Prevalence of Pre-Analytical Errors in Clinical Chemistry Diagnostic Labs in Sulaimani City of Iraqi Kurdistan

Pal Bela Szecsi,Dereen Najat

doi:10.1371/journal.pone.0170211

Abstract

BackgroundLaboratory testing is roughly divided into three phases: a pre-analytical phase, an analytical phase and a post-analytical phase. Most analytical errors have been attributed to the analytical phase. However, recent studies have shown that up to 70% of analytical errors reflect the pre-analytical phase. The pre-analytical phase comprises all processes from the time a laboratory request is made by a physician until the specimen is analyzed at the lab. Generally, the pre-analytical phase includes patient preparation, specimen transportation, specimen collection and storage. In the present study, we report the first comprehensive assessment of the frequency and types of pre-analytical errors at the Sulaimani diagnostic labs in Iraqi Kurdistan.Materials and MethodsOver 2 months, 5500 venous blood samples were observed in 10 public diagnostic labs of Sulaimani City. The percentages of rejected samples and types of sample inappropriateness were evaluated. The percentage of each of the following pre-analytical errors were recorded: delay in sample transportation, clotted samples, expired reagents, hemolyzed samples, samples not on ice, incorrect sample identification, insufficient sample, tube broken in centrifuge, request procedure errors, sample mix-ups, communication conflicts, misinterpreted orders, lipemic samples, contaminated samples and missed physician’s request orders. The difference between the relative frequencies of errors observed in the hospitals considered was tested using a proportional Z test. In particular, the survey aimed to discover whether analytical errors were recorded and examine the types of platforms used in the selected diagnostic labs.ResultsThe analysis showed a high prevalence of improper sample handling during the pre-analytical phase. In appropriate samples, the percentage error was as high as 39%. The major reasons for rejection were hemolyzed samples (9%), incorrect sample identification (8%) and clotted samples (6%). Most quality control schemes at Sulaimani hospitals focus only on the analytical phase, and none of the pre-analytical errors were recorded. Interestingly, none of the labs were internationally accredited; therefore, corrective actions are needed at these hospitals to ensure better health outcomes. Internal and External Quality Assessment Schemes (EQAS) for the pre-analytical phase at Sulaimani clinical laboratories should be implemented at public hospitals. Furthermore, lab personnel, particularly phlebotomists, need continuous training on the importance of sample quality to obtain accurate test results.

Highlights

Accurate laboratory results are vital for patient safety and improving the medical diagnosis of patients, and many studies have shown that 70% of medical diagnostic decisions depend on the accuracy of laboratory tests
The total testing process includes every step from the test request to the receipt of results (Fig 1)
First is the pre-analytical phase, which according to the International Organization for Standardization (ISO) 15189:2012 standard for laboratory accreditation, encompasses all the steps from test request, sample collection, transport and registration of the sample up to the start of specimen analysis

Summary

Introduction

Accurate laboratory results are vital for patient safety and improving the medical diagnosis of patients, and many studies have shown that 70% of medical diagnostic decisions depend on the accuracy of laboratory tests. The total testing process includes every step from the test request to the receipt of results (Fig 1). The lab testing process generally comprises three phases. First is the pre-analytical phase, which according to the International Organization for Standardization (ISO) 15189:2012 standard for laboratory accreditation, encompasses all the steps from test request, sample collection, transport and registration of the sample up to the start of specimen analysis. Third is the post-analytical phase, which includes the interpretation of the results, approval from the lab manager and reporting to the clinician [2]. Recent studies have shown that up to 70% of analytical errors reflect the pre-analytical phase. The pre-analytical phase comprises all processes from the time a laboratory request is made by a physician until the specimen is analyzed at the lab.

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