This rule is being amended to update the list of reportable diseases or conditions to add COVID-19 to the list of reportable diseases and conditions and to clarify reporting requirements.

 

DEPARTMENT OF HEALTH

Division of Disease Control

RULE NO.:RULE TITLE:

64D-3.029Diseases or Conditions to be Reported

PURPOSE AND EFFECT: This rule is being amended to update the list of reportable diseases or conditions to add COVID-19 to the list of reportable diseases and conditions and to clarify reporting requirements.

SUMMARY: Diseases or conditions that are required to be reported by physicians, hospitals, and laboratories.

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 on 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), (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: Carina Blackmore, Florida Department of Health, 4052 Bald Cypress Way, Tallahassee, Florida 32399-1703, [phone].

 

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) 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)	Timeframes
	Suspect Immediately	Immediately	Next Business Day	Other		Submit isolates or specimens for confirmation *1	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 weeks	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				Including but not limited to: Flaviviridae, Togaviridae (e.g. chikungunya, Western equine encephalitis), Bunyaviridae (e.g. Heartland, Rift Valley Fever) *5	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) *6				6 months	Pathological or tissue diagnosis of cancer (except non-melanoma skin cancer and including benign and borderline intracranial and CNS tumors)					6 months
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 *7					3 days
Chancroid			X		Haemophilus ducreyi				X
Chlamydia *8			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 *9				6 months	Congenital anomalies	Laboratory tests as specified in Rule 64D-3.035, F.A.C.
Conjunctivitis in neonates < 14 days old			X		Conjunctivitis in neonates < 14 days old	Laboratory Reporting Not Applicable
Coronavirus (COVID-19) *23		X			Coronavirus (COVID-19) *23			X
Creutzfeld-Jakob disease (CJD) *10			X		14-3-3 or tau protein detection in CSF or immunohistochemical test or any brain pathology suggestive of CJD *10				X
Cryptosporidiosis *4b			X		Cryptosporidium species *4b				X
Cyclosporiasis			X		Cyclospora cayetanensis	X			X
Dengue *5	X				Dengue virus *5	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 *8			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 *11	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, 12		X			Hepatitis A*4b, 12			X
Hepatitis B, C, D, E and G *12			X		Hepatitis B, C, D, E and G Virus *12				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 *13			X		HSV 1 or HSV 2 by direct FA, PCR, DNA or Culture *13				X
HSV – anogenital in children < 12 years of age *8, 13			X		HSV 1 or HSV 2 by direct FA, PCR, DNA or Culture *13				X
Human immunodeficiency virus (HIV) infection				2 weeks	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.*14, 15					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 *8			X		HPV DNA				X
Human papillomavirus (HPV) – anogenital papillomas in children < 12 years of age *8			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, 16			X		All blood lead test results (positive and negative) *3, 4, 16				X
Legionellosis			X		Legionella species				X
Leptospirosis			X		Leptospira species				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 *18				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 *19	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 *17	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 *20				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) *21			X		Mycobacterium tuberculosis complex *21	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 Paratyphi A, Paratyphi B, and Paratyphi C *4b	X		X
Typhus fever (epidemic)	X	X			Rickettsia prowazekii	X	X	X
Vaccinia disease	X	X			Vaccinia virus	X	X	X
Varicella (Chickenpox) *22			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 through *22 No change.

*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, 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, [phone], 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,             .

NAME OF PERSON ORIGINATING PROPOSED RULE: Carina Blackmore

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Scott A. Rivkees, MD, Surgeon General and Secretary

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: June 22, 2021

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: June 1, 2020