Mark W. Linder PhD.

, DABCC
Executive Vice President Associate Professor, Pathology and Laboratory Medicine, University of Louisville School of Medicine

‡ Maintain Quality, Integrity, and Availability of

LDT¶s

‡ Medical Director Qualifications and Training

‡ COMACC, CP Boards ‡ Accountability

‡ Compliance with CLIA (e.g. Subpart K) ‡ Guidance Documents (e.g. CAP, AMP) ‡ Maximize effectiveness of existing law and practices.

‡ Revision of regulatory environment should include:

‡ ‡ ‡ ‡ ‡

Representation of Laboratory Medical Directors Not to exceed current norms Focus on protecting interests of patients Reconcile, consolidate and clarify regulatory authority Avoid disruption of current qualified activities

‡ (Recognition of current CLIA certified services)

‡ Allow for post-market credentialing