CLIA Lab Consultant
  • Home
  • Lab Startup
  • Services
  • Blog
  • Home
  • Lab Startup
  • Services
  • Blog
Search
Picture

CLIA Lab Consultant

CLIA Lab Consultant provides comprehensive consulting services to clients in AI, biotechnology, concierge medicine, digital pathology, Contract Research Organizations (CROs), in-vitro diagnostics companies, pharmaceuticals, physician offices, reproductive and fertility centers, university incubators, and urgent care facilities. We serve clients across the United States as well as international locations, including Europe, Canada, and Asia. Our expertise spans technical, regulatory, managerial, technological, and financial consulting, delivering tailored solutions to meet the unique needs of each organization.


The lab startup program had helped over 100 labs obtain CLIA and state licenses.

Based in Los Angeles, we specialized in California (LFS - Lab Field Services) regulations, we have successfully started up more than 50 California labs (waived, moderate and high complexity).

Other Services: Inspection preparation/response. We had extensive experience working with COLA STAT (Staff Technical Accreditation Team) and CA LFS response.
​

The CLIA Connect program helps laboratories recruit personnel to fulfill CLIA and state requirements
Lab Director (MD/PhD), Technical supervisor and consultant
. The programs also included lab director licensed in California and New York.

California waived lab director program had over 20 waived labs in California.

​The Inspection Prep program had helped labs successfully passed CAP, CLIA, COLA, Joint Commission and California state audit.


Email:
[email protected]
Phone:
626-236-2706

For Laboratory Continued Education visit us on Acorn CE
https://acornce.com/
For CLIA certified and California licensed clinical lab with mobile specimen collection and biorepository visit us 
Acorn Laboratory
https://acornlaboratory.com/
Picture
Regulatory/Compliance
  • Inspection preparation (CLIA, CAP, Joint Commission, COLA, CA State LFS)
  • Completing CLIA, CAP, COLA and state application
  • Validation of new analyzers and assays including Lab Developed Tests (LDTs)
  • Creating Individualized Quality Control Plan (IQCP)
  • CLSI competency assessment template that meet CLIA 6 elements requirement
  • Quality management, document control and proficiency testing program


Picture


Consulting
  • Six Sigma/Lean and workflow optimization
  • Data analytics on quality metrics 
  • Create cost reduction strategy
  • Customized procedure, safety and chemical hygiene plan based on CLSI/CAP
  • On-going technical support 


​
Picture
CLIA Connect
  • To connect laboratory with lab director, technical/clinical consultant to meet CLIA requirement
  • ​Ensure laboratory have the right personnel to meet federal and state requirement

Trusted Biotech, IVD, Healthcare and International Partners

Submit
Copyright © 2020 CLIALabConsultant.com
Photos from mikecohen1872, EpicTop10.com, mignon.jacques Homedust
  • Home
  • Lab Startup
  • Services
  • Blog