483.181 Acceptance, collection, identification, and examination of specimens.—
(1) A clinical laboratory may examine human specimens at the request only of a licensed practitioner or other person authorized by law to use the findings of clinical laboratory examinations. An individual forwarding a sample of the individual’s own blood to a clinical laboratory, when such blood sample has been taken pursuant to a home access HIV test kit approved by the United States Food and Drug Administration, shall be considered a person authorized to request and use a clinical laboratory test for human immunodeficiency virus, for the purposes of this part.
(2) The results of a test must be reported directly to the licensed practitioner or other authorized person who requested it, and appropriate disclosure may be made by the clinical laboratory without a patient’s consent to other health care practitioners and providers involved in the care or treatment of the patient as specified in s. 456.057(7)(a). The report must include the name and address of the clinical laboratory in which the test was actually performed, unless the test was performed in a hospital laboratory and the report becomes an integral part of the hospital record.
(3) The results of clinical laboratory tests performed by a clinical laboratory complying with this part and performed before a patient’s admission to a facility licensed under chapter 395 must be accepted in lieu of clinical laboratory tests required upon a patient’s admission to the facility and in lieu of tests that may be ordered for patients of the facility, except that the facility may not be required to accept transfusion compatibility test results. The agency shall establish, by rule, standards for accepting laboratory test results to specify acceptable timeframes for such laboratory tests to assure that the timeframes do not adversely affect the accuracy of the test.
(4) All specimens accepted by a clinical laboratory must be tested on the premises, except that specimens for infrequently performed tests may be forwarded for examination to another clinical laboratory approved under this part. This subsection does not prohibit referring specimens to a clinical laboratory excepted under s. 483.031. However, the clinical laboratory director of the referring clinical laboratory must assume complete responsibility.
(5) A clinical laboratory licensed under this part must make its services available to a practitioner licensed under chapter 458, chapter 459, chapter 460, chapter 461, chapter 462, chapter 463, s. 464.012, or chapter 466, or to a consultant pharmacist or doctor of pharmacy licensed under chapter 465. A clinical laboratory shall not charge different prices for its services based upon the chapter under which a practitioner is licensed.
History.—s. 18, ch. 67-248; s. 3, ch. 76-168; s. 2, ch. 77-48; s. 1, ch. 77-457; ss. 2, 3, ch. 81-318; ss. 17, 29, 30, ch. 83-276; s. 81, ch. 85-81; s. 19, ch. 93-40; ss. 12, 25, ch. 93-178; s. 2, ch. 95-308; s. 5, ch. 97-91; s. 2, ch. 2009-127; s. 5, ch. 2009-172; s. 11, ch. 2013-26; s. 2, ch. 2015-119.
Section: Previous 483.041 483.051 483.061 483.091 483.101 483.111 483.172 483.181 483.191 483.201 483.221 483.23 483.245 483.26 NextLast modified: September 23, 2016