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.)