How to Prevent the Top 10 CLIA Deficiencies
A laboratory safety expert shares the most common CLIA citations from recent lab inspections, and how your lab can avoid similar problems.
One of the most crucial aspects of laboratory operations is CLIA compliance. The Clinical Laboratory Improvement Amendments of 1988 (CLIA) set the gold standard for ensuring the accuracy, reliability, and timeliness of patient test results. Laboratories may be directly audited by CLIA inspectors, or they may be inspected by an approved accrediting body, such as the College of American Pathologists, to ensure the lab is following CLIA standards. Even the best labs can err when it comes to following every standard, and every year, data is published about which CLIA standards are cited most often. The most recent complete data as well as more recent partial data has been released.1,2,3 However, the top cited issues do not change frequently from year to year. Based on that data, here are 10 of the most cited CLIA violations, and ways to ensure your laboratory avoids them:
1. Proficiency Testing (PT) Problems: Failure to participate in PT or improper handling of PT samples.
It is important to make sure your laboratory is enrolled in the appropriate proficiency testing (PT) programs for all tests performed. Proficiency testing samples can be purchased or the lab may create its own program using internal blind studies. Create policies that ensure staff follow the exact same procedures for PT samples as for patient specimens, and be sure to perform and submit PT results promptly in order to meet scheduled deadlines.
2. Personnel Qualifications and Competency: Staff performing tests without appropriate qualifications or competency assessments.
Laboratories should routinely verify the credentials of all testing personnel and ensure they meet CLIA requirements. Implement a robust laboratory training program and perform competency assessments at regular intervals, not just during initial training. Keep detailed records of qualifications, training, and competency assessments for each employee. Competency assessments can be complicated, and managing them well takes strong oversight and an eye for detail.
3. Quality Control (QC) Issues: Inadequate or improper QC practices.
Leaders with section oversight should ensure that QC is performed and documented daily for all tests performed. Adhere strictly to the QC guidelines provided by test kit and equipment manufacturers. Be sure to regularly review QC data to detect trends that could indicate potential issues before they affect patient results. Having a second set of eyes reviewing records can be beneficial.
4. Laboratory Director Responsibilities: The laboratory director not fulfilling their duties adequately.
Ensure the lab director is actively involved in the laboratory’s operations and is not just acting as a figurehead. The lab director should conduct regular reviews of the lab’s processes, QC data, and PT results. The director may delegate responsibilities appropriately, but they must stay informed and ensure compliance in all areas of the laboratory.
5. Test Performance Specifications: Failure to establish and verify performance specifications for new tests.
Section supervisors should conduct thorough validation studies for any new tests introduced to the lab and maintain detailed records of all validation studies and performance specifications. Regularly review and, if necessary, revalidate tests to ensure ongoing accuracy and reliability. Keep orderly records so they can be found when necessary.
6. Equipment Maintenance and Calibration: Neglecting routine maintenance and calibration of lab equipment.
Management should ensure that staff follow a strict schedule for maintenance and calibration of all laboratory equipment. Keep detailed and orderly logs of all maintenance and calibration activities. Adhere to the maintenance and calibration schedules set forth by equipment manufacturers.
7. Patient Test Management: Inadequate processes for test requisition, specimen handling, and result reporting.
The laboratory should develop and enforce standard operating procedures (SOPs) for test requisition, specimen handling, and result reporting. Implement a chain of custody protocol for specimens to ensure proper handling and tracking. Use safe and standard procedures when transporting specimens, both internally and externally. There are specific regulations regarding transport that reflect Occupational Safety and Health Administration (OSHA) and U.S. Department of Transportation requirements. Ensure that test results are accurately reported and promptly communicated to the appropriate healthcare providers.
8. Proficiency Test Result Evaluation: Failing to properly evaluate and respond to PT results.
This is a second proficiency hot topic, showing how complicated PT can be and how much good management of the process is needed. Section supervisors need to thoroughly review PT results and identify any discrepancies. Conduct an analysis for any PT failures and document corrective actions. Use PT evaluations as a tool for continuous improvement in test performance and accuracy.
9. Documentation and Recordkeeping: Poor documentation and recordkeeping practices.
Maintain comprehensive records of all lab activities, including QC, PT, equipment maintenance, and personnel training. Maintain an organized recordkeeping system that allows for easy retrieval of documents. Abide by CLIA’s document retention policies to ensure that all required records are kept for the appropriate duration. These and other citations highlight just how important it is to keep all lab records organized so that anyone can access them during inspections and other times when needed.
10. Corrective Actions: Failure to implement and document corrective actions when issues arise.
Ensure that the appropriate person acts quickly to address any deficiencies or issues identified through QC, PT, or internal audits. Document all corrective actions taken, including the steps implemented and the results of those actions. Periodically review the effectiveness of corrective actions to ensure they have resolved the underlying issues.
These most-cited elements do not indicate any issues with laboratory safety. Perhaps that means labs are improving in their safety cultures overall. CLIA compliance means following standardized protocols, maintaining proper documentation, and undergoing regular inspections, and safety should be included with those actions. Lab oversight of quality control, proficiency testing, and safety work together to keep those laboratory diagnostics on point.
Staying CLIA-compliant can be challenging, but with diligence, proper planning, and a proactive approach, your laboratory can avoid these common pitfalls. It’s not just about passing inspections—it’s about ensuring the highest standards of accuracy and reliability in patient testing. By focusing on these top ten CLIA deficiencies and implementing the prevention tips provided, you’ll be well on your way to a safer, more compliant laboratory.
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