CLIA and Quality Assurance

Quality Assurance, CLIA, & Your Lab

Quality assurance has been around much longer than the CLIA regulations. It is an ongoing, comprehensive program which analyzes every aspect of an entire operation; it involves determining a quality goal, deciding whether or not the goal has been achieved, and implementing corrective action if the goal has not been reached.

In the laboratory, quality assurance involves the entire testing process: pre-analytical, analytical (testing), and post-analytical processes.

The CLIA regulations (Subpart P) address specific quality assurance requirements. The Code of Federal Regulations (42 CFR 493) states laboratories “must establish and follow written policies and procedures for a comprehensive quality assurance program that is designed to monitor and evaluate the ongoing and overall quality of the total testing process.” The QA program must:

  1. Assess the effectiveness of the lab’s policies and procedures.
  2. Identify and correct problems.
  3. Assure the accurate, reliable, and prompt reporting of test results.
  4. Assure the adequacy and competency of the staff.

The lab must also initiate corrective action when problems occur and document all quality assurance activities. As the saying goes, if it is not written down, it did not happen.

CLIA Standards for Quality Assurance

The regulations specify ten different standards to be included in a laboratory’s quality assurance program.

The first standard emphasizes having a system in place for monitoring and evaluating the procedures for Patient Test Management, including:

  • Patient preparation
  • Specimen collection
  • Labeling
  • Preservation and transportation
  • Test requisition completeness
  • Relevance and necessity for testing
  • Use of appropriate criteria for specimen rejection
  • Test report completeness
  • Relevance and accuracy
  • Timely reporting of results
  • Accuracy and reliability of test reporting systems
  • Storage and retrieval of result

The second standard is quality control. The lab is to have systems in place to evaluate the effectiveness of corrective actions in regard to the QC program, including:

  • Problems identified during the evaluation of calibration and QC
  • Problems identified during the evaluation of patient test results (to verify the reference range of a test method)
  • Errors detected in results

The third standard is proficiency testing. The lab is to assess the effectiveness of corrective action taken to address any unacceptable, unsatisfactory, or unsuccessful PT results.

The fourth standard is a comparison of test results. If a laboratory has more than one method of performing the same test, the lab must (twice a year) evaluate and define the relationship between the two methods (i.e., run the same specimen by each method and check for comparable results). If the lab performs testing on non-regulated analytes, the lab must have a method for verifying the accuracy of its test results. Proficiency testing or split sampling may be used.

The fifth standard involves the relationship of patient information to patient test results. This is an internal quality assurance function. The lab must have a system in place to identify and evaluate patient test results when they appear inconsistent such criteria as the patient’s age, sex, diagnosis, and the relationship with other test results.

The sixth standard involves personnel assessment. The laboratory must have a system in place to evaluate the effectiveness of its policies and procedures for assuring employee competence. If the lab has an outside consultant, the lab should have a method for evaluating his/her effectiveness, also.

The seventh standard involves communications. The lab must have a mechanism for documenting problems arising as a result of a breakdown in communication. Corrective actions must be taken to both resolve the problem and minimize future communication breakdowns.

The eighth standard addresses complaint investigations. The lab must have a system to assure that all complaints and problems are documented. Investigations must be made and corrective action taken.

The ninth standard is quality assurance review with staff. In addition to documenting and assessing problems identified in QA reviews, the lab personnel must discuss the issues and take corrective action to prevent recurrences.

The tenth standard addresses QA records. Documentation of all QA activities must be made available to the Department of Health and Human Services.

Quality Assurance Standards: CLIA 88

Assessment required for:

  1. Patient test management
  2. Quality control
  3. Proficiency testing
  4. Test comparisons
  5. Relate results to clinical data
  6. Personnel
  7. Communications
  8. Complaints
  9. Staff review
  10. Records