Fla. Admin. Code R. 64D-3.031

Current through Reg. 50, No. 235-239, December 10, 2024

Section 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.

Fla. Admin. Code Ann. R. 64D-3.031

Rulemaking Authority 381.0011 (2), 381.003 (2), 381.0031(7), (8), 384.33, 392.66 FS. Law Implemented 381.0011, 381.003, 381.0031(2), 384.25(1), 392.53(1) FS.

New 11-20-06, Amended 11-24-08.