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