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PubMed2006

National survey on the execution of the oral glucose tolerance test (OGTT) in a representative cohort of Italian laboratories.

BACKGROUND: Recently revised diagnostic criteria for diabetes mellitus and the lack of universal agreement on the methodology for the screening and diagnosis of gestational diabetes mellitus (GDM) still generate inconsistency in execution of the oral glucose tolerance test (OGTT). The aim of the present survey was to evaluate the adherence of Italian laboratories to the internationally accepted guidelines in carrying out the OGTT for the diagnosis of diabetes in the general population and for the screening of GDM. METHODS: A questionnaire was designed to investigate the following issues related to the OGTT: 1) the relationship between laboratories and diabetes centres for the definition of standard protocols; 2) the amount of glucose administered; 3) the number and timing of blood samples; 4) the procedures used for the screening and diagnosis of GDM; and 5) reference to WHO guidelines for the interpretation of the results. The questionnaire was administered to 400 specialists in laboratory medicine working in public or private laboratories nationwide participating in the "Italian External Evaluation of Quality in Laboratory Medicine" Study Group. RESULTS: The survey was completed in the period from June to September 2003. In the observation period, 241 questionnaires were returned by specialists working in laboratories scattered throughout 15 out of the 20 Italian regions. Only 50% of the laboratories performed the OGTT according to protocols defined in agreement with local reference diabetes centres. OGTT using 75 g of glucose in adults and 1.75 g/kg for children as recommended by WHO was performed by 87.1% of the laboratories. WHO indications to collect samples at baseline and at 120 min were followed by 33.2% of the centres. Higher variability was highlighted with respect to the methodology for GDM screening: 49.8% of the laboratories always adopted the two-step procedure consisting of a glucose challenge test (GCT) and subsequent OGTT in positive cases; 4.9% performed the 100-g OGTT with four blood samples; 1.6% the 75-g OGTT with two blood samples; and 2.7% the 75-g OGTT with four blood samples. More than 30% of the centres referred to different diagnostic schemes, 62% of which used individually chosen procedures amongst those reported above, 19% used only the GCT and no subsequent OGTT in positive cases, and 18.4% used a variety of completely different, arbitrarily chosen methods. Finally, only 25.6% of the laboratories referred to the WHO limits for interpretation of the results. CONCLUSIONS: For the Italian laboratories investigated, relevant variability was highlighted for performance of the OGTT in general and GDM screening in particular. A variable relationship between laboratories and diabetes centres was also detected, which might represent a relevant indicator for the need for rationalisation or standardisation of the method for performing an OGTT. These data highlight the need for greater collaboration between these different bodies. We suggest that other similar investigations should be carried out in other countries within the framework of the IFCC Global Campaign on Diabetes Mellitus.

Blood Glucose↗
PubMed2003

Customer satisfaction in anatomic pathology. A College of American Pathologists Q-Probes study of 3065 physician surveys from 94 laboratories.

CONTEXT: Measurement of physicians' and patients' satisfaction with laboratory services has recently become a requirement of health care accreditation agencies in the United States. To our knowledge, this is the first customer satisfaction survey of anatomic pathology services to provide a standardized tool and benchmarks for subsequent measures of satisfaction. OBJECTIVE: This Q-Probes study assessed physician satisfaction with anatomic pathology laboratory services and sought to determine characteristics that correlate with a high level of physician satisfaction. DESIGN: In January 2001, each laboratory used standardized survey forms to assess physician customer satisfaction with 10 specific elements of service in anatomic pathology and an overall satisfaction rating based on a scale of rankings from a 5 for excellent to a 1 for poor. Data from up to 50 surveys returned per laboratory were compiled and analyzed by the College of American Pathologists. A general questionnaire collected information about types of services offered and each laboratory's quality assurance initiatives to determine characteristics that correlate with a high level of physician satisfaction. SETTING: Hospital-based laboratories in the United States (95.8%), as well as others from Canada and Australia. PARTICIPANTS: Ninety-four voluntary subscriber laboratories in the College of American Pathologists Q-Probes quality improvement program participated in this survey. Roughly 70% of respondents were from hospitals with occupied bedsizes of 300 or less, 65% were private nonprofit institutions, just over half were located in cities, one third were teaching hospitals, and 19% had pathology residency training programs. MAIN OUTCOME MEASURES: Overall physician satisfaction with anatomic pathology and 10 selected aspects of the laboratory service (professional interaction, diagnostic accuracy, pathologist responsiveness to problems, pathologist accessibility for frozen section, tumor board presentations, courtesy of secretarial and technical staff, communication of relevant information, teaching conferences and courses, notification of significant abnormal results, and timeliness of reporting). RESULTS: The database of 3065 physician surveys was derived from 94 laboratories. An average of 32.6 surveys (median 30) was returned per institution, with a range of 5 to 50 surveys per institution. The mean response rate was 35.6% (median 32.5%). The median (50th percentile) laboratory had an overall median satisfaction score of 4.4. The lowest satisfaction scores that were obtained all related to poor communication, which included timeliness of reporting, communication of relevant information, and notification of significant abnormal results. Statistically significant associations of customer satisfaction with certain institutional characteristics and laboratory performance improvement activities were identified. CONCLUSIONS: The importance of this satisfaction survey lies not in its requirement as an exercise for accrediting agencies but in understanding the needs of the customer (in this case the physician) to direct performance improvement in the delivery of quality anatomic pathology laboratory services.

Consumer Behavior↗
PubMed2005

Total long-term within-laboratory precision of cortisol, ferritin, thyroxine, free thyroxine, and thyroid-stimulating hormone assays based on a College of American Pathologists fresh frozen serum study: do available methods meet medical needs for precision?

CONTEXT: It is important that the total long-term precision of laboratory methods meet the medical needs of the patients being served. OBJECTIVES: To determine the long-term within- and between-laboratory variation of cortisol, ferritin, thyroxine, free thyroxine, and thyroid-stimulating hormone measurements using commonly available methods and to determine if these variations are within accepted medical needs. DESIGN: Two vials of pooled frozen serum were mailed 6 months apart to laboratories participating in 2 separate College of American Pathologists surveys. The data from those laboratories that analyzed an analyte in both surveys were used to determine for each method the total variance and the within- and between-laboratory components. SETTING: The study included the A mailing of the 2003 College of American Pathologists Ligand Survey and the C mailing of the Chemistry Survey. MAIN OUTCOME MEASURES: For each analyte, total variance was partitioned into within- and between-laboratory components for each analytic method. The within-laboratory variations were then compared with imprecision criteria based on biological variation. PARTICIPANTS: The laboratories that reported results on the same analyte using the same method in both surveys. RESULTS: For each analyte, the median of the long-term within-laboratory variances of each peer group was 78% to 95% of its total-survey variance, and the median long-term within-laboratory coefficients of variation varied from 5.1% to 7.6%. The number of methods that met within-laboratory imprecision goals based on biological criteria were 5 of 5 for cortisol; 5 of 7 for ferritin; 0 of 7 for thyroxine and free thyroxine; and 8 of 8 for thyroid-stimulating hormone. CONCLUSIONS: For all analytes tested, the total within-laboratory component of variance was the major source of variability in this study. In addition, there are several methods, especially for thyroxine and free thyroxine, that may not meet analytic goals in terms of their imprecision.

Clinical Laboratory Techniques↗
PubMed2005

Relationships among patient age, diagnosis, hospital type, and clinical laboratory utilization.

OBJECTIVE: The aging population will likely have a major impact on laboratory utilization. Utilization data will be necessary for laboratory managers to make informed decisions concerning staffing patterns and services offered. DESIGN: In a retrospective non-descriptive study, the relationships among age groups, hospital type, diagnosis, and the numbers and types of laboratory tests performed were investigated. SETTING: Half of the participants were from a private hospital, Touro Infirmary, and half were from a large public hospital, The Medical Center of Louisiana at New Orleans. Both facilities are located in New Orleans, Louisiana. PATIENTS: Laboratory records from a random sample of 250 inpatients age 21 to 64, a sample from 250 inpatients age 65 to 84, and a sample from 250 inpatients age 85 and over with at least one of five admission or discharge diagnoses were analyzed. INTERVENTIONS: Twenty-five records from each of the five diagnostic categories for each of the three age groups and two hospital types were analyzed, yielding a total sample of 750 records. MAIN OUTCOME MEASURES: Laboratory tests for each inpatient stay were counted and categorized for analysis. The one-way ANOVA was used to test the degree of concordance between age groups and numbers of tests ordered and between age groups and types of tests ordered across hospital types. RESULTS: Data analysis showed statistically significant differences in the total number of laboratory tests ordered for the three age groups regardless of facility (p 0.008). The age group with the highest number of total laboratory tests ordered was the group aged 65 to 84 (48.64 mean tests per patient). Across the total sample, more tests were ordered at the public facility than the private facility (51.75 and 32.42 mean tests per patient, respectively). Statistically significant differences in orders between the two facilities were noted in chemistry, hematology, and toxicology (p < 0.001). When analyzing numbers of tests by age group and facility, no statistically significant differences were noted in any laboratory category. Analysis of disease and laboratory test categories, regardless of facility, showed statistically significant differences in numbers of tests ordered in microbiology, cytology, histology (p < 0.001), and blood bank (p 0.001). When analyzing numbers of tests by disease category and facility, significant correlation was noted in toxicology (p 0.001). CONCLUSION: This research allowed comparisons in laboratory utilization between a private and a public hospital among different age groups. Differences were noted in both volume and type of laboratory tests ordered on patients with specific diagnoses in the two facilities. Although comorbidity was not well controlled for, the study does suggest that clinical laboratories may undergo changes in utilization as our nation's population ages.

Adult↗
PubMed1987

Laboratory performance and director qualifications.

Since 1971, federal laboratory regulations have required that directors of approved laboratories possess earned doctorates. Private accrediting agencies and some states also require doctoral directorship of accredited laboratories. No empirical studies have demonstrated that a director's earned doctorate is necessary to assure laboratory quality. Laboratories in physicians' offices (POLs) are exempt from federal regulation but receive federal reimbursement on the basis of the physicians' medical degree. No empirical studies have demonstrated that unregulated laboratories perform comparably with regulated laboratories. This investigation found no statistically discernible differences in quality when 1983 proficiency test data were used to compare statistically the performance of doctoral- and non-doctoral-directed Medicare-certified independent laboratories in California. When regulated non-doctoral-directed full-service laboratories were statistically compared with unregulated limited service POLs, regulated non-doctoral-directed laboratories consistently demonstrated superior per formance to POLs. Evidently a director's earned doctorate is neither a necessary nor a sufficient condition to assure laboratory performance. Government regulation appears to provide substantial quality assurance in the clinical laboratory field.

Accreditation↗
PubMed1995

Computer-aided clinical laboratory diagnosis in conjunction with the electronic medical textbook.

1. INTRODUCTION. Medical knowledge has been increasing and diversifying on a worldwide scale, while the specialization of physicians has been extended vigorously. Under this environment, it may be natural that mistakes are made in a comprehensive diagnosis, as the physician cannot master all of this dramatically increasing volume of knowledge. The knowledge has extended beyond the memory of human beings, thereby causing the deterioration of service; this is called the "Knowledge crisis." To tackle this problem, the Electronic Medical Textbook (EMT) has been conceived and set up as a medical knowledge base for physicians to optimize both their specialties and activities in clinical practice. Meanwhile, laboratory information systems were widely introduced. However, there are few systems which allow interpretation of the findings obtained. With this in mind, we have improved the utility of the EMT by enhancing its function with laboratory information follow-up, thesaurus back-up, Japanese language support, and online access. 2. SYSTEM DESCRIPTION. The knowledge database for medical decision-making consists of three categories: 1) Medical domain knowledge (including approximately 3500 diseases) from the AMA's "The Current Medical Information & Terminology (CMIT)"; 2) Knowledge on relationship between laboratory testing results and diseases from "The Effects of Disease on Clinical Laboratory," compiled by the AACC; and 3) Clinical testing knowledge from Otsuka's laboratory test handbook "Kensa-Kojien." These categories are connected by links in the process of cross-reference. In actual use, the first is to select the supporting system bringing up clinical signs and findings on CRT from which users can then choose any representations corresponding to the patient's clinical state. Once the relevant objects have been selected, the system presents the correlated investigative tests to be performed, along with a scope of laboratory tests ordering for its initial investigative task. The required tests against the data objects denoted by "High," "Low," or "Abnormal" are linked to possible diagnoses, which appear on CRT in order of likelihood. Similarly, the possible diagnoses can be obtained directly by consulting the patient's laboratory test results in linkage, by way of automated data transformation into the corresponding data object using the reference interval. If necessary, additional information relative to clinical signs can be added. With the repetition of this procedure, clinically useful tests can be located, thus increasing the likelihood of an appropriate diagnosis. The proposed diseases can be confirmed through cross-reference to the patient's clinical signs from the description in the Textbook on CRT. In order to bolster the efficiency of cross-checking on CRT, the sentences including hit-words are highlighted in red. Moreover, with regard to specific keywords for disease, those sentences are highlighted in green to emphasize differences in between. In parallel, the description points out an active behavior of laboratory test results in the progression of the disease and is also able to display applicable laboratory test listings. Furthermore, this knowledge-based interpretation system is directly accessible via online network services in referring to laboratory test results. 3. CONCLUSION. A combination of the CMIT and laboratory diagnostic information in the knowledge database allows the narrowing down of proposed diagnoses due to its flexible approach, which depends not only on clinical signs and findings, but also on applicable test-ordering support and suggestions. This enhances the potential usefulness of the EMT. The system contributes to the support of the diagnostic procedures and assists in educational setting, because the process can be operated in reverse based on clinical signs and laboratory findings in a dialogue style on CRT. The related disease description highlighted in color has won a good reputation dur

Artificial Intelligence↗
PubMed1997

Regulatory closure of cervical cytology laboratories: recommendations for a public health response.

The Papanicolaou test--or Pap smear test--is one of the most effective cancer screening tests available, and its ability to detect premalignant conditions has contributed to the decline in cervical cancer morbidity and mortality in the United States since its development in 1941. The success of this screening test has created confidence among women, health-care providers, and public health officials. However, this screening tool is not perfect: false-negative findings are a special concern because they can delay necessary follow-up of and treatment for women who have cervical cancer precursor lesions or invasive cervical cancer. Recent media attention has focused on cytology laboratories that have been closed as a result of deficiencies (including a high proportion of false-negative reports), and in some states legal action has been taken against individual laboratories. With the advent of revised federal regulations implementing the Clinical Laboratory Improvement Amendments (CLIA) of 1988, scrutiny of the quality of cytology laboratory practice has increased. Between 1992 and 1994, a total of 10 cytology laboratories were closed by regulatory action of the Health Care Financing Administration because they were considered a threat to the public's health. Although such closures represent <1% of CLIA-certified cytology laboratories, the attendant publicity may trigger anxiety among women. Public health officials must respond to those concerns with appropriate clinical and community actions to ensure the health and safety of women whose Pap smears were evaluated by the closed laboratories. There are no published recommendations to help develop a public health response to the regulatory closure of a cervical cytology laboratory. In April 1994, the Association of State and Territorial Public Health Laboratory Directors, through a cooperative agreement with CDC, convened a working group to provide background on the current practice of clinical cervical cytology in the United States, summarize the CLIA regulations that established specific quality assurance standards for this specialty, and recommend actions that a public health agency may initiate to deliver a measured response to laboratory closings and other regulatory sanctions. This report includes this background and summary of the workshop. The working group made three recommendations: (a) public health officials should plan for a cervical cytology laboratory closure, then, when a laboratory is closed by regulatory action, they should (b) assess the severity of the situation and determine an appropriate response and (c) provide accurate, timely information to the public.

Cell Biology↗
PubMed2002

Charting the course of medical laboratories in a changing environment.

BACKGROUND: In recent decades, dramatic changes have occurred in the organization, number and type of tests, and role of medical laboratories in healthcare. The role of laboratory professionals has undergone a radical change, which calls for greater analytical accuracy, and more stringent test selection, and interpretation of results. METHODS: The ancillary role of clinical laboratories in the past was analyzed in order to understand why the change has taken place, and to identify old and new areas in which laboratory information is largely used for improving upon decision making for treatment, and patient management. RESULTS: The availability of real-time laboratory results and more effective tests, the enhanced clinical consulting role, the involvement in therapeutic decisions, the efforts to prevent rather than cure disease, the shift from anecdotal care to evidence-based medicine, and the assessment of outcome for laboratory tests have all contributed to the changing role and duties of medical laboratories. CONCLUSIONS: Crucial elements in sustaining the changes in the role and contribution of medical laboratories to a high-quality healthcare are the ability of laboratory professionals to: guarantee the quality of laboratory tests irrespective of where they are performed; improve the quality of services; improve clinical outcomes; and perform joint clinical/laboratory research projects. A key factor in effecting the change has been the awareness of the importance of the knowledge and skills required for the new role of laboratory professionals.

Clinical Laboratory Techniques↗
PubMed1999

Laboratory medicine in Ontario: its downsizing and the consequences on quality.

Health care in Ontario consumes 35% of provincial government annual revenues. Fiscal constraint mandates restructuring of health services to maintain a fully, publicly-funded universally-accessible health system that is patient-focussed and health-outcome driven. Acute-care hospital restructuring under the authority of the Health Services Restructuring Commission and primary health-care reform characterise present government initiatives. Laboratory medicine services at about Can $1 billion annually account for about 5% of health expenditure. A Laboratory Services Restructuring Secretariat created by the Ministry of Health in 1995 has planned regionally-based integrated laboratory services systems bringing together public and private providers, designed a province-wide laboratory information system, developed a quality management program, reviewed the human resource needs for laboratory physicians, scientists and technologists, and recommended that the legislation be rewritten so as to be enabling - not controlling. Meanwhile both hospital and private laboratories have closed, leaving 296 in 1998 compared to 394 in 1991. Laboratory physician numbers at 39 per million population falls far short of the recommended target of 52 and many are within 10 years of retirement. Renewal of laboratory physicians and scientists to meet the shortfall is not occurring. The numbers of registered laboratory technologists has fallen by 6. 8% over 2 years. Consolidation and downsizing of laboratories with the formation of core laboratories has resulted in multi-discipline and cross discipline tasking of specialist technologists. Senior and middle level management technologists have been declared redundant. As a consequence, quality control practices have been hard hit. Plans to address these deficiencies through regional integration and sharing of resources remain to be implemented.

Clinical Laboratory Information Systems↗
PubMed2004

Improving the accuracy of malaria-related laboratory tests in Ghana.

BACKGROUND: Inaccurate malaria results can lead to patient mismanagement, misperceptions about malaria resistance patterns and public health misinformation. All laboratories need to be able to demonstrate that their results are accurate. Establishing and maintaining a system for monitoring test accuracy is a complex, expensive and technically demanding process, which very few poor countries have been able to implement. This study described the process and assessed the feasibility of establishing a nation-wide system for improving the accuracy of malaria-related tests in peripheral laboratories in Ghana. PROGRAMME IMPLEMENTATION: A baseline survey of all 693 laboratory staff in 205 sub-regional government and mission health laboratories in Ghana was conducted by a national network of laboratory supervisors. Survey results guided a training programme to improve test accuracy. Outcomes included changes in the quality of laboratory tests and the system was considered to be feasible if >50% of laboratory staff in each region received training and if test accuracy could be documented. PROGRAMME INDICATORS: 74% (mean) of the 693 laboratory staff were assistants with no professional qualifications. There were marked differences between regions in the availability of essential resources for malaria diagnosis (e.g. microscopes). 93% of laboratory staff received training; in six months there were increases of 11% and 7% respectively in the number of laboratories producing haemoglobin and malaria microscopy results of acceptable quality. CONCLUSIONS: It is possible to establish a system for improving and monitoring test accuracy in peripheral laboratories on a country-wide basis in a developing country using a model that could be adapted for use in other countries and for other components of health care provision.

Clinical Laboratory Techniques↗
PubMed1999

[Progress of the laboratory supporting system of the ordering system].

University hospitals and large public hospitals introduced a first-generation ordering system, which mainly involved an integrated system developed by each institution. This type of system considerably improved the efficiency of hospital jobs, but clinically increased the burden of data-input handling of hospital staffs because the software used was unique to the respective unit. Later, the development of both network technology and package software for the ordering system allowed construction of an easy, low-cost and high-performance ordering system. Most of the recent ordering systems are a type of distributed system which is referred to as a client-server system. In this system the terminal was replaced by personal computer loaded with widely distributed Windows OS, resulting in better performance of multi-tasks. In February 1998, our hospital information system was changed from an intensive host-type to a client-server system, in which the laboratory ordering system was also reconstructed. The laboratory ordering system mainly utilizes EG Main for Windows, package software by Fujitsu Co. Ltd., and has reduced the handling of laboratory ordering jobs with Graphical User Interface and better construction of screen images. In addition to extra-laboratory tests, ordering into this system allowed the database of all the laboratory tests ordered in our hospital to be unified. The previous laboratory ordering system supported laboratory data, especially those of laboratory tests and samples conducted within the last 10 years, and the new system will also provide this function. The new laboratory ordering system is further expected to support reference image-data from physiological tests as well as to allow consultation concerning laboratory test data. These clinical job-supporting systems will likely lead to further progress of the total laboratory system.

Clinical Laboratory Information Systems↗
PubMed1993

The structure and regulation of family practice residency laboratories.

BACKGROUND: Increasing regulation of physician office laboratories (POLs), increased complexity of outpatient care, and technological advances have increased the need to train family practice residents in POL management. There is little information on how residency laboratories are organized, how they are regulated, and how often quality controls and proficiency testing are done. METHODS: A questionnaire was sent to 385 ACGME-approved family practice residencies to determine the scope of testing, quality-assurance activities, and administrative structure of the residency laboratory. RESULTS: Two hundred and ninety-seven programs responded, for a response rate of 77%; 91.6% were performing routine office tests and 40.7% were performing automated testing. Of programs that performed automated tests, 71.2% were performing daily normal and abnormal quality-control specimens. Proficiency testing was only performed by 57.8% of programs. The program's parent hospital viewed the residency laboratory as a POL in 55.6% of cases and as a satellite of the hospital laboratory in 32.6%. CONCLUSIONS: Residency laboratories are more frequently organized as POLs than satellite laboratories of the parent hospitals. The POL model offers an excellent opportunity to teach residents about office laboratory management. Residency laboratories should be implementing proficiency testing for both patient safety and resident teaching. Many residency laboratories will need to increase the frequency of quality controls as the new CLIA '88 regulations are implemented. Accreditation by a private organization may be an attractive option for family practice office laboratories.

Clinical Laboratory Techniques↗
PubMed1997

Reliability of the quantitative angiographic measurements in the New Approaches to Coronary Intervention (NACI) registry: a comparison of clinical site and repeated angiographic core laboratory readings.

To assess the agreement of clinical site and angiographic core laboratory readings obtained in the New Approaches to Coronary Intervention (NACI) registry, we reviewed the angiographic results obtained in 787 lesions assessed both by the sites and the core laboratory, including 135 lesions analyzed twice (> or =2 months apart) by the angiographic core laboratory. Although moderate agreement was demonstrated between the clinical site and angiographic core laboratory for qualitative lesion morphology such as lesion calcium (kappa [kappa] = 0.42), only fair agreement was found between site and core laboratory estimation of lesion ulceration (kappa = 0.33); thrombus (kappa = 0.30); and eccentricity (kappa = 0.27); with poor agreement for angulation (kappa = 0.16); and proximal vessel tortuosity (kappa = 0.03). Agreement for qualitative morphology was better for repeated core laboratory readings of lesion eccentricity (kappa = 0.75); angulation (kappa = 0.72); thrombus (kappa = 0.68); proximal vessel tortuosity (kappa = 0.66); and calcification (kappa = 0.64). Quantitative angiographic measurements correlated moderately between the clinical site using the digital caliper method and the core laboratory using the automated edge-detection method, including preprocedural percentage diameter stenosis (intraclass correlation [R] = 0.50) and postprocedural percentage diameter stenosis (R = 0.63). Repeated core laboratory readings had almost perfect agreement, with R ranging from 0.88 for postprocedural percentage diameter stenosis to 0.93 for reference vessel diameter and pre- and postprocedural minimal lumen diameters. Repeated angiographic core laboratory readings provided highly consistent quantitative and qualitative morphologic results in the NACI registry, but the core laboratory readings varied substantially from those obtained at the clinical site. More standardized angiographic analytic criteria and core laboratory feedback to investigators may improve agreement between the clinical sites and the angiographic core laboratory in subsequent studies.

Angioplasty, Balloon, Coronary↗
PubMed1999

QUASIMEME laboratory performance study of the biological effects of tributyltin (imposex and intersex) on two marine gastropod molluscs.

The disruption of the endocrine systems of gastropod molluscs and consequential physiological changes (imposex and intersex) are used as biomarkers for environmental contamination by tributyltin compounds. The first international laboratory performance study on the determination of imposex and intersex in neogastropod molluscs, Nucella lapillus and Littorina littorea has been undertaken by the QUASIMEME (Quality Assurance of Information for Marine Environmental Monitoring in Europe) project. Samples of live gastropods were distributed and participants were asked to record shell height and sex, together with penis length and vas deferens sequence stage (VDS) in Nucella or the intersex stage (IS) and prostate length in Littorina. Calculations were made of vas deferens sequence index (VDSI) and the relative penis size index (RPSI) in Nucella and of intersex stage index (ISI) and the average female prostate length (FPrL) in Littorina. Thirteen (87%) of the 15 participating laboratories returned data. The remaining two laboratories asked to participate in later exercises. For Nucella, seven laboratories reported sex ratios significantly different from the reference laboratory data. Differences in penis length measurements between laboratories were largely random, although there were indications of systematic errors affecting the data from three laboratories. Seven laboratories reported satisfactory data (Z-score magnitude of Z < 2) for VDSI. The inclusion of a high proportion of sub-adults in the Nucella samples may have made separation of the sexes more difficult than in mature adults. The sub-adults will have had smaller pene than mature adults in the same population, and therefore any errors (random or systematic) in the measurement of penis length or observation of reproductive organs would have a potentially greater impact on the final reported values of the summary imposex indices. The Littorina sample did not show a high degree of intersex (ISI = 0.41). The laboratories could determine the sex of Littorina reliably and only one laboratory reported data significantly different from the reference laboratory. All except two laboratories reported satisfactory data for ISI.

Animals↗
PubMed2001

Types and frequency of preanalytical mistakes in the first Thai ISO 9002:1994 certified clinical laboratory, a 6 - month monitoring.

BACKGROUND: Reliability cannot be achieved in a clinical laboratory through the control of accuracy in the analytical phase of the testing process alone. Indeed a "mistake" can be defined as any defect occuring during the testing process. In the analysis of clinical specimens, there are many possible preanalytical sources of error. Therefore, the application of quality system to laboratory testing requires total quality management throughout the laboratory process, including the preanalytical and postanalytical phases. ISO 9002:1994 is a model for quality assurance in production, installation, and servicing, which includes a number of clauses providing guidance for implementation in clinical laboratories. Our laboratory at King Chulalongkorn Memorial Hospital, the largest Thai Red Cross Society hospital, is the first clinical laboratory in Thailand with ISO 9002:1994 certified for the whole unit. METHOD: In this study, we evaluated the frequency and types of preanalytical mistakes found in our laboratory, by monitoring specimens requested for laboratory analyses from both in-patient and out-patient divisions for 6 months. RESULT: Among a total of 935,896 specimens for 941,902 analyses, 1,048 findings were confirmed as preanalytical mistakes; this was a relative frequency of 0.11 % (1,048/935,896). A total of 1,240 mistakes were identified during the study period. Comparing the preanalytical mistakes to other mistakes in the laboratory process monitored in the same setting and period, the distribution of mistakes was: preanalytical 84.52 % (1,048 mistakes), analytical 4.35 % (54 mistakes), and postanalytical 11.13 % (138 mistakes). Of 1,048 preanalytical mistakes, 998 (95.2%) originated in the care units. All preanalytical mistakes, except for 12 (1.15 %) relating to the laboratory barcode reading machine, were due to human error. CONCLUSION: Most mistakes occurred before samples were analysed, either during sampling or preparation for analysis. This suggests that co-operation with clinicians and personnel outside the laboratory is still the key to improvement of laboratory quality.

Journal Article↗
PubMed2006

Teaching pediatric laboratory medicine to pathology residents.

CONTEXT: Laboratory data are essential to the medical care of fetuses, infants, children, and adolescents. However, the performance and interpretation of laboratory tests on specimens from these patients, which may constitute a significant component of the workload in general hospitals and integrated health care systems as well as specialized perinatal or pediatric centers, present unique challenges to the clinical pathologist and the laboratory. Therefore, pathology residents should receive training in pediatric laboratory medicine. OBJECTIVE: Children's Health Improvement through Laboratory Diagnostics, a group of pathologists and laboratory scientists with interest and expertise in pediatric laboratory medicine, convened a task force to develop a list of curriculum topics, key resources, and training experiences in pediatric laboratory medicine for trainees in anatomic and clinical pathology or straight clinical pathology residency programs and in pediatric pathology fellowship programs. DATA SOURCES: Based on the experiences of 11 training programs, we have compiled a comprehensive list of pediatric topics in the areas of clinical chemistry, endocrinology, hematology, urinalysis, coagulation medicine, transfusion medicine, immunology, microbiology and virology, biochemical genetics, cytogenetics and molecular diagnostics, point of care testing, and laboratory management. This report also includes recommendations for training experiences and a list of key texts and other resources in pediatric laboratory medicine. CONCLUSIONS: Clinical pathologists should be trained to meet the laboratory medicine needs of pediatric patients and to assist the clinicians caring for these patients with the selection and interpretation of laboratory studies. This review helps program directors tailor their curricula to more effectively provide this training.

Child↗
PubMed2002

Characteristics of educational software use in 106 clinical laboratories.

The University of Washington, Seattle, has developed educational software for clinical laboratories. We used a 32-question survey to study software implementation. Of 106 clinical laboratories (response rate, 60%) that purchased the software and completed the survey, 89 laboratories (84%) that reported using the software formed the basis for the study. The most common software users were laboratory personnel, followed by medical technologist or medical laboratory technician students, residents, and medical students; the mean (SD) number of personnel categories using the software per laboratory was 1.8 (0.8). The most common reasons for use were initial instruction, cross-training, and competency assessment. The most frequent setting for software use was an area where laboratory testing occurred, followed by a dedicated training location, a location chosen by the employee, a classroom, and a distance learning mode. On a scale of 1 (poor) to 5 (excellent), the average satisfaction rating as an instructional tool was 4.4 and as a competency assessment tool, 4.2. Compared with laboratories in hospitals with 400 beds or fewer, laboratories in hospitals with more than 400 beds used the software for more categories of users (P = .008), had a higher proportion of laboratories using it for residents (P = .003), and had a higher proportion of laboratories with dedicated training areas (P = .02).

Clinical Laboratory Techniques↗
PubMed2001

The effect of changes in laboratory practices on the rate of false-positive cultures for Mycobacterium tuberculosis.

CONTEXT: False-positive cultures for Mycobacterium tuberculosis have been found in nearly all DNA fingerprinting studies, but the effectiveness of interventions to reduce cross-contamination has not been evaluated. OBJECTIVE: To evaluate whether changes in laboratory policies and procedures reduced the rate of false-positive cultures. DESIGN: Retrospective study of isolates with matching DNA fingerprints. SETTING: A mycobacteriology laboratory serving an urban tuberculosis control program and public hospital system. PATIENTS: All M tuberculosis isolates processed from July 1994 to December 1999. METHODS: Isolates were fingerprinted using IS6110; pTBN12 was used to fingerprint isolates having fewer than 6 copies of IS6110. We further evaluated all patients having only one positive culture whose DNA fingerprint matched that of another isolate processed in the laboratory within 42 days. INTERVENTIONS: We changed laboratory policy to reduce the number of smear-positive specimens processed and changed laboratory procedures to minimize the risk of cross-contamination during batch processing. MAIN OUTCOME MEASURE: The rate of false-positive cultures. RESULTS: Of 13 940 specimens processed during the study period, 630 (4.5%) from 184 patients and 48 laboratory proficiency specimens grew M tuberculosis. There were no cases (0/184) of probable or definite cross-contamination, compared with the 4% rate (8/199) identified in our previous study (P =.008). We also fingerprinted a convenience sample of isolates from other laboratories in Denver; 13.6% (3/22) of these were false-positive, a rate similar to the 11.9% rate (5/42) identified for other laboratories in our previous study (P =.84). CONCLUSIONS: Laboratory cross-contamination decreased significantly after relatively simple, inexpensive changes in laboratory policies and practices. Cross-contamination continued to occur in other laboratories in Denver.

Colorado↗