Volume 2024 | No. 2
SURVEYOR
CLINICAL LABORATORY
CHAPTER 4: PROFICIENCY TESTING 04.02.05 Unsuccessful performance by analyte
n Ensure that competency assessments are completed by individuals in appropriate roles. The initial competency must be completed by an individual qualified as a Technical Supervisor (high complexity testing) or Technical Consultant (moderate complexity testing). Annual competency assessments can be completed by General Supervisors in the high complexity testing environment. n Audit personnel files periodically for inclusion and completeness of competency assessments.
Overview of the requirement:
For a specific analyte or test, if two or more consecutive events are unsatisfactory, the analyte/test is deemed unsuccessful participation. This requires suspension of that testing pending corrective action and demonstrated improvement. Surveyors review documentation of testing events to confirm satisfactory performance. The standard is cited when the laboratory fails to achieve two of three consecutive testing events fails to achieve successful performance.
Comment on deficiencies:
CHAPTER 3: PROVIDER PERFORMED MICROSCOPY AND WAIVED TESTING 03.02.07 Quality control for waived tests
Frequency of citation:
24%
Examples of surveyor findings:
n Review of documentation revealed unsuccessful performance for CA 15-3, parathyroid hormone, and ESR for consecutive testing events. Proficiency testing investigations have been submitted and accepted. n Review of documentation and interview with the Laboratory Manager revealed unsuccessful PT performance for body fluid crystals. Proficiency testing investigations were previously reviewed and accepted and testing has been discontinued. n Conduct a complete investigation of all proficiency testing results that are less than 100%. Issues may be first evident with a score of 80%. n Investigate the cause of all failures. Initial failures become repeat failures if only cursory initial investigations are completed. n Ensure that test results are submitted by the program due dates.
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. Compliance is assessed through response to interviews and document review. These standards were most often cited when the frequency of QC did not match the manufacturer’s instructions, or the laboratory did not follow its own policies regarding documentation of quality control.
Comment on deficiencies:
Tips for compliance:
Frequency of citation:
33%
Examples of surveyor findings:
n The laboratory is performing inconsistent quality control for hemoglobin, microalbumin, influenza A, B, or COVID with long periods of no QC. n QC was not performed for eight months in 2023 on urine hCG. n Review of documentation and staff interviews revealed that incorrect pH and specific gravity ranges were recorded on the Clinitek urinalysis QC log sheet resulting in QC values being compared to incorrect ranges. n Ensure that there is a formal procedure for each test method or that the manufacturer’s package insert is available to provide a detailed procedure for each test. Manufacturer instructions are typically found as part of the package insert available with each test kit. If the test kit does not include a package insert, instructions should be accessible on the manufacturer’s web site.
Tips for compliance:
Accuracy in results of waived tests is not less important to quality patient care than that of higher complexity testing.
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