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PubMed1998

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

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

Clinical Laboratory Information Systems↗
PubMed2006

[Progress of the Laboratory Consultation Office in Kyoto Prefectural University Hospital].

In an attempt to assist the clinical physicians at the outpatient clinics in Kyoto Prefectural University Hospital, we opened the laboratory consultation office in January 2005. This office is staffed by one medical technologist from 9 am to 4 pm on weekdays. The technologist shows the laboratory examination result of respective patient, and then explains the significance of reference interval using the personal computer. Additional explanation such about the mechanism of abnormal result or the general interpretation of diagnostic tests is also performed according to the patients' demands. Whereas, as the major premise, the consulting technologist never comments to the patients on the clinical relevance between their laboratory results and their own disease courses. Until March 2006, 1,430 outpatients have visited the office in total, resulting in 6.1 patients/day as mean value. Almost all of the visitors (97.9%) wanted to listen to the meaning of liver function test, which was followed by renal function test (95.3%). Consulting time required for respective patient has been quite variable from 10 to 120 minutes (30 minutes/patient as mean). The questionnaire survey after consultation revealed that all of the visitors felt satisfactory for consultation, and wanted to revisit to our laboratory consultation office. We believe that the laboratory consultation office contributes as a new medical service of our hospital to outpatients.

Ambulatory Care↗
PubMed2005

Missed hypothyroidism diagnosis uncovered by linking laboratory and pharmacy data.

BACKGROUND: Although diagnostic errors are important, they have received less attention than medication errors. Timely follow-up of abnormal laboratory test results represents a critical aspect of the diagnostic process, and failures at this step are a cause of delayed or missed diagnosis, resulting in suboptimal clinical outcomes and malpractice litigation. We linked laboratory and pharmacy databases to (1) explore the potential for linking laboratory and pharmacy databases to uncover diagnostic errors, and (2) determine the frequency of failed follow-up of elevated levels of thyroid-stimulating hormone (TSH). METHODS: We downloaded TSH test results for 2 consecutive years from a laboratory database and linked this database with a pharmacy database to screen for patients with TSH levels of 20 mU/mL or higher who were not receiving levothyroxine. Patients with elevated TSH levels lacking prescriptions were followed up by telephone and record review. RESULTS: During the 2-year period, 982 (2.7%) of 36 760 unique patients tested for TSH level had elevated TSH levels. Of these patients, 177 (18.0%) had no recorded levothyroxine prescriptions. We attempted to contact 177 patients with high TSH levels who were not taking thyroid medications and reached 123 (69.5%). Of the 123 patients we were able to reach, 12 in 2000 and 11 in 2001 were unaware of their abnormal test results or a diagnosis of hypothyroidism, representing 2.3% of 982 patients with elevated TSH levels. We were unable to reach another 54 patients (5.5% of the total number of patients with elevated TSH levels) by either telephone or mail. CONCLUSIONS: By linking laboratory and pharmacy databases, we uncovered patients who did not undergo follow-up for abnormal TSH results. Conservatively, there was no follow-up for abnormal TSH results in more than 2% of patients, and another 5% of patients were lost to follow-up and possibly unaware of their results. Uncovering patients with missed diagnosis illustrates a potential use of linking laboratory and pharmacy databases to identify vulnerabilities in the care system and improve patient safety.

Data Interpretation, Statistical↗
PubMed1998

The physicians' office laboratory: 1988 and 1996 survey of Illinois pediatricians. Pediatric Practice Research Group.

OBJECTIVES: To contrast practices of physicians' office laboratories in the years 1988 and 1996 and ascertain physicians' perception of the effect of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). DESIGN: Mailed surveys to members of the Illinois chapter of the American Academy of Pediatrics in 1988 and 1996. SUBJECTS: There were 525 and 980 respondents in 1988 and 1996, respectively; analyses included 282 and 374 surveys representing offices where direct patient care was provided in a nonhospital setting. A paired analysis was also conducted on 101 offices that responded to both surveys. RESULTS: There was a decline from 1988 to 1996 in the percentage of offices doing in-office laboratory testing (93% to 84%, respectively; chi2 test; P<.01) and median number of types of tests (6 tests vs 4 tests; Mann-Whitney U test; P<.001). Decreases (chi2 test; P<.01) were seen in the proportion of offices offering throat culture for group A streptococci (63% to 33%), urinalysis (54% to 33%), urine culture (53% to 22%), rapid hemagglutination slide test for mononucleosis (42% to 17%), theophylline level (27% to 4%), and total cholesterol (22% to 13%). The proportion of offices offering urine dipstick, hematocrit or hemoglobin, complete blood cell count, and stool occult blood tests remained stable. For solo practitioner offices only, streptococcal antigen detection testing decreased (66% to 39%; chi2 test; P<.001). Findings in the paired analyses were similar. In 1996, more offices participated in a formal proficiency testing program (60% vs 11%; chi2 test; P<.001). The CLIA guidelines were deemed responsible for increased documentation (58%), discontinuing 1 or more tests (56%), increased frequency of quality control (50%), joining a proficiency program (40%), and increased cost to patients (32%). CONCLUSIONS: These surveys provide large-scale data concerning change in office-based laboratories of physicians serving children during an 8-year period. Office laboratories reduced their menu of tests and enhanced documentation and quality control for the tests that were done. Data like these in multiple specialties over time contribute to a comprehensive picture of the effects of CLIA on office laboratory practices.

Humans↗
PubMed1999

Statewide system of electronic notifiable disease reporting from clinical laboratories: comparing automated reporting with conventional methods.

CONTEXT: Notifiable disease surveillance is essential to rapidly identify and respond to outbreaks so that further illness can be prevented. Automating reports from clinical laboratories has been proposed to reduce underreporting and delays. OBJECTIVE: To compare the timeliness and completeness of a prototypal electronic reporting system with that of conventional laboratory reporting. DESIGN: Laboratory-based reports for 5 conditions received at a state health department between July 1 and December 31, 1998, were reviewed. Completeness of coverage for each reporting system was estimated using capture-recapture methods. SETTING: Three statewide private clinical laboratories in Hawaii. MAIN OUTCOME MEASURES: The number and date of reports received, by reporting system, laboratory, and pathogen; completeness of data fields. RESULTS: A total of 357 unique reports of illness were identified; 201 (56%) were received solely through the automated electronic system, 32 (9%) through the conventional system only, and 124 (35%) through both. Thus, electronic reporting resulted in a 2.3-fold (95% confidence interval [CI], 2.0-2.6) increase in reports. Electronic reports arrived an average of 3.8 (95% CI, 2.6-5.0) days earlier than conventional reports. Of 21 data fields common to paper and electronic formats, electronic reports were significantly more likely to be complete for 12 and for 1 field with the conventional system. The estimated completeness of coverage for electronic reporting was 80% (95% CI, 75%-85%) [corrected] compared with 38% (95% CI, 36%-41%) [corrected] for the conventional system. CONCLUSIONS: In this evaluation, electronic reporting more than doubled the total number of laboratory-based reports received. On average, the electronic reports were more timely and more complete, suggesting that electronic reporting may ultimately facilitate more rapid and comprehensive institution of disease control measures.

Clinical Laboratory Information Systems↗
PubMed1996

Urinary testosterone (T) to epitestosterone (E) ratios by GC/MS. I. Initial comparison of uncorrected T/E in six international laboratories.

Six laboratories in six countries collaborated to investigate the analytical method for estimating the testosterone to epitestosterone ratio (T/E) in urine by gas chromatography/mass spectrometry in the context of detecting the application of T as a doping agent in sport. The protocol specified many but not all details of reagents and instrument conditions. The design included the distribution and analysis of four urines with different T/E values, three replicates per value, and one standard. The ranges of mean T/E values for the four urines estimated by peak area (PA) were 0.32-0.42, 0.72-0.94, 0.91-1.14 and 3.19-5.48. The analyses of variance for these data and for the peak height (PH) data were significant for the laboratory factor (p < 0.0001). In addition there was a significant interaction between the urine factor and the laboratory factor which indicates the complexity of the analysis. T/E calculated using PA was not significantly different from that using PH. For within-laboratory precision all values for PH and PA were < 8.3%, and for between-laboratory precision all values were < 11.7% except for one (20.1%). The data represent a baseline for future experiments designed to elucidate the sources of within-and between-laboratory variance, and to harmonize estimates of T/E.

Analysis of Variance↗
PubMedDate not supplied

Local lymph node assay responses to paraphenylenediamine: intra- and inter-laboratory evaluations.

The murine local lymph node assay (LLNA) is a method for the prospective identification of skin sensitizing chemicals. Proliferative responses induced in lymph nodes draining the site of topical application of the test chemical are measured and those chemicals that induce a stimulation index of three or more compared with concurrent vehicle-treated controls are considered to have the potential to cause skin sensitization. Dose-response data from the LLNA may be used to derive an estimate of relative skin sensitizing potency, based upon derivation of the concentration of chemical required to cause a stimulation index of 3 (EC3 value) as calculated by linear interpolation. The purpose of the present investigations was to examine the stability of LLNA responses and the consistency of derived EC3 values induced by the contact allergen paraphenylenediamine (PPD). Analyses were conducted once a month over a 4-month period in each of two independent laboratories. In all assays, and in both laboratories, PPD elicited a positive response. Although some minor differences in responses between and within laboratories were observed, the derived EC3 values were generally very consistent. In Laboratory 1, EC3 values varied between 0.06 and 0.09% PPD, whereas in Laboratory 2 the range was 0.09-0.20%. These EC3 values are consistent with clinical experience of this material insofar as it is a common and relatively potent cause of allergic contact dermatitis in humans. Taken together, these data confirm the stability of LLNA responses both with time and between laboratories and provide additional support for the use of derived EC3 values in the assessment of relative skin sensitizing potency.

Allergens↗
PubMed2006

Adverse pregnancy outcomes in offspring of fathers working in biomedical research laboratories.

BACKGROUND: Laboratory work may constitute a possible health hazard for workers as well as for their offspring, and involves a wide range of exposures, such as organic solvents, carcinogenic agents, ionizing radiation, and/or microbiological agents. Adverse pregnancy outcomes in the offspring of male employees in biomedical research laboratories are examined. METHODS: Offspring to males employed 1970-1989 at four Swedish universities were identified via the Medical Birth Register (MBR), along with other pregnancy parameters. Offspring of fathers with laboratory work (n = 2,281) is considered exposed, and of non-laboratory employees unexposed (n = 1,909). Exposure data were obtained by questionnaires to research group leaders. Logistic regression analysis estimated odds ratios (ORs) and 95% confidence intervals (CIs). RESULTS: Paternal laboratory work in general showed no statistically significant increased ORs concerning birth weight and/or gestational age, but work specifically with radioactive isotopes gave OR 1.8 (CI 1.0-3.2) for high birth weight and a relative risk of 1.2 (CI 1.0-1.4) for sex ratio (male/female). CONCLUSIONS: There was no clear association between periconceptional paternal laboratory work and adverse reproductive outcomes, but use of radioactive isotopes showed increased OR for high birth weight in offspring.

Adult↗
PubMed1980

Pregnancy abnormalities among personnel at a virological laboratory.

Observations on an increased spontaneous abortion rate initiated a study among personnel working at a laboratory for diagnostic virology. Personnel at a bacteriological laboratory and at another virological laboratory served as controls. Seventy-seven female employees at the laboratory for virology were interviewed, as well as 91 at the bacteriology laboratory and 45 women at another virological laboratory. A significantly increased perinatal death rate was found among the virology personnel, with no apparent clustering over the time period studied. A higher serum titer against common viruses was found among employees actively working with patient sera. A model experiment demonstrated the risk for aerosolization of serum samples during processing. No evidence of a relationship between chemical work environment factors and the increased perinatal death rate was found. It is concluded that the factor in the working environment most closely related to the increased perinatal death rate was exposure to viral aerosols.

Abortion, Spontaneous↗
PubMed1981

The centralized prenatal genetics screening program of New York City: II. Establishment of prenatal diagnosis laboratory.

Prenatal diagnosis of genetic disorders is now being made available to an increasing number of New York City women through the establishment of a large centralized laboratory. This laboratory contracts to provide genetic diagnostic services to municipal and private hospitals throughout the New York City area. It is the first project of such magnitude in the United States. Prior to the receipt of samples for diagnostic purposes, the laboratory was required to meet the highest technical standards, as established by a Cytogenetics Advisory Committee. A set of guidelines was drawn up detailing the procedure and protocols for all the analyses and the reporting of results, including a timetable according to which results were to be obtained. The Cytogenetics Advisory Committee continues to review cases on a regular schedule. One of the unique aspects of the laboratory has been the development of back-up agreements with other area laboratories to assist in dealing with any problem that might disrupt the routine diagnostic service. The first year of operation of the laboratory has shown that financial, legal, and physical problems associated with designing and instituting a megacenter can be over-come. Similar programs should be encouraged.

Female↗
PubMed2002

Laboratory testing in rheumatoid arthritis patients taking disease-modifying antirheumatic drugs: clinical evaluation and cost analysis.

OBJECTIVE: To develop and validate evidence-based recommendations for routine laboratory tests in patients with rheumatoid arthritis (RA) receiving traditional disease-modifying antirheumatic drugs (DMARDs), and to calculate the monitoring costs. METHODS: Outpatient charts of 362 RA patients taking DMARDs were reviewed, and all laboratory abnormalities recorded. Recommendations on monitoring DMARD therapy were derived and then tested in an independent validation cohort of 231 patients. Cost analysis was performed using a cost catalog. RESULTS: Laboratory abnormalities were seen in 10% of treatment courses; relevant abnormalities were seen only during the first 4 months of therapy. Laboratory tests should be performed in week 2 and 4, then monthly for the first 4 months of therapy, then 2 to 4 times per year. These were capable of detecting 98.3% of laboratory abnormalities in a timely manner in another RA cohort. Up to 78% of costs can be saved when the presented recommendations are compared with those of international rheumatology societies. CONCLUSION: Laboratory tests can be reduced substantially in patients receiving DMARD therapy. In consequence, costs can decrease significantly without oversight of adverse events.

Antirheumatic Agents↗
PubMed1994

Laboratory compliance with federal government and professional society recommendations.

Quality assurance issues have assumed growing importance in the cytology laboratory. The 1988 Clinical Laboratories Improvement Amendment (CLIA '88) (United States Department of Health and Human Services, Federal Register: U.S. Government Printing Office 1990;55:9495) regulates the patient identifiers and clinical data on the requisition form but does not mandate physician compliance to provide the information. We investigated the use of patient identifiers and clinical data by laboratories as specimen acceptance/rejection criteria. We surveyed 81 board certified cytopathologists and 235 randomly selected cytology laboratories for acceptance criteria of cytology specimens and received responses from 104. Approximately two thirds of all responding laboratories had specific criteria for rejecting specimens on the basis of inadequate identification or clinical data. While the vast majority required the specimens to be identified with patient name, collection date, and specimen source, a minority of laboratories required clinical information such as LMP, prior atypical cytologic/histologic specimens, and history of previous therapy. Little correlation was found between practice setting and the use of rejection criteria.

Laboratories↗
PubMedDate not supplied

Interpretation of hematological and biochemical laboratory data in large-scale, multicenter clinical trials.

The laboratory assessment of drug tolerability is central to a long-term trial. But because of its volume, its multicenter origin, and the importance of nondrug factors, the analysis of these data is complicated. Various methods, i.e., collection of investigators' opinion, comparison of before- and after-treatment means, and analysis of transitions, were found to be unsatisfactory. A fourth method, described in this paper, seems to be more promising. An initial computer screening of the laboratory data is conducted to identify all patients with the potentially clinically relevant laboratory abnormalities. Each laboratory abnormally is then examined by the pharmaceutical physician with regard to the patient's sex and age, the trial diagnosis, concomitant and intercurrent illnesses, concurrent medication, unwanted effects, and other laboratory results, and each result is assigned a probable etiology according to a pre-defined classification system. By this method it is then possible to compare the frequency and severity of possible or probable drug-related laboratory abnormalities occurring with the various trial drugs. Our opinion regarding the importance of using this method would appear justified by the fact that a possible or probable drug effect was considered to have been responsible for only 15 per cent (112/760) of the potentially clinically relevant abnormal tests reported.

Blood Cell Count↗
PubMed1979

Clinical evaluation of hypnotic drugs: contributions from sleep laboratory studies.

The most thorough and clinically relevant approach to hypnotic drug evaluation is one that balances the strengths and weaknesses of clinical trials and sleep laboratory evaluations. Advantages of clinical trials include the ability to evaluate large numbers of subjects and specific target groups and to thoroughly assess and quantify a drug's side effects, whereas sleep laboratory studies are very limited in all of these areas. Sleep laboratory studies however provide a rigorous, precise, and comprehensive profile of a drug's activity since there is more control over experimental variables and measurements are objective as well as continuous throughout the night. These benefits offset the shortcomings of clinical trials, which include a lack of objective measurements, less control over experimental variables, failure to evaluate a drug's effectiveness with continued use, and inattention to drug interaction and withdrawal effect. Several basic principles derived from sleep laboratory findings have been incorporated into both the clinical trials and sleep laboratory evaluations recommended in the new FDA Guidelines for the Clinical Evaluation of Hypnotic Drugs. These principles include provision for adequate baseline and withdrawal periods, use of multiple consecutive drug nights to assess a drug's effectiveness with continued use, and inclusion of an adequate washout period when a cross-over design is used. The guidelines do not emphasize either clinical trials or sleep laboratory studies at the expense of each other, but rather stress their complementary utilization.

Clinical Trials as Topic↗
PubMed1984

Laboratory tests for human male reproductive risk assessment.

The criteria for reproductive test selection which were set forth in the beginning of this chapter required that the tests be objective, technically sound, biologically stable, sensitive and feasible. All of the tests which have been discussed can generate objective quantitative data (Table 1). Testicular tonometry appears to be a technically sound procedure which measures a biologically stable parameter, although this remains to be proven. Sperm counts are definitely not a biologically stable parameter. There is insufficient information to judge the biological stability of data obtained from sperm cervical mucus interaction. Data from a number of laboratories suggest that the zona-free hamster egg assay gives stable results when repeated with the same donor, and the tests as performed in specialized laboratories are technically sound at the present time. However, the number of laboratories which can perform the assay is limited. Sensitivity to early toxicity is a very important criterion for test selection. Physical examination does not meet this criterion, endocrine studies do not, and sperm counts do not. Not enough information is currently available to determine the sensitivity of sperm motility assessment. Sperm morphology assessment may be the most sensitive early indicator of reproductive toxicity which is currently available. There is a large body of clinical and basic science literature which suggests that sperm morphology may reflect acute stress effects on the testes. The feasibility of these tests vary. Sperm motility may be feasible only in longitudinal studies in which the video equipment can be set up in a laboratory which is doing repeated assessments. Sperm morphology assessment does not require any specialized equipment in the field. Studies of sperm cervical mucus interaction, for the reasons already stated, remain non-feasible at this time. Tests of sperm-egg interaction are probably feasible if spermatozoa can be shipped to a specialized laboratory for assessment. Thus, there are now a number of new tests for male reproductive function which are available, and which are practical. It is time for this technology to be transferred from the basic science laboratory for application in human reproductive risk assessment.

Cervix Mucus↗
PubMed1988

Evaluation of a microcomputer-based clinical laboratory data acquisition system linked with a minicomputer-based patient data management system.

We describe a microcomputer-based clinical laboratory data acquisition system linked with a minicomputer-based patient data management system and report on its performance. The system consists of a microcomputer and six laboratory analyzers: a blood gas analyzer, a flame photometer, a plasma osmotic pressure meter, a chloride ion titrator, a blood sugar analyzer, and a hemoglobin concentration and saturation meter. With the addition of a previously developed microinterface unit to each laboratory analyzer, data from each analyzer can be automatically transmitted to the microcomputer through a communication network. These data are then automatically transmitted to the patient data management system and thereby become part of that data base. Performance of this system was evaluated in two ways: (1) by comparing the turnaround time from an anesthetist's order for a laboratory analysis to receipt of the analysis with the time required in a control situation and (2) by comparing the number of steps a laboratory technician is required to walk to obtain and deliver the laboratory result with the number of steps required in a control situation in which no system was used. The turnaround time and the number of steps walked using this system were 552 +/- 41 seconds (n = 19, P less than 0.001) and 197 +/- 31 steps, respectively (n = 19, P less than 0.001), contrasted with 622 +/- 52 seconds and 374 +/- 87 steps without the system.

Clinical Laboratory Information Systems↗
PubMed1994

The new diagnostic mycobacteriology laboratory.

Recent surveys in the USA show that many mycobacteriology laboratories continue to use less-than-optimum culture and susceptibility testing methods. This seems to be true for European countries as well. The past few years have brought significant changes to the clinical tuberculosis laboratory. High-performance liquid chromatography and direct detection of acid-fast bacilli in clinical specimens aim at the same goal: increased sensitivity and specificity of the diagnostic approach and reduction of turnaround time. This review outlines a brief comparison between contemporary traditional methods and the latest developments in the direct detection of acid-fast bacilli. If patient care and public health are always considered paramount, regardless of admission time, hospital type, etc., the current concept of services has several shortcomings. One way to manage this situation is to sort and allocate specimens according to a system of priorities. There is a growing realization that no single method by itself is the best. To streamline the best choice for laboratory diagnosis, an additional dynamic acid-fast network is presented: 'Point-of-Care,' 'Fast Track,' and 'Specialty' laboratories. The physician interacts with all three types of laboratories, so ongoing communication between the physician and the laboratory is essential. Laboratorians must work together in the formation of this dynamic acid-fast network to improve service rendered for our patients.

Bacteriological Techniques↗
PubMed2000

The role of the pathologist as tissue refiner and data miner: the impact of functional genomics on the modern pathology laboratory and the critical roles of pathology informatics and bioinformatics.

This article provides an overview of how functional genomics is likely to impact on the pathology laboratory and highlights how informatics and tissue banking will greatly facilitate the molecular age of medicine. Important aspects of functional genomics in the post-genome era, including the roles of laser capture microdissection, DNA- and complementary DNA-based microarrays, proteomic methods, collaborative human tissue banking, tissue microarrays, and pathobioinformatics in the modern pathology laboratory are discussed. The role of mass spectroscopy in the analysis of RNA, DNA, and protein and its impact on the clinical laboratory, particularly in cost-effectiveness and time savings, are evaluated. This article explores how laboratory information systems (LISs) and the devices that feed them information may need to be modified to adapt to greater volumes of data for the new testing modalities that require understanding sophisticated fluorescence detection methods and image processing. Emerging genomic testing methods and their impact on pathology laboratory testing, especially in the area of molecular classification of neoplasms, are examined. The role of the tissue bank in the modern pathology laboratory as an archive of control normal tissues, as well as subsamples of the spectrum of progressive neoplastic states, is discussed in light of its critical importance to the molecular classification of cancer. Establishing a database that combines structured reports in pathology LISs and construction of tissue banking information systems will provide a rich resource for pathology departments. The article discusses a hypothetical resource, such as the Shared Tumor Expression Profiler, that would provide access to well-characterized tissue-based research resources for clinicians and researchers. Last, the article emphasizes how LISs can prepare for these changes, and how training pathologists in pathology informatics and bioinformatics (pathobioinformatics) is critical to ensure pathology's overall leadership role in the post-genome era.

Clinical Laboratory Techniques↗