PEPFAR Quality Control and Method Validation Activity 11 Job Aid 1: General Guidelines for Proficiency Testing

115 Job Aid 1: General Guidelines for Proficiency Testing 1107 Laboratory proficiency testing (PT) is an essential element of laboratory quality assurance. Proficiency testing is an independent and unbiased assessment that evaluates the laboratory's ability to produce correct answers. Proficiency testing provides an assessment of the validity of testing in your laboratory. Handling Your PT Survey Pre-analytical Note the date of receipt for your shipment Immediately inspect and reconcile the contents of your shipment with the accompanying paperwork Are all required specimens available? Is the quality and appearance of the specimens acceptable? Store the shipment properly O Note due date of results O Reconstitute specimens with volumetric pipettes and correct diluent O O Mix samples well before analyzing Analytical Analyze specimens at correct temperature. If shipment was stored in the refrigerator, specimens may need to come to room temperature before testing. Always refer to your survey instructions for storage and specimen handling. Analyze PT specimens in the same fashion as patient specimens. Do not refer any PT samples to another laboratory, even if your instrument is non- functioning or is part of your testing algorithm. Rotate testing responsibility for PT specimens between all laboratory personnel that are routinely performing the analysis in your laboratory. Perform PT analysis well before due date of results. Post-Analytical Assure that your laboratory's results are reported according to the PT provider's instructions. Ensure the proper method and instrument code are recorded for each test so that you are part of the correct peer group. If test not performed is the correct answer because of equipment issues, then indicate this on the form. If the result obtained requires additional testing per your laboratory's algorithm, then indicate on the form to be sent to a reference laboratory or further testing required, but do not actually send the PT sample to another laboratory. Review results for clerical errors on answer sheet, including decimal point placement. Retain a copy of answer sheet for your records. Attach all raw data and the instrument print-out to the answer sheet. If possible, retain specimens in freezer for confirmatory testing if needed. If you use the PT sample materials to cross-check other instrument or methods, or as part of your competency training program, then be absolutely sure the PT results are submitted to the PT provider before starting these activities. Receipt of Results Review your results with your peer grouping. Investigate all unacceptable grades. Have the Laboratory Director and Supervisor review, and sign and date results. Review results with testing personnel. Retain a copy for competency assessment and place into personnel record. Investigate any failed responses and complete an EQA Failure Checklist assessment. Follow-up with remedial actions if indicated. HILS1746 Effective Date: 12/6/2016