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At least 973 records · Page 54Linked to original sources
PubMed2003

Performance evaluation for screening laboratories of the Asia-Pacific region.

The Centers for Disease Control and Prevention (CDC) has a long history of involvement in quality assurance (QA) activities for support of newborn screening laboratories. Since 1978, CDC's Newborn Screening Quality Assurance Program (NSQAP), has distributed dried-blood spot (DBS) materials for external QA and has maintained related projects to serve newborn screening laboratories. The first DBS materials were distributed for congenital hypothyroidism screening in 1978 and by 2001, NSQAP had expanded to over 30 disorders and performance monitoring for all filter paper production lots from approved commercial sources. In 2001, there were 250 active NSQAP participants, 167 laboratories from 45 countries and 83 laboratories in the United States. Of these laboratories, 31 are from the Asia Pacific Region representing nine countries primarily for two disorders. In 1999, US laboratories had more errors for Performance Evaluation (PE) specimens than other laboratories; but in 2000, US laboratories had fewer errors. International laboratories reported 0.3% false-negative PE clinical assessments for congenital hypothyroidism and 0.5% for phenylketonuria (0.5%) in 2000. Paperless PE data-reporting operation using an Internet website has recently been implemented.

Asia, Southeastern↗
PubMed2006

[Clinical laboratory system in a complete electronic hospital].

The use of a Laboratory Information System (LIS) and Laboratory Automation System (LAS) are clearly superior to manual results in terms of completeness and legibility. As the current clinical information system (CIS) in Gifu University Hospital consists of a complete electronic medical record system, the clinical laboratory was re-engineered to simplify workflow, pay attention to quality assurance, and decrease various costs by an intelligent laboratory management system. We named the new system Gifu Premiotic Intelligent Laboratory System (GPILS). Further advances will concentrate on the cost-effective use of LIS, and the potential use of GPILS in our laboratories will be discussed. In addition, because one of our clinical laboratories currently provides various useful clinical laboratory-oriented information to physicians and patients, we have developed new tools named the "Reference Data Base (RefDB)". In the near future, several different types of computer technology for various clinical laboratory information will lead to the development of highly specific platforms for LIS corresponding to a complete electronic medical record system.

Clinical Laboratory Information Systems↗
PubMed2006

Student laboratories as a component of a web-based curriculum.

OBJECTIVE: To enable place-bound working clinical laboratory technicians (CLTs) to benefit from hands-on student laboratory sessions taught in University of Texas Medical Branch (UTMB) facilities by UTMB professors. DESIGN: Weekend student laboratory sessions similar to "wet workshops" were implemented and integrated into regular coursework. Student laboratory sessions of 12 hours to 16 hours in length were provided. SETTING: The UTMB student laboratories. PARTICIPANTS: Web-based education in Clinical Laboratory Science (WEBCLS) students who are working CLTs in rural place-bound situations. MAIN OUTCOME MEASURES: Course grades and certification examination scores on laboratory and comprehensive examinations given to both on-campus students and WEBCLS students. RESULTS: Of 68 WEBCLS students enrolled in laboratory courses during the calendar years 2003, 2004, and 2005, 66.2% earned grades of A or B in the course compared with 64.2% of students enrolled in the same laboratory courses on-campus. Over a three year period, the WEBCLS students averaged 564.8 on certification exam scores, while on-campus students averaged 470.9.

Clinical Laboratory Techniques↗
PubMed1995

User interface reengineering. Innovative applications of bar coding in a clinical microbiology laboratory.

Some clinical laboratory departments (such as microbiology) provide extensive reporting of text and other data not generated by instruments that can be interfaced to a laboratory information system. These data are usually entered into the laboratory information system manually by keyboard data entry, which can be cumbersome and time consuming. Bar codes, which are already used in laboratories to facilitate rapid entry of sample-identifying information, have the potential to be used much more broadly as a generalizable data entry technique. We developed a comprehensive system that takes advantage of several applications of bar coding to facilitate the work of our Clinical Microbiology Laboratory. Central to our system is the use of bar code "scripts" to meet many of our complex data entry requirements. Use of these scripts is transparent to the laboratory information system (ie, no special "drivers" are needed) because data are received as if they had been generated by typing the characters on the keyboard. The scripts consist of bar codes that encode the series of keystrokes needed to give the appropriate response at the series of prompts offered by the laboratory information system. Both alphanumeric and other keys, including carriage returns and special characters, can be converted into bar codes and incorporated into scripts. By creating and printing these scripts in the laboratory using standard wordprocessing software and bar code fonts for personal computers, laboratorians without specialized computer training have the tools to substantially improve the data entry efficiency of existing data entry terminals for a variety of laboratory information systems.

Clinical Laboratory Information Systems↗
PubMed1995

A laboratory rotation for medical house officers. Bridging the gap.

In an attempt to improve physicians' laboratory practice behavior, the Department of Hospital Laboratories at the University of Massachusetts Medical Center developed a rotation for first year housestaff. Medical interns were chosen for this pilot program because they are the most frequent users of our laboratory facilities. Rotations provide an overview of the laboratory organization, quality control and assurance, appropriate use of laboratory testing, cost containment, and an introduction to different laboratory disciplines. As assessed by discussions during an interview following completion of the program, the participants have shown an increased understanding of how a modern hospital laboratory functions and of the complexity of services provided. The respect for the laboratory staff and confidence in test results issued have increased, and house officers are more likely to use laboratory services in a more cost-efficient manner.

Blood Banks↗
PubMed1996

Clinical laboratory performance on proficiency testing samples--United States, 1994.

Regulation of laboratory testing for human health is mandated by law in the United States; the most recently enacted regulatory law is the Clinical Laboratory Improvement Amendments of 1988 (CLIA). In accordance with this law, as of August 1995 a total of 154,721 laboratories had registered with the Health Care Financing Administration (HCFA), which is responsible for implementing the CLIA regulations. Of these laboratories, only 11% were subject to the federal laboratory practice regulations that existed before the enactment of CLIA. Under CLIA regulations, all laboratories were required to begin participation in a U.S. Department of Health and Human Services (DHHS)-approved proficiency testing (PT) program by January 1, 1994, for a prescribed group of tests (e.g., hematocrit), analytes (e.g., glucose), and testing specialties (e.g., bacteriology) if performed routinely. This report summarizes an assessment of the performance of laboratories participating in PT programs with a certificate of registration from HCFA in 1994 (n = 40,711) and indicates that physician office laboratories (POLs) and other newly regulated testing sites (OTSs) had higher rates of unsatisfactory PT performance than previously regulated hospital and independent laboratories (HIs).

Centers for Medicare and Medicaid Services, U.S.↗
PubMed2003

Linking laboratory and pharmacy: opportunities for reducing errors and improving care.

A myriad of errors and lost improvement opportunities result from failure of clinical laboratory and pharmacy information systems to effectively communicate. Pharmacotherapy could benefit from enhanced laboratory-pharmacy linkage with respect to (1) drug choice (laboratory-based indications and contraindications), (2) drug dosing (renal or hepatic, blood level-guided adjustments), (3) laboratory monitoring (laboratory signals of toxicity, baseline and ongoing monitoring), (4) laboratory result interpretation (drug interfering with test), and (5) broader quality improvement (surveillance for unrecognized toxicity, monitoring clinician response delays). Linkages can be retrospective or real-time. Many organizations could benefit now by linking existing pharmacy and laboratory data. Greater improvement is possible through implementation of electronic order entry with real-time decision support incorporating linked laboratory and pharmacy data. While many guidelines, admonitions, and rules exist regarding drugs and the laboratory, substantial new knowledge and evidence in this area are needed. Focusing on these unmet needs and accompanying logistical challenges is a priority.

Clinical Laboratory Information Systems↗
PubMed2006

Trends in histology laboratory teaching in United States medical schools.

Owing to competition for faculty time among the three major missions of today's academic medical centers, as well as the rapid development of computer-based instructional technologies, laboratory instruction in medical schools in the United States has been undergoing dramatic change. In order to determine recent trends in histology laboratory instruction at U.S. medical schools, a detailed Web survey was administered to histology course directors, with about two-thirds of schools responding. The survey was designed to identify trends in the number of hours of histology laboratory instruction that each medical student receives, the amount of faculty effort devoted to histology laboratory instruction, and the use of various computer-based technologies (including virtual microscopy and virtual slides) in histology laboratory instruction. Consistent with the long-term trend of declining total laboratory teaching hours in U.S. medical schools, there is an ongoing reduction in the number of hours of faculty-directed histology laboratory instruction that each medical student receives, with a concomitant reduction in hours of faculty time devoted to histology laboratory instruction. In terms of the tools used in the histology laboratory, there has been a dramatic increase in the use of various forms of computer-aided instruction (including virtual slides). The large increase in the number of schools using computer-aided instruction has not been accompanied by an equivalent decrease in the number of schools that utilize microscopes and glass slides. Rather, the clear trend has been toward a blending of the new computer-based instructional technologies with the long-standing use of microscopes and glass slides.

Clinical Laboratory Techniques↗
PubMed1993

Near-patient blood gas and electrolyte analyses are accurate when performed by non-laboratory-trained individuals.

OBJECTIVE: The objective of this study was to determine the accuracy of a near-patient blood gas and electrolyte analyzer when used by non-laboratory-trained clinicians in the critical care setting. METHODS: One hundred eighty-five blood samples (split samples) from 50 intensive care unit patients were analyzed by clinicians in the critical care environment using a near-patient blood gas and electrolyte analyzer (GEM Premier, Mallinckrodt Sensor Systems, Ann Arbor, MI). Near-patient measurements were compared with those obtained by laboratory technologists in an established intensive care unit laboratory. RESULTS: There was good agreement between the near-patient analyzer and the laboratory for pH, PCO2, sodium, potassium, ionized calcium, and hematocrit. Bias and precision were 0.006 and 0.03 for pH, 0.03 and 0.34 kPa for PCO2, 0.78 and 2.61 mmol/L for sodium, -0.11 and 0.12 mmol/L for potassium, -0.007 and 0.05 mmol/L for ionized calcium, and -0.99 and 1.33% for hematocrit. Bias between the laboratory instrument and the bedside analyzer was small for PO2 (-0.56 kPa). However, precision between instruments was significantly higher (2.39 kPa for all PO2 values and 1.61 kPa for PO2 < or = 13 kPa). CONCLUSIONS: The test instrument is accurate and reproducible when used in the clinical setting by non-laboratory-trained individuals. Non-laboratory-trained individuals can obtain laboratory results in the near-patient setting comparable to those obtained by trained laboratory technologists.

Blood Gas Analysis↗
PubMed1984

Skin tests and blood leukocyte histamine release of patients with allergies to laboratory animals.

Skin tests and in vitro histamine-release reactions were used to evaluate 130 patients observed in an employee allergy clinic at a biomedical research facility. The allergens used included extracts from pollens (ragweed, grasses, trees, weeds), molds, mixed feathers, house dust, cat, dog, mouse, rat, rabbit, guinea pig, and hamster. Of all patients, 66% complained of allergic symptoms on laboratory animal exposure, although only 52% worked directly with animals. Among patients with symptoms, 91% were positive by skin test to at least one laboratory animal, and 46% had asthma. The median length of exposure to laboratory animals before onset of symptoms was 2.8 yr with 60% of the patients developing their symptoms within 3 yr. Among patients who had allergic symptoms before exposure to laboratory animals, 79% were skin test positive to laboratory animals when they were evaluated in this study. There was a close association found between the skin test and histamine-release results with the laboratory animal allergens: 91% of the 4+ skin reactors had leukocytes positive for histamine release versus 5% of the leukocyte donors with less than 1+ skin reactions. A close relationship in positive reactions to different laboratory animal allergens was also found. For example, individuals positive to mouse were positive also to rat (95%), rabbit (79%), guinea pig (83%), and hamster (88%). Patients who reacted to laboratory animals also reacted to some extent to house dust and cat and dog allergens, and about one half of the animal-allergic individuals reacted to pollens. Although nonpollen-allergic individuals can develop sensitivity to laboratory animals, the group at higher risk are allergic individuals, especially those sensitive to house dust, cats, or dogs.

Adult↗
PubMed1986

Standardization of steroid receptor assays in human breast cancer--III. Selection of reference material for intra- and inter-laboratory quality control.

A comparison of estrogen and progesterone receptor (ER and PgR, respectively) analyses using minced frozen tissue and lyophilized cytosols of the same samples demonstrated that intra-laboratory variations in assays performed by 13 members of the EORTC Receptor Group are lowest using the lyophilized samples. Inter-laboratory variation in receptor values was on the same order of magnitude for both types of samples (ca 22% for ER and 30% for PgR). There was no correlation between receptor values measured within each laboratory for either ER or PgR in minced tissues compared to lyophilized cytosols, which illustrates that methods of tissue disruption, extraction of receptors, and preparation of cytosol are sources of intra- and inter-laboratory variation. In some laboratories the handling of the tissue was apparently sub-optimal since a slight but significant difference was found in the overall mean concentration of ER in minced tissue compared to lyophilized cytosol samples. It was concluded that lyophilized tissue samples are the material of choice for routine intra- and inter-laboratory quality controls. However, differences in methods of handling tissue to obtain cytosol should not be disregarded since they lead to increased intra-laboratory variation. A difference was demonstrated between use of a common batch of isotope and the different batches concurrently employed in the laboratories, but the differences were not large enough to warrant use of a common batch for routine inter-laboratory comparisons. Differences in methods used to convert cpm to dpm did not appreciably affect the results when counting samples of tritium containing from 30,000 to 105,000 dpm.

Biological Assay↗
PubMed2003

Variability of porcelain color reproduction by commercial laboratories.

STATEMENT OF PROBLEM: Many investigations in the field of metal ceramics have examined materials, manipulative variables, and the relationship of these factors to a restoration's color. However, the effect of the artistic component of restoration fabrication is not known. PURPOSE: The purpose of this study was to determine through instrumental colorimetry the variability in color reproduction for metal ceramic crowns fabricated by commercial dental laboratory technicians. MATERIALS AND METHODS: Fifty metal ceramic crowns were fabricated on standardized metal frameworks to the same shade specifications by 5 commercial dental laboratories (n=10). Laboratory prescriptions requested that the technician match the shade and translucency of a provided Vita Lumin A3.5 shade tab. Technicians used the porcelain and technique of their own selection to match the tab. Color differences were determined by use of a colorimeter between crowns and the prescribed shade tab at middle and incisal sites. Analysis of variance was used to determine whether differences in color reproduction existed among laboratories. Where statistically significant interactions existed, the Tukey honestly significant difference test was used to determine significant differences between laboratories according to sites (alpha=.05). RESULTS: Color reproduction was significantly different (P <.0001) among laboratories for both sites. Mean color difference from shade tabs ranged from 3.5 to 11.1 DeltaE units. All laboratories were better at matching shades in the incisal third of the crown. CONCLUSION: Within the limitations of this study, the ability to reproduce the color of the target shade tab differed among laboratories. Most crowns fabricated by the laboratories in this study, when compared to the prescribed shade tab, were above the clinical threshold for an acceptable shade match under intraoral conditions (DeltaE 3.7).

Analysis of Variance↗
PubMedDate not supplied

[Comparison of serological procedures used for the diagnosis of viral exanthema in laboratories participating in the measles elimination plan].

OBJECTIVE: The comparison of serological methods used by the laboratories participating in the Network for the Elimination of Measles to diagnose measles virus infection as well as differential diagnosis with other exanthematic diseases are compared. MATERIALS AND METHODS: One panel of 20 serum samples including measles (12), rubella (4), parvovirus B19 (2) and dengue (2) infections was established. All cases were diagnosed by detection of specific IgM. The panel was sent to the laboratories of the Network. The results were compared with those obtained at the reference laboratory. RESULTS AND DISCUSSION: Regarding measles, IgM response from 20 laboratories (19 by ELISA and 1 by indirect immunofluorescence) was obtained, with an agreement of 91.5%. Related to rubella IgM, replay from 6 laboratories, using ELISA, was received, with an agreement of 98.7%. With respect to parvovirus B19 IgM, response from 10 laboratories (8 by ELISA and 2 by indirect immunofluorescence) was obtained, with an agreement of 94.6%. Results about dengue virus were not reported by any laboratory. CONCLUSION: Some laboratories from the network should review the methods used for the diagnosis of measles and other exanthematic diseases. The results reassert the need for a reference laboratory to support confirmation of the results.

Antibodies, Viral↗
PubMed1998

Reproducibility of mtDNA analysis between laboratories: a report of the European DNA Profiling Group (EDNAP).

The aim of this collaborative exercise was to determine whether uniformity of mtDNA sequencing results could be achieved among different EDNAP laboratories. Laboratories were asked to sequence mtDNAHV1 region (16024-16365) from three bloodstains, proceeding in accordance with the protocol and strategies currently used in each individual laboratory. Cycle sequencing was used by 11 laboratories and solid phase single stranded sequencing was used by one laboratory. Different PCR strategies and PCR conditions were used by the different laboratories. Three laboratories used semi-nested PCR, two nested PCR, three direct amplification of HV1 and four amplification of overlapping fragments covering the HV1 region. Despite the diversity of methodologies used, all the laboratories reported the same results. The successful result of this exercise shows that PCR based mtDNA typing by automated sequencing is a valid, robust and reliable means of forensic identification despite the different strategies and methodologies used by the different laboratories.

DNA Fingerprinting↗
PubMed2003

Intra- and inter-laboratory variation in the scoring of micronuclei and nucleoplasmic bridges in binucleated human lymphocytes. Results of an international slide-scoring exercise by the HUMN project.

One of the objectives of the HUman MicroNucleus (HUMN) project is to identify the methodological variables that have an important impact on micronucleus (MN) or micronucleated (MNed) cell frequencies measured in human lymphocytes using the cytokinesis-block micronucleus assay. In a previous study we had shown that the scoring criteria used were likely to be an important variable. To determine the extent of residual variation when laboratories scored cells from the same cultures using the same set of standard scoring criteria, an inter-laboratory slide-scoring exercise was performed among 34 laboratories from 21 countries with a total of 51 slide scorers involved. The results of this study show that even under these optimized conditions there is a great variation in the MN frequency or MNed cell frequency obtained by individual laboratories and scorers. All laboratories ranked correctly the MNed cell frequency in cells from cultures that were unirradiated, or exposed to 1 or 2Gy of gamma rays. The study also estimated that the intra-scorer median coefficient of variation for duplicate MNed cell frequency scores is 29% for unexposed cultures and 14 and 11% for cells exposed to 1 and 2Gy, respectively. These values can be used as a standard for quality or acceptability of data in future studies. Using a Poisson regression model it was estimated that radiation dose explained 67% of the variance, while staining method, cell sample, laboratory, and covariance explained 0.6, 0.3, 6.5, and 25.6% of the variance, respectively, leaving only 3.1% of the variance unexplained. As part of this exercise, nucleoplasmic bridges were also estimated by the laboratories; however, inexperience in the use of this biomarker of chromosome rearrangement was reflected in the much greater heterogeneity in the data and the unexplained variation estimated by the Poisson model. The results of these studies indicate clearly that even after standardizing culture and scoring conditions it will be necessary to calibrate scorers and laboratories if MN, MNed cell and nucleoplasmic bridge frequencies are to be reliably compared among laboratories and among populations.

Analysis of Variance↗
PubMed1997

Semen analysis performed by different laboratory teams: an intervariation study.

Some recent studies have indicated that sperm concentration has decreased during the last 50 years. However, comparisons between laboratories have revealed that geographical differences seem to exist and that any decrease may not be global. One point of criticism concerning comparison of results from different laboratories has been that some of the discrepancies detected could reflect the lack of standardized methods used in the different laboratories. Four teams, each consisting of one physician and one technician from groups which have recently published data on semen quality, met in order to evaluate the variability between their laboratories on semen analysis. Twenty-six fresh semen samples from unselected men were analysed. The groups analysed the samples according to the normal practice in their laboratories, using their own equipment. The variation between laboratories was estimated through a random effects model. For sperm concentration and semen volume assessment a remarkable consistency between laboratories was detected, in contrast to the very considerable inter-individual variation. For sperm motility and morphology assessments interlaboratory consistency was much poorer. In conclusion, evaluation of sperm motility and morphology characteristics requires further standardization in order to achieve comparable data from different laboratories. However, semen volume and sperm concentration are characteristics which can be compared reliably between laboratories, when similar methodologies are used.

Adolescent↗
PubMed2000

ISI/INR system in Japan: experience from simultaneous measurement of the same plasma at four different laboratories.

In 1984, the Scientific and Standardization Committee (formerly ICTH) recommended the use of the International Sensitivity Index and International Normalized Ratio (ISI/INR) System for the monitoring of oral anticoagulant therapy. This system was introduced because the sensitivity of thromboplastin reagents used for the measurement of prothrombin time (PT) was widely different and comparison among hospitals employing different reagents was virtually impossible. In this study, we simultaneously measured the plasma from 7 patients with warfarin therapy at 4 different institutions for PT seconds, PT-INR, thrombotest (TT) seconds and TT-INR. The comparison between these laboratories revealed clinically important variances between the 4 laboratories even when PT was converted to PT-INR. Laboratory 1 and laboratory 3 were using the same thromboplastin reagents for the measurement of PT. The PT (seconds) in both laboratories showed similar numbers, but when they converted into INR, the variances were significant (maximum coefficient of variance 10.44). We investigated the reason why these differences occurred and found that the PT seconds (11.40) for normal control at laboratory 3 were somewhat larger than those of other laboratories. If we assume that PT-INR is identical to TT-INR, the estimated PT (second) for normal control at laboratory 3 can be calculated from TT-INR, and was found to be 10.56 +/- 0.10 seconds. This was nearly the same as the one that was used at laboratory 1. In conclusion, there still exist some difficulties that must be overcome before the ISI/INR system can be used reliably, and we suggest attention be given to the PT seconds used as normal control plasma.

Adult↗
PubMed2001

Proficiency testing for the evaluation of the ability of European Union-National Reference laboratories to determine aflatoxin M1 in milk at levels corresponding to the new European Union legislation.

In 1992, the European Union set up a network of National Reference Laboratories and charged the Community Reference Laboratory with the responsibility to design a proficiency testing scheme for assessing the analytical ability of laboratories involved in the official control of aflatoxin M1 in milk. Since 1996, two exercises of proficiency testing have been performed on samples of milk powder and liquid milk at various levels of aflatoxin M1 contents. The trials were conducted according to ISO Guide 43, in particular for the homogeneity testing of sample batches and for the calculation of laboratory z-scores. The National Reference Laboratories officially designated by their governments participated in this programme. Samples were naturally-contaminated milk obtained by feeding cows with aflatoxin B1-contaminated feed. The levels of aflatoxin M1 in the samples ranged from 0.2 to 0.7 microg/kg in milk powder and from 0.05 to 0.07 microg/l in liquid milk. These levels were chosen as being close to the European Union-regulated limit of 0.05 microg of aflatoxin M1 per litre. The results produced by laboratories were compiled and statistically analysed to detect any outlying results and to calculate the individual z-scores. Except for one laboratory in each exercise, all laboratories exhibited acceptable or questionable z-scores. The interlaboratory relative standard deviation for reproducibility (RSDR) obtained for both 1996 and 1998 exercises were in the range 15.7-30.3%. Compared with other published studies, this indicates a very good precision for the performance of this laboratory network in the analysis of traces of aflatoxin M1 in milk.

Aflatoxin M1↗