coding each year to make sure you are billing correctly .
We have a CLIA Certificate of Waiver so we really don ’ t have any requirements and aren ’ t going to be inspected . WRONG . CLIA requires that for all waived testing performed , you must follow the manufacturer ’ s guidelines for running that test . The package insert that comes with the test outlines how the test is to be performed , stored , and the controls that must be run . CLIA inspects about 5 % of Waived labs each year . You can have your lab testing shut down if they feel you are putting your patients in jeopardy by not following the guidelines .
For kit tests , I just buy whatever is cheapest when I reorder . Bad idea . Let ’ s look at Strep A tests for example . When you switch brands , the way the test is performed may change ( i . e . different incubation times , numbers of drops of reagent , etc ). If you change , does everyone get
documented on training for the new method ? Also the accuracy of kit tests can vary greatly . Check the package inserts and buy the ones with the highest accuracy to get the best results for your patients . CLIA and the accrediting agencies are focusing on employee competency and training . CLIA expects the following six items to be part of any competency
“ Just because insurance is paying you , does not mean you are billing the correct codes , it just means you haven ’ t got caught or audited yet .”
Barry Craig
evaluation for an employee . Some items may not be applicable to kits tests , but most items apply . 1 . Direct observations of routine patient test performance , including patient preparation , if applicable , specimen handling , processing and testing
2 . Monitoring the recording and reporting of test results
3 . Review of intermediate test results or worksheets , quality control records , proficiency testing results , and preventive maintenance records
4 . Direct observation of performance of instrument maintenance and function checks
5 . Assessment of test performance through testing previously analyzed specimens , internal blind testing samples or external proficiency testing samples
6 . Assessment of problem solving skills
I hope these tips help out . To stay up to date on all CLIA regulations visit : www . cms . gov / CLIA
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