How to Prepare for a CLIA Inspection
The Clinical Laboratory Improvement Amendments, law since 1988, mandate that nearly all laboratories handling human tissue medical tests be certified by state and federal governments. As government certification processes go, this one is not the most complex. The only real nerve-wracking part will likely be the biennial inspection visit. Fortunately, it's possible to give your lab its best chance for CLIA certification and still retain your sanity.
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Instructions
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Contact your state health department for a set of state-specific benchmarks that the inspection will be based on. Communicate these to your staff and make every effort to comply. Federal benchmarks generally require that you minimize potential contamination of lab samples, have observed safety procedures in place and have sufficient equipment and personnel to handle the volume of tests you're performing. These benchmarks are subject to the inspector's interpretation, but if you're following accepted best practices for a laboratory, issues in this area should be minimal.
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Organize your records so that you can access any the inspector may ask for. You don't get to choose which records you will submit for inspection, so make sure you have an effective organizational system in place (keeping records accessible is a legal requirement for running a laboratory anyway, so hopefully you've already been doing this). A CLIA inspector, unfortunately, does not have set list of records to request, but will likely request records based on what tests you perform, whether you've added new tests and the type of patients you serve. In other words, if your lab primarily reads cancer tests, you're likely to be asked for biopsy records. You are also responsible for running your own quality control assessments regularly. The inspector may want to use these as a starting point for the inspection and may check over these for unusual trends (too many "abnormal" or "normal" test results) and compliance with your internal quality control procedures.
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Test your staff to ensure they are are ready for the inspection. The inspector may require them to evaluate samples that measure their proficiency. The inspector will also observe staff, noting their proficiency in maintaining the integrity of test samples, their quality of work, their ability to evaluate test results and their quality of communication with each other and supervisors. If this is an initial CLIA inspection, the inspector will also evaluate the qualifications and credentials of all supervisory personnel and a cross-section of testing personnel.
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Ask your staff to anonymously point out any problems that may exist with your lab's procedures or facilities. They are more likely to be aware of problems "on the ground" and may be able to offer solutions. Keep in mind that the inspector may interview any of your staff, and it's better for you to find out about a problem before the inspection. That way you can at least say you're working on it.
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Tips & Warnings
Regular inspections happen once every two years, but a complaint by a patient or staff member to your state health department can lead to a surprise complaint inspection. Thus, it's best to promote good work practices in your lab at all times.
Specific federal benchmarks apply to each of dozens of test types. See the Resources section for where to find the guidelines that apply for your lab.
If you refuse to allow a CLIA inspector access to any part of your facility covered by your certification, Medicare will stop paying you for services and you may lose your CLIA certification. A bad inspection is better than none.
