902 KAR 2:080. Sexually transmitted diseases.
RELATES TO: KRS 211.180, 214.010, 214.160, 214.170, 214.185, 214.420, 42 U.S.C. 263a
STATUTORY AUTHORITY: KRS 194A.050, 211.090
NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.180 requires the Cabinet for Health and Family Services to implement a statewide program for the detection, prevention and control of communicable diseases and to adopt regulations specifying the information required in and a minimum time period for reporting a sexually transmitted disease. This administrative regulation establishes uniform procedures for the diagnosis, treatment, prevention and control of sexually transmitted diseases (STD).
Section 1. Definitions. (1) "Certified or Accredited laboratory" means a laboratory that has been:
(a) Issued a laboratory license from the state of Kentucky; or
(b) Evaluated and certified or accredited by one (1) of the following regulatory agencies:
1. The Joint Commission;
2. The College of American Pathologists (CAP);
3. The Centers for Medicare and Medicaid Services (CMS); or
4. The Commission on Office Laboratory Accreditation (COLA)..
(2) "Certified or approved serology test" means the Venereal Disease Research Laboratory Slide Test (VDRL) or rapid plasma reagin (RPR) 18 mm circle card test or other Food and Drug Administration (FDA) approved test performed in accordance with the directions of the manufacturer.
(3) "Midlevel health care practitioner" means a health care professional who meets the requirements of KRS 216.925(1).
(4) "Reasonably suspected of being infected with a sexually transmitted disease" means any person named in a controlled interview with a second person infected with an STD, as a sexual contact of that second person within the incubation period for the STD, or who has a laboratory test result consistent with an STD infection.
(5) "Sexually transmitted diseases" or "STD" means syphilis, gonorrhea, chancroid, granuloma inguinale, genital herpes, human immunodeficiency virus (HIV) infection, nongonococcal urethritis, mucopurulent cervicitis, chlamydia trachomatis infections including lymphogranuloma venereum, and human papillomavirus (HPV).
(6) "Sexually transmitted diseases for which a treatment exists to render them noninfectious" means syphilis, gonorrhea, chancroid, granuloma inguinale, nongonococcal urethritis, mucopurulent cervicitis and Chlamydia trachomatis infections including lymphogranuloma venereum.
Section 2. Medical Examination and Treatment of Sexually Transmitted Diseases for Which a Treatment Exists to Render them Noninfectious. (1) Any person infected with, or reasonably suspected of being infected with, a sexually transmitted disease shall undergo such medical examination as is necessary, including such laboratory testing procedures deemed advisable by the examining physician to reasonably determine the existence or nonexistence of the diagnosed or suspected sexually transmitted disease.
(2) If there is the potential that the person is incubating the disease, he shall undergo such treatment or follow-up as may be determined adequate by the examining physician to render the person noninfectious or to prevent the onset of disease.
(3) This section shall apply only to sexually transmitted diseases as defined by Section 1(4) of this administrative regulation.
Section 3. Investigation and Enforcement. (1) Only authorized personnel of the Cabinet for Health and Family Services and local health departments assigned to sexually transmitted disease control activities are empowered to carry out the prevention and control provisions set forth in this administrative regulation.
(2) Their duties shall include the investigation of persons known to be or reasonably suspected of being infected with a sexually transmitted disease.
(3) Such authorized personnel are empowered to direct that medical examinations, including laboratory tests, be conducted on persons reasonably suspected of having a sexually transmitted disease.
(4) This section shall apply only to sexually transmitted diseases as defined by Section 1(4) of this administrative regulation.
Section 4. Certified or Accredited Laboratories for Tests. (1) The laboratory shall hold certification or accreditation for performing tests for syphilis, in compliance with KRS 214.160.
(2) The laboratory shall have as its director a physician licensed to practice medicine in Kentucky or a person who meets the requirements set forth in 902 KAR 11:030, Sections 1(4)(f) or 1(6).
(3) A certified or accredited laboratory shall maintain performance that meets the requirements of the Clinical Laboratory Improvement Amendments (CLIA), 42 U.S.C. 263(a), or the laboratory's certifying or accrediting body regulations for syphilis and other sexually transmitted disease testing.
(4) All certified or accredited laboratories shall fully comply with all state and federal laws, including 42 U.S.C. 263a, and the rules and administrative regulations of the Cabinet for Health and Family Services.
Section 5. Requirements for Reporting STD to Public Health. (1) Midlevel health care practitioners and physicians shall report STD cases as set forth in 902 KAR 2:020.
(a) Cases shall be reported to the local health department or the Division of Epidemiology, Department for Public Health using the form EPID 200, Kentucky Reportable Disease Form, prepared and furnished by the Cabinet for Health and Family Services or a computer-generated facsimile with the same data fields listed.
(b) Midlevel health care practitioners shall report cases of primary, secondary, early latent, and congenital syphilis not later than twenty-four (24) hours after diagnosis.
(c) Cases of other types of syphilis or other reportable STD shall be reported within five (5) business days after diagnosis.
(2) Hospitals and institutions may conduct their own testing program within the institution or through a licensed medical laboratory.
(a) Hospitals and institutions that conduct their own testing program or contract with a licensed medical laboratory shall report positive test results within twenty-four (24) hours of testing to the attending physician or health care provider and shall report positive test results for primary, secondary, early latent, and congenital syphilis to the local health department or the Division of Epidemiology, Department for Public Health not later than twenty-four (24) hours after being processed by the laboratory.
(b) Positive test results for other types of syphilis and other STD should be reported to the local health department or Division of Epidemiology, Department for Public Health within five (5) business days.
(c) The obligation of hospitals and institutions that may conduct their own testing program within the institution or through a medical laboratory to report positive/reactive STD tests shall not supersede these reporting requirements for physicians or other midlevel health care practitioners.
(d) Reports to the Department for Public Health shall be submitted on the form EPID 240, Report of Positive/Reactive Test for STD, prepared and furnished by the Cabinet for Health and Family Services or a computer-generated facsimile with the same data fields listed.
Section 6. Incorporation by Reference. (1) The following material is incorporated by reference:
(a) "EPID 200, Kentucky Reportable Disease Form", edition 5/06; and
(b) "EPID 240, Report of Positive/Reactive Test for STD", edition 1/92.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Division of Laboratory Services, 100 Sower Boulevard Suite 204, Frankfort, Kentucky 40601, Monday through Friday, 8 a.m. to 4:30 p.m. (VD-1-1; 1 Ky.R. 189; eff. 12-11-74; Am. 4 Ky.R. 334; eff. 5-3-78; 11 Ky.R. 1918; 12 Ky.R. 343; eff. 8-13-85; 16 Ky.R. 667; 1188; eff. 11-22-89; 33 Ky.R. 3295; 34 Ky.R. 35; eff. 8-6-2007.)