As a healthcare and business law firm, we assist many clinical laboratories in compliance and regulatory matters, and because of COVID-19, Georgia has seen a rise in the number of clinical laboratories. A compliance question faced by many of our clients, particularly those who conduct COVID-19 testing, is how to properly maintain and share patient records. Herein, we note some of the rules around retaining and sharing patient records under Georgia law for clinical laboratories.
Georgia Code, Title 31, Chapter 22 provides rules for Clinical Laboratories. For entities that meet the definition of “clinical laboratory,” section 31-22-4(f) provides that “[r]ecords involving clinical laboratory services and copies of reports of laboratory tests shall be kept for the period of time and in the manner prescribed by the department.” The department refers to the Georgia Department of Community Health (“DCH”). DCH’s rules require reports of “all clinical laboratory services, including records of laboratory test requests and reports” to be retained for at least two (2) years for general laboratory records and quality control records, at least five (5) years for records of immunohematology and cytology, and at least ten (10) years for surgical pathology records. Rule 111-8-10-.26.