{"id":209,"date":"2016-02-16T00:00:00","date_gmt":"2016-02-16T00:00:00","guid":{"rendered":"https:\/\/www.thermofisher.com\/blog\/connectedlab\/working-clia-lab\/"},"modified":"2024-05-20T21:54:20","modified_gmt":"2024-05-20T21:54:20","slug":"working-clia-lab","status":"publish","type":"post","link":"https:\/\/www.thermofisher.com\/blog\/connectedlab\/working-clia-lab\/","title":{"rendered":"Working in a CLIA Lab"},"content":{"rendered":"

Moving from Research to Working with CLIA Lab Regulations<\/h2>\n

\"MovingMoving to a CLIA lab after working in a research-based facility involved a steep learning curve. My attention was split between sequencing and learning\u00a0CLIA<\/a>\u00a0and\u00a0HIPAA<\/a>\u00a0rules and regulations, learning how to validate tests, software, and instruments, as well as learning the ropes of new documentation.\u00a0 Needless to say, it was a challenge.<\/p>\n

Protected Health Information (PHI) in a CLIA Lab<\/h2>\n

Patients are the top priority for a CLIA lab \u2014 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.<\/p>\n

Accurate Test Results in a CLIA Lab<\/h2>\n

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)<\/a>, and proper documentation are all very important to the\u00a0CLIA lab validation process.<\/p>\n

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:<\/p>\n