The purpose and effect is to update the list of reportable diseases and conditions, to adjust the timeframe for reporting cases of reportable diseases or conditions, as well as cases of the Zika virus as provided in Emergency Rule 64DER16-1, and to ...

DEPARTMENT OF HEALTH

Division of Disease Control

RULE NOS.:RULE TITLES:

64D-3.029Diseases or Conditions to be Reported

64D-3.033Notification by Others

PURPOSE AND EFFECT:  The purpose and effect is to update the list of reportable diseases and conditions, to adjust the timeframe for reporting cases of reportable diseases or conditions, as well as cases of the Zika virus as provided in Emergency Rule 64DER16-1, and to reduce and clarify rule language.

SUMMARY: These rule amendments update the list of and requirements for reporting cases of reportable diseases or conditions.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION: The agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: Based on the SERC checklist, this rulemaking will not have an adverse impact or regulatory costs in excess of $1 million within five years as established in s.120.541(2)(a), F.S.

Any person who wishes to provide information regarding the statement of estimated regulatory costs, or to provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

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),(3), (4), (5), (6), (8), 383.06, 384.25, 385.202, 392.53 FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR:

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Janet Hamilton, Bureau of Epidemiology, Florida Department of Health, Bin A12, 4052 Bald Cypress Way, Tallahassee, FL 32399-1720; [phone]; [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

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 2014, incorporated by reference, available online at: https://www.flrules.org/Gateway/reference.asp?No=Ref-_______04150.

(b) through (e) No change.

(3) “Table of Reportable Diseases or Conditions to Be Reported”.

Practitioner Reporting					Laboratory Reporting
Reportable Diseases or Conditions	Timeframes				Evidence of current or recent infection with etiological agents and all associated testing results performed should be reported (e.g. species, serogroup, serotype, and antimicrobial susceptibility *2 results)	Submit isolates or specimens for confirmation *1	Timeframes
	Suspect Immediately	Immediately	Next Business Day	Other			Suspect Immediately	Immediately	Next Business Day	Other
Any case, cluster of cases, outbreak, or exposure to an infectious or non-infectious disease, condition, or agent found in the general community or any defined setting such as a hospital, school or other institution, not listed in this rule that is of urgent public health significance. This includes human cases, clusters, or outbreaks spread person-to-person, by animals or vectors or from an environmental, food or waterborne source of exposure; those that result from a deliberate act of terrorism; and unexplained deaths possibly due to unidentified infectious or chemical causes.	X	X			Detection in one or more specimens of etiological agents of a disease or condition not listed in this Rule that is of urgent public health significance. This includes the identification of etiological agents that are suspected to be the cause of clusters, or outbreaks spread person-to-person, by animals or vectors or from an environmental, food, or waterborne source of exposure; those that result from a deliberate act of terrorism; and unexplained deaths due to unidentified infectious or chemical causes.		X	X
Acquired Immune Deficiency Syndrome (AIDS)				2 wWeeks	Acquired Immune Deficiency Syndrome (AIDS)	Laboratory Reporting Not Applicable
Amebic Encephalitis		X			Naegleria fowleri, Balamuthia mandrillaris, or Acanthamoeba species			X
Anthrax	X	X			Bacillus anthracis	X	X	X
Antimicrobial resistance surveillance	Practitioner Reporting Not Applicable				Antimicrobial resistance surveillance (for organisms not otherwise listed in this table), Acinetobacter baumannii, Citrobacter species, Enterococcus species, Enterobacter species, Escherichia coli species, Klebsiella species, Pseudomonas aeruginosa, Serratia species, isolated from a normally sterile site *3				X
Arsenic Poisoning *4a			X		Laboratory results as specified in the surveillance case definition *4a				X
Arboviral infections, not otherwise listed in this table (disease due to) *5	X		X		Including but not limited to: Flaviviridae, Togaviridae (e.g. chikungunya, Western equine encephalitis), Bunyaviridae (e.g. Heartland, Rift Valley Fever) *5	X	X		X
Babesiosis			X		Babesia spp.	X			X
Botulism, foodborne, other (includes wound and unspecified)	X	X			Clostridium botulinum or botulinum toxin	X	X	X
Botulism, infant			X		Clostridium botulinum or botulinum toxin	X			X
Brucellosis	X	X			Brucella species	X	X	X
California serogroup viruses (disease due to)			X		California serogroup viruses such as Jamestown Canyon, Keystone, and Lacrosse	X			X
Campylobacteriosis *4b			X		Campylobacter species *4b				X
Cancer (except non-melanoma skin cancer, and including benign and borderline intracranial and CNS tumors) *65				6 mMonths	Pathological or tissue diagnosis of cancer (except non-melanoma skin cancer and including benign and borderline intracranial and CNS tumors)					6 mMonths
Carbon monoxide poisoning			X		A volume fraction ≥ 0.09 (9%) of carboxyhemoglobin in blood				X
CD-4 absolute count and percentage of total lymphocytes	Practitioner Reporting Not Applicable				CD-4 absolute count and percentage of total lymphocytes *76					3 days
Chancroid			X		Haemophilus ducreyi				X
Chlamydia *87			X		Chlamydia trachomatis				X
Cholera	X	X			Vibrio cholerae	X	X	X
Ciguatera fish poisoning			X		Ciguatera fish poisoning	Laboratory Reporting Not Applicable
Congenital anomalies *98				6 mMonths	Congenital anomalies	Laboratory tests as specified in Rule 64D-3.035
Conjunctivitis in neonates < 14 days old			X		Conjunctivitis in neonates < 14 days old	Laboratory Reporting Not Applicable
Creutzfeld-Jakob disease (CJD) *109			X		14-3-3 or tau protein detection in CSF or immunohistochemical test or any brain pathology suggestive of CJD *109				X
Cryptosporidiosis *4b			X		Cryptosporidium species *4b				X
Cyclosporiasis			X		Cyclospora cayetanensis	X			X
Dengue *5	X		X		Dengue virus *5	X	X		X
Diphtheria	X	X			Corynebacterium diphtheriae	X	X	X
Eastern equine encephalitis			X		Eastern equine encephalitis virus	X			X
Ehrlichiosis/Anaplasmosis			X		Anaplasma species or Ehrlichia species	X			X
Escherichia coli Shiga toxin-producing (disease due to) *4b			X		Escherichia coli Shiga toxin-producing *4b	X			X
Giardiasis (acute) *4b			X		Giardia species *4b				X
Glanders	X	X			Burkholderia mallei	X	X	X
Gonorrhea *87			X		Neisseria gonorrhoeae				X
Granuloma inguinale			X		Calymmatobacterium granulomatis				X
Haemophilus influenzae, meningitis and invasive disease, in children < 5 years old	X	X			Haemophilus influenzae, all ages, isolated from a normally sterile site *1110	X	X	X
Hansen disease (Leprosy)			X		Mycobacterium leprae				X
Hantavirus infection		X			Hantavirus	X		X
Hemolytic uremic syndrome		X			Not Applicable
Hepatitis A*4b, 1211		X			Hepatitis A*4b, 1211			X
Hepatitis B, C, D, E and G *1211			X		Hepatitis B, C, D, E and G Virus*1211				X
Hepatitis B surface antigen (HBsAg)-positive in a pregnant woman or a child up to 24 months old			X		Hepatitis B surface antigen (HBsAg)				X
Herpes B virus, possible exposure		X			Herpes B virus, possible exposure	Laboratory Reporting Not Applicable
Herpes simplex virus (HSV) in infants up to 60 days old with disseminated infection with involvement of liver, encephalitis and infections limited to skin, eyes and mouth *1312			X		HSV 1 or HSV 2 by direct FA, PCR, DNA or Culture *1312				X
HSV – anogenital in children < 12 years of age *87, 1312			X		HSV 1 or HSV 2 by direct FA, PCR, DNA or Culture *1312				X
Human immunodeficiency virus (HIV) infection				2 wWeeks	Repeatedly reactive enzyme immunoassay, followed by a positive confirmatory tests, (e.g. Western Blot, IFA): Positive result on any HIV virologic test (e.g. p24 AG, Nucleic Acid Test (NAT/NAAT) or viral culture). All viral load (detectable and undetectable) test results.*1413, 1514					3 days
Human immunodeficiency virus (HIV) Exposed Newborn – infant < 18 months of age born to a HIV infected woman			X		All HIV test results (e.g., positive or negative immunoassay, positive or negative virologic tests) for those < 18 months of age					3 days
Human papillomavirus (HPV) associated laryngeal papillomas or recurrent respiratory papillomatosis in children < 6 years of age *87			X		HPV DNA				X
Human papillomavirus (HPV) – anogenital papillomas in children < 12 years of age *87			X		HPV DNA				X
Human papillomavirus (HPV)	Practitioner Reporting Not Applicable				HPV DNA *3				X
Influenza due to novel or pandemic strains	X	X			Isolation of influenza virus from humans of a novel or pandemic strain	X	X	X
Influenza-associated pediatric mortality in persons aged < 18 years		X			Influenza virus – associated pediatric mortality in persons aged < 18 years (if known)	X		X
Influenza	Practitioner Reporting Not Applicable				Influenza virus, all test results (positive and negative) *3				X
Lead poisoning *4, 1615			X		All blood lead test results (positive and negative) *3, 4, 1615				X
Legionellosis			X		Legionella species				X
Leptospirosis			X		Leptospira species interrogans				X
Listeriosis		X			Listeria monocytogenes	X		X
Lyme disease			X		Borrelia burgdorferi				X
Lymphogranuloma Venereum (LGV)			X		Chlamydia trachomatis				X
Malaria			X		Plasmodium species	X			X
Measles (Rubeola)	X	X			Measles virus *16	X	X	X
Melioidosis	X	X			Burkholderia pseudomallei	X	X	X
Meningitis, bacterial or mycotic			X		Isolation or demonstration of any bacterial or fungal species in cerebrospinal fluid				X
Meningococcal disease	X	X			Neisseria meningitidis	X		X
Mercury poisoning *4a			X		Laboratory results as specified in the surveillance case definition *4a				X
Mumps			X		Mumps virus				X
Neonatal Abstinence Syndrome *1817				6 months	Neonatal Abstinence Syndrome	Laboratory Reporting Not Applicable
Neurotoxic shellfish poisoning		X			Laboratory results as specified in the surveillance case definition *4a			X
Pertussis		X			Bordetella pertussis			X
Pesticide-related illness and injury *4			X		Laboratory results as specified in the surveillance case definition *4				X
Plague	X	X			Yersinia pestis	X	X	X
Poliomyelitis	X	X			Poliovirus	X	X	X
Psittacosis (Ornithosis)			X		Chlamydophila psittaci	X			X
Q Fever			X		Coxiella burnetii	X			X
Rabies, animal or human		X			Rabies virus		X	X
Rabies, possible exposure *1918	X	X			Rabies, possible exposure	Laboratory Reporting Not Applicable
Respiratory syncytial virus	Practitioner Reporting Not Applicable				Respiratory syncytial virus, all test results (positive and negative) *3				X
Ricin toxicity	X	X			Ricinine (from Ricinus communis castor beans)	X	X	X
Rocky Mountain spotted fever and other Spotted Fever Rickettsioses			X		Rickettsia rickettsii and other Spotted Fever Rickettsia species	X			X
Rubella, including congenital	X	X			Rubella virus *1716	X	X	X
St. Louis encephalitis (SLE)			X		St. Louis encephalitis virus	X			X
Salmonellosis *4b			X		Salmonella species *4b	X			X
Saxitoxin poisoning including Paralytic shellfish poisoning (PSP)			X		Saxitoxin				X
Severe acute respiratory disease syndrome-associated with a Coronavirus infection	X	X			Coronavirus associated with severe acute respiratory disease	X	X	X
Shigellosis *4b			X		Shigella species *4b				X
Smallpox	X	X			Variola virus (orthopox virus)	X	X	X
Staphylococcus aureus isolated from a normally sterile site	Practitioner Reporting Not Applicable				Staphylococcus aureus isolated from a normally sterile site *3				X
Staphylococcus aureus with intermediate or full resistance to vancomycin (VISA,VRSA)		X			Staphylococcus aureus with intermediate or full resistance to vancomycin (VISA, VRSA); Laboratory results as specified in the surveillance case definition *4	X		X
Staphylococcus enterotoxin B		X			Staphylococcus enterotoxin B	X		X
Streptococcus pneumoniae, invasive disease in children < 6 years, drug sensitive and resistant			X		Streptococcus pneumoniae, all ages, isolated from a normally sterile site *2019				X
Syphilis			X		Treponema pallidum				X
Syphilis in pregnant women and neonates		X			Treponema pallidum			X
Tetanus			X		Clostridium tetani				X
Trichinellosis (Trichinosis)			X		Trichinella spiralis				X
Tuberculosis (TB) *2120			X		Mycobacterium tuberculosis complex *2120	X			X
Tularemia	X	X			Francisella tularensis	X	X	X
Typhoid fever and paratyphoid fever *4b		X			Salmonella enterica serotype Typhi and Salmonella enterica serotypes Paratyhpi A, Paratyphi B, and Paratyphi C species*4b	X		X
Typhus fever (epidemic)	X	X			Rickettsia prowazekii	X	X	X
Vaccinia disease	X	X			Vaccinia virus	X	X	X
Varicella (Chickenpox) *2221			X		Varicella virus				X
Varicella mortality			X		Varicella virus				X
Venezuelan equine encephalitis	X	X			Venezuelan equine encephalitis virus	X	X	X
Vibriosis (infections by Vibrio species and closely related organisms, other than Cholera)			X		All non-cholera Vibrio species Photobacterium damselae, (formerly V. damsela); Grimontia hollisae (formerly V. hollisae)	X			X
Viral hemorrhagic fevers	X	X			Ebola, Marburg, Lassa, Machupo Lujo, new world Arena, or Congo-Crimean hemorrhagic fever viruses	X	X	X
West Nile virus (disease due to)			X		West Nile virus	X			X
Yellow fever	X	X			Yellow fever virus	X		X
Zika fever *5	X				Zika fever virus *5	X	X

 

*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 through *3 no change.

*4 a. Surveillance Case Definitions for Select Reportable Diseases in Florida, 20162014.

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.

*5 through 12 renumbered *6 through *13 No change.

*1413 Special requirements for STARHS (Serologic Testing Algorithm for Recent HIV Seroconversion):

a. Laboratories Each laboratory that report reports confirmed positive HIV tests test in persons ≥13 years of age and older old must also report STARHS results result.

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 testing. 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 Resistance Coordinator, HIV/AIDS and Hepatitis Section, Florida Department of Health, at [phone] 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.

*1514 If Laboratories shall submit a genotype for each confirmed positive HIV specimen on a is performed, the fasta file files containing the nucleotide sequence data, including the protease and reverse transcriptase regions must be reported.

*1615 – 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 deveices used to perform blood lead analysis) less than 10 µg/dL must be reported within 10 business days.  Electronic reporting of results is preferred.

* 16 through *21 renumbered *17 through *22 No change.

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,____.

 

64D-3.033 Notification by Others.

(1) through (3) No change.

(4)  Reports shall include as much of the following as is available to the reporter:

(a) The animal’s: name; species; breed, sex; color; age; rabies vaccination status; date of onset of signs; signs; and ownership status (owned/feral/wild); location of the animal sighting(s) even if no person was exposed.

1. Name;

2.  Species;

3. Breed;

4. Sex;

5. Color;

6. Age;

7. Rabies vaccination status;

8. Date of onset of signs;

9. Signs;

10. Ownership status (Owned/feral/wild).

(b) If the animal is owned, the animal owner’s: first, middle and last name; address, including street, street number, city, state and zip code; and telephone numbers (work, home and/or cell), including area code.

1. First and last name, including middle initial;

2. Address, including street, city, state and zip code;

3. Telephone number, including area code.

(c) Where relevant, the exposed person’s: first, middle and last name; address including street, street number, city state and zip code; telephone numbers (work, home and/or cell), including area code; age; sex; date of exposure; the geographic location where the exposure occurred or location of the animal sighting(s); date of onset of symptoms; name, address and telephone numbers, including the area code of the reporter; and any other epidemiological information requested by the Department.

1. First and last name, including middle initial;

2. Address, including street, city, state and zip code;

3. Telephone number, including area code;

4. Age;

5. Sex;

6. Date of exposure;

7. The geographic location where the exposure occurred or location of the animal sighting if no person was exposed;

8. Date of onset of symptoms;

9. Name, address and telephone number, including the area code of the reporter; and

10. Any other epidemiological information requested by the Department.

(d) Reports from an Animal Disease Laboratory shall include: the submitting veterinarian’s first, middle and last name; address, including street, street number, city, state and zip code; telephone numbers (work, home and/or cell), including area code; type of diagnostic tests (for example culture, IgM, serology, Western Blot or culture); type(s) of specimen (for example feces, urine, blood, mucus, etc.); date(s) of specimen collection; site (for example cloaca, eye, etc., if applicable); diagnostic test results, including titer when quantitative procedures are performed, and including all available results on grouping or typing of organisms.

1. The submitting veterinarian’s;

a. First and last name, including middle initial;

b. Address, including street, city, state and zip code;

c. Telephone number, including area code.

2. Type of diagnostic tests (for example culture, IgM, serology, Western Blot or culture);

3. Type of specimen (for example feces, urine, blood, mucus, etc.);

4. Date of specimen collection;

5. Site (for example cloaca, eye, etc., if applicable);

6. Diagnostic test results, including titer when quantitative procedures are performed, and including all available results on grouping or typing of organisms.

Rulemaking Authority 381.0011(2), 381.0031(8) FS. Law Implemented 381.0031(3), (4), (8) FS. History–New 11-20-06, Amended________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Janet Hamilton

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Celeste Philip, MD, MPH, Surgeon General and Secretary

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: July 18, 2016

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: May 2, 2016