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PubMed2003

[Undergraduate teaching project on clinical laboratory medicine].

Undergraduate teaching in clinical laboratory medicine is at the center of contemporary medical education. Students are expected to learn advanced laboratory medicine and basic diagnostic skills such as blood sampling, peripheral blood cell counting, blood typing, cross match test, urinalysis, electrocardiography, and bacteriological examinations through their training program. In our department, we have compulsory lectures, a basic practical training course and an advanced training course for the medical students. The compulsory lectures are programmed for the students in the fourth grade to obtain basic knowledge of clinical laboratory medicine and the patho-physiology of diseases. The teaching staff makes every effort to make their lectures exciting and interesting. As we experienced as medical students in the past, boring lectures give students nothing but a nap. For every senior teaching staff in our school, it is obligatory to be evaluated on their lectures by the students and other teaching staff every year to improve their teaching skills and materials. Teaching materials utilizing personal computers and the Internet are becoming more and more important. The basic practical training course is for the students in the fifth grade. The laboratory technicians help us teach students basic diagnostic skills in this program. The students in the advanced training course have to attend morning conferences in the department, including reverse clinico-pathological conferences and laboratory investigations. The reversed clinico-pathological conferences are popular among the students. Through our training programs, we hope that the students raise many questions that they solve themselves in the future, as well as learning established clinical laboratory medicine.

Clinical Laboratory Techniques↗
PubMed2003

[Our practical training program in laboratory medicine for medical students--Yamagata University].

At the Department of Laboratory Medicine at Yamagata University, our medical students are trained to have practical knowledge and the ability to plan laboratory examinations for the clinical diagnosis of patients. For 4th-year medical students, 31 clinical lectures are scheduled on a variety of subjects concerning laboratory findings. The 2-week practical training of 5th-year students includes an educational curriculum that allows them to master the various aspects of laboratory examinations, such as collecting blood samples, determining flow-volume curves, and conducting abdominal echograms. Finally, 6th-year medical students undergo a 5-week training period during which they learn the essentials of laboratory examinations. We are proud of our present clinical curriculum for medical students. However, within a couple of years, the clinical educational program for medical students will be changed for the purpose of better preparing medical doctors in Japan. The advisory organ of the Japanese Ministry of Health, Labor, and Welfare has recommended the induction of a newly developed model core curriculum that will be nationally standardized and will focus on problem-based learning for medical students. Therefore, the present educational system, even in the field of laboratory medicine, will have to be changed.

Clinical Laboratory Techniques↗
PubMed2004

[Accreditation of clinical laboratories based on ISO standards].

International Organization for Standardization (ISO) have published two international standards (IS) to be used for accreditation of clinical laboratories; ISO/IEC 17025:1999 and ISO 15189:2003. Any laboratory accreditation body must satisfy the requirements stated in ISO/IEC Guide 58. In order to maintain the quality of the laboratory accreditation bodies worldwide, the International Laboratory Accreditation Cooperation (ILAC) has established the mutual recognition arrangement (MRA). In Japan, the International Accreditation Japan (IAJapan) and the Japan Accreditation Board for Conformity Assessment (JAB) are the members of the ILAC/MRA group. In 2003, the Japanese Committee for Clinical Laboratory Standards (JCCLS) and the JAB have established the Development Committee of Clinical Laboratory Accreditation Program (CLAP), in order to establish the CLAP, probably starting in 2005.

Accreditation↗
PubMed2003

Development of a newborn screening laboratory quality assurance system in Shandong, China.

Shandong is a large province in northeastern China with a population of over 80 million. There are over 800,000 births annually with newborn screening testing currently being performed in 15 laboratories in city maternity and child health care hospitals. Since 1996, the number of newborns screened has steadily increased until the number screened annually now exceeds 600,000 (over 70%). During the period from 1996--2000, there were 97 cases of classical PKU confirmed and 399 cases of congenital hypothyroidism giving incidences of 1:11,644 and 1:2,831 respectively. The large number of newborns screened and the relatively large number of screening laboratories presents a quality control challenge since ideally each newborn should receive identical newborn screening services and the laboratories should be of equal abilities. With assistance from the US Centers for Disease Control (CDC), a provincial laboratory quality control program has been established and provides oversight for a newborn screening system from blood collection through treatment of patients. The goal is to ensure that patients with the disorders of interest can be identified from within the normal newborn population with an acceptable minimum number of false positives while attempting to eliminate false negatives. External proficiency testing materials are provided quarterly by the CDC, repackaged by the Center for Newborn Screening Quality Control of Shandong (CNQCS), and distributed to the testing laboratories. Analytical results are reported within a specified period of time and then compared to CDC reported results. Laboratories unable to analyze the samples correctly are provided technical assistance. Additionally, the CNQCS oversees and provides educational assistance in training phlebotomists and other health workers associated with newborn screening. Brochures, posters, videotapes and parent support groups are also developed as a function of the CNQCS. Ultimately, control materials will be prepared for distribution with linkages to CDC for international comparability.

Centers for Disease Control and Prevention, U.S.↗
PubMed2005

[The role of regional research laboratories of the local government in administering regional EQA programs].

In 1981, the Japanese Ministry of Health and Welfare revised the enforcement of regulations of the Medical Technologists' Act. The amendments stipulate that all independent laboratories are legally obliged to introduce laboratory quality assurance programs and are responsible for the quality of all test results. To ensure adherence to these regulations, regional research laboratories of local governments such as the Tokyo Metropolitan Research Laboratory of Public Health should conduct regional external quality assessment (EQA) programs. We did a survey, in the form of a questionnaire, of the regional research laboratories of public health across the country. We found that commitment to the regional EQA in almost all of these public laboratories is insufficient. The main problem is that restructuring of local governments has resulted in lower budgets and so they are short of human resources. Nationwide EQA programs are only able to detect gross errors and use invalid methods for evaluating routine performance. We conclude that the regional EQA should be further developed.

Japan↗
PubMed2005

The preanalytical phase--can the requirements of the DIN-EN-ISO 15189 be met practically for all laboratories? A view of the "German situation".

This article describes practical problems in carrying out witness audits in terms of the international normal ISO 15189, with special regard to the situation in medical diagnostic laboratories in Germany. The presence of central laboratories--for example in hospitals--and decentralised laboratories--usually in the private sector--present different problems, especially in terms of the preanalytical phase and its control during witness audits for laboratories accredited according to ISO 15189. Whereas the preanalytical phase can be--at least in theory--controlled completely in and by a centralised hospital laboratory, for example by the use of "sample-collection teams", the problems in preparation and transporting of samples from a peripheral practice to a decentralised analytical laboratory cannot be fully controlled. Other aspects of the preanalytical phase including biological variability, wrong specimen additives, wrong patient preparation and the ADR 2005 / UN Packaging regulations are briefly discussed together with the aims of an optimised pre-analytical phase. The paragraphs of the normal ISO 15189 which cannot be fully controlled during a witness audit are listed, together with compromise solutions.

Accreditation↗
PubMed2005

[Biosafety of microbiological laboratories in Korea].

OBJECTIVES: The biosafety level (BSL) practiced in microbiology laboratories in Korea according to the laboratory biosafety manual published by the World Health Organization (WHO) was evaluated using the data obtained by a survey. METHODS: Under the advise of Clinical Laboratory Physicians, 144 types of microorganisms were screened based on the guidelines of biosafety in microbiological and biomedical laboratories published by the US Center for Disease Control and Prevention and classified into 1-4 risk groups. A questionnaire containing 21 questions in 5 areas was developed using the biosafety manual by published WHO. Of the 1,876 different organizations sent the survey, 563 responded to the survey (response rate: 30.0%). The species of microoganisms handled by as well as the biosafety level in microbiology laboratories were analyzed. RESULTS: There were 123 species of microorganisms handled in microbiology labs in Korea. The BSL required in 512 microbiology labs was answered by the survey responders as the first grade in 33 labs (6.4%), 2nd in 437 (85.4%), 3rd in 42 (8.2%), and 4th in none. The average number of items satisfied was 12.2, showing only a 57.9% satisfactory rate and normal distribution. CONCLUSIONS: The state of overall observance of BSL in most microbiology labs of Korea was evaluated as lagging compared with the standard set up by WHO. Therefore, the Korean government need to produce and distribute a biosafety manual in microbiology laboratories and make efforts to prevent this threat through measures such as training in biosafety in microbiology labs.

Guideline Adherence↗
PubMed2005

[From the perspective of a clinical laboratory physician].

In Japan, self-monitoring of specific physical conditions is needed, and clinical laboratory testings have been increasingly performed outside of the hospital without the control and/or the supervision of medical doctors. Various items have been measured, which include not only body fat but biochemical markers, cellular analyses for malignancies, sexually transmitted bacterium and so on. Qualitative urinalyses for glucose and protein and for pregnancy, the reagents for which are purchased from pharmacy stores, have been estimated by the examinees themselves. Specimens for most other items described above are collected by examinees themselves, transported via mail or other media and measured in the commercial clinical laboratories. Quality assurance of sampling, transportation and measurement is essential. Therefore, a check-system not only by the owner or manager of the laboratories but also by the non-laboratory staff specialist is needed. Appropriate and exact informations regarding the results must be given to the examinees in consideration of their responsibility concerning the total processes, from preanalytical and analytical to postanalytical processes, of the measurement. Laboratory physicians and technologists should pay more attention to laboratory tests being performed by examinees and outpatients themselves, and participate more in improving and evaluating the usefulness of these tests.

Clinical Laboratory Techniques↗
PubMed1990

Use of computers in quality assurance of laboratory testing.

Implementation of comprehensive internal quality control programmes and participation in external quality assessment schemes to monitor analytical performance of laboratory tests have been widely accepted as an essential and integral part of good laboratory practice. As these programmes involve a great deal of repetitive statistical calculations and graphic presentation of data on quality control materials, many laboratories and practically all organisers of inter-laboratory quality assessment schemes increasingly rely on computers to handle the burdensome processing of data and to provide timely feedback in a manner that is easily understood and readily interpreted by analytical staff. However, in spite of the best effort to ensure reliable analytical performance, spurious and misleading results can still occur as a result of non-analytical errors which are not readily detected by methods designed to monitor the quality of analytical process. The use of sophisticated computer system has enabled our laboratory to check for the existence of some of these errors. This paper describes the application of computers in a variety of internal and external quality assessment programmes and demonstrates the usefulness of retrieving patients' cumulative test results and at the same time performing delta or percentage difference checks on such data in the detection of non-analytical errors and unexpected variations in results. The role of the computer in minimising transcription errors, reducing turn-around time of testing and reporting, as well as improving the quality of laboratory reports is also mentioned.

Clinical Laboratory Information Systems↗
PubMed1988

Medical relevance of laboratory tests. A clinical perspective.

To address the role of proficiency testing in the medical usefulness of laboratory tests, nine steps involved in the generation and application of a laboratory test result are identified and discussed: test ordering, patient preparation, specimen, sample, analysis, result, reporting, recognition, and action. Clinical uses of test results are enumerated. Good clinical skills are necessary for optimal test efficiency. Clinicians should improve their selection of tests, pay attention to proper patient preparation, and refine the process of interpretation of test results using disease-based reference ranges and more formal analysis of predictive value. By better definition of the clinical uses of laboratory tests, appropriate attention can be directed to steps in the laboratory domain such as medically relevant goals for accuracy and precision. With clearer understanding of the testing process, proficiency testing for monitoring laboratory performance can be more fully utilized. Audit models should be developed that include assessment of the outcome of the laboratory testing process.

Clinical Competence↗
PubMed1986

Painless office laboratory regulation.

In summary, the attention focused on the work performed in the physicians' office laboratories need not create any apprehension on the part of the physician-directors. If the physician's office laboratory is subject to government regulations, be assured that the only objective is to provide assistance in accomplishing a mutual objective of quality work. The approach is one of a cooperative effort between professionals, and the physician's office laboratory should take advantage of the services, both consultation and training, offered by the regulatory agency. If the physician's office laboratory is not subject to regulations, the physician-director should personally direct the operation of his or her laboratory and keep abreast of the latest developments in laboratory medicine applicable to the specific areas of testing performed. The simplest way to do this is to take advantage of the voluntary certification programs being developed and any state or federal guidelines readily available.

Clinical Laboratory Techniques↗
PubMed1995

The mobile laboratory in alternative site testing.

The establishment of mobile or portable laboratories as one strategy for delivery of laboratory services at alternative sites is evaluated. The mobile laboratory may be used to replace centralized laboratory testing in areas of critical need, such as critical care areas of the hospital in which relatively large numbers of tests are needed quickly. Other possible areas of use include outpatient clinics and other outreach settings in which care of the patient may be hastened by the availability of laboratory data on a real-time basis. In such areas where a need is established, mobile laboratory testing may be performed economically and may enhance the position of the medical technologist as a hands-on clinical caregiver.

Clinical Laboratory Information Systems↗
PubMed1995

The cost of implementation of the Clinical Laboratory Improvement Amendments of 1988--the example of pediatric office-based cholesterol screening.

OBJECTIVE: To measure the additional costs of office-based laboratory testing due to the implementation of the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88), using cholesterol screening for children as an example. METHODS: Four- to ten-year-old children who received their well child care at one of seven participating pediatric practices were screened for hypercholesterolemia. The average number of analyses per day and days per month were derived from the volume of testing completed by the practices. Nurses and technicians time in the screening process were measured and personnel costs were calculated based on salary and fringe benefit rates. Costs of supplies, analyzing control samples, instrument calibration, and instrument depreciation were included. Costs estimates of screening were then completed. CLIA '88 implementation costs were derived from appropriate proficiency testing and laboratory inspection programs. RESULTS: In six practices completing a low volume of testing, 2807 children (5 to 6 children per week) were screened during the observation period, while 414 (about 25 children per week) were screened in one high-volume practice implementing universal screening over a 4-month period. For the six low-volume practices, the cost of screening was $10.60 per child. This decreased to $5.47 for the high-volume practice. Estimated costs of CLIA '88 implementation, including additional proficiency testing and laboratory inspection, added $3.20 per test for the low-volume practices, and $0.71 per test for the high-volume testing. CONCLUSIONS: Implementation of CLIA adds significantly to the cost of office-based chemistry laboratory screening. Despite these additional expenses, the cost of testing is still within a reasonable charge for laboratory testing, and is highly sensitive to the volume of tests completed.

Calibration↗
PubMed1994

Clinical laboratory automation: concepts and designs.

Compared with other industries, automation in the healthcare arena has been slow to evolve. Changes in reimbursement for services provided are forcing hospitals and other healthcare providers to look for more cost effective mechanisms to provide all forms of health related services. Clinical laboratory services are essential to the support of hospital operations and most clinic operations. The current paradigm for clinical laboratory operations is based upon a mix of both batch and random access testing and is highly dependent upon clinical laboratory personnel. Changes in the paradigm for clinical laboratory operations may result in a significant cost savings when fully implemented while maintaining a high level of quality and service for the patients. Several different laboratory organization structures are discussed. The Nebraska automation project is described including the development of a modular conveyor system, the use of automated guided vehicles, software, and network architectures. Future directions for the development of clinical laboratory operations including the creation of a "docking device" to link automation systems to instruments is proposed.

Clinical Laboratory Information Systems↗
PubMed1993

[A trial approach to the ideal control-management and systematization of clinical laboratory].

Clinical laboratory examinations have continued to expand with the increase in demand for medical care. However, recent high-technology, medical care has made introduction of a new system of quality control in the clinical laboratory indispensable. First, regarding personnel (clinical laboratory technicians), reducing staff hours led to a drop in the employment of newcomers and subsequent aging of the staff. Next, introducing a system to save labor is extremely expensive, making the cost effectiveness very poor and consequently making it difficult to introduce such a system in many laboratories. This symposium was initiated to assist the search for ways in which the present clinical laboratory can survive despite rising personnel expenses and reagent costs, while reducing medical expenses. And at the same time developing a guide to establishing our ideal for the clinical laboratory of the 21st century.

Clinical Laboratory Information Systems↗
PubMed1995

[The assessment of quick turnaround service in clinical laboratories].

The quick turnaround service of laboratory data has been a basic and fundamental service of clinical laboratories. To realize this service, there are three basic requirements in the hospital and laboratory information systems. The first is cooperation with the hospital information system providing bar-coded label sampling system and test requisition from the information system terminal. The second is real time quality assurance system fully supported from the laboratory information system. The third is random and sequential automated analyzer supported by the bar-code system. In 1994, we set up an automated system in our clinical laboratories. The effect of the quick turnaround service of reporting was analyzed and is discussed herein. Employing this system, the quick turnaround service system was established for 31 items of biochemistry, glucose, Thrombo test and complete cell counting of hematology. Furthermore, these items were available within 30 minutes before medical consultation. Effective sample conveying system, quick sample preparation without clotting and arrival information system of laboratory data as a mailing system are further requirements for this quick turnaround service system.

Clinical Laboratory Information Systems↗
PubMed1998

The influence of CLIA '88 on physician office laboratories.

BACKGROUND: The study objectives were to examine the influence of the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) on laboratory testing activities in physician offices, and to identify relationships between the characteristics of practices and their responses to the regulation. METHODS: The data come from a 1995 survey of physician office laboratories conducted by Mathematica Policy Research, and are supplemented by data from a 1991 laboratory survey. Primary care physician practices performing level I and level II tests in 1991 were resurveyed in 1995. Respondents were asked a series of questions pertaining to the types of laboratory tests performed in their offices, and whether CLIA '88 had any influence on the decision to change testing practices. We present descriptive statistics to examine differences across practices in response to CLIA '88. Significant determinants of the decision to drop or modify onsite testing activities are identified using multivariate analysis. RESULTS: More than 64% of physicians surveyed cited CLIA '88 as a factor in their decision to reduce or eliminate in-office testing. The most striking effect of CLIA '88 appears to be on pediatric practices and practices in rural areas, of which more than 70% have reduced or eliminated onsite testing. Where the potential burden of compliance is smaller, as in large practices, CLIA '88 has had less impact. CONCLUSIONS: CLIA '88 has had significant influence on access to laboratory testing services. According to the data from the 1995 survey, almost two thirds of physicians have eliminated some or all in-office tests. Of those physicians previously conducting in-office tests, 70% have chosen to send patients and specimens to outside facilities, resulting in greater inconvenience for patients and delays in diagnosis and treatment. These delays, and the potential for patient noncompliance stemming from the inconvenience of obtaining tests, have serious implications for the quality of medical care.

Clinical Laboratory Techniques↗
PubMed1996

Laboratory diagnosis of HIV infection in Papua New Guinea.

In Papua New Guinea, the laboratory diagnosis of HIV infection is based on proof of HIV antibody in the patient's serum. Under the government scheme, the testing is done in 30 laboratories, including the Papua New Guinea HIV Reference Laboratory (NRL), the Red Cross Blood Transfusion Service in Port Moresby, and 19 provincial and 9 district laboratories. An alternative testing strategy was adopted in 1993 based on a WHO recommendation, replacing the classical testing strategy (enzyme immunoassay + Western blot). The alternative testing strategy uses several EIA, rapid or simple HIV antibody assays for the detection and confirmation of the HIV antibody. This approach is faster and cheaper, with the same sensitivity and specificity as the classical testing algorithm. Except for the NRL, the Serodia Fujirebio HIV-1 gelatin particle agglutination assay is used throughout the country as the screening test. The PNG National HIV Reference Laboratory is the only laboratory authorized to perform confirmatory testing and to release positive results. Therefore, all serum samples reactive in the screening assay are sent to the NRL for confirmation by the battery of EIA, rapid or simple assays in accordance with the alternative testing strategy adopted. The paper explains the alternative testing strategy and highlights the principle of each individual test that is employed.

AIDS Serodiagnosis↗