CLIA Connect
The CLIA Connect program provide laboratory directors (MD/DO/PhD), technical and clinical consultants to meet federal and state regulatory requirement including California and New York. Personnel requirement is confusing for a number of reasons, let us assist you to ensure the lab have qualified personnel to meet federal and state requirements.
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
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
Inspection Prep
As the COVID cases dramatically dropping nationwide, accrediting agencies and CLIA offices are resuming routine inspection. Laboratories that had ramped up quickly during COVID-19 might find themselves unprepared for inspections due to staff shortage and increased workload. The Inspection Prep programs help the lab identified deficiencies and work on resolving the deficiencies even if those deficiencies cannot be resolve as it occurred in the past the lab still will have an improvement plan in place to show the inspector.
- Initial review including test menu, package insert, existing documentations.
- On-site or remote audit
- Gap analysis
- Provide laboratory with resolution and improvement plan
Regulatory Service
Inspection preparation and deficiency response (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 assistant with laboratory Developed Tests (LDTs) Validation (Ex. body fluid chemistry)
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
Create and revised SOPs following CLSI standards and templates
Completing CLIA, CAP, COLA and State application
Validation of assistant with laboratory Developed Tests (LDTs) Validation (Ex. body fluid chemistry)
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 a cost reduction strategy
Comprehensive laboratory testing strategy
Data analytics on quality metrics
Create a cost reduction strategy
Comprehensive laboratory testing strategy