Tumor specimens have a great role in basic and clinical translational researches on cancer, especially in the era of precision medicine. Thus the standardization of cancer biobank is of high importance. The establishment and maintenance of cancer biobank require comprehensive quality management, so as to provide high quality service for basic and clinical researches. At present, sample-oriented collection and management, and clinical and pathological data annotation are the main focuses of biobank standardization in China.
Biological Specimen Banks ; standards ; Biomedical Research ; China ; Documentation ; standards ; Humans ; Neoplasms ; Precision Medicine ; Specimen Handling ; standards

For many years, the clinical laboratory's focus on analytical quality has resulted in an error rate of 4-5 sigma, which surpasses most other areas in healthcare. However, greater appreciation of the prevalence of errors in the pre- and post-analytical phases and their potential for patient harm has led to increasing requirements for laboratories to take greater responsibility for activities outside their immediate control. Accreditation bodies such as the Joint Commission International (JCI) and the College of American Pathologists (CAP) now require clear and effective procedures for patient/sample identification and communication of critical results. There are a variety of free on-line resources available to aid in managing the extra-analytical phase and the recent publication of quality indicators and proposed performance levels by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) working group on laboratory errors and patient safety provides particularly useful benchmarking data. Managing the extra-laboratory phase of the total testing cycle is the next challenge for laboratory medicine. By building on its existing quality management expertise, quantitative scientific background and familiarity with information technology, the clinical laboratory is well suited to play a greater role in reducing errors and improving patient safety outside the confines of the laboratory.
Clinical Laboratory Techniques/standards ; Diagnostic Errors ; Humans ; Laboratories/*standards ; Quality Assurance, Health Care/standards ; Specimen Handling

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

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

Animals ; Male ; Prostate-Specific Antigen ; analysis ; metabolism ; Prostatectomy ; adverse effects ; standards ; Specimen Handling ; methods ; standards

BACKGROUND: One of the major concerns with biobanking is the absence of standard operating procedures to eliminate pre-analytical variation arising from sample collection, preparation, and storage. Currently, there is a lack of tools to carry out quality control procedures for stored blood samples. The aim of this study is to assess the quality of stored blood samples in our biobank and to suggest appropriate indicators for their quality control. METHODS: The stored blood samples that we tested have been registered into our biobank since 2003. These were transferred to our biobank after carrying out routine requested tests, because the samples would have otherwise been discarded. For the purpose of quality control, we analyzed the concentrations and the integrity of DNA and RNA extracted from the stored samples and tested the levels of several serum proteins; the results were compared with the corresponding pre-storage levels. RESULTS: A total of 19 samples were stored from 2006 to 2009. Of the 22 samples stored between 2003 and 2005, 50% showed complete DNA integrity. However, sufficient RNA integrity was noted in only 1 sample stored as recently as 2009. High blood urea nitrogen levels were also noted in the stored sera, but the increase did not correlate to the duration of storage. CONCLUSIONS: The amount and integrity of nucleic acids extracted from stored blood samples are potential indicators that can be used for quality control. A guideline for the quality assessment of stored blood samples in a biobank is urgently needed.
Blood Banks/*standards ; Blood Proteins/chemistry/standards ; Blood Urea Nitrogen ; DNA/*analysis/chemistry/standards ; Laboratory Techniques and Procedures ; Quality Control ; RNA/*analysis/chemistry/standards ; Specimen Handling/methods

To assess the influence of different sampling methods on Human Amniotic Fluid (HAF) during metabonomics analysis, and to establish a metabolite profile database for normal human amniotic fluid, four experimental groups (the group of freeze-drying, of freeze-thawing, of storage at -20 degrees C, and of keeping in room temperature) and a control group were investigated by use of 1H-NMR spectroscopy, respectively; the data of H-NMR spectroscopy was treated by principal components analysis (PCA). The results showed that, by comparison with the control, there were distinct differences in the experimental groups except the group of storage at -20 degrees C. Therefore, It is possible to use 1H-NMR-based metabonomics technique for analysis of HAF; moreover, during the tests, careful treatments of HAF should be institued to minimize the influence on the samples.
Amniotic Fluid ; metabolism ; Female ; Humans ; Magnetic Resonance Spectroscopy ; methods ; Metabolome ; Metabolomics ; methods ; Pregnancy ; Principal Component Analysis ; Specimen Handling ; methods ; standards

Body Fluids ; cytology ; Cytodiagnosis ; methods ; Humans ; Immunohistochemistry ; methods ; Lung Neoplasms ; pathology ; Pleural Effusion, Malignant ; pathology ; Quality Control ; Specimen Handling ; standards

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

INTRODUCTIONThis paper shows the importance and value of external proficiency testing programmes in monitoring and improving a laboratory's diagnostic skills. It reviews and documents the wide variety of inherited metabolic disorders (IMDs) encountered in the programmes organised by the Human Genetics Society of Australasia and the College of American Pathologists.

MATERIALS AND METHODSThe programmes used actual patient specimens to assess a laboratory's ability to provide diagnoses based on laboratory tests results and brief clinical information. Participating laboratory was also required to suggest additional test(s) to confirm diagnoses.

RESULTSThe results of diagnoses on 116 samples were reviewed. Altogether 49 IMDs were encountered, including 26 organic acidurias, 16 aminoacidurias, 3 urea cycle defects, 5 mucopolysaccharidoses, and 1 each of mucolipidosis and purine disorder. Our report for 21 of the 116 samples (18.1%) deviated from the actual diagnoses. Deviations from the final diagnoses were recorded along with the reasons for them. The main reasons for the deviations were: the lack of standards for recognising metabolites of pathognomonic significance, absence of characteristic metabolites in samples collected during treatment, the presence of misleading unusual metabolites, inadequate clinical information, and inability to perform additional tests due to insufficient specimens.

CONCLUSIONSThe programmes provided a wide variety of IMDs, some of which we have yet to encounter in our patients. They also enabled us to learn about the varied biochemical manifestations at different stages of disease and the identity of previously unidentified metabolites. They enhanced our knowledge and experience and improved our diagnostic skills.

Australia ; Humans ; Laboratories ; standards ; Metabolism, Inborn Errors ; diagnosis ; New Zealand ; Pathology, Clinical ; standards ; Professional Competence ; Program Evaluation ; Quality Assurance, Health Care ; Quality Control ; Specimen Handling ; standards