**Preface XI**


Preface

Quality control (QC) is the most important component of any hospital or laboratory project. Clinical laboratory science has undergone a vast change in the last 25 years. Although a good design with properly prepared drawings and specifications is essential for a quality end product, the QC and quality assurance (QA) efforts are also essential to assure that the construction complies with the drawings and specifications. Various different reports on medical/laboratory fallacy/misconception have raised the visibility for the necessity to aug‐ ment patient safety and quality resourcefulness. Prominence has relocated from simply di‐ agnosing and treating disease to identifying and controlling disease, risk factors and maintaining health. The purpose of establishing laboratory quality standards is to ensure the accuracy of test results; to increase the confidence of patients, clinicians and communities in the value of laboratory testing; and to elucidate in patient management. Quality standards are an integral part of the quality system. They are designed to help laboratories meet regu‐ latory requirements, including local health regulations, and monitor laboratory functions, thereby ensuring laboratory safety and consistency of performance. The purpose of this book is to provide procedures, guidance, references, checklists and worksheets to help in the quality control (Internal Quality Control and External Quality Assurance), quality manage‐ ment and QA and to help in performing periodic quality assurance inspection. The book stresses prominence on three facets: (1) components such as cases and controls, defined and well-managed processes, and integrity and performance aspects, (2) competence and (3) quality of laboratory reports. Each administrative and technical procedure in the laboratory must be subject to a quality monitoring process developed with the help of relevant labora‐ tory staff. Each process must be documented using a step-by-step approach. Heads of labo‐ ratories are responsible for ensuring that each document is understood, and all processes are fully implemented by laboratory staff. Advances in technology have totally changed the way we practise diagnosis and treatment. Now, the testing techniques have moved from test tubes, beakers and large, automated analysers to microanalytic systems ("lab on a chip") that allow reduced sample size, fewer reagents and smaller instruments. Nowadays, pa‐ tients can even carry small-sized instruments with them that can help them in finding out various parameters. The continuation, prolongation and preservation of a quality manage‐ ment system are crucial to a laboratory for providing the correct test results every time. All these, however, require rigid quality control. Establishing and maintaining laboratory quali‐ ty standards are essential. They are important for several reasons, including ensuring the quality and traceability of patients' results, supporting clinical and public health decisionmaking, procuring equipment, using standard techniques and reagents, sharing documenta‐ tion, training programmes, quality assurance, meeting requirements for reimbursement for national insurance schemes, and complying with national or international accreditation and licencing systems. A well-staffed and well-financed organization centre is critical for estab‐
