BRIDGING THE NAVIGATIONAL GAP PERTAINING TO THE ROLE AND RESPONSIBILITY OF THE CLINICAL/MEDICAL DIRECTOR WITHIN THE CONFINES OF REGULATORY OVERSIGHT AND INTERNAL GOVERNANCE
*Dr. Ghazala Nathu
The clinical laboratory is one of the most highly regulated areas of medicine. Unlike other clinical disciplines, the actions of laboratories are governed by multiple regulatory layers: national and state laws, institutional policies, and laboratory policies. Clinical laboratories are routinely inspected and have ongoing examination of performance through proficiency testing. Within this complex environment, laboratory directors are ultimately responsible for the actions of all laboratory team member who contact patient specimens. In addition to ensuring the quality of clinical laboratory testing, laboratory professionals must be compliant with regulations of patient data and privacy and financial practices. Ignorance of applicable laws and regulations is not an adequate defense, and laboratorians should be proficient in laws and best practices that apply to the clinical laboratory.
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