Rule 111-8-10-.20 - Quality Control for Screening and Monitoring Tests(1) Facilities performing only screening and monitoring tests shall establish a training program with written guidelines and must keep documentation of the training of those personnel designated for performance of specific tests.(2) Quality control procedures for screening and monitoring tests shall be performed for each test, if available. Controls and control frequency shall be according to published guidelines. Only tests approved by the Department may be performed; a list of approved tests shall be available from the Department. Proficiency testing is required for all tests, where such is available and graded.(3) Results of exempt screening and monitoring tests, including all quality control records, shall be maintained separate from the patient's medical record for two years. The records must include the test date, time, patient's first and last name or unique identifier, test site, control/calibration results, lot numbers of reagents/controls, and identification of testing personnel.(4) Reports of test results provided to non-physicians shall contain a statement which recommends that the results of the test be reviewed by a physician or that medical advice be obtained.(5) The results of the tests shall be clearly identified as being performed by a nonlicensed facility and shall be displayed in a manner which will clearly differentiate them from results of a licensed laboratory.(6) Screening test results which indicate abnormal conditions shall be noted with a recommendation that the abnormal results be confirmed by a definitive laboratory test performed in a licensed laboratory.(7) Safety instruction using CDC's universal precaution guide lines for handling blood and instructions for packaging, labeling and disposal of potentially infectious waste materials and sharps, must be available to and practiced by the facility personnel.(8) Each facility, performing whole blood cholesterol, HDL or other approved screening procedures, shall establish a training program with written guidelines and retain documentation of the training of those personnel designated for performing these procedures. The training shall include all areas of the testing process including the use of the instrument.(a) Prior to performing cholesterol testing, the facility must evaluate the procedure for accuracy and precision. Maintenance and testing for proper operation of any analyzers shall be performed with the frequency specified by the manufacturer.(b) Two levels of control must be performed at the beginning of each day of testing and one level of control must be performed if testing equipment is moved from site to site.(c) Maintenance, quality control, current procedure manuals and test participant records shall be available at each test site or with each instrument in use.(d) The screening facility shall recommend referrals for further cholesterol testing in accordance with the National Cholesterol Education Program (NCEP) published guidelines.(e) Reports shall show the name, telephone number, street address, city and state of the screening facility/agency. The screening facility/agency shall provide privacy for blood sampling and confidential counseling about test results.(f) Each screening entity shall have a medical review officer who is licensed to practice medicine in Georgia. This officer may authorize testing.Ga. Comp. R. & Regs. R. 111-8-10-.20
O.C.G.A. § 31-22-1et seq.
Original Rule entitled "Quality Control for Screening and Monitoring Tests" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.