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PubMedDate not supplied

The quality of medical laboratory practice in Trinidad and Tobago, West Indies.

The introduction of automated chemical analyzers in the laboratory service has the potential of adversely affecting professionalism in laboratory practice. The present study assesses the quality of medical laboratory technicians in Trinidad and Tobago using structured questionnaires. Some of the critical questions included job status, years of experience, training, qualification(s) and knowledge of quality assurance and its application. About 82% of laboratory technicians responded to the study. The majority of technicians (62%) had diploma certificates while only one (1.2%) had a postgraduate degree. Although the majority (91.7%) of technicians knew about quality assurance, 36% learnt on the job and 59% knew they were not professionally trained. The results showed that there is paucity of highly trained laboratory technicians in Trinidad and Tobago and this has significant implications on the technical initiative and quality of medical laboratory practice in this country. We recommend the establishment of appropriate professional institutions for training medical laboratory technologists and regular expert inspection and accreditation of all medical laboratories in the country.

Adult↗
PubMed2006

An external quality assessment program for von Willebrand factor laboratory analysis: an overview from the European concerted action on thrombosis and disabilities foundation.

The laboratory diagnosis of von Willebrand disease (vWD) is complex and requires a panel of different laboratory tests. Because of this complexity, a proper quality control process is necessary. Since 2003, the European Concerted Action on Thrombosis and Disabilities Foundation has provided an external quality control program for several laboratory tests included in the diagnosis of vWD. Currently, ~180 different laboratories participate in this program, of which the vast majority perform both von Willebrand factor (vWF):antigen (Ag) and activity tests. The lowest between-laboratory variation was observed for the vWF antigen assay (10 to 24%), with a better performance for the latex immunoassay (8 to 24%) than the enzyme immunoassay (13 to 25%). Both the ristocetin cofactor activity assay (RCo) and the collagen-binding assay showed a higher between-laboratory variation (20 to 40% and 17 to 29%, respectively). We have observed that the within-laboratory repeatability for normal samples ranged from 0 to 40% for the antigen assay and from 0 to 86% for the ristocetin cofactor activity assay. Normal samples were interpreted correctly by the majority of the participants. However, type 1 vWD samples were wrongly interpreted by 20 to 40% of the participants, which was mainly caused by a discordance in the vWF:RCo/vWF:Ag ratio. It can be concluded that further improvement in the laboratory diagnosis of vWD is necessary.

Clinical Laboratory Techniques↗
PubMed1978

Clinical laboratories. Profit center, production industry or patient-care resource?

The clinical laboratory is an essential component of the medical-care system. Rapidly increasing expenditures for laboratory services, fraudulent practices and reports of laboratory error are precipitating legislative and regulatory actions that will affect clinical laboratories and how they are used by physicians in caring for their patients. Many problems related to clinical laboratories are due to the rapid introduction of new technologies, to methods of educating medical students and house officers, to the rapidly expanding scientific base of medicine and to economic factors that have subordinated medical and scientific objectives in the laboratory to economic ones. Implementation of existing legislation would settle many of the economic issues, but more effective integration of the clinical laboratory into the patient-care process and better methods for educating medical students in the use of laboratory information are critical tasks for the medical profession.

Accounting↗
PubMed1999

Effect of accreditation schemes on the setting of quality specifications by laboratories.

In the future, there will be a universal standard for quality management in medical laboratories: ISO 15189. This standard follows the basic principles of ISO 17025, the general standard for test laboratories, but also adds several specific aspects. A comparison between these standards is given. The language of ISO 15189 is designed to be understood by medical laboratory professionals. As this standard is applicable to all medical laboratory fields, requirements are given in general terms requiring the laboratory to implement them correctly. Because it is essential that information provided by laboratory results is useful for healthcare, the requirements covered by ISO 15189 are compared with those needed for providing good medical laboratory services. The capabilities of the personnel at the laboratory clinic interface are the most difficult to assess and evaluate in an adequate quality management system.

Accreditation↗
PubMed2003

Development of the Global Measles Laboratory Network.

The routine reporting of suspected measles cases and laboratory testing of samples from these cases is the backbone of measles surveillance. The Global Measles Laboratory Network (GMLN) has developed standards for laboratory confirmation of measles and provides training resources for staff of network laboratories, reference materials and expertise for the development and quality control of testing procedures, and accurate information for the Measles Mortality Reduction and Regional Elimination Initiative. The GMLN was developed along the lines of the successful Global Polio Laboratory Network, and much of the polio laboratory infrastructure was utilized for measles. The GMLN has developed as countries focus on measles control activities following successful eradication of polio. Currently more than 100 laboratories are part of the global network and follow standardized testing and reporting procedures. A comprehensive laboratory accreditation process will be introduced in 2002 with six quality assurance and performance indicators.

Clinical Laboratory Techniques↗
PubMed2004

Survey of clinical laboratory practices for parasitic diseases.

To gain knowledge about laboratory testing practices for parasitic diseases, in 2000 we surveyed 562 laboratories in 9 US states, and 455 (81%) responded. Most laboratories (59%) indicated that they send specimens off site for parasite screening, and most laboratories (89%) did not routinely test fecal specimens for Cryptosporidium species, Cyclospora cayetanensis, or microsporidia, unless testing for these organisms was specifically requested by a physician. Only 39 laboratories offered serological testing for Toxoplasma gondii, and most (78%) that had their results confirmed did so at national commercial laboratories rather than a Toxoplasma reference laboratory. Because most clinical laboratories do not routinely test fecal specimens for Cryptosporidium species, C. cayetanensis, or microsporidia, physicians must request specific testing for these organisms when they are clinically suspected; because of this lack of routine testing, it is difficult to estimate the true burden of disease due to these organisms.

Animals↗
PubMed1999

Proficiency of clinical laboratories in Spain in detecting vancomycin-resistant Enterococcus spp. The Spanish VRE Study Group.

Studies in a variety of U.S. clinical laboratories have demonstrated difficulty in detecting intermediate and low-level vancomycin-resistant enterococci (VRE). The misclassification of "at least intermediate resistant isolates" as vancomycin susceptible may have both clinical implications and a negative impact on measures to control the spread of VRE. No published study has assessed the ability of clinical laboratories in Europe to detect VRE. So, the apparent low prevalence of VRE in European hospitals may be, in part, secondary to the inability of these laboratories to detect all VRE. In an effort to assess European laboratories' proficiency in detecting VRE, we identified 22 laboratories in Spain and asked them to test four VRE strains and one susceptible enterococcal strain from the Centers for Disease Control and Prevention collection. Each organism was tested by the routine antimicrobial susceptibility testing method used by each laboratory. Overall, VRE were correctly identified in 61 of 88 (69.1%) instances. The accuracy of VRE detection varied with the level of resistance and the antimicrobial susceptibility method. The high-level-resistant strain (Enterococcus faecium; MIC, 512 microg/ml) was accurately detected in 20 of 22 (91. 3%) instances, whereas the intermediate-resistant isolate (Enterococcus gallinarum; MIC, 8 microg/ml) was accurately detected in only 11 of 22 (50%) instances. Classification errors occurred in 27 of 88 (30.9%) instances. Misclassification as vancomycin susceptible was the most common error (16 of 27 [59.3%] instances). Our study shows that the participating Spanish laboratories had an overall acceptable proficiency in detecting VRE but that a substantial proportion of VRE isolates with low or intermediate levels of resistance were not detected. We recommend that studies be conducted to validate laboratory proficiency testing as an important step in the prevention and control of the spread of antimicrobial resistance.

Centers for Disease Control and Prevention, U.S.↗
PubMed2001

Laboratory testing under managed care dominance in the USA.

The uncontrolled escalation of total health care expenditure despite the government's endeavours during the past decades in the USA had led to the rapid infiltration of managed care organisations (MCOs). Traditional hospital based laboratories have been placed in a crucial situation with the advent of the managed care era. A massive reduction of in house testing urged them to develop strategies against financial difficulty. Consolidation and networking, participation in the outreach testing market, and emphasis on point of care/satellite laboratory testing in non-traditional, ambulatory settings are major strategies for the survival of hospital laboratories. Several physicians' office laboratories (POLS) have closed their doors in response both to regulatory restrictions imposed by the Clinical Laboratory Improvement Amendments of 1988 and to managed care infiltration. It seems likely that POLs and hospital laboratories will continue to reduce test volumes, whereas commercial reference laboratories will thrive through contracting with MCOs. In the current climate of managed care dominance in the USA, clinical laboratories are changing their basic operation focus and mission in response to the aggressively changing landscape.

Humans↗
PubMed2003

Who--or what--are the rats (and mice) in the laboratory.

This paper explores the many meanings attached to the designation, "the rodent in the laboratory" (rat or mouse). Generations of selective breeding have created these rodents. They now differ markedly from their wild progenitors, nonhuman animals associated with carrying all kinds of diseases. Through selective breeding, they have moved from the rats of the sewers to become standardized laboratory tools and (metaphorically) saviors of humans in the fight against disease. This paper sketches two intertwined strands of metaphors associated with laboratory rodents. The first focuses on the idea of medical/scientific progress; in this context, the paper looks at laboratory rodents often depicted (in advertising for laboratory products) as epitomizing medical triumph or serving as helpers or saviors. The second strand concerns the ambiguous status of the laboratory rodent who is both an animal (bites) and not an animal (data). The paper argues that, partly because of these ambiguous and multiple meanings, the rodent in the laboratory is doubly "othered"--first in the way that animals so often are made other to ourselves and then other in the relationship of the animal in the laboratory to other animals.

Animal Experimentation↗
PubMed1999

Assessment of the feasibility of conducting population prevalence studies of chronic renal failure according to ethnic group: a survey of clinical biochemistry laboratories in Greater London and south east England.

The planning of renal replacement therapy is based on assessment of population need for the white population, but uses historical trends in treatment uptake for black and Asian ethnic minority groups, for whom the incidence of chronic renal failure (CRF) is not known. Epidemiological studies of CRF are based upon follow-up of plasma creatinine results obtained from clinical biochemistry laboratories. We conducted a postal questionnaire survey of UK National Health Service (NHS) and private clinical biochemistry laboratories in Greater London and the south east of England to arrange the design and test the feasibility of carrying out a study to determine ethnic-specific rates of CRF. Fifty-five NHS laboratories (90%) and 19 private laboratories (57%) responded. Few pathology computer systems recorded ethnic group, patient post code, or diagnosis; although 31 of the laboratory computers (42%) were linked with the hospital Patient Administration System which could supply these data. Approximately 5.5 million electrolyte profiles and 20 million individual renal function tests are carried out annually in south east England. Ninety per cent of those were performed within NHS laboratories, implying that a study can use NHS sources alone without risk of any undue bias. Sixty laboratories (81%) included creatinine in their routine electrolyte profile, which would be a requirement for any study. Thirty-one laboratories (42%) archived tests within 1 year of entry, which would rule out a retrospective study design. A prospective study is feasible and should be carried out as soon as is practicable.

Clinical Laboratory Information Systems↗
PubMed2004

Pseudohyperkalaemia at commercial laboratories in Japan: a questionnaire survey.

BACKGROUND: Pseudohyperkalaemia caused by recentrifugation after storage or delay in separation of serum from blood cells is not uncommon. The purpose of this study was to audit pseudohyperkalaemia at commercial laboratories in Japan. METHODS: A questionnaire asking about how samples are handled for potassium measurement and information on pseudohyperkalaemia was sent to 431 commercial laboratories. RESULTS: A total of 263 (response rate 61%) questionnaires were returned and suitable for analysis. Pseudohyperkalaemia caused by recentrifugation was seen at 145 (70%) laboratories. Pseudohyperkalaemia caused by delay in separation of serum was also seen in many laboratories. Blood samples were centrifuged on site in only 46% of hospitals and in 17% of clinics served by these laboratories. The longest average time from venesection to centrifugation was 18 h. Although half the laboratories had asked their client facilities to centrifuge blood samples on site, very few complied. CONCLUSION: Pseudohyperkalaemia is not uncommon at commercial laboratories in Japan. Further efforts are necessary to avoid inappropriate handling at blood collection sites and in laboratories.

Blood Specimen Collection↗
PubMed2006

Definition of an XML markup language for clinical laboratory procedures and comparison with generic XML markup.

BACKGROUND: Clinical laboratory procedure manuals are typically maintained as word processor files and are inefficient to store and search, require substantial effort for review and updating, and integrate poorly with other laboratory information. Electronic document management systems could improve procedure management and utility. As a first step toward building such systems, we have developed a prototype electronic format for laboratory procedures using Extensible Markup Language (XML). METHODS: Representative laboratory procedures were analyzed to identify document structure and data elements. This information was used to create a markup vocabulary, CLP-ML, expressed as an XML Document Type Definition (DTD). To determine whether this markup provided advantages over generic markup, we compared procedures structured with CLP-ML or with the vocabulary of the Health Level Seven, Inc. (HL7) Clinical Document Architecture (CDA) narrative block. RESULTS: CLP-ML includes 124 XML tags and supports a variety of procedure types across different laboratory sections. When compared with a general-purpose markup vocabulary (CDA narrative block), CLP-ML documents were easier to edit and read, less complex structurally, and simpler to traverse for searching and retrieval. CONCLUSION: In combination with appropriate software, CLP-ML is designed to support electronic authoring, reviewing, distributing, and searching of clinical laboratory procedures from a central repository, decreasing procedure maintenance effort and increasing the utility of procedure information. A standard electronic procedure format could also allow laboratories and vendors to share procedures and procedure layouts, minimizing duplicative word processor editing. Our results suggest that laboratory-specific markup such as CLP-ML will provide greater benefit for such systems than generic markup.

Clinical Laboratory Information Systems↗
PubMed2004

Quality indicators and specifications for the extra-analytical phases in clinical laboratory management.

BACKGROUND: Quality management systems should cover all the steps involved in the overall testing and non-testing processes. AIM: To identify quality indicators for extra-analytical processes in the clinical laboratory and to specify acceptability limits, in order to provide a useful tool for continuous improvement of laboratory service. METHODS: A literature review by Medline search was performed using the keywords: Q-Tracks and Q-probes alone, and management, error, mistake, and indicator crossed with quality, laboratory and medicine. The indicators retrieved were organized according to the various laboratory processes. Their expression was standardized in relation to the total activity of each process reported in each paper reviewed. The magnitude of the errors reported was considered to be the current state of the art for the extra-analytical step and was proposed as the quality specification. RESULTS: Examples of indicators and specifications for the pre-analytical process: Analytical request: Error in patient identification (0.08%), request unintelligible (0.1%). SAMPLING: Requested but not collected (7%), redraws (2%). Transport and reception of samples: Inadequate transportation conditions (0.005%), hemolyzed sample (0.2%). Examples of indicators and specifications for the post-analytical process: Report validation: Test not performed (1.4%), test performed but not requested (1.1%). Intra-laboratory reports: Laboratory reporting errors (0.05%), delivery outside specified time (11%). Consulting service: average time to communicate critical values for inpatients (6 min). CONCLUSIONS: These extra-analytical indicators and their specifications, expressed in a standardized manner, constitute a preliminary basis for comparison of individual laboratory performance with the purpose of improving laboratory quality.

Clinical Laboratory Techniques↗
PubMed1998

An overview of the roles and structure of international high-security veterinary laboratories for infectious animal diseases.

The unique structure, role and operations of government high-security (HS) laboratories which work on animal diseases are described, with particular reference to the laboratories of nine countries. High-security laboratories provide cost-effective insurance against catastrophic losses which could occur following exotic disease outbreaks. The importance of these laboratories is reflected in the fact that several new laboratories have recently been constructed at considerable expense and older facilities have undergone major renovations. Biosecurity is fundamental to the operation of high-security laboratories, so good facility design and microbiological security practices are very important. High-security laboratories conduct exotic disease diagnosis, certification and surveillance, and also perform research into virology, disease pathogenesis and improvements to diagnostic tests and vaccines. The mandate of these laboratories includes the training of veterinarians in the recognition of exotic diseases. One extremely important role is the provision of expert advice on exotic diseases and participation (both nationally and internationally) in policy decisions regarding animal disease issues.

Animals↗
PubMed2005

Laboratory exposures to brucellae and implications for bioterrorism.

Brucellae are class 3 organisms and potential agents of bioterrorism. Because of effective public health measures, brucellosis has become a rare disease in industrialized countries, and clinical microbiology laboratories are frequently unfamiliar with the genus. A low index of suspicion by physicians or failure to notify the laboratory, equivocal Gram-stain results, misidentification of the organism by commercial systems, unsafe laboratory practices, and laboratory accidents have been responsible for numerous cases of exposure to the organism and laboratory-acquired disease in recent years. Discovery of a laboratory exposure to brucellae should prompt an exhaustive investigation of the event and its circumstances, definition of the population at risk, enforcement of safe laboratory practices, and antimicrobial drug prophylaxis for exposed persons. Inadvertent exposures to brucellae in the clinical laboratory indicate a widespread lack of preparedness to cope with eventual biologic threats involving use of the organism.

Brucella↗
PubMed2005

Time to pregnancy among Danish laboratory technicians who were a part of the National Birth Cohort.

OBJECTIVES: The Danish National Birth Cohort was used to examine whether laboratory work was associated with reduced fecundity. METHODS: Self-reported data on laboratory work and waiting time to pregnancy (0-2, 3-5, 6-12 and > 12 months) were used for 829 female laboratory technicians interviewed in 1997-2003. Altogether 6250 female teachers formed the reference group. A discrete-time survival analysis with a complementary log-log link was applied to estimate the fecundability ratio between the exposed and unexposed women, with adjustment for maternal age, gravidity, smoking, prepregnancy body mass index, and paternal job. RESULTS: No difference in time to pregnancy was found between the laboratory technicians and teachers or between the laboratory technicians with different exposures. The adjusted fecundability ratio for the laboratory technicians was 0.94 [95% confidence interval (95% CI) 0.86-1.02] for all pregnancies and 0.98 (95% CI 0.86-1.13) for first pregnancies. A healthy worker effect was found for the laboratory technicians working with the work processes under study. CONCLUSIONS: The results do not suggest that laboratory work in Denmark at present impairs female fecundity.

Adult↗
PubMed2005

Plan to implementation: an in-depth look into a well-orchestrated, functional, CORE laboratory.

The overall objective was implementation of a fully integrated and functional CORE laboratory. The "CORE laboratory" is a model of a fully integrated and functional, multifaceted, clinical laboratory. Delineation of the process is to enable clinical laboratory managers, in the government or civilian sectors, to make sound decisions about formulating and implementing the CORE laboratory concept. The defining and comprehensive decisions should be based on concept requirements, advantages, disadvantages, and employee core competency assessments. Operationally, the organizational change resulted in well-rounded, multidisciplinary, multiskilled laboratorians and instructors/mentors for the Phase II military medical laboratory technician (91K student) training program. As of this time, our laboratory is the only Department of the Army medical center that operates a fully integrated and functional CORE laboratory.

Efficiency, Organizational↗
PubMed2006

Laboratory errors as judged by test request slips and test reports.

OBJECTIVE: To evaluate common laboratory transcription errors made in requisition forms and rate of report failure in test result reports. DESIGN: Descriptive study. PLACE AND DURATION OF STUDY: Jinnah Postgraduate Medical Center (JPMC) from February 01, till February 28, 2002. PATIENTS AND METHODS: One hundred and eight patient s records were collected randomly from 24 different departments of the hospital, during the month of February 2002. Each record was scrutinized for requisition slips and test reports. Tabulation of the content matter of all requisition slips and the test reports was done on the spread sheet, for the transcription errors; and compared with the minimum standards of requisition forms, as laid down by clinical laboratory improvement amendments; 1988 (CLIA 88). Request forms on which urgent test/any comment was given, were tabulated separately. Differences in the number of tests ordered and actually performed were also tabulated. Percentage of error was calculated. RESULTS: Four hundred and sixty-nine test request forms, requesting 1112 tests, were analyzed. None of them had pre-formatted laboratory forms. They were written on torn file papers, Out-patient department (OPD) slips and plain papers. The transcription errors included physician s identification errors (469/469 or 100%), patient s name, age, sex and unique identifier errors (0, 94, 95 and 81%) respectively, error in patients data aiding diagnosis (100%) and report failure error (37%). The requesting pattern of the laboratory tests ordered by clinicians revealed inclination towards panel-test ordering. The results of requested tests were available in 63% requested tests, and not available in 37% tests. No reason for rejection of the specimen was found on feed-back/report. Further analysis of un-reported results revealed that the emergency tests of electrolytes and sugar were the most affected ones, followed by PT/APTT, ESR and urine analysis. Tests for serum electrolytes done in elective and emergency setup, showed that out of 152 test requests for electrolytes, 124 requests were sent in elective and 28 in emergency setup. There was report failure in 84 cases (67.7%) in former and 13 cases (46.4%) in the latter. CONCLUSION: A good insight on error-prone steps in the laboratory process is essential to achieve error reduction; hence, in addition to maintaining quality standards within laboratory, it is imperative to go outside the laboratory to identify the common errors made in laboratory process and to reorganize the activity of the wards.

Clinical Laboratory Information Systems↗