Managing hemolysis in serum neuron-specific enolase measurements - an automated algorithm for routine practice.

Neuron-specific enolase (NSE) derived from neurons and peripheral neuroendocrine cells is a biomarker for neuroendocrine tumors and for prognostication in comatose cardiac arrest survivors. However, as platelets and erythrocytes contain NSE, hemolysis causes falsely elevated NSE. We used native serum and hemolysate derived from the same patients to make serial dilutions, and subsequently measured NSE (mNSE) and hemolytic index (HI) in each dilution. An algorithm suitable for the laboratory information system was developed based on the mNSE, HI and the estimated gradient of hemolytic interference from 30 patients. We estimated the associated uncertainty of the corrected NSE (cNSE) results based on the observed range of the gradient and derived an equation for cNSE for samples with limited hemolysis (i.e. 5 < HI ≤ 30): cNSE = mNSE - HI × (0.34 ± 0.23) µg/L. By semi-quantitatively grading the contribution from limited hemolysis, a texted result noting the hemolysis-associated degree of uncertainty can accompany the cNSE result. The major challenge of hemolysis when using serum NSE as a biomarker can be managed using an automated algorithm for correction of NSE results based on degree of hemolysis. However, laboratorians and clinicians should be aware of the limitations associated with in vivo hemolysis.

Enhancing Patient Understanding of Laboratory Test Results: Systematic Review of Presentation Formats and Their Impact on Perception, Decision, Action, and Memory.

BACKGROUND: Direct access of patients to their web-based patient portal, including laboratory test results, has become increasingly common. Numeric laboratory results can be challenging to interpret for patients, which may lead to anxiety, confusion, and unnecessary doctor consultations. Laboratory results can be presented in different formats, but there is limited evidence regarding how these presentation formats impact patients' processing of the information. OBJECTIVE: This study aims to synthesize the evidence on effective formats for presenting numeric laboratory test results with a focus on outcomes related to patients' information processing, including affective perception, perceived magnitude, cognitive perception, perception of communication, decision, action, and memory. METHODS: The search was conducted in 3 databases (PubMed, Web of Science, and Embase) from inception until May 31, 2023. We included quantitative, qualitative, and mixed methods articles describing or comparing formats for presenting diagnostic laboratory test results to patients. Two reviewers independently extracted and synthesized the characteristics of the articles and presentation formats used. The quality of the included articles was assessed by 2 independent reviewers using the Mixed Methods Appraisal Tool. RESULTS: A total of 18 studies were included, which were heterogeneous in terms of study design and primary outcomes used. The quality of the articles ranged from poor to excellent. Most studies (n=16, 89%) used mock test results. The most frequently used presentation formats were numerical values with reference ranges (n=12), horizontal line bars with colored blocks (n=12), or a combination of horizontal line bars with numerical values (n=8). All studies examined perception as an outcome, while action and memory were studied in 1 and 3 articles, respectively. In general, participants' satisfaction and usability were the highest when test results were presented using horizontal line bars with colored blocks. Adding reference ranges or personalized information (eg, goal ranges) further increased participants' perception. Additionally, horizontal line bars significantly decreased participants' tendency to search for information or to contact their physician, compared with numerical values with reference ranges. CONCLUSIONS: In this review, we synthesized available evidence on effective presentation formats for laboratory test results. The use of horizontal line bars with reference ranges or personalized goal ranges increased participants' cognitive perception and perception of communication while decreasing participants' tendency to contact their physicians. Action and memory were less frequently studied, so no conclusion could be drawn about a single preferred format regarding these outcomes. Therefore, the use of horizontal line bars with reference ranges or personalized goal ranges is recommended to enhance patients' information processing of laboratory test results. Further research should focus on real-life settings and diverse presentation formats in combination with outcomes related to patients' information processing.

Establishing and Leading a 3D Postprocessing Radiology Lab: A Managerial and Leadership Perspective.

The rapid acquisition of larg volumes of thin-section CT images has created a considerable need and interest for 3D postprocessing during the interpretation of medical imaging. As a result of the increasing number of postprocessing applications, requiring diagnostic radiologists to perform postprocessing is no longer realistic. This article is a comprehensive review of medical resources regarding establishing a postprocessing radiology laboratory. Besides, leadership and managerial aspects have been covered through a professional business lens. In large-volume settings, a dedicated 3D postprocessing lab ensures the quality, reproducibility, and efficiency of images. Adequate staffing is necessary to fulfill the postprocessing requirements. Educational and experience requirements for 3D technologists may vary among different running laboratories. To evaluate the establishment and running of a 3D lab, it is beneficial to implement diagnostic radiology cost-effectiveness tools. Although establishing a 3D lab has many benefits, certain challenges should be considered. Outsourcing or offshoring may serve as alternatives for establishing a postprocessing laboratory. Building and operating a 3D lab is a significant change in healthcare facilities, and it is crucial for organizations to be aware of the strong resistance toward alternatives the status quo, known as the status quo trap. The change process has essential steps, and skipping the steps creates an illusion of speed but never produces satisfactory results. The organization should ensure the engagement of all interested parties in the whole process. Moreover, a clear vision and proper communication of the vision are vital, and it is crucial to value small wins and ensure expectation clarity in leading the lab during the process.

Caring for transgender populations: A primer for the dermatopathologist.

With increasing access to electronic health records, patients may encounter dermatopathology reports more readily. Dermatopathologists should consider their impact and interactions with transgender patients, who may face specific health and healthcare inequities. Rendering accurate diagnosis for skin diseases requires accurate information about patient's sex assigned at birth and gender identity. Understanding how sex and gender identity data flow between electronic health records, laboratory information systems, insurance billing systems, and patients will be important to avoid patient misgendering, to render accurate diagnoses, to maintain consistency in dermatopathology reports, and to avoid insurance billing denials. Dermatopathologists have important roles to build patient trust in the healthcare system and to help dermatologists diagnose, treat, and characterize skin diseases in transgender populations.

A scientific mind embraces medicine: Donald Lindberg's education and early career.

As a young pathologist, Donald A.B. Lindberg, M.D., tirelessly sought scientific solutions to clinical and research problems. Directing several clinical laboratories at the University of Missouri in Columbia, Dr. Lindberg developed the world's first computerized laboratory information system, speeding analysis and reporting. He directed his team in building computer systems to help clinicians retrieve medical knowledge, enable patients to find information about personal or family health issues, and provide expert automated assistance to physicians in reaching differential diagnoses outside their specialties. Developing superior functionalities with the limited information technologies of the time, Dr. Lindberg's pioneering work in Columbia foreshadowed his subsequent inspired leadership as Director of the United States National Library of Medicine.

Percentile transformation and recalibration functions allow harmonization of thyroid-stimulating hormone (TSH) immunoassay results.

Background The comparability of thyroid-stimulating hormone (TSH) results cannot be easily obtained using SI-traceable reference measurement procedures (RPMs) or reference materials, whilst harmonization is more feasible. The aim of this study was to identify and validate a new approach for the harmonization of TSH results. Methods Percentile normalization was applied to 125,419 TSH results, obtained from seven laboratories using three immunoassays (Access 3rd IS Thyrotropin, Beckman Coulter Diagnostics; Architect System, Abbott Diagnostics and Elecsys, Roche Diagnostics). Recalibration equations (RCAL) were derived by robust regressions using bootstrapped distribution. Two datasets, the first of 119 EQAs, the second of 610, 638 and 639 results from Access, Architect and Elecsys TSH results, respectively, were used to validate RCAL. A dataset of 142,821 TSH values was used to derive reference intervals (RIs) after applying RCAL. Results Access, Abbott and Elecsys TSH distributions were significantly different (p < 0.001). RCAL intercepts and slopes were -0.003 and 0.984 for Access, 0.032 and 1.041 for Architect, -0.031 and 1.003 for Elecsys, respectively. Validation using EQAs showed that before and after RCAL, the coefficients of variation (CVs) or among-assay results decreased from 10.72% to 8.16%. The second validation dataset was used to test RCALs. The median of between-assay differences ranged from -0.0053 to 0.1955 mIU/L of TSH. Elecsys recalibrated to Access (and vice-versa) showed non-significant difference. TSH RI after RCAL resulted in 0.37-5.11 mIU/L overall, 0.49-4.96 mIU/L for females and 0.40-4.92 mIU/L for males. A significant difference across age classes was identified. Conclusions Percentile normalization and robust regression are valuable tools for deriving RCALs and harmonizing TSH values.

Reference interval by the indirect approach of serum thyrotropin (TSH) in a Mediterranean adult population and the association with age and gender.

Background The serum concentration of thyrotropin (TSH) represents a first-line test in diagnostic algorithms. The estimation of TSH reference intervals (RIs) is still a matter of debate due to the high prevalence of subclinical disease making difficult the definition of truly healthy subjects. The aim of this study was to estimate TSH RIs in healthy subjects and to evaluate the effect of age and gender on TSH concentration. Methods Forty-four thousand one hundred and fifty-six TSH data were collected between July 2012 and April 2018 at the Department of Laboratory Medicine, University-Hospital, Palermo. Common and sex-specific RIs were estimated by Arzideh's indirect method after exclusion of individuals younger than 15 years, subjects with repeated TSH tests and with abnormal free thyroxine (fT4), free triiodothyronine (fT3) or anti-thyroid-peroxidase antibodies. The combined effect of age and gender on TSH values was evaluated. Results RIs estimated in the selected individuals (n = 22602) were, respectively, 0.18-3.54 mIU/L (general), 0.19-3.23 mIU/L (men) and 0.18-3.94 mIU/L (women). Women showed significantly higher median TSH than men (1.46 vs. 1.39 mIU/L; p < 0.0001). Both in men and in women, median TSH decreased along with age; however, although up to 60 years in both men and women showed similar values, afterwards women showed constantly higher TSH than men. Accordingly, statistical analysis showed a significant interaction between gender and age (p = 0.001), suggesting that the effect of age on TSH is different between genders. Conclusions Our findings suggest that the indirect method, with appropriate cleaning of data, could be useful to define TSH RIs.

Communicating laboratory results to patients and families.

People are increasingly able to access their laboratory results via patient portals. The potential benefits provided by such access, such as reductions in patient burden and improvements in patient satisfaction, disease management, and medical decision making, also come with potentially valid concerns about such results causing confusion or anxiety among patients. However, it is possible to clearly convey the meaning of results and, when needed, indicate required action by designing systems to present laboratory results adapted to the people who will use them. Systems should support people in converting the potentially meaningless data of results into meaningful information and actionable knowledge. We offer 10 recommendations toward this goal: (1) whenever possible, provide a clear takeaway message for each result. (2) Signal whether differences are meaningful or not. (3) When feasible, provide thresholds for concern and action. (4) Individualize the frame of reference by allowing custom reference ranges. (5) Ensure the system is accessible. (6) Provide conversion tools along with results. (7) Design in collaboration with users. (8) Design for both new and experienced users. (9) Make it easy for people use the data as they wish. (10) Collaborate with experts from relevant fields. Using these 10 methods and strategies renders access to laboratory results into meaningful and actionable communication. In this way, laboratories and medical systems can support patients and families in understanding and using their laboratory results to manage their health.

Change in HbA1c concentration as decision parameter for frequency of HbA1c measurement.

Hemoglobin A1c (HbA1c) is a long-term measure for glucose concentration in plasma. Since its introduction as a diabetes monitoring tool, and its more recent application as a diagnostic tool, the number of measurements of HbA1c have risen dramatically. However, HbA1c change is slow, so repeating measurements should not be done too often. We use a large, unfiltered dataset from 52,017 patients to determine the possible rate of change in HbA1c concentration. In our laboratory, the critical difference between HbA1c measurements is 8.5%. Our data show that a 1-unit HbA1c rise takes 4 weeks to occur, hence, at a HbA1c concentration around 50 mmol/mol Hgb, a critically increased HbA1c concentration cannot be determined until after 16 weeks. Conversely a critically lower HbA1c can manifest itself after 2 weeks, but after 7 weeks the dropping tendency stops. The amount of measurements that can be cancelled because they were taken sooner than 16 weeks is 23 percent.

Design and evaluation of a LIS-based autoverification system for coagulation assays in a core clinical laboratory.

BACKGROUND: The autoverification system for coagulation consists of a series of rules that allow normal data to be released without manual verification. With new advances in medical informatics, the laboratory information system (LIS) has growing potential for the autoverification, allowing rapid and accurate verification of clinical laboratory tests. The purpose of the study is to develop and evaluate a LIS-based autoverification system for validation and efficiency. METHODS: Autoverification decision rules, including quality control, analytical error flag, critical value, limited range check, delta check and logical check, as well as patient's historical information, were integrated into the LIS. Autoverification limited range was constructed based on 5 and 95% percentiles. The four most commonly used coagulation assays, prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), and fibrinogen (FBG), were followed by the autoverification protocols. The validation was assessed by the autoverification passing rate, the true-positive cases, the true-negative cases, the false-positive cases, the false-negative cases, the sensitivity and the specificity; the efficiency was evaluated in the turnaround time (TAT). RESULTS: A total of 157,079 historical test results of coagulation profiles from January 2016 to December 2016 were collected to determine the distribution intervals. The autoverification passing rate was 77.11% (29,165/37,821) based on historical patient data. In the initial test of the autoverification version in June 2017, the overall autoverification passing rate for the whole sample was 78.75% (11,257/14,295), with 892 true-positive cases, 11,257 true-negative cases, 2146 false-positive cases, no false-negative cases, sensitivity of 100% and specificity of 83.99%. After formal implementation of the autoverification system for 6 months, 83,699 samples were assessed. The average overall autoverification passing rate for the whole sample was 78.86% and the 95% confidence interval (CI) of the passing rate was [78.25, 79.59%]. TAT was reduced from 126 min to 101 min, which was statistically significant (P < 0.001, Mann-Whitney U test). CONCLUSIONS: The autoverification system for coagulation assays based on LIS can halt the samples with abnormal values for manual verification, guarantee medical safety, minimize the requirements for manual work, shorten TAT and raise working efficiency.

Communicating laboratory results through a Web site: Patients' priorities and viewpoints.

BACKGROUND: Patients can access laboratory results using various technologies. The aim of this study was to integrate the laboratory results into the hospital Web site based on patients' viewpoints and priorities and to measure patients' satisfaction. METHODS: This descriptive-analytical study was conducted in 2015. First, a questionnaire was distributed among 200 patients to assess patients' priorities to receive laboratory results through the Web site. Second, those who agreed (n = 95) to receive their laboratory results through the Web site were identified. Then, the required changes were made to the hospital Web site based on patients' viewpoints and priorities. Third, patients were divided into two groups. The first group received their laboratory results through the Web site on the date had been announced during their visit to the laboratory. The second group was informed by SMS once their results were shown on the Web site. After receiving laboratory results, patients' satisfaction was evaluated. RESULTS: More than half of the participants (n = 53, 55.8%) were highly satisfied with receiving the results electronically. The higher number of people in SMS group (n = 9, 20.9%) reported that they were satisfied with time-saving compared to other group (n = 2, 3.8%) (P = .04). Participants after receiving the results through the Web site considered the functionalities of reprinting (P < .0001) and timeliness (P = .017) more important. CONCLUSION: Integrating laboratory results into the hospital Web site based on the patients' viewpoints and priorities can improve patient satisfaction and lower the patients' concern regarding confidentiality of their results.

Effect of Harm Anchors in Visual Displays of Test Results on Patient Perceptions of Urgency About Near-Normal Values: Experimental Study.

BACKGROUND: Patient-facing displays of laboratory test results typically provide patients with one reference point (the "standard range"). OBJECTIVE: To test the effect of including an additional harm anchor reference point in visual displays of laboratory test results, which indicates how far outside of the standard range values would need to be in order to suggest substantial patient risk. METHODS: Using a demographically diverse, online sample, we compared the reactions of 1618 adults in the United States who viewed visual line displays that included both standard range and harm anchor reference points ("Many doctors are not concerned until here") to displays that included either (1) only a standard range, (2) standard range plus evaluative categories (eg, "borderline high"), or (3) a color gradient showing degree of deviation from the standard range. RESULTS: Providing the harm anchor reference point significantly reduced perceived urgency of close-to-normal alanine aminotransferase and creatinine results (P values <.001) but not generally for platelet count results. Notably, display type did not significantly alter perceptions of more extreme results in potentially harmful ranges. Harm anchors also substantially reduced the number of participants who wanted to contact their doctor urgently or go to the hospital about these test results. CONCLUSIONS: Presenting patients with evaluative cues regarding when test results become clinically concerning can reduce the perceived urgency of out-of-range results that do not require immediate clinical action.

Improving the Understanding of Test Results by Substituting (Not Adding) Goal Ranges: Web-Based Between-Subjects Experiment.

BACKGROUND: Most displays of laboratory test results include a standard reference range. For some patients (eg, those with chronic conditions), however, getting a result within the standard range may be unachievable, inappropriate, or even harmful. OBJECTIVE: The objective of our study was to test the impact of including clinically appropriate goal ranges outside the standard range in the visual displays of laboratory test results. METHODS: Participants (N=6776) from a demographically diverse Web-based panel viewed hypothetical glycated hemoglobin (HbA1c) test results (HbA1c either 6.2% or 8.2%) as part of a type 2 diabetes management scenario. Test result visual displays included either a standard range (4.5%-5.7%) only, a goal range (6.5%-7.5%) added to the standard range, or the goal range only. The results were displayed in 1 of the following 3 display formats: (1) a table; (2) a simple, two-colored number line (simple line); or (3) a number line with diagnostic categories indicated via colored blocks (block line). Primary outcome measures were comprehension of and negative reactions to test results. RESULTS: While goal range information did not influence the understanding of HbA1c=8.2% results, the goal range only display produced higher levels of comprehension and decreased negative reactions to HbA1c=6.2% test results compared with the no goal range and goal range added conditions. Goal range information was less helpful in the block line condition versus the other formats. CONCLUSIONS: Replacing the standard range with a clinically appropriate goal range could help patients better understand how their test results relate to their personal targets.

[Developing and application of an autoverification system for clinical chemistry and immunology test results].

Objective: To develop and validate an autoverification system for biochemistry and immunology test results for application in routine work. Methods: Algorithms was designed and translated into the laboratory information system. Parameters including verify limit, delta check, logic relation between tests was set up in the system. Verification rate of every test and the causes of fails were analyzed, according to which the system and parameters were modified. The autoverified reports were evaluated by chief technicians. Only when all of the autoverified results pass the evaluation, the system applied for routine work of releasing the results. Autoverification rate and turnaround time(TAT) were calculated for evaluation of the efficiency of the system. Results: A brand new autoverification system was developed and applied for routine work. The autoverification rate for each single test was 91.1%-96.6%. The autoverification rate for reports was 74%. With the autoverification system, the media of TAT reduced from 111.6(53.9-270.7) min to 87.2(45.4-202.4) min, whereas the time from instrument finishing analysis to releasing the reports reduced from 18.6(1.0-99.3) min to 0.1(0-58.3)min. The number of staff specified for results validation reduced from three to one. Conclusions: The newly developed system can be used for autoverification of biochemistry and immunology test results. The autoverification system can greatly reduce TAT and raise working efficiency. It's essential to employ carefully designed algorithm, appropriate parameters and comprehensive evaluation when developing a new autoverification system.

Earlier intervention for acute kidney injury: evaluation of an outreach service and a long-term follow-up.

BACKGROUND: There have been few studies of earlier systematic intervention to reduce the impact of acute kidney injury (AKI). In 2009, we piloted an AKI outreach service with a before and after study, and we report on the study and its longer-term follow-up. METHODS: AKI patients were identified using a laboratory delta check for creatinine of 75%. In the 4-week before phase patients received standard care. In a consecutive 7-week after phase an outreach team of nephrology doctors and nurses reviewed all alerts twice daily, 5 days a week. The primary clinical team caring for the patient was called to be given advice on AKI care. RESULTS: There were 157 and 251 patients in the before and after groups, respectively, who were comparable in their characteristics. The mean age was 70 years in both groups and ∼ 80% of each group were admitted to the hospital. In the after group, the Outreach telephone call was successful in 88%, at a median of 14 h. Substantial numbers of recommendations were made, largely related to fluid balance, investigations and medication use. Survival showed an immediate non-significant improvement in the after group, but converged at about 4 years. CONCLUSION: Outreach shows potential to improve outcomes in AKI. In order to achieve this it seems likely that at least a five-day per week service will be needed to assist good renal and general medical care for this vulnerable group.

Survey of Laboratory Medicine's national response to the HSE cyberattack in the Republic of Ireland.

BACKGROUND: On Friday 14 May 2021, the Health Service Executive (HSE) was subjected to a serious cyberattack on their information technology (IT) infrastructure. Healthcare workers lost access to HSE-provided clinical and non-clinical IT systems, including laboratory systems. AIM: The aim of this national survey was to capture Laboratory Medicine's response across the Republic of Ireland during the HSE cyberattack. METHOD: An electronic survey developed using Microsoft Forms® was emailed on 24 September 2021 to 58 local representatives of the PeriAnalytic and Laboratory Medicine Society (PALMSoc). RESULTS: The survey was sent to 43 clinical laboratories across the Republic of Ireland. A total of 41 responses from 43 laboratories across all laboratory disciplines were received (95% response rate). From these, 55% did not have access to a functioning LIS, with 56% of these not having access to a LIS for greater than 2 weeks. A decrease in specimen requests received during this period was reported by 74% of laboratories, with 32% experiencing a reduction that lasted in excess of one month. Over half of the laboratories (55%) experienced a reduction of > 30% in requests, indicating that clinicians stopped investigating patients (87% reduction in primary care), further escalating the disruption to healthcare. CONCLUSION: The cyberattack burdened the HSE and laboratories at a time when healthcare staffs were coming to terms with the impact of the COVID-19 pandemic. Despite this, the survey confirms the agility of laboratory staff in meeting the demands placed on it during this time.

Working with the Electronic Health Record and Laboratory Information System to Maximize Ordering and Reporting of Molecular Microbiology Results.

Molecular microbiology assays have a higher cost of testing compared to traditional methods and need to be utilized appropriately. Results from these assays may also require interpretation and appropriate follow-up. Electronic tools available in the electronic health record and laboratory information system can be deployed both preanalytically and postanalytically to influence ordering behaviors and positively impact diagnostic stewardship. Next generation technologies, such as machine learning and artificial intelligence, have the potential to expand upon the capabilities currently available and warrant additional study and development but also require regulation around their use in health care.

Toward Laboratory Notification in Pediatric Emergency Departments.

This study explores how patient's laboratory result are accessed in pediatric emergency departments. The rapid turnaround of laboratory results and their timely access by the medical team are crucial for effective patient management and care decision-making. This study revealed a systematic access prioritization to the Electronic Health Record, led by physicians, followed by nurses, and then other healthcare staff Despite efforts to streamline access through computerized laboratory results, optimized laboratory turnaround time and integration of final results into the electronic health record remain key challenges. Delays in accessing analysis results issued by the central hospital laboratory are consistently experienced across various laboratory types, indicating broader systemic workflow issues rather than inefficiencies specific to individual laboratories.

Analysis of laboratory data transmission between two healthcare institutions using a widely used point-to-point health information exchange platform: a case report.

Objective: The objective was to identify information loss that could affect clinical care in laboratory data transmission between 2 health care institutions via a Health Information Exchange platform. Materials and Methods: Data transmission results of 9 laboratory tests, including LOINC codes, were compared in the following: between sending and receiving electronic health record (EHR) systems, the individual Health Level Seven International (HL7) Version 2 messages across the instrument, laboratory information system, and sending EHR. Results: Loss of information for similar tests indicated the following potential patient safety issues: (1) consistently missing specimen source; (2) lack of reporting of analytical technique or instrument platform; (3) inconsistent units and reference ranges; (4) discordant LOINC code use; and (5) increased complexity with multiple HL7 versions. Discussion and Conclusions: Using an HIE with standard messaging, SHIELD (Systemic Harmonization and Interoperability Enhancement for Laboratory Data) recommendations, and enhanced EHR functionality to support necessary data elements would yield consistent test identification and result value transmission.

Development of a SNOMED CT Mapping Process and Tool at a Data Integration Centre - Lessons Learned.

INTRODUCTION: 16 million German-language free-text laboratory test results are the basis of the daily diagnostic routine of 17 laboratories within the University Hospital Erlangen. As part of the Medical Informatics Initiative, the local data integration centre is responsible for the accessibility of routine care data for medical research. Following the core data set, international interoperability standards such as FHIR and the English-language medical terminology SNOMED CT are used to create harmonised data. To represent each non-numeric laboratory test result within the base module profile ObservationLab, the need for a map and supporting tooling arose. STATE OF THE ART: Due to the requirement of a n:n map and a data safety-compliant local instance, publicly available tools (e.g., SNAP2SNOMED) were insufficient. Concept and Implementation: Therefore, we developed (1) an incremental mapping-validation process with different iteration cycles and (2) a customised mapping tool via Microsoft Access. Time, labour, and cost efficiency played a decisive role. First iterations were used to define requirements (e.g., multiple user access). LESSONS LEARNED: The successful process and tool implementation and the described lessons learned (e.g., cheat sheet) will assist other German hospitals in creating local maps for inter-consortia data exchange and research. In the future, qualitative and quantitative analysis results will be published.