Armadillo Analytical LLC

CLIA Certified Clinical Laboratory Consulting and Training

Specialized in High Complexity Testing with Liquid Chromatography Mass Spectrometry (LC-MS)

Begin your clinical laboratory learning experience from here!

Starting with a free consultation!

Email: armadillo.analytical@gmail.com

Phone : (682) 268-0533‬

Consultant

Dr. Li is a Principal Consultant at Armadillo Analytical LLC. She earned her Ph.D. in Analytical Chemistry, focusing on LC-MS from the University of Texas at Arlington. Her postdoctoral work at Georgia Tech and UT Southwestern helped sharpen her skills in both LC-MS and biomedical research. Since 2022, she’s been actively training and consulting for CLIA-certified clinical labs in hope of applying her skills directly in patient care. She often works with clinical labs that need support with high-complexity clinical laboratory for drug screening.

With over 15 years of hands-on experience in HPLC and mass spectrometry, Dr. Li has helped train countless lab techs and students. She enjoys making complex instruments feel less intimidating and loves helping others troubleshoot, set up methods, and build confidence in the lab.

Her training and consulting cover everything from setting up new toxicology labs that meet CLIA regulations to supporting existing labs with sample prep, instrument operation, troubleshooting, and data analysis using established SOPs. No matter the topic, Dr. Li always keeps CLIA requirements in mind and weaves them into her training in a practical, easy-to-understand way.

Dr. Li is currently the director of a Clinical Pharmacology Core facility that housed three advanced Sciex mass spectrometry instruments at the Texas Tech University Health Sciences Center in Dallas. She is also a faculty member that teaches graduate and pharmacy student’s courses.

Follow her on LinkedIn: https://www.linkedin.com/in/li-li-12123317/

Regulatory CLIA

Depending on the type of CLIA certification, laboratory tests are generally classified into three categories. LC-MS (liquid chromatography–mass spectrometry) falls under high-complexity testing.

  1. Waived Testing: Simple procedures with a low risk of error, such as urine cup tests.

  2. Moderate Complexity Testing

  3. High Complexity Testing: Includes advanced methods like LC-MS toxicology.

CLIA requirements become more rigorous as the complexity of testing increases. High-complexity testing has the most stringent standards for personnel qualifications, documentation, and training.

Instrument Expertise

Mass Spectrometry Platforms

  • Sciex: 5500, 5600, 6500+, 7500, 7600

  • Agilent: Triple Quadrupole, Single Quadrupole

  • Waters: Synapt G2 (Ion Mobility MS)

  • Bruker: Rapiflex MALDI (Tissuetyper)

  • Thermo Scientific: Medical LCQ / LTQ

  • Shimadzu: LCMS-IT-TOF

  • Other Techniques: MALDI-TOF, Ion Trap, and Hybrid MS systems

Complementary Analytical & Imaging Techniques

  • Flow Cytometry

  • Gas Chromatography–Mass Spectrometry (GC-MS)

  • Total Organic Carbon Analysis (TOC)

  • Fourier-Transform Infrared Spectroscopy (FT-IR)

  • UV-Visible and Fluorescence Spectroscopy

Quality Control

QC in High complexity Testing Laboratory including:

  • Validation and verification of test methods

  • Calibration and maintenance of instruments

  • Use of Quality Control (QC) samples (daily checks)

  • Participation in Proficiency Testing (PT)

  • Documentation of errors or test failures

  • Ensuring personnel competency and ongoing training

Implement a Structured Training Program

Your training will cover:

  • Test procedures and instrument operation

  • Specimen handling and processing

  • Quality control (QC) and quality assurance (QA)

  • Safety protocols (e.g., OSHA, biosafety)

  • Result reporting and documentation

  • CLIA regulatory compliance basics

✅ Document all training, including dates, trainers, materials used, and completion signatures.

Please submit your general or technical questions below.
You may also request free copies of mass spectrometry user manuals from Sciex and Agilent