Introduction to Ethical and Legal Aspects

Abstract

Ethical and legal aspects and understanding of the complex interplay between medical practices, patient rights, and the legal framework is extremely important to run a clinical laboratory. Fundamental principles of medical ethics guide the conduct of healthcare professionals and the delivery of services. Informed consent, genetic testing, and issues related to equity and access to laboratory tests are key aspects of medical ethics in clinical laboratory. Domains related to incidental findings, direct-to-consumer testing, and ethical considerations in transfusion medicine are some of the ethical challenges that laboratories may encounter. Issues like disclosure of laboratory errors and measurement uncertainty, proper collection of information and specimens, special procedures, performance of tests, reporting of results, retention of medical records, and financial arrangements are all explored in detail in the present chapter. Ethics in laboratory research and confidentiality are crucial for protecting patient privacy. This chapter details the concept of a clinical laboratory as a legal entity and its legal issues along with a brief look at medicolegal issues and examples of possible litigation to help the readers understand this facet of clinical laboratory management.