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Laboratory accidents--a matter of attitude.

This is a prospective study on accidents occurring in the Pathology laboratories of Hospital Ipoh over the 3-year period from January 1996 to October 1999. 15 mishaps were recorded. The location of the accidents were the histology (40%), microbiology (33%), haematology (20%) and cytology (7%) laboratories. No mishaps were reported from the clinical chemistry, blood bank and outpatient laboratories. Cuts by sharp objects were the most common injuries sustained (47%) followed by splashes and squirts by fluid such as blood or chemicals (27%). There was 1 case each of contact with biohazardous fluid, burn, allergy and accidental drinking of disinfectant. 67% of the accidents involved medical laboratory technicians, 20% involved attendants and the rest were medical officers and the junior laboratory technicians. Although the accidents reported appeared trivial, it is vital to document them and bring them to the attention of all concerned in the laboratory, in order to prevent major accidents and also because of medico-legal implications. The role of the Laboratory Safety Committee cannot be overemphasised. Modification of staff attitude is considered an important remedial goal.

Accidents, Occupational↗

Why is the laboratory an afterthought for managed care organizations?

Market forces have dramatically influenced the environment in which healthcare is delivered, but these changes do not need to be interpreted negatively by community laboratorians. Only total vertical integration of laboratory medicine can control episode-of-care cost. Opportunities also exist for horizontal integration with community partners to provide geographical coverage and to compete favorably for managed care contracts. Lowering cost through "economies of scale" may apply to the procurement of supplies and equipment, but the delivery of services must be considered in the context of their overall effect on episode-of-care cost. Laboratory services may make up 5% of a hospital's budget but leverage 60-70% of all critical decision-making such as admittance, discharge, and medication. Laboratory outreach can help the medical center's financial stability by: (a) providing tests and service that can reduce or avoid a hospital stay; (b) using the additional volume of testing to distribute existing fixed costs and lower unit cost; and (c) adding revenue as a direct contribution to margin. To successfully compete for contracted managed care services, the laboratory must network with other providers to demonstrate comprehensive access and capacity. Community hospital laboratories perform 50% of all laboratory tests in this country and have adequate excess capacity to fulfill the remaining community needs.

Health Care Costs↗

[Medical audit in laboratory medicine. A description of the course and some results].

All general practitioners of the Danish counties of Funen, Vejle and North Jutland were invited to participate in a medical audit concerning laboratory medicine organised by the Audit Project Odense (APO) in co-operation with the Consultative Arrangement for General Practice, emanating from the clinical/chemical departments of Funen. During three weeks the participants registered all clinical problems which would result in one or more laboratory tests. APO performed computer registrations and analyses of the results where upon each participant received a reply letter indicating the results of his own as well as the group's registrations. At a subsequent meeting the participants discussed the conception of "good general practice" as regards the use of laboratory medicine within defined clinical problems. The course of the audit demonstrated that the APO method is suitable for identification of a number of professional problems related to general practitioners' use of laboratory medicine and to reveal the variation in general practitioners' handling of laboratory medicine. Furthermore, the project showed that continuous quality development demands profound study of and research into the professional problems which the general practitioners encounter when using laboratory medicine.

Denmark↗

A grading system for bone marrow cytogenetics and its use as a standard for quality control.

A grading system has been developed to assess the quality of the results of bone marrow cytogenetic procedures. The results of 3 1/2 years use of this grading system are reported. This grading system is a satisfactory internal standard for quality control and is adaptable for use as an external standard. The use of such an internal standard will improve the performance of the cytogenetics laboratory and will validate the quality of the results of cytogenetic examination. The use of an external standard will stimulate the standardization and improvement of cytogenetic laboratory techniques and may be used to develop performance standards for accreditation of both bone marrow and other cytogenetic laboratories. Internal and external quality controls have been used in general medical laboratories for many years, and their use should be instituted by cytogenetic laboratories as well.

Bone Marrow↗

Is quality assurance in semen analysis still really necessary? A view from the andrology laboratory.

Quality assurance (QA) is a fundamental part of laboratory medicine, of which internal and external QA (proficiency testing) is an important part. In a recent debate article published in Human Reproduction, it was argued that it was no longer necessary for semen analysis to be subject to QA, primarily because it is now being performed robustly and there is little evidence that it has any real clinical value. In response to this argument, it is suggested here that although there may have been some improvements in the training of laboratory scientists, recent studies have shown that the techniques of semen analysis are still poorly implemented at many locations. Moreover, as the impact of the introduction of QA into the andrology laboratory begins to take effect, there are a growing number of studies showing that the results of semen analysis do correlate well with natural conception and some assisted reproductive technologies. However, since the processes of QA are central to the principles of total quality management, which in turn underpins the process of laboratory accreditation, QA needs to remain in the andrology (and embryology) laboratory so that they can achieve the same accredited status as medical laboratories in other disciplines.

Andrology↗

PROCORAD's international intercomparisons highlight the evolution of techniques used to determine uranium in urine.

Inter-laboratory tests are a means of assessing the analytical coherence of medical laboratories. In radiotoxicology, this kind of exercise makes it possible to keep up with laboratory know-how and with the evolution and relative performances of analytical techniques. The intercomparison exercises organised by PROCORAD (Association for the Promotion of Quality Controls in Radiotoxicological Bioassays) provide an opportunity to compare and contrast radiochemistry and metrology for the in vitro analysis of urine and faeces. For uranium compounds, the development of new techniques such as inductively coupled plasma-mass spectrometry (ICP-MS), alpha spectrometry, and laser spectrofluorimetry makes it possible to compare the effectiveness of these protocols with respect to radiation protection monitoring, both in routine and special situations. Detection limits, flexibility, repeatability, reproducibility and isotopic quantification are the criteria considered in this study. The authors present the evolution of performances for the analysis of uranium in urine over the years. However, the goal of the laboratories taking part in these annual exercises is not only to check the accuracy of their results but also to have analytical discussions and the opportunity to exchange experiences that will enrich the group's general competence.

France↗

Evaluation of diagnostic tests for influenza in a pediatric practice.

INTRODUCTION: Recent advances in the diagnosis and treatment of influenza virus infections include: (1) rapid bedside diagnosis methods with simple commercially available tests; and (2) Food and Drug Administration approval of treatment for children 1 year of age and older with neuraminidase inhibitor drugs. For proven benefit antivirals should be used within 2 days of onset of symptoms. OBJECTIVES: We conducted a performance improvement exercise comparing the sensitivity and specificity of four rapid tests for influenza viruses: (1) Flu OIA (Biostar); (2) Quickvue Influenza Test (Quidel); (3) Z Stat Flu (ZymeTx); and (4) Directigen Flu A (Becton Dickinson). METHODS: During the 1999 to 2000 epidemic, symptomatic patients seen at the private practice of one of the authors provided specimens collected and processed according to the manufacturer's directions. Throat swabs only were used to collect the specimens for the Z Stat Flu Kit. Directigen was performed immediately, and the others were run in parallel within 12 to 24 h. Specimens were frozen first at -20 degrees C for up to 3 days and shipped in transport medium to the Virology Research Laboratory of the Virginia State Health Department for culture where they were stored at -60 degrees C until cultured. Some of the samples were processed by a commercial laboratory. RESULTS: Specimens from 116 patients were available for influenza culture; for 88 of these culture was performed at the State Health Department Laboratory, and for 28 culture was performed at a local commercial medical laboratory. Influenza virus (A) was detected in 58 of 116 (50%) specimens, 10 (17%) of these only by direct fluorescent antigen samples. Viral culture-direct fluorescent antigen results were used as the standard. Of the 4 tests Biostar and Z Stat Flu required more technician time (by an average of 2-fold). The 4 tests had sensitivities ranging from 72 to 95%. Z Stat differed significantly in sensitivity from the other three (P = 0.001). The specificities of Directigen, Quickvue, Flu OIA and Z Stat Flu were similar (76 to 86%). The positive predictive value of Directigen, Quickvue and FluOIA and Z Stat ranged from 80 to 86%. The negative predictive value of all 4 tests ranged from 75 to 94%. Z Stat Flu had a lower negative predictive value than the other 3 tests (75%; P = 0.001. CONCLUSION: In this first head-to-head comparison of four rapid diagnostic tests for influenza, Directigen Flu A, Quickvue and Flu OIA appear equivalent in sensitivity, specificity, positive predictive value and negative predictive value. Z Stat Flu was not as sensitive or as efficient as the other three tests.

Adolescent↗

Research as a path to wide-scale implementation of antiretroviral therapy in Africa.

Although some would deny the importance of research in resource-poor countries, the benefits of research to implementation of treatment for HIV infection are innumerable. These benefits include the development of infrastructure, training of staff, creation and validation of algorithms appropriate for the setting, and answering questions necessary for a safe and effective roll-out of therapy. This was true in the USA in 1986, 1 year after the antibody test for HIV was developed, and is true in Africa today. Shortly after the development of the HIV antibody test and before any antiretroviral therapy, few physicians or centres were willing to provide care for HIV patients and fewer had adequate facilities to do so. At that time it was not known how to make an adequate diagnosis of many of the opportunistic infections nor was there a clear idea of how to treat the patients. No-one knew either the best or most cost-effective method to prevent infections. Even as roll-out of therapy proceeded in early 1987 with the approval of zidovudine by the US Food and Drug Administration, physicians were clueless as to when to start treatment. With the addition of other medications in the armamentarium, clinicians began to make mistakes in their ignorance, adding on medications one at a time as they were approved, which led to accumulation of resistance mutations for a generation of patients. These mutations were transmitted to partners and children. What single-handedly helped advance treatment in the USA and Europe in the 1980s was the willingness of respective governing authorities to create clinical research groups not only to develop new drugs but to help create cost-effective ways to use them. All the current treatment guidelines were developed from that research. Over the years these research groups provided care, including medications, laboratory tests and physician and nurse time, for thousands of patients. Medical centres, where these indigent patients were receiving their care, were encouraged to open their doors, creating state of the art clinics and inpatient wards. A generation of clinicians was trained at these research centres where the bulk of US HIV patients were treated. They provided care as they were conducting research. The ability of resource-poor countries to deliver large-scale roll-out plans is dependent on the development of leadership and skills to implement the programmes. South Africa, despite a delay in initiating a national treatment programme, is an example of a country where the research conducted in the period 1996 to 2004 has enabled a skilled set of clinicians, pharmacists and paramedical staff to provide leadership in the scale up of antiretroviral therapy programmes. Guideline development, training and implementation have been led by treatment experts who learned their skills in the research arena.

Africa South of the Sahara↗

An international laboratory survey.

Lyopholized and liquid aliquots of human serum and blood were distributed in 1973 and 1974 to 50 international medical laboratories that took part in a pilot study sponsored by the College of American Pathologists (CAP) and the Commission on World Standards of the World Association of Societies of Pathology (COWS/WASP). The results were compared with data derived from more than 4,000 United States laboratories that received the same samples. Sodium, potassium, urea nitrogen, glucose, hemoglobin and hematocrit assays show a strikingg similarity in mean values when the World group (COWS/WASP) is compared with participants in the United States. The results suggest that laboratory testing in the international group follows the pattern seen in the United States. The study measures differences and similarities and the collected data serve as a springboard for discussion on international standards of laboratory testing.

Africa↗

Medical clearance and screening of psychiatric patients in the emergency department.

OBJECTIVES: To study the frequency of medical complaints and need for routine ED medical, laboratory, and toxicologic clearance for patients presenting with psychiatric chief complaints. METHODS: A retrospective, observational analysis of psychiatric patients seen in an urban teaching hospital ED over a 2-month period was performed. The individual sensitivities of history, physical examination, vital signs, and complete blood counts and chemistry panels for identifying medical problems were determined. The sensitivities and predictive values of patient self-reporting of recent illicit drug and ethanol use were also determined. RESULTS: 352 patients were seen with psychiatric chief complaints. A complete data set was available for 345 patients (98%). Of those with complete data, 65 (19%) had medical problems of any type. History, physical examination, vital signs, and laboratory testing had sensitivities of 94%, 51%, 17%, and 20%, respectively, for identifying these medical problems. Screening without universal laboratory testing would have missed 2 asymptomatic patients with mild hypokalemia. Patient self-reporting had a 92% sensitivity, a 91% specificity, an 88% positive predictive value (PPV), and a 94% negative predictive value (NPV) for identifying those with a positive drug screen, and a 96% sensitivity, an 87% specificity, a 73% PPV, and a 98% NPV for identifying those with a positive ethanol level. CONCLUSION: The vast majority of medical problems and substance abuse in ED psychiatric patients can be identified by initial vital signs and a basic history and physical examination. Universal laboratory and toxicologic screening of all patients with psychiatric complaints is of low yield.

Adolescent↗

[Educational program of clinical laboratory medicine to develop the ability to use proper laboratory examinations in medical practice].

A model core curriculum for medical education was proposed in 2001 as a guideline to standardize and improve the educational program in Japanese medical schools. Many subjects involved in clinical laboratory medicine were listed in this model core curriculum. Original and characteristic educational curricula in each medical school were also required in this guideline. In our university, we constructed the educational program of clinical laboratory medicine with lectures, clinical practice, and small group seminars including reversed CPC, according to the guideline. We need further trials to achieve the goal, i.e. education to develop the ability to use proper laboratory examinations in medical practice, as a good clinical doctor.

Clinical Laboratory Techniques↗

[On-site screening of toxic substances in clinical laboratory and poisoning information system].

An accurate screening system is required to treat acute poisoning patients in clinical toxicology. However, the medical center analysis of poisonous substances using machines is not sufficient. Moreover, the handling and maintenance of such machines are tedious and costly. To improve these problems and employ effective information, we have developed a simple detection method and constructed a support system using the Internet. Various support systems have been attempted for the training of analysts who can cope with a poisoning incident (accident) involving toxic substances. Our simple detection method for toxic substances in the medical center was developed without using expensive analysis apparati. As technical support for the analysts of medical laboratories, the following items were completed: 1) training for analysts, 2) research of analytical techniques in the medical centers (accuracy management), 3) creation of an analysis manual, 4) construction of on-line analysis manuals, 5) construction of the poisoning information system on the Internet, 6) construction of a system for requesting analysis of poisoning, 7) a quick-detection method for toxic substances and 8) examination of the insurance application.

Clinical Laboratory Information Systems↗

System for laboratory proficiency testing in bacteriology: organisation and impact on microbiology laboratories in health care facilities funded by the Ontario Government.

The Ministry of Health requires that all medical laboratories in the Province of Ontario participate in a laboratory proficiency testing program (LPTP). In bacteriology compliance has been excellent. Eighty-six laboratories, for various reasons over the period under review, have surrendered their licence or, because of poor performance on LPTP test surveys, have had their licence withdrawn by the Ministry. The highest percentage of withdrawals occurred in small hospitals in isolated areas. In April 1979 there were 249 participating laboratories. Participants' results are first analysed by computer, and, subsequently, approximately 20% of participants' reports are reviewed by the Committee. Various Committee actions ensue: correspondence with the laboratory director regarding errors; an offer of a visit; and possibly a report via a senior LPTP committee to the Ministry that a laboratory is non-proficient and, in LPTP's terms of reference, non-remediable. Subsequent Ministry action might be the withdrawal of a laboratory's licence. However, this last recourse only occurs when educational efforts have proved ineffectual. Overall, performance in LPTP bacteriology surveys has improved over the period 1975-8, with 68% of 263 laboratories achieving a score of 70% or higher and 26% of 263 laboratories scoring less than 60%.

Bacteria↗

Use of bar code labels on collection tubes for specimen management in the clinical laboratory.

A new generation in specimen handling has arrived with the introduction of bar code readers on medical laboratory equipment. The incorporation of this technology into laboratory information systems offers a streamlining of specimen workflow never before achievable in a laboratory environment. The use of evacuated collection tubes as the primary sampling container on a random-access chemistry analyzer interfaced to a laboratory information system creates a very simplified sampling/analysis system with tremendous advantages. There are significant labor savings, superior service to clinicians, and reduced chances for clerical error.

Computers↗

Medical applications of Raman spectroscopy: from proof of principle to clinical implementation.

Raman spectroscopy has recently been applied ex vivo and in vivo to address various biomedical issues such as the early detection of cancers, monitoring of the effect of various agents on the skin, determination of atherosclerotic plaque composition, and rapid identification of pathogenic microorganisms. This leap in the number of applications and the number of groups active in this field has been facilitated by several technological advancements in lasers, CCD detectors, and fiber-optic probes. However, most of the studies are still at the proof of concept stage. We present a discussion on the status of the field today, as well as the problems and issues that still need to be resolved to bring this technology to hospital settings (i.e., the medical laboratory, surgical suites, or clinics). Taken from the viewpoint of clinicians and medical analysts, the potential of Raman spectroscopic techniques as new tools for biomedical applications is discussed and a path is proposed for the clinical implementation of these techniques.

Arteriosclerosis↗

Breaking out of the silo: one health system's experience.

Pharmacoeconomic evidence for inpatient deep vein thrombosis (DVT) treatment with low-molecular-weight heparins (LMWHs) and one health system's experience with this treatment compared with unfractionated heparins (UFHs) are examined. Applying clinical and pharmacoeconomic evidence to clinical practice can be challenging, especially when using high-cost therapies, because of the limited financial resources of health systems. While LMWHs have higher acquisition costs, they offer several advantages over UFHs, contributing to their overall pharmacoeconomic value. Inpatient treatment of DVT with LMWHs has not been widely adopted, despite the clinical evidence supporting their use, partly because of the up-front cost of these medications. A cost-minimization analysis was performed to estimate the cost impact of switching from UFHs to LMWHs for inpatient treatment of DVT at the Detroit Medical Center (DMC). The costs of once- and twice-daily administration of enoxaparin were compared with those of UFH. The costs of medications, laboratory tests, and pharmacist time were calculated. Costs for hospital stay and medical fees were assumed to be similar among all treatment groups. The annual cost for DVT treatment for the entire DMC was then estimated using pharmacoeconomic modeling and Monte Carlo simulation. Inpatient UFH costs totaled $138,580, once-daily LMWHs were $177,531, and twice-daily LMWHs cost $205,569 for 500 patients with primary DVT. Treatment with LMWHs cost $20-$34 more per patient per day than UFHs, but incurred savings by reducing readmission and reocclusion rates. LMWHs are a cost-effective treatment for DVT, from both a third-party-payer and a societal perspective.

Anticoagulants↗

Inherent biological variation and reference values.

There is a need for revisiting theoretical concepts and practical applications of conventional population-based reference values to make for better clinical use of laboratory data. Knowledge of the underlying biological variation of quantities examined in medical laboratories is vital to understanding the proper generation and application of traditional population-based reference values. Appreciation of the biological changes that occur over the span of life is a necessary prerequisite to deciding whether stratification of reference values according to age is likely to be necessary. Knowledge of the detail of predictable biological cyclical rhythms is required for correct clinical interpretation of laboratory data and appropriate collection of specimens at times relevant to the clinical purpose. Quantitative data on inherent within- and between-subject biological components of variation have shown the marked individuality of most quantities of interest in laboratory medicine. This individuality casts light on why examinations are not generally very successfully applied in population screening or case-finding. Consideration of individuality demonstrates why stratification of reference values is often very advantageous. Individuality provides an indisputable argument for better use of individual specific reference values.

Humans↗

Blood transfusions leading to apparent hemoglobin C, S, and O-Arab hemoglobinopathies.

CONTEXT: Apparent hemoglobinopathies caused by blood transfusions rarely have been reported in the scientific literature. OBJECTIVE: To interpret the abnormal hemoglobins appearing as small peaks on hemoglobin chromatograms or electrophoresis membranes. DESIGN: In the clinical laboratories of a university hospital and a metropolitan hospital affiliated with a medical school, we interpreted hemoglobin chromatograms and electrophoresis membranes; correlated them with patients' medical, laboratory, and transfusion records; and when possible, identified the abnormal hemoglobin in the donors' transfusion segments. RESULTS: We detected 52 incidences of apparent hemoglobinopathies in 32 recipients caused by blood transfusion, of which 46 were hemoglobin C, 4 were hemoglobin S, and 2 were hemoglobin O-Arab. When first detected, the abnormal hemoglobins in recipients ranged from 0.8% to 14% (median, 5.6%). Multiple transfusions with abnormal hemoglobins occurred in 11 patients with 2 patients receiving hemoglobin C blood 5 separate times. One patient received hemoglobin C and later S, and another patient received C and later O-Arab. CONCLUSIONS: Apparent hemoglobinopathies caused by blood transfusions are far more common than previously reported and represent diagnostic challenges. Misdiagnosis could lead to unnecessary testing, treatment, and counseling. If a hemoglobinopathy from a unit of transfused blood is identified in a recipient, we recommend notifying the donor of that abnormality.

Anemia, Sickle Cell↗