BACKGROUND: We investigated the influence of pre-analytical factors on the results of clinical tests and thereby analyzed approaches to improve quality management in clinical laboratories. METHODS: Unqualified clinical samples were selected from all the samples received at our clinical laboratory. The data were collected for 2009 and 2010, i.e., the years before and after the establishment of the laboratory quality management system. The rate and causes of generation of unqualified samples were analyzed, and measures to improve the laboratory practices were studied and implemented. RESULTS: A total of 1,051 unqualified samples were identified from among the 553,158 samples (the overall incidence rate of unqualified samples was 0.19%). The number of unqualified samples substantially varied according to the nature of the sample, and clinical samples collected for routine blood tests or coagulation tests were the predominant unqualified samples. The main causes of generation of unqualified samples were insufficient sample volumes and improper methods of mixing the samples. The rate of generation of unqualified samples decreased significantly after the implementation of improvement measures (0.26% in 2009 vs. 0.13% in 2010, P<0.001). CONCLUSIONS: The number of unqualified samples decreased significantly after the establishment of the laboratory quality management system, which promoted active communication among and training of the clinical staff to reduce the occurrence of pre-analytical errors. Comprehensive control of pre-analytical factors is an important approach in improving the clinical laboratory practices.
Clinical Laboratory Techniques/standards ; Diagnostic Errors/statistics & numerical data ; Humans ; Laboratories, Hospital/*standards ; Specimen Handling/standards

BACKGROUND: Documentation is very important; a considerable number of documents exist for use in accreditation inspection. However, most laboratories do not effectively manage the processes of documentation, organization, and storage. The purpose of this study was to facilitate the establishment of a strategically effective and sustainably standardized document management system. METHODS: A document code formatting system was modified by comparing the document list data received from 3 major university hospitals. In addition, a questionnaire regarding document code standardization was created and sent to 268 institutes to establish document classifications and generate a standard coding scheme. A computerized document management system was developed. RESULTS: Only 32% (8 out of 25 institutes) answered that they were able to identify all of the document types and their numbers. In total, 76% of institutes (19 out of 25) answered that a systematic document management system was necessary. Disorganized document files were systemized by classifying them into 8 major groups according to their characteristics: patient test records (T), test quality control (Q), manuals (M), equipment and environment management (E), statistics (S), division administration (A), department administration (R), and others (X). CONCLUSIONS: Our documentation system may serve as a basis for the standardization of documents and the creation of a document management system for all hospital laboratories.
Documentation/*standards ; Hospitals, University ; Laboratories, Hospital/*standards ; Questionnaires ; Tertiary Healthcare ; User-Computer Interface

Hemolysis frequently causes preanalytical errors in laboratory measurements. We aimed to develop a quality improvement indicator for evaluating the extent of inappropriate procedures causing hemolysis in clinical samples collected in medical care units. We defined the threshold value of the hemolysis index (H index) causing significant interference with analyte measurement and analyzed the H index values of clinical samples in relation to the threshold. The H index threshold value causing a 10% bias in the measurement of lactate dehydrogenase was found to be 25. The monthly mean H index and monthly frequency of samples with an H index >25 were significantly different among the types of ward (P=0.001, respectively), and significantly decreased after replacement of a laboratory centrifuge lacking temperature control (20.6±0.58 vs 23.30±1.08, P=0.01; 23.4±1.69% vs 32.6±1.78%, P=0.01). The monthly mean H index and the monthly frequency of samples with an H index above a threshold value may be useful quality improvement indicators for detection of inappropriate procedures in the acquisition and handling of blood samples in medical care units.
Hemoglobins/analysis ; Hemolysis ; Humans ; L-Lactate Dehydrogenase/analysis ; Laboratories, Hospital/*standards ; Quality Improvement/*standards ; Specimen Handling

BACKGROUND: Manual slide review (MSR) is usually triggered by the results of automated hematolgy analyzers, but each laboaratory has different ciriteria for MSR. This study was carried out to investigate the current status of MSR criteria of automated complete blood cell count (CBC) and white blood cell (WBC) differential results and to propose a basic guideline for MSR. METHODS: Total 111 laboratories were surveyed regarding MSR using questionnaires. The questionnaire asked: kinds of automated hematology analyzers used and the presence of criteria triggering MSR in seven categories: 1) CBC results, 2) 5 differential WBC counts, 3) 3 differential WBC counts, 4) automated reticulocyte counts, 5) delta check, 6) instrument flags (or messages), 7) clinical information (wards or diseases). Based on the survey results, we determined basic and extended criteria for MSR. With these criteria, we consulted nine hematology experts to get a consensus. RESULTS: All 111 laboratories had their own MSR criteria. Among 111 laboratories, 98 (88.3%) used more than three criteria for MSR including CBC results and 5-part WBC differential count results and 95 (85.6%) had criteria of flags triggering MSR. For MSR criteria with numeric values, the 10th, 50th, and 90th percentiles of upper and lower threshold values were obtained. The basic guideline for MSR was made. CONCLUSIONS: We proposed a basic guideline for MSR. This guideline would be helpful to hematology laboratories for their daily operation and providing more rapid and accurate CBC and WBC differential results.
Automation ; Blood Cell Count/instrumentation/*methods/standards ; Humans ; Laboratories, Hospital ; Leukocyte Count/instrumentation/*methods/standards ; Quality Control ; Questionnaires

This paper is to introduce the conception, basic constitution and working flow of laboratory automatic systems, and the domestic and world developments of the laboratory pipelining systems. It analyses the problems and the preferred scheme which should be given careful consideration when a system is to be built in the hospital.
Automation ; Clinical Laboratory Information Systems ; Clinical Laboratory Techniques ; instrumentation ; Computer Systems ; Laboratories, Hospital ; standards ; Software ; Specimen Handling ; instrumentation ; methods

BACKGROUND: We aimed to compare the diagnostic accuracy of the Alere Triage Cardio3 Tropinin I (TnI) assay (Alere, Inc., USA) and the PathFast cTnI-II (Mitsubishi Chemical Medience Corporation, Japan) against the central laboratory assay Singulex Erenna TnI assay (Singulex, USA). METHODS: Using the Markers in the Diagnosis of Acute Coronary Syndromes (MIDAS) study population, we evaluated the ability of three different assays to identify patients with acute myocardial infarction (AMI). The MIDAS dataset, described elsewhere, is a prospective multicenter dataset of emergency department (ED) patients with suspected acute coronary syndrome (ACS) and a planned objective myocardial perfusion evaluation. Myocardial infarction (MI) was diagnosed by central adjudication. RESULTS: The C-statistic with 95% confidence intervals (CI) for diagnosing MI by using a common population (n=241) was 0.95 (0.91-0.99), 0.95 (0.91-0.99), and 0.93 (0.89-0.97) for the Triage, Singulex, and PathFast assays, respectively. Of samples with detectable troponin, the absolute values had high Pearson (R(P)) and Spearman (R(S)) correlations and were R(P)=0.94 and R(S)=0.94 for Triage vs Singulex, R(P)=0.93 and R(S)=0.85 for Triage vs PathFast, and R(P)=0.89 and R(S)=0.73 for PathFast vs Singulex. CONCLUSIONS: In a single comparative population of ED patients with suspected ACS, the Triage Cardio3 TnI, PathFast, and Singulex TnI assays provided similar diagnostic performance for MI.
Acute Coronary Syndrome/*diagnosis ; Biomarkers/analysis ; Emergency Service, Hospital ; Humans ; Laboratories/standards ; Myocardial Infarction/diagnosis ; *Point-of-Care Systems ; Prospective Studies ; Reagent Kits, Diagnostic ; Sensitivity and Specificity ; Troponin I/*analysis

To understand the potential causes of laboratory-acquired infections and to provide possible solutions that would protect laboratory personnel, samples from a viral laboratory were screened to determine the main sources of contamination with six subtypes of Rhinovirus. Rhinovirus contamination was found in the gloves, cuffs of protective wear, inner surface of biological safety cabinet (BSC) windows, and trash handles. Remarkably, high contamination was found on the inner walls of the centrifuge and the inner surface of centrifuge tube casing in the rotor. Spilling infectious medium on the surface of centrifuge tubes was found to contribute to contamination of centrifuge surfaces. Exposure to sodium hypochlorite containing no less than 0.2 g/L available chlorine decontaminated the surface of the centrifuge tubes from Rhinovirus after 2 min.
Equipment Contamination ; statistics & numerical data ; Humans ; Laboratories, Hospital ; manpower ; standards ; statistics & numerical data ; Occupational Exposure ; analysis ; statistics & numerical data ; Virus Diseases ; virology ; Viruses ; genetics ; growth & development ; isolation & purification

Pharmacogenetic testing for clinical applications is steadily increasing. Correct and adequate use of pharmacogenetic tests is important to reduce unnecessary medical costs and adverse patient outcomes. This document contains recommended pharmacogenetic testing guidelines for clinical application, interpretation, and result reporting through a literature review and evidence-based expert opinions for the clinical pharmacogenetic testing covered by public medical insurance in Korea. This document aims to improve the utility of pharmacogenetic testing in routine clinical settings.
Anticoagulants/therapeutic use ; Antidepressive Agents/therapeutic use ; Antimetabolites, Antineoplastic/therapeutic use ; Antitubercular Agents/therapeutic use ; Arylamine N-Acetyltransferase/genetics ; Coronary Artery Disease/drug therapy/genetics ; Cytochrome P-450 CYP2C19/genetics ; Cytochrome P-450 CYP2C9/genetics ; Cytochrome P-450 CYP2D6/genetics ; Depressive Disorder/drug therapy/genetics ; Genotype ; Isoniazid/therapeutic use ; Laboratories, Hospital/standards ; Methyltransferases/genetics ; Pharmacogenomic Testing/*methods/standards ; Platelet Aggregation Inhibitors/therapeutic use ; Pulmonary Embolism/drug therapy/genetics ; Ticlopidine/analogs & derivatives/therapeutic use ; Tuberculosis/drug therapy/genetics ; Vitamin K Epoxide Reductases/genetics ; Warfarin/therapeutic use