59A-6.027. Collection and Transmittal of Specimens

(1) No center shall collect specimens from the human body where prudent medical practice requires that such specimens only be collected during the course of a physical examination by a physician. The following procedures are prohibited:

(a) Papanicolaou Tests (PAP Smears) unless such test is collected by a physician licensed under Chapter 458 or 459, F.S.; and

(b) Prothrombin Time.

(2) A center may not hold itself out to the public as collecting specimens for testing for the human immunodeficiency virus (HIV) unless it complies with Section 381.004, F.S.

(3) If clinical specimens are collected, each licensed center shall have an operating refrigerator, or other means of refrigeration, each capable of maintaining a temperature of 2-8 degrees centigrade for the proper storage of specimens. Refrigerator temperature readings shall be recorded each day of use and maintained for a minimum of two years.

(4) Each specimen must be sent to the testing laboratory for analysis as rapidly as possible, but no later than 12 hours after collection unless appropriate measures are taken to preserve the specimen.

(a) No specimen shall be collected and delivered at any time beyond which the integrity of such specimens is valid and will provide reliable results.

(b) Appropriate measures shall be taken to assure specimen preservation where applicable and such measures shall be noted in the patient record specified under subsection 59A-6.026(1), F.A.C.

(5) Mobile centers must provide for proper transfer of laboratory specimens which shall include, but not be limited to, appropriate refrigeration.

(6) Serum or plasma shall be removed from red blood cells in instances where results may be adversely affected by the presence of red blood cells.

Rulemaking Authority 483.291 FS. Law Implemented 483.291 FS. History–New 3-20-94.