Diseases or Conditions to be Reported, Notification by Practitioners, Notification by Laboratories

 

DEPARTMENT OF HEALTH
Division of Disease Control

RULE NO: RULE TITLE
64D-3.029: Diseases or Conditions to be Reported
64D-3.030: Notification by Practitioners
64D-3.031: Notification by Laboratories

NOTICE OF CHANGE

Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 34, No. 26, June 27, 2008 issue of the Florida Administrative Weekly.

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 Rules 64D-3.030-64D-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: (No change.)

(a) “Notifiable Diseases or Conditions” – The definitions of “case” and “suspected case” and “confirmed case” for reportable diseases or conditions are set forth in “Surveillance Case Definitions for Select Reportable Diseases in Florida,” August 2008, incorporated by reference, available online at: http://www.doh.state.fl.us/disease_ctrl/epi/surv/CaseDefAug2 008.pdf. 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]. (No change.)

(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]. (No change.)

(d) “Next Business Day” – Report before the closure of the County Health Department’s next business day following suspicion or diagnosis. (No change.)

(e) “Other” – Report consistent with the instruction in and footnotes to subsection (3) below. (No change.)

(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		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, 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) *3 *2				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 ag *5e *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
Human papillomavirus ONLY physicians licensed as pathologists need report as directed under Laboratory Reporting*14  HPV cancer associated strains*12			X		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) DNA typing of HPV strains 16, 18, 31, 33, 35, 36, 45 Abnormal histologies consistent with Bethesda 2001 Terminology *13				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 results*16 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			SARSassociated 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 (outbreak) (epidemic)	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: (No change.)

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 designated 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 ________.

 

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. (No change.)

(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. (No change.)

(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: (No change.)

(a) The patient’s: (No change.)

1. First and last name, including middle initial; (No change.)

2. Address, including city, state and zip code; (No change.)

3. Telephone number, including area code; (No change.)

4. Date of birth; (No change.)

5. Sex; (No change.)

6. Race; (No change.)

7. Ethnicity (specify if of Hispanic descent or not of Hispanic descent); (No change.)

8. Pregnancy status if applicable; (No change.)

9. Social Security number; (No change.)

10. Date of onset of symptoms; (No change.)

11. Diagnosis. (No change.)

(b) Type of diagnostic tests (for example culture, IgM, serology, Mantoux TB skin test, nucleic acid amplification test or Western Blot); (No change.)

(c) Type of specimen (for example stool, urine, blood, mucus, etc.); (No change.)

(d) Date of specimen collection; (No change.)

(e) Site (for example cervix, eye, etc., if applicable); (No change.)

(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; (No change.)

(h) Treatment given; (No change.)

(i) Name, address and telephone number of the attending practitioner; (No change.)

(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 and provide is responsible for obtaining and providing the information required by 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: (No change.)

(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. 03/2007, 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, (09/08), (December 2006), 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)(a),(b), F.A.C.

(6)(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 ________.

 

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. (No change.)

(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. (No change.)

(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: (No change.)

(a) The Patient’s: (No change.)

1. First and last name, including middle initial; (No change.)

2. Address including street city, state and zip code; (No change.)

3. Phone number, including area code; (No change.)

4. Date of birth; (No change.)

5. Sex; (No change.)

6. Race; (No change.)

7. Ethnicity (specify if of Hispanic descent or not of Hispanic descent); (No change.)

8. Pregnancy status if applicable; (No change.)

9. Social Security number; (No change.)

(b) The Laboratory (No change.)

1. Name, address and telephone number of laboratory performing test; (No change.)

2. Type of specimen (for example stool, urine, blood, mucus, etc.); (No change.)

3. Date of specimen collection; (No change.)

4. Site (for example cervix, eye, etc., if applicable); (No change.)

5. Date of report; (No change.)

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; (No change.)

7. Submitting provider’s name, address including street, city, zip code and telephone number, including area code; (No change.)

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. (No change.)

(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, Health Level Seven Specifications for Electronic Laboratory-Based Reporting of Public Health Information, October 1997, 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 online at: http://www.cdc.gov/nedss/ELR/HL7Spec.pdf. 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: (No change.)

1. The initial contact with the reporting laboratory; (No change.)

2. A content review and testing of the laboratories’ HL7 transmissions; and (No change.)

3. The transition from testing to production for the HL7 laboratory transmissions. (No change.)

(b) The Department and laboratory will agree on a date of implementation (No change.)

(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; (No change.)

(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. (No change.)

(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. (No change.)

(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. (No change.)

(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: (No change.)

1. Type of diagnostic test; (No change.)

2. Patient’s date of birth; (No change.)

3. Patient’s sex; (No change.)

4. Race; (No change.)

5. Ethnicity (specify if of Hispanic descent or not of Hispanic descent). (No change.)

(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. (No change.)

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 ________.

 

Editorial Note: History–Formerly 10D-3.66, 10D-3.066, 64D-3.003, 64D-3.017 and 64D-3.023