Most labs will have citations during their inspection, however, knowledge of the most frequent areas of noncompliance can help reduce the number and severity of them. The top noncompliance areas include Calibration, Quality Control, Personnel, Quality Assurance, and Proficiency Testing. Let’s take a look at some examples:
- Calibration: Observe the performance of instrument maintenance (if applicable) to make sure that maintenance and regular calibration is being performed correctly, and on time. Direct observation can be documented in the competency assessment by noting the date of the observation of the specific maintenance procedures that were observed. Any need for retraining should be documented in the records as well.
- Quality Control: QC programs should be established and maintained to identify failures in quality as they occur. Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system. Assure that appropriate technical staff reviews QC regularly to confirm that policies and procedures are being followed by all staff.
- Quality Assurance: Assure that QA reviews are effective at identifying and preventing errors, and that corrective actions are followed up for effectiveness. Establish written policies and procedures for evaluating performance specifications. It’s a good idea to specify the remedial actions to take when they are not met. Most importantly, make sure your lab policy states that patient results are NOT to be reported when the test system is not functioning properly (i.e., QC is out of range, etc.). Ensure that all staff know and follow this policy.
- Personnel: Competency is required to be documented for all testing personnel, except the Laboratory Director, and must include the 6 elements required by CLIA. If personnel do not perform testing (i.e. CC, TC, GS), then a competency based on their job description must be documented. Competencies should be completed by the reviewer and given a final sign off by the Technical Consultant or Lab Director. There should be an SOP in place for all competency requirements. Remember that training does not count as competency!
- Proficiency Testing: PT results should be reviewed once made available by the PT provider. Review can be designated to the Technical Consultant or General Supervisor, but the Laboratory Director should review the results as well. When reviewing PT results, don’t just focus on the analytes that were incorrect. Be sure that every analyte in your test menu is present based on what the PT is showing as present. Document any corrective action, if necessary, as well as who performed the review and when. Review should take place within 1 month of result receipt.
- Bonus! Laboratory Directors should be involved! Many times we hear the saying, “Where do I sign?” If you have an LD like this, try to involve them as much as you can, even with a simple explanation for what they are signing. LD’s can delegate any signature within the laboratory EXCEPT the signing of policies and procedures. If an LD delegates a signature, only the delegated person has to sign, not both.
If you do struggle with compliance, it may be wise to hire a consultant to do a mock audit before your inspection to see where your lab’s strengths and weaknesses are. Preparation is always better than remediation when it comes to inspections. There are endless citation possibilities, but focusing on the areas of Calibration, QC, Personnel, QA, and PT is sure to keep noncompliance in your laboratory to a minimum.
-Written by Jennifer Kelley and Glen Ziolo
June 15th 2018