To update the rule to reflect current public health needs for disease reporting.

DEPARTMENT OF HEALTH

Division of Disease Control and Health Protection

RULE NO.: RULE TITLE

64D-3.029Diseases or Conditions to Be Reported

PURPOSE AND EFFECT:  To update the rule to reflect current public health needs for disease reporting.

SUMMARY: The rule lists the disease and conditions of public health significance which must be reported to the Department by health care practitioners and laboratories.

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

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein:  The proposed changes include both additions and deletions to the list of reportable diseases and are not expected to significantly change the workload for providers and laboratories. This proposed rulemaking will not have an adverse impact or effect regulatory costs in excess of $1 million within five years as established in Section 120.541, F.S.

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.

RULEMAKING AUTHORITY: 381.0011(2), 381.003(2), 381.0031(8), 384.33, 392.53(2), 392.66 FS.

LAW IMPLEMENTED: 381.0011(3), (4), (7), 381.003(1), 381.0031(1), (2), (4), (5), (6), (8), 383.06, 384.23, 384.25, 385.202, 392.53 FS.

IF REQUESTED WITHIN 21 DAYS OF THIS NOTICE, A HEARING WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW:

DATE AND TIME: March 10, 2014, 12:00 p.m. – 2:00 p.m.

PLACE:  4025 Esplanade Way, Room 301, Tallahassee, Florida 32399

Individuals may also participate by calling 1(888)670-3525 and using code 111-389-2532

Pursuant to the provisions of the Americans with Disabilities Act, any person requiring special accommodations to participate in this workshop/meeting is asked to advise the agency at least 7 days before the workshop/meeting by contacting: Dr. Carina Blackmore, Deputy State Epidemiologist, Division of Disease Control and Health Protection, 4052 Bald Cypress Way, Bin #A09, Tallahassee, Florida, 32399-1710. If you are hearing or speech impaired, please contact the agency using the Florida Relay Service, 1(800)955-8771 (TDD) or 1(800)955-8770 (Voice).

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS:  Dr. Carina Blackmore, Deputy State Epidemiologist, Division of Disease Control and Health Protection, 4052 Bald Cypress Way, Bin #A09, Tallahassee, Florida, 32399-1710

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64D-3.029 Diseases or Conditions to be Reported.

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

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

(a) “Reportable Notifiable Diseases or Conditions” – The definitions of “suspected case” and “confirmed case” for reportable diseases or conditions are set forth in “Surveillance Case Definitions for Select Reportable Diseases in Florida,” 2014August 2008, incorporated by reference, available online at: __________http://www.doh.state.fl.us/disease_ctrl/epi/surv/CaseDefAug2008.pdf.

(b) “Suspect Immediately” – A reportable notifiable condition of urgent public health importance. Report without delay upon the occurrence of any of the following: iInitial 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 reportable notifiable condition of urgent public health importance. Report without delay upon the occurrence of any of the following: aAn 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 Reportable Notifiable Diseases or Conditions to Be Reported”.

 

Practitioner Reporting					Laboratory Reporting
Reportable Notifiable Diseases or Conditions	Timeframes				Evidence of current or recent infection with etiological agents and all associated testing results performed should be reported (e.g. species, serogroup, serotype, and antimicrobial susceptibility *2 results)	Submit isolates or specimens for confirmation*1	Timeframes
	Suspect Immediately	Immediately	Next Business Day	Other			Suspect Immediately	Immediately	Next Business Day	Other
Any case, cluster of cases, or outbreak, or exposure to an infectious or non-infectious of a disease, or condition, or agent found in the general community or any defined setting such as a hospital, school or other institution, not listed in this rule that is of urgent public health significance. This includes human cases, clusters, or outbreaks spread person-to-person, by animals or vectors or from 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; and unexplained deaths possibly due to unidentified infectious or chemical causes.	X	X			Detection in one or more specimens of etiological agents of a disease or condition not listed in this Rule that is of urgent public health significance. This includes the identification of etiological agents that are suspected to be the cause of clusters, or outbreaks spread person-to-person, by animals or vectors or from an environmental, food, or waterborne source of exposure; those that result from a deliberate act of terrorism; and unexplained deaths due to unidentified infectious or chemical causes.		X	X
Acquired Immune Deficiency Syndrome (AIDS)				2 Weeks	Acquired Immune Deficiency Syndrome (AIDS)	Laboratory Reporting Not Applicable
Amebic Encephalitis		X			Naegleria fowleri, Balamuthia mandrillaris, or Acanthamoeba species spp.			X
Anthrax	X	X			Bacillus anthracis	X	X	X
Antimicrobial resistance surveillance	Practitioner Reporting Not Applicable				Antimicrobial resistance surveillance (for organisms not otherwise listed in this table), Acinetobacter baumannii, Citrobacter species, Enterococcus species, Enterobacter species, Escherichia coli species, Klebsiella species, Pseudomonas aeruginosa, Serratia species, isolated from a normally sterile site *3				X
Arsenic Poisoning *4a2			X		Laboratory results as specified in the surveillance case definition for arsenic poisoning *4a2				X
Arboviral infections, not otherwise listed in this table (disease due to)			X		Including but not limited to: Flaviviridae, Togaviridae (e.g. Western equine encephalitis), Bunyaviridae	X			X
Botulism, foodborne, other (includes wound and unspecified)	X	X			Clostridium botulinum or botulinum toxin	X	X	X
Botulism, infant			X		Clostridium botulinum or botulinum toxin	X			X
Botulism, other (includes wound and unspecified)	X	X			Clostridium botulinum or botulinum toxin	X	X	X
Brucellosis	X	X			Brucella species abortus, B. melitensis, B. suis, B. canis	X	X	X
California serogroup virusesvirus neuroinvasive and non-neuroinvasive (disease due to)			X		California serogroup viruses such asencephalitis, Jamestown Canyon, Keystone, and Lacrosse, snowshoe hare, trivittatus viruses	X			X
Campylobacteriosis *4b			X		Campylobacter species *4b				X
Cancer (except non-melanoma skin cancer, and including benign and borderline intracranial and CNS tumors) *53				6 Months	Pathological or tissue diagnosis of cancer (except non-melanoma skin cancer and including benign and borderline intracranial and CNS tumors)					6 Months
Carbon monoxide poisoning			X		A volume fraction ≥ 0.09 (9%) of carboxyhemoglobin in blood				X
CD-4 absolute count and percentage of total lymphocytes	Practitioner Reporting Not Applicable				CD-4 absolute count and percentage of total lymphocytes *64					3 days
Chancroid			X		Haemophilus ducreyi				X
Chlamydia *7			X		Chlamydia trachomatis				X
Chlamydia in pregnant women and neonates			X		Chlamydia trachomatis				X
Chlamydia in children < 12 years of age*5			X		Chlamydia trachomatis				X
Cholera	X	X			Vibrio cholerae	X	X	X
Ciguatera fish poisoning (Ciguatera)			X		Ciguatera fish poisoning	Laboratory Reporting Not Applicable
Congenital anomalies *86				6 Months	Congenital anomalies	Laboratory tests as specified in Rule 64D-3.035 Not Applicable
Conjunctivitis in neonates < 14 days old			X		Conjunctivitis in neonates < 14 days old	Laboratory Reporting Not Applicable
Creutzfeld-Jakob disease (CJD) *97			X		14-3-3 or tau protein detection in from CSF or immunohistochemical test or any brain pathology suggestive of CJD *97				X
Cryptosporidiosis *4b			X		Cryptosporidium species *4bparvum				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			X		Anaplasma species or phagocytophilum, Ehrlichia species chaffeensis, or E. ewingii.	X			X
Ehrlichiosis/Anaplasmosis – undetermined or unspecified			X		Ehrlichia or Anaplasma species, other	X			X
Ehrlichiosis, human other or unspecified agent			X		Ehrlichia species other				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 Shiga toxin-producing (disease due to) *4b O157:H7		X	X		Escherichia coli Shiga toxin-producing *4b O157:H7	X		X	X
Enteric disease due to other pathogenic Escherichia coli*8		X			Escherichia coli*8			X
Giardiasis (acute) *4b			X		Giardia species *4b				X
Glanders	X	X			Burkholderia mallei,	X	X	X
Gonorrhea *7			X		Neisseria gonorrhoeae				X
Gonorrhea in children < 12 years of age*5			X		Neisseria gonorrhoeae				X
Gonorrhea in pregnant women and neonates			X		Neisseria gonorrhoeae				X
Gonorrhea (Antibotic Resistant)			X		Neisseria gonorrhoeae*9				X
Granuloma iInguinale			X		Calymmatobacterium granulomatis				X
Haemophilus influenzae, meningitis and invasive disease, in children < 5 years old	X	X			Haemophilus influenzae, all ages, isolated from a normally sterile site *10	X	X	X
Hansen disease (Leprosy)			X		Mycobacterium leprae				X
Hantavirus infection		X			Hantavirus	X		X
Hemolytic uremic syndrome		X			Not Applicable
Hepatitis A*4b, 1110		X			Hepatitis A*4b, 1110			X
Hepatitis B, C, D, E and G *11 Virus*10			X		Hepatitis B, C, D, E and G Virus*1110				X
Hepatitis B surface antigen (HBsAg)-positive in a pregnant woman or a child up to 24 months old			X		Hepatitis B surface antigen (HBsAg)				X
Herpes B virus, possible exposure		X			Herpes B virus, possible exposure	Laboratory Reporting Not Applicable
Herpes simplex virus (HSV) in infants up to 60 days old with disseminated infection with involvement of liver, encephalitis and infections limited to skin, eyes and mouth *1211			X		HSV 1 or HSV 2 by direct FA, PCR, DNA or Culture *1211				X
HSV – anogenital in children < 12 years of age *7, 125*11			X		HSV 1 or HSV 2 by direct FA, PCR, DNA or Culture *1211				X
Human immunodeficiency virus (HIV) infection				2 Weeks	Repeatedly reactive enzyme immunoassay, followed by a positive confirmatory tests, (e.g. Western Blot, IFA): Positive result on any HIV virologic test (e.g. p24 AG, Nucleic Acid Test (NAT/NAAT) or viral culture). All viral load (detectable and undetectable) test results.*12 *13, 14					3 days
Human immunodeficiency virus (HIV) Exposed Newborn – infant < 18 months of age born to a HIV infected woman			X		All HIV test results (e.g., positive or negative immunoassay, positive or negative virologic tests) for those < 18 months of age					3 days
Human papillomavirus (HPV) associated laryngeal papillomas or recurrent respiratory papillomatosis in children < 6 years of age *75			X		HPV DNA				X
Human papillomavirus (HPV) – anogenital papillomas in children < 12 years of age *75			X		HPV DNA				X
Human papillomavirus (HPV) ONLY physicians licensed as pathologists need report as directed under Laboratory Reporting*14 	Practitioner Reporting Not ApplicableX				HPV DNA *31) 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
Influenza	Practitioner Reporting Not Applicable				Influenza virus, all test results (positive and negative) *3				X
Lead poisoning *4, 15 16			X		All blood lead test results (positive and negative) *3, 4, 1516				X
Legionellosis			X		Legionella species				X
Leptospirosis			X		Leptospira interrogans				X
Listeriosis		X			Listeria monocytogenes	X		X
Lyme disease			X		Borrelia burgdorferi				X
Lymphogranuloma Venereum (LGV)			X		Chlamydia trachomatis				X
Malaria			X		Plasmodium speciesfalciparum, P. vivax, P. ovale, P. malariae	X			X
Measles (Rubeola)	X	X			Measles virus *1617	X	X	X
Melioidosis	X	X			Burkholderia pseudomallei	X	X	X
Meningitis, bacterial or, 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 dDisease, includes meningitis and meningococcemia	X	X			Neisseria meningitidis (serogroup needed)	X		X
Mercury poisoning *4a			X		Laboratory results as specified in the surveillance case definition *4afor mercury poisoning				X
Mumps			X		Mumps virus				X
Neonatal Abstinence Syndrome *17				6 months	Neonatal Abstinence Syndrome	Laboratory Reporting Not Applicable
Neurotoxic shellfish poisoning		X			Laboratory results as specified in the surveillance case definition *4a for Neurotoxic shellfish poisoning			X
Pertussis		X			Bordetella pertussis			X
Pesticide-related illness and injury *4			X		Laboratory results as specified in the surveillance case definition *4 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 or human		X			Rabies virus		X	X
Rabies, human		X			Rabiesvirus		X	X
Rabies, possible exposure *18	X	X			Rabies, possible exposure	Laboratory Reporting Not Applicable
Respiratory syncytial virus	Practitioner Reporting Not Applicable				Respiratory syncytial virus, all test results (positive and negative) *3				X
Ricin toxicity	X	X			RicinineRicin toxin (from Ricinus communis castor beans)	X	X	X
Rocky Mountain spotted fever and other Spotted Fever Rickettsioses			X		Rickettsia rickettsii and other Spotted Fever Rickettsia species	X			X
Rubella, including congenital	X	X			Rubella virus *1617	X	X	X
St. Louis encephalitis (SLE) virus neuroinvasive and non-neuroinvasive disease			X		St. Louis encephalitis virus	X			X
Salmonellosis *4b			X		Salmonella species *4b by species serogroup and serotype				X
Saxitoxin poisoning including Paralytic shellfish poisoning (PSP)			X		Saxitoxin				X
Severe aAcute rRespiratory disease sSyndrome-associated with a Coronavirus infection (SARS-CoV) disease	X	X			SARS–associated Coronavirus associated with severe acute respiratory disease(SARS-CoV)	X	X	X
Shigellosis *4b			X		Shigella species *4b 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
Staphylococcus aureus isolated from a normally sterile site	Practitioner Reporting Not Applicable				Staphylococcus aureus isolated from a normally sterile site *321				X
Staphylococcus aureus with intermediate or full resistance to vancomycin (VISA,VRSA)		X			Staphylococcus aureus with intermediate or full resistance to vancomycin (VISA, VRSA); Laboratory results as specified in the surveillance case definition *4.*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 < 65 years, drug sensitive and resistant			X		Streptococcus pneumoniae, all ages, isolated from a normally sterile site *1923				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) *2024			X		Mycobacterium tuberculosis complex *2024	X			X
Tularemia	X	X			Francisella tularensis	X	X	X
Typhoid fever *4b		X			Salmonella Ttyphi *4b	X		X
Typhus fever (epidemicoutbreak)	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 (ChickenpoxChickenPox) *2125			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 (infections by Vibrio species and closely related organismsVibrio infections, other than Cholera)			X		All non-cholera Vibrio species Photobacterium damselae, (formerly V. damsela); Grimontia hollisae (formerly V. hollisae) 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 Lujo, new world Arena, or Congo-Crimean hemorrhagic fever viruses	X	X	X
West Nile virus neuroinvasive and non-neuroinvasive (disease due to)			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 to the Florida Department of Health, Bureau of Public Health Laboratories:

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

b. Hospitals, practitioners and laboratories Persons submitting specimens for reportable laboratory tests to the Florida Department of Health, Bureau of Laboratories, pursuant to subsection 64D-3.031(3)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 the 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 reportable notifiable disease listed in the Table of Reportable Diseases or Conditions to be Reported in this Rule as requested by the Department 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 Reportable Notifiable Diseases or Conditions to be Reported in this rule.

*2 – Include MIC (minimum inhibitory concentration), zone sizes for disk diffusion; MICs for E-test or agar dilution and interpretation (susceptible, intermediate, resistant).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 – Paper reports are not required. Applies only to laboratories performing electronic laboratory reporting as described in subsection 64D-3.031(5), F.A.C.

*4 – a. Surveillance Case Definitions for Select Reportable Diseases in Florida, 2014.

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

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

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

*64 – All CD-4 absolute count and percentage of total lymphocytesCD4s, with or without confirmed HIV infection.

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

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

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

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

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

*1110 – Special reporting requirements for Hepatitis B (acute and chronic), C (acute and chronic), D, E, G:

a. Positive results should be accompanied by any hepatitis testing conducted (positive and negative results); and

b. a All serum aminotransferase levels, and if applicable, pregnancy test result or if testing is conducted as part of a pregnancy panel. For laboratories performing electronic laboratory reporting as described in subsection 64D-3.031(5), F.A.C., all test results performed (positive and negative) are to be submitted, including screening test results (positive and negative).

*1211 – 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.

*1312 – 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 testing (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 Public Health Laboratories, 1217 Pearl Pearle Street, Jacksonville, Florida 32202-3926 or 1325 NW 14th Avenue, Miami, Florida 33125.

c. Laboratories electing to send a blood specimen will contact the Incidence and Resistance Coordinator, HIV/AIDS and Hepatitis Section, Florida Department of Health, Bureau of Laboratories at [phone][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.

*1413 – If a genotype is performed, the fasta files containing the nucleotide sequence data, including the protease and reverse transcriptase regions must be reported.

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

*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 Section 64D-3.031(5)(b), F.A.C., once Electronic Laboratory Reporting is initiated with the Department, all reports should be made electronically.

*1516 – Special reporting requirements for reporting blood lead tests:

a. All blood lead tests are considered evidence of a suspected case and are to be reported electronically 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. Results produced by on-site blood lead analysis devices (i.e., portable lead care analyzers or other portable deveices used to perform blood lead analysis) less than 10 µg/dL must be reported within 10 business days.  Electronic reporting of results is preferred. All such reports must be received by the Department electronically.

*1617 – IgM serum antibody or viral culture test orders for measles (rubeola) or rubella should be reported as suspect immediately, but not IgG orders or results.

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

*18 – Exposure to Rabies, as defined in Rule 64D-3.028, F.A.C., Includes a bite or other significant exposure to a human or domestic animal (including all pets and livestock) by an animal:

a. tThat results in rabies prophylaxis for the person exposed, rabies testing, isolation, 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 Section 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.

*1923 – Special reporting requirements Ffor Streptococcus pneumoniae test results associated with persons older than 5 years, only electronic reporting is required, in accordance with subsection 64D-3.031(5), F.A.C. :

a. Antibiotic sensitivities must be included.

*2024 – Special reporting requirements for Tuberculosis:

a. Test results must also be submitted by laboratories to the Department of Health, Bureau of Tuberculosis Control Section 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.

*2125 – Special reporting requirements for Varicella (chickenpox) – Besides the information required to be reported in subsection 64D-3.030(3), F.A.C., Ppractitioners shall also provide dates date of varicella vaccination.

Rulemaking Authority 381.0011(2), 381.003(2), 381.0031(8), 384.33, 392.53(2), 392.66 FS. Law Implemented 381.0011(3), (4), (7), 381.003(1), 381.0031(1), (2), (4), (5), (6), (8), 383.06, 384.23, 384.25, 385.202, 392.53 FS. History–New 11-20-06, Amended 11-24-08,_________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Dr. Carina Blackmore, Deputy State Epidemiologist, Division of Disease Control and Health Protection

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: John H. Armstrong, MD, FACS, Surgeon General and Secretary of Health

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: February 05, 2014

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: December 12, 2013