Fla. Admin. Code Ann. R. 64D-3.031 - Notification by Laboratories
(1) Each person
or designee who is in charge of a public, federal, private, military or
hospital laboratory responsible for receiving the initial order to perform
serologic, immunologic, microscopic, biochemical, molecular or cultural tests
on specimens derived from a human body or an animal or for collecting the
specimen shall report or cause to be reported any laboratory test suggestive of
or diagnostic of diseases or conditions listed in the Table of Notifiable
Diseases or Conditions, Rule
64D-3.029,
F.A.C., per this rule.
(2) Receipt
of a laboratory test order requesting the identification of reportable agents
shall be considered by the laboratory as an indication of suspected diagnosis.
However, laboratories need only to report suspected cases if indicated in the
"suspect immediately" column under laboratories in the Table of Notifiable
Diseases or Conditions, Rule
64D-3.029,
F.A.C.
(3) To allow follow-up of
laboratory findings suggestive of or diagnostic of diseases or conditions in
the Table of Notifiable Diseases or Conditions, the form upon which the
information will be reported shall be furnished by the laboratory that includes
the following information:
(a) The Patient's:
1. First and last name, including middle
initial;
2. Address including
street, city, state and zip code;
3. Phone number, including area
code;
4. Date of birth;
5. Sex;
6. Race;
7. Ethnicity (specify if of Hispanic descent
or not of Hispanic descent);
8.
Pregnancy status if applicable;
9.
Social Security number;
(b) The Laboratory:
1. Name, address and telephone number of
laboratory performing test;
2. Type
of specimen (for example stool, urine, blood, mucus, etc.);
3. Date of specimen collection;
4. Site (for example cervix, eye, etc., if
applicable);
5. Date of
report;
6. Type of tests performed
and results, including reference range, titer when quantitative procedures are
performed, and including all available results on speciating, grouping or
typing of organisms;
7. Submitting
provider's name, address including street, city, zip code and telephone number,
including area code.
8. National
Provider Identification (NPI) Number.
(4) Laboratories located out of state,
licensed under Part I, Chapter 483, F.S., who collect specimens in Florida or
who receive the initial order for testing from a practitioner, blood bank,
plasmapheresis center or other health care provider located in Florida, shall
report in the same way as if the findings had been made by a laboratory located
in Florida.
(5) Upon the
Department's implementation of its Electronic Laboratory Reporting System (ELR)
for laboratory findings suggestive of or diagnostic of diseases or conditions,
reports will be submitted electronically to the Department using Health Level
Seven (HL7) version 2.3.1 format or ASCII delimited flat files which reflect
comparable content to HL 7 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.
(a) The Department's ELR System shall
include:
1. The initial contact with the
reporting laboratory;
2. A content
review and testing of the laboratories' HL7 transmissions; and
3. The transition from testing to production
for the HL7 laboratory transmissions.
(b) The Department and laboratory will agree
on a date of implementation;
(c)
Laboratories reporting electronically through ELR and the Department shall
agree to a date that the transmission of findings suggestive of or diagnostic
of diseases or conditions listed in the Table of Notifiable Diseases or
Conditions, Rule
64D-3.029,
F.A.C., electronically in HL7 version 2.3.1 format to the Department is
acceptable and considered good faith reporting and the laboratory will no
longer be required to submit paper forms pursuant to subsection 64D-3.031(3),
F.A.C.;
(d) The Department shall
ensure access to the laboratory findings suggestive of or diagnostic of disease
or conditions listed in the Table of Notifiable Diseases or Conditions to
authorized representatives of the Department.
(6) This section does not prohibit a
laboratory from making a report by telephone, in writing, or facsimile to the
county health department having jurisdiction for the area in which the office
of the submitting practitioner or the patient's residence is located.
(7)
(a) In
order to study disease incidence, each laboratory licensed to perform tests for
any notifiable disease or condition shall report the test volume for each
related diagnostic test performed for the notifiable diseases listed in Rule
64D-3.029,
F.A.C.
(b) Reports are to be filed
annually on or before April 1 of each year to the Department electronically in
a format agreed upon by the department and the laboratory with the following
information:
1. Type of diagnostic
test;
2. Patient's date of
birth;
3. Patient's sex;
4. Race;
5. Ethnicity (specify if of Hispanic descent
or not of Hispanic descent).
(8) Each laboratory licensed to perform tests
for any reportable disease or condition shall make its records for such
diseases or conditions available for on-site inspection by the Department or
its authorized representatives.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.