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Laboratory Lead Reporting Requirements
Magellan Diagnostics, Inc. and the U.S. Food and Drug Administration (FDA) have issued a recall notice concerning the use of some LeadCare® Blood Lead Tests (certain LeadCare II, LeadCare Plus, and LeadCare Ultra test kit lots that were manufactured and distributed between October 27, 2020, and June 15, 2021. The use of these devices may cause serious injuries because they might underestimate blood lead levels.
Please refer to the attached FDA recall notice for additional information, instructions, and recommendations for future blood lead testing. Learn more
This page summarizes the blood lead test reporting responsibilities of laboratories as per Chapter 64D-3 of the Florida Administrative Code (F.A.C.), Control of Communicable Diseases and Conditions which may significantly affect public health. The document also provides information on electronic reporting formats, enforcement, and penalties.
Blood Lead Test Reporting Responsibilities of Laboratories
If you have additional questions regarding blood lead test result reporting please contact the Florida Lead Poisoning Prevention Program at (850) 245-4401.
All laboratories must report all blood lead test results with the information listed below by the close of the next business day following laboratory findings. Reports must be sent electronically to the Florida Department of Health, Bureau of Epidemiology, Lead Poisoning Prevention Program (CLPPP). Please note, these requirements also stand for Laboratories located out of state that collect specimens in Florida or that receive an order for blood lead analysis from a practitioner located in Florida.
Information Provided by Laboratories to the Florida Department of Health:
As per Chapter 64D-3, F.A.C laboratories are responsible for providing all of the following information with each blood lead record:
(a) The Patient's:
- First and last name, including middle initial
- Address, including city, state, and zip code
- Phone number, including area code
- Date of birth
- Ethnicity (specify if of Hispanic descent or not of Hispanic descent)
- Pregnancy status
- Social security number
(b) The Laboratory's
- Telephone number of laboratory performing blood lead test
- Type of specimen (for example, venous vs. capillary specimen)
- Date of specimen Collection
- Date of report
- Type of test(s) performed
- All available results
(c) The Submitting Provider's
- Telephone number, including area code
Enforcement and Penalties: Any practitioner, hospital or laboratory who is subject to the provisions of Chapter 64D-3, F.A.Cwho fails to report a disease or condition as required or otherwise fails to act in accordance with this rule is guilty of a misdemeanor of the second degree, and, upon conviction thereof, shall be fined not more than five hundred dollars ($500.00) as provided in Sections 775.082 or 775.083, Florida Statutes. Each violation is considered a separate offense. All violations by practitioners, hospitals or laboratories may be reported to the appropriate professional licensing authorities and public financing programs.