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[Status of the clinical laboratory in the mandatory postgraduate medical training system: in our Kyoto Prefectural University of Medicine (KPUM) University Hospital].

Since the beginning of mandatory postgraduate medical training in 2004, our clinical laboratory has introduced an obligatory training program for all medical trainees in our university hospital. This program is a two-hour course consisting of Gram's staining method, the laboratory ordering system, blood gas analysis and personal protective equipment against hospital infection. In addition, four medical trainees had applied to study our advanced elective training program for clinical laboratory medical education in 2005. This program requires two months for each trainee, consisting of a three-step curriculum from "basic" to "maniac". In the "basic" step, each trainee studies to acquire fundamental knowledge and techniques in such fields as electrocardiography, ultrasonic cardiography, respiratory function, blood transfusion and laboratory hematology. Assistant work in the laboratory information office is also included in this step. On the other hand, highly specific laboratory techniques such as flow cytometry (FCM) and cardiopulmonary exercise testing (CPX) are classified as "maniac". The remaining laboratory fields such as blood chemistry, therapeutic drug monitoring (TDM) or urinary sedimentation are classified as "special", and each trainee is expected to master them during the training period. To date, all trainees who have finished our elective training program feel moderate to great satisfaction. I believe that clinical laboratories in both university hospitals and clinical teaching hospitals play an important role in mandatory postgraduate medical training for each trainee to learn fundamental medical knowledge and techniques, and moreover, to learn how to work and co-operate with various co-medical partners.

Curriculum↗

Introducing clinical laboratory science: CLS students help shape the future.

OBJECTIVES: The profession of clinical laboratory science (CLS) is in dire need of increased exposure to young people. By introducing the clinical laboratory sciences to students at a critical point in their science education and by making it relevant to their lives, more choices are made available to them when considering future career options. With this in mind, the CLS faculty at Texas Tech University Health Sciences Center (TTUHSC) redesigned a recruitment program and developed it into one making use of CLS student knowledge, enthusiasm, and professionalism. CLS students were given the assignment of designing an entire curriculum for a ten day presentation of clinical laboratory science topics to middle and secondary school students. Following the presentations, participants in the program were asked to provide feedback regarding CLS student performance and overall opinion of their interest in clinical laboratory science. The objectives of this study were twofold: 1) to determine if educational methodologies could be appropriately applied by CLS students to present CLS disciplines to middle and high school students; and 2) to determine if the student presentation was successful in initiating interest in the CLS profession based on outcome measures. DESIGN: As a component of the CLS laboratory management course, CLS students were instructed in education methodologies including objective writing, teaching-unit preparation, and evaluation tool design. In the following semester, these students were divided into groups and assigned a specific CLS discipline that would then be presented to middle and secondary school students in a two week, 30 hour educational program. This program was offered by the TTUHSC CLS program in cooperation with the Institute for the Development and Enrichment of Advanced Learners (IDEAL) at Texas Tech University. The curriculum prepared by the CLS students (with faculty supervision) provided the framework for the present study. SETTING: Didactic instruction of the CLS students regarding objective writing, curriculum design, and preparation of evaluations was included as a component of a CLS laboratory management course. The educational program presented by IDEAL in conjunction with the TTUHSC CLS program within the School of Allied Health Sciences occurred in the CLS student laboratories located in Lubbock, Texas. PARTICIPANTS: TTUHSC senior CLS students in a 2 + 2 baccalaureate level CLS program acted as instructors in the educational program which was presented to middle and secondary school students from around the region. CLS program faculty served as supervisors of this program. MAIN OUTCOME MEASURES: Questionnaires with Likert-scaled responses were used to evaluate outcomes. These questionnaires regarded 1) faculty assessment of CLS student performance relative to instruction in education methods; 2) participant feedback on the effectiveness and competence of the CLS student instructors and overall appeal of the presented subject material; and 3) peer evaluations of attitude, contribution, and effort of the group members. RESULTS: CLS faculty strongly agreed that the CLS students demonstrated a high level of competence when writing objectives, planning age-appropriate curriculum and activities, and demonstrating a positive image of the profession. Regarding satisfaction of the IDEAL student participant, questionnaire responses demonstrated a high rate (84% or greater for middle school participants and 85% for high school students). The program design has been so successful that it has been implemented for several other programs offered by TTU and IDEAL. CONCLUSION: The education methods used in presenting the IDEAL program mirror those found in clinical and academic settings and is an effective technique to introduce CLS students to the varied aspects of educational methodology. The presentation by the CLS students also demonstrated that introduction of clinical laboratory science disciplines early in the education of middle and secondary school students leads to an interest in the CLS profession and to the desire to learn more about it.

Clinical Laboratory Techniques↗

Building a laparoscopic surgical skills training laboratory: resources and support.

BACKGROUND: Technical skills have historically been developed and assessed in the operating room. Multiple pressures including resident work hour limitations, increasing costs of operating room time, and patient safety concerns have led to an increased interest in conducting these activities in a safe, reproducible environment. To address some of these issues, many residency programs have developed laparoscopic surgical skills training laboratories. We sought to determine the current status of laparoscopic skills laboratories across residency programs. METHODS: In December 2004, surveys were mailed to all 251 United States general surgery residency program directors. This brief 2-page survey consists of 9 questions regarding laparoscopic skills training laboratories. RESULTS: Of the 251 mailed surveys, 111 completed surveys were returned (44%). Of the respondents, 81 have laparoscopic skills training laboratories in place (80%). Skills laboratories that used a defined curriculum, and general surgery programs that shared their laboratories with other training programs were determined to have significantly more resources. A wide variety of funding sources have been used to develop and support these skills laboratories. CONCLUSIONS: Significant variability in training practices and equipment currently used exists between laboratories. A more efficient, standardized approach to skills training across residency programs is a desirable goal for the immediate future.

Data Collection↗

Laboratory systems integration: robotics and automation.

Robotic technology is going to have a profound impact on the clinical laboratory of the future. Faced with increased pressure to reduce health care spending yet increase services to patients, many laboratories are looking for alternatives to the inflexible or "fixed" automation found in many clinical analyzers. Robots are being examined by many clinical pathologists as an attractive technology which can adapt to the constant changes in laboratory testing. Already, laboratory designs are being altered to accommodate robotics and automated specimen processors. However, the use of robotics and computer intelligence in the clinical laboratory is still in its infancy. Successful examples of robotic automation exist in several laboratories. Investigators have used robots to automate endocrine testing, high performance liquid chromatography, and specimen transportation. Large commercial laboratories are investigating the use of specimen processors which combine the use of fixed automation and robotics. Robotics have also reduced the exposure of medical technologists to specimens infected with viral pathogens. The successful examples of clinical robotics applications were a result of the cooperation of clinical chemists, engineers, and medical technologists. At the University of Virginia we have designed and implemented a robotic critical care laboratory. Initial clinical experience suggests that robotic performance is reliable, however, staff acceptance and utilization requires continuing education. We are also developing a robotic cyclosporine which promises to greatly reduce the labor costs of this analysis. The future will bring lab wide automation that will fully integrate computer artificial intelligence and robotics. Specimens will be transported by mobile robots. Specimen processing, aliquotting, and scheduling will be automated.(ABSTRACT TRUNCATED AT 250 WORDS)

Artificial Intelligence↗

Hantavirus infection in laboratory and wild rodents in Argentina.

Serum samples from urban and laboratory rats, laboratory mice and wild and laboratory cricetids in Argentina were tested by immunofluorescence and plaque reduction neutralization tests to investigate prevalence of anti-Hantavirus antibodies. A total of 102 sera were obtained from laboratory rodents in 4 different animal-rooms, 31 from harbor rats and 30 from wild cricetids in 1985-1987. Anti-Hantavirus antibodies were detected in 22.5% of Rattus norvegicus in 3 of the animal-rooms but harbor rats were found to be free of Hantavirus infection. Previously, the presence of anti-Hantavirus antibodies had been demonstrated in the sera obtained from laboratory workers in these same 3 animal-rooms; it can be concluded that the laboratory rats were the source of this human infection. On the contrary, laboratory mice and cricetids failed to show Hantavirus infection while the wild vesper mouse Calomys musculinus (the main Junin virus reservoir) showed a prevalence of 23.5%. The presence of Hantavirus infection is hereby reported for the first time in wild C. musculinus and in laboratory R. norvegicus in Argentina.

Animals↗

[Relative contribution of history-taking, physical examination, and stat laboratory test to diagnosis in chest pain patients].

To evaluate the relative importance of the medical history, physical examination, and stat laboratory tests in diagnosis, twelve general internists recorded their hypotheses (diseases) with subjective probabilities assigned to them after taking the history, and after performing the physical examination, and again after obtaining stat laboratory test results. The resultant hypotheses generated for chest pain patients were compared with the final diagnoses which were determined an average of 7.6 months later. A hypothesis subjectively determined to have the highest probability was shown to agree with the final diagnosis in 71.1% of the patients after taking the history: the physical examination was useful in raising this proportion only by 5.0%. Stat laboratory tests, however, raised the proportion from 63.6% to 81.4% for patients where stat laboratory tests were done. When subjective probabilities were used as a measuring index, earlier hypotheses were correct with an average predictive value of 0.57 after the history-taking, 0.62 after the physical examination, and 0.73 after stat laboratory tests. The average subjective probability after physical examination for a group of patients who subsequently underwent stat laboratory tests was 0.59, while that for a group of patients who did not undergo stat laboratory tests was 0.78. Based on these results test-treatment threshold was estimated to be approximately 0.69. The number of hypotheses were, on the average, 2.48 after the history-taking, 2.35 after the physical examination, and 1.90 after stat laboratory tests. From the stand point of social responsibility and individual patient perspectives quantitative measurement of physicians' predictions should be provided as the basis for assessment of the benefit of high medical technologies.

Chest Pain↗

Progress in lipid reporting practices and reliability of blood cholesterol measurement in clinical laboratories in Nebraska. Efforts to align results with the Centers for Disease Control, and feasibility of meeting National Cholesterol Education Program Guidelines.

The National Cholesterol Education Program has recommended that all laboratories be consistent, precise, and accurate in the reporting and measurement of blood cholesterol levels. In a follow-up to a 1984 survey study, we assessed the changes in reporting procedures for measurements of blood lipid levels in 16 clinical laboratories in Nebraska. Using human serum reference materials of known cholesterol concentrations provided by the Centers for Disease Control, we also assessed the precision and accuracy of measurement of blood cholesterol levels in clinical laboratories in Nebraska. Fourteen of the 16 laboratories restudied in 1987 had altered the reference range for total serum cholesterol since 1984, 86% of whom lowered the upper limit of the reference range. Eleven of 16 laboratories expressed reference ranges for total serum cholesterol in terms of patient age in 1987, while only 7 of 20 did in 1984. Gender-based reference ranges increased from 0 to 5 from 1984 to 1987. Similar trends were seen in the reporting of high-density lipoprotein cholesterol and triglyceride concentrations. Reporting procedures varied greatly; only 1 laboratory used National Cholesterol Education Program risk levels for measuring total serum cholesterol levels. Fifteen laboratories met the National Cholesterol Education Program recommendation for precision (coefficient of variation, less than or equal to 5%) and 78% of laboratories obtained results that satisfied the current recommendation for accuracy (within 5% of "true value," as determined by the Centers for Disease Control).

Adult↗

The regionalization of laboratory services at the University of Utah Medical Center. Associated Regional and University Pathologists Inc (ARUP).

We feel that now, four years out, we have achieved the interim goals that we set for ourselves. There are some key aspects that we would do differently if we were now starting over, and we have provided that information to those seeking to begin similar off-site ventures who have sought our advice. There is an interesting constellation of factors that must be present for such an operation to succeed, and the individual components of that constellation will differ by institution and location. The rationale and circumstance will vary profoundly, and what is "right" in one setting may be entirely "wrong" in another. I feel compelled to caution the reader about the myriad of determinants and ingredients that must be considered. Study the precedents and seek knowledgeable advice from financial, legal, insurance, human resource (personnel), and laboratory management professionals. Regional laboratories can succeed. Hospitals may well benefit from a strategy of marketing services to physician staff members and the incremental financial and service benefits from added testing volume can be significant. However, the more expansive the business design, the more complicated the management requirements and demands and, potentially, the higher the risks, costs, pressures, and down-side factors. We feel very strongly about our focus of supporting the pathology and medical technology professions. Our value-added services are geared not only to providing technology, management, and financial services support for our clients, but also to not competing with them for local clientele. We have a program of teaching them how to market to that clientele and of providing the support materials to assist them in so doing. We have progressed from being a hospital laboratory to being a hospital laboratory referral laboratory, and now have also become a referral laboratory for other reference laboratories. As a full-service reference laboratory we send out very few tests, and are continually incorporating new tests and technologies. We have referral testing accounts currently in 42 states and we want to be the very best at what we do, namely, esoteric reference testing. Our credo is that quality at ARUP is making best continually better.

Academic Medical Centers↗

Regulation of physicians' office laboratories. The Idaho experience.

Timely availability of reliable test results enhances the office practitioner's ability to provide high-quality care that is personally satisfying to patients. Modern technology allows physicians to have such timely information available through test analyses performed in an office laboratory. Studies of physicians' office laboratories in Idaho found the performance, initially, to be unacceptably variable for many hematology, urinalysis, clinical chemistry, and microbiology tests. State regulation, requiring each office laboratory to comply with quality assurance guidelines and to participate in a proficiency testing program, resulted in a marked improvement in the proficiency level of office laboratory testing in Idaho. With the increasing dispersion of clinical laboratory technology, it is essential that standards of practice for the office laboratory be developed that ensure, within reasonable limits, the reliability of test information used in patient care. If widespread acceptance of such standards cannot be developed with a voluntary approach, states should consider regulation of office laboratories within their jurisdiction. Compliance with standards of practice, voluntarily or as a result of regulation, should promote quality performance in the office laboratory and allow the physician to use confidently the timely test information in dealing with diagnostic and management problems in patient care.

Facility Regulation and Control↗

Primary virus isolation by a satellite laboratory.

A hospital-based satellite laboratory designed to isolate viral pathogens frequently found in renal transplant and hematology-oncology patients was compared with a system based on isolation by a state-wide reference laboratory. The hospital-based laboratory identified 12 viral isolates from the total 97 clinical specimens submitted. The hospital-based laboratory identified seven viral isolates from the first 50 clinical specimens, whereas the statewide reference laboratory identified six isolates from identical paired specimens. The average time from specimen collection to reporting results for the 97 specimens was 9.2 days for the hospital laboratory, as compared with 11.2 days for the first 50 duplicate specimens sent to the state laboratory. The cost per clinical specimen was $18.10, which compares favorably with costs for routine aerobic bacteriology. The use of a satellite laboratory system for primary viral isolation appears to provide rapid, accurate, and accessible viral diagnosis at an affordable cost.

Costs and Cost Analysis↗

Laboratory testing in the office of family physicians.

A survey of family physicians was carried out among members of the state academies of family practice and graduates of residency programs in Ohio and North Carolina. Results of the survey demonstrated both an increasing number of laboratories in the offices of all family physicians as well as in increasing variety of laboratory procedures offered. It was found that solo practitioners frequently perform laboratory work themselves, while group practitioners more often delegate laboratory work to other office staff, such as certified laboratory technicians or nurses. Quality control was offered in one-half of the private offices surveyed, and in three-quarters of the office that employed certified laboratory technicians. Results of this study suggest that the increasing number of family practice residency graduates may result in an increased demand for certified laboratory technicians in private office laboratories.

Clinical Laboratory Techniques↗

The office laboratory in family practice residency programs.

A survey of family practice residency programs explored several aspects of the educational and clinical work of the office laboratories in residency centers. Many residency laboratories were found to have limited equipment and undertook only a few of the common procedures. Only 56 percent of residency programs had identified a specific educator for laboratory teaching. Only 15 percent or programs had established a formal curriculum in laboratory medicine. Curricula were poorly developed in the areas of quality control, equipment purchase, laboratory design, and the training of laboratory personnel. Recommendations are made for improving residency laboratories resident education in laboratory medicine.

Family Practice↗

[What is the ideal attainment of clinical laboratory works?].

This is the specified address delivered at the 20th meeting of the Chugoku-Shikoku District of the Japanese Society of Clinical Pathologists (JSCP). More than 40 years have elapsed since the incipient epoch of clinical pathology in this country, when physicians, surgeons and pathologists gathered, for the first time, to institute a scientific medical association (JSCP) for the purpose of elevating daily medical services to the modernized level through active use of clinical laboratory examination. Since then the laboratory examination has undergone a rapid progress and many new techniques have appeared. Excellent equipments and reagents are being supplied from the engineering and pharmaceutical companies. Thus, the clinical laboratories have assumed an out-look of a big factory equipped with a variety of automatic analysers and a large number of computers, and the figures of many laboratory staffs are peeped among them. In this situation there arose several problems urgently needed for control to hole the laboratory ideal in service to the medical doctors as well as to the patients. 1. Management of personnels (medical technologists and others) who are dissatisfied with daily robot-like works and discordant human relations. 2. Report sheets sent to the medical doctors are not employed adequately for the care of patients, because they are handed over in uncooked style without clinical laboratory interpretation and recommendation. Therefore, the laboratory medical doctors are ranked below the medical doctors on the wards and outpatient clinic. 3. Too many tests are ordered to the laboratory without adequate recognition of their usefulness.(ABSTRACT TRUNCATED AT 250 WORDS)

Clinical Laboratory Techniques↗

Accuracy and precision of serum gastrin measurements in commercial laboratories.

Patients referred to us with "positive" secretin tests and the diagnosis of Zollinger-Ellison syndrome were found to be achlorhydric. This observation led us to study prospectively the accuracy and precision of serum gastrin determinations from commercial laboratories. Synthetic gastrin (G17) was added to serum to achieve gastrin concentrations of 50, 100, 250, 500, 750, 1000, 3000, and 5000 pg/mL after subtraction of the basal value (24 pg/mL). Three aliquots of each concentration were analyzed by radioimmunoassay in our laboratory (Health Science Center at Brooklyn) and sent to four major commercial laboratories that perform 5000 to 25,000 gastrin assays per year. The reported gastrin concentrations of the triplicate samples demonstrate that many commercial laboratories failed to accurately measure gastrin. Commercial laboratories generally reported higher-than-actual gastrin concentrations in samples containing less than 500 pg/mL and lower-than-actual gastrin concentrations in samples containing more than 500 pg/mL. Of all aliquots containing 100 pg/mL or less, 14 of 24 samples (58%) were reported by commercial laboratories to contain elevated gastrin concentrations. At gastrin concentrations from 250 to 5000 pg/mL, the range of values (highest- to lowest-reported value for each concentration) was greater than 200 pg/mL in 62% of triplicate samples reported by commercial laboratories. These data indicate that determinations by some commercial laboratories lack the precision required to satisfy the current diagnostic criterion (a postsecretin rise from basal gastrin of 200 pg/mL or greater) for Zollinger-Ellison syndrome. Clinicians should be aware of this problem and obtain more basal serum gastrin samples to allow for an analysis of the range of baseline values prior to secretin injection.

Biomarkers↗

Impact of CLIA on physician office laboratories in rural Washington State.

BACKGROUND: Despite physician concerns to the contrary, the United States Health Care Financing Administration (HCFA) estimated that its regulations implementing the Clinical Laboratory Improvements Act of 1988 (CLIA) would cause few physician office laboratories to either close or reduce testing. METHODS: A survey requesting information about tests performed before and after the implementation of CLIA was developed and mailed to all members of the rural practice section of the Washington Academy of Family Physicians. RESULTS: There were significant changes in the complexity of laboratory tests performed before and after implementation of CLIA. Among independent family physicians' office laboratories, waived-status laboratories (i.e., those performing only the simplest and lowest risk tests) increased from 1% to 34%, laboratories performing tests of moderate complexity declined from 76% to 53%, and laboratories performing high-complexity tests declined from 23% to 13%. The shift to waived status was more pronounced among solo and small group physicians in smaller communities. CONCLUSIONS: HCFA seriously underestimated the impact of CLIA on rural physician office laboratories.

Centers for Medicare and Medicaid Services, U.S.↗

[Coding for clinical laboratory information].

The field of clinical laboratory tests is facing an increase in the number of test items as well as a corresponding diversification due to the demands of medical institutions as well as improvements in analytical techniques. To respond to this situation, medical institutions have been promoting systematization of their testing procedures; information exchange among the institutions has likewise expanded with the use of media such as on-line systems and internet. Standardization of interfaces has been proposed to secure a common framework compatible with different types of information. Some embodiments in this country includes; (1) Interface Standards on Clinical Laboratory Information For information exchange, the format and reporting comments used in the media systems were standardized under the sponsorship of The Medical Information System Development Center, with a publication issued on 1993. (2) Standardization of Laboratory Test Code Standardization of codes for information exchange has been established under the sponsorship of The Japan Society of Clinical Pathology (Laboratory Test Coding Committee), through the systematization of laboratory test code used in media systems. A publication entitled "Classification & Coding for Clinical Laboratory Tests (8th edition in 1992, 9th edition in 1994 and supplement in 1996)" has been issued. The system for "Classification & Coding for Clinical Laboratory Tests" is divided into 5 components; (1) analyte code, (2) identification code, (3) specimen code, (4) methodology code, and (5) data classification code. The Laboratory test codes are precisely classified by "(1) analyte code", and then are identified by combination of additional codes such as specimen and methodology codes. In this year, we are making a new easily-used-codes composed of 5 Arabic figures.

Clinical Laboratory Information Systems↗

Analytical approaches of European Union laboratories to drugs of abuse analysis.

We report a survey on urine drug testing within a total of 269 laboratories of the European Union. Clinical laboratories predominated over forensic laboratories (59.5% vs 28.5%). Screening without identification/quantification was the common approach used by clinical laboratories, whereas screening with identification/quantification was the approach used by almost all forensic laboratories. Screening was primarily performed by immunoassay in both types of laboratories. Gas chromatography coupled to mass spectrometry was the main analytical method used for specific identification/quantification of drugs, but other methods (including immunoassays) were also used. Cutoff values applied varied by laboratory type, country, and method used. A high percentage of laboratories did not use or report cutoff values. Overall, countries of the European Union vary significantly in regards to drugs tested, analytical approach, and screening and identification cutoff values. It is recommended to clearly state the analytical method and the cutoff values used when reporting results for drugs of abuse testing.

Clinical Laboratory Techniques↗

Investigation of cross contamination in a Mycobacterium tuberculosis laboratory using IS6110 DNA fingerprinting.

SETTING: A laboratory for routine culturing of Mycobacterium tuberculosis. OBJECTIVE: Investigation of an episode of laboratory cross contamination using IS6110 restriction fragment length polymorphism (RFLP) typing. Improvement of laboratory protocols to prevent contaminations in the future. To stress the importance of 'good laboratory practice', and interaction with clinicians about laboratory results. DESIGN: Fingerprinting of mycobacterial isolates from 1) cultures suspected of being contaminated and 2) strains suspected of being the source of the cross-contamination. RESULTS: RFLP typing results indicated that clinical samples were contaminated by strains which had been processed in species identification procedures one day earlier in the same safety cabinet. This cross contamination also resulted in exceptional RFLP typing results--mixed banding patterns. Three patients were treated on the basis of false-positive laboratory results. Because the laboratory results were confusing for the clinicians, the treatment of one true tuberculosis patient was severely delayed. CONCLUSION: 'Good laboratory practice' is very important to prevent cross contamination. RFLP typing proved to be a useful tool to trace the source of contamination. Interaction with clinicians receiving doubtful results is of the utmost importance.

Bacterial Typing Techniques↗