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Practitioner Lead Reporting Requirements

Florida Health

Lead Poisoning Prevention

Blood Lead Test Reporting Requirements and Information for Practitioners

This site summarizes the responsibilities of practitioners for blood lead test reporting 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. According to this rule practitioners are required to provide demographic information to laboratories with each blood lead specimen. Practitioners are also required to report blood lead test results to the local county health department (CHD) and the Florida Department of Health, Childhood Lead Poisoning Prevention Program (FL CLPPP). The specific reporting requirements for practitioners are addressed below.

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

 


 

Compilation of Questions About the CDC HAN of LeadCare® Blood Lead Tests Due to Risk of Falsely Low Results

Response

The CDC has sent the Recall of LeadCare® Blood Lead Tests Due to Risk of Falsely Low Results Health Alert to CMS.

Response

Medicaid will pay for re-testing because blood lead screening tests are mandatory services. State Medicaid agencies should recognize the need to pay for re-testing but if any specific issues arise, please contact Mary Beth Hance by email at marybeth.hance@cms.hhs.gov.

Response

While there may be concerns about costs, the risk of a falsely low blood lead level result due to the recall notice is a public health priority; hence re-testing is recommended as stated in the HAN.

Response

LeadCare tests using capillary samples are not as accurate at lower blood lead levels as venous samples tested using high complexity methods (i.e. ICP-MS and GFAAS). In addition, since certain results with LeadCare capillary tests must be confirmed with a high complexity test, there is a concern that parents and caregivers may not have their child get a follow up test. Additionally, because months could have passed since a child got a falsely low result, re-testing with a high complexity method is most expedient.

Response

Per the FDA’s recall notice, customers with questions about this recall should contact Magellan's LeadCare Product Support Team at 1-800-275-0102, or email at LeadCareSupport@magellandx.com.

Response

The HAN was updated on July 6, 2021 to clarify the end date for when tests could have possibly been performed using the recalled test kit lots before the HAN was released.

Response

A joint call is not planned at this time. CDC will continue to monitor the situation and provide updates as needed.

Response

No.

Response

Yes.

Response

We recommend following the re-testing guidance in the July 6, 2021, HAN.

Response

Per the FDA’s recall notice, customers with questions about this recall should contact Magellan's LeadCare Product Support Team at 1-800-275-0102, or email at LeadCareSupport@magellandx.com.

Response

We recommend that the decision to re-test be made by the healthcare provider in consultation with the affected child’s family.

Response

This should be determined by the provider in consultation with the patient’s insurance.

 


Practitioners are responsible for obtaining and providing all of the following information to laboratories at the time the specimen is sent to or received by the laboratory. Supplying this information enables laboratories to fulfill electronic laboratory reporting requirements under Chapter 64D-3.030, F.A.C.

 a) The patient's:

  1. First and last name, including middle initial
  2. Address, including city, state, and zip code
  3. Telephone number, including area code
  4. Date of birth
  5. Sex
  6. Race
  7. Ethnicity (Hispanic / non-Hispanic)
  8. Pregnancy status if applicable
  9. Social Security number

b) Type of specimen (e.g. venous vs. capillary specimen)

c) Date of specimen collection

d) Submitting Provider's:

  1. Name
  2. Address, including street, city, state, and zip code
  3. Telephone number, with the area code of the provider requesting the test

Lead poisoning is a reportable condition in Florida under Rule 64D-3.029, Florida Administrative Code. Local health care providers, laboratories, and public health professionals are required to report all blood lead level results to the CHDs. Blood lead levels measured at 5 µg/dL or greater are indicative of lead poisoning.

a) The patient's:

  1. First and last name, including middle initial
  2. Address, including city, state, and zip code
  3. Telephone number, including area code
  4. Date of birth
  5. Sex
  6. Race
  7. Ethnicity (Hispanic / non-Hispanic)
  8. Pregnancy status if applicable
  9. Social Security number

b) Type of diagnostic tests

c) Type of specimen (e.g. venous vs. capillary specimen)

d) Date of specimen collection

e) Diagnostic test results

f) Treatment given

g) Name, address, and telephone number of the attending practitioner

h) Other necessary epidemiological information requested by the CHD

Chapter 64D-3 F.A.C. authorizes the LPPP to collect the results of all blood lead test results from all practitioners. However, in most cases, Lead poisoning is a reportable condition in Florida under Rule 64D-3.029, Florida Administrative Code. Local health care providers, laboratories, public health professionals, and other point-of-care testers are required to report all blood lead level results to DOH.

Blood lead levels ≥5 µg/dL must be reported to DOH by the next business day. All blood lead levels <5 µg/dL must be reported to DOH within 10 business days.

All reports of blood lead test results must be sent electronically. To send test results electronically, facilities must register using the following link:

https://elrportal.floridahealth.gov/COVID19Antibody/FacilityRequest/RequestForm

Additional instructions will be emailed post registration.

 

All reports must include the following information:

a) The patient's:

  1. First and last name, including middle initial
  2. Address, including city, state, and zip code
  3. Telephone number, including area code
  4. Date of birth
  5. Sex
  6. Race
  7. Ethnicity (Hispanic / non-Hispanic)
  8. Pregnancy status if applicable
  9. Social Security number
  10. Date of onset of symptoms (if applicable)
  11. Diagnosis

b) Type of diagnostic tests

c) Type of specimen (e.g. venous vs. capillary specimen)

d) Date of specimen collection

e) Diagnostic test results

f) Treatment given

g) Name, address, and telephone number of the attending practitioner

h) Other necessary epidemiological information requested by the CHD

*Information on Approved Electronic Reporting Formats:
The Florida Department of Health is developing an Electronic Laboratory Reporting (ELR) system that will make use of HL7 Format. Upon the Department's implementation of its electronic disease surveillance system, reports of diseases or conditions must be submitted electronically to the Department using an application and reporting format provided by the Department. At least nine (9) months in advance of requiring practitioners and laboratories to submit reports electronically in this format, the Department will publish a notice in the Florida Administrative Weekly announcing when electronic reporting will begin. The Department will also notify appropriate professional organizations affected by Chapter 64D-3, F.A.C.

Any practitioner who is subject to the provisions of this rule who fails to report a disease or condition as required by this rule 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, F.S. Each violation is considered a separate offense. All violations by practitioners, hospitals or laboratories shall be reported to the appropriate professional licensing authorities and public financing programs.

*Note: This page contains materials in the Portable Document Format (PDF). The free Acrobat Reader may be required to view these files.