Quality Assurance Exam 16 Questions with Verified Answers,100% CORRECT

Quality Assurance Exam 16 Questions with Verified Answers Name the three types of audit - CORRECT ANSWER Horizontal audit Vertical audit Examination audit What is a horizontal audit? - CORRECT ANSWER A horizontal audit is where one element of the quality system is assessed e.g. staff training or equipment calibration. This type of audit is a good way of ensuring that individual elements of the quality system are in place and functioning properly. However, it is less valuable at assessing how the system fits together. What is an examination audit? - CORRECT ANSWER In an examination audit, the member of staff undertaking the task is assessed by the auditor as the test is being performed. They can observe whether an SOP is being followed, if the member of staff is able to work competently and safely. It is an opportunity to talk to a staff member to ascertain whether they are satisfied with their training, have the correct level of supervision, a good understanding of all aspects of the procedure they are audited against and are aware of the bigger picture for example the impact that their work has. What is a vertical audit? - CORRECT ANSWER A vertical audit is where more than one element in a process, on one item is assessed to ensure that all activities that contribute to the final report are conforming with the procedures in place. This audit tracks a sample from receipt to the issue of a result, checking each operation associated with processing of the sample. As well as tracking the sample itself, a vertical audit should include aspects such as the training record of personnel involved in testing the sample, records of equipment and reagents used to perform assays, IQA and IQC results relevant for the time the test was performed etc. The advantage of the vertical audit is that it covers all areas of work and shows how the process operates as a whole. What are the quality assurance procedures? - CORRECT ANSWER Quality assessment - External quality assessment (EQA) and Internal quality assessment (IQA) Quality controls - Internal quality control (IQC) Equipment monitoring Audit What does External Quality Assurance mean? - CORRECT ANSWER External Quality Assessment (EQA) Schemes mainly provide comparisons between laboratories, between detection systems and allow comprehensive discussion of results and discrepancies. It is used nationwide Clinical specimens and "spiked" samples are distributed from external sources or reference laboratories, to assess a broad range of techniques and assays performed in the clinical laboratory. The limited frequency of EQA distributions and their clearly identifiable nature allows the potential for handling these samples in ways which exceed normal laboratory procedures e.g. handled by senior staff, repeated testing. Therefore, efforts should be made to ensure EQA samples are handled in a "routine" manner. EQA is available for the majority of assays and organisms routinely tested. Analysis of results and peer group comparisons will be performed externally. The results of distributions should be widely disseminated within the laboratory so as to encourage staff and to allow full discussions on any problems identified through the scheme. Laboratory management should also monitor the results of external quality assessment and participate in the implementation of corrective actions when control criteria are not fulfilled. Some of the EQA providers include - UK NEQAS (United Kingdom National External Quality Assessment Service), QCMD (Quality control for Molecular Diagnostics) and RIQAS (Randox International Quality Assessment Scheme). What are the outcomes of an audit? - CORRECT ANSWER The outcome of an audit can include preventative and corrective action to improve quality and performance in the laboratory. This can occur in the form of SOP updates, further staff training. The most important value of an audit is to improve quality in the laboratory. What does IQA mean? - CORRECT ANSWER IQA mean Internal Quality Assessment. It is a scheme used to monitor all activities involved in the passage of specimens through the laboratory, starting from reception and ending in the dispatch of the final report. In the IQA scheme, a number of specimens are received in the laboratory which are anonymised and resubmitted for testing. The speciemn selection should be random in an IQA scheme for general serology however they should reflect the proportion of the total workload submitted for each analyte. Once both the specimens have been received, processed and the results reported, the anonymised sample and original sample results are compared with the discrepancies being analysed and corrective action taking place if needed. The discrepancies found between the results of the 2 samples should be recorded with a report being sent to senior members of staff in the relevant section of the laboratory asking for any advice or comments on the discrepancies. There should be a wide circulation of the results and staff should be encouraged to discuss any discrepancies found. What is the importance of Internal Quality Controls? - CORRECT ANSWER Internal Quality Controls are an in - house monitoring procedure performed within the lab. Quality control is performed on a daily basis on all the analysers. What are the expected outcomes of audits? - CORRECT ANSWER After conducting audits, the outcomes expected are the findings of non - conformities, the root cause of anomalies and in turn the introduction of preventative & corrective action via the implementation of SOP updates, further training of staff and equipment servicing. The value of an audit is for the purpose of quality improvement which will enhance the function of laboratories. What do you do if Quality Control tests fail? - CORRECT ANSWER Retest the control tests, if that still fails, use and open a new kit and if that still fails escalate it further by approaching a senior staff or section lead. What does 'quality' mean to you? - CORRECT ANSWER The degree to which a set of inherent characteristics fulfils requirements. In microbiology a quality product or service can be defined as "the right result on the right specimen from the right patient that is accurate, timely and properly interpreted". The objective of any test laboratory should therefore be to produce cost effective, accurate, reproducible and timely results which are comparable with the results obtained in a similar laboratory elsewhere which are promptly, effectively and appropriately communicated to the users of the service. The results must be unchallengeable. In this way the quality of the product or service can be guaranteed. How do you maintain quality assurance? - CORRECT ANSWER Laboratories achieve quality service through quality assurance which can be defined as "the total process whereby the quality of laboratory reports can be guaranteed". It comprises all the different measures taken to ensure the reliability of investigations. It also seeks to minimise any variability in test results arising. Examples of such variables include the quality of training and education of staff, the quality of reagents, apparatus and specimens and the suitability of the techniques in use. What is the significance of an Internal Quality Control? - CORRECT ANSWER Internal quality control (IQC) samples should be included in all assays performed in the laboratory and are used to validate test results. Results obtained with IQC samples are used in the decision making process to validate test kits and equipment. IQC samples can be international, national or local standard sera or pools of sera, well characterised in previous assays, and having values within clinically significant ranges. What is Equipment Monitoring? - CORRECT ANSWER It is worth noting that laboratories should verify upon installation and before use, that the equipment to be used is capable of achieving the necessary performance and that it complies with requirements relevant to any examinations concerned. The performance of equipment (e.g. temperature of water baths, incubators and freezers) should be checked at regular intervals and records kept of the data obtained. Spectrophotometers and balances should be checked against available standards and recalibrated if necessary. Adjustable and fixed volume pipettes should be calibrated when new and the calibration checked at regular intervals. The introduction of computer controlled liquid handling devices, capable of performing immunoassays, offers the possibility of increased efficiency and reproducibility. As a regular or even intermittent use can lead to poor performance, equipment should be monitored on a day to day basis and serviced, preferably by a qualified service engineer, at the intervals recommended by the manufacturer. What is an audit? - CORRECT ANSWER An audit is defined as "a systematic, independent and documented process for obtaining evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled". It can also be defined as the process used to amend, evaluate and improve procedures in a systematic way in order to enhance quality. It is often used to highlight differences in those procedure(s) or to identify bottlenecks. The choice of tests performed on specific categories of patients or clinical syndromes when compared to a standard and specimen turnaround times are examples of procedures chosen for audit in the clinical laboratory. An audit can be categorised as internal or external. Internal audits are organised and carried out by laboratory management in areas such as the quality management system, examination processes, etc. External audits are carried out by external inspection bodies such as UKAS, and also through participation in external quality assessment schemes