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PubMed1996

Quality assurance in occupational and environmental laboratory medicine.

In a medical laboratory service, quality assurance (QA) concerns all those actions necessary to provide confidence that the results of laboratory tests will satisfy defined standards for quality. Taking into account the type of testing concerned and the techniques involved, quality assurance will encompass all steps taken to ensure that laboratory results are reliable. It covers the use of scientifically and technically sound practices for laboratory investigations, including selection, collection, transport, identification, storage, preparation and manipulation of specimens and recording, reporting and interpretation of the results. QA refers also to other activities designed to improve the reliability of investigations such as staff training and management, evaluation of the adequacy of the laboratory environment, maintenance and calibration of instruments and the use of technically validated and properly documented methods. All these activities should be described in a quality manual. This document is a prerequisite to obtain certification of the quality system or laboratory accreditation, according to the International Standard ISO 29000 series or the European Standard EN 45001, respectively.

Accreditation↗
PubMed1997

New tools for laboratory design and management.

The clinical laboratory is changing from a place of activity based on sample analysis to an in vitro diagnostic network. To convince our team, partners, and administrators, we need new comprehensive tools to define a strategy with limited risk of failure or conflicts. Specific quality goals should be established before choosing automated tools for sample handling, analytical systems, laboratory information systems, communication systems, or advanced technologies. A system approach maps and simplifies the process, based more on a functional study than on classical disciplines. A customer-supplier approach establishes the requirements between partners either inside or outside the laboratory. The quality system must be a management tool, linking samples, tasks, information, and documents. Quantitative simulation modeling explores different automation alternatives and their impact on laboratory workflow. Finally, integration of results in interactive semirealistic simulation tools for laboratory design or reengineering can be used as communications tools to involve laboratory professionals in the change of their practice.

Chemistry, Clinical↗
PubMed1976

A computerized data management system for the clinical laboratory.

This report describes the computerized clinical laboratory data management system developed at the University of Alabama Hospitals Clinical Laboratory. The system uses the computer's data management capabilities to assist the laboratory in handling patient and laboratory data associated with the total processing of laboratory requisitions from their receipt to the production of a patient's cumulative test results. It supports all sections of the laboratory including the blood bank. It primary objectives are to reduce the clereical workload, reduce errors, decrease turn-around-time, and produce a patient's cumulative summary test results.

Blood Banks↗
PubMed1997

[Analysis of the microbiological information derived from the sentinel laboratory network for the monitoring of the human immunodeficiency virus infection in Catalonia (1989-1995)].

BACKGROUND: The epidemiologic information on AIDS derived exclusively from the AIDS case registry presents a series of limitations. To solve some of these epidemiologic surveillance systems of HIV infection have been designed. The information of the microbiology laboratories in which anti-HIV antibody detection tests are performed has been one of the most commonly used sources of information. MATERIAL AND METHOD: The detection activity of the anti-HIV antibodies from a surveillance laboratory network in Catalonia from 1989 to 1995 was collected. RESULTS: A continuous increase was observed in the number of tests performed in the network laboratories (30012 in 1989 up to 63323 in 1995) as was a significant decrease in the number of tests which were reactive (20.7% in 1989 to 6.1% in 1995). Great variability was found in the results among the different laboratories as well as in the diagnostic algorythms used. CONCLUSIONS: Laboratories are an important source to take into account to perform epidemiologic surveillance of HIV infection. The collaboration among the laboratories and public health care officials allows information to be obtained that aids in better defining the characteristics of people who currently have HIV infection and in designing preventive activities directed at the needs of each community. This collaboration also allows homogeneous diagnostic algorythmns and common criteria to be established to ensure quality control.

Acquired Immunodeficiency Syndrome↗
PubMed1998

Quality control practices for calcium, cholesterol, digoxin, and hemoglobin: a College of American Pathologists Q-probes study in 505 hospital laboratories.

OBJECTIVE: To assess quality control (QC) practices and their impact on hospital laboratories using the College of American Pathologists (CAP) Q-Probes process. DESIGN: Self-directed data gathering, using a questionnaire to determine QC practices, data input forms for 6 months retrospective quality control use and run failure rates, and input forms for 3 months prospective data concerning QC failure rates and corrective steps taken. Participants submitted data for four analytes: calcium, cholesterol, digoxin, and hemoglobin. PARTICIPANTS: Laboratories enrolled in the 1994 CAP Q-Probes program. MAIN OUTCOME MEASURES: Retrospective and prospective QC failure rates compared with QC protocols and the corrective steps. RESULTS: Five hundred five hospital laboratories returned various components of the study. Median retrospective run rejection rates per 1000 runs: calcium, 4.3; cholesterol, 3.6; digoxin, 4.3; and hemoglobin, 2.4. Corresponding median prospective run rejection rates per 1000 runs: calcium, 5.8; cholesterol, 5.6; digoxin, 6.5; and hemoglobin, 3.6. Participants resolved most out-of-control events in less than 20 minutes, with no patient samples repeated. More than 95% of the time, participants resolved out-of-control events simply by repeating controls. Most participants used a single control rule based on a target mean plus or minus a multiple of the standard deviation. A few laboratories used multirule systems. CONCLUSIONS: Current testing methods yield few out-of-control events, which usually are resolved rapidly, with little impact on laboratory operation. We recommend modification and simplification of laboratory QC practices to decrease false rejection rates and to use modern instrumentation more efficiently.

Calcium↗
PubMed1998

Meta-analyses of studies of the diagnostic accuracy of laboratory tests: a review of the concepts and methods.

OBJECTIVE: To provide practicing pathologists and other laboratory professionals with the necessary background for reading and evaluating published reports of meta-analyses of studies of the diagnostic accuracy of laboratory tests. STUDY SELECTION: English language literature, 1980 to present, pertaining to the rationale, objectives, and interpretation of meta-analyses of randomized controlled trials, and meta-analyses of studies of the diagnostic accuracy of laboratory tests. CONCLUSIONS: Meta-analysis has several applications in the investigation of the diagnostic accuracy of laboratory tests. It can improve the quality of future primary studies by drawing attention to the methodologic deficiencies of existing reports; it can identify reasons for the variation in the results of those reports; and it can generate valid summary estimates of the diagnostic accuracy of laboratory tests based on all completed investigations, providing that the available primary studies are of high scientific validity. Several statistical techniques for integrating data from reports on diagnostic test accuracy have either been developed or are under development, but meta-analysis is often limited by the poor quality of the primary studies and the effect of publication bias. Meta-analysis can evolve into a reliable tool for assessing the accuracy of laboratory tests if both investigators and editors strive to improve the quality of the primary studies and to reduce the extent of publication bias in this area of the literature.

Clinical Laboratory Techniques↗
PubMed1998

Surveillance of influenza in Wales: interpreting sentinel general practice rates using contemporaneous laboratory data. Opportunities and limitations.

OBJECTIVES: To evaluate the opportunities and limitations of using laboratory data to enhance sentinel general practice surveillance of influenza. DESIGN: Descriptive study of active sentinel surveillance of clinically diagnosed influenza in general practice and passive total population surveillance of laboratory reports of influenza A, influenza B, Mycoplasma pneumoniae, and respiratory syncitial virus infections. SETTING: Wales. SUBJECTS: Total sentinel practices population (currently 228,130); population of Wales (2,913,000, 1994 mid-year estimate). MAIN OUTCOME MEASURES: Simplicity, flexibility, acceptability, sensitivity, predictive value positive, representativeness, and timeliness of a surveillance system. Rate of influenza and other respiratory infections. RESULTS: Sentinel general practice surveillance of influenza in Wales is simple, flexible, acceptable, timely, representative, and relatively sensitive. Current laboratory surveillance is complex and less timely than sentinel practice surveillance but is complete and has a relatively high positive predictive value. For the period January 1993 to September 1996, peaks in rates of influenza reported by sentinel practices during winters 1993/94 and 1995/96 were temporally associated with increased rates of laboratory confirmed influenza A and respiratory syncitial virus, whereas the peak in 1994/95 was associated with increased rates of laboratory confirmed influenza B, M pneumoniae, and respiratory syncitial virus. CONCLUSIONS: Timely laboratory data can add value to influenza data already obtained from sentinel general practice surveillance. However continuous audit is essential to resolve the possible limitations of either surveillance system.

Evaluation Studies as Topic↗
PubMed2005

A survey of the UK maxillofacial laboratory service: profiles of staff and work.

We sent questionnaires to 98 maxillofacial laboratories in the United Kingdom and asked about the composition of their staff, the kind of work that they do, and their activities in relation to the treatment of disfigured patients who require facial and body prostheses. We received 59 replies about 193 laboratory staff, most of whom had 10 or more years experience and held basic and advanced qualifications in dental technology. Most laboratories did all sorts of work including maxillofacial, orthodontic, dental prosthetic and crown and bridge work. Only five confined themselves to maxillofacial work. One hundred and eighteen staff (61%) had contact with 4,259 disfigured patients who required prostheses. Fifty-three laboratory managers (89%) thought that maxillofacial prosthetists and technologists gave psychological support to these patients, but only 12 laboratories (21%) had staff with formal training in counselling.

Counseling↗
PubMed2005

Lack of compliance by UK andrology laboratories with World Health Organization recommendations for sperm morphology assessment.

BACKGROUND: Sperm morphology is known to correlate with the probability of conception both in vitro and in vivo, but the assessment of sperm morphology in the laboratory remains problematic. The 4th edition (1999) of the World Health Organization (WHO) Laboratory Manual has attempted to improve matters by giving rigorous recommendations regarding sperm morphology assessment. However, it is unknown how well these recommendations have been implemented in practice. METHODS: A survey of the methods used to undertake the assessment of sperm morphology during semen analysis was undertaken in 37 laboratories in the UK. RESULTS: In total, only two laboratories (5%) were compliant with all current WHO guidelines regarding morphology assessment, including methods of staining and observation, classifying and sampling methods, and the participation in internal and external quality control programmes. CONCLUSION: These results illustrate an urgent need for education and training initiatives to encourage laboratories to become compliant with current WHO guidelines for sperm morphology assessment.

Andrology↗
PubMed2004

Competency assessment in the clinical microbiology laboratory.

The laboratory comprises an invaluable part of the total health care provided to patients. Competency assessment is one method by which we can verify that our employees are competent to perform laboratory testing and report accurate and timely results. To derive the greatest benefit from the inclusion of competency assessment in the laboratory, we must be sure that we are addressing areas where our efforts can be best utilized to optimize patient care. To be competent, an employee must know how to perform a test, must have the ability to perform the test, must be able to perform the test properly without supervision, and know when there is a problem with the test that must be solved. In some cases, competency assessment protocols may demonstrate areas of competence but can fail to disclose incompetence. For example, challenges of low-complexity tasks (such as reading the technical procedure manual) are inferior to challenges that measure understanding and execution of a protocol, and poorly designed competency challenges will probably not detect substandard laboratory performance. Thus, if we are to receive the greatest benefit from our competency assessment programs, which may be time-consuming for the supervisors and the staff as well, we must not only meet the letter of the law but also find a way to make these assessments meaningful, instructive, and able to detect areas of concern. As we address competency assessment in our laboratories, we must understand that when done properly, competency assessment will reward our organizations and assist us in providing the best possible care to our patients.

Clinical Laboratory Techniques↗
PubMed2003

Obtaining a clinical laboratory science degree via distance technology.

OBJECTIVE: To identify institutions and program officials associated with clinical laboratory science (CLS) academic programs available via distance technology; to collect and summarize data from these programs with regard to on-line instructional methodologies; to determine the level of success of educational strategies and methodologies utilized in on-line CLS programs; to determine the feasibility of developing an on-line program at Seward County Community College (SCCC), Liberal, Kansas. DESIGN: An on-line CLS program survey tool was sent to eight higher education institutions which had previously indicated that they offer a CLS academic program at the associate, bachelor, or master level via distance technology. Program officials were asked to answer questions pertaining to areas such as program format, on-line admission requirements, program costs, student costs, faculty workload, and on-campus versus on-line student performance. SETTING AND PARTICIPANTS: The survey was sent to eight program officials who identified their institutions as having a CLS program available through distance technology. MAIN OUTCOME MEASURES: Responses from current distance technology CLS program officials were collected and tallied. Responses were recorded as 'yes' or 'no' in categories such as program format, program and student costs, and comparison of on-campus versus on-line student performance. The two groups of students were compared in areas of success rate, retention rate, graduation rate, external certification pass rate, employment placement rate, and employer satisfaction level. RESULTS: The response rate for the survey was 87.5% (7/8). Program officials indicated that various educational methodologies were incorporated in providing CLS education via distance technology. All of the respondents utilize some type of Web-enhanced, Internet based access to deliver course material. Clinical laboratory procedures are taught via instruction within a cooperative laboratory, program clinical affiliate laboratory, or during on-campus student laboratories. Program officials indicated that student enrollment has increased due to the availability of the distance technology. Students enrolled via distance technology perform as well or better than the on-campus students on certification exams and in the clinical setting. Data from these institutions indicate that it is feasible to develop an on-line program at SCCC in an effort to increase student enrollment. CONCLUSION: The results indicate that CLS programs which offer the curriculum via distance technology have experienced increased student enrollment thus graduating more students to fill the employment needs. These current distance technology programs are leading the future trends in CLS education of the 21st century.

Clinical Laboratory Techniques↗
PubMed2004

Role of tuberculosis laboratories in Saudi Arabia. A call to implement standardized procedures.

There is no doubt that the laboratory is the backbone for the diagnosis of tuberculosis (TB). Only through testing in the laboratory can the physician confirm suspicion of TB despite any previous clinical and x-ray findings. Recent visits to several laboratories in the Kingdom of Saudi Arabia showed that some need considerable improvement. Unless there are standardized procedures to diagnose TB, and safety measures are implemented in all laboratories, it will be impossible to diagnose accurately and control TB. The laboratories should be redesigned to conform to international TB Diagnostic Centers, with well trained staff and proper safety procedures.

Bacteriological Techniques↗
PubMed2005

A national survey of laboratory animal workers concerning occupational risks for zoonotic diseases.

In this cross-sectional survey of laboratory animal workers in the United States, 23 of 1367 persons reported 28 cases of infection with zoonotic agents from research animals at their workplace during the past 5 years, with six persons indicating that their infections were medically confirmed. Based on these data, the annualized incidence rate for work-related transmission of zoonotic agents from laboratory animals was 45 cases per 10,000 worker-years at risk (95% confidence interval, 30 to 65 cases), approximating the rate for nonfatal occupational illnesses in the agricultural production-livestock industry and for those employed in the health services during 2002. Logistic regression analysis found various characteristics of persons and their employers that were significantly associated with the likelihood of having been medically evaluated for exposure to a zoonotic agent from laboratory animals. Most (95.595% +/- 1.1%) persons working with laboratory animals or their tissues indicated that they knew whom to talk to at their institution for medical evaluation and care should they be concerned about the possibility of an occupationally acquired zoonotic disease in future. However, occupational illnesses and exposures among laboratory animal workers was underreported, as 10 of the 28 (36%) alleged zoonotic disease cases were not communicated to the employee's supervisor. Lack of concern about the potential significance to their health and the perception of punitive consequences to the employee were some of the reasons cited for underreporting, an issue which must be vigorously addressed in the interests of continuing progress toward zoonotic disease prevention in this field.

Animals↗
PubMed1987

Changing technologies in the reference laboratory.

Changes in technology will have a profound impact on specialized reference laboratories. In their research and development efforts, reference laboratories will have to pursue the incorporation of the technologies of molecular and cell biology into clinical practice. Computers can be applied to the management of clinical laboratory data bases and to the organization of scientific and clinical knowledge for medical consultation. Because of the distance between the site of acquisition of referred specimens and the laboratory, research on analyte stability is needed. Computer networking will help to solve problems of inadequacy of clinical information, and bar code technology will address the problems of specimen identification. Finally, improved telecommunication will permit reference laboratories of the future to be true medical consultation centers rather than just technical analysis operations.

Clinical Laboratory Information Systems↗
PubMed1996

Value of laboratory investigations in clinical suspicion of cytomegalovirus-induced upper gastrointestinal tract ulcerations in HIV-infected patients.

To assess the value of laboratory investigations for the diagnosis and treatment of cytomegalovirus-induced upper gastrointestinal tract ulcerations, the medical records and biopsy material from HIV-infected patients were reviewed retrospectively during a 12-month period. Clinical diagnosis of cytomegalovirus (CMV) ulceration, based on characteristic endoscopic appearance of extensive ulceration of the mid- to distal esophageal or gastric mucosa and responsiveness to anti-CMV therapy, was compared with laboratory investigations of biopsies. Laboratory procedures consisted of both histopathological examination of the biopsy specimens and viral culture. Twenty episodes in 12 HIV-infected patients could be evaluated. Clinical diagnosis of CMV ulceration appeared to be justified in 14 of 20 episodes (70%), which were confirmed by laboratory investigations. Of the remaining six episodes, which showed partial or no response to anti-CMV therapy, laboratory investigations were negative in two episodes and discrepant in four episodes (histopathology or viral culture positive). A good response to anti-CMV therapy was more frequent in patients whose biopsies proved positive by histopathological examination and/or viral culture than in patients with negative tests (82% versus 0%), which indicates the importance of both investigations. In conclusion, laboratory diagnosis of CMV-induced upper gastrointestinal tract ulcerations supported the diagnosis and decisions on treatment of CMV-induced upper gastrointestinal tract ulcerations.

Cytomegalovirus↗
PubMed2005

Virtual laboratory manual for microscopic anatomy.

Using digital technology, we have assembled a virtual laboratory manual (VLM) that is a Web-based copy of our traditional laboratory manual. The VLM is used to enhance traditional laboratory instruction in histology. For each reference in the VLM to either a histological slide or an electron micrograph (EM), hyperlinks are included that download digital images derived from the students' glass slide sets or scanned EMs. The VLM serves as an atlas of digital images for concurrent study of similar sections by light microscopy during laboratory sessions. In addition, students can review the images from the VLM at remote locations. We have encouraged continued use of light microscopes in laboratories by basing the majority of practical examination identifications on analysis of marked histological slides that require students to use their own microscopes. The VLM provides the convenience of a Web-based resource with high-quality images, yet allows retention of the many excellent traditional aspects of our course. An example of a VLM laboratory on epithelium is available online (http://users.von.uc.edu/michaeje/VLM-Epithelium/exLab4.pdf).

Computer-Assisted Instruction↗
PubMed1999

Digital assessment of the epicardial electrocardiogram: novel methodology for a core laboratory for clinical studies.

BACKGROUND: The epicardial electrocardiogram (ECG) is a sensitive marker for cardiac ischemia and has been used as a measure of ischemia in clinical trials. We sought to examine the utility of a central ECG laboratory for determining ischemic-type ST-segment shifts from epicardial ECG recordings obtained from multiple clinical sites. HYPOTHESIS: We speculated that an operator-assisted digital ECG core laboratory is feasible, reliable, and efficient, with the ability for rapid and accurate interpretation of the epicardial ECG. METHODS: The epicardial ECG was recorded via an angioplasty guidewire placed in a coronary artery of a patient undergoing angioplasty. Site investigators visually determined the time-to-onset of 0.1 and 0.3 mm ST-segment elevation, and the maximal ST-segment elevation during balloon inflation, and then compared the measurements with those made at an operator-assisted digital ECG core laboratory. RESULTS: Agreement between the two methods occurred in 78% of the time-to-onset measurements, but in only 39% of the maximal ST-segment measurements. Overall, the visual measurements of the clinical investigators of time-to-onset differed from the digital core laboratory by 11.8 +/- 11.6 s for 0.1 mV, and 15.8 +/- 20.6 s for 0.3 mV. Recorded maximal ST-segment shifts differed by a mean of 0.47 +/- 0.69 mV. CONCLUSION: The magnitude of inconsistency between the ECG core laboratory results using an operator-assisted digital method and the interpretations of clinical investigators using manual caliper-type analysis was surprisingly large. These results support the need for an ECG core laboratory in clinical trials where ECG ST-segment shifts are used as a response variable.

Adult↗
PubMed2001

Chronic myelogenous leukemia: laboratory diagnosis and monitoring.

Rapid developments have occurred both in laboratory medicine and in therapeutic interventions for the management of patients with chronic myelogenous leukemia (CML). With a wide array of laboratory tests available, selecting the appropriate test for a specific diagnostic or therapeutic setting has become increasingly difficult. In this review, we first discuss, from the point of view of laboratory medicine, the advantages and disadvantages of several commonly used laboratory assays, including cytogenetics, fluorescence in situ hybridization (FISH), and qualitative and quantitative reverse transcriptase-polymerase chain reaction (RT-PCR). We then discuss, from the point of view of clinical care, the test(s) of choice for the most common clinical scenarios, including diagnosis and monitoring of the therapeutic response and minimal residual disease in patients treated with different therapies. The purpose of this review is to help clinicians and laboratory physicians select appropriate tests for the diagnosis and monitoring of CML, with the ultimate goal of improving the cost-effective usage of clinical laboratories and improving patient care.

Cytogenetic Analysis↗