Amends TCA Title 4 and Title 68.

This bill revises and adds to provisions relating to the Tennessee Medical Laboratory Act (the "Act"), as discussed below. <br /> <br /> QUALITY CONTROL PROGRAMS<br /> <br /> Present law requires each medical laboratory director to establish the director's own quality control program acceptable to the medical laboratory board, including use of, where applicable, reference or control sera and other biological samples, concurrent calibration standards, and control charts recording<br /> <br /> This bill replaces such requirement with authorization for the board to promulgate rules on standardization of quality control and electronic recordkeeping programs for each medical laboratory.<br /> <br /> This bill requires each medical laboratory director to transmit a laboratory quality control report electronically to the board, which report must include an electronic copy of the quality control data of equipment and personnel used in the test. This bill authorizes the board to require that an electronic copy of quality control test results are reported to the department of health so that the department may enter the quality control test results into a consolidated database for research purposes. Costs associated with the department creating, maintaining, using, and allowing authorized research from a consolidated database may be defrayed through user and participant fees or cost-sharing agreements with research organizations as determined by the board in conjunction with the department.<br /> <br /> REPORTING OF TEST RESULTS<br /> <br /> Under present law, no person may examine human specimens without the written request of a heath care professional, or the written request of a law enforcement in accordance with breath and blood tests to determine alcohol or drug content of a motor vehicle operator's blood. The results of a test must be reported directly to the requesting health care professional, and the report must include the name of the director and the name and address of the medical laboratory in which the test was actually performed. <br /> <br /> This bill revises the test results provision above to provide that the results of a test must be reported directly to requesting health care provider, except as provided by the quality control programs provision of this bill, discussed below. This bill replaces the requirement that the report include the name of the lab director and name and address of the laboratory with a requirement that the report comply with electronic reporting standards set by the board.<br /> <br /> LICENSES RENEWAL AND FEES <br /> <br /> Under present law, each licensee must renew the licensee's license on forms provided by the board and pay a fee as set by the board. The fee, in the form of a check or money order, must accompany the renewal application. This bill adds that any reporting fees set by the board must be included with the renewal fee.<br /> <br /> EFFECTIVE DATE<br /> <br /> This bill takes effect upon becoming a law for rulemaking purposes, and on January 1, 2022, for all other purposes.<br />