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[QUASA-the apheresis registry]
J Dräger1, S Petzold, H Ristau
1Fachhochschule Stralsund, Zur Schwedenschanze 15, 18435 Stralsund, Germany. juergen-draeger@fh-stralsund.de
Insights
A new quality assurance registry for LDL apheresis (LDL apheresis) enables physicians to document patient data and fulfill quality guidelines. This registry supports evidence-based practice and public health through data analysis.
Area of Science:
- Cardiology
- Nephrology
- Public Health
Background:
- Extracorporeal LDL apheresis therapy (LDL apheresis) requires quality assurance measures mandated by national guidelines (NUB) and SGB V legislation.
- Complementary BUB guidelines were introduced in 1999 to assess the therapeutic benefit of LDL apheresis.
- Treatment documentation is explicitly required beyond quality assurance during execution.
Purpose of the Study:
- To introduce a quality assurance registry for LDL apheresis to meet regulatory requirements.
- To enable voluntary participation of apheresis physicians in data collection.
- To facilitate EDV-based individual patient documentation and analysis.
Main Methods:
- Development of a non-profit quality assurance registry by Quasa gGmbH.
- Voluntary online participation for apheresis physicians since March 2003.
- Recording of clinical patient history and treatment-relevant data.
Main Results:
- The registry enables the medical profession to fulfill LDL apheresis quality assurance guidelines.
- Physicians can establish EDV-based individual patient documentation.
- Epidemiological data evaluation is regularly accomplished and results are made public.
Conclusions:
- The LDL apheresis quality assurance registry facilitates compliance with national guidelines and legislative requirements.
- It provides a platform for comprehensive patient data documentation and analysis.
- Regular data evaluation supports evidence-based practice and public health initiatives in LDL apheresis.
Abstract:
Quality saving measures are required at the execution of extracorporeal LDL apheresis therapy (LDL apheresis) by the NUB guidelines of the national committee of physicians and health insurance. The saving measures apply to specialist, organizational and apparatical conditions for execution and accounting of treatment methods. Furthermore, as a result of the lawful requirements of SGB V, complementary BUB guidelines were introduced in 1999. These ought to engage the therapeutic benefit of a LDL apheresis treatment. Beyond measures for quality assurance at execution a documentation of treatment is explicitly demanded. For two years now the non-profit Quasa gGmbH has been developed the quality assurance registry for LDL apheresis with the background of those requirements. Since March 2003 the apheresis physicians can voluntarily take part in the registry initiative by internet. Beside the clinical patient's medical history, treatment relevant data are recorded. Because of the analysis of the nationally ascertained clinical data, for the first time it will be possible for the medical profession to fulfill the guidelines of quality assurance for LDL apheresis. Moreover the treating apheresis physicians can establish an EDV-based individual patient documentation. All necessary measures of data protection and data security are in process on the technical and logistic realization of this registry initiative. An epidemiological data evaluation is regularly accomplished and the results are provided to the public.
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