The purpose of these changes is to remove lower-priority diseases that are currently reportable to the Department of Health by physicians, hospitals and/or laboratories from the list of reportable diseases. Cases of reportable diseases are tracked ...

DEPARTMENT OF HEALTH
Division of Disease Control

Rule No.: RULE TITLE
64D-3.029: Diseases or Conditions to be Reported
64D-3.031: Notification by Laboratories
PURPOSE AND EFFECT: The purpose of these changes is to remove lower-priority diseases that are currently reportable to the Department of Health by physicians, hospitals and/or laboratories from the list of reportable diseases. Cases of reportable diseases are tracked and investigated by the Department of Health for the purposes of preventing additional cases and disease outbreaks.
SUMMARY: Subject area to be addressed: Communicable disease monitoring. The following diseases will be removed from the list of reportable diseases: Encephalitis, other (non-arboviral); Meningitis, bacterial, cryptococcal and mycotic; Streptococcal disease, invasive Group A; Toxoplasmosis; Typhus fever (endemic).
The following diseases will have clarifications to their reporting requirements: Creutzfeldt-Jakob Disease; Hepatitis C, chronic; Haemophilus influenzae, meningitis and invasive disease; Lead poisoning; Rocky Mountain Spotted Fever; Vibriosis; Streptococcus pneumoniae, viral hemorrhagic fevers.
Central-line-associated bloodstream infections in hospitalized patients are made reportable by giving DOH access to reports already being made by hospitals to the US Department of Health and Human Services (HHS).
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No statement of estimated regulatory cost was prepared. The proposed amendment will lower compliance costs to regulated entities.
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: 381.0031(6) FS.
LAW IMPLEMENTED: 381.0031(6) 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: Monday, January 24, 2011, 11:00 a.m. EST
PLACE: Florida Department of Health, 2855 Merchants Row Blvd., Prather Bldg., Room 320P, Tallahassee, Florida
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Janet J Hamilton, Surveillance and Reporting Section Administrator, Florida Department of Health, Bureau of Epidemiology, 4052 Bald Cypress Way, Bin A-12, Tallahassee, FL 32399, [phone]

THE FULL TEXT OF THE PROPOSED RULE IS:

64D-3.029 Diseases or Conditions to be Reported.

(1) Diseases or conditions listed in subsection (3) below are 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 or conditions not listed by rule.

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

(a) “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,” 2011 August 2008, incorporated by reference, available online at: http://www.flrules.org/Gateway/reference.asp?No=Ref-00086.

(b) “Suspect Immediately” – A notifiable condition of 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 an infectious or non-infectious 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 cases, clusters, or outbreaks spread those indicative of person-to-person, by animals or vectors or from an 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 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 part 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 possibly due to unidentified infectious causes.		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, 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				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
Central Line-Associated Bloodstream Infection in a hospitalized patient *4				X*4	Not applicable
CD-4	Not Applicable				CD-4 absolute count and percentage of total lymphocytes*5 4					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*6 5			X		Chlamydia trachomatis				X
Cholera	X	X			Vibrio cholerae	X	X	X
Ciguatera fish poisoning (Ciguatera)			X		Not Applicable
Congenital anomalies*7 6				6 Months	Not Applicable
Conjunctivitis in neonates < 14 days old			X		Not Applicable
Creutzfeld-Jakob disease (CJD) *8 7			X		14-3-3 and tau protein from CSF or any brain pathology suggestive of CJD*8 7				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			X		Anaplasma phagocytophilum, Ehrlichia chaffeensis, or E. ewingii	X			X
Ehrlichiosis/Anaplasmosis undetermined or unspecified			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*9 8		X			Escherichia coli *9 8			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*6 5			X		Neisseria gonorrhoeae				X
Gonorrhea in pregnant women and neonates			X		Neisseria gonorrhoeae				X
Gonorrhea (Antibotic Resistant)			X		Neisseria gonorrhoeae*10 9				X
Granuloma Inguinale			X		Calymmatobacterium granulomatis				X
Haemophilus influenzae, meningitis and invasive disease, in a person aged equal to or less than 5 years old	X	X			Haemophilus influenzae in a specimen from a normally sterile site, all ages *11	X	X	X
Hansen disease (Leprosy)			X		Mycobacterium leprae				X
Hantavirus infection		X			Hantavirus	X		X
Hemolytic uremic syndrome		X			Not Applicable
Hepatitis A*12 10		X			Hepatitis A*12 10			X
Hepatitis C, acute symptoms of viral illness			X		Hepatitis C, acute*12 10				X
Hepatitis C, chronic	Not applicable				Hepatitis C, chronic *12 10				X
Hepatitis B, C, D, E and G Virus*12 10			X		Hepatitis B, C, D, E and G Virus*12 10				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 with disseminated infection with involvement of liver, encephalitis and infections limited to skin, eyes and mouth*13 11			X		HSV 1 or HSV 2 by direct FA, PCR, DNA or Culture* 13 11				X
HSV  anogenital in children < 12 years of age*6 5*13 11			X		HSV 1 or HSV 2 by direct FA, PCR, DNA or Culture*13 11				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*13 13*15 13					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*6 5			X		HPV DNA				X
HPV  anogenital in children <12 years of age*6 5			X		HPV DNA				X
Human papillomavirus ONLY physicians licensed as pathologists need report as directed under Laboratory Reporting* 16 14 			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)*17 15 2) Abnormal cervical and anogenital cytologies consistent with “Bethesda 2001 Terminology”*18 15 3) Abnormal histologies including*17 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*18 16			X		All blood lead test results*18 16				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*19 17	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*20 18	X	X			Not Applicable
Ricin toxicity	X	X			Ricin toxin (from Ricinus communis castor beans)	X	X	X
Rocky Mountain spotted fever and other closely related Spotted Fever Rickettsiosis			X		Rickettsia rickettsii and other Rickettsia spp. found to cause spotted fever rickettsiosis; including but not limited to: Rickettsia aeschlimannii, R. africae, R. australis, R. conorii, R. heilongjangensis, R. helvetica, R. honei, R. japonica, R. marmionii, R. massiliae, R. mongolotimonae, R. parkeri, R. siberica R. slovaca	X			X
Rubella, including congenital	X	X			Rubella virus*19 17	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*21 19			X		Staphylococcus aureus - community associated mortality*22 20	X
Not Applicable					Staphylococcus aureus isolated from a normally sterile site *23 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. *24 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 *25 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) *26 24			X		Mycobacterium tuberculosis complex*26 24				X
Tularemia	X	X			Francisella tularensis	X	X	X
Typhoid fever		X			Salmonella typhi	X		X
Typhus fever (epidemic or louse-borne 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) *27 25			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 organisms, (Vibrio infections, other than Cholera)			X		All non-cholera Vibrio species including, V. alginolyticus, V. fluvialis, V. furnissii, , V. mimicus, V. parahaemolyticus, V. vulnificus Photobacterium damselae, (formerly V. damsela) Grimontia hollisae (formerly V. hollisae)	X			X
Viral hemorrhagic fevers	X	X			Ebola, Marburg, Lassa, Machupo Lujo viruses, a new world Arenavirus, or Congo-Crimean hemorrhagic fever	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, 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-3.003(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–              Notification within six months of diagnosis and within six months of each treatment.

Exceptions are located in Rule 64D-3.038, F.A.C.

*4–              Special reporting requirements for Central Line-Associated Bloodstream Infection (CLABSI)– Reporting applies only to hospitals that choose to participate in the Centers for Medicare and Medicaid Services Hospital Inpatient Quality Reporting Program. Hospitals that participate in this program fulfill reporting requirements of this Rule by the one-time action of conferring rights to join the DOH User Group in the National Healthcare Safety Network (NHSN). This Rule does not require reporting data elements beyond those required by Centers for Medicare and Medicaid Services Hospital Inpatient Quality Reporting Program.

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

*65–              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.

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

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

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

*109–              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.

*11–              Special reporting requirements for Haemophilus influenza: For test results associated with persons greater than 5 years old, paper reports are not required. In accordance with paragraph 64D-3.031(5)(c), F.A.C., once Electronic Laboratory Reporting is initiated with the Department, all reports should be made electronically.

*1210–              Special reporting requirements for Hepatitis A, 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. All serum aminotransferase levels.

*1311–              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.

*1412–              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.

*1513–              If a genotype is performed, the fasta files containing the nucleotide sequence data, including the protease and reverse transcriptase regions must be reported.

*1614–              Practitioners need not report, unless licensed as a pathologist.

*1715–              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)(c), F.A.C., once Electronic Laboratory Reporting is initiated with the Department, all reports should be made electronically.

*1816–              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.

              c. Results less than 10µg/dL produced by on site blood lead analysis devices (i.e., portable lead care analyzers or other portable devices used to perform blood lead analysis) must be reported within 10 business days.

*1917–              IgM serum antibody or viral culture test orders for measles (rubeola) or rubella should be reported as suspect immediately, but not IgG results.

*2018–              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 or quarantine of the animal causing the exposure; or

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

*2119–              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.

*2220–              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].

*2321–              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)(c), F.A.C., once Electronic Laboratory Reporting is initiated with the Department, all reports should be made electronically.

*2422–              Special reporting requirements for Staphylococcus aureus with intermediate or full resistance to vancomycin (VISA, VRSA):

              a. Antibiotic sensitivities must be included.

*2523–              Special reporting requirements for Streptococcus pneumoniae:

              a. Antibiotic sensitivities must be included.

              b. For test results associated with persons greater than 5 years old, paper reports are not required. In accordance with paragraph 64D-3.031(5)(c), F.A.C., once Electronic Laboratory Reporting is initiated with the Department, all reports should be made electronically.

*2624              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.

*2725–              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.

Rulemaking 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 11-24-08,_________.

 

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

 

64D-3.031 Notification by Laboratories.

(1) Each person or designee who is in charge of a public, federal, private, military or hospital laboratory that performs diagnostic tests 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 environmental specimen for collecting the specimen shall report or cause to be reported any laboratory test result suggestive of or diagnostic of diseases or conditions listed in the Table of Notifiable Diseases or Conditions, Rule 64D-3.029, F.A.C., as specified in that rule per this rule.

(2) 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:

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, office 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 an 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, Health Level Seven Specifications for Electronic Laboratory-Based Reporting of Public Health Information, October 1997, 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’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) through (8) No change.

Rulemaking 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 11-24-08,_________.

 

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

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Janet J Hamilton, M.P.H, Surveillance and Reporting Section Administrator

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Julia Gill, Ph.D., M.P.H., Director, Division of Disease Control

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: December 20, 2010

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: December 30, 2010