In-Laboratory Polysomnography Worsens Obstructive Sleep Apnea by Changing Body Position Compared to Home Testing.

(1) Background: Home sleep apnea testing, known as polysomnography type 3 (PSG3), underestimates respiratory events in comparison with in-laboratory polysomnography type 1 (PSG1). Without head electrodes for scoring sleep and arousal, in a home environment, patients feel unfettered and move their bodies more naturally. Adopting a natural position may decrease obstructive sleep apnea (OSA) severity in PSG3, independently of missing hypopneas associated with arousals. (2) Methods: Patients with suspected OSA performed PSG1 and PSG3 in a randomized sequence. We performed an additional analysis, called reduced polysomnography, in which we blindly reassessed all PSG1 tests to remove electroencephalographic electrodes, electrooculogram, and surface electromyography data to estimate the impact of not scoring sleep and arousal-based hypopneas on the test results. A difference of 15 or more in the apnea-hypopnea index (AHI) between tests was deemed clinically relevant. We compared the group of patients with and without clinically relevant differences between lab and home tests (3) Results: As expected, by not scoring sleep, there was a decrease in OSA severity in the lab test, similar to the home test results. The group of patients with clinically relevant differences between lab and home tests presented more severe OSA in the lab compared to the other group (mean AHI, 42.5 vs. 20.2 events/h, p = 0.002), and this difference disappeared in the home test. There was no difference between groups in the shift of OSA severity by abolishing sleep scoring in the lab. However, by comparing lab and home tests, there were greater variations in supine AHI and time spent in the supine position in the group with a clinically relevant difference, either with or without scoring sleep, showing an impact of the site of the test on body position during sleep. These variations presented as a marked increase or decrease in supine outcomes according to the site of the test, with no particular trend. (4) Conclusions: In-lab polysomnography may artificially increase OSA severity in a subset of patients by inducing marked changes in body position compared to home tests. The location of the sleep test seems to interfere with the evaluation of patients with more severe OSA.

Comparison of clinical pathways for hypoglossal nerve stimulation management: in-laboratory titration polysomnography vs home-based efficacy sleep testing.

STUDY OBJECTIVES: We conducted this study to evaluate whether laboratory or home-based hypoglossal nerve stimulation (HNS) management would have equivalent objective and subjective obstructive sleep apnea outcomes 6 months after activation. METHODS: Patients undergoing standard-of-care HNS implantation were randomly assigned in a prospective, multicenter clinical trial to either a 3-month postactivation in-laboratory titration polysomnography (tPSG) or an efficacy home sleep study (eHST) with tPSG by exception for eHST nonresponders at 5 months. Both groups underwent an eHST 6 months postactivation. RESULTS: Sixty patients were randomly assigned. Patients experienced equivalent decreases in the apnea-hypopnea index (mean difference: -0.01 events/h [-8.75, 8.74]) across both groups with HNS; the selection of tPSG or eHST did not associate with therapy response rates (tPSG vs eHST: 63.2% vs 59.1%). The Epworth Sleepiness Scale (median of differences: 1 [-1, 3]) and device usage (median of differences: 0.0 hours [-1.3, 1.3]) outcomes were similar but did not meet a priori statistical equivalence criteria. CONCLUSIONS: This prospective, multicenter, randomized clinical trial demonstrated that patients undergoing HNS implantation experienced statistically equivalent improvements in objective obstructive sleep apnea outcomes and similar improvements in daytime sleepiness regardless of whether they underwent tPSG. HNS titration with tPSG may not be required for all postoperative patients. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Name: Inspire Home Study: Utilization of Home Monitoring During Therapy Optimization in Patients With an Inspire Upper Airway Stimulation System (Comparison of Home Sleep Testing vs. In-lab Polysomnography Testing) (HOME); URL: https://clinicaltrials.gov/ct2/show/NCT04416542; Identifier: NCT04416542. CITATION: Kent D, Huyett P, Yu P, et al. Comparison of clinical pathways for hypoglossal nerve stimulation management: in-laboratory titration polysomnography vs home-based efficacy sleep testing. J Clin Sleep Med. 2023;19(11):1905-1912.

Implementing metrological traceability of C-reactive protein measurements: consensus summary from the Joint Committee for Traceability in Laboratory Medicine Workshop.

The Joint Committee for Traceability in Laboratory Medicine (JCTLM) currently lists the secondary commutable certified reference material (CRM) ERM DA-474/IFCC (DA-474) "C-Reactive Protein in Human Serum" and two generic immunoassay-based method principles as the basis for implementing the metrological traceability of C-reactive protein (CRP) measurements by end-user measurement procedures used by medical laboratories. The current metrological traceability has produced well harmonized results for clinical samples among different end-user measurement procedures. New higher-order pure substance and secondary commutable CRMs have been nominated for listing by the JCTLM. However, the data supporting performance of these new candidate CRMs, including use of new mass spectrometry based candidate reference measurement procedures (RMPs), was not clear regarding the influence that introducing these new CRMs would have on the current well harmonized results achieved with the existing metrological traceability to DA-474. The clinically relevant CRP measurand in blood serum or plasma is a pentamer of identical subunits, which adds complexity to the application of higher-order CRMs and RMPs. The JCTLM convened a workshop in December 2022 to review the appropriate implementation of metrological traceability of CRP measurements. The workshop consensus was that the extent-of-equivalence data must include considerations about the impact of a new CRM when used for its intended purpose in the calibration hierarchies of existing end-user measuring systems; and that a new RMP must compare results with another existing well validated candidate RMP or with a globally available end-user measurement system.

The European Register of Specialists in Clinical Chemistry and Laboratory Medicine: code of conduct, version 3 - 2023.

Whilst version 2 focussed on the professional conduct expected of a Specialist in Laboratory Medicine, version 3 builds on the responsibilities for ethical conduct from point of planning to point of care. Particular responsibilities that are outlined include: - The need for evidence when planning a new service, providing assurance that a new test does not do harm - Maintaining respect for patient confidentiality, their religious/ethnic beliefs, the need for informed consent to test, agreement on retrospective use of samples as part of governance envelopes in the pre-analytical phase - Ensuring respect for patient autonomy in the response to untoward results generated in the analytical phase - Supporting the safety of patients in the post-analytical phase through knowledge-based interpretation and presentation of results - The duty of candour to disclose and respond to error across the total testing process - Leading initiatives to harmonise and standardise pre-analytical, analytical and post-analytical phases to ensure more consistent clinical decision making with utilisation of demand management to ensure more equitable access to scarce resources - Working with emerging healthcare providers beyond the laboratory to ensure consistent application of high standards of clinical care In identifying opportunities for wider contributions to resolving ethical challenges across healthcare the need is also highlighted for more external quality assurance schemes and ethics-based quality indicators that span the total testing process.

Establishing metrological traceability for small molecule measurands in laboratory medicine.

For molecules that can be well described metrologically in the sense of the definition of measurands, and which can also be recorded analytically as individual substances, reference measurement service traceability to a metrologically sound foundation is a necessity. The establishment of traceability chains must be initiated by National Metrology Institutes (NMIs) according to applicable standards; they are at the top and leading position in this concept. If NMIs are not in the position to take up this task, alternative approaches must be sought. Traceability initiatives established by in vitro device industry or academia must meet the quality standards of NMIs. Adherence to International Organization for Standardization (ISO) procedure 15193 must be a matter of course for the establishment of reference measurement procedures (RMPs). Certified reference material (CRM) characterization must be thorough, e.g., by the application of quantitative nuclear magnetic resonance measurements and by adherence to ISO 15194. Both for RMPs and CRMs Joint Committee for Traceability in Laboratory Medicine (JCTLM) listing must be the ultimate goal. Results must be shared in a transparent manner to allow other stakeholders including NMIs to reproduce and disseminate the reference measurement procedures.

An Objective Structured Laboratory Animal Science Examination (OSLASE) to ensure researchers' professional competence in laboratory animal science.

The evaluation of the competence of personnel working with laboratory animals is currently a challenge. Directive 2010/63/EU establishes that staff must have demonstrated competence before they perform unsupervised work with living animals. Nevertheless, there is a lack of research into education and training in laboratory animal science, and the establishment of assessment strategies to confirm researchers' competence remains largely unaddressed.In this study, we analysed the implementation of a practical assessment strategy over three consecutive years (2018-2021) using the Objective Structured Laboratory Animal Science Exam (OSLASE) developed previously by us to assess professional competence. The interrater reliability (IRR) was determined based on the assessors' rating of candidates' performance at different OSLASE stations using weighted kappa (Kw) and percentage of agreement. Focus group interviews were conducted to access trainees' acceptability regarding the OSLASE.There was a moderate-to-good Kw for the majority of the scales' items (0.79 ± 0.20 ≤ Kw ≥ 0.45 ± 0.13). The percentages of agreement were also acceptable (≥75%) for all scale items but one. Trainees reported that the OSLASE had a positive impact on their engagement during practical training, and that it clarified the standards established for their performance and the skills that required improvement. These preliminary results illustrate how assessment strategies, such as the OSLASE, can be implemented in a manner that is useful for both assessors and trainees.Examen structuré objectif de science animale de laboratoire (OSASSE) pour assurer la compétence professionnelle des chercheurs en SAL.

Association between cyclic variation in the heart rate index and biomarkers of neurodegenerative diseases in obstructive sleep apnea syndrome: A pilot study.

PURPOSE: Obstructive sleep apnea syndrome (OSAS) has mostly been examined using in-laboratory polysomnography (Lab-PSG), which may overestimate severity. This study compared sleep parameters in different environments and investigated the association between the plasma levels of neurochemical biomarkers and sleep parameters. METHODS: Thirty Taiwanese participants underwent Lab-PSG while wearing a single-lead electrocardiogram patch. Participants' blood samples were obtained in the morning immediately after the recording. Participants wore the patch for the subsequent three nights at home. Sleep disorder indices were calculated, including the apnea-hypopnea index (AHI), chest effort index, and cyclic variation of heart rate index (CVHRI). The 23 eligible participants' derived data were divided into the normal-to-moderate (N-M) group and the severe group according to American Association of Sleep Medicine (AASM) guidelines (Lab-PSG) and the recommendations of a previous study (Rooti Rx). Spearman's correlation was used to examine the correlations between sleep parameters and neurochemical biomarker levels. RESULTS: The mean T-Tau protein level was positively correlated with the home-based CVHRI (r = 0.53, p < 0.05), whereas no significant correlation was noted between hospital-based CVHRI and the mean T-tau protein level (r = 0.25, p = 0.25). The home-based data revealed that the mean T-Tau protein level in the severe group was significantly higher than that in the N-M group (severe group: 24.75 ± 6.16 pg/mL, N-M group: 19.65 ± 3.90 pg/mL; p < 0.05). Furthermore, the mean in-hospital CVHRI was higher than the mean at-home values (12.16 ± 13.66 events/h). CONCLUSION: Severe OSAS patients classified by home-based CVHRI demonstrated the higher T-Tau protein level, and CVHRI varied in different sleep environments.

The potential for isotope dilution-LC-MS/MS to improve laboratory measurement of C-peptide: Reasons and critical determinants.

Human C-peptide is secreted in equimolar amounts with insulin by pancreatic beta-cells. Measurement of C-peptide plays an important role in the diagnosis and treatment of diabetes where it is used to evaluate the function of islet cells. However, C-peptide measurement results across different laboratories vary considerably and there is an urgent need to improve comparability between laboratories. As it is sensitive and specific, isotope dilution-liquid chromatography-tandem mass spectrometry (ID-LC-MS/MS) has made a major contribution and will continue to play a significant role in the standardization of C-peptide measurement. Here, we reviewed the application of ID-LC-MS/MS in C-peptide measurement by discussing the biochemical properties of C-peptide, common sample preparation procedures, and the sensitivity problems often encountered with ID-LC-MS/MS C-peptide measurement. Collectively, these factors are crucial for the development of ID-LC-MS/MS methods for C-peptide measurement. We also discussed the advantages, disadvantages, and progress of implementing ID-LC-MS/MS as a routine measurement tool for C-peptide in clinical laboratories. Finally, we summarized the existing reference system and the status of C-peptide measurement in clinical laboratories to convey the necessity of improving the comparability of C-peptide measurement in clinical laboratories using ID-LC-MS/MS.

The Interactive Stress Assessment in Basic Animal Science Training.

In order to assess the extent to which the legally prescribed training for the acquisition of animal experimentation expertise provides scientific personnel with the necessary competence and expertise to carry out a correct harm-benefit analysis in the context of animal experimentation applications, we conducted an interactive stress assessment concerning the basic animal experimentation expertise course. First, before the practical part of the course and then, after the practical part, the participants assessed images and video material of healthy and stressed animals. The results were assessed comparatively and showed a significant increase in performance in all categories (p-value < 0.001). In addition, the results were comparatively assessed against those of scientists already experienced in animal experiments and experienced animal caretakers in research and clinics. In all groups, the vast majority of participants were able to recognise stress in laboratory animals. A significant proportion of the participants were also able to rate the level of stress correctly according to three degrees of severity: mild, moderate and severe. Nevertheless, a small number of participants were unable to distinguish between healthy and stressed animals and thus, the stress in the individual groups was assigned very differently from the different degrees of severity. The results of this study illustrate, on the one hand, the high significance that training must have in order to acquire the expertise, and, on the other hand, how strongly the assessment of stress is influenced by subjectivity.

Standardization of methods for determining ESR.

The study presents a historical analysis of the problems of standardization of methods for determining ESR. The modern approaches to the automation of ESR research are presented. It is shown that the solution to the problems of standardization of methods for determining ESR lies in the plane of regular intra-laboratory quality control. In accordance with the principles of evidence-based medicine, recommendations are given on the use of methods for determining ESR in clinical practice.

A proposed Common Training Framework for Specialists in Laboratory Medicine under EU Directive 2013/55/EC (The Recognition of Professional Qualifications).

European Union (EU) Directive 2013/55/EC (The Recognition of Professional Qualifications) allows Member States to decide on a common set of minimum knowledge, skills and competences that are needed to pursue a given profession through a Common Training Framework. To be adopted the framework must combine the knowledge, skills and competences of at least one third of the Member States. Professionals who have gained their qualifications under a Common Training Framework will be able to have these recognised automatically within the Union. The backbone of the European Federation of Clinical Chemistry and Laboratory Medicine's (EFLM) proposed Common Training Framework for non-medical Specialists in Laboratory Medicine is outlined here. It is based on an Equivalence of Standards in education, training, qualifications, knowledge, skills, competences and the professional conduct associated with specialist practice. In proposing the recognition of specialist practice EFLM has identified 15 EU Member States able to meet Equivalence and in whom the profession and/or its training is regulated (an additional EU Commission requirement). The framework supports and contributes to the Directive's enabling goals for increasing professional mobility, safeguarding consumers and ensuring a more equitable distribution of skills and expertise across the Member States. It represents EFLM's position statement and provides a template for professional societies and/or competent authorities to engage with the EU Commission.

Differentiation Model for Insomnia Disorder and the Respiratory Arousal Threshold Phenotype in Obstructive Sleep Apnea in the Taiwanese Population Based on Oximetry and Anthropometric Features.

Insomnia disorder (ID) and obstructive sleep apnea (OSA) with respiratory arousal threshold (ArTH) phenotypes often coexist in patients, presenting similar symptoms. However, the typical diagnosis examinations (in-laboratory polysomnography (lab-PSG) and other alternatives methods may therefore have limited differentiation capacities. Hence, this study established novel models to assist in the classification of ID and low- and high-ArTH OSA. Participants reporting insomnia as their chief complaint were enrolled. Their sleep parameters and body profile were accessed from the lab-PSG database. Based on the definition of low-ArTH OSA and ID, patients were divided into three groups, namely, the ID, low- and high-ArTH OSA groups. Various machine learning approaches, including logistic regression, k-nearest neighbors, naive Bayes, random forest (RF), and support vector machine, were trained using two types of features (Oximetry model, trained with oximetry parameters only; Combined model, trained with oximetry and anthropometric parameters). In the training stage, RF presented the highest cross-validation accuracy in both models compared with the other approaches. In the testing stage, the RF accuracy was 77.53% and 80.06% for the oximetry and combined models, respectively. The established models can be used to differentiate ID, low- and high-ArTH OSA in the population of Taiwan and those with similar craniofacial features.

Inducing signal-verified lucid dreams in 40% of untrained novice lucid dreamers within two nights in a sleep laboratory setting.

Dreams in which the dreamer is aware of the dream state (lucid dreams, LD) are difficult to induce in naïve subjects in-laboratory. Recently, Stumbrys and Erlacher (2014) used a combination of existing induction techniques together with a self-developed experiment protocol and achieved comparatively high LD induction rates. In this study, we simplified their methodology slightly and repeated their experiment with twenty naïve subjects who spent one or two nights in our sleep laboratory. After about six hours of sleep, they were woken up during REM sleep and engaged in a series of cognitive tasks before going back to bed. Ten subjects reported a LD during the following period of sleep in one of the nights. Eight of these subjects gave a predefined eye signal, which was clearly visible in the electrooculogram during REM sleep. In summary, we replicated Stumbrys and Erlacher's results using a simplified version of their induction protocol.

Low-cost automatic temperature monitoring system with alerts for laboratory rearing units.

Monitoring accurately temperature is a key issue in biological studies involving living experimental material. It is especially true for insects which body temperature is mostly controlled by environmental temperature, with profound consequences of a few degrees variation on most physiological processes such as survival, development, fecundity, and mobility. If programmable rearing units can be purchased, it remains important to monitor and store temperature information acquired inside the rearing unit to ensure that observed phenomena are not the result of unintended and not scarily noticeable changes in temperature, and to account for the effect of temperature variation in statistical analysis. As most laboratories involved in insect rearing dispose of a large number of rearing units, the technical solution should meet the monitoring needs while being affordable and adaptable to various experimental designs. For that purpose, we designed a low cost (below 100€) and open source automatic temperature monitoring system for rearing units in laboratory. Key features providing advantage over pre-existing methods include: •Highly configurable temperature monitoring and life-time storage capacity•Email alerts based on configurable user-defined threshold•Automatic configurable reports in the form of dashboards.

Teaching the pony new tricks: competences for specialists in laboratory medicine to meet the challenges of disruptive innovation.

The 20th century digital revolution has already seen the introduction of faster, more diverse, easier to use technologies with extended capacity and capability that has enhanced productivity in Laboratory Medicine and allowed more effective use of human resource. With increasing demands for better health and best care the challenge to future healthcare systems is to deploy technology, facilities and human resources more effectively. For the 21st century the digital age heralds opportunities for information-led technology providers to become healthcare providers when algorithm driven care can support patients' needs at the point of care close to or in their homes. For Specialists in Laboratory Medicine the opportunity arises for working beyond the laboratory in partnership with the emerging providers. The challenge to specialists is to extend their skill and competence to leadership roles that (a) determine clinical need and strategic direction for local environments, (b) ensure technology solutions are cost-effective, safe and reliable, (c) assume the business acumen to market, negotiate and manage change in services, (d) expect understanding of the clinical bioinformatics that underpin genomics, health information science (data mining and health economics) and physical sciences (e) expect knowledge and skills in the provision of direct clinical care in the face of staffing shortfalls experienced by many healthcare systems and (f) enhance their communication and interactive skills. In growing their leadership contribution a partnership approach in education and training across healthcare divides, in conjunction with the diagnostics and/or information technology industries, through integrated professional organisation approaches, joint approaches with academia and policy related healthcare organisations is recommended.

System-related and cognitive errors in laboratory medicine.

Current efforts focusing on better defining the prevalence of diagnostic errors, their causes and remediation strategies should address the role of laboratory testing and its contribution to high-quality care as well as a possible source of diagnostic errors. Data collected in the last few years highlight the vulnerability of extra-analytical phases of the testing cycle and the need for programs aiming to improve all steps of the process. Further studies have clarified the nature of laboratory-related errors, namely the evidence that both system-related and cognitive factors account for most errors in laboratory medicine. Technology developments are effective in decreasing the rates of system-related errors but organizational issues play a fundamental role in assuring a real improvement in quality and safety in laboratory processes. Educational interventions as well as technology-based interventions have been proposed to reduce the risk of cognitive errors. However, to reduce diagnostic errors and improve patient safety, clinical laboratories have to embark on a paradigmatic shift restoring the nature of laboratory services as an integral part of the diagnostic and therapy process.

The European Federation of Clinical Chemistry and Laboratory Medicine syllabus for postgraduate education and training for Specialists in Laboratory Medicine: version 5 - 2018.

Although laboratory medicine practise varies across the European Union's (EU) member states, the extent of overlap in scope is such that a common syllabus describing the education and training associated with high-quality, specialist practise can be identified. In turn, such a syllabus can help define the common set of skills, knowledge and competence in a Common Training Framework (CTF) for non-medical Specialists in Laboratory Medicine under EU Directive 2013/55/EU (The recognition of Professional Qualifications). In meeting the requirements of the directive's CTF patient safety is particularly enhanced when specialists seek to capitalise on opportunities for free professional migration across EU borders. In updating the fourth syllabus, the fifth expands on individual discipline requirements, new analytical techniques and use of statistics. An outline structure for a training programme is proposed together with expected responsibilities of trainees and trainers; reference is provided to a trainee's log book. In updating the syllabus, it continues to support national programmes and the aims of EU Directive 2013/55/EU in providing safeguards to professional mobility across European borders at a time when the demand for highly qualified professionals is increasing in the face of a disparity in their distribution across Europe. In support of achieving a CTF, the syllabus represents EFLM's position statement for the education and training that underpins the framework.

Sleep-Disordered Breathing in Children with Recurrent Wheeze/Asthma: A Single Centre Study.

The relationship between asthma and sleep-disordered breathing is bidirectional due to common risk factors that promote airway inflammation. Obstructive sleep-disordered breathing and recurrent wheeze/asthma are conditions that involve the upper and the lower respiratory system, respectively. The aim of the present study was to investigate the sleep disordered breathing in children with recurrent wheeze/asthma. This was a retrospective study concerning children older than 2 years who underwent-between January 2014 and November 2016-an in-laboratory overnight polygraphic study. We match the children between those who do or do not have recurrent wheeze/asthma disease. We examined the clinical records of 137 children. We excluded eight patients because of neurological and genetic conditions. Children with recurrent wheeze/asthma (N = 28) were younger (p = 0.002) and leaner (p = 0.013) compared to non-affected children (N = 98). Children with wheeze/asthma and unaffected ones had a similar obstructive apnea-hypopnea index (p = 0.733) and oxygen desaturation index (p = 0.535). The logistic regression analysis, in which the condition of wheeze/asthma (yes/no) was a dependent variable, while demographic (age, sex, body mass index (BMI) Z-score) and polygraphic results during sleep (obstructive apnea-hypopnea index, central apnea index, peripheral oxygen saturation (SpO2), and snoring) were covariates, showed that children with wheeze/asthma had higher central apnea index (Exp(B) = 2.212; Wald 6.845; p = 0.009). In conclusion, children with recurrent wheeze/asthma showed an increased number of central sleep apneas than unaffected children. This finding may suggest a dysfunction of the breathing control in the central nervous system during sleep. Systemic or central inflammation could be the cause.

A survey of patients' views from eight European countries of interpretive support from Specialists in Laboratory Medicine.

BACKGROUND: There is increasing interest in direct patient engagement including receiving their laboratory medicine results. We previously established an appetite for Specialists in Laboratory Medicine to support patients in understanding results. The aim of this study was to establish whether patients agreed with such an approach, determined through surveying views in eight European countries. METHODS: A standardized five-question survey was administered across eight European countries to a total of 1084 individuals attending medical outpatient clinics, with 100 patients each in Poland, Serbia, Netherlands, Turkey and Czech Republic, 101 in Estonia, 116 in Denmark and 367 in Norway. The responses across countries were compared using the chi-square test (p<0.05). RESULTS: Patients wanting their results ranged from 50% to 94% (mean 65%) of those responding positively, a mean of 72% wanted additional information with their results; direct receipt was preferred over referral to a website. Specialists in Laboratory Medicine providing such information were acceptable to a mean of 62% of those respondents wishing their results; in countries where payment was possible, there was little interest in making additional payment for such a service. CONCLUSIONS: A clear proportion of patients are interested in receiving their laboratory medicine results, the majority with explanatory notes; a role for Specialists in Laboratory Medicine is acceptable and raises the potential for direct engagement by such specialists with patients offering a new paradigm for the provision of laboratory medicine activities.

Quality Indicators for the Total Testing Process.

ISO 15189:2012 requires the use of quality indicators (QIs) to monitor and evaluate all steps of the total testing process, but several difficulties dissuade laboratories from effective and continuous use of QIs in routine practice. An International Federation of Clinical Chemistry and Laboratory Medicine working group addressed this problem and implemented a project to develop a model of QIs to be used in clinical laboratories worldwide to monitor and evaluate all steps of the total testing process, and decrease error rates and improve patient services in laboratory testing. All laboratories are invited, at no cost, to enroll in the project and contribute to harmonized management at the international level.