Current through Register Vol. 51, No. 3, September 1, 2024
RELATES TO:
KRS
211.180,
214.010,
214.160,
214.170,
214.185,
214.420,
42 U.S.C.
263a
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, mucopuru-lent
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.
STATUTORY AUTHORITY:
KRS
194A.050,
211.090