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PubMed1993

Are you ready for a CLIA inspection?

Despite talk within the Clinton administration of watering down the Clinical Laboratory Improvement Amendments (CLIA) of 1988, currently CLIA is the law of the land. Federal officials say that physicians shouldn't expect any significant changes in the law until 1995 at the earliest. Already, surveyors have begun inspecting physician office laboratories across the country. This article, written by staff from ASIM's Medical Laboratory Evaluation (MLE) program, explains how to prepare your lab for inspection. The article originally appeared in "Focus On ... Physician Office Laboratories," a newsletter for MLE participants. More information on MLE is available by calling (202) 835-2746, ext. 274.

Accreditation↗
PubMed2005

[Procedure for accurate evaluation of laboratory data and its international trends].

From the work at ISO/TC212 (Clinical laboratory testing and in vitro diagnostic test systems), the international standards on medical laboratories--particular requirements for quality and competence and reference materials were issued. The accreditation of clinical laboratory was started using ISO 15189. Furthermore, on setting and usage of reference materials were constituted with compatibility global harmonization by newly organizing JCTLM (Joint Committee on Traceability in Laboratory Medicine). As the results, the work of the standardization based on reliability such as validation of reagent's kits and the measured values and uncertainty evaluation would be internationally advanced.

Accreditation↗
PubMed1998

Clinical laboratory test menu changes in the Pacific Northwest: 1994 to 1996.

Laboratory testing services are presently undergoing dynamic changes in response to a wide range of external factors. Government regulations, reimbursement, and managed care are only a few of the influences affecting the availability of testing services and on-site testing capabilities in hospital, independent, and physician office laboratories. Medical practice changes, marketplace influences, test technologies, and costs also play a role in determining where testing is being performed. To better understand the factors influencing clinical laboratory test volumes and menus and to identify on-site testing deemed essential in physician office laboratories, we gathered information from a network of clinical laboratories in the Pacific Northwest. Questionnaires were sent to 257 Laboratory Medicine Sentinel Monitoring Network participants in March 1996. In the past 2 years, changes in on-site test volumes and test menus have been primarily due to medical practice changes and marketplace influences. When laboratories had a decrease in test volumes or test menu choices, the size of the patient workload and the volumes of test orders have had the greatest impact. Laboratory regulations and managed care contracts have played a role in shifting on-site testing to outside sources; however, these factors did not appear to be primary influences. Only 5% of physician office laboratories identified tests that they believed were essential for optimal patient care but did not perform on-site.

Alaska↗
PubMed2003

[New medical education of laboratory medicine at Tohoku University].

The purpose of this paper is to give an insight into the medical education program of our division at Tohoku University. Laboratory medicine in medical education is a field of learned basic clinical tests. Students have to learn the clinical laboratory through early clinical exposure in the first grade and try clinical technology through small-group learning in the fifth grade. Finally, they learn laboratory medicine such as infection control in our or another clinical hospital. The objects of our course are to encourage and promote the highest standards of training and post-graduate education of physicians and scientists at our university.

Clinical Laboratory Techniques↗
PubMed1993

Evaluation of Questor urine screening system for bacteriuria and pyuria.

AIMS: To evaluate the Questor automated bacteriuria and pyuria screening system; to compare its performance with that of a reference method; and to assess its usefulness in a routine clinical laboratory. METHODS: The Questor urine screening system was compared with a comprehensive regimen to detect urinary tract infection, using pour-plate viable counts to determine the numbers of bacteria present in urine samples, a wide range of other cultural methods, microscopic findings and clinical information. RESULTS: The optimal performance in detecting significant growths was a sensitivity of 93%, a specificity of 74%, a positive predictive value of 43% and a negative predictive value of 98%. The list price per test is 0.17 pounds and the capital cost of the system is 39,950 pounds. Questor can test 50 samples an hour and can be operated by one member of the laboratory staff, who is not required to make interpretative judgments--for example, a medical laboratory assistant. CONCLUSIONS: The sensitivity and specificity of the Questor was better than that obtained from other screening systems using the same protocol. The system was easy to use and is a useful addition to the methods available for screening for bacteriuria.

Bacteriuria↗
PubMed2000

External quality assessment in the examination of blood films for malarial parasites within Ontario, Canada.

OBJECTIVE: To assess laboratory practice in the examination of blood films for malarial parasites. METHOD: Ontario medical laboratories, licensed by the Ministry of Health, are required to participate in external quality assessment by the Laboratory Proficiency Testing Program, which assesses performance of laboratory assays and also examines the total testing process. Educational strategies are used to improve performance. RESULTS: A 1995 survey indicated shortcomings in detection and identification of malarial parasites in blood films. Consequently, recommendations for the investigation of malarial parasites in blood were issued. In 1996 and 1997, 16 workshops were conducted. A 1997 follow-up external quality assessment survey indicated that problems persist as 27% of laboratories failed to correctly speciate Plasmodium falciparum. Good Practice Guidelines were issued in 1998. CONCLUSION: Further education and assessment are required. Laboratories lacking expertise must establish referral arrangements with more proficient laboratories.

Animals↗
PubMedDate not supplied

Cryptosporidiosis in Harare, Zimbabwe.

OBJECTIVE: To determine the prevalence of Cryptosporidium parvum in diarrhoeal patients. DESIGN: This was a laboratory-based cross sectional study on cryptosporidiosis in diarrhoeal patients. SETTING: Department of Medical Laboratory Sciences, College of Health Sciences in Harare, Zimbabwe. SUBJECTS: People of all ages with diarrhoea presenting at primary level health centres in Harare. MAIN OUTCOME MEASURES: Patient's age, laboratory results. RESULTS: Cryptosporidium parvum was the commonest enteric pathogen and was detected in 5.8% of the 500 diarrhoeal patients of all ages followed by Shigella species (3.8%) and Salmonella species (2.0%). The highest detection rate of C. parvum oocysts was observed in children less than five years old (11.2%) followed by children between six and 10 years old (6.3%) and then the 31 to 40 year age group (5.9%). CONCLUSIONS: Cryptosporidiosis affects people of all ages in Harare but is more common in children, particularly those under five years. The C. parvum oocysts should be looked for routinely in diarrhoeal stool specimens particularly those from children less than five years since C. parvum may be one of the causative agents of diarrhoea in this age group.

AIDS-Related Opportunistic Infections↗
PubMed1985

Routine laboratory testing for medical disorders in psychiatric inpatients.

We examined the clinical utility of routine admission laboratory testing for medical disorders in 250 psychiatric inpatients by using clinical criteria to classify laboratory abnormalities as true- or false-positive results. The mean number of tests per patient was 27.7. The mean percentage of true-positive results was 1.8%; the mean predictive value was 12%. When three clinically defined subgroups were examined, both measures of test performance varied in direct proportion to the pretest probability of medical disease. Eleven patients (4%) had important medical problems discovered through routine laboratory testing. A testing battery consisting of nine tests in women and 13 in men would have identified all of these patients. Our results suggest that extensive, routine testing for medical disorders in this setting is unnecessary and that more efficient and accurate testing strategies, based on clinical information, can and should be developed.

Adolescent↗
PubMed1996

Quality improvement of diagnostic microbiology through a peer-group proficiency assessment program. A 20-year experience in Ontario. The Microbiology Committee.

OBJECTIVE: To evaluate the microbiology laboratory performance in Ontario over a 20-year period of participation in a quality assessment program and to assess the impact of quality improvement strategies. DESIGN: Longitudinal review of isolation, identification, and antimicrobial susceptibility testing of bacteria from lyophilized, simulated patient samples. SETTING: Ontario medical laboratories, licensed by the Ministry of Health, have been subjected to mandatory testing by the Laboratory Proficiency Testing Program of the Ontario Medical Association since 1974. Survey reports, information bulletins, correspondence, on-site consultations, educational assistance tutorials, and teleconference education are used as quality improvement strategies. PARTICIPANTS AND INTERVENTIONS: Laboratories were subjected annually to 20 external quality assessment challenges. Performance was assessed against consensus reference values. Single survey and cumulative profiles were reviewed by a peer-group panel for acceptable or unacceptable performance. Specific interventions are used to improve collective and individual laboratory performance. RESULTS: The number of microbiology laboratories declined from 335 in 1974 to 190 in 1994. Twenty-one percent failed expected performance standards on initial review. One hundred forty-two on-site consultations and 61 educational assistance tutorials have been provided. Twenty-five laboratories were declared nonproficient. Since 1989, 50% of the laboratories have scored at or above 80% for isolation and identification, but 25% have scored at or below 50% on susceptibility testing, and 10% or fewer have scored at or above 80%. Poor susceptibility testing performance is due to inappropriate agent selection, not testing errors. CONCLUSIONS: The emphasis of the Laboratory Proficiency Testing Program is on quality improvement, not punishment. Performance has improved, but poor performers have the same characteristics as in 1974. Identification to species is common owing to the use of commercial systems. Automated susceptibility testing has increased to 45% of participants.

Bacterial Infections↗
PubMed1996

The CCL conferences revisited.

The history of the ten conferences on Computing in Clinical Laboratories (CCL) since the first one in Birmingham, UK, 1975, mirrors the developments in medical laboratory computing during nearly twenty years.

Clinical Laboratory Information Systems↗
PubMed1991

The control of medical devices in Canada. Canadian Society of Laboratory Technologists.

Medical devices should not be allowed into Canada until they have been approved by a Canadian Regulatory Agency. The approval process should be carried out expeditiously in order to ensure timely availability of medical devices to Canadians, BUT the protection of the public must always be paramount in regulatory decisions. Premarket review of devices should include: a) Testing by the manufacturer to ensure that they operate efficiently b) testing by the manufacturer to validate that they can be operated effectively by the targeted user group(s) c) review of published reports d) investigation of experience with the device in other jurisdictions, through a network of contacts with regulatory agencies in other countries e) if the agency requires it, independent testing of the device should be performed at the expense of the manufacturer Post market surveillance should include: a) adverse incident reporting by health professionals which must be confidential b) review of published reports c) ongoing review of experience with the device in other jurisdictions d) dissemination of adverse experience reports to health care professionals Availability of medical devices should be restricted to situations where they are prescribed and monitored by appropriately-trained health care professionals. The effectiveness of the existing Bureau of Medical Devices should be evaluated. Adequate resources must be provided to a Canadian Regulatory Agency to enable it to ensure that medical devices meet the public's expectations for safety and effectiveness.

Canada↗
PubMedDate not supplied

Neck and body loads--"All the data is needed".

Over the past few years, it has become apparent that multiaxis accelerations to the human head and body have become a more important problem to aviators. Fortunately, there are mechanical models and testing facilities to obtain the dynamic motions of the head and body resulting from frontal impacts as well as lateral and oblique impacts. Compact six-component balance systems, to measure the dynamic forces and moments the head applies to the neck and those applied to the lumbar spine from the upper body segments, have been developed by the Robert A. Denton Corporation, and are starting to be used extensively in manikins to measure the dynamic loads applied to these critical parts of the body. While it is important to be able to measure the absolute loadings accurately, the measurement accuracy becomes critical when evaluating the comparative effects of various head encumbrances on the loads applied to the human neck. Changes in loadings of 5 to 10 percent can be critical, and accurate measurements of the applied loads is very important if the comparative difference of the effects of applied loading are to be evaluated. Unfortunately, it is believed that the balance systems are simplistically calibrated to obtain a measure of the axial or moment loadings. This paper will discuss the design and fabrication of a test apparatus that was developed by Systems Research Laboratories, Inc. (SRL), under the sponsorship of the Air Force Harry G. Armstrong Aerospace Medical Laboratory at Wright-Patterson Air Force Base to conduct a complete calibration of the different manikin load cells. A 6 x 6 calibration matrix that properly relates the forces and moments about and along three orthogonal axes is obtained through the use of this apparatus. The technique that was developed to calibrate the manikin load cells was based on utilizing the procedures that are commonly used to calibrate the complete interaction associated with six-component wind tunnel balance systems. The value of the calibration fixture and procedure developed will be demonstrated by comparing results obtained by this technique with those obtained using the simplistic procedure most widely used at the present time during manikin testing as well as those obtained using the manufacturer's 6 x 6 calibration matrix. The results presented will demonstrate the difference in the measurements obtained by use of the different calibration procedures and the need to utilize the complete calibration matrix, if accurate multiaxis loading information is to be recorded.

Acceleration↗
PubMed2003

[Laboratory accreditation and proficiency testing].

ISO/TC 212 covering clinical laboratory testing and in vitro diagnostic test systems will issue the international standard for medical laboratory quality and competence requirements, ISO 15189. This standard is based on the ISO/IEC 17025, general requirements for competence of testing and calibration laboratories and ISO 9001, quality management systems-requirements. Clinical laboratory services are essential to patient care and therefore should be available to meet the needs of all patients and clinical personnel responsible for human health care. If a laboratory seeks accreditation, it should select an accreditation body that operates according to this international standard and in a manner which takes into account the particular requirements of clinical laboratories. Proficiency testing should be available to evaluate the calibration laboratories and reference measurement laboratories in clinical medicine. Reference measurement procedures should be of precise and the analytical principle of measurement applied should ensure reliability. We should be prepared to establish a quality management system and proficiency testing in clinical laboratories.

Accreditation↗
PubMedDate not supplied

The Lebanese External Quality Assessment Scheme for laboratories: was it worth establishing?

The Lebanese External Quality Assessment Scheme (LEQAS) was established in 2000 with the aim of helping medical laboratories to improve the quality and comparability of their results. Participation in the scheme for hospital and private laboratories, from all over the country, was voluntary. Between the years 2000 and 2003, the participants took part in three series of surveys and were asked to analyze between 10 and 23 clinical chemistry analytes. Their results, revealed in the present study, were assessed using the Variance Index scoring system. At the start of the programme, the overall performance of the participants was unsatisfactory. But as the scheme progressed, and its educational aspects were also emphasized, interest in the scheme increased and overall as well as individual performance were significantly enhanced. The findings of this study, and particularly the improvement in laboratory performance observed during the study period, highlight the importance of establishing the Lebanese External Quality Assessment Scheme, and justify further efforts to expand and strengthen this scheme.

Chemistry, Clinical↗