![]() ![]() However, the cost of an individual LBC test is considerably higher, although ancillary molecular testing, such as high-risk HPV testing in the case of atypical squamous cells of undetermined significance (ASC-US), can be performed on the same sample. In general, the proportion of unsatisfactory samples is remarkably lower in LBC when compared to conventional cytology, and the interpretation of LBC requires less time. The quality of the evaluation of the performance of these technologies is frequently disputed because they are rarely based on histologically defined outcomes using randomised study designs. The occurrence of false-negative and unsatisfactory Pap smears supported the primary efforts to develop liquid-based cytology (LBC) methodology and automation-based screening devices. ![]() Importantly, the Manual should be constantly updated and revised. In order to achieve the best performance of a laboratory under the ISO 9000 certification, 6 basic elements must be considered: (1) define the quality policy, (2) elaborate the organizational chart of the laboratory, (3) provide job descriptions for all staff members, (4) implement the human resource management policy, including continuous education and a reward system, (5) document all procedures, with special regard for those related to QC, the handling of complaints by laboratory users and the maintenance of equipment and (6) define the organization and its responsibility for quality. For this reason, it is assumed that ISO 9000 supports good practices for the QA process. QA procedures offer improved guarantees that the procedure protocols will be effectively implemented QC, on the other hand, only measures outputs. Īccording to ISO 9000, an internationally based certification programme, all the important documentation should be collected in a Quality Manual. Audit is a mandatory component in the era of molecular pathology and immunocytochemistry, with the huge amount of diagnostic and prognostic information and the rapid evaluation of equipment and methodologies that demand robust validation studies and continued audit procedures. This is critical for cytotechnologists and biomedical scientists, in particular, due to the central role that these professionals play in cancer prevention programmes and non-gynaecological cytology. Audit procedures of QA and QC protocols are essential for maintaining standards of quality, and imply a continuous process of education and critical evaluation of all steps related to the quality protocols. Accreditation in the health field is equivalent to the certification of the system of quality in the industrial world according to the standards of the International Organization for Standardization (ISO). QA and AccreditationĪudit is the inspection and examination of a process or quality system to ensure compliance with requirements. ![]() ![]() It would therefore be useful to replace the term QA with the term continuous quality improvement (CQI) for 2 reasons: (1) we cannot guarantee the quality, but only the intention or efforts towards ensuring the quality and (2) CQI includes traditional QC measures in the laboratory but has a wider scope, comprising not only the undertaking of corrective actions (if the laboratory falls below an agreed standard) but also offering continuous improvement in the quality of diagnostic services, a well-coordinated multi-disciplinary professional team and the setting of new and higher standards once original targets have been achieved, in order to further enhance the quality of the service. The term ‘continuous quality improvement' can also be found this term better clarifies that the purpose of the activity is not about the individualization and the knowledge of errors as much as continuous improvements in timing, performance and achievement of a uniform quality. QC had its origins in industry, starting as industrial QC and then expanding, in health care, from clinical chemistry to other laboratories and also into the clinical world, where it took the name QA. ![]()
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