Are You Ready For a CLIA Inspection
In 1988 the Clinical Laboratory Improvement Amendments become law
. These amendments direct labs that conduct medical tests on human tissue to be certified by state and federal governments.As a result, a regular CLIA inspection or survey is scheduled once every two years. However, if a patient complains, this can prompt the state health department to set up a surprise complaint inspection. For this reason, educating staff and promoting good work practices will decrease the likelihood of a surprise CLIA inspection.
If a lab decides not to allow a CLIA inspector access to any area covered by the certification, Medicare will stop paying for lab services and the lab could loose its CLIA certification. It is not a good idea to skip a CLIA inspection or to deny inspectors access to any areas of the lab covered by the certification.
During the CLIA Inspection, the surveyors will check the accuracy, reliability and timeliness of test results.They will also review the skills of all personnel and check the adequacy of the facilities, equipment and supplies for the job. If the lab does quality work, there is very little to worry about during a CLIA inspection, but it is possible to take steps to better ensure that the facility and equipment, records and staff are very prepared for the CLIA Inspection.The biggest area of preparation encompasses internal communication and staff education.
To prepare for the CLIA inspection, it is best to check with the state health department for a list of the benchmarks in the inspection. In addition, the inspection encompasses federal benchmarks like:
Minimizing the potential for contaminated lab samples
Observing safety procedures
Having enough equipment and staff to handle the volume of tests being performed.
It is very important to facilitate good communication in the lab. Share the CLIA Inspection benchmarks with the lab staff. Try to establish an effective internal communications protocol to allow employees to anonymously communicate concerns about laboratory safety and violations of standards related to laboratory testing. Laboratories should post a notice in a conspicuous place telling laboratory personnel to inform either staff or an outside party about any adverse events or compliance violations.
Labs should be prepared to locate and share any records that the inspector needs. A CLIA inspector usually requests records based on the most numerous tests and the newest tests that the lab performs. It is also a good idea to share the lab's internal quality control procedures with the CLIA inspector.
A well-educated staff is also a good indication of CLIA compliance.During the survey, the CLIA inspector may have lab staff evaluate samples to test their proficiency, their quality of work, and their ability to communicate, and evaluate test results. The inspector will also review lab personnel qualifications and credentials.
Laboratories with well-educated staff, good internal communication facilities, and excellent quality control will fair well during a CLIA inspection. It is important to document any problems with equipment, quality or staff and resolve all issues quickly. If any complaints are filed, it is also important to resolve them quickly and document them.
Are You Ready For a CLIA Inspection
By: Sue Mccrossin
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