engleski

Automation and controlled monitoring and management of nonconformities in preanalytical phase

The Clinical Institute of Laboratory Diagnosis is in the process of preparing for accreditation according to the internationally accepted ISO 15 189. In this complex and challenging process of implementation, quality indicators and eligibility criteria are defined. Although the number of analysis from year to year is growing, our policy is to reduce the number of non compliance to a minimum by identifying, recording, resolution and analysis of non compliance in all aspects of testing with special emphasis on preanalytical phase. Program writing and recording nonconformities issue findings within a specific time and statistical data processing were performed using a computer program support in Laboratory informatic system (LIS). Indicators quality and eligibility criteria are defined by incidence of hemolysis in the serum/plasma (<1.0%) incidence of clots in blood samples (<1.0%) ; issue findings within a specified time (>90%). In the last quarter of 2010. from the number of 83 018 patients and 159 144 number of samples submitted, there were 1712 nonconformities, which is 0.01% of total samples. The largest number of nonconformities do not passed urine 0.58%, and the number of samples hemolysis 0.14%, sample for hematological tests is not passed 0.09%. In the annual report in the first two quarters of 2010. year nonconformities were recorded manually, there we observed large discrepancies. Last quarter record an increase of about 80% of nonconforming due to the introduced electronic recording of the findings. The introduction of electronic recording of nonconformities in the last quarter of 2010. year there was a significant increase in the number of nonconformities recording which is much more realistic.

nonconformitie ; hemolysis ; preanalytical

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