395.0091 Alternate-site testing.—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. At a minimum, the criteria must address hospital internal needs assessment; a protocol for implementation, including the identification of tests to be performed and who will perform them; selection of 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 and initial and ongoing competency validation; an appropriate internal and external quality control protocol; an internal mechanism for the central laboratory to identify and track alternate-site testing; and recordkeeping requirements. Alternate-site testing locations must register when the hospital applies to renew its license. For purposes of this section, the term “alternate-site testing” includes any laboratory testing done under the administrative control of a hospital but performed out of the physical or administrative confines of the central laboratory.
