Based on a blind research of in-vitro diagnostic devices in use,this paper analyses the error rates of clinical laboratory items in hospitals of different levels, and gives some advies and suggestions for clinical laboratory administration.
Clinical Laboratory Techniques ; instrumentation ; standards ; utilization ; Humans

The source of measure error and how to control the quality, reduce error, increase examination quality are described in the paper in clinical electrolyte analysis and measurements. The related factors include patient readiness, sample collection and preparation, condition of the instrument and reagents, data management, result report and so on.
Clinical Laboratory Techniques ; standards ; Electrolytes ; blood ; Humans ; Quality Control

Biological Products ; standards ; China ; Clinical Laboratory Techniques ; instrumentation ; standards ; Laboratories ; standards ; Safety Management ; legislation & jurisprudence ; standards

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

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

The semen analysis is one, if not the most, important and widely used clinical laboratory test to evaluate the fertility potential of the male. However, recent reports have suggested that the semen analysis is unreliable. Quality control in the andrology laboratory is often seen as problematic, and many laboratories do not routinely employ QC procedures in semen testing. Quality assurance is an often overlooked and unappreciated aspect of overall quality laboratory performance. External proficiency testing programs in andrology are not universally accepted, and the results from the few programs currently available demonstrate huge variations between laboratories. Numerous different standards and criteria are being used by andrology laboratories, making it difficult if not impossible to compare results from one laboratory to another. However, reliable semen analyses can be obtained by following several recommendations: (1) all laboratories performing the semen analysis should adopt universally accepted performance standards and criteria, (2) all laboratories performing this test should participate in external proficiency testing programs, (3) andrology laboratories should implement effective internal quality control and quality assurance programs to ensure that the results reported are accurate and reproducible, and (4) physicians should only refer their patients to, or accept semen analysis results from, laboratories that have stringently followed these recommendations.
Clinical Laboratory Techniques ; standards ; Humans ; Male ; Quality Control ; Reproducibility of Results ; Semen ; Sperm Count ; standards ; Sperm Motility

Clinical Laboratory Techniques ; standards ; Humans ; Male ; Quality Control ; Semen ; Sperm Count ; methods ; 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

No abstract available.
*Algorithms ; Automation ; Clinical Laboratory Information Systems/*standards ; Humans ; Immunoassay/*methods ; Indicator Dilution Techniques ; alpha-Fetoproteins/*analysis

Traditional Chinese medicine (TCM) and Western medicine have the common purpose and can complement each other, though they belong to different medical systems. Laboratory medicine can provide the scientific bases for modernization and standardization of TCM by offering elaborate and objective laboratory data. Fully playing the role of laboratory medicine in TCM diagnosis and treatment will not only be beneficial to the rush of TCM out of China toward the world, and also be favorable to the innovating and developing of laboratory medicine in integrative medicine.
Biomarkers ; blood ; Clinical Laboratory Techniques ; Diagnosis, Differential ; Humans ; Medicine, Chinese Traditional ; methods ; standards