Introducing

1
Introducing LeadCare II
2
Background

• ESA Biosciences, Inc.
• Founded in 1968 by 3 MIT graduates
• ESA Environmental Science Associates
• Developers of ASV
• Anodic Stripping Voltammetry
• ESA and CDC
• ASV technology used to establish lead poisoning
  thresholds in the 1980s
• CDC grant funded the development of LeadCare and
  LeadCare II systems

3
Lead Poisoning Still the 1 Environmental Threat
to Children
The Facts

• The CDC estimates that 300,000 children under
  age six have blood-lead levels greater than 10
  µg/dL

4
Lead Poisoning The Silent Epidemic
There are typically no symptoms, but the
consequences can be dire

• 20-30 of special education caseload in urban
  areas is due to lead poisoning.
• Kids with elevated blood-lead levels are
• 6x more likely to have a reading disability
• 7x more likely to drop out of high school
• Prone to violent behavior

Total US economic impact 43 billion per year
5
Lead Poisoning Still the 1 Environmental Threat
to Children
More Facts

• 80 of confirmed cases of lead exposure are
  Medicaid children.
• 1 in 4 US homes still contain lead.
• 50 of Medicaid children move every 6 months.
• A Medicaid child will live in 4 different homes
  before his/her 2nd birthday.

Chances are at least 1 of these homes is leaded!
6
Point-of-Care Testing is Better Medicine
7
A Real-Life Case Study
Kent County, Michigan

• In January, 2005, Kent County moved its blood
  lead testing from the central lab to 8 WIC
  Clinics.
• The Results

• Real-time results have IMPACT!
• Parents take an awareness of the dangers of lead
  poisoning with them to their new homes.
• Real-time results empower parents to protect
  their children!

8
Healthy People 2010 Initiative
Goal eliminate lead poisoning in children by 2010

• Healthy People 2010 target is to increase
  screening rates of at-risk population to 80
• CDC funded the development of LeadCare II
  specifically to address access issues by bringing
  testing to community settings, where at-risk
  children live and receive care

9
Ohio Information

• Ohio Requirements for Implementing LeadCare II
• Valid CLIA certificate (waiver or higher)
• Complete Application for Clinical Laboratory
  Approval (HEA5808)
• Lisa Zumstein [phone] or
  lisa.zumstein_at_odh.ohio.gov
• Provide 300 annual application fee
• Contact OHIO CLPPP for electronic reporting
• Chris Alexander [phone] or
  chris.alexander_at_odh.ohio.gov
• Sign up for WSLHs Free Blood Lead Proficiency
  Program
• Call [phone] to sign up.

10
Ohio Information
Ohio Department of Health Lead Poisoning
Prevention Program Application for Clinical
Laboratory Approval 1. Check one only ? New
application ? Renewal Approval
______________________ 2. Application, including
check shall be typed and sent to the Ohio
Department of Health, Attn Revenue
Processing Unit, P.O. Box 15278, Columbus, OH
43215. 3. Checks shall be made payable to
Treasurer, State of Ohio, for the amount of Three
Hundred Dollars (300.00) for new and
renewal applications. 4. Applicant Information
5. Is the laboratory in possession of a current
Clinical Laboratory Improvement Admendments
(CLIA) certification? ? Yes ? No If
yes, please provide proof, i.e. a copy of letter
acknowledging receipt of your application. 6. Do
you agree to forward a copy of the labs
performance results in the CLIA certification
program to the Ohio Department of Health every
four months? ? Yes ? No 7. Do you agree
to comply with the recordkeeping requirement of
rules 3701-30-05 and 3701-32-14 of the Ohio
Administrative Code? ? Yes ? No 8. Do
laboratory employees at least meet the CLIA
Personnel qualification requirements? ? Yes ?
No
11
Ohio Reimbursement
CPT Code 83655 (add QW for Medicaid)
12
Kentucky Information

• Kentucky Requirements for Implementing LeadCare
  II
• Valid CLIA certificate (waiver or higher)
• Contact KY CLPPP
• Krista L. Bailey
• Tel [phone], Ext 3527
• Email kristal.bailey_at_ky.gov
• Note KY currently only requires reporting of
  elevated levels

13
Kentucky Reimbursement
CPT Code 83655 (add QW for Medicaid)
14
LeadCare II Easy as 1-2-3

• 1. Collect 2. Dispense
  3. Test

15
LeadCare II It Changes Everything!
early detection early intervention healthy
bodies sharp minds

• a truly innovative application of technology to
  an entirely important public health challenge.
  Admiral John Agwunobi, MD

3 minutes 2 drops of blood 1 visit 0 loose
ends
Accurate, on-the-spot lead testing Improves
health outcomes Saves money More children
screened!