Make your next audit a “no stress audit”
CLIA was created in 1988 to ensure uniform quality and standards among clinical testing sites. Becoming a CAP / CLIA certified lab is a big step for any organization. It opens the facility up for a new world of work and potential clients. It also opens your lab up for increased scrutiny by regulatory organizations.
Surviving a CLIA audit
CLIA exists to protect consumers and to ensure the information they receive is correct. However, as a scientist who faces the scrutiny of a CLIA audit the strict policies feel like something else altogether. In fact you no longer feel like a researcher, you feel like a…
The moment you receive notice of an upcoming CLIA audit you are a suspect– a suspect in a case where the crime is unknown. You are not presumed innocent. In fact, until you can prove beyond a reasonable doubt that your data is sound, you will remain under investigation.
The integrity of your data
It’s all about the integrity of your data. No matter the technology or workflows your lab uses, the basics of an audit are still the same. CLIA sets high standards for quality control, validation of data and tests, equipment calibration, proper training and certification of users and clear end result reporting. Every aspect of every iteration of the sample should be validated and tested to make sure the final analysis is correct. It should be an open and shut case. But yet, is still feels like an…
The CLIA Audit
The notice of an upcoming audit should not send a lab into lockdown as everyone from bench scientists to managers scurry about ensuring all is up to code. Conference room audits are possible as long as you follow your standard operating procedures and keep immaculate records which verify and validate your results. But, even with meticulous record keeping, records can be lost. With an efficient Laboratory Information Management System (LIMS) you’ll never misplace or lose your paperwork again and it will be easily retrievable in any situation.
LIMS for NGS Sequencing Labs
Next Generation Sequencing creates voluminous amounts of data. As a lab, the onus is on you to make sure you analyze it and store it correctly. Sequencing using NGS is a multistep process with the opportunity for mistakes or the loss of data integrity at every turn. A CLIA audit is designed to find those inconsistencies. During a CLIA audit you need to prove your data is telling the truth. You need…
Designed for NGS Labs
The genomics workflow applications for Thermo Scientific™ Core LIMS™ software were specifically created for NGS labs. The applications include pre-built standardized workflows including Illumina and Ion Torrent. Core LIMS software is highly configurable, so you can easily modify workflows and applications to best suite your laboratory needs. The system integrates with all lab instruments and reporting programs. Operational steps, equipment calibration, test validation, quality control and proficiency testing are all recorded within the LIMS. The integrity of the system allows for streamlined QC and QA, and after testing is complete, validated electronic signatures ensure legibility and proper reporting of information.
Core LIMS software uses a time and date stamp to track all users and activities, plus every user has a unique password and persona in the system. User privileges such as the ability to access records and experiments, and the ability to delete data or change workflows are all controlled by the LIMS administrator. Only trained staff may operate the LIMS or operate any other workflow in the lab. Proficiency testing and training schedules are monitored in the system.
The best way to prove the integrity of your data is with a system which allows you to pull information out as easily as you put it in. The NGS workflow applications for the Core LIMS software are designed with this in mind and will allow you to quickly pull audit-ready, signed reports in a variety of formats. With these reports you can easily prove your data is…
A Good CLIA Audit = Quality Research/Data
During a CLIA audit the checklist is long and diverse, but in reality the audit is checking one thing… the integrity of your data. With just one bad audit your work and your lab can go from promising and respected, to suspected and accused. The best way to defend the validity of your data is to avoid having it called into question in the first place. The best way to prove your data is sound is by tracking it all with an effective LIMS.
Make your next audit a “conference room audit” with the help of genomics applications for Core LIMS software.