64D-3.029 Diseases or Conditions to be Reported.

(1) Diseases or conditions listed in subsection (3), below, are identified by the Department as being of public health significance. These diseases or conditions must be reported by the practitioner, hospital, laboratory, or other individuals via telephone (with subsequent written report within 72 hours, see Rules 64D-3.030-.033, F.A.C.), facsimile, electronic data transfer, or other confidential means to the Department, which includes the County Health Departments. Reporters are not prohibited from reporting diseases or conditions not listed by rule. Reports should include all associated testing results performed (e.g. serogroup, serotype, and antimicrobial susceptibility results). Physicians and other healthcare providers using point of care tests for diagnosis of infectious diseases must report test results to the Department when they are indicative of an infectious disease reportable directly to the Department by laboratories unless such point of care testing is subject to routine reflex testing by a supplementary or confirmatory testing the results of which would be reportable.

(2) Definitions to be used with subsection (3), below:

(a) "Reportable Diseases or Conditions" - The definitions of "suspected case" and "confirmed case" for reportable diseases or conditions are set forth in "Surveillance Case Definitions for Select Reportable Diseases in Florida," January 2016 version 1.1, incorporated by reference, available online at: https://www.flrules.org/Gateway/reference.asp?No=Ref-07442.

(b) "Suspect Immediately" - A reportable condition of urgent public health importance. Report without delay upon the occurrence of any of the following: initial suspicion, receipt of a specimen with an accompanying request for an indicative or confirmatory test, findings indicative thereof, or suspected diagnosis. Reports that cannot timely be made during the County Health Department business day shall be made to the County Health Department after-hours duty official. If unable to do so, the reporter shall contact the Department after-hours duty official at (850)245-4401.

(c) "Immediately" - A reportable condition of urgent public health importance. Report without delay upon the occurrence of any of the following: an indicative or confirmatory test, findings indicative thereof, or diagnosis. Reports that cannot timely be made during the County Health Department business day shall be made to the County Health Department after-hours duty official. If unable to do so, the reporter shall contact the Department after-hours duty official at (850)245-4401.

(d) "Next Business Day" - Report before the closure of the County Health Department's next business day following suspicion or diagnosis.

(e) "Other" - Report consistent with the instruction in and footnotes to subsection (3), below.

(3) "Table of Reportable Diseases or Conditions to Be Reported"

*1 - Submission of isolates or specimens for confirmation to the Florida Department of Health, Bureau of Public Health Laboratories:

a. Each laboratory that obtains a human isolate or a specimen from a patient shall send isolates or specimens (such as sera, slides or diagnostic preparations) for confirmation or additional characterization of the organism.

b. Hospitals, practitioners and laboratories submitting specimens for reportable laboratory tests, pursuant to subsection 64D-3.031(3), F.A.C., are required to supply the laboratories with sufficient information to comply with the provisions of this section.

c. For the address of the closest Florida Department of Health laboratory location, contact: 1(866)352-5227.

d. Laboratories shall submit isolates or specimens for confirmation or additional characterization of the organism for any reportable disease listed in the Table of Reportable Diseases or Conditions to be Reported in this rule as requested by the Department.

e. Laboratories are not prohibited from submitting isolates or specimens from a patient for a disease or condition that is not designated in the Table of Reportable Diseases or Conditions to be Reported in this rule.

f. Submission should occur within two weeks from the time the isolate or specimen is received by the laboratory, unless otherwise noted by the Department.

*2 - Include MIC (minimum inhibitory concentration), zone sizes for disk diffusion; MICs for E-test or agar dilution and interpretation (susceptible, intermediate, resistant).

*3 - Paper reports are not required. Applies only to laboratories performing electronic laboratory reporting as described in subsection 64D-3.031(5), F.A.C.

*4 - a. Surveillance Case Definitions for Select Reportable Diseases in Florida, 2016.

b. Reports should include occupational information (e.g. employer name, address, phone number).

*5 - Report on suspicion of infection. Reports should occur without delay on initial suspicion but reports do not need to be made after-hours. Reports on initial suspicion are to allow for disease control measures to be immediately implemented (such as notification of mosquito control) in order to prevent local transmission.

*6 - Notification within six months of diagnosis and within six months of each treatment.

*7 - All CD-4 absolute count and percentage of total lymphocytes, with or without confirmed HIV infection.

*8 - Child abuse should be considered by a practitioner upon collection of a specimen for laboratory testing in any person 12 years of age or younger, excluding neonates. Reporting of a sexually transmissible disease (STD) case to a county health department does not relieve the practitioner of their mandatory reporting responsibilities regarding child abuse pursuant to Section 39.201, F.S.

*9 - Exceptions are located in Rule 64D-3.035, F.A.C.

*10 - Practitioners should contact the Department of Health, Bureau of Epidemiology at (850)245-4401 to arrange appropriate autopsy and specimen collection.

*11 - For Haemophilus influenza test results associated with persons older than 4 years of age, only electronic reporting is required, in accordance with subsection 64D-3.031(5), F.A.C.

*12 - Special reporting requirements for Hepatitis B (acute and chronic), C (acute and chronic), D, E, G: Positive results should be accompanied by any hepatitis testing conducted (positive and negative results); all serum aminotransferase levels, and if applicable, pregnancy test result or if testing is conducted as part of a pregnancy panel. For laboratories performing electronic laboratory reporting as described in subsection 64D-3.031(5), F.A.C., all test results performed (positive and negative) are to be submitted, including screening test results (positive and negative).

*13 - A 4-fold titer rise in paired sera by various serological tests confirmatory of primary infection; presence of herpes-specific IgM suggestive but not conclusive evidence of primary infection.

*14 - Special requirements for STARHS (Serologic Testing Algorithm for Recent HIV Seroconversion):

a. Laboratories that report a confirmed positive HIV tests in persons ≥13 years old must also report STARHS results.

b. In lieu of producing this test result, each laboratory that reports a confirmed positive HIV test must submit a sample for additional testing using STARHS. The laboratory is permitted to send the remaining blood specimen or an aliquot of at least 0.5 ml to the Bureau of Public Health Laboratories, 1217 Pearl Street, Jacksonville, Florida 32202-3926 or 1325 NW 14th Avenue, Miami, Florida 33125.

c. Laboratories electing to send a blood specimen will contact the Incidence and Molecular Coordinator, HIV/AIDS Section, Florida Department of Health, at (850)245-4430 to receive specimen maintenance and shipping instructions.

d. Nationally based laboratories with an existing contract to ship specimens directly to a STARHS laboratory designated by the Centers for Disease Control and Prevention will not be required to send a specimen to the Department.

*15 - Laboratories shall submit a genotype for each confirmed positive HIV specimen on a fasta file containing the nucleotide sequence data, including the protease and reverse transcriptase regions.

*16 - Special reporting requirements for reporting blood lead tests:

a. All blood lead tests are considered evidence of a suspected case and are to be reported electronically. This reporting requirement pertains to: 1) laboratories and, 2) practitioners that conduct on-site blood lead analysis (i.e., practitioners that use portable lead care analyzers or other devices to perform blood lead analysis).

b. Results produced by on-site blood lead analysis devices (i.e., portable lead care analyzers or other portable devices used to perform blood lead analysis) less than 10 µ g/dL must be reported within 10 business days. Electronic reporting of results is preferred.

*17 - IgM serum antibody or viral culture test orders for measles (rubeola) or rubella should be reported as suspect immediately, but not IgG orders or results.

*18 - Each hospital licensed under Chapter 395, F.S., shall report each case of neonatal abstinence syndrome occurring in an infant admitted to the hospital. If a hospital reports a case of neonatal abstinence syndrome to the Agency for Health Care Administration in its inpatient discharge data report, pursuant to Chapter 59E-7, F.A.C., then it need not comply with the reporting requirements of subsection 64D-3.029(1), F.A.C.

*19 - Exposure to Rabies, as defined in Rule 64D-3.028, F.A.C., that results in rabies prophylaxis for the person exposed, rabies testing, isolation or quarantine of the animal causing the exposure.

*20 - For Streptococcus pneumonia test results associated with persons older than 5 years, only electronic reporting is required, in accordance with subsection 64D-3.031(5), F.A.C.

*21 - Test results must be submitted by laboratories to the Department of Health, Tuberculosis Control Section, 4052 Bald Cypress Way, Bin A20, Tallahassee, Florida 32399-1717, (850)245-4350.

*22 - Practitioners shall also provide dates of varicella vaccination.

*23 - Special reporting requirements for COVID-19:

a. All PCR and antigen test results (positive, negative, and inconclusive results), including screening test results, must be immediately reported, and accompanied by the type of test performed (e.g. PCR and antigen).

b. Point-of-Care Test Reporting Requirements - Practitioners, laboratories, facilities, and all others using point-of-care tests for the diagnosis of COVID-19, including those operating under CLIA waivers, must report both the negative and positive test results to the Department within 24 hours of test administration.

c. In addition to the data element fields required by Rules 64D-3.030 and 64D-3.031, F.A.C., all test results reported must include the CLIA number of the reporting practitioner, laboratory, or facility.

d. All test results must be submitted electronically, using one of the electronic reporting methods listed below. Registration in one of these methods, must be completed within 7 days of obtaining the ability to conduct testing. Until electronic laboratory reporting has been established, positive test results must be submitted by facsimile to the Florida Department of Health's Bureau of Epidemiology confidential fax line, (850)414-6894, or to the patient's local county health department. List of county health department reporting contact information can be found at www.FLhealth.gov/chdepicontact. For enrollment into electronic laboratory reporting or the direct entry web portal, visit www.FloridaHealth.gov/ElectronicReportingRegistration.

1. Electronic laboratory reporting for reporting entities that can generate an electronic comma-separated value (CSV) or Health Level 7 (HL7) formatted message.

2. Web portal for entities that perform COVID-19 testing and are unable to generate an electronic CSV or HL7 formatted message. Such entities may include long-term care facilities, assisted living facilities, nursing homes, rehabilitation centers, schools, colleges, universities, or other congregate care settings.

3. National Healthcare Safety Network (NHSN) COVID-19 module for CMS-certified long-term care facilities. Test data submitted to NHSN will be reported to appropriate state and local health departments using standard electronic laboratory messages.

Rulemaking Authority 381.0011(2), 381.003(2), 381.0031(8), 384.33, 392.53(2), 392.66 FS. Law Implemented 381.0011(3), (4), 381.003(1), 381.0031(2), (4), (5), (6), (8), 383.06, 384.25, 385.202, 392.53 FS. History - New 11-20-06, Amended 11-24-08, 6-4-14, 10-20-16, 8-18-21.