Total Lab Care
Laboratory Consulting Services

Regulatory:

CLIA and Accreditation Forms
TLC ensures your laboratory obtains the correct CLIA Certificate by assisting in completing the CMS-116. TLC explains, complete with a cost analysis and a list of pros and cons, the differences in a Certificate of Compliance and a Certificate of Accreditation. If you choose to obtain a Certificate of Accreditation, TLC assists your laboratory in completing all necessary registration forms.

Proficiency Testing Analysis
TLC provides your laboratory with a Proficiency Testing Analysis with recommendations as to which Proficiency Testing Provider your laboratory should choose. TLC assists your laboratory in completing all necessary paperwork to enroll in Proficiency Testing.

SOP, OSHA, Lab Use Guidelines and Quality Assessment Manuals
TLC audits the daily operations of your laboratory and customizes all Standard Operating Procedures, OSHA, Lab Use Guidelines and Quality Assessment Manuals in accordance with federal, state and local regulations. Once these materials have been accepted and approved, TLC will train your laboratory staff to ensure proper implementation.

CLIA Final Rule Verification
CMS published the CLIA “Final” Regulations in January 2003 with an effective date of April 24, 2003. TLC will ensure that your laboratory is compliant with the “Final” regulations via complete and approved Method Validation Studies for accuracy, precision, reportable range and reference range, along with required calibration verification.

Regulatory Updates
TLC provides Technical Bulletins that will keep you up to date on technical and regulatory changes that may affect your laboratory.