Statements
Statements
Positions taken
Comment on the petition of ALM e.V.
The German Society for Clinical Chemistry and Laboratory Medicine (DGKL) deals in detail with the petition of the ALM e.V. “Serum as an alternative material must be retained for routine care!” and corrects false statements.
January 2024
Position paper: National strategic plan for laboratory medicine
Comprehensive, high-quality and technologically advanced laboratory medicine is essential for healthcare in Germany – in view of this fact, the German Society for Clinical Chemistry and Laboratory Medicine (DGKL) has drawn up a groundbreaking position paper entitled “National Strategic Plan for Laboratory Medicine”.
December 2024
Statement on the draft bill for a law to strengthen heart health
The DGKL has submitted a statement to the Federal Ministry of Health on the above-mentioned draft bill and generally welcomes the objective of strengthening preventive measures in the area of cardiovascular diseases. However, the DGKL firmly rejects the law in its current form as cost-driving and questionable for the health of the population. As a result of the investigations to be initiated under the Act and taking into account the current threshold values, a large proportion of the population will probably be classified as “in need of treatment”. This implies not only effects on the individual, such as side effects, in the planned administration of medication. The issue of costs must also be reconsidered in this context and with regard to the quality of the examinations.
Statement July 2024
Statement on the change in waiting list management and organ procurement for liver transplantation
The DGKL has submitted a statement to the German Medical Association on the amendment of the above-mentioned guideline, essentially commenting on the correct use of the INR value.
Statement November 2022
Statement on the coronavirus test regulation
A further update of the coronavirus test regulation was commented on by the DGKL at short notice. It addresses the prioritization of PCR tests in times of high incidence and heavy workload for laboratories as well as other urgent points.
Statement February 2022
Statement on REV2E information for genetic tests
The new version of this guideline of the Genetic Diagnostics Commission improves the information provided to patients in the case of genetic tests for medical purposes and specifies the qualifications of the treating physicians.
Statement January 2022
Statement on REV1E pharmacogenetics
The DGKL has commented on the new version of the guideline on the significance of pharmacogenetic properties of the Genetic Diagnostics Commission and welcomes, among other things, the addition of relevant examples of pharmacogenetic properties.
Statement January 2022
Opinion on the amendment to the Coronavirus Testing Ordinance
In a statement on the renewed amendment of the Coronavirus Test Ordinance (TestV) of 21 September 2021, the DGKL supports prioritizing the performance of PCR analyses for SARS-CoV-2 by employees with contact to particularly vulnerable groups of people.
Statement January 2022
Ordinance amending the Coronavirus Testing Ordinance (2)
In a further statement on the amendment of the Coronavirus Testing Ordinance within a very short space of time, the DGKL has explicitly spoken out against the extension of PoC PCR tests to doctors’ surgeries and pharmacies. This is particularly relevant against the background of adequate quality assurance and to avoid a further shortage of closed NAT systems to maintain emergency care in hospitals.
Statement from November 2021
Preventive measures required to combat the pandemic
On the occasion of the 4th wave of the corona pandemic, the task force “COVID-19 Guidelines” of the AWMF, in which the DGKL is represented alongside 43 other medical-scientific societies, has issued an urgent appeal for the immediate and consistent implementation of preventive measures to combat the pandemic.
Position paper from December 2021
SARS-CoV-2 pre-exposure prophylaxis (PrEP) with neutralizing monoclonal antibodies
As part of the AWMF COVID-19 Task Force, the DGKL has contributed to a position paper on the passive immunization of patients at high risk of serological vaccination failure. These patients, who also have the highest risk of severe courses, can be passively immunized with pre-exposure prophylaxis using SARS-CoV-2 neutralizing monoclonal antibodies (nMABs).
Position paper from November 2021
Amendment to the coronavirus test regulation
The DGKL’s Corona Task Force has issued a statement as part of a comment process on the amendment of the Coronavirus Testing Ordinance. In it, the DGKL welcomes the reintroduction of free citizen testing and, against the background of increasing asymptomatic infections and a growing number of vaccination breakthroughs, advocates the wider use of PCR-based testing procedures, especially in community facilities and other social units (restaurants, cinemas, etc.).
Statement from November 2021
Recommendations for the implementation of patient-oriented analysis systems for the molecular detection of infectious agents in the clinical environment
The aim of this statement is to provide recommendations for the implementation and appropriate clinical use of nucleic acid testing procedures for the direct detection of infectious agents that can be used in close proximity to patients. The medical profession should be made more aware of the fact that, due to their complexity, these test procedures should only be used in conjunction with a multidisciplinary institution with comprehensive responsibilities and responsibility for the diagnostic processes and with in-depth knowledge of the test specifications, risks and quality assurance. This ensures that patient safety is improved and economically questionable expenditure is avoided.
Statement of the POCT section of the DGKL from April 2021
Efficacy and use of currently available SARS-CoV-2 vaccines in Germany
The DGKL supports the statement prepared by the German Society for Pediatric Infectiology and the German Society for Infectiology on the currently available vaccines against SARS-CoV-2. With the update of March 31, 2021, the document was supplemented by statements on side effects of the AstraZeneca vaccine and the approval of another vaccine (Johnson & Johnson).
Statement from March 2021
Statement on REV1-E Medical significance of genetic characteristics
The revision of the GEKO guideline on the medical significance of genetic characteristics updates and specifies relevant points in the handling of genetic tests. The DGKL supports these revisions, as they have become necessary in the course of scientific and technical developments.
Statement from March 2021
Statement on the draft bill ÄApprO
The DGKL supports the introduction of new licensing regulations for doctors and, following the initial comment process in January 2020, has now also commented on the BMG’s corresponding draft bill. In it, the DGKL comments on some important points of medical training from the perspective of laboratory medicine.
Statement from January 2021
Statement on the action plan to improve the safety of drug therapies 2021-2024
Following the implementation of the first action plan to improve drug therapy safety, a draft for the update of this action plan for the years 2021-2024 is now available, on which the “Therapeutic Drug Monitoring and Clinical Toxicology” section of the DGKL has submitted a statement to the BMG. The main criticism is that TDM as a helpful and established method for controlling drug therapies is not mentioned at all in the current draft.
Statement from December 2020
Statement on newborn screening for 5q-associated spinal muscular atrophy
The new therapeutic options (gene therapy, anti-sens drug), in conjunction with early detection, give rise to expectations of further success in the treatment of spinal muscular atrophy type 1 and type 2. The DGKL therefore welcomes the introduction of newborn screening for the early detection of 5q-associated spinal muscular atrophy and the inclusion of this new target disease in Section I “Extended newborn screening” of the pediatric guideline.
Statement from October 2020
Statement on the amendment to the health check-up guideline: "Introduction of screening for hepatitis B and hepatitis C"
As part of an official opinion procedure of the G-BA, the DGKL has commented on the introduction of general screening for hepatitis B and C in the sense of laboratory medicine in which it supports the exclusive use of antigen tests at screening level. Further documents on the commenting procedure can be found here.
Statement from August 2020 / published November 2020
Statement on the MTA Reform Act
The DGKL welcomes the initiative to reform the training of MTAs and has submitted an official statement to the BMG on the draft bill for an MTA reform law.
Statement from August 2020
Statement on the Hospital Future Act - KHZG
The DGKL submitted a corresponding statement to the BMG as part of a comment process for the formulation of a draft law that is intended to make the equipment, financing and working methods of hospitals fit for the future.
Statement from August 2020
Statement on the amendment to the pediatric guideline: Screening for sickle cell disease in newborns
The DGKL e. V. welcomes the introduction of newborn screening for the early detection of sickle cell disease and the inclusion of this new target disease in Section I “Expanded newborn screening” of the pediatric guideline. In its statement, the DGKL comments on both the measurement methods and some organizational aspects of the implementation and execution of this screening. You can find the complete documents for the commenting procedure here.
Statement from August 2020 / published November 2020
Statement on the draft bill "Regulation on statutory health insurance benefits for tests to detect the presence of an infection with the SARS-CoV-2 coronavirus"
In this statement, the DGKL takes a position on the planned expansion and the associated remuneration of SARS-CoV-2 tests. In this context, the
The need to link the commissioning of third parties to carry out laboratory medical examinations to compliance with the quality criteria as defined by the Rili-BÄK was emphasized.
Statement from May 2020
Opinion on the draft of a second law to protect the population in the event of an epidemic situation of national importance
The DGKL took part in the comment process on the “Second Pandemic Act” of the Federal Ministry of Health and commented on the critical points from the point of view of laboratory medicine. These are essentially the extension of laboratory medical services to veterinary laboratories and the documentation of vaccination and immune status.
Statement from April 2020
Statement on the working draft ÄApprO 2020
As the German Society for Clinical Chemistry and Laboratory Medicine, we support the efforts of the Ministry of Health to adapt the training of young medical students to current and future social needs and to amend the existing licensing regulations accordingly.
Statement from January 2020
Statement of the DGKL e. V. on the inclusion of the non-invasive prenatal test (NIPT) for trisomy 21, 18 and 13 in the benefits catalog of statutory health insurance companies
As part of the official opinion procedure of the Federal Joint Committee (G-BA) on the topic of “Non-invasive prenatal diagnostics to determine the risk of autosomal trisomies 13, 18 and 21 using a molecular genetic test (NIPT) for use in pregnancies with special risks”, the DGKL participated with its own opinion as a medical society entitled to comment. Our comments focused on the various aspects of quality assurance of these modern test procedures and the professional requirements for the physician performing the test. You can find the complete documentation on the commenting procedure at https://www.g-ba.de/beschluesse/3955/
Statement from May 2019 / published September 2019
Statement of the DGKL e. V. on the standardization of the cap color
For different laboratory medical requirements, the appropriate collection tubes must be used, which have been color-coded for decades for easier handling in order to be able to distinguish the different additives and tube types without any problems. However, in the past there were two different color codes, which are due to historical reasons.
Statement from January 2019
Statement on the personal provision of medical laboratory services in the GOÄ
Patients are at the center of medical practice. Individualized and patient-oriented care with laboratory diagnostics is essential for the quality and safety of patient care. Specialists in the fields of laboratory medicine, microbiology, virology and infection epidemiology are the right specialists for the overall management of laboratory diagnostics due to their specific specialist training and experience.
Statement from October 2017
Statement of the DGKL e. V. on the AM-VSG
Since both wet-chemical, conventional laboratory methods for determining CRP and POCT methods are subject to the guidelines of the German Medical Association for quality assurance in laboratory medicine, it is advisable to consult experts who can also assess the results of the internal and external quality assurance required by the German Medical Association in order to develop an appropriate, neutral picture of the quality of the available methods (POCT and laboratory methods). We recommend experts from the two proficiency testing organizations appointed by the German Medical Association, INSTAND e.V., Düsseldorf, and the Reference Institute for Bioanalytics (RfB), Bonn.
Statement from August 2016
Molecular laboratory medical diagnostics in peripheral blood and body fluids
Diagnostics from blood and body fluids is the task of clinical chemistry and laboratory medicine and includes biomarkers of different molecular classes, organ provenance as well as processing and metabolic products. A position paper by Prof. Dr. Michel Neumaier and Prof. Dr. Stefan Holdenrieder published in September 2015.
Hospital laboratory diagnostics in the future - benefits for the hospital?
Only targeted diagnostics can provide adequate treatment for the patients entrusted to us. Today, the progressive opening of sector boundaries (outpatient and inpatient) poses new challenges and opportunities, especially for diagnostic disciplines such as radiology, pathology and laboratory medicine. Author Prof. Dr. Michael Neumeier published 2015 on management-krankenhaus.de
Point-of-care testing
Only targeted diagnostics can provide adequate treatment for the patients entrusted to us. Today, the progressive opening of sector boundaries (outpatient and inpatient) poses new challenges and opportunities, especially for diagnostic disciplines such as radiology, pathology and laboratory medicine. Author Prof. Dr. Michael Neumeier published 2015 on management-krankenhaus.de
