In a win for the Tennessee Society of Pathologists (TSP) and the CAP, a measure that would have placed additional burdens on clinical laboratories when reporting test results failed to advance out of the subcommittee on March 30. The TSP and CAP worked collaboratively to raise awareness about the negative effects of the measure on laboratories in the state.

House Bill 579, introduced by State Rep. John Ragan, would require clinical laboratories to report test results to ordering providers in an electronic format dictated by the Medical Laboratory Board and transmit a laboratory control report electronically to the board and Department of Health. In addition, the bill also required all laboratory test results to be transmitted to the state and stored in what would be a future, contemplated state database containing all patient information generated by clinical laboratories. Additionally, the measure would have given the board authority to impose fees, if necessary, to accomplish the provisions of the legislation.

In a memorandum of opposition sent to lawmakers, the TSP said it opposed the legislation for several reasons:

• The legislation would impose a new, substantial regulatory burden on clinical laboratories at a time when laboratory personnel and resources are strained under the unprecedented weight of pandemic-related testing;
• The legislation is vague and without definition in citing key terms that are not amenable to electronic data field reporting (ie, “concurrent calibration standards and control charts recording”);
• The reporting frequency for this requested information is not prescribed in the bill.
• The legislation grants an extraordinary authority to the Laboratory Board to collect individual patient health and clinical data, which exceeds the predicate statutory authority of the board and transcends the historical role of the board in focusing on laboratory quality oversight; and
• The legislation expressly allows the board to rely upon “internationally recognized standards” for state regulation of clinical laboratory reporting. Reliance upon international standards that are not used, endorsed, or promulgated in the United States is of questionable merit, says the TSP, noting “there would likely be a strong reason for such standards to have been rejected in the United States.”

The CAP considers this a win for Tennessee pathologists and clinical laboratories, which already face tremendous regulatory burdens and financial pressures.