engleski

Quality Indicators in Pre-analytical Phase in Accredited Serology Laboratory

Background: Serology laboratory for diagnostic of hepatitis A, B, C and D, and HIV, Syphilis, CMV, Toxo, Borrelia, HTLV-I/II and EBV infections is accredited due to ISO 15189:2008 since March 2014. Institute is also certificated according to ISO 9001:2008 (since 2001). As a part of quality assurance, Quality Indicators (QIs) are established to monitor and evaluate performance of critical aspects in pre-analytical, analytical and post-analytical phases. Patient samples are from inpatients (collected in CITM) and outpatients (collected outside CITM- hospitals, private laboratories, ect). Materials and methods: Appropriate QIs in pre-analytical phase were determined: a. outside CITM: a1. request-misidentified, a2. sample-improperly labeled, a3. sample-nonconform (a3.1. lipemia, a3.2. hemolysis and a3.3. icterus-due to color chart with our guidelines or a3.4. viscosity), a4. sample-clotted, a5. sample-insufficient, a6. sample-improper transport, a7. sample-damaged, a8. insufficient patient”s data, a9. order-in-correct, a10. container-inappropriate, b. inside CITM but outside laboratory: entry data (e-Delphyn Information System) errors- b1. wrong name, b2. wrong DOB, b3. wrong identification number, b4. missed test. Since January 2014-October 2014 we tested 18605 patient samples and QIs were analyzed. Results: In mentioned period we identified 2 samples for a1 nonconformity, 2 samples for a2, 2 samples for a3.2, 1 for a3.4, 1 for a4, 2 for b1, 1 for b2, 1 for b3 and 1 for b4. The QIs for and „entry data errors“ are the primary nonconformities. Conclusions: QIs in pre-analytical phase show that the most prevalent errors are in pre-pre-analytical phase (outside CITM) and errors in data entry to e-Delphyn Information System. Due to risk assessment and risk analysis (FMEA-Failure mode and Effects Analysis) of the TTP (Total Testing Processes) in the laboratory, the highest risk levels are also in determined pre-analytical phases. QIs are valuable tools for quantifying the quality comparing against a defined criteria, they are plan and action.

serology laboratory; quallity indicators; pre-analytical phase

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