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[Fundamentals of quality control systems in medical-biochemical laboratories--the role of marketing].

The basic criterion for the overall quality system in medical biochemistry laboratories concerning equipment, premises and laboratory staff in primary health care (PHC) (Regulations on quality systems and good laboratory practice of the Croatian Medical Biochemists Chamber, 1995, Regulations on categorization of medical biochemistry laboratories of the Croatian Medical Biochemists Chamber, 1996, EC4: Essential criteria for quality systems in medical laboratories. Eur J Clin Chem Clin Biochem 1997 in medical biochemical laboratories included in the First Croatia health project, Primary health care subproject, has been met by the marketing approach to the project. The equipment ensuring implementation of the complete laboratory program (NN/96), more accurate and precise analytical procedures, and higher reliability of laboratory test results compared with previous equipment, has been purchased by an international tender. Uniform technology and methods of analysis have ensured high standards of good laboratory services, yielding test results than can be transferred from primary to secondary health care level. The new equipment has improved organization between central and detached medical biochemistry laboratory units, while the high quality requirement has led to improvement in the staff structure, e.g., medical biochemists have been employed in laboratories that had previously worked without such a professional. Equipment renewal has been accompanied by proper education for all levels of PHC professionals.

Chemistry, Clinical↗

Clinical pathologist in Korea--training program and its roles in laboratories.

A rapid development of practice of laboratory medicine in Korea owes its success to the clinical pathologists (CP), who have played a role of a pathfinder for laboratories. The Korean CP postgraduate education (residency) program is unique in that it is exclusively for laboratory medicine. The training program for clinical pathologists includes diagnostic hematology, diagnostic immunology, clinical microbiology, clinical chemistry, blood bank, diagnostic genetics, informatics and laboratory management. The program has produced a strong group of about 600 laboratory physicians, officially clinical pathologists since 1963. Most of Korean clinical pathologists work as laboratory directors, directors of university hospital laboratories or teaching faculty members in medical schools. The roles of clinical pathologists are laboratory management, interpretation of laboratory test results, clinical consulting services to clinicians and patients, ordering secondary tests after reviews of requested test results and utilization management. The clinical pathologists have developed clinical laboratories to be a main contributor for improved medical practice. During the last 40 years under the turbulent healthcare system, clinical pathologists have significantly contributed to safeguard the laboratory interests. The education program and the role of clinical pathologists are described.

Curriculum↗

[The quality of bacteriological detection and determination of drug sensitivity of Mycobacterium tuberculosis by the participants of the External Clinical Laboratory Study Quality Assessment made by the Federal System in 2002-2003].

The paper presents the results of the assessment of the quality of cultural detection and determination of Mycobacterium tuberculosis (MBT) sensitivity at Russia's public health laboratories, which has been made by the Federal System for External Assessment of the Quality of Clinical Laboratory Studies in 2002-2003. The "Bacteriological Detection" Section involved 102 laboratories, of them 57 laboratories also participated in the section "Detection of Drug Resistance". Sixty-three laboratories operated as part of specialized tuberculosis-controlling service facilities and 39 laboratories worked as part of general medical care therapeutic-and-prophylactic institutions. A set of 5 lyophilized samples containing 2.5 x 10(6) M. tuberculosis H37Rv (n = 1); 2.5 x 10(4) M. tuberculosis H37Rv (n = 2); M. fortuitum (n = 1); E. coli in the mixture with autoclaving-killed M. tuberculosis H37Rv (n = 1). 77% of the laboratories could detect in the cultural sample with a high content of M. tuberculosis, by obtaining a correct result; 85% revealed MBT if only in every three MBT-containing samples; 15% of the laboratories could not find MBT in none of the three positive samples. 12% of the laboratories took the growth of microorganisms in the M. fortuitum-containing sample for that of M. tuberculosis. 58% of the laboratories obtained correct results if only in one sample containing M. tuberculosis H37Rv; 42% reported the detection of resistance to one or several antituberculous drugs in the samples containing the drug-sensitive strain H37Rv (a false drug resistance). All the results of determination of drug resistance (DR) in the M. fortium-containing sample were correct. The findings suggest that it is necessary to increase the professional competence of laboratory personnel to the level that ensures the adequate of fulfillment of the standard protocols for detecting MTB and determining DR, which have been introduced by the Ministry of Health of the Russian Federation through its order No. 109 on March 21, 2003.

Anti-Infective Agents↗

A survey of platelet serology in UK laboratories (1987): an assessment of the efficacy of using chloroquine-treated platelets to distinguish between platelet-specific and anti-HLA antibodies. The UK Platelet and Granulocyte Serology Working Group.

This survey was designed to determine the ability of participants to distinguish between platelet specific and anti-HLA antibodies. Four well characterized reference reagents and 10 unknown samples were sent to 29 laboratories affiliated to the UK Platelet and Granulocyte Serology Working Group and to three overseas reference laboratories. Results were obtained from 27 Working Group laboratories and from 2 reference laboratories. Overall, the results indicate that the use of chloroquine-treated platelets alone, without an independent test for anti-HLA antibodies, was insufficiently reliable to elucidate mixtures of platelet specific and anti-HLA antibodies. Laboratories using chloroquine-treated platelets were no more successful in elucidating the antibody composition of sera containing platelet-specific and anti-HLA antibodies than those laboratories which did not use this technique. The results may indicate a lack of experience with the chloroquine technique and suggest that further studies into the performance of the technique are required. The survey also provided insights into other areas of platelet serology: (1) There was a decrease in the incidence of false-positive results compared to earlier UK surveys. [2) All laboratories detected potent platelet-specific antibodies but weakly reactive antibodies were less readily detected. (3) Laboratories using fluorescent antiglobulin techniques recorded fewer errors than laboratories using ELISA techniques. (4) Laboratories using paraformaldehyde (PFA)-treated platelets in fluorescent antiglobulin techniques did not perform better than laboratories using untreated platelets.

Antibody Specificity↗

Strategies of organization and service for the critical-care laboratory.

Critical-care medicine requires rapidity of treatment decisions and clinical management. To meet the objectives of critical-care medicine, the critical-care laboratory must consider four major aspects of laboratory organization in addition to analytical responsibilities: specimen collection and delivery, training of technologists, selection of reliable instrumentation, and efficient data dissemination. One must also consider the advantages and disadvantages of centralization vs decentralization, the influence of such a laboratory on patient care and personnel needs, and the space required for optimal operation. Centralization may lead to workflow interruption and increased turnaround time (TAT); decentralization requires redundancy of instrumentation and staff but may shorten TAT. Minimal TAT is the hallmark of efficient laboratory service. We surveyed 55 laboratories in 33 hospitals and found that virtually all hospitals with 200 or more beds had a critical-care laboratory operating as a satellite of the main laboratory. We present data on actual TAT, although these were available in only eight of the 15 routine laboratories that provided emergency service and in eight of the 40 critical-care laboratories. In meeting the challenges of an increasing workload, a reduced clinical laboratory work force, and the need to reduce TAT, changes in traditional laboratory practice are mandatory. An increased reliance on whole-blood analysis, for example, should eliminate delays associated with sample preparation, reduce the potential hazards associated with centrifugation, and eliminate excess specimen handling.

Centralized Hospital Services↗

[External control of drug sensitivity determination in mycobacteriologic laboratories in the Czech Republic].

In 1992 and 1993 an external control of sensitivity assessment of coded strains of M. tuberculosis to five basic antituberculotics was made: isoniazide, streptomycin, pyrazinamide, ethambutol and rifampicin. In 1992 from 11 participating laboratories an erroneous result was recorded in 9 (3 laboratories made two mistakes, 6 laboratories one mistake), two laboratories did not provide complete results. Unsatisfactory results were obtained during external controls in 1993. Of 15 participating laboratories four laboratories made one mistake, two laboratories two mistakes, four laboratories three mistakes. Five laboratories (i.e. one third) made more than three mistakes. Analysis of the results revealed a low reproductibility of results of drug sensitivity tests. To eliminate these shortcomings it will be necessary to make systematic external controls with subsequent solution of the shortcomings, restriction of the number of laboratories making these examinations to those who will systematically produce correct results. And it will be also necessary to test the sensitivity tests to antituberculotics in resistant strains in the National reference laboratory for mycobacteria.

Antitubercular Agents↗

Quality of lipid and lipoprotein measurements in community laboratories.

OBJECTIVE: To determine the reliability of cholesterol and lipoprotein measurements conducted in local community laboratories. METHODS: Standardized duplicate serum aliquots at three concentrations (low, intermediate, and high) of total cholesterol, triglycerides, and high-density lipoprotein cholesterol were sent to 21 laboratories used by the physicians participating in the Cholesterol-Lowering Intervention Program. Results obtained from the laboratories were compared with values obtained from the Centers for Disease Control and Prevention-standardized Heinz Lipid Laboratory and with the means of the entire sample. RESULTS: The mean coefficient of variation (CV) was 1.3% or less for all three levels of total cholesterol, which demonstrates a high degree of precision. Accuracy was also high; over 80% of all laboratories were within 5% of the Heinz Laboratory low reference value, and all were within the 5% range for the medium and high samples. The CVs for triglycerides (< 2.3%) and high-density lipoprotein cholesterol (< 2.2%) were similar to that for total cholesterol, but up to 56% and 61% of the values fell outside the Heinz reference range for high-density lipoprotein cholesterol (intermediate concentration) and triglycerides (low concentration), respectively. As the Heinz Laboratory has a negative 2.7% bias versus the Centers for Disease Control and Prevention for total cholesterol and high-density lipoprotein cholesterol measurements, a higher percentage of laboratories fell outside the Centers for Disease Control and Prevention range. For medium and high total cholesterol samples, 16% of the laboratories were outside the 5% Centers for Disease Control and Prevention range, and the value was 58% for the low total cholesterol sample. For high-density lipoprotein cholesterol the percentages were 61%, 56%, and 39% for the low, medium, and high samples, respectively. CONCLUSIONS: These data suggest that according to the standards set by the National Cholesterol Education Program Laboratory Standardization Panel, reliability of total cholesterol measurements in local laboratories is high. Lower levels of accuracy were noted for triglycerides and high-density lipoprotein cholesterol measurements.

Blood Chemical Analysis↗

Clinical microbiology laboratories do not always detect resistance of Haemophilus influenzae with disk or tablet diffusion methods. Finnish Study Group for Antimicrobial Resistance (FiRe).

The performance of disk diffusion testing of Haemophilus influenzae was evaluated in 20 laboratories. Thirteen disk-medium-breakpoint-inoculum modifications were used in Finnish clinical microbiology laboratories. The performance of various methods was evaluated by testing a susceptible control strain and one with non-beta-lactamase-mediated ampicillin resistance 10 times in 16 laboratories. Gaps in millimeters were measured between these two groups of results. The strains were separated by a gap of at least 5 mm in 8/16 laboratories testing ampicillin, in 7/15 laboratories testing cefaclor, in 5/ 16 laboratories testing cefuroxime, and in 15/16 laboratories testing trimethoprim-sulfa. Detection of ampicillin resistance was better with 2.5 microg tablets than with 10 microg disks or 33 microg tablets. For MIC-determinations, 785 isolates and their disk diffusion results were collected. None of the 12 clinical isolates with non-beta-lactamase-mediated ampicillin resistance was detected as resistant in the participating laboratories. The ampicillin and cefaclor results of the isolates were no better even when a laboratory was able to separate the control strains. Cefaclor results were unreliable because of poor disk diffusion-MIC correspondence and incoherent breakpoint references. Interlaboratory variation of the zone diameters caused false intermediate results of cefuroxime-susceptible strains. When ampicillin, cefaclor and cefuroxime were tested, the discrimination of laboratories using disks and tablets was equal, whereas the laboratories using paper disks were better able to detect trimethoprim-sulfa resistance.

Diffusion↗

Contemporary exercise physiology: fifty years after the closure of Harvard Fatigue Laboratory.

The relationships between the discipline of exercise physiology and the activities of the Harvard Fatigue Laboratory were examined. Even though 5 decades have elapsed since the Laboratory's closure, its existence, leaders, and accomplishments continue to be revered by exercise physiologists. The Laboratory was unique because it was the first research facility of its type and because no single exercise physiology laboratory in the United States since 1947 has been able to attract the stature of the national and international investigators that conducted the interdisciplinary research published by the Laboratory. Despite the inference from its name, the Laboratory's purpose was not to advance the discipline of exercise physiology; rather, it was to advance our understanding and interactions of applied physiology, physiology, and sociology. Consequently, its contributions to the critical mass of exercise physiology literature were limited even though may of the publications were seminal in nature. As documented by the Horvaths, the closure resulted in the establishment of many different research laboratories by former Laboratory staff members and associates (R.E. Johnson at Illinois, Horvath at Santa Barbara, and Dill at Nevada); however, their impact on exercise physiology was delayed because Keys and Robinson had left for Minnesota and Indiana, respectively, well in advance of closing. Unfortunately, the administrative structure and organization of the Laboratory was not conducive to the training of Ph.D candidates with an interest in exercise physiology. Consequently, only two individuals graduated during its existence. Since departments of physiology or biology had limited faculty or interest in preparing students for such a future before and after closure, departments of physical education with specialization graduate programs in exercise physiology assumed this responsibility, which was facilitated by post-World War II funding that supported mass education, graduate training, health related research, and facility development. Today, the majority of the leaders in exercise physiology are the "products" of the specialization movement. Although undergraduates were encouraged to participate in the research activities, the talented faculty of the Laboratory did not offer formal courses in exercise physiology. Thus, the development of an academic discipline in exercise physiology was left to institutions that required a science-oriented curriculum in their undergraduate and graduate degree programs in physical education, exercise science, or kinesiology. The emergence of exercise physiology as a discipline in the United States was enhanced by the publications of the Journal of Applied Physiology in 1948 and by Medicine and Science in Sports in 1969. These were peer-reviewed journals that were interested in publishing research studies on exercise topics. Two other reasons contributed to its development. The first was the creation of an Applied Physiology Study Section at the National Institute of Health in 1964, whose purpose was to evaluate grant proposals in subject matter area intrinsic to exercise physiology, while the second reason was the formation of the American College of Sports Medicine in 1954. ACSM was an important for the establishment of the discipline because it had an organizational structure that encouraged exercise physiologists to join, provided opportunities for members to present at regional and national meetings, and would publish their findings. Although the American Physiological Society had been established more than a 100 years ago, only a limited number of its members were interested and active in exercise physiology at the time of the Laboratory's closure or at the beginning of the specialization era (1963). However, in 1977, APS created a membership section that included exercise physiology in its title. Currently, both APS and ACSM are effectively representing the professional interests of exercise ph

Boston↗

[JSCP Technical Committee on Laboratory Informatics; its 10th anniversary and future perspective].

The Technical Committee on Laboratory Informatics of the Japan Society of Clinical Pathology (JSCP) was established in 1988 by the late Professor Takaoki Miyati, Department of Clinical Laboratory Medicine, Yamaguchi University School of Medicine at the 35th JSCP Annual Meeting. Since then, the chairpersons have been succeeded by Prof. Nobuyoshi Matsuda (Kawasaki Medical University) and currently Prof. Masayuki Kambe (Hiroshima University School of Medicine). Open committee meetings have been held twice a year; the one during the JSCP Annual Meeting and the other independently in Spring. There have been many important subjects discussed at the past 20 meetings, including optical card utilization, laboratory information system, quality assurance in clinical laboratory, laboratory data base, outputs and presentations of laboratory results, reference values and intervals, medical support and expert systems for laboratory results, practice guidelines in laboratory medicine, laboratory support systems for medical education and research, and medical consultation in clinical laboratory. Roles of laboratory informatics will increase steadily in the circumstances of computer-multimedia networks.

Clinical Laboratory Information Systems↗

Tracing our roots: new opportunities and new challenges in clinical laboratory science (1977-1992).

OBJECTIVE: To describe new opportunities and challenges facing clinical laboratory science between 1977 and 1992. DESIGN: A survey of literature on the history of clinical laboratory science was conducted. References consulted include various books and professional journals. CONCLUSION: Between 1977 and 1992 the role of clinical laboratory scientist continued to evolve and expand as new tests and instruments were introduced. Over time, they began to assume greater responsibilities for analyzing and interpreting test results, evaluating and implementing quality assurance programs and new methodologies, and became involved, to a greater extent, in laboratory management and supervision, education, and research. A wide variety of career opportunities were opened to clinical laboratory scientists, providing them with employment opportunities beyond the milieu of the clinical laboratory. Federal regulations aimed at controlling cost of healthcare had a significant effect on the clinical laboratory and clinical laboratory personnel. Stricter guidelines for reimbursement of laboratory services by third-party payees and private insurers forced laboratories to scrutinize their costs and develop creative strategies to attract clients. Attrition, job satisfaction, salaries, and personnel shortages grew in importance during this period as well, prompting research in these areas.

Clinical Laboratory Techniques↗

[Consultation on laboratory information--from the perspectives of clinical pathologists and medical technologists].

There is increasing demand for consultation on clinical laboratory test results. To respond to this demand, the Clinical Laboratory of Kitasato University Hospital opened the "Clinical Laboratory Information (Consulting) Center" in July 1995, which has been supporting medical care and research. The Center is located on the second floor of the Clinical Laboratory building of Kitasato University Hospital, and is staffed by one medical technologist and a clinical pathologist specialized in clinical laboratory medicine. The Center staff consults by telephone from 9 am to 5 pm on weekdays, and get inquiries after work hours and during weekends either by e-mail or fax. Since January 1998, the Center has been open to physicians belonging to the Japanese Medical Association, in the area surrounding Kitasato University Hospital. The Center aims to improve medical care by providing accurate and up-to-date information on clinical laboratory test and the interpretation. The staff of the Center attempts to advise physicians thus regarding appropriate tests for particular patients. This avoids the ordering of unnecessary tests, and benefits the patient, the physician, and the hospital. The staff should keep abreast of new findings on a wide array of clinical laboratory tests. The Center staff should respond immediately to requests and complaints, thereby always seeking to improve the Center. Since physicians who receive training in Clinical Pathology at this hospital must do a rotation in the Internal Medicine Department for at least two years, the clinical pathologist at the Center can provide not only interpretation of the test result but also clinical advice. More than 80% of the inquiries can be answered by medical technologists. It is important that the Center staff answer every question in a courteous and polite manner. Establishment of this Center increased the efficiency of the clinical laboratories at this hospital, as the other medical technologists were freed from answering questions over the telephone. Our Center is the first such clinical laboratory in Japan that is staffed by both a clinical pathologist and a medical technologist, and our Center could be a pilot program for a new service of hospital clinical laboratories.

Clinical Laboratory Information Systems↗

[Active laboratory consultation for the clinical supporting system in the general hospital].

As an active laboratory-initiated consultation, we describe the patient-oriented laboratory comment, a kind of interpretative report, on selected abnormal test results. Appropriate laboratory data check and clinical finding checks are necessary as a precondition for effectively reporting laboratory comments. Over the past five years, we reported 303 laboratory comments on hematologic and chemical test results. Clinical finding checks were performed on only 0.05% of the total number of these tests, but the frequency of reported laboratory comments after clinical finding checks were 6.3% in chemical test results and 47.1% in hematologic test results. As in our previous report, 33% of laboratory comments had an effect on diagnosis and treatment. For effective laboratory-initiated consultation, we must establish standard methods for laboratory data check and for selection of clinical finding checks. In addition, not only consultation but liaison service is needed for the clinical laboratory.

Clinical Laboratory Information Systems↗

Multiple laboratory comparison of the doubly labeled water technique.

A double-blind study was conducted to determine between-laboratory variability in the doubly labeled water method for measurement of total energy expenditure in humans, and to compare the accuracy and precision of three widely-used procedures for calculating rates of carbon dioxide production from the original isotope data. Eighteen laboratories from five countries participated in the study. All laboratories were provided with five water standards containing varying amounts of 2H and 18O, and in addition 11 laboratories were provided with urine and dose specimens from one (six laboratories) or two (five laboratories) healthy elderly subjects of normal height and weight undergoing a calorimetric validation of the doubly labeled water method. The data from the five water standards were analyzed to predict between-laboratory variability in the doubly labeled water technique in all laboratories. In addition, data from the subjects were analyzed using the "slope-intercept", "2-point" and "modified" methods of calculation. The results confirm that the doubly labeled water method can be an accurate technique for the measurement of energy expenditure in adult human subjects in some laboratories. However, there was substantial between-laboratory variability in the results and some laboratories returned physiologically impossible results. There was no significant effect of calculation procedure on the accuracy of the technique in this limited comparison, although the slope-intercept procedure appeared to be more susceptible to analytical error than the other procedures. The isotope standards analyzed by participants in this study will be made available to other investigators on request.

Aged↗

Laboratory standardization of a large international clinical trial: the DAIS experience. DAIS Project Group. Diabetes Atherosclerosis Intervention Study.

OBJECTIVE: To implement a quality control program for the standardization and harmonization of lipid and lipoprotein analyses as performed at two core laboratories (St. Paul's Hospital, UBC [Vancouver], and NPHI [Helsinki]) for the Diabetes Atherosclerosis Intervention Study (DAIS). DESIGN AND METHODS: A DAISSOFT computer program was designed to minimize the occurrence of data and sample management errors during the course of the study. Fresh human serum was used for the provision of an accuracy based external quality control program that monitored the analytical performance of lipid testing at these two laboratories. A separate program was designed for monitoring hemoglobin A1c (HbA1c). At the outset of the study, allowable total error goals were established for each analyte. Ongoing performance was monitored using bimonthly blinded challenges of fresh human serum. The two EQA programs routinely monitored the analysis of total cholesterol, calculated LDL-cholesterol, HDL-cholesterol, net triglycerides, apoprotein A-1, apoprotein B, and HbA1c. RESULTS: The EQA precision and accuracy data for the measurement of total cholesterol at the two core laboratories over the last 5 years indicated both laboratories operated with good precision, approximately 1% CV over the time period. The accuracy at both laboratories was similar initially. Part way through the study, the accuracy of the cholesterol method at NHPI tended to drift upward with an operating positive bias (+3%) relative to the Abell Kendall reference method. Triglyceride measurements were the most problematic for the study. By EQA cycle 8, the accuracy of the method at UBC had stabilized and was meeting the accuracy goals of the study. NPHI's method was negatively biased relative to the accuracy base of the DAIS study. In spite of recalibrating their method, NPHI found it difficult to maintain consistent accuracy for the measurement of triglycerides during the study. Both laboratories operated their HDL methods with excellent precision. Accuracy at NHPI was well maintained over the course of the study whereas the accuracy of HDL measurements at UBC was more problematic. There was an inconsistent variation in the accuracy of apoprotein A-1 measurements at both laboratories. In most cases, the bias would be corrected by the time of the next EQA challenge. In the case of apo B, one laboratory was standardized to the CDC while the other laboratory was standardized to IFCC/WHO. The discrepancy between these two accuracy bases was >20%. Recalibration to a common accuracy base rectified the problem. Only minor problems were encountered with the precision and accuracy of the DIAMAT assay for hemoglobin A-1c. The two DAIS core laboratories consistently operated within the 9% total error goals of the study for HbA1c. CONCLUSIONS: Through the use of this program, the two DAIS core laboratories were able to maintain their lipid analyses within the limits of allowable total error that had been established for the study.

Apolipoprotein A-I↗

Clinical utility of anticardiolipin antibody assays: high inter-laboratory variation and limited consensus by participants of external quality assurance programs signals a cautious approach.

Antibodies that bind phospholipid (anti-phospholipid antibodies [APA]) are a focus of major interest to both clinical and laboratory personnel across a variety of disciplines because of the assortment of disorders with which they are reportedly associated. A solid phase assay using cardiolipin as the test phospholipid (anti-cardiolipin antibody assay [ACA]) has now become a laboratory standard for the detection of APA. In the current report, data from two separate external quality assurance programs (QAP) and collected over the past four years, have been evaluated to assess the utility of the ACA. Despite attempted standardizations, exceedingly high inter-laboratory variation and a general lack of test result consensus would signal the adoption of a cautious clinical approach towards laboratory findings. For example, for a total of 21 cross-laboratory tested serum samples (tested for both IgG and IgM for 41 quantitative estimations), inter-laboratory variation for both ACA-IgG and ACA-IgM was higher than 50% in 20 of 41 testing cases (48.8%). The situation with regard to testing consensus was equally concerning. Total consensus (i.e., 100% of participating laboratories agreed that a given serum sample gave an ACA result of either negative or positive) occurred in less than 20% of cases for ACA-IgG. More importantly, in about 50% of serum testing occasions there was no general consensus in returned laboratory data (i.e., more than 80% of labs could not agree on whether a serum sample tested was either ACA-positive or ACA-negative). Thus, despite attempted international standardizations, exceedingly high inter-laboratory variation and a general lack of test result consensus would argue that the assay has limited utility. We conclude that single point laboratory results must be used with considerable caution before accepting that ACA activity is present in patient serum or not. We agree with recommendations indicating that laboratory tests should be repeated at least once prior to making a clinical diagnosis of any APS-like disorder.

Antibodies, Anticardiolipin↗

[Role of clinical laboratory physicians in clinical hematology].

The specialty for laboratory hematology has been difficult to define in Japan, since both the clinical laboratory physician and clinical hematologist usually engage in this field. I propose herein that the specialty for laboratory hematology belongs to laboratory medicine. This makes it possible for the clinical laboratory physician to provide active medical assistance for laboratory diagnosis of hematological disorders so that the clinical hematologist can effectively perform practical management of the patient. For this purpose, I describe the program of postgraduate education for doctors in laboratory hematology. General instructional objectives (GIOs) and specific behavioral objectives (SBOs) are proposed to set the education program for clinical laboratory physicians and to establish the specialty of laboratory hematology in Japan. For the establishment of this system, the committee for the Japanese educational program for the medical board should authorize this newly developed conception for the clinical laboratory physicians who work in the hematology laboratory.

Certification↗

Basal metabolic temperature vs. laboratory assessment in "posttraumatic hypothyroidism".

OBJECTIVES: To compare standard laboratory analytical methods with measurement of basal metabolic temperature in cases of hypothyroidism arising posttraumatically. SETTING: Private medical office. SUBJECTS: One hundred and one consecutive status post-whiplash trauma patients. DESIGN: All subjects were evaluated with standard laboratory tests (T3RU, T4, FT4I, TSH) for thyroid function. Ninety-four were also evaluated with the newer fluorescence-activated microsphere assay test (FAMA) and basal metabolic temperature (BMT) was measured in all. Correlations were investigated between BMT, age, gender, standard laboratory values and the FAMA test. The differences between low and high BMT vs. normal and abnormal standard laboratory values and the differences between normal and abnormal standard laboratory values vs. normal and elevated FAMA test results were also investigated. RESULTS: In 86.4%, the BMTs were below normal. Of this subgroup, 30% had abnormal standard laboratory values. Of the 13% whose BMT was within the normal range, 33% had abnormal standard laboratory values and 66% had increased FAMA titers. Statistically significant correlation was found between BMT and T3RU (p = .05), whereas the correlation between BMT and T4 was somewhat weaker (p = .07). Correlations between BMT and all other laboratory indices failed to reach significance. The laboratory abnormalities observed in this group of subjects were atypical for common types of hypothyroidism. A significant portion of our posttraumatic hypothyroid group (30%) were not identified with either standard laboratory tests or the FAMA test-a group we referred to as lab-normal. CONCLUSIONS: Measurement of BMT seems to be a sensitive screening test, in combination with laboratory analysis, for the hypothyroidism seen after whiplash trauma. Whiplash seems to result in a form of hypothyroidism suggesting direct injury to central tissues.

Adolescent↗