The Genetic Testing Quality Assurance Program
Michele Caggana, Sc.D., FACMG Emory University/Centers for Disease Control and Prevention Atlanta, GA May 20, 2004
MY ROLE AS SECTION HEAD
• Approve Certificate of Qualification • Review and Critique Method Validation • Review Non-Permitted Lab Requests • Review Survey Results • Compile Questionnaire Data • Liaison for Counselors, Testing, Coverage • Field Questions About CLEP or the Section • Insurance Companies
Wadsworth Center
INITIAL LABORATORY PERMIT APPLICATION (GETE)
Requirements
• Application Form with Categories • Application Fees $1,100 • SOPM Validation
• Certificate of Qualification Holder/Dir. or Asst.
• Survey and Correction of Deficiencies • Issuance of Permit • http://www.wadsworth.org/labcert/
Wadsworth Center
CERTIFICATE OF QUALIFICATION
Requirements
•Earned Doctoral or Medical Degree •Four Years Post-doctoral Training; 2 in GETE •Knowledge of the Diseases and Methods •Knowledge of Linkage and Bayesian Analyses •Experience or Training in Clinical Laboratory Management May be Restricted to Commensurate Experience
Wadsworth Center
IMPORTANT !!!!
In Genetic Testing: Approvals To Offer Tests Are ANALYTE-SPECIFIC This means that the laboratory has specific approval for each test they perform.
Wadsworth Center
WHAT IF NO LAB IS APPROVED?
•Non-Permitted Lab Request Form
•Test, Patient, Referral Information •Justification for Testing •Urgency
CLEP generates admin letter to the requestor, referral lab, and referring lab
Wadsworth Center
WHAT REQUESTS ARE APPROVED?
•Continuity of Care
•Additional Testing After Approved Lab Has Completed Testing •Compassion
Approvals are not issued for financial reasons
Wadsworth Center
LIMITATIONS
•Referral Laboratory CLIA-approved Non-US -- limited •“Restricted Laboratory Permit” •Up To Fifty Tests Annually For A Given Analyte “The patient, physician, and laboratory must acknowledge that these tests are conducted outside the regulatory oversight of the Clinical Laboratory Evaluation Program and its quality assurance surveillance.”
Wadsworth Center
SOME NUMBERS TO PONDER
•60+ Laboratories with Genetic Testing Category
•224 Approved Certificate of Qualification Holders
•130 Molecular Tests
50+ Biochemical Tests
•620+ SOPM Reviews •1326 Non-Permitted Laboratory Request Reviews
Wadsworth Center