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

Date Published: January 20, 2017

Publisher: Public Library of Science

Author(s): Dereen Najat, Pal Bela Szecsi.

http://doi.org/10.1371/journal.pone.0170211

Abstract

Laboratory 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.

Over 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.

The 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.

Partial Text

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. Despite advanced automation in diagnostic labs, there are still considerable error rates at clinical diagnostic labs [1].

Over 2 months, 5500 venous blood samples were collected from 10 public diagnostic labs in Sulaimani City (550 samples were collected from each hospital). We documented the occurrence of pre-analytical phase errors from February to April 2016.

During a two-month period, 5500 venous blood samples were analyzed in this study for pre-analytical errors. Each sample was followed strictly from the start of the blood test order by the clinician to the final reporting of the test results.

Pre-analytical phase errors have been the focus of research in past decades. Previous studies have focused on the analytical phase of diagnostic tests, and many quality control programs were initiated at diagnostic labs to monitor analytical phase errors. However, post- and pre-analytical errors were neglected worldwide, and currently many studies are focusing on the importance of the pre-analytical phase to obtain accurate lab results. An American pathologist program conducted a study enrolling 660 laboratories and showed that order error rate from outpatient centers was 4.8% [6]. The College of American Pathologists, including 120 labs, concluded that misidentification is a common laboratory error [7]. Interestingly, a Danish study on laboratory errors showed that 81% of lab errors were pre-analytical, while only 10% of lab errors were analytical. Moreover, 82.6% human errors and 4.3% technical errors were observed [7].

All ten diagnostic labs lacked vigorous quality control programs, and there is an urgent need to improve the quality control schemes at the selected hospitals; although internal quality controls have been used at these hospitals, the detected errors are primarily specific for the analytical phase, and the labs lack external quality control schemes. Notably, all neighboring countries (Turkey, Iran, Jordan, Saudi Arabia, Lebanon) are internationally accredited for all analytical phases. It is crucial to implement international external quality at these labs, and the College of American Pathologists (CAP) should monitor these labs. The CAP offers international services and extensive quality control assurance programs, assessments and many continuing educational programs. Thus, our government should make the extra effort to ensure equal quality at public hospitals.

 

Source:

http://doi.org/10.1371/journal.pone.0170211

 

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