Autonomy and Privacy in Clinical Laboratory Science Policy and Practice.

Rapid advancements in diagnostic technologies coupled with growth in testing options and choices mandate the development of evidence-based testing algorithms linked to the care paths of the major chronic diseases and health challenges encountered most frequently. As care paths are evaluated, patient/consumers become partners in healthcare delivery. Clinical laboratory scientists find themselves firmly embedded in both quality improvement and clinical research with an urgent need to translate clinical laboratory information into knowledge required by practitioners and patient/consumers alike. To implement this patient-centered care approach in clinical laboratory science, practitioners must understand their roles in (1) protecting patient/consumer autonomy in the healthcare informed consent process and (2) assuring patient/consumer privacy and confidentiality while blending quality improvement study findings with protected health information. A literature review, describing the current ethical environment, supports a consultative role for clinical laboratory scientists in the clinical decision-making process and suggests guidance for policy and practice regarding the principle of autonomy and its associated operational characteristics: informed consent and privacy. ABBREVIATIONS: CDC – U.S. Centers for Disease Control and Prevention CDS – clinical decision support, CLS – clinical laboratory scientist(s)/clinical laboratory science, CLIA – Clinical Laboratory Improvement Amendments of 1988, EBP - evidence-based practice, HHS – U.S. Department of Health and Human Services, IRB – institutional review board, LDS – limited data set(s), PHI – protected health information, QI – quality improvement, TQM – total quality management