QC Explained 1. 0 - Quality Control for Point of Care Testing QUALITY CONTROL QC Explained 1.0 - Quality Control for Point of Care Testing QC Explained 1.0 - Quality Control for Kee, Sarah., Adams, Lynsey., Whyte, Carla J., McVicker, Louise. Point of Care Testing QC Explained 1. 0 - Quality Control for Point of Care Testing Kee, Sarah., Adams, Lynsey., Whyte, Carla J., McVicker, Louise. Background Point of care testing (POCT) refers to testing that is performed near or at the site of a patient with the result leading to a possible change in the care of the patient. Over the past few years, the Point of care testing (POCT) refers to popularity and demand of POCT has been testing that is performed near or at the growing rapidly. This should come as no site of a patient with the result leading surprise as there are many advantages to to a possible change in the care of the POCT, for example, the added patient. Over the past few years, the convenience of being able to obtain a popularity and demand of POCT has been rapid result at the patient’s bedside, thus growing rapidly. This should come as no allowing immediate action, saving time surprise as there are many advantages to and improving the potential outcome for POCT, for example, the added the patient. convenience of being able to obtain a Although there the patient’s bedside,using rapid result at are many benefits of thus POCT devices in action, saving their terms of time allowing immediate convenience, these benefits are only true if and improving the potential outcome for the patient. produced are both accurate results and reliable. Ensuring accuracy and Although there are many benefits of using POCT devices in terms of their convenience, these benefits are only true if 1 the results produced are both accurate and reliable. Ensuring accuracy and reliability is the primary responsibility of Quality Control. Quality control is composed of two key elements; internal quality control (IQC) and external quality assessment (EQA). IQC reliability is the primary responsibility of involvesControl. quality control material Quality running that contains analytes of known Quality control is composed of two key concentration to monitor the precision of elements; internal quality control (IQC) the analytical process over time. Whereas and external quality assessment (EQA). IQC EQA involves running blind patient-like involves running quality control material samples, comparing your results to peer that contains analytes of known results, in order to retrospectively monitor concentration to monitor the precision of the accuracy of reporting. EQA samples the analytical process over time. Whereas should be treated as if they were a patient EQA involves running blind patient-like sample and therefore must be run by samples, comparing your results to peer personnel who would be using the device. results, in order to retrospectively monitor This provides confidence in the reliability the accuracy of reporting. EQA samples of patient test results. should be treated as if they were a patient sample and therefore must be run by personnel who would be using the device. This provides confidence in the reliability of patient test results

QC Explained 1. 0 - Quality Control for Point of Care Testing QUALITY CONTROL Section Title Page 1.0 Importance of Quality Control for POCT Devices 3 3.0 Choosing an Appropriate QC Procedure for your POCT Device 4 3.1 Balancing risk with the stringency of your POCT quality 4 control procedure 3.1.1 Choosing a QC procedure for High Throughput Analyser 5 Type POCT Instruments 3.1.2 Choosing a QC procedure for Cartridge Based Instruments 5 3.1.3 Choosing a QC procedure for Strip Based Instruments 6 3.1.4 Choosing a QC procedure for manually read POC...

QC Explained 1. 0 - Quality Control for Point of Care Testing QUALITY CONTROL ISO 15189 states that "Quality Control materials shall be periodically examined with a frequency that is based on the stability of the procedure and the risk of harm to the patient from an erroneous result" (1). Therefore, when implementing a QC strategy for POCT devices the risk of harm to the patient should be the foundation of the plan: where and why do errors occur and what are the consequences of an erroneous result to the patient? It is important to balance the risk of harm to the patient with the stringency...

QC Explained 1. 0 - Quality Control for Point of Care Testing QUALITY CONTROL on patient outcome was 14.7% (3), demonstrating that for POCT devices there is larger room for error and a greater need for quality control. Some POCT device manufacturers advise that QC procedures similar to those found in the laboratory are unnecessary for POCT devices. However, this is not the opinion of the majority of laboratory professionals who believe a place undoubtedly remains for traditional IQC and EQA practices for POCT. This view is supported by the introduction of the new ISO POC specific regulations....

QC Explained 1. 0 - Quality Control for Point of Care Testing QUALITY CONTROL • tests used to support the clinician's decision in isolation, • tests acted upon immediately, and • tests performed on specimens that are difficult to collect. The POCT strategy will depend on the POC device that is being used as POCT devices can be broadly split into three categories: 1. "High Throughput Analyser"- Full size instruments used at the point of care, e.g.: blood gas analysers. 2. "Cartridge Based Instruments"- For example HbA1c and INR analysers. 3. "Strip Based Instruments" e.g.: electrochemical or...

QC Explained 1. 0 - Quality Control for Point of Care Testing QUALITY CONTROL Each time the laboratory receives a new batch of cartridges they should be evaluated using multi-level, third party controls to ensure that the cartridges have not been damaged during transport. It is also a good idea to periodically test quality control samples over the shelf life of a particular batch. Ideally a third party control should be used every day of patient testing to ensure the stability of the on-board reagents and the accuracy of the results obtained, as recommended by ISO 15189. However, it's important...