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Once-a-day Concerta methylphenidate versus three-times-daily methylphenidate in laboratory and natural settings.

OBJECTIVE: Methylphenidate (MPH), the most commonly prescribed drug for attention-deficit/hyperactivity disorder (ADHD), has a short half-life, which necessitates multiple daily doses. The need for multiple doses produces problems with medication administration during school and after-school hours, and therefore with compliance. Previous long-acting stimulants and preparations have shown effects equivalent to twice-daily dosing of MPH. This study tests the efficacy and duration of action, in natural and laboratory settings, of an extended-release MPH preparation designed to last 12 hours and therefore be equivalent to 3-times-daily dosing. METHODS: Sixty-eight children with ADHD, 6 to 12 years old, participated in a within-subject, double-blind comparison of placebo, immediate-release (IR) MPH 3 times a day (tid), and Concerta, a once-daily MPH formulation. Three dosing levels of medication were used: 5 mg IR MPH tid/18 mg Concerta once a day (qd); 10 mg IR MPH tid/36 mg Concerta qd; and 15 mg IR MPH tid/54 mg Concerta qd. All children were currently medicated with MPH at enrollment, and each child's dose level was based on that child's MPH dosing before the study. The doses of Concerta were selected to be comparable to the daily doses of MPH that each child received. To achieve the ascending rate of MPH delivery determined by initial investigations to provide the necessary continuous coverage, Concerta doses were 20% higher on a daily basis than a comparable tid regimen of IR MPH. Children received each medication condition for 7 days. The investigation was conducted in the context of a background clinical behavioral intervention in both the natural environment and the laboratory setting. Parents received behavioral parent training and teachers were taught to establish a school-home daily report card (DRC). A DRC is a list of individual target behaviors that represent a child's most salient areas of impairment. Teachers set daily goals for each child's impairment targets, and parents provided rewards at home for goal attainment. Each weekday, teachers completed the DRC, and it was used as a dependent measure of individualized medication response. Teachers and parents also completed weekly standardized ratings of behavior and treatment effectiveness. To evaluate the time course of medication effects, children spent 12 hours in a laboratory setting on Saturdays and medication effects were measured using procedures and methods adapted from our summer treatment program. Measures of classroom behavior and academic productivity/accuracy were taken in a laboratory classroom setting during which children completed independent math and reading worksheets. Measures of social behavior were taken in structured, small-group board game settings and unstructured recess settings. Measures included behavior frequency counts, academic problems completed and accuracy, independent observations, teacher and counselor ratings, and individualized behavioral target goals. Reports of adverse events, sleep quality, and appetite were collected. RESULTS: On virtually all measures in all settings, both drug conditions were significantly different from placebo, and the 2 drugs were not different from each other. In children's regular school settings, both medications improved behavior as measured by teacher ratings and individualized target behaviors (the DRC); these effects were seen into the evening as measured by parent ratings. In the laboratory setting, effects of Concerta were equivalent to tid MPH and lasted at least through 12 hours after dosing. Concerta was significantly superior to tid MPH on 2 parent rating scores, and when asked, more parents preferred Concerta than preferred tid IR MPH or placebo. Side effects on children's sleep and appetite were similar for the 2 preparations. In the lab setting, both medications improved productivity and accuracy on arithmetic seatwork assignments, disruptive and on-task behavior, and classroom rule following. Both medications improved children's rule following and negative behavior in small group board games, as well as in unstructured recess settings. Individual target behaviors also showed significant improvement with medication across domains in the laboratory setting. Children's behavior across settings deteriorated across the laboratory day, and the primary effect of medication was to prevent this deterioration as the day wore on. Results support the use of background behavioral treatment in clinical trials of stimulant medication, and illustrate the utility of a measure of individualized daily target goals (ie, the DRC) as an objective measure of medication response in both the laboratory and natural school settings. CONCLUSION: This investigation clearly supports the efficacy of the Concerta long-acting formulation of MPH for parents who desire to have medication benefits for their child throughout the day and early evening. (ABSTRACT TRUNCATED)

Analysis of Variance↗

The fourth International Standard for Human Urinary FSH and LH: specificities of LH seminal vesicle weight gain assays in the collaborative study differ between laboratories.

The fourth International Standard for Human Urinary FSH and LH (IS; in ampoules coded 98/704) was compared with the third International Standard for Urinary FSH and LH (IS 71/264) by 10 laboratories in nine countries, using FSH and LH in vivo bioassays. Estimates of the FSH content of the IS by augmented ovarian weight gain assays were homogeneous within each laboratory and over all laboratories. The combined weighted geometric mean estimate of FSH content of the IS (with 95% fiducial limits) in terms of IS 71/264 was 71.9 (69.0-74.9) IU/ampoule. Although estimates by seminal vesicle weight gain (SVW) assays of the relative LH activities of the IS and IS 71/264 were homogeneous within laboratories, estimates were heterogeneous between laboratories. This indicated differences between the spectrum of LH isoforms in the IS and IS 71/264, which were obtained from different manufacturers, and differences between the specificities of SVW assays performed in different laboratories. The differences between the specificities of SVW assays appeared to be related to interactions among mean laboratory seminal vesicle weights, age and genetic strain of rat. The finding of inter-laboratory differences in the specificities of SVW assays is of some significance, as this assay method has been generally adopted by Pharmacopoeias for the control of the LH content of therapeutic products. The combined unweighted geometric mean estimate of LH content of the IS (with 95% fiducial limits) in terms of IS 71/264 by SVW and ovarian ascorbate depletion assays was 70.2 (61.7-80.0) IU/ampoule. Estimates of the FSH and LH content of ampoules of the IS kept at increased temperatures suggested that the IS would be adequately stable under normal storage conditions. On the basis of these results, the World Health Organization Expert Committee on Biological Standardization established the preparation in ampoules coded 98/704 as the fourth International Standard for Human Urinary FSH and LH, and assigned to the contents of each ampoule an activity of 72 International Units of urinary FSH and an activity of 70 International Units of urinary LH.

Animals↗

Utilization of commercial laboratory results in management of hyperandrogenism in women.

OBJECTIVE: To compare results from testosterone radioimmunoassay kits commonly used by commercial laboratories as well as their reference ranges and to analyze the scientific literature for ranges of serum testosterone levels in normal women and those with hyperandrogenism. METHODS: We reviewed quality assurance reports of various testosterone ligand challenges from four groups of laboratories and summarized testosterone data from 17 published reports about normal women and 14 studies of hyperandrogenic women. RESULTS: A significant variability was demonstrated between the radioimmunoassay kits at all concentrations (for example, a sample with a mean testosterone level of 96.1 ng/dL was reported by some laboratories as containing 71.8 ng/dL and by others as 123.4 ng/dL). All laboratories provide essentially the same "reference range" (approximately 10 to 90 ng/dL) but do not report how the range was established. The scientific literature clearly shows a significant separation in serum testosterone levels between normal (that is, not hyperandrogenic) and hyperandrogenic women. Most hyperandrogenic women had testosterone levels >50 ng/dL, whereas most normal control subjects had levels <40 ng/dL. Thus, most of these women with hyperandrogenism would have been considered to have normal testosterone levels if the reference ranges of commercial laboratories were used. CONCLUSION: These data illustrate the difficulty that physicians face when they are required to use different commercial laboratories to measure serum testosterone levels. We propose that (1) reference ranges be established on a clinically defined population for each hormone and method used, (2) laboratory reports include information about method and reference range population, and (3) physicians be allowed to choose which laboratories are used for their patients' hormone determinations, for consistency of results.

Journal Article↗

Multi-laboratory evaluation of a scrub typhus diagnostic kit.

Scrub typhus is a major cause of febrile illness throughout the Asia-Pacific region. It is commonly undiagnosed, partly because of the lack of a simple, reliable diagnostic test which can be used in clinical laboratories. The indirect immunoperoxidase technique, configured into a test kit, was provided to technicians who were trained in its use. They used the kit during a 2 year field trial in their respective clinical hospital laboratories throughout Malaysia. In an evaluation using 1,722 consecutive sera tested in those laboratories, the kit was found to have a median sensitivity for IgG detection of 0.85 (range 0.33-0.95), a median specificity of 0.94 (range 0.88-1.00), reproducibility of 0.86, and efficiency of 0.92 when compared to the reference laboratory. In a proficiency survey in which 10 laboratories received 3 coded test samples, all but 2 laboratories had results within 1 dilution of the reference laboratory in quantitating specific IgG, whereas 7 laboratories were within 1 dilution in quantitating IgM. The shelf life of the kit was at least 1 year at 4 degrees C.

Antibodies, Bacterial↗

Clinical and laboratory diagnosis of nutritional problems.

The objective of this article is to familiarize the dentist with clinical signs and laboratory methods used in diagnosing nutritional deficiencies, and to indicate which laboratory methods may be useful to the clinician in cases of suspected nutritional deficiency. It should be noted that the suggested laboratory methods were selected on the basis of their applicability for the clinical situation as well as their reliability as indicators of nutritional status. Therefore these suggested methods of choice may not in every instance be the most accurate of all indicators of nutritional status for a particular nutrient. The dentist who wishes to utilize one of the laboratory methods has a number of options. He can take the appropriate sample in his office, or refer the patient directly to a clinical laboratory for the simpler analyses, or refer his patient to a physician for appropriate metabolic testing. The first option may be more appropriate for the dentist practicing in areas where a clinical laboratory is not within reasonable distance. In this instance the dentist should contact the laboratory for specific information, such as sample volume and special instructions for taking, handling, and shipping the sample. The second option is available to the dentist practicing in an urban area where clinical laboratory facilities are readily available. Finally, the dentist should work in conjunction with a physician when complex metabolic testing is required.

Anthropometry↗

Availability and use of hepatitis B vaccine in laboratory and nursing schools in the United States.

Hepatitis B is a well-documented occupational hazard for health care workers, including both laboratory and nursing personnel. Since the development of effective hepatitis B vaccines, the Immunization Practices Advisory Committee (ACIP) has recommended that health care workers receive the vaccine. In this study, 78 laboratory training programs and 83 nursing training programs were surveyed regarding availability and usage of hepatitis B vaccine. The hepatitis B vaccine was made available to students in 81 percent of the laboratory programs and 23 percent of the nursing programs. In those programs making the vaccine available, only 59 percent of the laboratory programs and 5 percent of the nursing programs reported a high (greater than 75 percent) use by students. Concern about cost and payment for the vaccine was the most common reason (80 percent) noted by laboratory schools that did not have hepatitis B vaccination programs for students. Of the nursing schools that did not have vaccine programs, 58 percent had not yet considered a program. At laboratory schools with vaccination programs, who paid for the vaccine (hospital or school versus student) was among the most important determinants for vaccine usage by students. These findings point out that some laboratory schools and many nursing schools have not applied the ACIP recommendations to their own programs. Educational efforts and creative payment plans for the vaccine are needed to increase the availability and use of hepatitis B vaccine among laboratory and nursing students.

Hepatitis B↗

Clinical and laboratory features of murine typhus in south Texas, 1980 through 1987.

OBJECTIVE: --The clinical and laboratory features of patients with murine typhus have not been extensively reviewed since 1946. We have updated these findings in patients from south Texas who were examined by modern clinical and laboratory methods from 1980 through 1987. DESIGN: --Patients were identified by serological methods in this case series, and clinical, epidemiologic, laboratory, and therapeutic data were compiled and analyzed. SETTING: --The majority of patients (77 of 80) were identified in a primary care community hospital setting; the remainder (3 of 80) were ambulatory hospital outpatients. PATIENTS: --From 1980 through 1987, a total of 345 patients were diagnosed with murine typhus; 90 of these patients were seen at four hospitals in south Texas; of these, 80 had clinical and laboratory data available for review. MAIN OUTCOME MEASURES: --The frequency of common clinical manifestations (eg, headache, fever, and rash) and laboratory findings (eg, leukocyte and platelet counts and serum chemistry abnormalities) of patients with infectious diseases was tabulated. Clinical severity was semiquantitatively assessed and was correlated with clinical, laboratory, and therapeutic results. RESULTS: --Most cases (69%) occurred from April through August. Rash occurred in 54%; the triad of fever, headache, and rash was observed in only 12.5% of patients when first examined by a physician; respiratory and gastrointestinal symptoms were also frequent. Multiple organ involvement was documented by frequent abnormal laboratory findings of the hematologic, respiratory, hepatic, and renal systems. Disease severity was related to older patient age, the presence of renal dysfunction, leukocytosis, and hypoalbuminemia, and previous therapy with sulfa antibiotics. CONCLUSIONS: --Infection by Rickettsia typhi causes a systemic illness with clinical and laboratory abnormalities not previously recognized or described. Early clinical diagnosis and treatment are needed to avoid undue morbidity and mortality.

Diagnosis, Differential↗

Laboratory reproducibility of endogenous hormone levels in postmenopausal women.

We conducted several studies to assess the ability of laboratories to reproducibly measure plasma levels of estrone, estradiol, percent free estradiol, sex hormone binding globulin, dehydroepiandrosterone sulfate, androstenedione, testosterone, progesterone, follicle-stimulating hormone, and prolactin in postmenopausal women. We sent four to seven replicate samples of plasma to each of four well-established endocrine laboratories in the United States on one or two separate occasions. All replicate samples were handled identically during processing, storage, and retrieval, and were labeled to preclude their identification by the receiving laboratory. The within-person coefficient of variation, a measure of laboratory error, was consistently low (< 15%) for follicle-stimulating hormone and prolactin. For estrone and estradiol, hormones present at low levels in postmenopausal women, the laboratory error was often large (> 25%) and the ratio of between-person variation to laboratory error was often less than 2.0. Reproducibility of androstenedione, dehydroepiandrosterone sulfate, testosterone, progesterone, sex hormone binding globulin, and percent free estradiol was also variable. Our results emphasize the need for evaluating laboratory performance before sending samples for hormone analysis and for increased collaboration between epidemiologists and laboratory investigators in improving hormone measurements for use in epidemiological research.

Androgens↗

Prevalence of antibody to the human immunodeficiency virus among clinical laboratory specimens: findings from a survey of primary care physicians.

To evaluate human immunodeficiency virus type 1 (HIV-1) infection among patients of primary care physicians, we performed anonymous, unlinked HIV-1 antibody testing on leftover blood specimens submitted to 10 large commercial clinical laboratories for complete blood cell count or hematocrit determination, the most commonly ordered diagnostic tests. From January through August 1990, 55,613 specimens submitted by general internists, pediatricians, and family practitioners were sampled; 1,104 (2.0%) had HIV-1 antibody. Seroprevalence among the laboratories varied 50-fold, from 0.3 to 12.4%. The HIV-1 prevalence at each laboratory was not always consistent with the AIDS incidence in the area served by the laboratory. Overall the seroprevalence was almost eight times higher in men (3.9%) than in women (0.5%). Specimens from seropositive persons, especially from men, were unevenly distributed among the physician practices; only three practices submitted approximately 50% of all specimens from seropositive men. These data indicate that a few physicians treat the majority of HIV-1-infected primary care patients. The HIV-1 prevalence among specimens at a clinical laboratory is thus determined by whether few physicians submit specimens to that laboratory. These results could be of use, for instance, in analyzing proposals to mandate physician reporting of HIV-1 infection. The high HIV-1 prevalence among laboratory specimens underscores the potential for exposure to HIV-1-infected blood by clinical laboratory personnel and emphasizes the need for universal precautions for all blood specimens.

Adolescent↗

Current nursing practice of point-of-care laboratory diagnostic testing in critical care units.

BACKGROUND: The development of user-friendly laboratory analyzers, combined with the need for rapid assessment of critically ill patients, has led to the performance of in vitro diagnostic testing at the point of care by personnel without formal laboratory training. OBJECTIVES: To determine the range of laboratory testing performed by critical care nurses and their attitudes toward this role. METHODS: A survey of critical care nursing consultants was conducted, using a modified Likert scale, to assess objective measures of point-of-care testing practice in critical care units and to determine nurses' attitudes toward the practice of point-of-care testing. Statistical analysis was performed to determine significant trends in responses. RESULTS: Of the units responding to the survey, 35% used critical care nurses exclusively to perform point-of-care testing, 32.5% used laboratory technicians and critical care nurses, and 25% used other personnel. Of critical care nurses performing laboratory testing, 95.5% performed blood glucose analysis; 18.7%, arterial blood gas analysis; 4.5%, electrolyte analysis; 4.5%, hematology profiles; and 22.7%, other testing. Most agreed that stat tests were not reported promptly, thereby necessitating bedside testing. Respondents indicated that they would prefer that laboratory personnel operate in vitro diagnostic equipment and that requirements for critical care nurses to perform laboratory testing detracted from other patient care duties. CONCLUSIONS: Most nurses who perform point-of-care testing responded that it was necessary and helpful in patient management. However, they would prefer, because of their other patient care responsibilities, that laboratory personnel take this responsibility.

Attitude of Health Personnel↗

A comparison of the effectiveness of malignancy detection in body fluid examination by the cytopathology and hematology laboratories.

BACKGROUND: Body fluid specimens in many institutions are submitted for cytologic examination as well as for examination in a clinical microscopy or hematology laboratory. The cytology laboratory is generally seen as the standard for detection of malignancy, whereas the clinical microscopy laboratory is often depended on predominantly for cell counting and categorization. METHODS: To analyze the effectiveness of the hematology laboratory at detecting malignant fluids, this study retrospectively analyzed reports on 397 body fluid specimens (cerebrospinal, pericardial, peritoneal, and pleural) that were concurrently submitted over a 12-month period to both the cytopathology laboratory and the hematology laboratory. RESULTS: Thirty-seven (9.3%) of the cases were diagnosed as malignant by at least one of the two examinations. The cytopathology examination reported 27 (73%) of the 37 malignant cases as malignant and 30 (81.1%) as at least atypical (27 malignant and 3 inconclusive), and the hematology examination reported 34 (91.9%) as malignant and 36 (97.3%) as at least atypical. A concordant malignant diagnosis was given by both laboratories in 24 (64.9%) of the 37 cases. CONCLUSIONS: These results show that examination of specimens by the hematology laboratory can provide a highly sensitive diagnostic evaluation in addition to its more customary role of providing timely cell counts.

Ascitic Fluid↗

Repeated HIV-1 resistance genotyping external quality assessments improve virology laboratory performance.

The performance of French virology laboratories belonging to the ANRS network has been assessed annually for 3 years. The performance of these laboratories was compared between the years 2002 and 2003. Ten and 7 coded samples were sent to 38 virology laboratories in 2002 and 45 virology laboratories in 2003, respectively. Each panel of coded samples included at least one HIV-negative control, a pair of duplicate specimens, samples with a wide range of viral loads, and samples with a large number of resistance mutations. The laboratories used their standard sequencing procedures and were asked to report the amino acids at codons associated with resistance mutations, based on the IAS-USA expert panel list. The reference amino acid sequences were defined as those most frequently reported by the participants. The specificity of detection of RT mutations was significantly better in 2003 (99.9%) than in 2002 (99.7%) (P = 0.05). There was no difference between 2002 and 2003 in the specificity of detection of protease mutations (99.6% and 99.8%) or the sensitivity of detection of RT mutations (98.8% and 98.2%). The sensitivity of detection of protease mutations improved significantly between 2002 and 2003 (97.6% and 99.0%, respectively; P = 0.037). The proportion of laboratories reporting fully accurate results, in terms of amplification, specificity, sensitivity, and reproducibility, tended to increase between 2002 and 2003 (P = 0.077). No errors were made by 19% of laboratories in 2002, compared to 42% in 2003. These results show the value of repeated external quality assessments.

Clinical Laboratory Techniques↗

Eradication of hantavirus infection among laboratory rats by application of caesarian section and a foster mother technique.

Hantavirus antibodies were demonstrated by the indirect immunofluorescent antibody assay, in the serum of inbred strains of laboratory rats, during the period 1973-1982, at the Unit of Experimental Immunology in the Catholic University of Louvain, Brussels, Belgium. LOU rats, as well as immunocytomas, which were requested by laboratories in the U.K. and The Netherlands, were supplied at a time when the infection was unknown and unsuspected in Europe. Hantavirus-infected laboratory rats were rendered free of virus through re-derivation by caesarian section and suckling by virus-free foster mothers. Immunocytomas were tested for the presence of hantaviruses by implantation into seronegative laboratory rats. The strain of hantavirus causing the laboratory infection was clearly different from the one circulating in free-living bankvoles in Belgium. The exchange of laboratory rats and rat tumours in relation to the potential risk of laboratory-acquired hantavirus infection, is discussed.

Animals↗

Serum osmolality in alcohol ingestions: differences in availability among laboratories of teaching hospital, nonteaching hospital, and commercial facilities.

Freezing point depression osmometry is preferred over vapor pressure with ingestions of volatile substances. Sixty-six laboratories nationwide (23 teaching hospital, 22 nonteaching hospital, and 21 commercial facilities) were surveyed to determine the availability and use of these techniques. Overall, 80% conducted serum osmometry (teaching, 100%; nonteaching, 82%; commercial, 57%). Freezing point depression was the most common method used by all laboratories; however, 33% of commercial laboratories and 11% of nonteaching laboratories used vapor pressure exclusively. One half of all laboratory supervisors did not identify why one method was preferred. Only 3% identified vapor pressure as a possible source of error in ingestions of volatile substances. Most laboratories estimated that they were aware of the patient diagnosis less than 50% of the time. Because vapor pressure osmometry is a potential source of false negative results when estimating serum concentrations of volatile substances, clinicians treating patients who have ingested ethanol, ethylene glycol, isopropanol, or methanol need to be aware of the methodology used in their reference laboratories.

Alcohols↗

Defining the typical work environment for assisted reproductive technology laboratories in the United States.

OBJECTIVE: To determine time and staffing requirements as they relate to laboratory personnel in the field of assisted reproductive technology (ART). DESIGN: Descriptive study. SETTING: Assisted reproductive technology clinics in the United States. PERSONNEL: All personnel working in ART laboratories, which included laboratory directors and technicians (those laboratory personnel trained in specific areas of embryology, andrology, and endocrinology). INTERVENTION(S): None. MAIN OUTCOME MEASURES(S): Frequencies were determined for time and staffing requirements as they pertained to individuals and procedures (e.g., oocyte retrieval, embryo transfer, semen analysis, hormone assay, etc.) performed in embryology, andrology, and endocrine laboratories. RESULT(S): Two different surveys of ART clinics in the United States were combined in this report. The average technician worked 40 hours a week, whereas the average laboratory director worked 49 hours per week. The average embryologist performed 181 procedures (not cases) per year. The average andrologist performed 648 procedures (not cases) per year, while the average endocrinologist completed 2,673 procedures (not cases) per year. CONCLUSION(S): This is the first report to describe time and staffing requirements as they relate to the laboratory personnel in an ART facility.

Attitude of Health Personnel↗

The national health system: future possibilities for the clinical laboratory.

BACKGROUND: The heavy burden of the costs of medical care has brought changes in the public health policy. The changes are partly related to the health management factors, but several cultural, social and environmental factors have also had a significant impact on healthcare. The role of the laboratory is now considered amidst changes that have occurred in the American health model (free-trader) and in the European-Canadian model (universalistic). Moreover, costs and clinical decision-making in laboratories in Italy have also changed in response to the new focus on the pre- and post-analytical phases of the testing process. METHODS: In the present study, we used the Laboratory Information System (LIS) to evaluate whether the time involved in stages in the turnaround time (TAT) (admission, performance of tests, validation and decision-making for treatment) were reduced following improvements made to the laboratory organization and management of the pre-analytical and post-analytical phases. In particular, an analysis was made of laboratory testing for myocardial markers in patients with acute coronary syndrome. RESULTS: TAT for myocardial markers in an emergency setting was reduced by 30% following changes made in the laboratory organization and in the management of the pre-analytical and post-analytical phases of the testing process. CONCLUSIONS: Thanks to changes in healthcare service/system in Italy, laboratory services will now play a crucial role in cultural and socioeconomic changes, particularly where testing processes and techniques are concerned.

Canada↗

Laboratory medicine in France. A jeopardized situation.

The expenses for health care in France have risen considerably during the present decade, ranking third after USA and Canada in the Western world. In spite of the very low cost of laboratory medicine (2.4% of the total expenditure in 1995), clinical laboratories have undergone a severe squeeze, due to two limiting factors; a decrease in the ordering of laboratory tests from private physicians and a reduction in the total expenses for laboratory services from the Social Security. Consequently, there has been unemployment of technical and secretarial staff and severe restriction in investment for buying new equipment. However, hospital laboratories will manage to assume their challenge in developing robotics, automation, molecular pathology techniques and expert systems. Private laboratories, in spite of their efforts to follow the technological advances in automation, will survive thanks to consolidation of regional networks that operate in a cooperative rather than competitive mode. Therefore, the challenge will be not in the adaptation of clinical laboratories, but in the limitation of overspending at the national level and in modification of the behaviour of irresponsible citizens accustomed to spending freely on health care services.

Clinical Laboratory Techniques↗

Total laboratory automation in Japan. Past, present, and the future.

The history of systematized automation in clinical laboratories in Japan started in 1981. At that time, about 12 laboratory technicians worked in a typical private University hospital laboratory (average size 1000 beds), whereas in national university hospitals (typical size 600 beds), the number of technicians was as low as 18-25. In 1981, the Kochi Medical School was founded as a new national school, and laboratory staffing was limited by the Ministry of Education to only 19 technicians for the first 3 years. Therefore, we started to develop a fully automated laboratory system by ourselves rather than accepting an intolerable shortage of technicians. The system was based on conveyor and robotic technology, and we called this approach systematization. Ten years later, systematized automation was introduced into the Japanese market. As a result, 72% of the national university hospitals in Japan installed commercial systems for systematization. There is a trend now in hospitals with sufficient numbers of technicians, to introduce fully automated systems in their laboratories as well, and even small hospitals with less than 100 beds are planning to introduce such systems. However, current technology is too expensive and not sufficiently standardized to meet the needs of these market segments in Japan. We recommend that companies agree on common shapes and sizes of racks and include more flexible robotic technology in their sample handling systems, to allow for plug and play systems and to make systematization affordable for every laboratory in the world.

Automation↗