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PubMed1993

[Automation in hematologic cytology].

Automation in hematological cytology can identify blood cells in suspension by new parameters: electrical field variations, light intensity modifications absorbtion or diffraction by one or two lasers, fluorescence intensity, cytochemical reactions or specific lysis. The new technology change the strategy of hematological laboratories. Automation realizes perfectly the white blood cell differential and modifies hematological language with respect to anemia and white blood cells diseases.

Automation↗
PubMed2001

[Standardization and recommendations for the appropriate use of automated devices for self-monitoring blood glucose].

The effectiveness of the self-monitoring of blood glucose(SMBG) for the management of diabetic patients has widely been accepted, and many improvements in the devices to meet the demands of lay users have been made, yet no standardization has been performed in Japan. Expert committees of the Japan Society of Clinical Chemistry and Clinical Laboratory Automation and the Japan Diabetes Society made, in cooperation, a report on the characteristics of the devices and the present status of technical performance evaluation in April, 2001. This paper is based mainly on the committee's report and refers to the future trials being prepared by the committee to achieve standardization of the devices. The importance of technical assistance by trained healthcare professionals in applying the devices for the treatment of diabetic patients and the appropriate frequency of SMBG for good glycemic control are also mentioned.

Blood Glucose Self-Monitoring↗
PubMed2000

A study on task-analysis of clinical pathologists as medical consultants in Nihon University Hospital--a Japanese perspective by comparison with current status in the USA.

To identify our role and the customers' satisfaction, the on-call consultation service records of the Department of Clinical Pathology, Nihon University School of Medicine, Itabashi Hospital (NUIH), were analyzed. Between 1995 and 1998, 1,789 consultation services were recorded, and approximately 40% were from physicians, and 50% were from medical technologists. During office hours, many physicians made contact with us at the office of clinical pathology, the clinical laboratory and other places in the hospital by various means. They asked us to interpret multidisciplinary laboratory data, and to provide the specific information that might affect clinical management. Medical technologists asked for clinical information of patients with extreme measured values and requested that we contact with physicians. In contrast, on weekends/holidays or after routine working hours, physicians sometimes requested non-automated laboratory tests such as peripheral blood smears/bone marrow smears or Gram stains. The major contents of our responses to medical technologists were concerned with blood banking and handling of instruments not to be operated in routine work. These results reconfirm that we are still required to have clinical competence for common laboratory procedures and to have the capability of interpretation of multidisciplinary laboratory data in the university hospital. Traditionally, most Japanese clinical pathologists have been focused their attention on bench work in research laboratories. However, the present study shows that the clinical pathologists need to bridge the real gap between laboratory technology and patient care. Our on-call service system can enhance the education of clinical pathologists, and improve not only laboratory quality assurance but also patient care. In addition, in response to a need for customer access to this service with a shortage of clinical pathologists, a more effective method would be to set up a proactive systemic approach in a more rigorous academic environment adopting advances in medical informatics.

Consultants↗
PubMed1992

Effect of "standard order" deletion on emergency department coagulation profile use.

STUDY OBJECTIVES: To determine whether the test ordering of physicians working in a teaching hospital emergency department could be influenced by modification of automated laboratory order sets. DESIGN: Prospective, using data from the same ED before and after intervention. SETTING: A 58,000-visit public university hospital ED. TYPE OF PARTICIPANTS: Emergency physicians caring for adult patients admitted from the ED to the ward medical services. INTERVENTION: Beginning July 1, 1989, coagulation studies were deleted from the automated admission order sets used in the study hospital ED. MEASUREMENTS AND MAIN RESULTS: Patient charts were examined to assess the effect of coagulation study deletion on the frequency and appropriateness of coagulation test ordering. A tripling of the percentage of patients who did not receive coagulation parameter testing was noted (P less than .0001, chi 2). In no case were the tests omitted when a high-yield indication for their use was present. This resulted in an estimated reduction of $20,000 per year in patient charges. CONCLUSION: Modification of ED "standard orders" can result in reduction of laboratory use without an adverse effect on patient care.

Adolescent↗
PubMed2004

What does the future hold for clinical microbiology?

In the past decade, clinical microbiology laboratories have undergone important changes with the introduction of molecular biology techniques and laboratory automation. In the future, there will be a need for more rapid diagnoses, increased standardization of testing and greater adaptability to cope with new threats from infectious microorganisms, such as agents of bioterrorism and emerging pathogens. The combination of the new tools that are now being developed in research laboratories, the general reorganization of clinical laboratories and improved communication between physicians and clinical microbiologists should lead to profound changes in the way that clinical microbiologists work.

Bacteria↗
PubMed2002

[Laboratory logistics for infectious diseases--from clinical laboratory physicians].

The diagnosis of bacterial meningitis rests on examination of the CSF. The gross appearance of the fluid may be cloudy or turbid if the white cell count is elevated. Gram's staining should always be used in examining CSF, as it permits rapid and accurate identification of the etiologic agent in approximately 60 to 90 percent of cases of bacterial meningitis. The CSF culture is positive in approximately 70 to 85 percent of patients with bacterial meningitis. Many other rapid diagnostic tests have been developed to aid in the diagnosis of bacterial meningitis when Gram's staining gives negative results. Nevertheless, newer techniques are more rapid and sensitive, postgraduate training in laboratory medicine should include basic clinical skills (Communication skills, physical examination and common laboratory procedures such as Gram's stain, Wright-Giemsa stain, etc.) and 24 hours on-call service system by laboratory physicians. It must not be focused solely on the sophistication of laboratory methods. We must notice that an increasing gap between the clinic and the laboratory. Current needs require us to make a major attempt to bridge this gap. We, laboratory physicians must modify our behavior effectively and accept the value and limitations of laboratory automation and information technology. We must work more closely with physicians and other health care professionals to establish a good collaborative partnership with them.

Bacteriological Techniques↗
PubMed1997

Glucometer analysis of one-hour glucose challenge samples.

OBJECTIVE: Our purpose was to explore a cost-saving measure for diabetes screening by using glucometer testing on venous whole blood obtained after a 1-hour glucose challenge test. Glucometer results falling above an upper threshold would predict abnormal plasma values and mandate a glucose tolerance test; results below the lower threshold would predict normal plasma values and avoid further testing. Results between the thresholds would require traditional plasma analysis. STUDY DESIGN: We performed a prospective cohort study on 222 consecutive pregnant women. A standard 50 gm glucose screen was performed with venous blood drawn at 1 hour. We immediately removed a drop of whole blood from the venous sample and analyzed it on a portable glucometer, Accu-Chek III. The remaining sample was submitted immediately for routine plasma analysis. All values were obtained on the same glucometer, which was calibrated daily in our clinic laboratory. Regression analysis was performed on 129 samples to select the two thresholds. The selected thresholds were then applied prospectively to the next 93 consecutive samples for validation. RESULTS: Excellent correlation (r = 0.9045) exists between the glucometer and laboratory values. Glucometer threshold values of 110 mg/dl and 155 mg/dl were selected because they predicted plasma values < 135 mg/dl or > 135 mg/dl with 95% certainty, respectively. Prospectively, the thresholds were completely accurate in classifying the values. CONCLUSION: Venous whole blood assayed by glucometer can reliably predict an elevated or normal automated plasma glucose value. By applying thresholds, three fourths of all patients can immediately receive reassuring information, whereas the patients with poorest glucose tolerance are immediately identified and diagnostic testing is scheduled. Additionally, our model reduces the number of automated laboratory studies by 80% and reduces the cost of diabetic screening.

Blood Glucose↗
PubMed1995

[Management of total laboratory system and its efficacy].

The Osaka City University Hospital was reopened in May 1993. In the Central Clinical Laboratory our Total Laboratory Automation System, a comprehensive online analyzing system, covers the entire process from collecting blood to completing tests. Our study showed that an average of 2,800 outpatients were examined per day in 1994, compared with 1,900 per day in 1992, an increase of 47.4%. The number of tests performed by the central laboratory in 1994 was 5,610,000 as compared to 3,720,000 in 1992, an increase of 50.8%. After the installation of the transport line and computerization the following can be noted: 1) We were able to extend reception hours by two hours. 2) We are now able to assign lab medical technologists to physiology analysis, emergency analysis, and initial outpatient testing. We conclude that these effects have been very large.

Clinical Laboratory Information Systems↗
PubMed1976

[Serum calcium evaluation and incidence of primary hyperparathyroidism in hospitalized patients (author's transl)].

Automated laboratory procedures have made possible to "screen" a large population for specific biochemical abnormalities. Primitive hyperparathyroidism is for several respects an excellent disease model for testing "mass screening". Il is often asymptomatic, not uncommon, and is manifested by abnormalities in the levels of serum calcium and inorganic phosphorus, that can be detected cheaply with automated equipment. A computer program has been developed to screen patients with hypercalcaemia. During a period of 18 months 22720 hospitalized patients were investigated by the evaluation of serum calcium, and 80 hypercalcaemic patients were found. The diagnosis of primary hyperparathyroidism was established in 24 patients (in 19 histologically confirmed) so that the incidence of primary hyperparathyroidism (1,05%) compares favorably with that reported from some foreign Authors.

Adult↗
PubMed2001

[Clinical laboratory's trends in the 21st century].

The new century presents numerous challenges and opportunities for the clinical laboratory scientists. Japan's economic recession has affected health care system directly. Clinical laboratories in particular have been hard hit financially. Laboratory people have striven for financial efficiency and balance within their own fields but now must broaden their view beyond this familiar field to the wider sphere of economics and medicine as whole. As laboratory professionals, we must be able to anticipate and respond to the current changes in disease frequencies, the fewer number of children in the nation, the health needs of the aging society, and the resulting economic implications. We, Japanese scientists, bring into the 21st century two major achievements. One is establishment of a fully automated laboratory system equipped with a transfer module. The second is reduced variation in inter-laboratory test results. Greater uniformity in the test results has been provided for by the supply of certified and calibrated reference materials as well as the dissemination of standard procedure for the measurement of catalytic amounts of enzymes published by the Japan Society of Clinical Chemistry(JSCC). Advances in the fields of diagnostic imaging were marvelous and received widespread attention. No less important were advances in high sensitivity immunoassay systems molecular biology-based diagnostic systems, and miniaturization of laboratory systems. The immediate future of laboratory medicine will be built upon these advanced technologies.

Blood Glucose↗
PubMed1977

[A model of cooperative analytical diagnosis].

The special branch of clinical chemistry and laboratory diagnostics as an independent speciality has specific comprehensive tasks in research, teaching and education as well as in medical care. Here the organisation of scientific work in the branch of public health concerned is of great importance. For the territory of Leipzig a model a cooperation of medical diagnostics was developed in which a central automation laboratory, a district laboratory and 22 corrdination area laboratories whith all institutions have achieve a high level according to the conditions existing at present.

Clinical Laboratory Techniques↗
PubMed1990

Decision support alerts for clinical laboratory and blood gas data.

We have designed and implemented a computerized Intensive Care Unit (ICU) decision support alerting system which analyzes all incoming laboratory and blood gas data for critically abnormal values and trends. A computerized patient data management system (HP 78709A PDMS, Hewlett-Packard Co., Waltham, MA) serving 20 Surgical ICU beds is networked to a Clinical Laboratory Information System and a blood gas computer system. The ALERTS subsystem operates on the PDMS as an automatic program triggered by the receipt of fresh laboratory data. Three types of ALERTS are detected: (1) high and low critical values, (2) calculation-adjusted critical values, and (3) critical trends. Once detected, a specific ALERT message is displayed at the bottom of the patient's bedside PDMS terminal and at the central station. Over an eight month period a total of 1,515 ALERTS were detected from amongst approximately 115,000 laboratory data results transmitted to the Surgical Intensive Care Unit (SICU). Slightly over half of all ALERTS were caused by critical blood gas values. ALERTS were found to be a sensitive indicator of severity of illness: patients with one or more ALERTS suffered an ICU mortality of 9.52%, compared to 0% mortality in patients with no ALERTS. We conclude that automated laboratory data ALERTS represent a valuable decision support tool for the management of high risk ICU patients.

Blood Gas Analysis↗
PubMedDate not supplied

Required steps for the validation of a Laboratory Information Management System.

The task of managing laboratory data is not a new one. Over the past two decades, the use of Laboratory Information Management Systems (LIMS) has revolutionized how laboratories manage their data. A LIMS is more than software; it has become the workhorse of the laboratory, encompassing laboratory work-flow combined with user input, data collection, instrument integration, data analysis, user notification, and delivery of information and reporting. Types of organizations that utilize LIMS vary greatly from research laboratories to manufacturing laboratories to environmental testing laboratories. Commercially-available LIMS have been around since the 1980s. In addition, many laboratories have designed, implemented, and maintained in-house LIMS. The heart of any LIMS is the software. Like other laboratory systems, the LIMS software is subject to quality control and quality assurance checks. In regulatory environments this associated QA/QC is referred to as "system validation." The primary purpose of system validation is to ensure that the software is performing in a manner for which it was designed. For example, the system acceptance criteria should be established and tested against quantifiable tasks to determine if the desired outcome has been achieved. LIMS features, such as autoreporting, reproducibility, throughput, and accuracy must be quantifiable and verifiable. System validation ensures that the entire system has been properly tested, incorporates required controls, and maintains and will continue to maintain data integrity. Laboratories must establish protocols and standards for the validation process and associated documentation. Although vendors of commercial LIMS perform initial internal system validations, the system must be revalidated whenever the end user, vendor or third party adds modifications or customizations to the LIMS. Currently, detailed guidance regarding system validation of LIMS is not available to the user. The issue is addressed in Good Automated Laboratory Practices (GALP) and National Environmental Laboratory Accreditation Conference (NELAC) documents which indicate specific requirements or recommendations for operational checks and periodic testing; however, it is up to the laboratory to determine suitable methods to accomplish these tasks. Proper validation of a LIMS will allow a laboratory to comply with regulations and also provide comprehensive documentation on the system that is necessary to troubleshoot future problems.

Clinical Laboratory Information Systems↗
PubMed2003

Total testing process: appropriateness in laboratory medicine.

BACKGROUND: The need to reduce costs in Laboratory Medicine is often related to the possibility of reducing test requests without taking into account patients' outcomes. Therefore, the term "appropriateness" in Laboratory Medicine as referred to the specific steps (pre-analytical, analytical, post-analytical) and related to the clinical process could allow the improvement of clinical effectiveness and economic efficiency. METHODS: Our experience has shown an improvement in analytical appropriateness (reorganization and re-engineering by Laboratory automation) and pre-analytical appropriateness (critical revision of the panel for cardiac markers) by evaluating the workload and errors rate in the pre-analytical phase. RESULTS: We obtained an economic saving (119,580 euro/year) in cardiac markers request (analytical appropriateness: 60%, pre-analytical appropriateness: 40%) and also an improvement in clinical appropriateness (diagnosis and therapy). CONCLUSIONS: Our data confirm the need to improve communications between physicians and Laboratory Medicine as regards the pre-analytical step and to implement educational programs for defining criteria and procedures. Appropriateness in analytical and post-analytical steps contribute to achieve economic saving (Core lab, POCT) and improvement of the turn-around time (TAT).

Humans↗
PubMed1990

A decade of development in immunoassay methodology.

Immunoassays are now very widely used in the clinical laboratory, either because no other type of assay system is feasible or because they are often the most effective and suitable of the possible analytical methods. The last decade has seen the development and refinement of many new immunoassay reagents and systems. The major trend has been away from liquid-phase assays involving radioisotopic labels, towards fast homogeneous or solid-phase assays capable of operation anywhere; and towards precise and reliable nonisotopic, automated or semi-automated laboratory assays, often with detection limits measured in pico- or attomoles. The use of monoclonal antibodies is now widespread, and the methodologies of labels and of solid-phase components are much more sophisticated. New assay formulations, novel homogeneous systems, immunosensors, free-analyte assays, the importance of thorough validation and of interfering substances, and future trends are discussed.

Immunoassay↗
PubMed1998

[Our challenge in Kagoshima University Hospital--development of more useful clinical laboratory].

In 1995, we newly developed a clinical laboratory system equipped with an expert system, which was named HIPOCLATES (Hospital Intelligent POwers of Clinical Laboratory Automation Technology with Expert System). Since this system includes an expert system, we have been able to support diagnostic and therapeutic procedure in clinics and begin developing a "zonal verification method" and "early-stage DIC diagnosis support system". The former is one of the individual quality control methods and we have attempted to develop a test assurance system in HIPOCLATES using this method. The latter system is to diagnosis DIC in the early phase. Here, we introduce the detail of our project using HIPOCLATES. Following the introduction HIPOCLATES, we attempted to develop a highly integrated system in physiological examinations, and succeeded in establishment PLATON (Physiological LAboratory TOtal Network system) in 1997. Thereafter, we planned a graphic reporting system named GALIREO (Graphic Assistant Laboratory Informational REport Operating system). In GALIREO, we attempted to connect the Department of Clinical Laboratory, Ultrasonic waves test room, Fiberscope test room, Department of Pathology and Surgical center by computer network. Developing these computer network system in our clinical laboratory we want to create electronic medical record linking with THINK (HIS in our hospital). We plan to make these expert system and electronic medical record available to clinical staff via a network to realize evidence-based medicine (EBM) and utilize these to support treatment and education.

Clinical Laboratory Information Systems↗