DIN Standards Committee Health Technologies
DIN 58964
Quality assurance of POCT results - Assessment criteria for comparison measurement and implementation
Sicherstellung der Qualität von POCT-Ergebnissen - Bewertungskriterien für Vergleichsmessungen bei Implementierung
Overview
This standard is aimed at manufacturers and users. In the following, procedures for the assessment of comparison measurements are described that consider the specific situation of simultaneous application of POCT procedures and methods in the central laboratory. "POCT" are examination procedures that use in vitro diagnostic medical devices that are used at the bedside or in the immediate vicinity of the patient. Internationally, the term "Point-of-Care-Testing" has become established. A standard, globally accepted definition for POCT does not exist. Important properties of POCT are summarized below. In exceptional cases, in vitro diagnostic testing is also known as POCT if not all but the main criteria that determine the typical character of such diagnostic procedures are met: 1. location of the analytical system outside of a central or satellite laboratory; 2. in vitro diagnostic testing in the immediate vicinity of the patient; 3. examination is carried out mainly of blood, without sample preparations; 4. analytics with measuring equipment, intended primarily for single sample measurement; 5. ready-to-use reagents for only one analysis (unit-use); 6. simple device functions that can be operated by POCT users without detailed medical-technical skills; 7. regular automatic monitoring of the device function; 8. rapid availability of the testing results for immediate therapeutic consequences. This standard specifies measures for the analytical and clinical assessment of a measurand when using different diagnostic methods (both POCT and non-POCT) in medical diagnostic testing. The measures shall ensure that results that are determined in various sample materials are concordant. POCT is used, for example, in the following functional areas: - emergency hospitalization; - operating room/recovery room; - intensive care unit; - delivery room/neonatal ward; - wards with diabetic care; - pulmonary function tests; - invasive radiology; - outpatient facilities such as established doctors' practices and dialysis centres; - care facilities. Samples within the meaning of this standard are native blood or anti-coagulated blood, urine and other body fluids of patients treated in the facility. POCT is used in the context of medical treatment, but also outside of medical science. This standard only applies for POCT within the context of medical science but not for POCT in self-testing. This document (DIN 58964) has been prepared by NA 063-03-11 AA "Patientennahe Sofortdiagnostik (POCT)" ("Point-of-Care-Testing (POCT)" at DIN Standards Committee Medicine (NAMed) at DIN, the German Institute for Standardization e. V.
