In a contract multiphasic health testing center, electrocardiograms and X rays must be read and interpreted by the medical director of the contract center or respectively by a board-certified cardiologist or radiologist authorized by the medical director to read and interpret the electrocardiograms and X rays and report results to the medical director. (1) Each center licensed under this part shall employ a medical director who is either a physician licensed under chapter 458 or an osteopathic physician licensed under chapter 459 and who, as part of her or his usual medical practice, interprets electrocardiograms.
For purposes of this subsection, the term “alternate-site testing” means any laboratory testing done under the administrative control of a hospital, but performed out of the physical or administrative confines of the central laboratory.
Alternate-site testing locations must register when the clinical laboratory applies to renew its license.
The elements to be addressed in the rule include, but are not limited to: a hospital internal needs assessment a protocol of implementation including tests to be performed and who will perform the tests criteria to be used in selecting the method of testing to be used for alternate-site testing minimum training and education requirements for those who will perform alternate-site testing, such as documented training, licensure, certification, or other medical professional background not limited to laboratory professionals documented inservice training as well as initial and ongoing competency validation an appropriate internal and external quality control protocol an internal mechanism for identifying and tracking alternate-site testing by the central laboratory and recordkeeping requirements. The agency, in consultation with the Board of Clinical Laboratory Personnel, shall adopt, by rule, the criteria for alternate-site testing to be performed under the supervision of a clinical laboratory director.