The Value of Clinical Laboratory Sciences Research

Extract

Consumer demand for increased value in clinical laboratory services delivery has intensified. On the heels of the Health Insurance Portability and Accountability Act (HIPAA) of 1996,¹ Protection of Human Subjects, “Common Rule,”² and Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009,³ the U.S. Department of Health and Human Services, effective April 7, 2014, amended Clinical Laboratory Improvement Amendments of 1988 (CLIA) and HIPAA Privacy regulations to allow patients/consumers direct access to their laboratory reports.⁴

The nexus of these regulatory forces, along with unprecedented health information access and exchange characterizing our society, suggests a prominent consultative role in services delivery for clinical laboratory practitioners. However, the interpretation of duty to patients, society, and other healthcare professionals, as codified in the clinical laboratory science Code of Ethics,⁵ becomes critical to ethical practice as issues of societal duty and “good” are viewed through the lens of patient/consumer autonomy. Our responsibility broadens and deepens if we accept the challenge to transform laboratory information into actionable knowledge for patients/consumers and providers alike.

With these recent environmental changes, principles of access to meaningfully interpreted best evidence for providers' clinical decision support and patients/consumers' shared decision making compete with confidentiality concerns in everyday services delivery. We must internalize not only the laws and regulations governing protected health information, but we must also operationalize decision-making grounded in fundamental ethical principles guiding thorough informed consent. Patients/consumers expect to gain knowledge from us that will equip them to share in decisions regarding their medical care; they…