Analysis and Reporting System for the Improvement of Patient Safety through Real-Time Integration of Laboratory Findings

The aim of the consortium partners involved in the AMPEL project is to develop a software that enhances clinical care and increases patient safety through digital networking. The user-oriented software solution in the making strives to have a lasting effect on the quality of patient care by ensuring that an appropriate course of therapy is ascertained through electronic monitoring of diagnostics in real time.

This measure is co-funded with tax revenues based on the budget adopted by the members of the Saxon State Parliament.

Project

The data information, evaluation, notification and reporting system planned within the framework of the AMPEL project (Analysis and Reporting System for the Improvement of Patient Safety through Real-Time Integration of Laboratory Findings) is intended to support medical decision-makers in their work to provide patient care – even in smaller peripheral medical care facilities – through improved availability and automatic prioritisation of medical information.

The core element of the project is the reporting system, which alerts the laboratory physician within seconds if there are indications of acute clinical patterns and delays in further diagnosis and treatment. After a medical evaluation of all relevant information has been conducted, the laboratory physician immediately establishes contact with the treating physician in order to inform, accelerate further procedures and minimise risks for the patient. A complex consolidation of data serves as the basis for the comprehensive bioinformatic-supported laboratory medical evaluation of the results and data from the laboratory and hospital information system.

At the end of the project, a product will be developed that evaluates possible further treatment steps and therapy options in real time and transmits them to the attending physician by means of an electronic reporting system. Suitable and predominantly method-independent reporting of significant pathological results will also support the treatment success after the patient has been discharged.

After the project is completed, the product will be transferred to the controlling software VISMEDICA of XANTAS AG and made available for commercial use.

Goals

Improvement of Clinical Care

The telemedical solution to be developed and established will automatically form links in real time to additional patient-related clinical information from the hospital’s patient information system on the basis of laboratory medical findings.

Alert in case of Delayed or Inadequate Therapeutic Action

If possible delays or deviations are indicated, a medical reporting system is immediately activated to ensure the necessary steps are taken on short notice in the dialogue between the laboratory physician and the responsible practitioner.

Patient Safety Enhancement

In order to increase patient safety, the system will monitor and report in real time whether medically appropriate consequences and follow-up examinations have been derived from the requested laboratory values in a timely manner.

Interpretation Aids for Particular Constellations of Findings

The to-be-developed telemedical solution will use the ILM’s quality-assured laboratory medical diagnostics to provide information regarding the presence of specific symptoms and clinical patterns and analyse within seconds (“real time”) whether the correct consequences and follow-up examinations have been derived from the requested laboratory values.

Development of Regulatory Frameworks

The rules and regulations used in the AMPEL system are based on decision trees that critically consider current literature, as well as retrospective analyses of results from routine laboratory medical diagnostics.

Transferability of the results

The AMPEL system should also support smaller hospitals in patient care. Laboratory medical findings are ideally suited for this purpose, since their high quality and good comparability, even between different medical laboratories, already represent a promising starting position for suitable clinical decision support systems. This will be further improved by the implementation of a uniform parameter designation LOINC (Logical Observation Identifiers Names and Codes).

Documentation of Findings and Diagnoses

The results of the laboratory medical reporting system are collected for each patient case over the entire inpatient stay. Together with other significantly notable laboratory medical results, they are then transferred in a suitable form from the IT system to the physician’s letter within the scope of patient discharge management.

Medical Coding of Findings and Diagnoses

The software retrospectively analyses the final documentation of clinical cases and facilitates the consideration of relevant coding and billing aspects. Not only is this of great economic importance, especially from the point of view of billing with health insurance companies, but it also provides data that can be used for a retrospective evaluation of the treatment process.

Consortium

Leipzig University of Medicine / Institute for Laboratory Medicine

The Institute for Laboratory Medicine, Clinical Chemistry and Molecular Diagnostics (ILM) of the University Medical Centre of Leipzig (UML) is one of the leading laboratory medical institutes in Germany. Within the scope of patient care, roughly 1,500 patient examinations with a total of about 20,000 laboratory medical analyses are carried out daily for the clinic, faculty and the Medical Care Centre (MedVZ) of the UHL. The ILM is accredited according to the 98/79/EC and DIN EN ISO/IEC 17025 directives as well as the 93/42/EEC, 90/385/EEC and DIN EN ISO 15189 directives. The range of services includes clinical chemistry, haematological diagnostics, haemostaseology, immune and cerebrospinal fluid diagnostics, endocrinological diagnostics, as well as molecular and special diagnostics.

In addition, as the Screening Centre of Saxony together with the Dresden location, the ILM provides about 50,000 new-born screening examinations for congenital metabolic diseases annually for the Free States of Saxony and Thuringia. Research at the ILM includes metabolome and protein analysis as well as molecular and genetic research of vascular diseases and metabolic disorders. Furthermore, the Institute has its own department for the laboratory analysis of clinical studies. There are research cooperations with numerous national and international cooperation partners from the research and science sectors. In this context, the ILM is also an significant partner in important study projects such as the “LIFE” study (Leipzig Research Centre for Civilization Diseases) and the Medical Informatics Initiative of the German Federal Ministry of Education and Research “SMITH” (Smart Medical Information Technology for Healthcare).

Muldental Clinics Inc. (non-profit)

The non-profit organisation Muldental Clinics Inc. is the reliable health partner for the residents and communities in the district of Leipzig. More than 950 employees provide around-the-clock regional basic and regular care within the disciplines of surgery, internal medicine, gynaecology/obstetrics as well as paediatrics and youth medicine with a total of 355 beds – all state-of-the-art and ISO-certified. In addition, the Muldental Clinics offer recognised specialised services in hand surgery, tumour surgery and therapy, thyroid gland operations and palliative medicine.

Muldental Clinics Inc. has its headquarters in Wurzen. The two traditional hospitals in Grimma and Wurzen, the Medical Care Centres (MVZ) in Colditz, Wurzen and Grimma and the Muldental Home for the Elderly gGmbH in Wurzen and Brandis belong to the non-profit company of the Muldental Clinics. The sole shareholder of the municipal company, which has been successful since 1997, is the district of Leipzig.

XANTAS AG

Founded in 2007, XANTAS AG is a SME that develops software for data analysis in hospitals. The software development centre is located in Leipzig. XANTAS predominantly produces the software solution VISMEDICA, which, thanks to its modular structure, is now used by more than 100 hospitals in Germany, Austria and Switzerland. In these hospitals – with a total capacity of almost 50,000 hospital beds – the software is the sound basis for analyses of over 5 million outpatients and inpatients treated annually in the medical, surgical or financial controlling fields.

The focus of the software development to date has been on the one hand on connecting SAP-based clinical information systems, and on the other hand on creating classic data warehouse models based on a nomenclature and system especially developed for the healthcare sector. Ten years of experience in the field of systematisation in the analysis process design of a hospital enables the company to react quickly and comprehensively to new challenges in the health care system and to pursue innovative approaches.

Associated Partner

University Hospital Leipzig AöR

As the second oldest German university hospital, The University Hospital of Leipzig (UHL) together with the Medical Faculty looks back on a rich tradition. Today, the hospital has one of the most modern structural and technical infrastructures in Europe with around 1,450 beds. Every year, over 400,000 in- and outpatients are treated here at the highest medical level. These patients benefit from the cutting-edge research power UHL’s scientists, as the latest findings from medical research are quickly and reliably transferred into medical practice here.

News

We are planning our upcoming TO DOs, e.g. a central training course for employees using the ULMC internal platform UKLearn.

We are drafting the milestones for the upcoming project year 2021. Also: the AMPEL Cockpit went online. During the development of AMPEL frameworks it has become clear that the project shines a light on the accessibility of electronic patient data and fosters its improvement through collaboration with multiple ULMC departments.

We initiated a cooperation with the Department of Transfusion Medicine! Many terrific and clinically relevant ideas for frameworks are already being put into action.

AMPEL runs completely on our HANA from now on and we are planning separate test and production systems. The numbers show: medical controlling can be supported through our system, which, in the end, will also increase patient benefit.

(Picture: Roberto Fischer/hippo.tv)

The AMPEL project was nominated from 55 applicants as one of 10 projects for the MSD Health Award. The MSD honours outstanding health solutions and promotes their implementation and further development. From 31.07.2020 you can vote for our project: publikumspreis-2020.msd.de (only available in German)

We are teaming up with the Cardiology Department at ULMC and are looking forward to the collaboration! Valuable medical input for the development of frameworks will now be incorporated.

Access to our HANA was handed over to the Xantas AG. We are excited about discussing the first results of the Machine Learning algorithm used for one of our frameworks.

The AMPEL Cockpit is taking shape and we are planning further steps towards LOINC mapping in the project.

The team discussed possible changes in the use and customization of the AMPEL system. We decided on an additional tool, which facilitates central administrative processes (AMPEL Cockpit).

Our first digital-only workshop. We are organizing and setting up new collaborative tools for the coming months. Questions regarding infrastructure and all data flow processes of our system were answered.

We are welcoming three new team members. Two new frameworks have been started as regular operations at ULMC. Their long-term effectiveness will be assessed via a randomized clinical trial. For the first time, we are transferring data to the HANA system.

The AMPEL project was represented with two posters at the Life Science Research 2020 exhibition.
Felix Eckelt: Improved Patient Safety with the AMPEL system – A Proof of Concept for Severe Hypokalemia
Dr Johannes Remmler: Development of a Laboratory Based Clinical Decision Support System (AMPEL) for the Management of Acute Kidney Injury

Installation of the most extensive update yet. The use of AMPEL on selected test stations is fine-tuned so that it can be subjected to practical testing.

Presentation of the AMPEL concept and results at the MEDICA forum in Düsseldorf.

Advanced research results on the individual regulations were presented at the 16th Annual Conference of the German Society for Clinical Chemistry and Laboratory Medicine (DGKL) in Magdeburg. The AMPEL team won a poster prize.

At the board meeting, the AMPEL team coordinated with the management at Muldental Clinics Inc. to initiate the next steps.

Introduction of new team members and the AMPEL method.

New team members were introduced. Results of the AMPEL rules and regulations were evaluated and the data structure for the programme concept was adjusted.

Presentation of first evaluations of several rules and regulations. In the case study, the functionality of a set of regulations was explained in greater detail.

The ideas for the SAP presentation and the functionality of the AMPEL system were further specified.

The evaluation of the system times and the presentation of first set of rules and regulations were the main focus of the second workshop. Initial ideas for AMPEL in SAP were discussed.

Project participants coordinated for the first time face-to-face to create basic project structures.

Presentation of the first research results at the Research Festival of the University of Leipzig. The AMPEL team won the poster prize in the Clinical Research category.

The funding notice was handed over to the AMPEL team by Barbara Klepsch, Saxon Minister of State for Social Affairs and Consumer Protection.

Press

The Clinical Decision Support System AMPEL for Laboratory Diagnostics: Implementation and Technical Evaluation

03.06.2021

This work describes, apart from the experiences with AMPEL, the main components of the system in a general manner to make it applicable to a wide range of medical institutions and to empower colleagues to implement a similar system in their facilities. [More]
Source: JMIR Medical Informatics

Real-time interpretation supports patient safety

09.09.2020

Laboratory medicine is an elementary component of health care, as it provides a great deal of decision-relevant information that is fundamental for diagnostics and therapy. 60-70% of treatment decisions are based entirely or at least partly on laboratory results. [More]
Source: Management & Krankenhaus

Improved patient safety through a clinical decision support systems in laboaratory medicine

27.03.2020

Medical errors are among the most common causes of death in industrialised countries. The research project on digital laboratory medicine (AMPEL) aims at developing a clinical decision support system based on laboratory diagnostics, which supports practitioners in ensuring the necessary medical consequences. The system also supports medical documentation. [More]
Source: Der Internist

Focus on patient safety - One year of the AMPEL project

10.01.2020

Traffic lights are not only important on the road – they can also make life safer in hospitals. AMPEL (in German traffic lights) stands for Analysis and Reporting System for the Improvement of Patient Safety through Real-Time Integration of Laboratory Findings. The aim is to ensure that no vital laboratory value gets lost in everyday medical life. [More]
Source: University of Leipzig Medical Center

Telemedicine on the rise - video consultation hours and digital projects help patients

11.05.2019

Digitisation in the health care system is gaining momentum. Politicians and the health system hope for better, faster and more cost-effective care. [More]
Source: heise online

New Tele project to improve security

11.01.2019

In a new telemedicine project, laboratory values of patients are to be linked to already existing patient data. This is intended to provide information about the diseases that are present. [More]
Source: Ärzte Zeitung

Millions in funding for AMPEL: Clinical research project of digital laboratory medicine for increased patient safety

17.12.2018

Barbara Klepsch, Saxon State Minister of Social Affairs and Consumer Protection, presented a grant of more than 2.6 million euros to the Institute of Laboratory Medicine, Clinical Chemistry and Molecular Diagnostics. [More]
Source: University of Leipzig Medical Center

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13.12.2018

The AMPEL project receives financial support from the Free State of Saxony. The measures are co-financed by taxes on the basis of the budget adopted by the members of the Saxon state parliament. [More]
Source: Saxon State Chancellery