC testing should be performed for validating performance of HIL indices in routine and urgent conditions, at least 2 times per day, and systematically recorded. We also suggest that results may be unacceptable when a single value of IQC material exceeds the mean target value by ±3 standard deviations. When results do not meet their set performance goals, the ensuing procedure mirrors that of conventional laboratory IQC management.

Errors in the Total Testing Process in the Clinical Chemistry Laboratory at the University of Gondar Hospital, Northwest Ethiopia.

Laboratory services have been described as the major processes contributing to safe patient care in the modern healthcare sector. However, occurrences of errors in the overall testing processes impair the clinical decision-making process. Such errors are supposed to be high in resource-poor countries, like Ethiopia. The objective of this study was to assess errors in the total testing process in the Clinical Chemistry laboratory of the University of Gondar Hospital, Northwest Ethiopia. A cross-sectional study was conducted at the University of Gondar Hospital from February to March 2016. All the required data were collected using established quality indicators. Data were analyzed using SPSS version 20. Frequencies and cross-tabulations were used to summarize descriptive statistics. A total of 3259 samples and corresponding laboratory request forms were received for analysis. The analysis of the overall distribution of errors revealed that 89.6% were pre-analytical errors, 2.6% were analytical, and 7.7% were post-analytical errors. Of the pre-analytical errors, incomplete request form filling was the most frequent error observed, followed by sample rejection rate (3.8%). Analytical errors related to internal and external quality control exceeding the target range, (14.4%) and (51.4%) respectively, were reported. Excessive turnaround time and unreported critical value cases were the major defects in the post-analytical phase of quality assurance. The present finding showed relatively high frequency of errors, which alarms the importance of quality indicators to assess errors in the total testing process. The University of Gondar Hospital laboratory should improve the quality of healthcare services based on these findings using laboratory standards.

Are we getting better at the preanalytical phase or just better at measuring it?

There is now consolidated evidence that the vast majority of laboratory errors occur in the extra-analytical phases of the total testing process, and especially in the preanalytical phase. Although development and dissemination of best practice recommendations for this crucial area of diagnostic testing have greatly contributed to reinforce error identification and reporting strategies, it is also undeniable that the combination of greater consciousness about preanalytical issues and technological advancements have helped decreasing the inherent vulnerability of many preanalytical activities, thus finally making the preanalytical phase less vulnerable to errors, slips and lapses. Many potential strategies can be adopted for reducing preanalytical errors, including education and training of healthcare staff on phlebotomy practice and preanalytical errors, greater observance of available phlebotomy guidelines, dissemination of specimen collection modules or phlebotomist check-lists, certification of phlebotomists, transmission of periodic preanalytical quality reports to phlebotomists, establishment of direct feed-back between laboratory professionals and phlebotomists, use of quality and validated blood collection systems for drawing blood, along with introduction of harmonized means for recording preanalytical errors.

Assessment of bone turnover in osteoporosis: harmonization of the total testing process

Abstract An imbalance between bone formation and bone resorption is a factor in the development of osteoporosis. Bone turnover markers (BTM) are useful in assessing bone remodeling at the cellular level. Measurement of BTM is useful for assessing bone turnover and therefore fracture risk as well as for monitoring response to treatment response. This paper describes the steps that have been taken so far and the ongoing work to harmonize the total testing process for the assessment of bone turnover in osteoporosis internationally and collaboratively between the clinical and laboratory professions. The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) in collaboration with the International Osteoporosis Foundation (IOF) as well as the National Bone Health Association (NBHA) in the US have designated procollagen type I N propeptide (s-PINP), and cross-linked β-isomerized type I collagen C-telopeptide (s-βCTX), in blood as reference standard BTM. Collaborative efforts are ongoing in order to standardize preanalytical steps as well as the analysis of s-PINP and s-CTX by standardizing or harmonizing their measurement as appropriate and reporting of values. Reporting units have been standardized. Reference interval studies and examination of appropriate decision thresholds, reference change values and treatment targets are ongoing with the aim of harmonizing the total testing process for the assessment of bone turnover in osteoporosis.

Quality indicators in laboratory medicine: A fundamental tool for quality and patient safety

Human error in medicine does exist and is a profound challenge. When seeking to solve any problem, the problem must first be described and the factors contributing to it be identified. Laboratory testing, a highly complex process commonly called the total testing process (TTP), is usually subdivided into three traditional (pre-, intra-, and post-) analytical phases. The majority of errors in TTP originate in the preanalytical phase, being due to individual or system design defects. Quality indicators represent valuable tools for quantifying the quality of selected aspects of care by comparing it against a defined criterion.

Extra-analytical quality indicators - where to now?

A large body of evidence collected in recent years demonstrates the vulnerability of the extra-analytical phases of the total testing process (TTP) and the need to promote quality and harmonization in each and every step of the testing cycle. Quality indicators (QIs), which play a key role in documenting and improving quality in TTP, are essential requirements for clinical laboratory accreditation. In the last few years, wide consensus has been achieved on the need to adopt universal QIs and common terminology and to harmonize the management procedure concerning their use by adopting a common metric and reporting system. This, in turn, has led to the definition of performance specifications for extra-analytical phases based on the state of the art as indicated by data collected on QIs, particularly by clinical laboratories attending the Model of Quality Indicators program launched by the Working Group "Laboratory Errors and Patient Safety" of the International Federation of Clinical Chemistry and Laboratory Medicine. Harmonization plays a fundamental role defining not only the list of QIs to use but also performance specifications based on the state of the art, thus providing a valuable interlaboratory benchmark and tools for continuous improvement programs.

Selecting a Risk-Based SQC Procedure for a HbA1c Total QC Plan.

Recent US practice guidelines and laboratory regulations for quality control (QC) emphasize the development of QC plans and the application of risk management principles. The US Clinical Laboratory Improvement Amendments (CLIA) now includes an option to comply with QC regulations by developing an individualized QC plan (IQCP) based on a risk assessment of the total testing process. The Clinical and Laboratory Standards Institute (CLSI) has provided new practice guidelines for application of risk management to QC plans and statistical QC (SQC). We describe an alternative approach for developing a total QC plan (TQCP) that includes a risk-based SQC procedure. CLIA compliance is maintained by analyzing at least 2 levels of controls per day. A Sigma-Metric SQC Run Size nomogram provides a graphical tool to simplify the selection of risk-based SQC procedures. Current HbA1c method performance, as demonstrated by published method validation studies, is estimated to be 4-Sigma quality at best. Optimal SQC strategies require more QC than the CLIA minimum requirement of 2 levels per day. More complex control algorithms, more control measurements, and a bracketed mode of operation are needed to assure the intended quality of results. A total QC plan with a risk-based SQC procedure provides a simpler alternative to an individualized QC plan. A Sigma-Metric SQC Run Size nomogram provides a practical tool for selecting appropriate control rules, numbers of control measurements, and run size (or frequency of SQC). Applications demonstrate the need for continued improvement of analytical performance of HbA1c laboratory methods.

Novel Opportunities for Improving the Quality of Preanalytical Phase. A Glimpse to the Future?

Summary The preanalytical phase is crucial for assuring the quality of in vitro diagnostics. The leading aspects which contribute to enhance the vulnerability of this part of the total testing process include the lack of standardization of different practices for collecting, managing, transporting and processing biological specimens, the insufficient compliance with available guidelines and the still considerable number of preventable human errors. As in heavy industry, road traffic and aeronautics, technological advancement holds great promise for decreasing the risk of medical and diagnostic errors, thus including those occurring in the extra-analytical phases of the total testing process. The aim of this article is to discuss some potentially useful technological advances, which are not yet routine practice, but may be especially suited for improving the quality of the preanalytical phase in the future. These are mainly represented by introduction of needlewielding robotic phlebotomy devices, active blood tubes, drones for biological samples transportation, innovative approaches for detecting spurious hemolysis and preanalytical errors recording software products.

Congruity in Quality Indicators and Laboratory Performance.

Proficiency of laboratory services is the mainstay in clinical medicine in providing error free diagnostic results. The efficiency of the laboratory needs to be evaluated as per standard international criterion. The quality indicators of the different phases of total testing process are considered the fundamental measurable tool for evaluation of laboratory performance. In order to optimize the laboratory's proficiency and accreditate it as per international standard in our newly established lab, the study was conducted to evaluate the frequency of errors incurred by laboratory and nonlaboratory professionals during the whole testing process. Retrospective analysis was done for data received from April 2016 to Dec 2016 in our lab. Total number of samples received was 61,674, out of which 43200 samples could be analyzed for quality indicators. Total numbers of tests processed in these samples were 172,800. In the study samples, 26.5% errors were due to pre-analytical factors whereas 9.4% of errors were contributed by analytical phase and 18% by post-analytical phase. Inappropriateness of test requisition was observed to be the major attributing determinant for pre-analytical errors. Instrumentation efficiency in form of frequent breakdown (~7%), greatly affected the proficiency of analytical phase in our lab. 12% of post-analytical errors were ascribed by excessive turn-around-time. However, timeliness of critical value call out and reporting for STAT samples revealed high proficiency up to 97%. High error rates were observed in pre-pre- and pre-analytical phases that also accorded for high error frequency in post analytical phase. This emphasizes urgent need to formulate guidelines for processing all steps of total testing process and initiate strategic measures for reducing risk of errors and increasing patient safety.

The key incident monitoring and management system - history and role in quality improvement.

The determination of reliable, practical Quality Indicators (QIs) from presentation of the patient with a pathology request form through to the clinician receiving the report (the Total Testing Process or TTP) is a key step in identifying areas where improvement is necessary in laboratories. The Australasian QIs programme Key Incident Monitoring and Management System (KIMMS) began in 2008. It records incidents (process defects) and episodes (occasions at which incidents may occur) to calculate incident rates. KIMMS also uses the Failure Mode Effects Analysis (FMEA) to assign quantified risk to each incident type. The system defines risk as incident frequency multiplied by both a harm rating (on a 1-10 scale) and detection difficulty score (also a 1-10 scale). Between 2008 and 2016, laboratories participating rose from 22 to 69. Episodes rose from 13.2 to 43.4 million; incidents rose from 114,082 to 756,432. We attribute the rise in incident rate from 0.86% to 1.75% to increased monitoring. Haemolysis shows the highest incidence (22.6% of total incidents) and the highest risk (26.68% of total risk). "Sample is suspected to be from the wrong patient" has the second lowest frequency, but receives the highest harm rating (10/10) and detection difficulty score (10/10), so it is calculated to be the 8th highest risk (2.92%). Similarly, retracted (incorrect) reports QI has the 10th highest frequency (3.9%) but the harm/difficulty calculation confers the second highest risk (11.17%). TTP incident rates are generally low (less than 2% of observed episodes), however, incident risks, their frequencies multiplied by both ratings of harm and discovery difficulty scores, concentrate improvement attention and resources on the monitored incident types most important to manage.

Laboratory Information System - Where are we Today?

SummaryWider implementation of laboratory information systems (LIS) in clinical laboratories in Serbia has been initiated ten years ago. The first LIS in the Railway Health Care Institute has been implemented nine years ago. Before the LIS was initiated, manual admission procedures limited daily output of patients. Moreover, manual entering of patients data and ordering tests on analyzers was problematic and time consuming. After completing tests, laboratory personnel had to write results in patient register (with potential errors) and provide invoices for health insurance organisation. First LIS brought forward some advantages with regards to these obstacles, but it also showed various weaknesses. These can be summarised in rigidity of system and inability to fulfil user expectation. After 4 years of use, we replaced this system with another LIS. Hence, the main aim of this paper is to evaluate advant ages of using LIS in laboratory of the Railway Health Care Institute and also to discuss further possibilities for its application. After implementing LIS, admission procedure has proven to be much faster. LIS enabled electronic requests, barcoded specimens prevent identification errors, bidirectional interface replaces redundant data entry steps, QC data are transferred automatically, results are electronically validated and automatically archived in data base, billing information is transferred electronically, and more. We also use some advanced options, like delta check, HIL feature, quality indicators and various types of reports. All steps in total testing process are drastically improved after the implementation of LIS, which had a positive impact on the quality of issued laboratory results. However, we expect development of some new features in the future, for example auto-verification and inventory management. On the example of the laboratory of the Railway Health Care Institute, we show that it is crucial that laboratory specialists have the main role in defining desirable characteristics of LIS which institution aims to buy. This paper suggests that the main feature of LIS should be the flexibility of system and capability of adjustment to user needs and requests.

ISO 15189 Accreditation: Navigation Between Quality Management and Patient Safety.

SummaryAccreditation is a valuable resource for clinical laboratories and the development of an International Standard for their accreditation represented a milestone on the path towards improved quality and safety in laboratory medicine. The recent revision of the International Standard, ISO 15189, has further strengthened its value not only for improving the quality system of a clinical laboratory but also for better answering the request for competence, focus on customers’ needs and ultimate value of laboratory services. Although in some countries more general standards such as ISO 9001 for quality systems or ISO 17025 for testing laboratories are still used, there is increasing recognition of the value of ISO 15189 as the most appropriate and useful standard for the accreditation of medical laboratories. In fact, only this International Standard recognizes the importance of all steps of the total testing process, namely extra-analytical phases, the need to focus on technical competence in addition to quality systems, and the focus on customers’ needs. However, the number of accredited laboratories largely varies between European countries and also major differences affect the approaches to accreditation promoted by the national bodies. In particular, some national accreditation bodies perpetuate the use of fixed scopes, while the European co-operation for accreditation (EA) and the European Federation of Laboratory Medicine (EFLM) Working Group promote the use of flexible scopes. Major issues in clinical laboratory accreditation are the verification of examination procedures for imprecision, trueness and diagnostic accuracy and for estimating measurement uncertainty. In addition, quality indicators (QIs) are a fundamental requirement of the ISO 15189 International Standard.

Errors in the Extra-Analytical Phases of Clinical Chemistry Laboratory Testing.

The total testing process consists of various phases from the pre-preanalytical to the post-postanalytical phase, the so-called brain-to-brain loop. With improvements in analytical techniques and efficient quality control programmes, most laboratory errors now occur in the extra-analytical phases. There has been recent interest in these errors with numerous publications highlighting their effect on service delivery, patient care and cost. This interest has led to the formation of various working groups whose mission is to develop standardized quality indicators which can be used to measure the performance of service of these phases. This will eventually lead to the development of external quality assessment schemes to monitor these phases in agreement with ISO15189:2012 recommendations. This review focuses on potential errors in the extra-analytical phases of clinical chemistry laboratory testing, some of the studies performed to assess the severity and impact of these errors and processes that are in place to address these errors. The aim of this review is to highlight the importance of these errors for the requesting clinician.

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 1year 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.

External Quality Assessment in Croatia: problems, challenges, and specific circumstances.

In Croatian medical laboratories (ML), external quality assessment (EQA) has a long tradition of almost half of a century. At national level, EQA is provided by Croatian Centre for Quality Assessment in Laboratory Medicine (CROQALM) which is a part of Croatian Society of Medical Biochemistry and Laboratory Medicine. This case study aimed to summarize the main challenges, which are set to CROQALM and their possible solutions. CROQALM has 10 schemes, covering majority of analysis for which medical biochemistry laboratories in Croatia are authorized for, including pre-analytical and post-analytical phase of laboratory work. Assessment scheme has three exercises per year. One sample per scheme and exercise is distributed to participants depending on their application. All data transfer and evaluation of the results are done using web interface and statistical software for evaluation of quality in laboratory medicine. Since CROQALM has relatively small number of participating laboratories (N = 197) with lot of different manufacturers of instruments used for analysis in all schemes, constant challenges are present in the evaluation of the results (commutability problems, statistical analysis etc.). Further, number of participating medical laboratories is even lower for highly specific parameters, which are in the scope of clinical laboratories only. Despite the obstacles we are faced to, EQA at national level is useful tool regarding standardization and harmonization aspects in total testing process within the country. Furthermore, it gives participating laboratories recognition and proof for meeting expected quality criteria in the community they serve.

An overview of the European Organization for External Quality Assurance Providers in Laboratory Medicine (EQALM).

The European Organisation for External Quality Assurance Providers in Laboratory Medicine (EQALM) was founded in 1996 and currently has members from 29 European countries and 6 countries from outside Europe. EQALM provides a forum for co-operation and exchange of knowledge on quality-related matters in laboratory medicine, especially with regard to external quality assessment (EQA) programs in Europe. In addition, EQALM represent the EQA providers in laboratory medicine at European level vis-ŕ-vis political, professional, scientific and other bodies, including patients’ organisations. To this end EQALM promotes activities such as organizing meetings with scientific and practical themes for members and other interested parties, issuing scientific publications, developing EQA projects and representing laboratory medicine EQA activities within other organisations and networks. EQALM is active in scientific and educational activity in different fields such as survey frequency, haematology, haemostasis, microbiology, nomenclature, virtual microscopy, traceability, accreditation, and quality assurance of the total testing process. The aim of this paper is to give an overview of the EQALM organisation.

Preanalytical Issues in Hemostasis and Thrombosis Testing.

Hemostasis testing is critical to many hemorrhagic and thrombotic disorders, wherein laboratory diagnostics can provide critical information for diagnosis, prognostication, and therapeutic monitoring. Due to this crucial role in modern medicine, hemostasis tests should be carried out at their highest degree of quality, thus encompassing standardization and monitoring of all phases of the testing process. It is now clearly established that the preanalytical phase is the most critical and vulnerable part of the total testing process, since up to 70% of diagnostic errors are due to highly manual activities encompassing patient preparation and collection of biological samples, as well as handling, transportation, preparation and storage of blood specimens. Due to the peculiar sample matrix required for hemostasis testing (i.e., plasma anticoagulated with buffered sodium citrate), additional critical issues may impair the reliability of these tests. Therefore, this article aims to provide an updated overview of the most important preanalytical variables that may ultimately impair the quality of hemostasis and thrombosis testing.

Improving quality in the preanalytical phase through innovation, on behalf of the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Preanalytical Phase (WG-PRE).

It is now undeniable that laboratory testing is vital for the diagnosis, prognostication and therapeutic monitoring of human disease. Despite the many advances made for achieving a high degree of quality and safety in the analytical part of diagnostic testing, many hurdles in the total testing process remain, especially in the preanalytical phase ranging from test ordering to obtaining and managing the biological specimens. The Working Group for the Preanalytical Phase (WG-PRE) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) has planned many activities aimed at mitigating the vulnerability of the preanalytical phase, including the organization of three European meetings in the past 7 years. Hence, this collective article follows the previous three opinion papers that were published by the EFLM WGPRE on the same topic, and brings together the summaries of the presentations that will be given at the 4th EFLM-BD meeting "Improving quality in the preanalytical phase through innovation" in Amsterdam, 24-25 March, 2017.