The purpose of the rule amendments was to clarify current rule language and amend the list of reportable diseases or conditions. These changes will enhance communicable disease reporting efficiency and clarify reporting and testing requirements for ...

 

DEPARTMENT OF HEALTH
Division of Disease Control

RULE NO: RULE TITLE
64D-3.028: Definitions
64D-3.029: Diseases or Conditions to be Reported
64D-3.030: Notification by Practitioners
64D-3.031: Notification by Laboratories
64D-3.040: Procedures for Control of Specific Communicable Diseases
64D-3.041: Epidemiological Investigations
64D-3.046: Immunization Requirements: Public and Nonpublic Schools, Grades Preschool, and Kindergarten Through 12, and Adult Education Classes
PURPOSE AND EFFECT: The purpose of the rule amendments was to clarify current rule language and amend the list of reportable diseases or conditions. These changes will enhance communicable disease reporting efficiency and clarify reporting and testing requirements for health care providers, laboratories, hospitals and other entities required to report communicable diseases or conditions that may affect public health.
SUMMARY: The proposed rule amendments:
Add to the list of notifiable diseases or conditions “Amebic Encephalitis”, “Arsenic”, “Carbon monoxide poisoning”, “Staphylococcus aureus-community associated mortality”, and “Staphylococcus aureus isolated from a normally sterile site”.
Delete from the list of notifiable diseases or conditions Clostridium perfringens, epsilon toxin (disease due to).
Modify within the list of notifiable diseases or conditions “Any disease outbreak in a community, hospital or other institution or a foodborne or waterborne outbreak”, “Any grouping or clustering of patients having similar disease, symptoms or syndromes that may indicate the presence of a disease outbreak including those of biological agents associated with terrorism”, “Erlichiosis”, “Herpes simplex virus (HSV) in infants up to six (6) months of age with disseminated infection with involvement of liver, encephalitis and infections limited to skin, eyes and mouth”, “Human immunodeficiency virus (HIV) Exposed Newborn- infant < 18 months of age born to a HIV infected woman”, “Human papilloma virus (HPV) associated laryngeal papillomas or recurrent respiratory papillomatosis in children <6 years of age”, “HPV cancer associated strains”, “Lead poisoning”, and “Poliomyelitis”.
Update several other sections, which include Definitions, Notification by Practitioners, Notification by Laboratories, Procedures for Control of Specific Communicable Diseases, Epidemiological Investigations, and Immunization Requirements: Public and Nonpublic Schools, Grades Preschool, Kindergarten Through 12, and Adult Education Classes.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared.
Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.
SPECIFIC AUTHORITY: 381.0011(6), 381.0011(7), 381.0011(13), 381.003(1), 381.003(2), 381.0031(5), 381.0031(6), 381.005(2), 381.006(16), 383.06, 384.25(1), 384.25(2), 384.33, 392.53(1), 392.53(2), 392.66, 1003.22 FS.
LAW IMPLEMENTED: 381.0011, 381.003, 381.0031, 381.005(1)(i), 383.06, 384.23, 384.25, 384.26, 384.27, 385.202, 392.52, 392.53, 392.54, 1003.22 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE HELD AT THE DATE,TIME AND PLACE SHOWN BELOW(IF NOT REQUESTED, THIS HEARING WILL NOT BE HELD):
DATE AND TIME: July 21, 2008, 9:00 a.m. – 11:00 a.m.
PLACE: Florida Department of Health, Building 4052, Room 301, 4052 Bald Cypress Way, Tallahassee, Florida 32399
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Kimberly Quinn, Florida Department of Health, Bureau of STD Prevention and Control, 4052 Bald Cypress Way, Bin A19, Tallahassee, FL 32399, [phone], [e-mail]

THE FULL TEXT OF THE PROPOSED RULE IS:

64D-3.028 Definitions.

When used in Chapter 64D-3, F.A.C., the following terms shall mean:

(1) “15 Digit Spoligotype (Octal Code)” – Spoligotyping (spacer oligonucleotide typing) is an amplification-based genotyping method that determines the presence or absence of 43 spacer sequences in the direct repeat region in the M. tuberculosis chromosome. The complement of spacers is initially recorded in binary code and then converted to the reportable 15 digit octal code commonly referred to as the ‘spoligotype’.

(2) “Authorized Representative” – An employee of the Department or personnel assigned to the Department by another state or federal agency supervised and approved by the Department.

(3) “BED” – The BED HIV-1 Capture EIA is the assay currently used in STARHS for performing HIV incidence surveillance. The FDA has labeled the assay for surveillance use not for diagnostic or clinical use.

(4) “Carrier” –

(a) A person who harbors pathogenic organisms of a communicable disease but who does not show clinical evidence of the disease; or

(b) A person to whom evidence points as the source of one (1) or more cases of any communicable disease but who refuses to submit clinical specimens to the Department or county health department for examination; or

(c) A person who, in the judgment of the State Health Officer or county health department director or administrator or their designee, is suspected to be a carrier and who refuses to submit to examination when ordered to do so for good cause shown by the State Health Officer or county health department director or administrator or their designee; or

(d) A person reported to the Department or the county health department to be a carrier by the health authorities of any municipality, county, or state in the United States, of any foreign nation or of any international organization of which the United States is a member; or

(e) An animal which, in the judgment of the State Health Officer or county health department director or administrator or their designee, is suspected to harbor pathogenic organisms of a communicable disease without presentation of clinical evidence of disease.

(5) “Case” – An instance of a suspected or diagnosed disease or condition in a person or animal.

(6) “Communicable Disease” – An illness due to a specific infectious agent or its toxic products which arises through transmission of that agent or its products from a reservoir to a susceptible host either directly as from an infected person or animal or indirectly, through an intermediate plant or animal host, vector or the inanimate environment.

(7) “Contact” – A person or animal that has been in such association with an infected person or animal or a contaminated environment as to have had opportunity to acquire the infection. This will include household members or persons who frequent the dwelling of the case or carrier. For sexually transmitted diseases contact means a sex/needle sharing partner.

(8) “County Health Department” – A public health department created under Part 1, Chapter 154, F.S.

(9) “Department” – The State of Florida, Department of Health.

(10) “Electronic Data Transfer” – The sending and receiving of messages via standard electronic formats and established file transfer protocols, which contain data elements that would normally be contained on a typical business document or form.

(11) “Enteric Disease” – An infection or condition transmitted by ingestion of such agents as Campylobacter jejuni, Cyclospora cayetanensis, Cryptosporidium parvum, Escherichia coli O157:H7 and other pathogenic E. coli, hepatitis A, Giardia lamblia, Salmonella species, Shigella species and Vibrio cholerae.

(12) “Epidemic or Outbreak” – The occurrence in persons in a community, institution, region or other defined area of one or more cases of an illness of similar nature clearly in excess of normal expectancy.

(12)(13) “Epidemiological Investigations” – An inquiry into the incidence, distribution and source of diseases or conditions to determine its cause, means of prevention or control, and efficacy of control measures.

(13)(14) “Epizootic” – The occurrence in animals in a community, institution, region or other defined area of a group of cases of an illness of similar nature in excess of normal expectancy.

(14)(15) “Exposure to Rabies” – Any bite, scratch or other situation in which saliva or nervous tissue of a potentially rabid animal enters an open or fresh wound, or comes in contact with mucous membranes by entering the eye, mouth or nose of another animal or person.

(15) “Fasta Files” – Standard text-based format for representing nucleic acid sequences that are generated when performing a genotype.

(16) “Health Authorities” – The State Health Officer or any local county health department director or administrator or their designee; any chief health official of any municipality, county, or state in the United States, of any foreign nation or of any international organization of which the United States is a member.

(17) Health Level 7(HL7) – An industry standard for electronic data exchange between healthcare entities.

(18) “Human Immunodeficiency Virus (HIV) Exposed Newborn” – An infant 18 months of age or younger born to a HIV infected woman.

(19) “Outbreak” – An increase in the number of cases of a disease or condition compared to the expected number in a particular period of time and geographical area. For diseases where the expected number is zero, a single case constitutes an outbreak.

(20)(19) “Practical Method of Quarantine” – A location where a person infected with or exposed to an infectious agent that threatens public health will have food, clothing and shelter as necessary while separated and restricted from contact with people who have not been infected with that disease or immunized against that infection.

(21)(20) “Probable” – A case that meets the clinical criteria for a communicable disease and the epidemiologic criteria for likely exposure to the infectious agent but is unable to be confirmed.

(22)(21) “Sensitive Situation” – A setting in which the presence of a case would increase significantly the probability of spread of the diagnosed or suspected disease or condition and would, therefore, constitute a public health hazard. Examples of such settings are: schools, child-care facilities, hospitals and other patient-care facilities, food storage, food processing establishments or food outlets.

(23)(22) “Sexually Transmissible Disease” – Acquired Immune Deficiency Syndrome (AIDS), Chancroid, Chlamydia trachomatis, Gonorrhea, Granuloma Inguinale, Hepatitis A through D, Herpes simplex virus (HSV), Human immunodeficiency virus Infection (HIV), Human papillomavirus (HPV), Lymphogranuloma Venereum (LGV), and Syphilis.

(24)(23) “Source of Infection” – The person, animal, object or substance from which an infectious agent passes directly or indirectly to the host.

(25)(24) “STARHS” – Serologic Testing Algorithm for Recent HIV Seroconversion – A surveillance test performed on confirmed HIV positive specimens using the BED assay, approved by the Food and Drug Administration for surveillance purposes.

(26)(25) “Suspect” or “Suspect Case” – A person or animal whose medical history and symptoms suggest the imminent development of a notifiable or other communicable disease or condition, or a person or animal with disease not yet diagnosed.

(27)(26) “Terminal Disinfection” – Cleaning procedures designed to eradicate infectious agents or unsafe conditions from the physical environment.

(28) “Urgent Public Health Significance” – A characteristic of a disease or condition that requires rapid public health response due to the:

(a) Potential to cause significant morbidity or mortality;

(b) Potential for infectiousness between humans or spread to humans; and

(c) The number of cases.

Specific Authority 381.0011(13), 381.003(2), 381.0031(6), 384.33, 392.66 FS. Law Implemented 381.0011(4), 381.003(1), 381.0031, 384.23, 392.52 FS. History–New 11-20-06, Amended 7-15-07,__________.

 

Editorial Note: History–Formerly 10D-3.61, 10D-3.061, 64D-3.001, 64D-3.014, 64D-3.015 and 64D-3.021.

 

64D-3.029 Diseases or Conditions to be Reported.

(1) Diseases or conditions listed in subsection (3) below are of public health significance identified by the Department as of the date of these rules which must be reported by the practitioner, hospital, laboratory, or other individuals via telephone (with subsequent written report within 72 hours, see Rule 64D-3.030 – 3.033, F.A.C.), facsimile, electronic data transfer, or other confidential means of communication to the County Health Department having jurisdiction for the area in which the office of the reporting practitioner, hospital, laboratory or patient’s residence is located consistent with the specific section and time frames in subsection (3) below relevant to the practitioners, hospitals and laboratories, respectively. Reporters are not prohibited from reporting diseases and/or conditions not listed by rule.

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

(a) “Notifiable Diseases or Conditions” – The definitions of “case” and “suspected case” for reportable diseases or conditions are set forth in “Surveillance Case Definitions for Select Reportable Diseases in Florida,” incorporated by reference, available online at: www.doh.state.fl.us/disease_ctrl/epi/topics/surv.htm. For any disease or condition for which Florida surveillance case definitions do not exist, the CDC case definitions set forth in Nationally Notifiable Infectious Diseases, Definition of Terms Used in Case Classification, incorporated by reference, available online at: www.cdc.gov/epo/dphsi/casedef/ definition_of_terms.htm should be used. Also see the footnotes to subsection (3).

(b) “Suspect Immediately” – A notifiable condition or 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 Florida Department of Health after hours duty official at [phone].

(c) “Immediately” – A notifiable 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 Florida Department of Health after hours duty official at [phone].

(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 Notifiable Diseases or Conditions to be Reported”

 

Practitioner Reporting					Laboratory Reporting
Notifiable Diseases or Conditions	Timeframes				Evidence of current or recent infection with etiological agents	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, or outbreak of a disease or condition 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 those indicative of person to person spread, zoonotic spread, the presence of an environmental, food or waterborne source of exposure and those that result from a deliberate act of terrorism. Any disease outbreak in a community, hospital or other institution or a foodborne or waterborne outbreak	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. Any grouping or clustering of patients having similar etiological agents that may indicate the presence of a disease outbreak.		X		X
Any grouping or clustering of patients having similar disease, symptoms or syndromes that may indicate the presence of a disease outbreak including those of biological agents associated with terrorism	X	X			Any grouping or clustering of patients having similar etiological agents that may indicate the presence of a disease outbreak including those of biological agents associated with terrorism.		X		X
Acquired Immune Deficiency Syndrome (AIDS)				2 Weeks	Not Applicable
Amebic Encephalitis		X			Naegleria fowleri, Balamuthia mandrillaris, or Acanthamoeba spp.				X
Anthrax	X	X			Bacillus anthracis	X		X	X
Arsenic*2			X		Laboratory results as specified in the surveillance case definition for arsenic poisoning *2					X
Botulism, foodborne	X	X			Clostridium botulinum or botulinum toxin	X		X	X
Botulism, infant			X		Clostridium botulinum or botulinum toxin	X				X
Botulism, other (includes wound and unspecified)	X	X			Clostridium botulinum or botulinum toxin	X		X	X
Brucellosis	X	X			Brucella abortus, B. melitensis, B. suis, B. canis	X		X	X
California serogroup virus neuroinvasive and non-neuroinvasive disease			X		California encephalitis virus, Jamestown Canyon, Keystone, Lacrosse, snowshoe hare, trivittatus viruses	X				X
Campylobacteriosis			X		Campylobacter species					X
Cancer (except non-melanoma skin cancer, and including benign and borderline intracranial and CNS tumors)*2*3				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	Not Applicable				CD-4 absolute count and percentage of total lymphocytes*4*3						3 days
Chancroid			X		Haemophilus ducreyi					X
Chlamydia			X		Chlamydia trachomatis					X
Chlamydia in pregnant women and neonates			X		Chlamydia trachomatis					X
Chlamydia in children < 12 years of age*5*4			X		Chlamydia trachomatis					X
Cholera	X	X			Vibrio cholerae	X		X	X
Ciguatera fish poisoning (Ciguatera)			X		Not Applicable
Clostridium perfringens, epsilon toxin (disease due to)			X		Clostridium perfringens, epsilon toxin					X
Congenital anomalies*6*5				6 Months	Not Applicable
Conjunctivitis in neonates < 14 days old			X		Not Applicable
Creutzfeld-Jakob disease (CJD) *7*6			X		14-3-3 protein from CSF or any brain pathology suggestive of CJD*7*6					X
Cryptosporidiosis			X		Cryptosporidium parvum					X
Cyclosporiasis			X		Cyclospora cayetanensis	X				X
Dengue			X		Dengue virus	X				X
Diphtheria	X	X			Corynebacterium diphtheriae	X		X	X
Eastern equine encephalitis virus neuroinvasive and non-neuroinvasive disease			X		Eastern equine encephalitis virus	X				X
Ehrlichiosis/Anaplasmosis Ehrlichiosis, human granulocytic (HGE)			X		Anaplasma phagocytophilum, Ehrlichia chaffeensis, or E. ewingii Ehrlichia phagocytophilia.	X				X
Ehrlichiosis, human monocytic (HME)			X		Ehrlichia chaffeensis					X
Ehrlichiosis/Anaplasmosis – undetermined or unspecified Ehrlichiosis, human other or unspecified agent			X		Ehrlichia or Anaplasma species, other	X				X
Encephalitis, other (non-arboviral)			X		Isolation from or demonstration in brain or central nervous system tissue or cerebrospinal fluid, of any pathogenic virus					X
Enteric disease due to Escherichia coli O157:H7		X			Escherichia coli O157:H7	X			X
Enteric disease due to other pathogenic Escherichia coli*8*7		X			Escherichia coli*8*7				X
Giardiasis (acute)			X		Giardia species					X
Glanders	X	X			Burkholderia mallei,	X		X	X
Gonorrhea			X		Neisseria gonorrhoeae					X
Gonorrhea in children < 12 years of age*5*4			X		Neisseria gonorrhoeae					X
Gonorrhea in pregnant women and neonates			X		Neisseria gonorrhoeae					X
Gonorrhea (Antibotic Resistant)			X		Neisseria gonorrhoeae*9*8					X
Granuloma Inguinale			X		Calymmatobacterium granulomatis					X
Haemophilus influenzae, meningitis and invasive disease	X	X			Haemophilus influenzae	X		X	X
Hansen disease (Leprosy)			X		Mycobacterium leprae					X
Hantavirus infection		X			Hantavirus	X			X
Hemolytic uremic syndrome		X			Not Applicable
Hepatitis A*10*9		X			Hepatitis A*10*9				X
Hepatitis B, C, D, E and G Virus*10*9			X		Hepatitis B, C, D, E and G Virus*10*9					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 simplex virus (HSV) in infants up to 60 days old six (6) months of age with disseminated infection with involvement of liver, encephalitis and infections limited to skin, eyes and mouth*11*10			X		HSV 1 or HSV 2 by direct FA, PCR, DNA or Culture*11*10					X
HSV – anogenital in children < 12 years of age*5*11*4*10			X		HSV 1 or HSV 2 by direct FA, PCR, DNA or Culture*11*10*					X
Human immunodeficiency virus (HIV)				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. *12*13*11						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 papilloma virus (HPV) associated laryngeal papillomas or recurrent respiratory papillomatosis in children <6 years of age*5*4			X		HPV DNA					X
HPV – anogenital in children <12 years of age*5*4			X		HPV DNA					X
HPV cancer associated strains*12 Human papillomavirus ONLY physicians licensed as pathologists need report as directed under Laboratory Reporting*14			X		DNA typing of HPV strains 16, 18, 31, 33, 35, 36, 45 Abnormal histologies consistent with Bethesda 2001 Terminology*13 1) Positive test for any high risk human papillomavirus (HPV) type (e.g., 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 59, 68, etc)*15 2) Abnormal cervical and anogenital cytologies consistent with “Bethesda 2001 Terminology”*15 3) Abnormal histologies including*15: a. cervical vaginal intraepithelial neoplasia (CIN 1, 2, or 3) b. vulvar intraepithelial neoplasia (VIN 1, 2, or 3) c. vaginal intraepithelial neoplasia (VAIN 1, 2, or 3) d. anal intraepithelial neoplasia (AIN 1, 2, or 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
Lead poisoning*16*14			X		All blood lead test results16* tests with detectable blood lead values *14					X
Legionellosis			X		Legionella species					X
Leptospirosis			X		Leptospira interrogans					X
Listeriosis		X			Listeria monocytogenes				X
Lyme disease			X		Borrelia burgdorferi					X
Lymphogranuloma Venereum (LGV)			X		Chlamydia trachomatis					X
Malaria			X		Plasmodium falciparum, P. vivax, P. ovale, P. malariae	X				X
Measles (Rubeola)	X	X			Measles virus*17*15	X		X	X
Melioidosis	X	X			Burkholderia pseudomallei	X		X	X
Meningitis, bacterial, cryptococcal and mycotic (other than meningococcal or H. influenzae or pneumococcal)			X		Isolation or demonstration of any bacterial or fungal species in cerebrospinal fluid					X
Meningococcal Disease, includes meningitis and meningococcemia	X	X			Neisseria meningitidis (serogroup needed)	X		X	X
Mercury poisoning			X		Laboratory results as specified in the surveillance case definition for mercury poisoning					X
Mumps			X		Mumps virus					X
Neurotoxic shellfish poisoning		X			Laboratory results as specified in the surveillance case definition for Neurotoxic shellfish poisoning				X
Pertussis		X			Bordetella pertussis				X
Pesticide-related illness and injury			X		Laboratory results as specified in the surveillance case definition for pesticide related illness and injury					X
Plague	X	X			Yersinia pestis	X	X		X
Poliomyelitis, paralytic and non-paralytic	X	X			Poliovirus	X	X		X
Psittacosis (Ornithosis)			X		Chlamydophila psittaci (formerly known as Chlamydia psittaci)	X				X
Q Fever			X		Coxiella burnetii	X				X
Rabies, animal		X			Rabiesvirus		X		X
Rabies, human		X			Rabiesvirus		X		X
Rabies, possible exposure*18*16	X	X			Not Applicable
Ricin toxicity	X	X			Ricin toxin (from Ricinus communis castor beans)	X	X		X
Rocky Mountain spotted fever			X		Rickettsia rickettsii	X				X
Rubella, including congenital	X	X			Rubella virus*17*15	X	X		X
St. Louis encephalitis (SLE) virus neuroinvasive and non-neuroinvasive disease			X		St. Louis encephalitis virus	X				X
Salmonellosis			X		Salmonella species by species serogroup and serotype					X
Saxitoxin poisoning including Paralytic shellfish poisoning (PSP)			X		Saxitoxin					X
Severe Acute Respiratory Syndrome-associated Coronavirus (SARS-CoV) disease	X	X			SARS–associated Coronavirus (SARS-CoV)	X	X		X
Shigellosis			X		Shigella species by species serogroup					X
Smallpox	X	X			Variola virus (orthopox virus)	X	X		X
Staphylococcus aureus - community associated mortality*19			X		Staphylococcus aureus - community associated mortality*20	X
Not Applicable					Staphylococcus aureus isolated from a normally sterile site *21					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.*22	X			X
Staphylococcus enterotoxin B		X			Staphylococcus enterotoxin B	X			X
Streptococcal disease, invasive, Group A			X		Streptococcus pyogenes, Group A, isolated from a normally sterile site (does not include throat specimens)					X
Streptococcus pneumoniae, invasive disease	Not Applicable				Streptococcus pneumoniae isolated from a normally sterile site*23					X
Streptococcus pneumoniae, invasive disease in children < 5 years, drug sensitive and resistant			X		Streptococcus pneumoniae isolated from a normally sterile site*23					X
Syphilis			X		Treponema pallidum					X
Syphilis in pregnant women and neonates		X			Treponema pallidum				X
Tetanus			X		Clostridium tetani					X
Toxoplasmosis, acute			X		Toxoplasma gondii					X
Trichinellosis (Trichinosis)			X		Trichinella spiralis					X
Tuberculosis (TB) *24*17			X		Mycobacterium tuberculosis complex*24*17					X
Tularemia	X	X			Francisella tularensis	X	X		X
Typhoid fever		X			Salmonella typhi	X			X
Typhus fever (epidemic) (outbreak)	X	X			Rickettsia prowazekii	X	X		X
Typhus fever (endemic)			X		Rickettsia typhi, R. felis	X				X
Vaccinia disease	X	X			Vaccinia virus	X	X		X
Varicella (ChickenPox) *25*18			X		Varicella virus					X
Varicella mortality			X		Varicella virus					X
Venezuelan equine encephalitis virus neuroinvasive and non-neuroinvasive	X	X			Venezuelan equine encephalitis virus	X	X		X
Vibriosis (Vibrio infections, other than Cholera)			X		All non-cholera Vibrio species including, V. alginolyticus, V. damsela, V. fluvialis, V. furnissii, V. hollisae, V. mimicus, V. parahaemolyticus, V. vulnificus	X				X
Viral hemorrhagic fevers	X	X			Ebola, Marburg, Lassa, Machupo viruses	X	X		X
West Nile virus neuroinvasive and non-neuroinvasive disease			X		West Nile virus	X				X
Western equine encephalitis virus neuroinvasive and non-neuroinvasive disease			X		Western equine encephalitis virus	X				X
Yellow fever	X	X			Yellow fever virus	X			X

 

*1 – Submission of isolates or specimens for confirmation:

              a. Each laboratory that obtains a human isolate or a specimen from a patient shall send specimens (such as isolates, sera, serums, slides or diagnostic preparations) to the Florida Department of Health, Bureau of Laboratories for confirmation or additional characterization of the organism. Contact 1(866)352-5227 for the address of your regional laboratory, which will maintain a record indicating the date that these specimens were submitted to the laboratory.

              b. Persons submitting specimens for reportable laboratory tests to the Florida Department of Health, Bureau of Laboratories, pursuant to subsection 64D-3.003(4), 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 your closest regional Florida Department of Health laboratory location, contact 1(866)352-5227. This location will receive isolates or specimens and maintain a record to indicate the date that these specimens were submitted to the laboratory.

              d. Laboratories shall submit isolates or specimens to the Florida Department of Health, Bureau of Laboratories for confirmation or additional characterization of the organism for any notifiable disease as requested by the county health department director or administrator or their designee. Some additional information regarding such requests can be found in the document “Surveillance Case Definitions for Select Reportable Diseases in Florida”.

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

*2 – Special reporting requirements for Arsenic: Test results should only be reported if the test occurred 72 hours after the patient’s consumption of seafood.

*3*2 – Notification within six months of diagnosis and within six months of each treatment.

Exceptions are located in Rule 64D-3.007, F.A.C.

*4*3 – All CD4s, with or without confirmed HIV infection.

*5*4 – Child abuse should be considered by a practitioner upon collection of a specimen for laboratory testing in any person 12 years of age or under, excluding neonates. Reporting of a STD case to a county health department does not relieve the practitioner of their mandatory reporting responsibilities regarding child abuse pursuit to Section 39.201, F.S.

*6*5 – Exceptions are located in Rule 64D-3.035, F.A.C.

*7*6 – Practitioners should contact the Department of Health, Bureau of Epidemiology at [phone] to arrange appropriate autopsy and specimen collection.

*8*7 – Non-O:157:H7, including enterotoxigenic, enteroinvasive, enteropathogenic, enterohemorrhagic, enteroaggregative strains and shiga toxin positive strains.

*9*8 – Special reporting requirements for Antibotic Resistant Neisseria gonorrhoeae:

              a. Report susceptibility test results (zone sizes for disk diffusion; MICs for E-test or agar dilution) for the following antibiotics: Azithromycin, Cefixime, Ceftriaxone, Ciprofloxacin, Erythromycin, Ofloxacin, Penicillin, Spectinomycin, and Tetracycline.

*10*9 – Special reporting requirements for Hepatitis:

              a. Positive results should be accompanied by any hepatitis testing conducted: and

              b. All serum aminotransferase levels.

*11*10 – 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.

*12*11 – Special requirements for STARHS (Serologic Testing Algorithm for Recent HIV Seroconversion):

              a. Each laboratory that reports a confirmed positive HIV test in persons 13 years of age and older must also report a serologic testing algorithm for recent HIV seroconversion (STARHS) test 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 (Serologic Testing Algorithm for Recent HIV Seroconversion). The laboratory is permitted to send the remaining blood specimen or an aliquot of at least 0.5 ml to the Florida Department of Health, Bureau of Laboratories, 1217 Pearl Street, Jacksonville, Florida 32202-3926.

              c. Laboratories electing to send a blood specimen will contact the Florida Department of Health, Bureau of Laboratories 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 National Centers for Disease Control and Prevention will not be required to send a specimen to the Florida Department of Health Laboratory.

*13 – If a genotype is performed, the fasta files containing the nucleotide sequence data, including the protease and reverse transcriptase regions must be reported.

*12 – Practitioners need only to report the presence of cancer associated strains, not abnormal cytologies to the Florida Department of Health, Bureau of STD Prevention and Control, 4052 Bald Cypress Way, Bin A-19, Tallahassee, Florida 32399-1712, [phone].

*14 – Practitioners need not report, unless licensed as a pathologist.

*13 – Special reporting requirements for abnormal histologies:

              a. Report only classifications consistent with Bethesda 2001 Terminology of ASC-US, ASC-H, HSIL, LSIL, CIN 1, CIN 2, CIN 3 and AGC to the Florida Department of Health, Bureau of STD Prevention and Control, 4052 Bald Cypress Way, Bin A-19, Tallahassee, Florida 32399-1712, [phone].

              b. All such reports must be received by the Department electronically in HL-7 format.

*15 – Special reporting requirements for laboratories and pathologists:

              a. Report to the Florida Department of Health, Bureau of STD Prevention and Control, 4052 Bald Cypress Way, Bin A-19, Tallahassee, Florida 32399-1716, [phone].

              b. Paper reports are not required. In accordance with paragraph 64D-3.031(5)(b), F.A.C., once Electronic Laboratory Reporting is initiated with the Department, all reports should be made electronically.

*16*14 – 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 to the Florida Department of Health, Bureau of Community Environmental Health, Childhood Lead Poisoning Prevention Program, 4052 Bald Cypress Way, Bin A08, Tallahassee, Florida 32399-1712, [phone]. 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. All such reports must be received by the Department electronically.

*17*15 – IgM serum antibody or viral culture test orders for measles (rubeola) or rubella should be reported as suspect immediately, but not IgG results.

*18*16 – Includes a bite or other significant exposure to a human or domestic animal (including all pets and livestock) by an animal:

              a. That results in rabies prophylaxis for the person exposed, rabies testing and/or quarantine of the animal causing the exposure; or

              b. That is capable of transmitting herpes B viruses (includes exposures from nonhuman primates).

*19 – As specified in the surveillance case definition for mortality in a person infected with community associated Staphylococcus aureus. For S. aureus mortality cases, a S. aureus culture shall be sent to the Florida Department of Health, Bureau of Laboratories, 1217 Pearle Street, Jacksonville, Florida 32202-3926, [phone]. When pneumonia was present, a suitable respiratory specimen for viral testing should be submitted if available.

*20 – Laboratories that have an isolate from a patient known to have died from community associated Staphylococcus aureus must submit isolates to Florida Department of Health, Bureau of Laboratories, 1217 Pearle Street, Jacksonville, Florida 32202-3926, [phone].

*21 – Special reporting requirements for Staphylococcus aureus:

a. Antibiotic sensitivities must be included.

b. Paper reports are not required. In accordance with paragraph 64D-3.031(5)(b), F.A.C., once Electronic Laboratory Reporting is initiated with the Department, all reports should be made electronically.

*22 – Special reporting requirements for Staphylococcus aureus with intermediate or full resistance to vancomycin (VISA, VRSA):

a. Antibiotic sensitivities must be included.

*23 – Special reporting requirements for Streptococcus pneumoniae:

a. Antibiotic sensitivities must be included.

*24*17 – Special reporting requirements for Tuberculosis:

              a. Test results must also be submitted by laboratories to the Department of Health, Bureau of Tuberculosis and Refugee Health, 4052 Bald Cypress Way, Bin A20, Tallahassee, Florida 32399-1717, [phone];

              b. The 15-digit spoligotype (octal code) must be reported. If the spoligotyping is not available, the isolate must be submitted to the Department of Health, Bureau of Laboratories, 1217 Pearle Street, Jacksonville, Florida 32202-3926, [phone]. The Department will provide the mailing materials and pay mailing costs.

*25*18 – Special reporting requirements for Varicella (chickenpox) – Besides the information required to be reported in subsection 64D-3.030(3) F.A.C., practitioners shall also provide date of vaccination.

Specific Authority 381.0011(13), 381.003(2), 381.0031(6), 384.33, 392.53(2), 392.66 FS. Law Implemented 381.0011(4), 381.003(1), 381.0031(1), (2), (6), 383.06, 384.23, 384.25, 385.202, 392.53 FS. History–New 11-20-06, Amended 7-15-07,__________.

 

Editorial Note: History–Formerly 10D-3.62,10D-3.062, and 64D-3.002.

 

64D-3.030 Notification by Practitioners.

(1) Each practitioner licensed under Chapters 458, 459, 460, 462, 464, 467 and 474, F.S., and medical examiner appointed pursuant to Chapter 406, F.S., who diagnoses, treats or suspects a case, or who suspects an occurrence of a disease or condition listed in the Table of Notifiable Diseases or Conditions, Rule 64D-3.029, F.A.C., including in persons who at the time of death were so affected, shall report or cause to be reported all such diagnoses or suspicions per this rule. Reporting of specimen results by a laboratory to a county health department director, administrator or designee does not nullify the practitioner’s obligation to report said disease or condition.

(2) Any request for laboratory test identification shall be considered a suspicion of disease. However, practitioners need only to report suspected cases if indicated in the “suspect immediately” column under practitioners in the Table of Notifiable Diseases or Conditions, Rule 64D-3.029, F.A.C.

(3) Any report of a notifiable disease or condition required by this rule, except for cancer, congenital anomalies and HIV/AIDS, shall be reported on the Florida Department of Health Disease Report Form (DH Form 2136, 3/06), incorporated by reference, available at the Department of Health, Division of Disease Control, 4052 Bald Cypress Way, Bin A-09, Tallahassee, FL 32399-1714, or on a form supplied by the provider that includes the following:

(a) The patient’s:

1. First and last name, including middle initial;

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

3. Telephone number, including area code;

4. Date of birth;

5. Sex;

6. Race;

7. Ethnicity (specify if of Hispanic descent or not of Hispanic descent);

8. Pregnancy status if applicable;

9. Social Security number;

10. Date of onset of symptoms;

11. Diagnosis.

(b) Type of diagnostic tests (for example culture, IgM, serology, Mantoux TB skin test, nucleic acid amplification test or Western Blot);

(c) Type of specimen (for example stool, urine, blood, mucus, etc.);

(d) Date of specimen collection;

(e) Site (for example cervix, eye, etc., if applicable);

(f) Diagnostic test results including: reference range, titer when quantitative procedures are performed, and all available results concerning additional characterization of the organism;

(g) For Tuberculosis, the 15-digit spoligotype (octal code) must be reported;

(h) Treatment given;

(i) Name, address and telephone number of the attending practitioner;

(j) Other necessary epidemiological information as well as additional specimen collection or laboratory testing requested by the county health department director or administrator or their designee.

(4) The practitioner who first authorizes, orders, requests or submits a specimen to a licensed laboratory for testing for any agent listed in Rule 64D-3.029, F.A.C., shall obtain is responsible for obtaining and provide providing the information required by sub-subparagraphs 64D-3.031(3)(a)1.-10., F.A.C., at the time the specimen is sent to or received by the laboratory.

(5) Special reporting requirements for HIV and AIDS:

(a) All cases of HIV or AIDS, which meet the Centers for Disease Control and Prevention (CDC) case definitions set forth in CDC Guidelines for National Human Immunodeficiency Virus Case Surveillance, Including Monitoring for Human Immunodeficiency Virus Infection and Acquired Immunodeficiency Syndrome, published in Morbidity and Mortality Weekly Report (MMWR) Vol. 48 [RR-13, December 10, 1999], incorporated by reference, available online at: www.cdc.gov/mmwr/PDF/RR/RR4813.pdf, shall be reported on the Adult HIV/AIDS Confidential Case Report, CDC 50.42A Rev. 01/2003, incorporated by reference, or the Pediatric HIV/AIDS Confidential Case Report, CDC 50.42B Rev. 01/2003, incorporated by reference, along with the Department of Health Addendum for Adult HIV/AIDS Confidential Case Report, DH Form 2134, incorporated by reference. All forms are available at county health departments or at the Department of Health, Bureau of HIV/AIDS, 4052 Bald Cypress Way, Bin A-09,Tallahassee, Florida 32399-1715, [phone].

(b) HIV exposed newborns shall be reported on the Pediatric HIV/AIDS Confidential Case Report, CDC 50.42B Rev. 01/2003, incorporated by reference in paragraph 64D-3.030(5)(b), F.A.C.

(7) Each practitioner who makes a diagnosis of or treats any notifiable disease or condition shall make their patient medical records for such diseases or conditions available for on-site inspection by the Department or its authorized representatives.

Specific Authority 381.0011(13), 381.003(2), 381.0031(5), 381.0031(6), 383.06, 384.25(1), 384.33, 392.53(1), 392.66 FS. Law Implemented 381.0011(4), 381.003(1), 381.0031(1), (2), (6), 384.23, 384.25, 385.202, 392.53 FS. History–New 11-20-06, Amended 7-15-07,__________.

 

Editorial Note: History–Formerly 10D-3.097, 64D-3.016 and 64D-3.022.

 

64D-3.031 Notification by Laboratories.

(1) Each person or designee who is in charge of a public, federal, private, military or hospital laboratory responsible for receiving the initial order to perform serologic, immunologic, microscopic, biochemical, molecular or cultural tests on specimens derived from a human body or an animal or for collecting the specimen shall report or cause to be reported any laboratory test suggestive of or diagnostic of diseases or conditions listed in the Table of Notifiable Diseases or Conditions, Rule 64D-3.029, F.A.C., per this rule.

(2) Receipt of a laboratory test order requesting the identification of reportable agents shall be considered by the laboratory as an indication of suspected diagnosis. However, laboratories need only to report suspected cases if indicated in the “suspect immediately” column under laboratories in the Table of Notifiable Diseases or Conditions, Rule 64D-3.029, F.A.C.

(3) To allow follow-up of laboratory findings suggestive of or diagnostic of diseases or conditions in the Table of Notifiable Diseases or Conditions, the form upon which the information will be reported shall be furnished by the laboratory that includes the following information:

(a) The Patient’s:

1. First and last name, including middle initial;

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

3. Phone number, including area code;

4. Date of birth;

5. Sex;

6. Race;

7. Ethnicity (specify if of Hispanic descent or not of Hispanic descent);

8. Pregnancy status if applicable;

9. Social Security number;

(b) The Laboratory

1. Name, address and telephone number of laboratory performing test;

2. Type of specimen (for example stool, urine, blood, mucus, etc.);

3. Date of specimen collection;

4. Site (for example cervix, eye, etc., if applicable);

5. Date of report;

6. Type of tests performed and results, including reference range, titer when quantitative procedures are performed, and including all available results on speciating, grouping or typing of organisms;

7. Submitting provider’s name, address including street, city, zip code and telephone number, including area code;

8. National Provider Identification (NPI) Number.

(4) Laboratories located out of state, licensed under Part 1, Chapter 483, F.S., who collect specimens in Florida or who receive the initial order for testing from a practitioner, blood bank, plasmapheresis center or other health care provider located in Florida, shall report in the same way as if the findings had been made by a laboratory located in Florida.

(5) Upon the Department’s implementation of its Electronic Laboratory Reporting System (ELR) for laboratory findings suggestive of or diagnostic of diseases or conditions, reports will be submitted electronically to the Department using Health Level Seven (HL7) version 2.3.1 format or ASCII delimited flat files which reflect comparable content to HL7 version 2.3.1. utilized by the Department of Health. The CDC Implementation Guide for Transmission of Laboratory-Based Reporting of Public Health Information using version 2.3.1 of the Health Level Seven (HL7) Standard Protocol, incorporated by reference, is available at the Department of Health, ELR Project, 4052 Bald Cypress Way, Bin A-12, Tallahassee, Florida 32399-1715.

(a) The Department’s ELR System shall include:

1. The initial contact with the reporting laboratory;

2. A content review and testing of the laboratories’ HL7 transmissions; and

3. The transition from testing to production for the HL7 laboratory transmissions.

(b) The Department and laboratory will agree on a date of implementation

(c) Laboratories reporting electronically through ELR and the Department shall agree to a date that the transmission of findings suggestive of or diagnostic of diseases or conditions listed in the Table of Notifiable Disease or Conditions, Rule 64D-3.029 F.A.C., electronically in HL7 version 2.3.1 format to the Department is acceptable and considered good faith reporting and the laboratory will no longer be required to submit paper forms pursuant to subsection 64D-3.031(3), F.A.C;

(d) The Department shall ensure access to the laboratory findings suggestive of or diagnostic of disease or conditions listed in the Table of Notifiable Diseases or Conditions to authorized representatives of the department.

(6) This section does not prohibit a laboratory from making a report by telephone, in writing, or facsimile to the county health department having jurisdiction for the area in which the office of the submitting practitioner or the patient’s residence is located.

(7)(a) In order to study disease incidence, each laboratory licensed to perform tests for any notifiable disease or condition shall report the test volume for each related diagnostic test performed for the notifiable diseases listed in Rule 64D-3.029, F.A.C.

(b) Reports are to be filed annually on or before April 1 of each year to the Department electronically in a format agreed upon by the department and the laboratory with the following information:

1. Type of diagnostic test;

2. Patient’s date of birth;

3. Patient’s sex;

4. Race;

5. Ethnicity (specify if of Hispanic descent or not of Hispanic descent).

(8) Each laboratory licensed to perform tests for any reportable disease or condition shall make its records for such diseases or conditions available for on-site inspection by the Department or its authorized representatives.

Specific Authority 381.0011(7), 381.0011(13), 381.003(2), 381.0031(5), 381.0031(6), 384.33, 392.66 FS. Law Implemented 381.0011, 381.003, 381.0031, 384.25(1), 392.53(1) FS. History–New 11-20-06, Amended 7-15-07,__________.

 

Editorial Note: History–Formerly 10D-3.66, 10D-3.066, 64D3.003, 64D-3.017 and 64D-3.023.

 

64D-3.040 Procedures for Control of Specific Communicable Diseases.

(1) Psittacosis (Ornithosis).

(a) All cases and suspected cases of psittacosis in people or birds shall be reported to the county health department director or administrator or their designee.

(b) Birds suspected of being infected or having been associated with infected birds shall not be removed from any premises until the State Health Officer or the county health department director or administrator or their designee, has investigated the situation and issued orders which may include quarantine, laboratory examination or prescribed treatment according to recommendations of the National Association of State Public Health Veterinarians, Inc., published in the Compendium of Measures to Control Chlamydophila psittaci (formerly Chlamydia psittaci) Infection Among Humans (Psittacosis) and Pet Birds (Avian Chlamydiosis), 2008 2006, incorporated by reference, available from the Department of Health, Division of Environmental Health, 4052 Bald Cypress Way, Bin A-08, Tallahassee, Florida 32399-1720.

(2) Rabies Control in Humans.

(a) Reporting of Suspected Human Exposure to Rabies – Any person having knowledge of an incident in which a person is bitten by or otherwise exposed to any known or suspected rabid animal shall notify the county health department director or administrator or their designee where the bite occurred immediately by telephone, facsimile, electronic data transfer or other confidential means.

(b) Prevention in Humans – Persons bitten or otherwise exposed to suspect rabid animals shall be evaluated for post-exposure treatment by the county health department director or medical director or their designee according to recommendations of Human Rabies Prevention-United States, 2008 1999, Recommendations of the Advisory Committee on Immunization Practices (ACIP), published in the Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report, Vol. 57 48 No. RR-13, May 26, 2008, January 8, 1999, incorporated by reference, available online at: http://www.cdc.gov/mmwr/PDF/rr/rr5703.pdfwww.cdc.gov/mmwr/PDF/rr/rr4801.pdf.

(3) Rabies Control in Animals.

(a) The county health department director or administrator or their designee shall promptly investigate reported bites or exposures by suspected rabid animals.

(b) The county health department director or administrator or their designee shall cause to be captured, confined or seized suspected rabid animals and isolate and quarantine or humanely euthanize and provide for laboratory examination, as outlined in the guidebook, Rabies Prevention and Control in Florida 2008 2006, incorporated by reference, available at:  www.myfloridaeh.com/community/arboviral/Zoonoses/Rabies guideUpdated.pdf.  This includes animals involved in human exposure (bite and non-bite) and animals exposed to rabid or suspected rabid animals. Other methods of controlling rabies in domestic or wild animals shall be administered by order of the county health department director or administrator or their designee according to recommendations of the Florida Rabies Advisory Committee.

(c) Upon official request from the health agency of another state or country, the appropriate county health department designee shall provide assistance in locating and placing in quarantine the suspect animal as required for proper completion of investigation of a potential rabies exposure incident.

(d) Epizootic Rabies. The State Health Officer, or the county health department director or administrator or their designee shall declare an area wide quarantine when prevalence of rabies so indicates. The conditions of the quarantine shall control the movement, sale, impoundment or required euthanasia of animals in the quarantine area as specified by departmental policy and procedure guidelines as defined in paragraph 64D-3.040(3)(b), F.A.C.

(4) Shigella and salmonella infections other than enteric disease outbreaks in child care settings, for which see subsection 64D-3.040(5), F.A.C., and Typhoid Fever, for which see subsection 64D-3.040(6), F.A.C.

(a) Sensitive Situations

1.  Persons with laboratory-confirmed or probable cases of Shigella and Salmonella infections (excluding typhoid fever) shall be prohibited from being present in sensitive situations until they are determined by the county health department director or administrator or their designee no longer to be a public health hazard. Release as no longer a public health hazard may be obtained by order of the director/administrator as provided for in subsections 64D-3.040(3), (4), F.A.C., for Salmonella, or by the infected person’s submitting a minimum of two (2) stool specimens in satisfactory condition to one of the Department’s laboratories or other clinical laboratory acceptable to the Department and meeting the following conditions:

a.  The specimens are negative for these organisms.

b.  The first specimen shall not be obtained sooner than forty-eight (48) hours after the cessation of any antibiotic therapy for those cases receiving antibiotics.

c.  The second and subsequent specimen shall not be obtained sooner than at 24-hour intervals.

2. Persons who are contacts to probable or confirmed cases of shigella and salmonella infections (excluding typhoid fever);

a.  Who have symptoms of an enteric illness or who have had such symptoms during the past two (2) weeks shall be presumed to be infected and shall be managed as a case as outlined in subparagraph 64D-3.040(4)(a)1., F.A.C.; or

b.  Persons who are contacts to probable or confirmed cases of Shigella and Salmonella infections (excluding typhoid fever) and who do not have symptoms of an enteric illness or who have not had those symptoms during the past two (2) weeks may be permitted to continue in their sensitive situation at the discretion of the county health department director or administrator or their designee.

3. Persons infected with Salmonella (excluding typhoid fever) without symptoms may attend schools or child care settings at the discretion of the county health department director or administrator or their designee, provided adequate sanitary facilities and hygienic practices exist.

(b)  Non-sensitive Situations

Cases, Contacts, and Carriers of Salmonella or Shigella who are not in non-sensitive situations should be counseled regarding disease transmission, food preparation and hand washing practices. Follow-up or release based on stool culture results is not required.

(5) Enteric disease outbreaks in child care settings [for typhoid fever, see subsection 64D-3.040(6), F.A.C.].  In the event of an outbreak in a child care setting of one of these diseases, the county health department director or administrator or their designee shall implement control procedures as defined in “Guidelines for Control of Outbreaks of Enteric Disease in Child Care Settings,” dated March 2000, incorporated by reference, available online at: www.doh.state.fl.us/disease%5Fctrl/epi/surv/enteric.pdf.

(6) Typhoid Fever.

(a) Cases:  Enteric isolation procedures are required for all cases during the acute stages of illness. The patient shall be under the supervision of the county health department director or administrator or their designee until bacteriologic cultures are obtained from feces and are negative in no less than three consecutive specimens taken at least 24 hours apart and not earlier than 1 month after onset of illness, provided the patient has been off antibiotic therapy for a period of 1 week. If any one specimen of this series yields typhoid organisms, then at least an additional three negative consecutive specimens of feces taken at least 24 hours apart are required for release of the case.

(b) Household contacts of a typhoid case who may be excreting S. typhi as determined by the county health department director or administrator or their designee and who are involved in food processing, food preparation or food service for public consumption or in any occupation bringing them in contact with children, ill persons, or the elderly or are present in other sensitive situations, as defined in subsection 64D-3.028(21), F.A.C., are prohibited from returning to such occupation or situation until no less than three specimens of feces taken at least 24 hours apart are negative for typhoid organisms. In addition, other appropriate tests may be required at the discretion of the county health department director or administrator or their designee.

(7) Perinatal Hepatitis B.

(a) Infants born to HBsAg-positive mothers The following infants shall receive hepatitis B immune globulin and hepatitis B vaccine once they are physiologically stable, preferably within 12 hours of birth, and shall complete the hepatitis B vaccine series according to the recommended vaccine schedule. Testing infants for HBsAg and antibody to hepatitis B surface antigen (anti-HBs) six (6) months after the completion of the hepatitis B vaccine series is recommended to monitor the success or failure of therapy.

1.  Infants born to HBsAg-positive mothers;

2.  All infants of mothers born in areas of high endemicity for hepatitis B infection.  These areas include China, Southeast Asia, Africa, Middle East, Pacific Islands and the Amazon Basin.

3.  Alaskan Native infants.

(b) Household members, sexual and needle-sharing partners of HBsAg-positive prenatal/postpartum hepatitis B women should be tested to determine susceptibility to the hepatitis B virus, and, if susceptible should receive the hepatitis B vaccine series.

(8) Vibrio Infections. All food service establishments serving raw oysters shall display, either on menus or on table placards, the following notice: “Consumer Information: There is risk associated with consuming raw oysters. If you have chronic illness of the liver, stomach or blood or have immune disorders, you are at greater risk of serious illness from raw oysters, and should eat oysters fully cooked. If unsure of your risk, consult a physician.”

Specific Authority 381.0011(6), (13), 381.003(2), 381.006(16), 384.25(2), 384.33 FS. Law Implemented 381.0011(4), (6), (8), 381.003(1), 381.0031, 384.25, 384.27 FS. History–New 11-20-06, Amended 7-15-07,__________.

 

Editorial Note: History–Formerly 10D-3.91, 10D-3.091, and 64D-3.013.

64D-3.041 Epidemiological Investigations.

(1) The Department and its authorized representatives, when deemed necessary to protect the public’s health, may conduct epidemiological investigations and follow-up to confirm the diagnosis, treatment and causes of any disease or condition to determine appropriate methods of outbreak epidemic and communicable disease control. Such investigations shall be considered official duties of the Department and may include, but are not limited to:

(a) Review of pertinent, relevant medical records by authorized representatives of the Department, if necessary to confirm the diagnosis; to investigate causes; to identify other related cases in an area, community, or workplace; to determine if a person with a reportable notifiable disease or condition has received adequate treatment to render themselves non-infectious or if exposed has received prophylaxis, if appropriate. Such review of records may occur without patient consent and shall be conducted at reasonable times and with such notice as is deemed reasonable under the circumstances.

(b) Perform interviews with an infected person or persons knowledgeable about the case to collect pertinent and relevant information about the cause(s) of or risk factors for the notifiable disease or condition.

(c) Conduct notification services by authorized Department representatives to inform persons who may have been in such association with an infected person or animal or a contaminated environment and who have had opportunity to acquire the infection. These will include, but are not limited to: household contacts, sexual partners, correctional facilities inmates and employees, patrons, employees and/or owners of business establishments, preschool staff and students, school staff and students, and other individuals who may have been in an infected persons’ social, business or environmental network.

(d) Medical examination and/or testing of persons exposed to or at risk of the notifiable disease or condition.

(e) Obtain from public or private businesses or institutions the identities and locating information of persons, travelers, passengers or transportation crews with a similar or common potential exposure to the infectious agent as a reported case (such exposure may be current or have occurred in the past).

(f) Interview or administer questionnaires confidentially to any resident of a community or any agent, owner, operator, employer, employee or client of a public or private business or institution, that is either epidemiologically associated with an outbreak, or with the reported case or has had similar exposure as the reportable case.

(g) Collect environmental samples of substances or measurements of physical agents that may be related to the cause of an outbreak or notifiable disease or condition.

(h) Enter a place of employment for the purpose of conducting epidemiological investigations of those processes, conditions, structures, machines, apparatus, devices, equipment, records and materials within the place of employment which are relevant, pertinent and necessary to the investigation of an outbreak of notifiable diseases or conditions during regular working hours or at other reasonable times with such notice as is reasonable under the circumstances.

(2) Information All information gathered in the course of an epidemiological investigation and follow-up shall be confidential to the degree permitted under and subject to the provisions of Sections 119.0712, 381.0031(4), 384.29, and 392.65, F.S.

Specific Authority 381.0011(7), 381.0011(13), 381.003(2), 381.0031(6), 384.25(2), 384.33 FS. Law Implemented 381.0011(4), 381.003(1) (c), 384.26, 392.54 FS.  History–New 11-20-06, Amended 7-15-07,__________.

 

Editorial Note: History–Formerly 10D-3.100, and 64D- 3.018.

 

64D-3.046 Immunization Requirements: Public and Nonpublic Schools, Grades Preschool, Kindergarten Through 12, and Adult Education Classes.

(1)(a) Immunization and Documentation Requirements –

(b) A student may attend a public or non-public school, grades preschool through 12 or an adult education class if younger than 21, if prior to admittance, attendance or transfer, they present one of the following for inspection for validity by an authorized school official:

1. DH Form 680, Florida Certification of Immunization (July 2008 January 2007), incorporated by reference, available from Department of Health (DOH) county health departments (CHDs) or physicians’ offices.

2. Documentation of receipt of or exemption from must be noted for the following immunizations: diphtheria, tetanus, pertussis, poliomyelitis, measles (rubeola), rubella, mumps, varicella and hepatitis B. The manner and frequency of administration of the immunizations shall conform to recognized standards of medical practice.

(2) Specific immunization requirements by grade, in addition to those in paragraph (1)(a), which must be documented prior to admittance, attendance or transfer:

(a) Preschool – Completion of Haemophilus influenzae type b vaccination.

(b) Preschool or kindergarten effective with the 2001/2002 school year – completion of varicella vaccination. Each subsequent year thereafter the next highest grade will be included in the requirement so that students transferring into Florida schools are added to the varicella immunized cohort.

1.  7th Grade – Completion of a tetanus-diphtheria booster.

2. Effective with the 2009/2010 school year, all immunizations required for entry and attendance in school, pre K, childcare facilities and family daycare homes will be referenced in the current Immunization Guidelines – Florida Schools, Child Care Facilities and Family Day Care Homes (incorporated by reference).

3.2. Additional Documentation Requirements for Exemptions.

4.3. For exemption from the rubeola immunization the practitioner must include with DH Form 680, Florida Certification of Immunization, incorporated by reference in subsection 64D-3.046(1), F.A.C., documentation on their own stationery of the physician’s request for exemption, asserting that the student had an illness comprised of a generalized rash lasting three or more days, a fever of 101 degrees Fahrenheit or greater, a cough, and/or coryza, and/or conjunctivitis and, in the physician’s opinion, has had the ten-day measles (rubeola) or serologic evidence of immunity to measles.

(c) Forms are to be fully executed by a practitioner licensed under Chapters 458, 459, 460, F.S., or their authorized representative (where permitted in the particular certification) per instructions for the appropriate school year as provided in DH Form 150-615, Immunization Guidelines – Florida Schools, Child Care Facilities and Family Day Care Homes (July 2008 March 2007), incorporated by reference, available online at: www.doh.state.fl.us/disease_ctrl/immune/schoolguide.pdf.

(d) Florida SHOTS (State Health Online Tracking System) Electronically Certified DH Form 680 produced by a CHD or a physician’s office, as provided in (7), may be utilized.

(e) DH Form 681, Religious Exemptions for Immunizations (English/Spanish/Haitian-Creole) (February 2002), incorporated by reference, available at DOH CHDs, must be issued and signed by the local county health department medical director or designee.

(f) Otherwise, required immunizations not performed must be accounted for under the Temporary or Permanent Medical Exemptions, DH Form 680, Florida Certification of Immunization, Parts B and C, incorporated by reference in subsection 64D-3.046(1), F.A.C.

(3) Documentation Requirements for Schools:

(a) The original of the form(s) required under paragraph (1)(a) shall remain in the student’s cumulative health record.

(b) Antigen doses by dates of immunization shall be transferred as data elements through the Florida Automated System for Transferring Education Records (FASTER).

(c) Compliance Reporting:

1. Each public and nonpublic school with a kindergarten and/or seventh grade shall submit an annual compliance report. The report shall be completed on DH Form 684, Immunization Annual Report of Compliance for Kindergarten and Seventh Grade (January 2007), incorporated by reference, available at DOH CHDs. The report shall include the immunization status of all children who were attending kindergarten and seventh grades at the beginning of the school year. The report shall be forwarded to the CHD director/administrator no later than October 1 of each school year where the data will be compiled on DH Form 685, Kindergarten and Seventh Grade Annual Report of Compliance County Summary (November 2006), incorporated by reference, available at DOH CHDs; or electronically generated by the Department of Education.

2. After consultation with the Department of Education, the Department of Health shall require compliance reports from public and nonpublic schools and preschools for selected grades (K-12 and preschool) in special situations of vaccine preventable disease outbreak control or identified need for monitoring through surveys for immunization compliance levels. Such reports shall include the status of all children who were attending school at the beginning of the school year. Reports shall be forwarded to the CHD director/administrator within a specified period, as determined by the DOH.

(4) Homeless, Transfers and Juvenile Justice – A temporary exemption to requirements of subsection (2) above not to exceed 30 days may be issued by an authorized school official for any of the following, consistent with the definitions in Section 1003.01, F.S.:

(a) A homeless child.

(b) A transfer student.

(c) A student who enters a juvenile justice education program or school.

(5) Notwithstanding subsection (2), the Department may:

(a) Designate any required immunization as unnecessary or hazardous, according to recognized standards of medical practice.

(b) Upon determination that a shortage of vaccine exists, approve issuance of temporary medical exemption with extended expiration dates by practitioners or authorized school officials until such time as, in the DOH’s opinion, vaccine will be available in sufficient quantity for such deferred vaccinations to be completed.

(6) Florida SHOTS (State Health Online Tracking System) Opt Out Provision – Parents or guardians may elect to decline participation in the Florida immunization registry, Florida SHOTS, by submitting a Florida SHOTS Notification and Opt Out Form to the DOH. The form, either a DH Form 1478 (English) or DH Form 1478S (Spanish) or DH Form 1478H (Haitian-Creole), incorporated by reference, is available from the DOH, Bureau of Immunization, 4052 Bald Cypress Way, Bin #A-11, Tallahassee, FL 32399-1719. The immunization records of children whose parents choose to opt-out will not be shared with other entities that are allowed by law to have access to the child’s immunization record via authorized access to Florida SHOTS.

(7) Florida SHOTS Private Provider Participation – Any health care practitioner licensed in Florida under Chapter 458, 459 or 464, F.S., may request authorization to access Florida SHOTS by filling out a DH Form 1479, Authorized Private Provider User Agreement for Access to Florida SHOTS (January 2007), incorporated by reference, available from the DOH Bureau of Immunization, 4052 Bald Cypress Way, Bin #A-11, Tallahassee, FL 32399-1719. The DH Form 1479 will be returned to the Department of Health for processing and authorization to access Florida SHOTS. Notification of access approval and instructions for accessing Florida SHOTS will be provided by the DOH. The authorized user and the applicable licensing authority or agency shall notify the DOH, Bureau of Immunization Florida SHOTS personnel when an authorized user’s license or registration has expired or has been suspended or revoked.

(8) Florida SHOTS School and Licensed or Registered Child Care Facility Participation – Any public or nonpublic school, or licensed or registered child care facility may request authorization to access Florida SHOTS by completing a DH Form 2115, Authorized School and Licensed or Registered Child Care Facility User Agreement for Access to Florida SHOTS (January 2007), incorporated by reference, available from the DOH, Bureau of Immunization, 4052 Bald Cypress Way, Bin #A-11, Tallahassee, FL 32399-1719. The DH Form 2115 will be returned to the DOH for processing and authorization to access Florida SHOTS. Notification of access approval and instructions for accessing Florida SHOTS will be provided by the DOH. The authorized user and the applicable licensing authority or agency shall notify the DOH, Bureau of Immunization Florida SHOTS personnel when an authorized user’s license or registration has expired or has been suspended or revoked.

Specific Authority 381.0011(13), 381.003(1), (2), 381.005(2), 1003.22 FS. Law Implemented 381.0011(4), 381.003(1), 381.005(1)(i), 1003.22 FS. History–New 11-20-06, Amended 7-15-07,__________.

Editorial Note: History–Formerly 10D-3.88, 10D-3.088 and 64D-3.011.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Dr. Karla Schmitt, Chief, Bureau of STD Prevention and Control

NAME OF SUPERVISOR OR PERSON WHO APPROVED THE PROPOSED RULE: Thomas Arnold, Deputy Secretary for Health, Public Health on behalf of Dr. Ana Viamonte Ros, State Surgeon General

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: June 16, 2008

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: April 18, 2008