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CLIA Connect and Lab Startup

The Lab Startup program is designed to simplify the lab startup process, the follow services are provided:
  • ​Completion of CMS-116 form
  • Completion of state application if necessary
  • ​Completion of accreditation documents if necessary
  • Test menu and instrument/methodology selection 
  • Provided customized procedures to meet CLIA requirements (Proficiency testing, Fire/safety/biohazard management, quality management system (pre-analytical, analytical and post-analytical)
  • Review and format validation study
  • Enrollment in proficiency testing
  • Provide personnel to meet CLIA requirement (Director, clinical/technical consultant/technical supervisor)
  • Mock inspection and audit

The Lab Startup program had successfully helped startup, both COVID-19 molecular and antibody testing labs in different state. The average time to obtain a CLIA number is 2 weeks.

The CLIA Connect program helps laboratories find CLIA medical directors (MD/DO/PhD), technical and clinical consultants to meet federal and state regulatory requirement. Personnel requirement is confusing for a number of reasons, let us assist you to ensure the lab have qualified CLIA personnel. 

College of American Pathologists (CAP) Personnel Requirements by Testing Complexity
https://webapps.cap.org/apps/docs/laboratory_accreditation/build/pdf/personnel_requirements_by_testing_complexity.pdf

COLA Personnel Requirement by Testing Complexity 
https://www.colacentral.com/files/pdf/LabGuide4.pdf

Joint Commission Personnel Requirement by Testing Complexity 
https://www.jointcommission.org/-/media/deprecated-unorganized/imported-assets/tjc/system-folders/topics-library/clia_required_personnel_qualificationspdf.pdf?db=web&hash=EB925F656724FE6D610624CB0BDB2748

Other Services

Inspection/Compliance related services:
Inspection preparation (CA State LFS, CAP, COLA and Joint Commission)
Create and revised SOPs following CLSI standards and templates
Completing CLIA, CAP, COLA and State application
Validation of common laboratory Developed Tests (LDTs) Validation (Ex. body fluid chemistry)
Create Individualized Quality Control Plan (IQCP)
Customize competency assessment template that seamlessly integrated into laboratory workflow
Validation of new analyzers and assays
Setup quality management plan and proficiency testing program
On-going remote proficiency testing and QC monitoring service

Consulting Service:
Six Sigma/Lean and workflow optimization
Data analytics on quality metrics 
Create cost reduction strategy

Past Consulting Projects:

Startup both COVID-19 PCR and antibody testing labs
Creating business plan for COVID-19 testing
​Individualized Quality Control Plan (IQCP) for hospital laboratory to meet regulatory requirement and reduced QC cost
Validation Plan for chemistry, immunoassay, urinalysis, hematology, coagulation and blood bank instrumentation
Provide collection tube validation for laboratory to meet regulatory requirement 
Prepare laboratory for full California State Laboratory Field Service (LFS) inspection
Serve as consultant for an out of state corporation that want to establish laboratory operation in California
Serve as CLS consultant on Non-Diagnostic General Health Assessment Supervisory committee for a community health center
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