Section 410 IAC 1-2.5-76 - Laboratories; reporting requirementsAuthority: 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: (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:(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:(D) other specimen submitter.(8) The: (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: (2) Arboviruses, including, but not limited to, the following: (F) Japanese encephalitis.(I) Dengue and dengue hemorrhagic fever.(5) Bordetella pertussis.(6) Borrelia burgdorferi.(8) Calymmatobacterium granulomatis.(9) Campylobacter species.(10) Carbapenemase-producing carbapenem-resistant Enterobacteriaceae (CP-CRE).(12) Chlamydia trachomatis.(13) Clostridium botulinum.(16) Corynebacterium diphtheriae.(18) Cryptococcus neoformans.(19) Cryptosporidium species.(20) Cyclospora cayetanensis.(22) Eastern equine encephalitis virus.(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.(27) Grimontia hollisae (Vibrio hollisae).(28) Haemophilus ducreyi.(29) Haemophilus influenzae, invasive disease, and antimicrobial susceptibility testing*.(31) The following hepatitis viruses:(B) HBsAg, HBeAg, or IgM anti-HBc.(C) Genotype, RNA (PCR, NAT), or anti-HCV (e.g., EIA or any combination).(E) Anti-HEV IgM and IgG.(32) Histoplasma capsulatum.(33) HIV and related retroviruses.(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.(41) Listeria monocytogenes, invasive disease.(44) Mycobacterium leprae.(45) Mycobacterium tuberculosis.(46) Neisseria gonorrhoeae.(47) Neisseria meningitidis, invasive disease, and antimicrobial susceptibility testing*.(49) Photobacterium damselae (Vibrio damsela).(52) Pneumocystis carinii.(54) Rabies virus (animal or human).(55) Rickettsia (non-rickettsii species).(56) Rickettsia rickettsii.(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).(70) Trichinella spiralis.(71) Varicella-zoster virus.(74) Western equine encephalitis virus.(76) Yersinia species, including the following:(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;(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. Indiana State Department of Health; 410 IAC 1-2.5-76; filed 11/25/2015, 2:54 p.m.: 20151223-IR-410150039FRAReadopted filed 11/12/2021, 8:41 a.m.: 20211208-IR-410210385RFA