1	CLSI Equivalent Quality Control Workshop Option 4 Proposal Luann Ochs Roche Diagnostics Chair, CLSI Evaluations Protocols Area Committee Chair, AdvaMed CLIA Working Group
2	History AdvaMed CLIA WG met with CDC, CMS, FDA on May 12, 2004 to discuss CLIA EQC options from Jan ’04 Surveyor’s Guidelines Followed up with letter on June 8, 2004, requesting establishment of a process for obtaining clearance/approval for product-specific quality control protocols (Option 4)
3	Option 4 – Manufacturer Validation of Alternative Quality Control AdvaMed proposal: A manufacturer validates an alternative quality control protocol for a specific product If FDA agrees that the validation shows that the alternative is equivalent to traditional QC, then Labs may use the alternative QC instead of the CLIA-mandated QC
4	Alternative QC – What is Validation? Prove that the alternative QC mitigates risk: Perform risk assessment Determine how to mitigate the risk Prove it works Submit the data to FDA for review and approval
5	CMS Responds Judy Yost scheduled series of meetings including FDA, CDC, AdvaMed, CLSI, AACC Wanted to obtain input from various stakeholders Led to decision to hold workshop
6	Workshop Participants Moderator, Dr. Robert Habig Intro and Goals, Dr. Thomas Hearn History of QC, Dr. Joe Boone, CDC CLIA QC Options, Judy Yost Risk Management, Dr. Don Powers Lab Issues, Dr. Valerie Ng What is Quality? Dr. James Westgard Personnel Issues, Elissa Passiment Technology Variations, Dr. Fred Lasky Option 4 and CLSI Documents, Luann Ochs
7	Breakout Sessions Regulations – Judy Yost Laboratory – Dr. Valerie Ng Option 4 – Luann Ochs
8	What’s Next Prepare CLSI Standard for Validation of QC (consensus guidance) Brainstorm what else can be done to improve lab quality (AACC, CMS, FDA, Industry) Possible CLSI documents focusing on laboratory quality systems, risk management
9	QC Validation Subcommittee Members Chair, Greg Cooper, Bio-Rad George Brotea, PhD, Ortho Clinical Fred Lasky, PhD, Genzyme Dai J. Li, MD, FDA Gregory Makowski, PhD, Univ of Connecticut Curtis Parvin, PhD, Washington Univ George Plummer, Dade Behring Jeffrey Vaks, PhD, Beckman Coulter Rhonda Whalen, CDC >40 Advisors and observers
10	CLSI Document Process Month 0, Authorization Month 1, First S/C meeting Month 9, S/C Vote Month 10, A/C Vote Month 11, Distribute P-level document Month 12, Delegate vote, Board review, 90-day consensus review Month 15, Second S/C meeting Month 18, Document edited Month 19, S/C Vote Month 20, A/C Vote Month 21, Board Vote Month 22, Distribute A-level document
11	Validated Alt-QC is the Foundation Any alternative QC protocol determined by using this document will serve as the foundation for quality control by the laboratory. Laboratory directors will still need to consider whether the alternative QC is appropriate for the conditions in their laboratory.
12	Validated QC is the Future CAP Today, 4/20/05: Dr. Steven Sarewitz, MD, CAP Laboratory Accreditation Program checklist commissioner: “…believes the Option 4 project will be the consensus document upon which the CMS will build much of its future foundation for QC. “In fact, I think the future of EQC is riding on this process,” he says.”