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PubMed2005

Laboratory identification of familial thrombophilia: do the pitfalls exceed the benefits? A reassessment of ABO-blood group, gender, age, and other laboratory parameters on the potential influence on a diagnosis of protein C, protein S, and antithrombin deficiency and the potential high risk of a false positive diagnosis.

Laboratory testing for familial thrombophilia defines a large proportion of the modern hemostasis laboratory workload. As part of an ongoing assessment of our activities, we have re-evaluated our laboratory procedures for antithrombin (AT), Protein C (PC), and Protein S (PS), inclusive of normal reference ranges (NRR), the potential influence of ABO-blood group, gender and age, as well as other laboratory parameters, in order to help assess the effectiveness of testing as an aid to clinical diagnosis. We did not observe a significant influence of ABO-blood group on AT, PC, or PS. However, there were gender-related effects for PS (lower in females) and AT (higher in females), but not for PC. There were also age-related effects for AT, PC, and PS. Data is compared with literature findings. We also audited the positive detection rate for PC and/or PS deficiencies. In a 6-month period of testing, we identified that 18.9% of tested samples yielded low or near-low PC and/or PS levels. However, 33.3% of such samples were potentially derived from patients on oral anticoagulant therapy (ie, potential false positives). Additional pre-analytical variables, intra-assay, inter-assay, and inter-laboratory variability also contribute to the possibility of false positive detection. Thus, whilst NRR can be developed for test parameters, the likelihood of a false-positive test result can still be shown to exceed the likelihood of a true positive result, and this casts a shadow over the clinical value of such testing in some cases. In conclusion, laboratory testing for these markers of familial thrombophilia may or may not assist in the clinical diagnosis of this condition and clinical specialists should be made aware of laboratory test limitations, and consult with laboratories prior to making a definitive diagnosis of AT, PC, or PS deficiency.

ABO Blood-Group System↗

PubMed1993

Quality of laboratory performance in testing for human immunodeficiency virus type 1 antibody. Identification of variables associated with laboratory performance.

To identify factors that may affect the quality of laboratory performance of human immunodeficiency virus type 1 (HIV-1) antibody testing, the Centers for Disease Control and Prevention Model Performance Evaluation Program surveyed laboratories in 1989 that performed enzyme immunoassay (EIA) and Western blot tests for HIV-1 antibody. Panels of 10 HIV-1-antibody-positive and antibody-negative plasma samples, some of which were duplicates, were mailed to program-participating laboratories. Laboratories were also mailed survey questionnaires to ascertain their laboratory characteristics and testing practices. Using 1988 data, researchers previously found that the overall analytic performance of laboratories performing HIV-1 antibody testing was independently associated with the following: (1) requiring a minimum degree of testing personnel; (2) having written criteria for identifying unsatisfactory specimens; (3) requiring in-house training for testing personnel; (4) having tested more than 10,000 specimens; (5) being identified as an "other" laboratory type; (6) having more than 24 months of testing experience; (7) laboratory uses specific (Abbott) materials for EIA; and (8) testing specimens collected by family-planning clinics. To verify these findings, we performed multivariate analysis on 1989 performance data. For the 1989 EIA analytic sensitivity, significant positive (P < or = .05) associations were detected with having written criteria for identifying unsatisfactory specimens and with having tested more than 10,000 specimens. For the 1989 overall EIA analytic performance, a significant negative (P < or = .05) association was found with using specific (Abbott) EIA materials, and a significant positive (P < or = .05) association was found with having tested more than 10,000 specimens. For Western blot results, the only significant (P < or = .05) associations were for both analytic sensitivity and overall analytic performance and having tested more than 10,000 specimens.

Blotting, Western↗

PubMed1993

A spreadsheet program measuring laboratory productivity in several ways: an application of College of American Pathology scores and other data to assess the overall economics of clinical laboratories.

A spreadsheet has been designed that measures the productivity of hospital or other clinical laboratories using several methods, one of which, used as a yardstick, is based on College of American Pathology (CAP) workload test scores with some departures from CAP conventions. In this method the CAP-assessed proportion of a laboratory's time utilised in performing pathology or other tests is compared with the time allocated to non-testing departmental activities as a group. A premise in the approach is that variation in the time allocated to these latter activities, in addition to variation in the efficiency of testing, also contributes significantly to the productivity and economics of hospital laboratories. The workload measure of productivity used in the study is referred to as total staff-paid-productivity (TSPP)--allied to paid-productivity of the CAP Manual 1991--and it is suggested that it be used together with several other result parameters to assess laboratories. However, there are two differences from CAP in the TSPP parameter: the salaries and hours of all staff whether medical, technical or scientific are included; and the professional component (time necessary for test interpretation) is also included where applicable. Necessary data include the goods and services costs, the total test-generated income, the total number of full-time staff equivalents and their hours in each unit or work group, the numbers of tests and raw CAP scores and in addition, an estimation of the professional/interpretive component of each test until the generation of a report. The method is illustrated with examples from six different departments with total staff-paid-productivities covering a wide range beyond the typical values of 65 per cent to 75 per cent. When the data for the laboratories are compared, it is observed that the various admixtures of non-testing activities are a stronger influence on differences in total staff-paid-productivity than the interpretative components of tests, although the latter vary markedly from discipline to discipline. When the interpretative components are included in workload measurements, it enables the productivity of different laboratories to be compared across disciplines. It is suggested that for laboratories to generate ongoing productivity they should be staffed at a rate that produces approximately a maximum total staff-paid-productivity of about 75 per cent.

Australia↗

PubMed2000

Planning for the future: the Department of Defense Laboratory Joint Working Group and Global Laboratory Information Transfer.

The Department of Defense (DoD) Laboratory Joint Working Group plans unified laboratory strategy under the auspices of the Armed Forces Institute of Pathology Board of Governors. One goal of the Laboratory Joint Working Group is to advocate clinical integration through automation of data transfer between medical treatment facilities using the DoD standard platform, Composite Health Care System (CHCS). A working group project team is implementing global laboratory information transfer, which enables CHCS-to-CHCS communication throughout the DoD. A prerequisite to global laboratory information transfer is the standardization of laboratory test nomenclature across all CHCS systems using LOINC (Logical Observation Identifiers, Names and Codes). This makes possible easier access to information among caregivers and therapeutic and public health disease managers and enhances global surveillance of disease outbreaks and continuity of care. The end result is the first-ever electronic transfer of laboratory results between all DoD facilities.

Clinical Laboratory Information Systems↗

PubMed2005

[Consulting work performed by the hospital laboratory. The usefulness of the Laboratory Information Office in Keio University Hospital].

To establish a consultation office for handling questions from physicians and other hospital staff is one way to provide laboratory information for effective utilization of laboratory data. Here I introduce the basis of our Laboratory Information Office in Keio University Hospital. A full-time specialized, technologist is stationed in the office. She answers inquiries using a computer database, informs physicians of abnormal laboratory findings and maintains information exhibited on the web site of the clinical laboratory in the intranet of our hospital. The number of consultations is about 280 per month. The most common area of inquiry that of immuno-serology. Cooperation between the technologist and the clinical pathologists makes it possible to respond more efficiently to the inquiries, and in the future could lead to more useful consultations with clinical physicians. In the future, mutual communication between laboratory consultation offices could be arranged to share knowledge. Also, direct consultation with patients concerning laboratory examinations should be considered, though this may be difficult to implement.

Clinical Laboratory Information Systems↗

PubMed2005

Knowledge, attitude and practice of aspects of laboratory safety in Pathology Laboratories at the University of Port Harcourt Teaching Hospital, Nigeria.

OBJECTIVE: To assess current knowledge, attitudes and practice of aspects of laboratory safety in pathology laboratories at the University of Port Harcourt Teaching Hospital in view of perceived inadequacies in safety practices in clinical laboratories in developing countries. MATERIALS AND METHODS: Sixty (60) self- administered questionnaires were distributed to all cadres of staff in four (4) different laboratories (Chemical Pathology, Haematology, Blood bank and Medical Microbiology) at the Hospital. RESULT: Gross deficiencies were found in the knowledge, attitudes and practice of laboratory safety by laboratory staff in areas of use of personal protective equipment, specimen collection and processing, centrifuge--related hazards, infective hazards waste disposal and provision and use of First Aid Kits. CONCLUSION: Issues pertaining to laboratory safety are not yet given adequate attention by both employers and employees in developing countries in this ear of resurgence of diseases such as HIV/AIDS and Hepatitis Band C, is emphasized.

Acquired Immunodeficiency Syndrome↗

PubMed1996

Laboratory precision performance: state of the art versus operating specifications that assure the analytical quality required by clinical laboratory improvement amendments proficiency testing.

OBJECTIVE: To estimate the percent of laboratories with precision performance sufficient to satisfy the operating specifications and guarantee the quality required by the proficiency testing criteria defined by the Clinical Laboratory Improvement Amendments of 1988 (CLIA). DESIGN: Cumulative distributions that describe state-of-the-art laboratory imprecision were obtained for 1500 laboratories participating in the 1990 College of American Pathologists Quality Assurance Service. Allowable imprecision was estimated from the x-intercepts of charts of operating specifications prepared for commonly used single and multirule quality control procedures having two to four control measurements per run. MAIN OUTCOME MEASURE: The derived values for allowable imprecision were imposed on the cumulative distributions to obtain graphical estimates of the percent of laboratories satisfying the operating specifications. RESULTS: Up to 28% of laboratories achieve the imprecision allowable for albumin, up to 64% for total bilirubin, 52% for calcium, 35% for chloride, 48% for cholesterol, 28% for cortisol, 84% for creatinine, 9% for digoxin, 61% for glucose, 64% for high-density lipoprotein cholesterol, 88% for hemoglobin, 95% for potassium, 66% for total protein, 18% for sodium, 29% for thyroxine, 87% for triglycerides, 35% for urea nitrogen, and 81% for uric acid. CONCLUSION: Improvements in precision are still needed for many laboratory tests to assure the analytical quality required by the CLIA proficiency testing total error criteria.

Blood Chemical Analysis↗

PubMed1998

Do we know what inappropriate laboratory utilization is? A systematic review of laboratory clinical audits.

OBJECTIVE: Laboratory utilization has steadily increased, and some studies suggest inappropriate utilization. Therefore, we wished to assess studies that measure inappropriate laboratory use in light of methodological criteria. DESIGN: Systematic review of published studies. DATA SOURCES: MEDLINE, HEALTHSTAR, and EMBASE databases were searched from 1966 to September 1997 using a broad and inclusive strategy with no language restriction. In addition, the references of all retrieved studies and 3 textbooks on diagnostic testing were hand-searched. STUDY SELECTION: All studies that provided and applied criteria for inappropriate laboratory use. DATA EXTRACTION: Studies were categorized based on whether the criteria were implicit (objective criteria for inappropriate utilization not provided or very broad) or explicit. Guidelines for evaluation were applied to each study by a single reviewer. DATA SYNTHESIS: Forty-four eligible studies were identified. Eleven studies used implicit criteria for inappropriate laboratory utilization and contained small numbers of patients or physicians. Most did not adequately assess the reliability of the implicit criteria. Thirty-three studies used explicit criteria based on the appropriateness of test choice, frequency, and timing, as well as the probability of a positive result. There were large variations in the estimates of inappropriate laboratory use (4.5%-95%). Evidence supporting the explicit criteria was frequently weak by the standards suggested for therapeutic maneuvers, but was nonetheless compelling based on principles of physiology, pharmacology, and probability. CONCLUSIONS: Many studies identify inappropriate laboratory use based on implicit or explicit criteria that do not meet methodological standards suggested for audits of therapeutic maneuvers. Researchers should develop alternative evidentiary standards for measuring inappropriateness of laboratory test use.

Clinical Laboratory Techniques↗

PubMed2003

Clinical laboratory consultation: appropriateness to laboratory medicine.

New and expensive treatments, introduction of difficult to interpret complex tests, a greater reliance on nurse practitioners as deliverers of primary care and patient initiated testing, all make it likely that in the future greater emphasis will be placed on appropriate use of cost-effective laboratory tests. The most promising solution to inappropriate utilization of laboratory services is a greater reliance on clinical laboratory consultants. At present, many laboratory physicians and scientists cannot compete with specialist physicians in terms of the ability to provide credible helpful advice on test selection and results interpretation. Educational prerequisites to effective consultation are: understanding of disease pathogenesis, knowledge of clinical problem solving and identification with clinical questions. The latter requires clinical experience or intensive training in clinical laboratory consultation. Further barriers to implementation of comprehensive laboratory consultation services include resistance on the part of practicing physicians, health care administrators and insurers. Whether these barriers can be overcome or not, the future will include comprehensive laboratory consultation services conducted through web-based access to advice on test selection and interpretation of results.

Clinical Laboratory Techniques↗

PubMed2006

Comparability of laboratory diagnosis and antimicrobial susceptibility testing of Neisseria gonorrhoeae from reference laboratories in Western Europe.

OBJECTIVES: The aim of this study was to obtain information on the comparability of methods for the laboratory diagnosis of bacterial sexually transmitted infections (STIs) that contribute to the surveillance data in the European Union (EU) and Norway. Surveillance of bacterial STIs is important across Europe because of the movement of individuals between countries at a time when STI incidence appears to be increasing in many countries. METHODS: Cross-sectional survey using a questionnaire, to provide information on laboratory methods for the diagnosis of gonorrhoea, and a panel of strains of Neisseria gonorrhoeae, to compare susceptibility testing, was circulated to laboratories in the EU and Norway. RESULTS: The questionnaire revealed marked diversity in the methodologies used for the laboratory diagnosis of gonorrhoea across Europe. Fourteen laboratories participated in an exchange of gonococcal strains to assess the methodology in current use for susceptibility testing. The methods included disc diffusion and determination of the minimum inhibitory concentration (MIC) using agar dilution and/or Etest. There was no common method used, each centre varied from another by at least one procedure. Overall agreement using all methods was >70%, being highest for ceftriaxone and lowest for tetracycline. Disc diffusion gave the lowest agreement with the consensus compared with determination of MIC by either agar dilution or Etest. CONCLUSIONS: A variety of methods were used across the EU and Norway for the laboratory diagnosis and susceptibility testing and resulted in poor concordance between laboratories on the definition of resistant N. gonorrhoeae. This suggests that there is a need for greater standardization of methodology that provides surveillance data in the EU and Norway.

Anti-Bacterial Agents↗

PubMed1999

Report of the Australian National Polio Reference Laboratory. 1 January 1999 to 30 June 1999. Towards WHO certification as wild poliovirus-free: laboratory surveillance in Australia.

Since 1994 the Australian National Polio Reference Laboratory at the Victorian Infectious Diseases Reference Laboratory has been responsible for virological confirmation of the eradication of poliomyelitis in Australia. The laboratory is also a World Health Organization Western Pacific regional polio reference laboratory and the national polio laboratory for the Pacific Island countries and for Brunei Darussalam. It is now over two years since the last case of poliomyelitis was detected in the Western Pacific region of the World Health Organization. The co-operation of staff in all laboratories where polioviruses are handled and where samples from acute flaccid paralysis (AFP) patients are submitted is required until Australia and the region can be declared wild poliovirus-free. The characterisation of all polioviruses isolated in Australia in this reporting period led to the apparent detection of a non Sabin vaccine-like poliovirus in an environmental sample. The virus was found to be identical to a laboratory control isolate by sequencing. The environmental virus is therefore characterised as a contaminant, not a wild isolate. The investigation is outlined in this article, as well as the results of investigation and characterisation of all referred polioviruses.

Acute Disease↗

PubMed1992

Medicare program; Medicare and laboratory certification program; enforcement procedures for laboratories--HCFA. Final rule.

These regulations set forth the rules for sanctions that HCFA may impose on laboratories that are found not to meet Federal requirements. These include the principal sanctions of suspending, limiting, or revoking the laboratory's certificate issued under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), and cancelling the laboratory's approval to receive Medicare payment for its services, and the alternative sanctions that may be imposed instead of or before the principal sanctions. These amendments are necessary to conform HCFA regulations to changes made in the law by the Omnibus Budget Reconciliation Act of 1987 (OBRA '87) and the 1988 amendments to section 353 of the Public Health Service Act (PHS Act). The latter are commonly referred to as "CLIA 88". The purpose of the amendments is to ensure that functioning laboratories are capable of providing accurate and reliable test results and that the health of individuals served by the laboratory and that of the general public is not adversely affected by laboratory operations and by testing procedures that do not meet the standards set forth in other subparts of part 493 of the HCFA regulations.

Centers for Medicare and Medicaid Services, U.S.↗

PubMed2000

[Clinical laboratory physicians and postgraduate training for laboratory technologists].

The number of clinical laboratory physicians is currently about 400, and is estimated to reach, at most, 1,500 after 20 years, even if we train 50 young clinical laboratory physicians every year. This is too few to display their abilities and to prove themselves as necessary specialists in the Japanese medical world. However, the number of laboratory technologists in Japanese hospitals and clinics is currently about 50,000. If we train excellent technologists to take part in the work of clinical laboratory physicians, we will be able to prove ourselves as necessary specialists in about 20 years. Postgraduate training for laboratory technologists is necessary to increasing their abilities and increasing the number of specialists in laboratory medicine. We consider this is the most effective method of developing Japanese laboratory medicine in the 21st century.

Education, Graduate↗

PubMed2000

A reference method laboratory network for cholesterol: a model for standardization and improvement of clinical laboratory measurements.

BACKGROUND: Accurate and precise measurement of blood cholesterol plays a central role in the National Cholesterol Education Program's strategy to reduce the morbidity and mortality attributable to coronary heart disease. Matrix effects hamper the ability of manufacturers to adequately calibrate and validate traceability to the National Reference System for Cholesterol (NRS/CHOL). CDC created the Cholesterol Reference Method Laboratory Network (CRMLN) to improve cholesterol measurement by assisting manufacturers of in vitro diagnostic products with validation of the traceability of their assays to the NRS/CHOL. METHODS: CRMLN laboratories established the CDC cholesterol reference method (modification of the Abell-Levy-Brodie-Kendall chemical method) and are standardized using CDC frozen serum reference materials. CRMLN laboratories use common quality-control materials and participate in monthly external performance evaluations conducted by CDC. The CRMLN performance criteria require member laboratories to agree with CDC within +/-1.0% and maintain a CV < or =2.0%. RESULTS: From 1995 to 200 the CRMLN laboratories met the accuracy criterion 97% of the time and the precision criterion 99% of the time. During this time period, the CRMLN maintained an average bias to CDC of 0.01% and an average collective CV of 0.33%. CONCLUSIONS: CDC established the CRMLN as the first international reference method laboratory network. The CRMLN assists manufacturers in the validation of the calibration of their diagnostic products so that clinical laboratories can measure blood cholesterol more reliably. The CRMLN can serve as a model for other clinical analytes where traceability to a hierarchy of methods is needed and matrix effects of the field methods with processed calibrators or reference materials are present.

Calibration↗

PubMedDate not supplied

Washington Clinical Laboratory Initiative: a vision for collaboration and strategic planning for an integrated laboratory system.

This article addresses the importance of public health, hospital, and clinical laboratories in the role of patient care, disease prevention, and surveillance. It also focuses on the coordination and planning that needs to take place between these institutions in order to develop a more cost-effective and responsive laboratory delivery system. The Washington Clinical Laboratory Initiative is an innovative state initiative illustrating that coordinated and integrated strategic planning of public and private sector laboratories can be accomplished within a state. It also has increased interaction, collaboration, and communication between health practitioners, health plans, hospitals, laboratories, government agencies, and academicians. This accomplishment has enabled the establishment of public policy concerning laboratory reimbursement and development of standards of laboratory practice.

Clinical Laboratory Information Systems↗

PubMed2002

[Laboratory logistics for infectious diseases--from clinical laboratory physicians].

The diagnosis of bacterial meningitis rests on examination of the CSF. The gross appearance of the fluid may be cloudy or turbid if the white cell count is elevated. Gram's staining should always be used in examining CSF, as it permits rapid and accurate identification of the etiologic agent in approximately 60 to 90 percent of cases of bacterial meningitis. The CSF culture is positive in approximately 70 to 85 percent of patients with bacterial meningitis. Many other rapid diagnostic tests have been developed to aid in the diagnosis of bacterial meningitis when Gram's staining gives negative results. Nevertheless, newer techniques are more rapid and sensitive, postgraduate training in laboratory medicine should include basic clinical skills (Communication skills, physical examination and common laboratory procedures such as Gram's stain, Wright-Giemsa stain, etc.) and 24 hours on-call service system by laboratory physicians. It must not be focused solely on the sophistication of laboratory methods. We must notice that an increasing gap between the clinic and the laboratory. Current needs require us to make a major attempt to bridge this gap. We, laboratory physicians must modify our behavior effectively and accept the value and limitations of laboratory automation and information technology. We must work more closely with physicians and other health care professionals to establish a good collaborative partnership with them.

Bacteriological Techniques↗

PubMed2006

Comparison of sexual compatibility between laboratory and wild Mexican fruit flies under laboratory and field conditions.

The sexual compatibility between laboratory (LF) and wild (WF) strains of the Mexican fruit fly, Anastrepha ludens (Loew), was analyzed using analogous methodologies and experimental arenas under both laboratory and field conditions. Sexual compatibility was quantified with the following indices: the isolation index (ISI), male relative performance index (MRP), female relative performance index (FRPI), and the relative sterility index (RSI). ISI detected a certain level of incompatibility between strains under both laboratory and field conditions, because LF females tended to mate with LF males. LF mating performance was higher under laboratory than under field conditions. The relative performance indices for LF and the relative sterility index were higher in the laboratory than in the field. Differences between LF and WF in the times that males started calling and mating were observed in both environments. Importantly, WF males reduced their sexual activity under laboratory environments, whereas LF maintained similar activity levels in both conditions. The possible applications of the above-mentioned methods, not only to assess fly quality but also to determine the suitability of conditions in mass-rearing facilities, are discussed. Correlating laboratory quality to sexual behavior may contribute in the development of environmental parameters for mass-rearing facilities.

Animals↗

PubMed1989

Evolving concepts of quality in laboratory practice. A historical overview of quality assurance in clinical laboratories.

Early concepts of quality in clinical laboratory services stressed accuracy and precision. In the 1960s voluntary and mandated programs for laboratory accreditation followed. The increasing complexity of laboratory standard setting led to the promulgation of voluntary consensus standards in the 1970s. This was followed by a national reference system to minimize bias among clinical laboratories. The concept of total quality control emphasized that quality assurance must be a way of life for laboratorians, and concerns about growing laboratory volume led to the idea that managing laboratory utilization is also a component of quality assurance. Recent conferences have expanded the concept of laboratory quality to encompass everyone who participates, even remotely, in the provision of services. Now quality is evaluated by how well the patient is served.

Certification↗