[Considering the Professionalism of Pharmacists from a Viewpoint of "Regulatory Science"].

Regulatory science underpins scientific regulations, including reflection papers, guidelines, and administrative notices, and is closely related to the quality assurance (QA) of pharmaceuticals, foods, and chemicals in our living environment. Historically, QA has been considered the basis of pharmaceutical science. Therefore, the Pharmaceutical and Medical Device Law specifies that pharmacists, as marketing directors of pharmaceutical products, are responsible for their QA. Furthermore, a pharmacist is responsible for the QA of foods and environmental chemicals by several laws; for example, as a food sanitation supervisor or an environmental sanitation training officer. This suggests that the professional expertise of pharmacists is expected in medical care where pharmaceuticals are used and in other fields associated with QA. Thus, I consider that the professionalism of a pharmacist is guided by spiritual concepts with a pragmatic attitude and conformance to these expectations.

[Six Sigma driven QC management in hepatitis C serology]. / La méthodologie six sigma dans la gestion des contrôles de qualité en sérologie de l'hépatite C.

The Westgard quality control (QC) rules are often applied in infectious diseases serology to validate the quality of results, but this requires a reasonable tradeoff between maximum sensitivity to errors and minimum false rejections. This article, in addition to illustrate the six sigma methodology in the QC management of the (anti-HCV Architect®) test, it discusses the main influencing factors on sigma value. Data from low positive and in-kit control materials spreading over 6 months and using four reagent kits, were used to calculate the precision of the test. The difference between the control material reactivity and the cut-off defined the error budget. Sigma values were > 6, which indicates that the method produces four erroneous results per million tests. The application of the six sigma concept made it possible to argue the choice of the new QC strategy (use of 13S rule with one positive control) and to relax the existing QC rules. This work provides a framework for infectious diseases serology laboratories to evaluate tests performances against a quality requirement and design an optimal QC strategy.

State Regulation of Ensuring the Quality Medical Care During Martial Law in Ukraine: Lessons for the International Community.

Background: Nowadays, the quality of medical care and health care measures is considered the main target function of the health care system and at the same time the determining criterion for its activities. Objective: The article examines state regulation of medical care quality post- COVID and during martial law, identifying improvement areas. It emphasizes state roles in healthcare standardization, continuous feedback monitoring, and studying patient satisfaction. Interrelationships among Ukraine's state regulation mechanisms are determined, highlighting the need to enhance tools such as criteria and quality indicators for medical care assurance. Methods: The authors of this article utilize various scientific methods, including analysis, synthesis, induction, and deduction, as well as historical and legal, formal legal, and comparative legal methods to examine the state regulation of ensuring the quality of medical care during martial law in Ukraine. Results: The article considered the interrelationships of mechanisms and instruments of state regulation of quality assurance of medical care in Ukraine. Conclusions: The state should enhance medical care quality regulation, drawing on international experiences from the EU and the USA and adapting best practices to national circumstances. The resilience of the healthcare system depends on effective quality assurance, ensuring preparedness, stability, and ongoing improvement prospects.

Analysis of measurable residual disease by IG/TR gene rearrangements: quality assurance and updated EuroMRD guidelines.

Minimal/measurable residual disease (MRD) diagnostics using real-time quantitative PCR analysis of rearranged immunoglobulin and T-cell receptor gene rearrangements are nowadays implemented in most treatment protocols for patients with acute lymphoblastic leukemia (ALL). Within the EuroMRD Consortium, we aim to provide comparable, high-quality MRD diagnostics, allowing appropriate risk-group classification for patients and inter-protocol comparisons. To this end, we set up a quality assessment scheme, that was gradually optimized and updated over the last 20 years, and that now includes participants from around 70 laboratories worldwide. We here describe the design and analysis of our quality assessment scheme. In addition, we here report revised data interpretation guidelines, based on our newly generated data and extensive discussions between experts. The main novelty is the partial re-definition of the "positive below quantitative range" category by two new categories, "MRD low positive, below quantitative range" and "MRD of uncertain significance". The quality assessment program and revised guidelines will ensure reproducible and accurate MRD data for ALL patients. Within the Consortium, similar programs and guidelines have been introduced for other lymphoid diseases (e.g., B-cell lymphoma), for new technological platforms (e.g., digital droplet PCR or Next-Generation Sequencing), and for other patient-specific MRD PCR-based targets (e.g., fusion genes).

Results of a Pilot External Quality Assessment Scheme for Genetic Testing of Newborns with Spinal Muscular Atrophy.

BACKGROUND: This study aims to evaluate the ability of laboratories to perform spinal muscular atrophy (SMA) genetic testing in newborns based on dried blood spot (DBS) samples, and to provide reference data and advance preparation for establishing the pilot external quality assessment (EQA) scheme for SMA genetic testing of newborns in China. METHODS: The pilot EQA scheme contents and evaluation principles of this project were designed by National Center for Clinical Laboratories (NCCL), National Health Commission. Two surveys were carried out in 2022, and 5 batches of blood spots were submitted to the participating laboratory each time. All participating laboratories conducted testing upon receiving samples, and test results were submitted to NCCL within the specified date. RESULTS: The return rates were 75.0% (21/28) and 95.2% (20/21) in the first and second surveys, respectively. The total return rate of the two examinations was 83.7% (41/49). Nineteen laboratories (19/21, 90.5%) had a full score passing on the first survey, while in the second survey twenty laboratories (20/20, 100%) scored full. CONCLUSIONS: This pilot EQA survey provides a preliminary understanding of the capability of SMA genetic testing for newborns across laboratories in China. A few laboratories had technical or operational problems in testing. It is, therefore, of importance to strengthen laboratory management and to improve testing capacity for the establishment of a national EQA scheme for newborn SMA genetic testing.

Meeting the Shortage of Human Cells and Tissues: The Andalusian Quality Assurance Programme for Tissue Donation.

Background A quality assurance programme for the tissue donation process was launched in Andalusia in 2020 to facilitate the integration of tissue donation into end-of-life care, and to respond to the growing need for human tissue for therapeutic purposes. The results of this programme are presented here. Methods After identifying the hospital departments in which to intensify the detection of tissue donors, expanding training activities and designing a specific data collection system for possible tissue donors who do not donate their tissues, the results of the donation activity were quantified and the causes of non-donation were analysed by applying the critical pathway for deceased tissue donation methodology. Results After an initial drop in activity, which coincided with the coronavirus pandemic, the number of tissue donors increased by 48.4% in 2022 compared to 2019. From the eligible donors, 83% were actual tissue donors and 71% were utilised donors. The modifiable causes of tissue donation loss, in order of frequency, were family refusal, followed by organisational or logistical issues, failure to notify or failure to identify possible donors, and failure to complete donor evaluation. Conclusion As a result of the collaboration of the various professionals involved in the programme, tissue donation activity has increased remarkably, the potential and effectiveness of the donation process have been evaluated, and areas for improvement have been identified, which we hope will lead to continuous improvement of the process.

Association between hospital ownership and patient selection, management, and outcomes after carotid endarterectomy or carotid artery stenting : - Secondary data analysis of the Bavarian statutory quality assurance database.

BACKGROUND: This study analyses the association between hospital ownership and patient selection, treatment, and outcome of carotid endarterectomy (CEA) or carotid artery stenting (CAS). METHODS: The analysis is based on the Bavarian subset of the nationwide German statutory quality assurance database. All patients receiving CEA or CAS for carotid artery stenosis between 2014 and 2018 were included. Hospitals were subdivided into four groups: university hospitals, public hospitals, hospitals owned by charitable organizations, and private hospitals. The primary outcome was any stroke or death until discharge from hospital. Research was funded by Germany's Federal Joint Committee Innovation Fund (01VSF19016 ISAR-IQ). RESULTS: In total, 22,446 patients were included. The majority of patients were treated in public hospitals (62%), followed by private hospitals (17%), university hospitals (16%), and hospitals under charitable ownership (6%). Two thirds of patients were male (68%), and the median age was 72 years. CAS was most often applied in university hospitals (25%) and most rarely used in private hospitals (9%). Compared to university hospitals, patients in private hospitals were more likely asymptomatic (65% vs. 49%). In asymptomatic patients, the risk of stroke or death was 1.3% in university hospitals, 1.5% in public hospitals, 1.0% in hospitals of charitable owners, and 1.2% in private hospitals. In symptomatic patients, these figures were 3.0%, 2.5%, 3.4%, and 1.2% respectively. Univariate analysis revealed no statistically significant differences between hospital groups. In the multivariable analysis, compared to university hospitals, the odds ratio of stroke or death in asymptomatic patients treated by CEA was significantly lower in charitable hospitals (OR 0.19 [95%-CI 0.07-0.56, p = 0.002]) and private hospitals (OR 0.47 [95%-CI 0.23-0.98, p = 0.043]). In symptomatic patients (elective treatment, CEA), patients treated in private or public hospitals showed a significantly lower odds ratio compared to university hospitals (0.36 [95%-CI 0.17-0.72, p = 0.004] and 0.65 [95%-CI 0.42-1.00, p = 0.048], respectively). CONCLUSIONS: Hospital ownership was related to patient selection and treatment, but not generally to outcomes. The lower risk of stroke or death in the subgroup of electively treated patients in private hospitals might be due to the right timing, the choice of treatment modality or actually to better structural and process quality.

[The quality and safety approach in radiotherapy : an added value for the patient]. / La démarche qualité et sécurité en radiothérapie : une plus-value pour le patient.

Radiation therapy is the use of radiation to treat cancer cells while preserving healthy tissue. More than half of cancer patients will receive radiation therapy at some point during their treatment. The implementation of a Quality Management System (QMS) in radiotherapy departments guarantees high quality care and optimal safety for patients. The QMS is a set of policies, procedures and processes aimed at ensuring effective management of the quality of treatments. It is crucial for planning, implementing, monitoring and continuously improving the care of radiotherapy patients. The benefits of the QMS for patients are multiple. It provides high quality support through specific protocols and deadlines. The security of processing is reinforced by the continuous training of personnel, the monitoring of incidents and the analysis of errors. Developing a culture of safety and continuous improvement also helps to minimize risk. In conclusion, the implementation of a QMS in radiotherapy departments guarantees quality care, secure and adapted to the individual needs of patients. This improves patient satisfaction while reducing the risk of errors.

La radiothérapie consiste à utiliser des radiations pour traiter les cellules cancéreuses, tout en préservant les tissus sains. Plus de la moitié des patients atteints de cancer recevront une radiothérapie à un moment donné de leur traitement. La mise en place d'un Système de Management Qualité (SMQ) dans les services de radiothérapie garantit des soins de haute qualité et une sécurité optimale pour les patients. Le SMQ est un ensemble de politiques, procédures et processus visant à assurer la gestion efficace de la qualité des traitements. Il est crucial pour planifier, implémenter, contrôler et améliorer continuellement la prise en charge des patients en radiothérapie. Les avantages du SMQ sont multiples. Il assure une prise en charge de haute qualité grâce à des protocoles et des délais spécifiques. La sécurité des traitements est renforcée par la formation continue du personnel, la surveillance des incidents et l'analyse des erreurs. Le développement d'une culture de sécurité et d'amélioration continue contribue également à minimiser les risques. En conclusion, la mise en place d'un SMQ dans les services de radiothérapie garantit des traitements de qualité, sécurisés et adaptés aux besoins individuels des patients. Cette approche améliore la satisfaction des patients, tout en réduisant les risques d'erreurs.

Building a NICU quality & safety infrastructure.

The American Academy of Pediatrics (AAP) Standards for Levels of Neonatal Care, published in 2023, highlights key components of a Neonatal Patient Safety and Quality Improvement Program (NPSQIP). A comprehensive Neonatal Intensive Care Unit (NICU) quality and safety infrastructure (QSI) is based on four foundational domains: quality improvement, quality assurance, safety culture, and clinical guidelines. This paper serves as an operational guide for NICU clinical leaders and quality champions to navigate these domains and develop their local QSI to include the AAP NPSQIP standards.

A high-resolution large-area detector for quality assurance in radiotherapy.

Hadron therapy is an advanced radiation modality for treating cancer, which currently uses protons and carbon ions. Hadrons allow for a highly conformal dose distribution to the tumour, minimising the detrimental side-effects due to radiation received by healthy tissues. Treatment with hadrons requires sub-millimetre spatial resolution and high dosimetric accuracy. This paper discusses the design, fabrication and performance tests of a detector based on Gas Electron Multipliers (GEM) coupled to a matrix of thin-film transistors (TFT), with an active area of 60 × 80 mm2 and 200 ppi resolution. The experimental results show that this novel detector is able to detect low-energy (40 kVp X-rays), high-energy (6 MeV) photons used in conventional radiation therapy and protons and carbon ions of clinical energies used in hadron therapy. The GEM-TFT is a compact, fully scalable, radiation-hard detector that measures secondary electrons produced by the GEMs with sub-millimetre spatial resolution and a linear response for proton currents from 18 pA to 0.7 nA. Correcting known detector defects may aid in future studies on dose uniformity, LET dependence, and different gas mixture evaluation, improving the accuracy of QA in radiotherapy.

Result of a Pilot External Quality Assessment Scheme for Clinical Diagnosis of Inherited Metabolic Disorders in China.

BACKGROUND: We aimed to evaluate the diagnostic capabilities of Chinese laboratories for inherited metabolic disorders (IMDs) using gas chromatography-mass spectrometry (GC-MS) on urine samples. Meanwhile, based on the result of the pilot external quality assessment (EQA) scheme, we hope to establish a standardized and reliable procedure for future EQA practice. METHODS: We recruited laboratories that participated in the EQA of quantitative analysis of urinary organic acids with GC-MS before joining the surveys. In each survey, a set of five real urine samples was distributed to each participant. The participants should analyze the sample by GC-MS and report the "analytical result", "the most likely diagnosis", and "recommendation for further tests" to the NCCL before the deadline. RESULTS: A total of 21 laboratories participated in the scheme. The pass rates were 94.4% in 2020 and 89.5% in 2021. For all eight IMDs tested, the analytical proficiency rates ranged from 84.7% - 100%, and the interpretational performance rate ranged from 88.2% - 97.0%. The performance on hyperphenylalaninemia (HPA), 3-methylcrotonyl-CoA carboxylase deficiency (MCCD), and ethylmalonic encephalopathy (EE) samples were not satisfactory. CONCLUSIONS: In general, the participants of this pilot EQA scheme are equipped with the basic capability for qualitative organic acid analysis and interpretation of the results. Limited by the small size of laboratories and samples involved, this activity could not fully reflect the state of clinical practice of Chinese laboratories. NCCL will improve the EQA scheme and implement more EQA activities in the future.

Quality assurance of add-on testing in plasma samples: stability limit for 29 biochemical analytes.

Introduction: Clinical laboratories should guarantee sample stability in specific storage conditions for further analysis. The aim of this study is to evaluate the stability of plasma samples under refrigeration for 29 common biochemical analytes usually ordered within an emergency context, in order to determine the maximum allowable period for conducting add-on testing. Materials and methods: A total of 20 patient samples were collected in lithium heparin tubes without gel separator. All analyses were performed using Alinity systems (Abbott Laboratories, Abbott Park, USA) and samples were stored at 2-8 °C. Measurements were conducted in primary plasma tubes at specific time points up to 48 hours, with an additional stability study in plasma aliquots extending the time storage up to 96 hours. The stability limit was estimated considering the total limit of change criteria. Results: Of the 29 studied parameters, 24 demonstrated stabilities within a 48-hour storage period in primary plasma tubes. However, five analytes: aspartate aminotransferase, glucose, lactate dehydrogenase, inorganic phosphate and potassium evidenced instability at different time points (7.9 hours, 2.7 hours, 2.9 hours, 6.2 hours and 4.7 hours, respectively). The stability study in plasma aliquots showed that all parameters remained stable for 96 hours, except lactate dehydrogenase, with a stability limit of 63 hours. Conclusions: A reduced stability of primary plasma samples was observed for five common biochemical analytes ordered in an emergency context. To ensure the quality of add-on testing for these samples, plasma aliquots provide stability for a longer period.

Dosimetric Systems in Pre-Treatment QA for Stereotactic Treatments: Correlation Agreements and Target Volume Dependency.

AIM: This study comprehensively investigated pre-treatment quality assurance (QA) for 100 cancer patients undergoing stereotactic treatments (SRS/SRT) using various detectors. METHODS: The study conducted QA for SRS/SRT treatments planned with a 6MV SRS beam at a dose rate of 1,000 MU/min, utilizing Eclipse v13.6 Treatment Planning System (TPS). Point dose measurements employed 0.01cm3 and 0.13cm3 cylindrical ionization chambers, while planar dose verification utilized Gafchromic EBT-XD Film and Portal Imager (aS1000). Plans were categorized by target volume, and a thorough analysis compared point dose agreements, planar dose gamma pass rates, and their correlations with chamber volume mean dose, detector type, and point dose agreement. Additionally, the consistency between different ionization chambers was assessed. RESULTS: Point dose agreement generally improved with increasing target volume, except for volumes over 10cm3 with 0.01cm3 chambers, showing a contrary trend. Significant differences (p<0.05) were observed between TPS and measured doses for both chambers. Gamma pass rate improved with increasing target volume in EBT XD and aS1000 analyses, except for the >10cm3 group in EBT XD. EBT XD demonstrated better agreement with TPS for target volumes up to 10cm3 compared to aS1000, with a statistically significant difference (p<0.05) between the detectors. Strong correlations were found between chamber point dose and chamber volume mean dose agreement, as well as between the two gamma criteria analyses of the same detector type in the planar dose correlation analysis. However, weak correlations were discovered for other analyses. CONCLUSION: This study found weak correlation between different detector types in pre-treatment QA for point dose and planar dose evaluation. However, within a specific detector type, strong correlation was observed for different point dose evaluation methods and gamma criteria. This highlights the importance of cautious interpretation of QA results, particularly for SRS QA, due to the lack of correlation between detector types.

Incorporating plan complexity into the statistical process control of volumetric modulated arc therapy pre-treatment verifications.

BACKGROUND: Statistical process control (SPC) is a powerful statistical tool for process monitoring that has been highly recommended in healthcare applications, including radiation therapy quality assurance (QA). The AAPM TG-218 report described the clinical implementation of SPC for Volumetric Modulated Arc Therapy (VMAT) pre-treatment verifications, pointing out the need to adjust tolerance limits based on plan complexity. However, the quantification of plan complexity and its integration into SPC remains an unresolved challenge. PURPOSE: The primary aim of this study is to investigate the incorporation of plan complexity into the SPC framework for VMAT pre-treatment verifications. The study explores and evaluates various strategies for this incorporation, discussing their merits and limitations, and provides recommendations for clinical application. METHODS: A retrospective analysis was conducted on 309 VMAT plans from diverse anatomical sites using the PTW OCTAVIUS 4D device for QA measurements. Gamma Passing Rates (GPR) were obtained, and lower control limits were computed using both the conventional Shewhart method and three heuristic methods (scaled weighted variance, weighted standard deviations, and skewness correction) to accommodate non-normal data distributions. The 'Identify-Eliminate-Recalculate' method was employed for robust analysis. Eight complexity metrics were analyzed and two distinct strategies for incorporating plan complexity into SPC were assessed. The first strategy focused on establishing control limits for different treatment sites, while the second was based on the determination of control limits as a function of individual plan complexity. The study extensively examines the correlation between control limits and plan complexity and assesses the impact of complexity metrics on the control process. RESULTS: The control limits established using SPC were strongly influenced by the complexity of treatment plans. In the first strategy, a clear correlation was found between control limits and average plan complexity for each site. The second approach derived control limits based on individual plan complexity metrics, enabling tailored tolerance limits. In both strategies, tolerance limits inversely correlated with plan complexity, resulting in all highly complex plans being classified as in control. In contrast, when plans were collectively analyzed without considering complexity, all the out-of-control plans were highly complex. CONCLUSIONS: Incorporating plan complexity into SPC for VMAT verifications requires meticulous and comprehensive analysis. To ensure overall process control, we advocate for stringent control and minimization of plan complexity during treatment planning, especially when control limits are adjusted based on plan complexity.

Image quality characterization of an ultra-high-speed kilovoltage cone-beam computed tomography imaging system on an O-ring linear accelerator.

PURPOSE: The quality of on-board imaging systems, including cone-beam computed tomography (CBCT), plays a vital role in image-guided radiation therapy (IGRT) and adaptive radiotherapy. Recently, there has been an upgrade of the CBCT systems fused in the O-ring linear accelerators called HyperSight, featuring a high imaging performance. As the characterization of a new imaging system is essential, we evaluated the image quality of the HyperSight system by comparing it with Halcyon 3.0 CBCT and providing benchmark data for routine imaging quality assurance. METHODS: The HyperSight features ultra-fast scan time, a larger kilovoltage (kV) detector, a more substantial kV tube, and an advanced reconstruction algorithm. Imaging protocols in the two modes of operation, treatment mode with IGRT and the CBCT for planning (CBCTp) mode were evaluated and compared with Halcyon 3.0 CBCT. Image quality metrics, including spatial resolution, contrast resolution, uniformity, noise, computed tomography (CT) number linearity, and calibration error, were assessed using a Catphan and an electron density phantom and analyzed with TotalQA software. RESULTS: HyperSight demonstrated substantial improvements in contrast-to-noise ratio and noise in both IGRT and CBCTp modes compared to Halcyon 3.0 CBCT. CT number calibration error of HyperSight CBCTp mode (1.06%) closely matches that of a full CT scanner (0.72%), making it suitable for adaptive planning. In addition, the advanced hardware of HyperSight, such as ultra-fast scan time (5.9 s) or 2.5 times larger heat unit capacity, enhanced the clinical efficiency in our experience. CONCLUSIONS: HyperSight represented a significant advancement in CBCT imaging. With its image quality, CT number accuracy, and ultra-fast scans, HyperSight has a potential to transform patient care and treatment outcomes. The enhanced scan speed and image quality of HyperSight are expected to significantly improve the quality and efficiency of treatment, particularly benefiting patients.

Clinical physicists' perceptions of weekly chart checks and the potential role for automated image review assessed by structured interviews.

BACKGROUND: This study utilizes interviews of clinical medical physicists to investigate self-reported shortcomings of the current weekly chart check workflow and opportunities for improvement. METHODS: Nineteen medical physicists were recruited for a 30-minute semi-structured interview, with a particular focus placed on image review and the use of automated tools for image review in weekly checks. Survey-type questions were used to gather quantitative information about chart check practices and importance placed on reducing chart check workloads versus increasing chart check effectiveness. Open-ended questions were used to probe respondents about their current weekly chart check workflow, opinions of the value of weekly chart checks and perceived shortcomings, and barriers and facilitators to the implementation of automated chart check tools. Thematic analysis was used to develop common themes across the interviews. RESULTS: Physicists ranked highly the value of reducing the time spent on weekly chart checks (average 6.3 on a scale from 1 to 10), but placed more value on increasing the effectiveness of checks with an average of 9.2 on a 1-10 scale. Four major themes were identified: (1) weekly chart checks need to adapt to an electronic record-and-verify chart environment, (2) physicists could add value to patient care by analyzing images without duplicating the work done by physicians, (3) greater support for trending analysis is needed in weekly checks, and (4) automation has the potential to increase the value of physics checks. CONCLUSION: This study identified several key shortcomings of the current weekly chart check process from the perspective of the clinical medical physicist. Our results show strong support for automating components of the weekly check workflow in order to allow for more effective checks that emphasize follow-up, trending, failure modes and effects analysis, and allow time to be spent on other higher value tasks that improve patient safety.

Primer Part 1 - Preparing a laboratory quality improvement project.

Quality in laboratory medicine encompasses multiple components related to total quality management, including quality control (QC), quality assurance (QA), quality indicators, and quality improvement (QI). Together, they contribute to minimizing errors (pre-analytical, analytical, or post-analytical) in clinical service delivery and improving process appropriateness and efficiency. In contrast to static quality benchmarks (QC, QA, quality indicators), the QI paradigm is a continuous approach to systemic process improvement for optimizing patient safety, timeliness, effectiveness, and efficiency. Healthcare institutions have placed emphasis on applying the QI framework to identify and improve healthcare delivery. Despite QI's increasing importance, there is a lack of guidance on preparing, executing, and sustaining QI initiatives in the field of laboratory medicine. This has presented a significant barrier for clinical laboratorians to participate in and lead QI initiatives. This three-part primer series will bridge this knowledge gap by providing a guide for clinical laboratories to implement a QI project that issuccessful and sustainable. In the first article, we introduce the steps needed to prepare a QI project with focus on relevant methodology and tools related to problem identification, stakeholder engagement, root cause analysis (e.g., fishbone diagrams, Pareto charts and process mapping), and SMART aim establishment. Throughout, we describe a clinical vignette of a real QI project completed at our institution focused on serum protein electrophoresis (SPEP) utilization. This primer series is the first of its kind in laboratory medicine and will serve as a useful resource for future engagement of clinical laboratory leaders in QI initiatives.

[Reliability of peer review-like dialogue in the German statutory quality assurance program]. / Reliabilität des Strukturierten Dialogs in der gesetzlich verpflichtenden Qualitätssicherung.

BACKGROUND: Quality measurement in the German statutory program for quality in health care follows a two-step process. For selected areas of health care, quality is measured via performance indicators (first step). Providers failing to achieve benchmarks in these indicators subsequently enter into a peer review process (second step) and are asked by the respective regional authority to provide a written statement regarding their indicator results. The statements are then evaluated by peers, with the goal to assess the provider's quality of care. In the past, similar peer review-based approaches to the measurement of health care quality in other countries have shown a tendency to lack reliability. So far, the reliability of this component of the German statutory program for quality in health care has not been investigated. METHOD: Using logistic regression models, the influence of the respective regional authority on the peer review component of health care quality measurement in Germany was investigated using three exemplary indicators and data from 2016. RESULTS: Both the probability that providers are asked to provide a statement as well as the results produced by the peer review process significantly depend on the regional authority in charge. This dependence cannot be fully explained by differences in the indicator results or by differences in case volume. CONCLUSIONS: The present results are in accordance with earlier findings, which show low reliability for peer review-based approaches to quality measurement. Thus, different results produced by the peer review component of the quality measurement process may in part be due to differences in the way the review process is conducted. This heterogeneity among the regional authorities limits the reliability of this process. In order to increase reliability, the peer review process should be standardized to a higher degree, with clear review criteria, and the peers should undergo comprehensive training for the review process. Alternatively, the future peer review component could be adapted to focus rather on identification of improvement strategies than on reliable provider comparisons.

[Development of an indicator set for the evaluation of the quality of routine ambulatory health care for common disorders in children and adolescents]. / Entwicklung eines Indikatorensets zur Evaluation der Versorgungsqualität in der ambulanten Routineversorgung häufiger Erkrankungen des Kindes- und Jugendalters.

BACKGROUND: In Germany, no consented quality indicator set (QI set) exists to date that can be used to assess the quality of pediatric care. Therefore, the aim of the project "Assessment of the quality of routine ambulatory health care for common disorders in children and adolescents" (QualiPäd) funded by the Innovation Committee of the Federal Joint Committee (grant no.: 01VSF19035) was to develop a QI set for the diseases asthma, atopic eczema, otitis media, tonsillitis, attention-deficit hyperactivity disorder (ADHD), depression and conduct disorder. METHODS: For the observation period 2018/2019, quality indicators (QIs) were searched in indicator databases, guidelines and literature databases and complemented in part by newly formulated QIs (e.g., derived from guideline recommendations). The QIs were then assigned to content categories and dimensions according to Donabedian and OECD and reduced by removing duplicates. Finally, a panel of experts consulted the QIs using the modified RAND-UCLA Appropriateness Method (RAM). RESULTS: The search resulted in a preliminary QI set of 2324 QIs. After the reduction steps and the evaluation of the experts, 282 QIs were included in the QI set (asthma: 72 QIs, atopic eczema: 25 QIs, otitis media: 31 QIs, tonsillitis: 12 QIs, ADHD: 53 QIs, depression: 43 QIs, conduct disorder: 46 QIs). The QIs are distributed among the following different categories: Therapy (138 QIs), Diagnostics (95 QIs), Patient-reported outcome measures/Patient-reported experience measures (PROM/PREM) (45 QIs), Practice management (31 QIs), and Health reporting (4 QIs). In the Donabedian model, 89% of the QIs capture process quality, 9% outcome quality, and 2% structural quality; according to the OECD classification, 61% measure effectiveness, 23% patient-centeredness, and 16% safety of care. CONCLUSION: The consented QI set is currently being tested and can subsequently be used (possibly modified) to measure the quality of routine outpatient care for children and adolescents in Germany, in order to indicate the status quo and potential areas for improvement in outpatient care.