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At least 955 records · Page 53Linked to original sources
PubMed2006

[The expectations for the third generation clinical laboratories in Japan].

The author expressed his hopes and expectations for third generation clinical laboratory schemes or systems in Japan. The history of development of the clinical laboratory in Japan can be classified three generations after the Second World War, the first generation (1945-1975), the second generation (1970-2005) and the third generation (2001-). The third generation clinical laboratory can be called "the clinical laboratory for the 21st century". The author advised some suggestions for the clinical laboratory for the 21st century. The main advice of the author is as follows: 1) The necessity of professional physicians of clinical laboratory medicine in hospitals. 2) The necessity of standardization and holding nationwide common reference values of main clinical laboratory tests. 3) The realization of a network of high-grade laboratory tests between all clinical laboratory divisions of the national university hospitals.

Clinical Laboratory Information Systems↗
PubMed2001

Laboratory testing of whole cell pertussis vaccine: a WHO proficiency study using the Kendrick test.

Whole cell pertussis vaccine (WCV), commonly in combination with vaccines for diphtheria and tetanus, has an important role in reducing morbidity and mortality among children in most parts of the world. Testing to assure the efficacy of such vaccines is essential. We have, therefore, carried out, under the Global Training Network (GTN) of the Department of Vaccines and Biologicals at the World Health Organization (WHO), a proficiency study involving 13 laboratories in 12 countries that routinely test WCV. Two vaccine samples were tested in this study and represented samples which were expected clearly either to pass (sample B, a full strength vaccine) or to fail (sample A, 1/8 strength of vaccine B). Data from this study showed good performance by the majority of participants. Most assays were statistically valid and were carried out to the level of precision achieved for these assays in previous studies. This study also indicated that, relative to the assay precision, the in-house reference (IHR) preparations are in general accurately calibrated. Statistically valid assays of the sub-potent vaccine, A, showed it to fail in all except one laboratory. Statistically valid assays of the potent vaccine, B, showed it to pass in all laboratories. Nevertheless, the between laboratory variability of estimates for vaccine B, and for comparisons of the two vaccine samples suggested that there are some differences in results in different laboratories. The introduction of a common working standard may assist in reducing inter-laboratory variation. This study has shown clearly satisfactory performance by most laboratories. However, a serious problem was detected in one laboratory where the sub-potent vaccine A could have been passed and was not distinguished from the eight-fold more potent vaccine B. There were also indications of possible problems in several other laboratories, where IHR preparation may not be accurately calibrated or where vaccine samples A and B may not be completely distinguished. Although this study provides reassurance that most laboratories perform well, it demonstrates the essential role of ongoing proficiency studies in high-lighting problems.

Animals↗
PubMed1996

[Mobile blood gas and laboratory monitoring. A new technology in clinical routine].

INTRODUCTION: Decision-making on therapy in acute cases involves clinical examination and monitoring of vital parameters and fluid balance; especially, however, laboratory parameters. The present study compared the results of a new bedside laboratory analysis system (PortLab, i-STAT Corp., Princeton NJ) with the analytical results obtained in our central laboratory. In a second phase personnel costs and turnover times of the two methods were evaluated comparatively. MATERIALS AND METHODS: The PortLab system consists of a basic unit (539 g) with an integrated display and disposable silicon cartridges with thin-film electrodes. Up to 8 parameters can be determined simultaneously in 60 microliters of whole blood. Fifty results obtained with the PortLab system of the parameters sodium, potassium, chlorid, glucose, BUN, hematocrit, the calculated haemoglobin and blood gas analysis were correlated with the results obtained by central laboratory analysis. In a second phase, all procedural steps, the time needed and the turnover times for laboratory analysis were compared with the expenditure for the same analyses performed with the PortLab system. RESULTS AND DISCUSSION: The results obtained using PortLab analysis correlated very well with those of the central laboratory (between 0.966 for the hematocrit and 0.994 for pO2). Three steps were required to perform bedside analysis with the PortLap system. The staff was occupied for 1 min. and 15 sec. and the results were ready within 4 min. and 45 sec. (pure analysis time < 2 min.). Analysis in the central laboratory required 8 steps, the intensive care staff was occupied for 6 min. and 15 sec., 5 min. and 15 sec. of which they were away from the patients' side. Analysis of blood gases required 4 steps, the result was ready in 4 min. 15 sec. The personnel was occupied for an equally long time. The use of PortLab saved personnel resources of 5 minutes per laboratory analysis and 3 minutes per blood gas analysis. CONCLUSION: The PortLab system proved easy to handle and reliable. Valuable personnel resources can be saved. This method cannot replace conventional laboratory analyses, but enables more extensive monitoring of patients and their laboratory parameters. The industry should develop analogous monitoring systems for modular solutions.

Blood Chemical Analysis↗
PubMed2004

How good are clinical chemistry laboratories at analysing ethylene glycol?

The results of an external proficiency test of clinical chemistry laboratories in Sweden when the target analyte was ethylene glycol (EG) are presented. Specimens of plasma were spiked with EG (10% w/v) to give assigned concentrations ranging from 5 to 50 mmol/L. Over a period of 6 years, two control specimens of plasma were sent for analysis on 21 occasions to between 14 and 20 participating laboratories as a declared proficiency trial. The analytical precision between and within laboratories was determined by spiking the plasma specimens with the same concentration of EG so that the results reported back could be considered a duplicate determination. On one occasion propylene glycol (PG) was substituted for EG without informing the participants. The standard deviation (SD) within laboratories expressed as the coefficient of variation (CV) was 4.5% compared with 11.4% between laboratories. Results reported by laboratories using gas chromatography (GC) were in good agreement with those when an enzymatic method was used. The between-laboratory SD increased with concentration of EG in the specimen and at a mean concentration of 18 mmol/L, the pooled SD was 4.11 mmol/L (CV = 23%). Four laboratories reported finding EG in plasma when PG was the diol present; three laboratories used an enzymatic method and one used GC. Clinical laboratories that provide a toxicology service should regularly participate in external quality assurance schemes that include low-molecular-weight alcohols such as EG. Efforts should be made to standardize the analytical methods used for toxicological analysis.

Clinical Chemistry Tests↗
PubMed2006

Improving the NHS cervical screening laboratory performance indicators by making allowance for population age, risk and screening interval.

OBJECTIVE: One of the key performance measures in the monitoring of the NHS cervical screening programme is the targeting of laboratories with very high or low percentages (outside the 10th-90th percentile) of adequate smears that have moderate dyskaryosis or worse. These laboratories are assumed to include those laboratories that may have extremes of sensitivity and specificity. A clear limitation with this methodology is that laboratories do not examine smears from women with the same underlying risk, age distribution or screening interval and adjustment for these factors should considerably improve the method. METHODS: This paper describes a method that allows for these confounding variables and a new age-risk-interval adjusted moderate dyskaryosis or worse rate (ARI-adjusted mod+ rate) can be calculated. The adjusted rate is the rate of moderate or worse dyskaryotic smears that the laboratory would have detected had it been screening women with an English 'average' age-risk-interval. All laboratories can therefore be compared using this method. RESULTS: The methodology is illustrated using data from the NHSCSP South West Region. The particularly low percentage of moderate or worse smears detected by one or two laboratories can be shown to be due to a local screened population with a very low risk because of a high mean age, relatively short screening interval and census variables associated with a low risk, rather than any under-calling by the associated laboratories. CONCLUSIONS: The ARI-adjusted mod+ rate requires to be calculated for all laboratories in England if it is to be used as a primary performance indicator. Alternatively, it can be used to further examine laboratories that are deemed to be outliers using the current methodology.

Adult↗
PubMedDate not supplied

Communication between the dental laboratory technician and dentist: work authorization for fixed partial dentures.

PURPOSE: A questionnaire was sent to laboratory technicians to determine the level of communication between dentists and dental laboratories in specific areas of the work authorization forms for the fabrication of fixed partial dentures. MATERIALS AND METHODS: A select number of dental laboratories were randomly chosen from the National Association of Dental Laboratories (NADL) for each of the 50 states. The questionnaire was mailed to the laboratory directors for a total of 199 dental laboratories. The survey asked questions pertaining to the following areas of work authorization: legibility and thoroughness of prescriptions, patient information, choice of materials for the prosthesis, design of the prosthesis, and shade description. For each question, the number of responses received was tabulated and converted to a percentage. RESULTS: Of the 199 laboratories surveyed, 114 (57%) responded to the questionnaire. Results from this survey suggest that there is lack of communication between dentists and dental laboratories through work authorization forms regarding choice of metal alloy, type of porcelain to be used, and choice of margin and pontic design for the prosthesis. CONCLUSIONS: Information obtained from the responding laboratories included effectiveness of work authorization forms. There were some similar trends indicated by the large percentage of dental laboratories agreeing on lack of communication by the dentists as reflected by the work authorization forms.

Communication↗
PubMed2005

Diagnostic evaluation of HER-2 as a molecular target: an assessment of accuracy and reproducibility of laboratory testing in large, prospective, randomized clinical trials.

PURPOSE: To critically assess the accuracy and reproducibility of human epidermal growth factor receptor type 2 (HER-2) testing in outside/local community-based hospitals versus two centralized reference laboratories and its effect on selection of women for trastuzumab (Herceptin)-based clinical trials. EXPERIMENTAL DESIGN: Breast cancer specimens from 2,600 women were prospectively evaluated by fluorescence in situ hybridization (FISH) for entry into Breast Cancer International Research Group (BCIRG) clinical trials for HER-2-directed therapies. RESULTS: HER-2 gene amplification by FISH was observed in 657 of the 2,502 (26%) breast cancers successfully analyzed. Among 2,243 breast cancers with central laboratory immunohistochemistry (10H8-IHC) analysis, 504 (22.54%) showed overexpression (2+ or 3+). Outside/local laboratories assessed HER-2 status by immunohistochemistry in 1,536 of these cases and by FISH in 131 cases. Overall, the HER-2 alteration status determined by outside/local immunohistochemistry showed a 79% agreement rate [kappa statistic, 0.56; 95% confidence interval (95% CI), 0.52-0.60], with FISH done by the central laboratories. The agreement rate comparing BCIRG central laboratory 10H8-IHC and outside/local laboratory immunohistochemistry was 77.5% (kappa statistic, 0.51; 95% CI, 0.46-0.55). Finally, HER-2 status, determined by unspecified FISH assay methods at outside/local laboratories, showed a 92% agreement rate (kappa statistic, 0.83; 95% CI, 0.73-0.93), with FISH done at the BCIRG central laboratories. CONCLUSIONS: Compared with the HER-2 status determined at centralized BCIRG reference laboratories, these results indicate superiority of FISH to accurately and reproducibly assess tumors for the HER-2 alteration at outside/local laboratories for entry to clinical trials.

Biomarkers, Tumor↗
PubMed1982

Temperatures used in the determination of enzyme activity in clinical biochemistry laboratories in Britain: results of a survey.

Information on the temperature used in the determination of enzyme activity in clinical biochemistry laboratories in Britain was obtained by circulating a questionnaire to 400 laboratories in Britain. Replies were analysed from 321 laboratories (80%). A large majority of laboratories use 37 degrees C to determine enzyme activity: 99% use this temperature for amylase, 88% for alkaline phosphatase, and 81% for aspartate and alanine amino-transferases. A greater proportion of laboratories with large workloads use 37 degrees C than do those with smaller workloads. The majority of laboratories use equipment with incubation temperatures that are selectable within the laboratory. When there is evidence of advantage in using a particular temperature most laboratories use this temperature. Almost one-quarter of the laboratories replying participate in a local agreement to use 37 degrees to determine enzyme activity. About one-third of laboratories consider it impracticable to change to 30 degrees C, and of those replying to the question on whether they were willing to change to 30 degrees C, 49% indicated that they were not willing to do so.

Alanine Transaminase↗
PubMed2005

A comparison of chronic cadmium effects on Hyalella azteca in effluent-dominated stream mesocosms to similar laboratory exposures in effluent and reconstituted hard water.

Laboratory single-species toxicity tests are used to assess the effects of contaminants on aquatic biota. Questions remain as to how accurately these toxicity tests predict site-specific bioavailability and chronic effects of metals, particularly in streams that are effluent-dominated or dependent on effluent discharge for flow. Concurrent 42-d Hyalella azteca exposures were performed with cadmium and final treated municipal effluent in the laboratory and at the University of North Texas Stream Research Facility (Denton, TX, USA), a series of outdoor lotic mesocosms. An additional 42-d laboratory test was conducted with H. azteca to evaluate Cd toxicity in reconstituted hard water (RHW). Endpoints included Cd body burden, survival, growth, and reproduction. Calculated average bioaccumulation factors were: 2,581 (stream mesocosm test) < 3,626 (laboratory effluent) < 7,382 (laboratory RHW). The 42-d survival lowest-observed-effect concentrations (LOECs) were 0.94, 4.53, and 22.97 microg/L for the laboratory RHW, laboratory effluent, and stream mesocosm exposures, respectively. Baseline growth (dry wt) and reproduction (young female(-1)) among the three exposures followed the relationship: Stream mesocosms > laboratory effluent > laboratory RHW. Differences among response variables in the three tests likely resulted from increased food sources and decreased Cd bioavailability in lotic mesocosms. Our results demonstrate that laboratory toxicity tests may overestimate chronic toxicity responses of H. azteca to Cd in effluent-dominated streams.

Amphipoda↗
PubMed1988

Detection of circulating Dirofilaria immitis antigens in random source laboratory dogs: evaluation of two commercial serodiagnostic tests.

Two commercially available serodiagnostic tests for Dirofilaria immitis antigens were evaluated for sensitivity, specificity, predictive values, and reliability using serum from 110 random source dogs. Both tests were performed in two separate laboratories on serum samples randomized in five blocks of 22 samples each. Dogs were examined for microfilariae using the modified Knott's technique, and for adult parasites by necropsy. Forty-eight of the 110 dogs (43.6%) had either adult or juvenile parasites within the cardiopulmonary vasculature or microfilariae in the peripheral blood. Of those 48, 26 (54.2%) were amicrofilaremic and had cardiopulmonary parasite populations ranging from one to greater than 50. In both laboratories, both commercial tests failed to detect infection in eight of the 26 amicrofilaremic dogs. Three amicrofilaremic dogs were positive by both tests in both laboratories. Four dogs (3.6%) had microfilariae without adults. Two of those four dogs were negative by both commercial tests in both laboratories. One commercial test had 38 false negatives in one laboratory, 13 of which were also negative in the second laboratory. The other test had 21 false negatives in one laboratory and 20 in the other laboratory. Fourteen of these samples were falsely negative in both laboratories. False positives were low in both laboratories for both tests.

Analysis of Variance↗
PubMed1998

Concepts for the third generation of laboratory systems.

This paper briefly describes the history of laboratory systems and discusses some of the recent concepts. The third generation of laboratory systems, which appeared around 1990, encompasses most of the pre-analytical, analytical and post-analytical procedural steps of the laboratory workflow, thus eliminating much of the so-called "3 D tasks" (dull, dirty, dangerous). These automation systems enable humans to focus on work of higher value such as result validation or development of tests in emerging areas. The new development started in Japan in 1981 and reached the Western hemisphere around 1995. Currently there are between 800 and 900 installations world-wide that meet the above criteria. The majority of them automate hematology, whereas systems that automate more complex areas such as clinical chemistry, immunochemistry, coagulation and urinalysis, represent only about one third. More than 60% of the world-wide system base has been installed in Japan. Future growth in the West and high market saturation in Japan are likely to decrease this percentage during the next few years. The two key concepts of third generation systems are "consolidation" and "integration". The following definitions are suggested: * Consolidation: Combining different analytical technologies or strategies on one instrument or on one group of connected instruments. * Integration: Linking analytical instruments or groups of instruments with pre- and post-analytical devices. Examples for the technical realization of both concepts and practical aspects of how to apply them in an individual laboratory are given. Components, which are specifically new in the context of laboratory automation, are conveyor belts, stationary and floor-running robots, and software for process control. The most attractive options to be considered when automating a laboratory are primary tube sorting and the use of secondary samples to increase speed and to avoid sample carryover. Other applications include automatic centrifugation (esp. for hospital laboratories), decapping (esp. for clinical chemistry), automatic loading and unloading of analyzers (esp. for large laboratories), automatic rerun and reflex testing as well as computer-based sample retrieval, result validation, and interpretation. Specific recommendations for automation planning include the need to see and discuss working installations either during site visits or via video documentations, and to conduct computer simulation experiments on the basis of a "virtual laboratory" model.

Automation↗
PubMed2004

Laboratory reporting of tuberculosis test results and patient treatment initiation in California.

Prompt laboratory reporting of tuberculosis (TB) test results is necessary for TB control. To understand the extent of and factors contributing to laboratory reporting delays and the impact of reporting delays on initiation of treatment of TB patients, we analyzed data from 300 consecutive culture-positive TB cases reported in four California counties in 1998. Laboratory reporting to the specimen submitter was delayed for 26.9% of smear-positive patients and 46.8% of smear-negative patients. Delays were associated with the type of laboratory that performed the testing and with delayed transport of specimens. Referral laboratories (public health and commercial) had longer median reporting time frames than hospital and health maintenance organization laboratories. Among patients whose treatment was not started until specimens were collected, those with delayed laboratory reporting were more likely to have delayed treatment than patients with no laboratory reporting delays (odds ratio [OR] of 3.9 and 95% confidence interval [CI] of 1.6 to 9.7 for smear-positive patients and OR of 13.1 and CI of 5.3 to 32.2 for smear-negative patients). This relation remained after adjustment in a multivariate model for other factors associated with treatment delays (adjusted OR of 25.64 and CI of 7.81 to 83.33 for smear-negative patients). These findings emphasize the need to reduce times of specimen transfer between institutions and to ensure rapid communication among laboratories, health care providers, and health departments serving TB patients.

Aged↗
PubMed2002

Health and safety of laboratory science students in Ibadan, Nigeria.

Laboratory science students are engaged in laboratory practice under supervision during the course of their training programme. They are exposed to the risk of laboratory-acquired infection and need to be adequately informed and equipped with facilities to protect their health. A questionnaire was administered to laboratory science students to determine their perception of hazards in laboratory practice and the observance of safety codes in their work practices. Of 128 students, 118 completed the questionnaire, a response rate of 92%. Sixty of them (51%) were males and 53 (45%) were females; five students did not indicate their sex. The results revealed that only 34 (29%) of the students use gloves for handling biological samples and 26 (22%) use gloves for handling clinical waste. Ninety-four students (80%) reported that they washed their hands after handling specimens. Eighteen of the students (15%) had been immunised against tuberculosis, 80 (68%) against tetanus, six (5%) against hepatitis B, and 18 (15%) against yellow fever. Ninety-six students (81%) thought the greatest hazard in laboratory practice was harmful biological organisms, while 13 (11%) indicated that chemical agents were the greatest hazard. Virology was thought to be the most hazardous specialty by 41 students (35%) while morbid anatomy was ranked as least hazardous by 48 (41%) of the students. These findings indicate that whilst laboratory science students are aware of the hazards in laboratory practice, this knowledge is not translated to safe practices and students may endanger their health as a result of exposure to laboratory practice. They therefore need to be provided with adequate facilities to protect themselves and adequate supervision to ensure that they imbibe safe work practices during their training years.

Attitude of Health Personnel↗
PubMed2003

Laboratory quality control: using patient data to assess analytical performance.

Quality control plays a vital role helping to ensure the reliability of laboratory test results. The application of statistical quality control has been a component of laboratory medicine for approximately 50 years. Many of the control rules based on the early applications of statistical quality control have remained essentially unchanged since their initial introduction. Optimization of quality control rules can vary depending on the application for which a test is to be used. This review explores the various applications of laboratory quality control procedures and their role in identifying laboratory error. The ubiquitous use of computers in today's laboratories has enabled the development of more sophisticated means of assessing laboratory quality. The use of the Six Sigma technique and its adoption by the laboratory community is one example. Other examples include the use of patient-derived quality control procedures as a means of assessing laboratory performance. Early examples of these types of applications include use of Bull's algorithm, anion gap measurements, and delta checking. More recent applications include the correlation of laboratory test results, the average of normals procedure, and the Bhattacharya method.

Chemistry, Clinical↗
PubMed2006

Laboratory productivity and the rate of manual peripheral blood smear review: a College of American Pathologists Q-Probes study of 95,141 complete blood count determinations performed in 263 institutions.

CONTEXT: Automated laboratory hematology analyzers are capable of performing differential counts on peripheral blood smears with greater precision and more accurate detection of distributional and morphologic abnormalities than those performed by manual examinations of blood smears. Manual determinations of blood morphology and leukocyte differential counts are time-consuming, expensive, and may not always be necessary. The frequency with which hematology laboratory workers perform manual screens despite the availability of labor-saving features of automated analyzers is unknown. OBJECTIVE: To determine the normative rates with which manual peripheral blood smears were performed in clinical laboratories, to examine laboratory practices associated with higher or lower manual review rates, and to measure the effects of manual smear review on the efficiency of generating complete blood count (CBC) determinations. DESIGN: From each of 3 traditional shifts per day, participants were asked to select serially, 10 automated CBC specimens, and to indicate whether manual scans and/or reviews with complete differential counts were performed on blood smears prepared from those specimens. Sampling continued until a total of 60 peripheral smears were reviewed manually. For each specimen on which a manual review was performed, participants indicated the patient's age, hemoglobin value, white blood cell count, platelet count, and the primary reason why the manual review was performed. Participants also submitted data concerning their institutions' demographic profiles and their laboratories' staffing, work volume, and practices regarding CBC determinations. The rates of manual reviews and estimations of efficiency in performing CBC determinations were obtained from the data. SETTING: A total of 263 hospitals and independent laboratories, predominantly located in the United States, participating in the College of American Pathologists Q-Probes Program. RESULTS: There were 95,141 CBC determinations examined in this study; participants reviewed 15,423 (16.2%) peripheral blood smears manually. In the median institution (50th percentile), manual reviews of peripheral smears were performed on 26.7% of specimens. Manual differential count review rates were inversely associated with the magnitude of platelet counts that were required by laboratory policy to trigger smear reviews and with the efficiency of generating CBC reports. Lower manual differential count review rates were associated with laboratory policies that allowed manual reviews solely on the basis of abnormal automated red cell parameters and that precluded performing repeat manual reviews within designated time intervals. The manual scan rate elevated with increased number of hospital beds. In more than one third (35.7%) of the peripheral smears reviewed manually, participants claimed to have learned additional information beyond what was available on automated hematology analyzer printouts alone. CONCLUSION: By adopting certain laboratory practices, it may be possible to reduce the rates of manual reviews of peripheral blood smears and increase the efficiency of generating CBC results.

Blood Cell Count↗
PubMedDate not supplied

Recent trends in clinical laboratory automation.

A convergence of concepts has allowed clinical laboratory automation to proceed in a greater number of laboratories: developing automation control interfaces, direct track sampling, and adopting a universal interface. The laboratory automation system (LAS) must interface to the laboratory information system (LIS), which provides the information necessary for routing and scheduling and for future rules-based processing, an important component of the LAS. The automation system also must operate in a real-time or near real-time environment and use the single tube per carrier paradigm. LAS capabilities should span the clinical laboratory and run parallel to the LIS with respect to information flow. The laboratory automation software will control the automated technology and the transportation system that binds clinical laboratory instruments together. It must be able to both drive the hardware components and interface with patient information sources, and it should further the goals of the health-care delivery system by supporting outcomes optimization and utilization management of laboratory resources. The development of workcells based on disciplines such as chemistry or hematology is having and will continue to have a significant effect on the acceptance of clinical laboratory automation technologies.

Autoanalysis↗
PubMedDate not supplied

Surfing the wave of clinical laboratory science evolution in Hawai'i.

OBJECTIVE: To describe the steps taken by the Hawaii Society for Clinical Laboratory Science, an affiliate of the American Society for Clinical Laboratory Science, to inform local laboratory professionals of current trends and to prepare for the future. RESULTS: A Strategic Planning workshop was conducted at the 1997 Hawaii Society for Clinical Laboratory Science Annual Meeting where participants reviewed the essential (but non-traditional) functions of clinical laboratory scientists, and described current realities, identified forces and players affecting the changes, and envisioned the future of our profession. CONCLUSION: As the way health care is provided changes in response to economics and advances in technology, the role of clinical laboratory scientists needs to be redefined. The Hawaii Society for Clinical Laboratory Science continues to provide timely support for members, and plans to work collaboratively with the local chapter of the Clinical Laboratory Managers' Association to advance clinical laboratory science to an appropriate place in the health care community.

Clinical Laboratory Techniques↗
PubMed2004

[CAP quality management system in clinical laboratory and its issue].

The CAP (College of American Pathologists) was established in 1962 and, at present, CAP-accredited laboratories include about 6000 institutions all over the world, mainly in the U.S. The essential purpose of CAP accreditation is high quality reservation and improvement of clinical laboratory services for patient care, and is based on seven points, listed below. (1) Establishment of a laboratory management program and laboratory techniques to assure accuracy and improve overall quality of laboratory services. (2) Maintenance and improvement of accuracy objectively by centering on a CAP survey. (3) Thoroughness in safety and health administration. (4) Reservation of the performance of laboratory services by personnel and proficiency management. (5) Provision of appropriate information to physicians, and contribution to improved quality of patient care by close communication with physicians (improvement in patient care). (6) Reduction of running costs and personnel costs based on evidence by employing the above-mentioned criteria. (7) Reduction of laboratory error. In the future, accreditation and/or certification by organizations such as CAP, ISO, etc., may become a requirement for providing any clinical laboratory services in Japan. Taking the essence of the CAP and the characteristics of the new international standard, ISO151589, into consideration, it is important to choose the best suited accreditation and/or certification depending of the purpose of clinical laboratory.

Accreditation↗