Compilation of Rules and Regulations of the State of Georgia › Department 111 - RULES OF DEPARTMENT OF COMMUNITY HEALTH › Chapter 111-8 - HEALTHCARE FACILITY REGULATION › Subject 111-8-10 - LICENSURE OF CLINICAL LABORATORIES › Rule 111-8-10-.20 - Quality Control for Screening and Monitoring Tests

Current through Rules and Regulations filed through June 27, 2024
(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.