Current through March 20, 2024
Authority: IC
16-19-3-4;
IC
16-41-2-1
Affected: IC
16-41-2-8
Sec. 76.
(a) Each
director, or the director's representative, of a medical laboratory in which
examination of any specimen derived from the human body yields:
(1) microscopic;
(2) bacteriologic;
(3) immunologic;
(4) serologic; or
(5) other; evidence of infection by any of
the organisms or agents listed in subsection (d) shall report the findings and
any other epidemiologically necessary information to the department. HIV
serologic results of tests performed anonymously in conjunction with the
operation of a counseling and testing site registered with the department shall
not be identified by the name of the patient, but by a numeric identifier code.
For the appropriate method to report the results, see subsection (b).
(b) The report required
by subsection (a) shall, at a minimum, include the following:
(1) The name, date, and results of the test
performed.
(2) The laboratory's
normal limits for the test.
(3) The
laboratory's interpretation of the test results.
(4) The laboratory's accession number or
other numeric identifier, or both.
(5) The name, address, and date of birth or
age if date of birth is not available of the person from whom the specimen was
obtained.
(6) The anatomic source
of the specimen.
(7) The name,
address, and telephone number of the:
(A)
attending physician;
(B)
hospital;
(C) clinic; or
(D) other specimen submitter.
(8) The name, address, telephone
number, and CLIA ID number of the laboratory performing the test.
(c) This subsection does not
preclude laboratories from testing specimens, which, when submitted to the
laboratory, are identified by a numeric identifier code and not by the name of
the patient. If testing of such a specimen, identified by numeric code,
produces results that are required to be reported under this rule, the
laboratory shall submit a report that includes the following:
(1) The name, date, and results of tests
performed.
(2) The laboratory's
normal limits for the test.
(3) The
laboratory's interpretation of the test results.
(4) The laboratory's accession number or
other numeric identifier, or both.
(5) The numeric identifier code of the person
from whom the specimen was obtained.
(6) The anatomic source of the
specimen.
(7) The name and address
of the:
(A) attending physician;
(B) hospital;
(C) clinic; or
(D) other specimen submitter.
(8) The:
(A) name;
(B) address;
(C) telephone number; and
(D) CLIA ID number; of the laboratory
performing the test.
(d) Laboratory findings that demonstrate
diseases that are to be reported immediately shall be reported by telephone or
other instantaneous means of communication on first knowledge or suspicion of
the result. Laboratory findings that demonstrate diseases that are to be
reported within twenty-four (24) hours shall be reported to the department
within twenty-four (24) hours. Laboratory findings that demonstrate diseases
that are to be reported within seventy-two (72) hours shall be reported to the
department within seventy-two (72) hours. Laboratory findings that demonstrate
diseases that are to be reported within five (5) business days shall be
reported to the department within five (5) business days. Laboratory findings
demonstrating evidence of the following infections, diseases, or conditions
shall be reported to the department:
(1)
Anaplasma species.
(2) Arboviruses,
including, but not limited to, the following:
(A) St. Louis.
(B) California group.
(C) Eastern equine.
(D) Western equine.
(E) West Nile.
(F) Japanese encephalitis.
(G) Yellow fever.
(H) Powassan.
(I) Dengue and dengue hemorrhagic
fever.
(J) Chikungunya.
(3) Babesia species.
(4) Bacillus anthracis.
(5) Bordetella pertussis.
(6) Borrelia burgdorferi.
(7) Brucella species.
(8) Calymmatobacterium
granulomatis.
(9) Campylobacter
species.
(10)
Carbapenemase-producing carbapenem-resistant Enterobacteriaceae
(CP-CRE).
(11) Chlamydia
psittaci.
(12) Chlamydia
trachomatis.
(13) Clostridium
botulinum.
(14) Clostridium
tetani.
(15)
Coccidioidomycosis.
(16)
Corynebacterium diphtheriae.
(17)
Coxiella burnetii.
(18)
Cryptococcus neoformans.
(19)
Cryptosporidium species.
(20)
Cyclospora cayetanensis.
(21)
Dengue virus.
(22) Eastern equine
encephalitis virus.
(23) Ehrlichia
species.
(24) Escherichia coli (E.
coli) infection (Shiga toxin-producing (STEC)), including, but not limited to,
E. coli 0157, E. coli 0157:H7, non-0157 E. coli, and Shiga toxin
detected.
(25) Francisella
tularensis.
(26) Giardia
species.
(27) Grimontia hollisae
(Vibrio hollisae).
(28) Haemophilus
ducreyi.
(29) Haemophilus
influenzae, invasive disease, and antimicrobial susceptibility
testing*.
(30)
Hantavirus.
(31) The following
hepatitis viruses:
(A) Anti-HAV IgM.
(B) HBsAg, HBeAg, or IgM anti-HBc.
(C) Genotype, RNA (PCR, NAT), or anti-HCV
(e.g., EIA or any combination).
(D)
Delta.
(E) Anti-HEV IgM and
IgG.
(32) Histoplasma
capsulatum.
(33) HIV and related
retroviruses.
(34)
Influenza.
(35) Interferon gamma
release assay (IGRA) for tuberculosis (positive results only).
(36) Japanese encephalitis virus.
(37) Kaposi's sarcoma (biopsies).
(38) La Crosse (California serogroup)
virus.
(39) Legionella
species.
(40) Leptospira
species.
(41) Listeria
monocytogenes, invasive disease.
(42) Measles virus.
(43) Mumps virus.
(44) Mycobacterium leprae.
(45) Mycobacterium tuberculosis.
(46) Neisseria gonorrhoeae.
(47) Neisseria meningitidis, invasive
disease, and antimicrobial susceptibility testing*.
(48) Novel influenza A.
(49) Photobacterium damselae (Vibrio
damsela).
(50) Plasmodium
species.
(51) Powassan
virus.
(52) Pneumocystis
carinii.
(53)
Poliomyelitis.
(54) Rabies virus
(animal or human).
(55) Rickettsia
(non-rickettsii species).
(56)
Rickettsia rickettsii.
(57) Rubella
virus.
(58) Salmonella
species.
(59) Salmonella serotype
Paratyphi and antimicrobial susceptibility testing*.
(60) Salmonella serotype Typhi (Typhoid
fever) and antimicrobial susceptibility testing*.
(61) Shigella species and antimicrobial
susceptibility testing*.
(62)
Smallpox (variola) virus.
(63) St.
Louis encephalitis virus.
(64)
Staphylococcus aureus, vancomycin resistance equal to or greater than eight (8)
ìg/mL.
(65)
Streptococcus pneumoniae, invasive disease, and antimicrobial susceptibility
testing*.
(66) Streptococcus group
A (Streptococcus pyogenes), invasive disease, and antimicrobial susceptibility
testing*.
(67) Streptococcus group
B, invasive disease, and antimicrobial susceptibility testing*.
(68) Taenia solium (and associated
cysts).
(69) Treponema
pallidum.
(70) Trichinella
spiralis.
(71) Varicella-zoster
virus.
(72) Vibrio
species.
(73) West Nile
virus.
(74) Western equine
encephalitis virus.
(75) Yellow
fever virus.
(76) Yersinia species,
including the following:
(A) Pestis.
(B) Enterocolitica.
(C) Pseudotuberculosis.
*Reporting of disease is required to follow the "When to
Report (from probable diagnosis)" time frame, and the antimicrobial
susceptibility testing results are to be reported as soon as they become
available.
(e) Laboratories may also report to the local
health officer, but any such local report shall be in addition to reporting to
the department. A laboratory may report by:
(1) electronic data transfer;
(2) telephone; or
(3) other confidential means of
communication.
Instead of electronic data transfer or reporting by
telephone, a laboratory may submit a legible copy of the laboratory report,
provided that the information specified in subsection (b) or (c) appears
thereon. Whenever a laboratory submits a specimen, portion of a specimen, or
culture to the department laboratory resource center for confirmation, phage
typing, or other service, this does not preclude a laboratory from reporting
requirements as specified in this section.
(f) Laboratories shall submit all isolates of
the following organisms to the department's microbiology laboratory for further
evaluation within three (3) business days of isolation:
(1) Carbapenemase-producing
carbapenem-resistant Enterobacteriaceae (CP-CRE). Isolates include organisms
that are nonsusceptible to at least one (1) carbapenem antibiotic with MIC
>=2 µg/ml or zone diameter <=22 mm (<=21 mm for ertapenem), and
meet one (1) of the following criteria:
(A)
Positive for carbapenemase production by a phenotypic test (e.g., Modified
Hodge or Carba NP).
(B)
Nonsusceptible to at least three (3) carbapenem antibiotics with MIC >=2
µg/ml or zone diameter <=22 mm (<=21 mm for ertapenem).
(C) Positive for a carbapenemase gene marker.
Only one (1) isolate that meets these criteria should be
submitted if the same organism is repeatedly recovered from the same
patient.
(2)
Haemophilus influenzae, invasive disease.
(3) Neisseria meningitidis, invasive
disease.
(4) Escherichia coli (E.
coli) (Shiga toxin-producing (STEC)) isolates, if not available, submit a Shiga
toxin detected enrichment broth from a clinical specimen. If detection of STEC
from a stool specimen using a nonculture based method (isolate or broth if not
available), submit stool specimen in Cary-Blair media.
(5) Staphylococcus aureus, vancomycin
resistance equal to or greater than eight (8) µg/mL.
(6) Mycobacterium tuberculosis.
(7) Streptococcus pneumoniae invasive disease
isolates from persons less than five (5) years of age.
(8) Listeria monocytogenes isolates from a
normally sterile site.
(9)
Salmonella species isolates collected from a clinical specimen. If detection of
Salmonella from a stool specimen using a nonculture based method, submit stool
specimen in Cary-Blair medium.
(10)
Shigella species isolates collected from a clinical specimen. If detection of
Shigella from a stool specimen using a nonculture based method, submit stool
specimen in Cary-Blair medium.
(11)
Vibrio cholerae isolates collected from stool or vomitus. If detection of
Vibrio cholerae from a stool specimen using a nonculture based method, submit
stool specimen in Cary-Blair medium.
(12) Vibrio species (other than toxigenic
Vibrio cholerae), Grimontia hollisae (Vibrio hollisae), and Photobacterium
damselae (Vibrio damsela) isolates from a clinical specimen. If detection of
Vibrio species, Grimontia hollisae (Vibrio hollisae), and Photobacterium
damselae (Vibrio damsela) from a stool specimen using a nonculture based
method, submit stool specimen in Cary-Blair medium.
(g) Laboratories shall submit all confirmed
positive remnant HIV diagnostic specimens to a department designated laboratory
for confirmation, testing, and further evaluation including, but not limited
to, confirmed western blot positives.
(h) Reporting by a laboratory, as required by
this section, shall not:
(1) constitute a
diagnosis or a case report; or
(2)
be considered to fulfill the obligation of the attending physician or hospital
to report.
(i) Failure
to report constitutes a Class A infraction as specified by IC
16-41-2-8.
