• CLIA and Quality Assurance

    Quality Assurance, CLIA, and 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), post-analytical processes, and staff performance. The CLIA regulations (Subpart K) addresses laboratory requirements and quality assurance systems. Medical decisions are made based on lab results performed in the office and at reference laboratories. Where the test is performed should not negate the significance of accurate and reliable results. Accurate test results are crucial to patient care. 

     Good Quality Assurance systems include the following:                 

    1. Establishes standard operating procedures (SOPs) for each step of the laboratory testing process, ranging from specimen handling to instrument performance validation;
    2. Defines administrative requirements, such as mandatory recordkeeping, data evaluation, and internal audits to monitor adherence to SOPs;
    3. Specifies corrective actions, documentation, and the persons responsible for carrying out corrective actions when problems are identified; and
    4. Assure high-quality test performance and competency of the staff.

    For information from CDC’s Lab Standards webpage, visit Laboratory Quality Assurance and standardization Programs.

    Quality Assurance Plan

    Assessing testing quality requires planned and systematic monitoring to test processes. Conducting these activities can lead to reduced errors, improved patient outcomes, improved patient and employee safety, and reduced costs. Both internal and/or external mechanisms for quality assurance may be used depending on the needs, resources, and practices of the testing site.

    First: Establish laboratory procedures for each step of the testing processing, include components of testing such as, but not limited to:

    • Patient identification & order entry
    • Specimen collection & labeling
    • Transportation to testing area
    • Specimen appropriateness, criteria for specimen rejection
    • Analytical testing process
    • Interpretation & accuracy of test result
    • Timely reporting of results
    • Evaluation and frequency of quality control (QC)
    • Actions for unexpected/failed QC results
    • Instrument verification and proficiency testing
    • Test kits and reagent storage
    • Personal protective equipment (PPE) and safety issues

    Second: Define administrative responsibilities to laboratory management. Consider things such as:

    • Laboratory medical director responsibilities 
    • Staff (office manager, lab tech, nurses, and consultants) responsibilities for recording QC, test kit and reagent logs, temperature logs, and product recalls
    • Review of quality control and testing logs, include corrective steps
    • Periodic review of SOPs

    Third: Specify, in writing, laboratory’s investigation plan and who will be responsible for follow through and implementation of correction action when problems or errors are identified. Document all quality assurance activities. As the saying goes, if it is not written down, it didn’t happen.

    Fourth: High-quality patient testing requires verification of staff competency and test methods employed in your medical lab.

    Staff competencies should assess their knowledge, skills and abilities needed to perform patient testing successfully. Staff assessments should be documented and performed annually after the first year of employment. During first year of employment, competency assessment is required semiannually.  

    Competency assessment must include the following 6 components for each test or test platform:

    1. Direct observation of routine patient test performance, including patient preparation, if applicable, specimen handling, processing, and testing
    2. Direct observation of instrument maintenance and function checks
    3. Monitoring test results reporting
    4. Review of records- i.e., test results, worksheets, quality control (QC) records, proficiency testing results, and maintenance records
    5. Assessment of test performance- i.e., proficiency testing, blind sample testing
    6. Assessment of problem-solving skills- e.g., evaluate problem/action logs, QC corrective action, specimen rejection events, or written quiz

    CLIA does not require competency assessment of staff for waived testing, however ensuring accurate results is essential to make the right patient diagnosis. Staff assessments are necessary to ensure staff are following manufacturers’ instructions. Keep in mind, any variation from manufacturer’s instructions of waived tests will negate waived status and test will be subject to all regulations as a moderate complex test.

    Laboratories with provider-performed microscopy (PPM) certificates are required to meet competency assessment in all 6 components. All testing personnel in PPM laboratories are required to have annual competency.

    For detailed information from CMS regarding staff competency, visit CMS brochure What Do I Need to Do to Assess Personnel Competency.

    Method verification of test procedures

    Method verification of test procedures is required to ensure, by objective evidence, the instrument or test method consistently provides accurate patient results Method verification must be completed prior to reporting your first patient test result. CMS has a published guide for Verification of Performance Specifications to help navigate this regulation.

    When should method verification be performed?

    • New test(s) or analytes introduced into the medical laboratory. This includes adding analytes to an existing test system.
    • New test kit or instrument introduced into the medical laboratory.
    • Relocation of medical practice or laboratory instrumentation. (e.g., instrument used at office in building A moves to new office same building A or new building (B))

    Who is responsible for ensuring verification is completed and meets criteria?

    • The Technical Consultant/Supervisor and/or Laboratory Director are responsible for ensuring procedures for verifying performance is adequate, defining criteria for acceptance, as well as evaluating the results generated during the verification process. Laboratory testing staff must participate in the verification process as they will be performing the tests on patient samples.  

    What performance specifications are included in verification?

    • Accuracy
    • Precision
    • Reportable Range
    • Normal values or range for the laboratory patient population

    How is test verification most commonly accomplished?

    • Proficiency testing
    • Previously tested patient specimens with known values
    • Split sampling of patient specimens
    • Commercial material with known values, such as calibrators

    These materials can be used in multiple ways to verify accuracy, precision, and reportable range. The number of specimens needed for each analyte and for each part of the verification process may vary. The Laboratory Director and Technical Consultant/Supervisor are responsible for determining the appropriate number of samples. As a rule of thumb, 20 specimens spanning the reportable range for quantitative analytes. Five positive and five negative specimens for qualitative analytes.

    Items of Note

    Most laboratory errors occur in the pre and post analytical phases, while less than 10% of all errors happen during the testing or analytical phase. Establishing robust processes to ensure quality patient results are obtained every time is the whole purpose of having a quality assurance plan.

    The most vulnerable components in the pre-analytical phase of testing and prone to errors are proper patient identification, good quality specimen collection, timely transport, and appropriate physician order. While timeliness in reporting and incorrect data entry are most prone errors in the post analytical phase.