Laboratory Director and CLIA Technical Consultant Services
Every non-waived CLIA laboratory must have a qualified laboratory director, and moderate-complexity labs need a technical consultant (high-complexity labs need a technical supervisor). Sound Lab Consultants helps labs fill and document these roles and carry out the duties CLIA assigns to them.
Roles we support
Laboratory director (moderate and high complexity)
Technical consultant (moderate complexity)
Technical supervisor and general supervisor (high complexity)
Clinical consultant
What the role covers
Review and approval of SOPs and method verifications
QC and proficiency testing review and corrective action
Competency assessment oversight
Delegation-of-duties documentation
Survey support and response to findings
Qualification review
We check personnel against 42 CFR 493 Subpart M and state licensure rules before anyone is listed on the CMS-116.
Related services
CLIA medical laboratory director
CLIA laboratory technical supervisor
Frequently asked questions
Does a waived lab need a laboratory director?
CLIA does not require Subpart M director qualifications for a Certificate of Waiver, though some states have their own rules.
What is a CLIA technical consultant?
The person responsible for the technical and scientific oversight of a moderate-complexity laboratory, including verification, QC, PT and competency.
Can these roles be remote?
Many duties can be performed remotely with documented review; on-site requirements depend on your certificate, accreditor and state.
What does it cost?
Plans start at $500, depending on complexity and test menu.
Sound Lab Consultants, PO Box 2135, Chandler, AZ 85244 (mailing address; we work remotely with labs nationwide).