Volume 2025 | No. 2
SURVEYOR
CLINICAL LABORATORY
CHAPTER 02: LABORATORY PERSONNEL 02.02.04 Testing personnel competency and evaluation 02.02.05 Personnel competency assessment policies Frequency of the citation: 02.02.04 15%, 02.02.05 24%
Compliance tips for:
The intent of standard 02.02.04 is that the technical supervisor/consultant evaluates competency of all testing personnel based on six criteria at specific frequencies. Standard 02.02.05 ensures that those in consulting and supervisory positions demonstrate competency based on responsibilities defined by federal regulations in addition to the six criteria required for testing personnel if they are also performing testing on patient specimens. ■ Audit personnel files for inclusion and completeness of competency assessments. ٝ This applies to all moderate and high complexity testing even if it is performed outside of the laboratory, including point of care testing. ■ Create a tracking document for all testing personnel that lists each test or test system they perform. ٝ Ensure that all six required elements are evaluated for each test system. ٝ Ensure competency assessment twice in the first year that a particular test is performed and annually thereafter for all testing personnel. ٝ In hospital environments, ensure that testing personnel outside of the laboratory are included in the competency assessments.
Nerd Newbies (understand the requirement)
Nerd Apprentices (audit for excellence)
Overview of the requirement: Policies and procedures establish competency assessment for all individuals who perform patient testing or who report patient test results. The technical supervisor/consultant is responsible for assessing and documenting staff competency to perform test procedures and report results, in accordance with required elements and intervals for evaluations. Comment on deficiencies: Compliance is assessed through document review, response to interview, and observation. Surveyors noted policies that did not include competency assessment for all roles, or that failed to include the six minimum requirements for evaluation.
Nerd Trailblazers (prepare the path for others)
Examples of ACHC Surveyor findings: 02.02.04
■ Competency was not being assessed for fecal fat testing and the tube method in the blood bank. ■ While all CLIA-required elements appear to have been addressed, there was no supporting documentation that included dates of performance of blind sample assessments for emergency department staff. ■ Competency assessments for the testing personnel in the radiology department who perform ACT moderate complexity testing did not include the six required CLIA competency assessment elements. ■ Training documentation, six-month competencies, and one-year competencies for testing for one individual performing waived testing and moderate complexity hematology testing were incomplete or missing. ■ Multiple test systems were not identified as needing competency assessments for the laboratory staff. Examples include tube direct antiglobulin (DAT) testing, gram stain, post-vas testing, manual cell count, wet prep, and CLO testing. As a result, the laboratory testing personnel were not deemed competent to operate these test systems. 02.02.05 ■ The laboratory did not have policies and procedures to assess competency based on CLIA position responsibilities. The Technical Supervisors and General Supervisors did not have documented competency assessments for their CLIA-named position responsibilities. ■ All personnel assessment documentation was incomplete. Final assessment dates verifying when the staff was competent to perform patient testing and pre-analytic functions were missing.
CHAPTER 03: PROVIDER PERFORMED MICROSCOPY AND WAIVED TESTING 03.02.07 Quality control for waived tests Frequency of the citation: 17%
Overview of the requirement: The laboratory must maintain and follow current manufacturer’s instructions for waived tests, including those for quality control. The laboratory reviews QC findings prior to reporting patient results and takes corrective action when QC identifies results outside of acceptable ranges. Comment on deficiencies: Compliance is assessed through response to interviews and document review. Surveyors noted issues with: ■ QC frequency that did not match the manufacturer’s instructions. ■ Documentation of internal QC.
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