Moving from Research to Working with CLIA Lab Regulations
Moving to a CLIA lab after working in a research-based facility involved a steep learning curve. My attention was split between sequencing and learning CLIA and HIPAA rules and regulations, learning how to validate tests, software, and instruments, as well as learning the ropes of new documentation. Needless to say, it was a challenge.
Protected Health Information (PHI) in a CLIA Lab
Patients are the top priority for a CLIA lab — protecting their information, and delivering them fast and accurate results. One of the first trainings for new employees in a CLIA lab is HIPAA training. Understanding these rules is integral to maintaining the integrity of the lab. HIPAA governs everything, from how information is entered into tracking systems to whether or not information can be printed from an Excel sheet. There is a huge liability to the company, should protected health information (PHI) be exposed. Usually, all HIPAA training is documented. This documentation is necessary for audits (though CLIA or internal) to certify all employees are trained to properly handle PHI.
Accurate Test Results in a CLIA Lab
Delivering accurate test results comes right behind protecting patient information. There are a number of important processes in place to ensure testing is done accurately. The tests themselves undergo an extensive validation. This validation demonstrates that the testing is accurate and precise, and the results are repeatable, and reproducible. If the tests are being done on an instrument such as a sequencer or a liquid handler, those will need to be validated as well. Establishing maintenance and calibration routines, writing standard operating procedures (SOPs), and proper documentation are all very important to the CLIA lab validation process.
Once every aspect of a test passes validation and it is ready to be put into production, the technicians are taught the process. Learning a new test usually includes three steps:
- Watching the test process
- Performing the process under supervision
- Conducting the test independently
Technicians are usually required to take a written test that covers the SOP and the science behind the test they are performing.
Documentation in a CLIA Lab
In a CLIA lab virtually everything needs to be documented. Due to the extensive amount of documentation necessary, a LIMS software system is usually the information repository of choice. One of the biggest and most important concepts for documentation is chain of custody and the paperwork surrounding it. It must be tracked at every step, from when a sample enters the lab to when its information is sent to a physician’s office in a report. Every step in the testing process must be tracked: Who touched the sample? Where was it stored? What reagents were used? What machines touched it? What tests were run on it? Who sent the final information? Plus, the tracking and documentation must be available on all of the secondary items, such as the validation of the machinery and the efficacy of the reagents.
The Need for a LIMS Software in a CLIA Lab
If anything goes wrong during any of the steps in the testing process, the associated data can be found in the laboratory information management system. This extensive tracking process is why most CLIA labs rely on a LIMS system. Every technician is trained to enter information into the LIMS system whenever they are performing tests. The tracking system is especially important during audits – depending on the state, CLIA can audit a lab annually, or on a bi-yearly basis.
Learning the ropes at a CLIA lab was an experience has given me greater insight into the industry as a whole, and solidified my current career working in laboratory informatics.
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Chrisanne Wnek is a Genomics Application Specialist at Core Informatics. She holds a Master’s degree in Medical Laboratory Sciences from Quinnipiac University and is an ASCP certified technologist in molecular biology. She’s spent over 8 years working in the field of genetic research in Sanger, NGS and CLIA labs.