Tuition fees and educational attainment

Following a landmark court ruling in 2005, more than half of Germany's universities started charging tuition fees, which were subsequently abolished until 2015. We exploit the unusual lack of grandfathering in these policies to show that fees increase study effort and degree completion among incumbent students. However, fees also decrease first-time university enrollment among high school graduates. Combining this enrollment impact with the effect on completion, we find that fees around the zero-price margin have only little effect on overall educational attainment. We conclude by discussing policies targeting the separate effect margins of fees and caution against a general abolition

Preparing Laboratories for Interconnected Health Care

In an increasingly interconnected health care system, laboratory medicine can facilitate diagnosis and treatment of patients effectively. This article describes necessary changes and points to potential challenges on a technical, content, and organizational level. As a technical precondition, electronic laboratory reports have to become machine-readable and interpretable. Terminologies such as Logical Observation Identifiers Names and Codes (LOINC), Nomenclature for Properties and Units (NPU), Unified Code for Units of Measure (UCUM), and SNOMED-CT can lead to the necessary semantic interoperability. Even if only single atomized results of the whole report are extracted, the necessary information for correct interpretation must be available. Therefore, interpretive comments, e.g., concerns about an increased measurement uncertainty must be electronically attached to every affected measurement result. Standardization of laboratory analyses with traceable standards and reference materials will enable knowledge transfer and safe interpretation of laboratory analyses from multiple laboratories. In an interconnected health care system, laboratories should strive to transform themselves into a data hub that not only receives samples but also extensive information about the patient. On that basis, they can return measurement results enriched with high-quality interpretive comments tailored to the individual patient and unlock the full potential of laboratory medicine

Users regard operator training as critical for successful POCT applications

Point-of-care tests (POCT) measure analytes close to the patients and complementary supplement the test menu of medical laboratories. However, the involvement of many different stakeholders makes it challenging to ensure reliable results. In a survey, we asked experienced POCT users how they control their total POCT process and what factors they consider essential for success. Results were verified in four in-depth interviews. Overall, 73 German participants from various medical disciplines completed the survey. All but one participant regarded operator training as important but only half of the participants’ institutions conducted operator training on a regular basis. Participants often requested e-learning, but face-to-face teaching is still preferred. 21 % of participants already used e-learning and reported mixed satisfaction. 55 % of the participants never refer to the quality management manual. Instead, 94 % stated that if a POCT error arises a contact person for POCT is always available at their workplace. The majority of participants think that external and in particular internal quality controls are important for POCT. Only a few difficulties for performing quality control such as “temporal expenditure” and “lack of information about the importance of internal quality control” were commonly mentioned. For future developments, participants expect evolution and improvements especially with regard to “measurement quality and reliability”. The answers of the experts in the in-depth interviews largely corresponded with the participants of the survey. The importance of operator training is well established and confirmed in this work. How to conduct this training is less certain but the answers in this survey suggest some form of blended learning with e-learning and practical elements. The discrepancy between the high importance that guidelines and other normative documents place on written information and their low practical usage was striking

Point-of-care testing (POCT) and IT security concepts

Point-of-care testing (POCT) has been an essential service in hospitals for many years with a main focus on reliability, classical laboratory quality criteria and easy handling. Hospital information technology (IT) security regulations, however, have not yet been adapted to the specificities of POCT. Following the POCT Symposium in Munich, the 1st Round Table POCT-IT-Security Meeting held in October 2019 in Cologne addressed these issues and managed to establish first consensus results in the essential fields of user, data and update management, as well as network connections and user-friendliness. First practical steps include optimizing the user management by connection to a directory service and definition of access control (including emergency authorization). Patient data economy on analyzers in combination with data and data transmission encryption as well as technically secure communication protocols are relevant steps in the fields of data management and network connections. An update management needs to be contractually defined for remote services and generally includes testing in a protocol-based scenario. Providing an organizational structure for POCT-IT security is a necessary prerequisite, as are continuous training and awareness for this topic with a strong focus on usability

Evaluation of the sensitivity and specificity of a novel line immunoassay for the detection of criteria and non-criteria antiphospholipid antibodies in comparison to established ELISAs.

BackgroundPersistent antiphospholipid antibodies (aPL) constitute the serological hallmark of the antiphospholipid syndrome (APS). Recently, various new assay technologies for the detection of aPL better suited to multiplex reaction environments than ELISAs emerged. We evaluated the diagnostic performance of such a novel line immunoassay (LIA) for the simultaneous detection of 10 different aPL.MethodsFifty-three APS patients and 34 healthy controls were investigated for criteria (antibodies against cardiolipin [aCL], β2-glycoprotein I [aβ2-GPI]) and non-criteria aPL (antibodies against phosphatidic acid [aPA], phosphatidyl-choline [aPC], -ethanolamine [aPE], -glycerol [aPG], -inositol [aPI], -serine [aPS], annexin V [aAnnV], prothrombin [aPT]) IgG and IgM by LIA. Criteria aPL were additionally determined with the established Alegria (ALE), AcuStar (ACU), UniCap (UNI), and AESKULISA (AES) systems and non-criteria aPL with the AES system. Diagnostic performance was evaluated with a gold standard for criteria aPL derived from the results of the four established assays via latent class analysis and with the clinical diagnosis as gold standard for non-criteria aPL.ResultsAssay performance of the LIA for criteria aPL was comparable to that of ALE, ACU, UNI, and AES. For non-criteria aPL, sensitivities of the LIA for aPA-, aPI-, aPS-IgG and aPA-IgM were significantly higher and for aPC-, aPE-, aAnnV-IgG and aPC- and aPE-IgM significantly lower than AES. Specificities did not differ significantly.ConclusionsThe LIA constitutes a valuable diagnostic tool for aPL profiling. It offers increased sensitivity for the detection of aPL against anionic phospholipids. In contrast, ELISAs exhibit strengths for the sensitive detection of aPL against neutral phospholipids

Evaluation of the sensitivity and specificity of a novel line immunoassay for the detection of criteria and non-criteria antiphospholipid antibodies in comparison to established ELISAs

Background: Persistent antiphospholipid antibodies (aPL) constitute the serological hallmark of the antiphospholipid syndrome (APS). Recently, various new assay technologies for the detection of aPL better suited to multiplex reaction environments than ELISAs emerged. We evaluated the diagnostic performance of such a novel line immunoassay (LIA) for the simultaneous detection of 10 different aPL. Methods: Fifty-three APS patients and 34 healthy controls were investigated for criteria (antibodies against cardiolipin [aCL], β2-glycoprotein I [aβ2-GPI]) and non-criteria aPL (antibodies against phosphatidic acid [aPA], phosphatidyl-choline [aPC], -ethanolamine [aPE], -glycerol [aPG], -inositol [aPI], -serine [aPS], annexin V [aAnnV], prothrombin [aPT]) IgG and IgM by LIA. Criteria aPL were additionally determined with the established Alegria (ALE), AcuStar (ACU), UniCap (UNI), and AESKULISA (AES) systems and non-criteria aPL with the AES system. Diagnostic performance was evaluated with a gold standard for criteria aPL derived from the results of the four established assays via latent class analysis and with the clinical diagnosis as gold standard for non-criteria aPL. Results: Assay performance of the LIA for criteria aPL was comparable to that of ALE, ACU, UNI, and AES. For non-criteria aPL, sensitivities of the LIA for aPA-, aPI-, aPS-IgG and aPA-IgM were significantly higher and for aPC-, aPE-, aAnnV-IgG and aPC- and aPE-IgM significantly lower than AES. Specificities did not differ significantly. Conclusions: The LIA constitutes a valuable diagnostic tool for aPL profiling. It offers increased sensitivity for the detection of aPL against anionic phospholipids. In contrast, ELISAs exhibit strengths for the sensitive detection of aPL against neutral phospholipids

Requirements for electronic laboratory reports according to the German guideline Rili-BAEK and ISO 15189

Objectives: Legal regulations and guidelines such as the Guidelines of the German Medical Association for the Quality Assurance of Laboratory Medical Examinations (Rili-BAEK) and ISO 15189 apply to electronic laboratory reports. However, many laboratories struggle with practical implementation of these regulations and guidelines. Methods: Laboratory and legal experts analyse the relevant guidelines and provide checklists and practical recommendations for implementation. Results: Laboratories have less control over the display of electronic laboratory reports than over paper documents. However, an electronic report alone is legally sufficient and need not be accompanied by a paper copy. Rili-BAEK and ISO 15189 stipulate a set of minimum information in every report. The laboratory must verify that reports are transmitted and displayed correctly. To help laboratories do so, agreements between laboratories and the report recipients can clarify responsibilities. Conclusions: Electronic laboratory reports can improve patient care, but laboratories need to verify their quality. Towards this end, Rili-BAEK and ISO 15189 set out helpful provisions

Glucose-EQA

Data from External Quality Assessment schemes for glucose measurements in Germany. Please be aware of commutability issues (EQA samples do not behave exactly as patient samples) when analysing the data. Feel free to contact me (Andreas Bietenbeck) if you have any questions

External quality assessment schemes for glucose measurements in Germany: factors for successful participation, analytical performance and medical impact.

Determination of blood glucose concentration is one of the most important measurements in clinical chemistry worldwide. Analyzers in central laboratories (CL) and point-of-care tests (POCT) are both frequently used. In Germany, regular participation in external quality assessment (EQA) schemes is mandatory for laboratories performing glucose testing. Glucose testing data from the two German EQAs "Reference Institute for Bioanalytics" (RfB) and "INSTAND - Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien" (Instand) were analyzed from 2012 to 2016. Multivariable odds ratios (OR) for the probability to reach a "good" result were calculated. Imprecision and bias were determined and clinical risk of measurement errors estimated. The device employed was the most important variable required for a "good" performance in all EQAs. Additional participation in an EQA for CL automated analyzers improved performance in POCT EQAs. The reciprocal effect was less pronounced. New participants performed worse than experienced participants especially in CL EQAs. Imprecision was generally smaller for CL, but some POCT devices reached a comparable performance. Large lot-to-lot differences occurred in over 10% of analyzed cases. We propose the "bias budget" as a new metric to express the maximum allowable bias that still carries acceptable medical risk. Bias budgets were smallest and clinical risks of errors greatest in the low range of measurement 60-115 mg/dL (3.3-6.4 mmol/L) for most devices. EQAs help to maintain high analytical performances. They generate important data that serve as the foundation for learning and improvement in the laboratory healthcare system