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Services Provided
College of American Pathologists (CAP) Certification
Clinical Laboratory Improvement Amendment (CLIA) Certification
Clinical Laboratory Improvement Amendment (CLIA) Certification
- Documentation and Inspection Preparation
- Deficiency Responses
- Clinical Lab and Biorepository Accreditation
- Initial and Competency Assessments for Employees
- Mock Inspection & Evaluations
Clinical Laboratory Improvement Amendment (CLIA) Certification
Clinical Laboratory Improvement Amendment (CLIA) Certification
Clinical Laboratory Improvement Amendment (CLIA) Certification
- Documentation and Inspection Preparation
- Competency Assessments
- Deficiency Response
- Filed Complaint Resolution
Occupational Safety and Health Administration (OSHA)
Clinical Laboratory Improvement Amendment (CLIA) Certification
Occupational Safety and Health Administration (OSHA)
- Hazard Recognition and Solutions
- Process Safety Management (PSM) Standard Application
- Chemical Hygiene Plan (CHP)
- Site Inspection and Evaluation
- OSHA Training
Laboratory Information Management Systems (LIMS)
Laboratory Information Management Systems (LIMS)
Occupational Safety and Health Administration (OSHA)
- System Installation & Validation
- Workflow automation
- Instrument Integration
- Sample Management
- 21 CFR Part 11, GMP, ISO 17025, and ALCOA+ guideline implementation
- LIMS Audit
Laboratory Instrumentation
Laboratory Information Management Systems (LIMS)
Laboratory Instrumentation
- Installation Qualification, Operational Qualification, Performance Qualification
- Instrument Documentation, Validation, and Integrations
- Assay Validation
Services Breakdown
- Clinical Laboratory Improvement Amendment (CLIA) Certification: Documentation and
Inspection Preparation
- College of American Pathologists (CAP) Certification: Documentation and Inspection
Preparation, Deficiency Responses. Clinical Lab and Biorepository accreditation.
- Standard Operating Procedure (SOP) Guidance, and Good Documentation Practices (GDP).
- CLIA Laboratory Developed Tests (LDTs) Direction.
- Good Laboratory Practice (GLP) Guidance.
- Training Direction: CAP Required Initial and Competency Assessments for Employees, OSHA
Required Trainings, and Lab Safety Training.
- Internal Review Board (IRB) Protocol and Consent Guidance.
- Laboratory Quality Control and Implementation of Quality Management Protocols:
Documentation, Practices, Code of Federal Regulation (CFR) 21CFR Part 11 compliance.
- Instrument Qualifications: Installation Qualification/Operational Qualification/Performance
Qualification.
- Laboratory Information Management Systems: sLIMS, LabVantage, Ovation, Custom Oracle, BC
Platforms (BC Samplemax and BC Clinical), Quickbase, and MediaLab.
- Molecular Laboratory Quality Control: Functional and analytical: Lunatic/DropSense, BioMark,
NanoDrop, TapeStation, BioMicroLab Volume Check, Brady Thermo Printers and Qbit.
- Laboratory Automation: Hamilton Easy Blood, Hamilton STAR, Chemagic 360, KingFisher Flex,
Brooks Biostore, Automated Cell Counting.
- Laboratory Processes: Nucleic Acid Isolation, Protein Isolation, Cell Culture, and PCR.
- Laboratory High Throughput PCR Set-up: Quantstudio 5, Quantstudio 12K, and BioMark
