Malaria remains a global health challenge, although an increasing number of countries will enter pre-elimination and elimination stages. The prompt and precise diagnosis of symptomatic and asymptomatic carriers of Plasmodium parasites is the key aspect of malaria elimination. Since the launch of the China Malaria Elimination Action Plan in 2010, China has formulated clear goals for malaria diagnosis and has established a network of malaria diagnostic laboratories within medical and health institutions at all levels. Various external quality assessments were implemented, and a national malaria diagnosis reference laboratory network was established to strengthen the quality assurance in malaria diagnosis. Notably, no indigenous malaria cases have been reported since 2017, but the risk of re-establishment of malaria transmission cannot be ignored. This review summarizes the lessons about malaria diagnosis in the elimination phase, primarily including the establishments of laboratory networks and quality control in China, to better improve malaria diagnosis and maintain a malaria-free status. A reference is also provided for countries experiencing malaria elimination.
China/epidemiology* ; Clinical Laboratory Techniques ; Global Health ; Humans ; Laboratories ; Malaria/prevention & control*

Exploring a new teaching mode of CHB laboratory diagnostics to improve the teaching quality through establishment a teaching model covered the whole process of CHB disease diagnosis and differential diagnosis, treatment, drug selection, the toxicity and side effects prediction, effect monitoring, and prognosis evaluation. According to the CHB clinical diagnosis and treatment guidelines, formulated the laboratory examination and detection strategies related to different stages of CHB, and established CHB clinical laboratory diagnostic pathway. Compared the classroom teaching effect by the questionnaire between the 2016 and 2017 eight-year undergraduates from the First Clinical College of Wuhan University. In this study,the CHB clinical laboratory diagnostic pathway was established and approved by clinicians, which covered the whole process of CHB disease diagnosis and differential diagnosis, treatment, drug selection, the toxicity and side effects prediction, effect monitoring, and prognosis evaluation. The teaching quality evaluation indicators and the scores on the class test had been greatly improved with the clinical diagnostic pathway teaching mode in the classroom teaching of 2017 clinical medicine undergraduates compared with the traditional teaching mode in the 2016 clinical medicine undergraduates. In summary, the medical students not only could realize the organic integration of laboratory diagnostics and clinical medicine, but also improves overall understanding of various laboratory tests in CHB diagnosis and treatment from the teaching model of laboratory diagnostics based on the CHB clinical laboratory diagnostic pathway,and the quality of teaching for CHB has been significantly improved.
Clinical Laboratory Techniques ; Hepatitis B, Chronic ; Humans ; Laboratories ; Laboratories, Clinical ; Records

As a special kind of in vitro diagnostic devices（IVDs）, laboratory developed tests（LDTs） are of great significance to the development of clinical laboratories. This study aims to explore the regulatory requirements ideas of LDTs. By introducing the development of LDTs and the changing of regulatory requirements in the United States, combing the current regulatory framework and discussing relevant ideas in the regulatory requirements of LDTs.
Clinical Laboratory Services ; Laboratories ; Reagent Kits, Diagnostic ; United States ; United States Food and Drug Administration

Clinical laboratories for in vitro diagnostics are facing pressure to preserve cost control while providing better services through new initiatives. Laboratory automation is a partial answer to this problem, having come a long way from the early days of clinical laboratory testing. The journey and implementation of automation in the Singapore General Hospital's Clinical Biochemistry Laboratory has allowed for sustained performance in the light of increasing workload and service commitments amid an evolving healthcare environment. Key to realising predicted outcomes is the optimisation of workflow processes, reduction of errors, and spatial placement of specimen reception and analytical areas. This paper gives an overview of our experience with automation in the clinical laboratory and its subsequent impact on service standards.
Aged ; Automation, Laboratory ; Clinical Laboratory Information Systems ; organization & administration ; Clinical Laboratory Techniques ; Efficiency, Organizational ; statistics & numerical data ; Hospitals, General ; Humans ; Laboratories, Hospital ; organization & administration ; Middle Aged ; Quality of Health Care ; Singapore ; Tertiary Healthcare ; organization & administration ; User-Computer Interface ; Workload

Harmonization of clinical laboratory results means that results are comparable irrespective of the measurement procedure used and where or when a measurement was made. Harmonization of test results includes consideration of pre-analytical, analytical, and post-analytical aspects. Progress has been made in each of these aspects, but there is currently poor coordination of the effort among different professional organizations in different countries. Pre-analytical considerations include terminology for the order, instructions for preparation of the patient, collection of the samples, and handling and transportation of the samples to the laboratory. Key analytical considerations include calibration traceability to a reference system, commutability of reference materials used in a traceability scheme, and specificity of the measurement of the biomolecule of interest. International organizations addressing harmonization include the International Federation for Clinical Chemistry and Laboratory Medicine, the World Health Organization, and the recently formed International Consortium for Harmonization of Clinical Laboratory Results (ICHCLR). The ICHCLR will provide a prioritization process for measurands and a service to coordinate global harmonization activities to avoid duplication of effort. Post-analytical considerations include nomenclature, units, significant figures, and reference intervals or decision values for results. Harmonization in all of these areas is necessary for optimal laboratory service. This review summarizes the status of harmonization in each of these areas and describes activities underway to achieve the goal of fully harmonized clinical laboratory testing.
Chemistry, Clinical ; Documentation ; Guidelines as Topic ; Laboratories/*standards ; Reference Values

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

Using three Austrian case studies, the variegated applications of molecular typing in today's public health laboratories are discussed to help illustrate preventive management strategies relying on DNA subtyping. DNA macrorestriction analysis by pulsed field gel electrophoresis has become the gold standard for subtyping of food borne pathogens like listeria, salmonella, campylobacter and Bacillus cereus. Using a Salmonella Mbandaka outbreak from the year 2010 as example, it is shown how the comparison of patterns from human isolates, food isolates, animal isolates and feed isolates can allow to identify and confirm a source of disease. An epidemiological connection between the simultaneous occurrence of tuberculosis in cattle and deer with cases of human tuberculosis due to Mycobacterium caprae in 2010 was excluded using mycobacterial interspersed repetitive units variable-number tandem repeats subtyping. Also in 2010, multilocus sequence typing with nonselective housekeeping genes, the so-called sequence based typing protocol, was used to elucidate connections between an environmental source (a hospital drinking water system) and a case of legionellosis. During the last decades, molecular typing has evolved to become a routine tool in the daily work of public health laboratories. The challenge is now no longer to simply type microorganisms, but to type them in a way that allows for data exchange between public health laboratories all over the world.
Bacterial Typing Techniques/*methods ; Clinical Laboratory Techniques/*methods ; DNA Fingerprinting ; DNA, Bacterial/*analysis ; Disease Outbreaks ; Electrophoresis, Gel, Pulsed-Field/methods ; Food Microbiology ; Humans ; Laboratories ; Molecular Typing/*methods ; Preventive Medicine ; *Public Health

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

The purpose of this study was to investgate and evaluate whether the recording information contained in the work authorization was performed properly and master casts were designed accurately according to the rationale and principles of the removable partial denture when the work authorization and the master casts were sent to the dental framework. the accurate recording of the work authorization sent to dental laboratory in Hwasun for removable partial denture framework, the normal form of the occlusal rest guiding plan of the surveyed crown using the surveyor, the location analysis of the occlusal rest seat, the design patten of the maxillary and mandibulary major connectors, the use of the surveyor on the master cast, the status of the secondary impression taken in the distal extension edentulous areas were investigated for this study. The following results were obtained : 1. In the status of the occlusal rest seat prepared in the abutment, the occlusal rest seat with normal form was 81.25%, 95.45%, that without form was 6.25%, 0.00%, respectively in Class I and Class II on the maxillary cast and the occlusal rest seat with normal form was 76.92%, 95.45%, that without form was 7.69%, 0.00% respectively in Class I and Class II on the mandibular cast. 2. In the status of the guiding plan, the guiding plan with the normal form was 79.17%, 86.36% that with abnormal form was 20.84%, 13.64% respectively in Class I and Class II on the maxillary cast and the guiding plan with normal form was 79.49%, 77.27%, that with abnormal form was 20.51%, 22.73% respectively in Class I and Class II on the mandibular cast. 3. The abutment splinting in the distal extension removable partial denture was 20.78%, 27.27%, respectively in Class I and Class II on the maxillary cast and was 25.64%, 13.64% respectively in Class I and Class II on the mandibular cast. 4. The location and form of the major connector delineated on the maxillary and mandibular master cast was 95.83%, 98.41% respectively. 5. The delineation and recording on the work authorization was incomplete as group II(73.33%), group I(14.07%), group III(12.59%) and group IV (0.00%) in investigating the contents of the work authorization. 6. Aker's clasp of the types of the direct retainer was nots used 72.22%, 74.60%, in the maxillary and mandibular casts respectively. 7. The location of the indirect retainer delineated on the maxillary and mandibular master cast was 51.43%, 50.82% respectively. 8. The types of metal used were mostly Cr-Co non-precious metal alloy and the cases using color coding on the drawing paper of work authorization were not observed. 9. The cases taking secondary impression in the distal extension removable partial denture were 45.71%, 52.46% respectively in the maxillary and mandibular master cast. 10. The delineation of tripoding or reference line on the master cast was not observed in surveying procedure.
Alloys ; Clinical Coding ; Crowns ; Denture, Partial, Removable ; Laboratories, Dental ; Splints