clinical case management and nc lead...2020/04/05 · testing and follow -up schedule for that risk...
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Melanie Napier (919) [email protected] Childhood Lead Poisoning
Prevention Program
Clinical Case Managementand NC LEAD
Statewide web-based systemClinical and environmental case management
Who should be tested and when?
Children ages 1 and 2, at well-child visits** Required for Medicaid-enrolled
AdopteesAt initial assessment
Refugees, ages 6 months to 16 yearsAt initial assessment and 3 months after
placement in housing
NC Case Definitions§ 130A-131.7.
Elevated blood lead level (EBL) – a blood lead concentration of 5 micrograms per deciliter or greater determined by the lower of two consecutive blood tests within a 12-month period. (5 - 9 µg/dL)
Confirmed lead poisoning (CLP) – a blood lead concentration of 10 micrograms per deciliter or greater determined by the lower of two consecutive blood tests within a 12-month period. (≥10 µg/dL)
How to collect initial capillary sample
“Wash the child’s hands thoroughly with soap and water, and then dry them with an appropriate towel.
THEN
Clean the ball or pad of the finger to be punctured with the alcohol swab. Dry the fingertip using the sterile gauze or cotton ball.”
Source: CDC Capillary Blood Sampling Protocol
When to collect diagnostic samples
Initial Test Result (µg/dL)
Perform Diagnostic Test on Venous Blood Within:
5-9 3 months10-19 1 month20-44 1 week45-59 48 hours60-68 24 hours≥70 Immediately,
as an emergency lab testPoint of care / Leadcare:
≥5 Immediately
The state requires the immediate collection of a diagnostic specimen for analysis by an outside reference laboratory* – without any repeat analysis using the POC analyzer before sending the diagnostic specimen out.
POC Lead AnalyzersDiagnostic (i.e., Confirmation) Testing
* CLIA certified laboratory using an analytical method categorized by CLIA as a high complexity test.
What about follow-up samples?
Capillary okLeadcare Analyzer ok
If a follow-up test falls in a higher risk category, need to
collect a diagnostic test for that higher risk category
(a) All laboratories doing business in this State shall report to the Department all environmental lead test results and blood lead test results for children less than six years of age and for individuals whose ages are unknown at the time of testing. Reports shall be made by electronic submission within five working days after test completion.
§ 130A-131.8. Laboratory Reports.
Point of Care (POC)Blood Lead Analyzers
Clinical Laboratory Improvement Amendments (CLIA) designates facilities using a POC lead analyzer as a laboratory.
POC Lead AnalyzersProtocol
Collect initial capillary specimen using LeadCare Analyzer. Follow proper hand washing protocol.
If initial result < 5 If initial result ≥ 5
Immediately collect diagnostic specimen – send to an outside reference laboratory for analysis.
Do not use LeadCare Analyzer for diagnostic tests
Follow the recommendations on the testing and follow-up schedule:
• Report blood lead test results to parents.
• Educate parents about lead sources.
Report blood lead test results to NC CLPPP.
POC Lead AnalyzersProtocol, cont’d
If diagnostic result ≥ 5
1. Complete Form 3651 (Exposure History of Child With Elevated Blood Lead Level) and fax a copy to (919) 841-4015.
2. Contact Environmental Health at the local health department for mandated environmental follow-up.
3. Follow the recommendations on the testing and follow-up schedule for that risk category.
If diagnostic result is in a higher risk category
1. Collect another diagnostic specimen, based on the higher risk category – send to an outside reference laboratory for analysis. Do not use LeadCare Analyzer for diagnostic tests.
2. If the diagnostic result is also in the higher risk category, follow the recommendations on the testing and follow-up schedule for the higher risk category.
Form 3651
Find the latest LeadCare Reporting Template on our website:https://ehs.ncpublichealth.com/hhccehb/cehu/lead/bloodleadanalyzers.htm
LeadCare Reporting
Contact Tena Hand to get set up with a
secure FTP account
LeadCare Reporting
Required data elements
Child's full nameDate of birthSex, Race, EthnicityAddressMedicaid number, if any
State LabLabCorp
Mayo
Commercial and Point of Care Labs
ReformatRecodeDirect
Feed
How does it work?
Clinical Workflow Overview
Blood lead test results
Case Processor Workflows
Follow-up is based on the truncated test result
Note: Test results are truncated to a whole number. For example, test results ≥4.0 to 4.9 µg/dL are truncated to 4 µg/dL.
All follow-up actions are based on the truncated value of 4
Workflow Queues
Workflow Queues
Workflow Details
Lab Results Tab
Surveillance Reports
Surveillance Reports
• Review children in need of diagnostic or follow-up testing, environmental referral
• Make sure all results have been reported
• FAX a copy of missing lab reports to confidential FAX (919) 841-4015
Surveillance Report
Event Print
• Delay in processing files• Name, date of birth didn’t
match• Laboratory reporting issue that
needs to be handled
Missing results?
Missing results?Name Birth Date Test Date ResultDoe, Jane 05/01/2018 07/05/2018 15 Doe, Jane 05/01/2016 07/18/2018 13Doe Smith, Jane
05/01/2016 09/01/2018 9
Smithdoe, Jane
05/10/2016 10/08/2018 7
Doe, Jone 05/01/2016 11/14/2018 5
Environmental ReferralElevated blood lead level (EBL) – a blood lead concentration of 5 micrograms per deciliter or greater determined by the lower of two consecutive blood tests within a 12-month period. (5 - 9 µg/dL)
Confirmed lead poisoning (CLP) – a blood lead concentration of 10 micrograms per deciliter or greater determined by the lower of two consecutive blood tests within a 12-month period. (≥10 µg/dL)
Follow-up Schedule
1. What should happen next?Test Date Result Specimen
TypeLaboratory
08/21/2018 8 C Any lab
03/18/2019 6 V State Lab
Environmental Referral
• When there are two consecutive test results ≥ 5 within 12 months
• Form 3651: Evaluation of Child with Elevated Blood Lead Level
Test Date Result Specimen Type
Laboratory
08/21/2018 8 C Any lab
03/18/2019 6 V State Lab
Follow-up Testing
Follow-up testing every 1-3 months until two consecutive tests < 5
Test Date Result Specimen Type
Laboratory
08/21/2018 8 C Any lab
03/18/2019 6 V State Lab
Test Date Result07/05/2018 8 07/18/2018 609/18/2018 12
2. What should happen next?
Test Date Result07/05/2018 8 07/18/2018 609/18/2018 12
Diagnostic test needed
Diagnostic test needed based on higher risk category
Test Date Result07/05/2018 8 07/18/2018 6 V09/18/2018 1209/20/2018 13 V
Confirmed Lead Poisoning
Refer to local health department for required environmental investigation.
3. Is this a confirmed case?Date Result Specimen
TypeLaboratory
12/16/2018 10 V LabCorp
4. Is this a confirmed case? What should happen next?
Test Date Result Specimen Type
Laboratory
12/16/2019 7 C Point of care (POC)
01/07/2020 10 C State Lab
Diagnostic test neededTest Date Result Specimen
TypeLaboratory
12/16/2019 7 C Point of care (POC)
01/07/2020 10 C State Lab
Diagnostic test needed based on higher risk category
5. Is additional testing necessary? Why?
Test Date Result Specimen Type
Laboratory
12/16/2019 7 C Point of care (POC)
01/07/2020 1 V State Lab
If age 1, retest at age 2
…unless there is reason to believe the child faces increased risk for lead exposure
Test Date Result Specimen Type
Laboratory
12/16/2019 7 C Point of care (POC)
01/07/2020 1 V State Lab
6. Is this a confirmed case?Test Date Result Specimen
TypeLaboratory
12/16/2019 7 C Point of care (POC)
01/07/2020 5 C Point of care (POC)
No - LeadCare Analyzer should not be used for diagnostic tests
Test Date Result07/21/2018 11 10/23/2019 12
7. Tricky question
Test Date Result07/21/2018 11 10/23/2019 12
Diagnostic test needed
Diagnostic test needed
Does not meet state definition of confirmed ≥10 because test results are not within 12 months of each other
What should happen next?
Date Result Specimen Type
Laboratory
12/16/2019 7 C any
The family was sent to the hospital for a venous test. The family comes back for
another appointment on February 5th 2020 -but no venous test was done.
Use the opportunity to collect a diagnostic venous specimen at this visit.
What should you do once a child is confirmed to have a
lead level ≥ 5?