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PubMed1978

Effective utilization of clinical laboratories.

Effective utilization of clinical laboratories requires that underutilization, overutilization, and malutilization be appreciated and eliminated or reduced. Optimal patient care service, although subjective to a major extent, is reflected in terms of outcome and cost. Increased per diem charges, reduced hospital stay, and increased laboratory workload over the past decade all require each laboratory to examine its internal operations to achieve economy and efficiency as well as maximal effectiveness. Increased research and development, an active managerial role on the part of pathologists, internal self-assessment, and an aggressive response to sophisticated scientific and clinical laboratory data base requirements are not only desirable but essential. The importance of undergraduate and graduate medical education in laboratory medicine to insure understanding as well as effective utilization is stressed. The costs and limitations as well as the accuracy, precision, sensitivity, specificity, and pitfalls of measurements and examinations must also be fully appreciated. Medical malpractice and defensive medicine and the use of critical values, emergency and routine services, and an active clinical role by the pathologist are of the utmost value in assuring effective utilization of the laboratory. A model for the optimal use of the laboratory including economy and efficiency has been achieved in the blood bank in regard to optimal hemotherapy for elective surgery, assuring superior patient care in a cost effective and safe manner.

Clinical Laboratory Techniques↗
PubMed2000

Potential impact of a computerized system to report late-arriving laboratory results in the emergency department.

BACKGROUND: Results of some laboratory tests for Emergency Department (ED) patients return hours to days after the patient is discharged. Inadequate follow-up for these late-arriving results poses medical and legal risks. We have developed, but not yet implemented, a computerized system called the Automated Late-Arriving Results Monitoring System (ALARMS). ALARMS scans the hospital's laboratory and ED registration databases to generate an electronic daily log of all late-arriving abnormal laboratory results for ED patients. OBJECTIVE: To determine the potential impact of ALARMS by assessing our ED's current quality of documented follow-up of late-arriving laboratory results. METHODS: We applied ALARMS retrospectively, to find all abnormal late-arriving laboratory results returned between 5/1/96 and 4/30/98 for ED patients for the following three tests: serum lead levels, Chlamydia cultures, or urine pregnancy tests. Medical records were reviewed for documentation of follow-up, which was considered appropriate if a clinician noted the abnormal result and documented a follow-up plan within 1 week after the result became available. Medical records were also reviewed for any evidence of complications attributable to delayed or inadequate follow-up. RESULTS: Over the 2-year study period, no appropriate follow-up was documented in 6/18 (33%) cases of elevated lead levels, 3/4 (75%) cases of late-arriving positive pregnancy tests, and 23/39 (59%) cases of positive Chlamydia cultures. One case of a positive Chlamydia culture, for which there was no documented follow-up, was associated with subsequent development of pelvic inflammatory disease. CONCLUSION: Our current system of documented follow-up for late-arriving laboratory results has deficiencies. ALARMS, a computerized system of alerts for emergency physicians, has the potential to substantially improve documented follow-up of late-arriving laboratory results in the ED.

Aftercare↗
PubMed2006

Recommended standards for modern tuberculosis laboratory services in Europe.

The principles underpinning these standards are that any tuberculosis laboratory-based diagnostic procedure should be performed by appropriately trained staff, working to standardised operating procedures in appropriately equipped and safe laboratories, against clear national and international proficiency and quality standards. Quality should be the pre-eminent criteria, not cost. The standards are technologically feasible, but initially may not be within the financial capacity of all laboratories. There is a requirement for government and international donors to adequately fund an appropriate safe infrastructure to enable staff to deliver accurate and timely results at whatever level of activity they are performing. There is a need for national reference laboratories to train a new cadre of mycobacterial laboratory experts. This will require the funding of appropriate individuals at these centres to train and assist in the implementation of good laboratory practice and evaluation to build sustainable capacity. Further operational research is needed to establish the optimal configuration of new technologies to determine isoniazid, rifampicin and second-line drug susceptibility in mycobacterial cultures and also, increasingly, directly on specimens. Improved integration of laboratory medicine as a core part of all tuberculosis programmes is needed to achieve and maximise the potential of new developments.

Clinical Laboratory Techniques↗
PubMed2006

Laboratory network of excellence: enhancing patient safety and service effectiveness.

Clinical laboratories have undergone major changes due to technological progress and economic pressure. While costs of laboratory testing continue to be the dominant issue within the healthcare service worldwide, quality, effectiveness and impact on outcomes are also emerging as critical value-added features. Five Italian laboratories are therefore promoting a network of excellence by investigating markers of effectiveness of laboratory services and sharing their experience of using them in clinical practice. In the present study we report preliminary data on indicators of quality in all phases of the so-called total testing process, the key to evaluating all phases of the total testing process, including the appropriateness of test requests and data interpretation. Initial findings in evaluating pre-analytical causes of specimen rejection in three different laboratories and the effects of introducing three laboratory clinical guidelines are reported. These data should stimulate debate in the scientific community and encourage more clinical laboratories to use the same indicators to improve clinical effectiveness and clinical outcomes within the healthcare service.

Clinical Laboratory Techniques↗
PubMedDate not supplied

Restructuring clinical laboratories in Ontario--a '90s revolution.

The results of the first-ever province-wide survey of laboratory restructuring initiatives in Ontario, Canada are presented. These initiatives coincide with the historically largest financial cuts to the publicly funded health-care delivery system in Ontario, Canada's most populous province. The laboratory system includes both public hospital and commercial sectors. A survey was mailed to every laboratory director in the province, with a 73% response rate from the hospital sector. The results show that most hospital laboratories are restructuring, the bed count of the hospital is not a determinant of change, and downsizing and multiskilling of staff are the most frequent strategies. Many hospital laboratories were also considering regional alliances or contracting out part or all of their services. Also, the survey showed that the majority of laboratories in community hospitals did not have Laboratory Information Systems, in contract to the situation in teaching facilities. Most hospitals employed some form of utilization management, with the most popular being education of their users. Many respondents viewed the effect of these changes on staff morale with disquiet and expressed anxiety about the potential adverse effects on quality. In many ways, these findings mirror those reported in the United States.

Clinical Laboratory Information Systems↗
PubMed1992

Specific list for categorization of laboratory test systems, assays and examinations by complexity--PHS. Notice with comment period.

The Clinical Laboratory Improvement Amendments of 1988, Public Law 100-578, requires that the Secretary provide for the categorization of specific laboratory test systems, assays and examinations by level of complexity. 42 CFR 493.17, published elsewhere in this issue of the Federal Register, establishes criteria for such categorization. It is the Department's intention to complete the categorization of all currently available clinical laboratory test systems, assays and examinations prior to the effective date of the amendments to 42 CFR Part 493 (September 1, 1992). This Notice announces the first of a series of lists containing specific clinical laboratory test systems, assays and examinations, categorized by complexity. Additional lists of test systems, assays and examinations will be published periodically. On or before September 1, 1992, a complete list of all laboratory test systems, assays and examinations, categorized by complexity, will be published in the form of a compilation of these Notices. Any clinical laboratory test system, assay or examination that is not on that final list will be considered high complexity, until categorized otherwise, as provided under 42 CFR 493.17. After publication of the compilation, applications will be taken to categorize (or recategorize) other laboratory test systems, assays and examinations following the procedures delineated in 42 CFR 493.17(d). Notices will be published periodically in the Federal Register to announce any additional test system, assay or examination that has been categorized (or re-categorize) during the preceding interval.

Autoanalysis↗
PubMedDate not supplied

Laboratory apprenticeships: a look back in history or a new paradigm?

The reality of the world and the workplace is changing rapidly, and continuing the "old" ways will not provide the solutions needed to address the problems the health-care industry faces today. "The organization of the laboratory, as we now know it, will change. An environment in which every instrument is run by highly trained medical technologists is not likely to be the norm. Instead, laboratories will be staffed by lesser trained technicians under the direction of a limited number of medical technologists.... Licensing and regulatory trends for laboratories will support the downgrading of the average level of laboratory expertise required to perform tests". Similarly, in 1993 a regional director of the National Labor Relations Board (NLRB) ruled that many medical technologists do not meet the NLRB definition of professional because they perform highly automated and routine work that does not require the consistent exercise of discretion and judgment. Does the laboratory industry need to have all of its work done by highly trained medical technologists? A look at current laboratories would seem to answer that question as "no." On the other hand, do we need highly trained medical technologists in the laboratories? The answer is yes, but it is apparent that medical technologists of the future need to prepare themselves in new ways to address future demands on the profession.(ABSTRACT TRUNCATED AT 250 WORDS)

Clinical Laboratory Techniques↗
PubMedDate not supplied

Computer programs that teach the interpretation of image-based laboratory tests.

OBJECTIVE: To review the effort of the University of Washington (UW) Department of Laboratory Medicine to develop and use personal computer programs to teach the interpretation of image-based clinical laboratory tests to medical technologists and other health care workers. DATA SOURCES: Professional journals and books; Software owned by and licensed by the University of Washington. STUDY SELECTION: Not applicable. DATA EXTRACTION: Not applicable. DATA SYNTHESIS: We have been developing interactive personal computer (PC) programs for teaching image-based laboratory tests to medical technologists and other health care workers. The programs, called "Laboratory Tutors," are useful for teaching microscope-based tests and tests based on electrophoresis. Our programs include ANA-Tutor, which teaches the immunofluorescence assay for anti-nuclear antibodies; Gram Stain-Tutor, which teaches the direct Gram stain; Electrophoresis-Tutor, which teaches the interpretation of agarose gel protein electrophoretic patterns; Urinalysis-Tutor, which teaches the microscopic examination of urine sediment; in addition to other programs. The tutorials are all based on high-quality digital images that were acquired and processed using digital imaging systems. They require minimal computer literacy and have a number of advantages over standard approaches to teaching image-based laboratory tests. The computer tutorials are used in UW's medical technology and medical school curriculum, where they are used as supplements to traditional instruction. CONCLUSION: Laboratory tutors are computer programs that use high resolution digital images to teach the interpretation of image-based laboratory tests. We plan to continue to develop these programs, study their educational effectiveness, and update them periodically.

Clinical Laboratory Information Systems↗
PubMed1999

The influence of an expert system for test ordering and interpretation on laboratory investigations.

BACKGROUND: The Laboratory Advisory System (LAS) is an expert system interface that works interactively with clinicians to assist them with test selection and result interpretation throughout the laboratory investigation of a patient. METHODS: To study the influence of the LAS on laboratory investigations, a repeated-measures experiment using clinical vignettes was conducted. To collect baseline data on how laboratory investigations are currently conducted, clinicians investigated one-half of the vignettes using a conventional (noncomputer) approach. To determine the influence of the LAS on clinicians' behavior, the other half of the vignettes were investigated using the LAS. RESULTS: Clinicians using the LAS (compared with conventional practice) ordered fewer laboratory tests during the diagnostic process (mean, 17.8 vs 32.7), completed the diagnostic workup with fewer sample collections (mean, 5.8 vs 7.5), generated lower laboratory costs (mean, $194 vs $232), shortened the time required to reach a diagnosis (mean, 1 day vs 3.2 days), showed closer adherence to established clinical practice guidelines, and exhibited a more uniform and diagnostically successful investigation. CONCLUSION: The LAS enhances the outcome of the investigation and improves laboratory utilization.

Clinical Laboratory Information Systems↗
PubMedDate not supplied

Tracing our roots: a new era in clinical laboratory science education.

OBJECTIVE: To describe the emergence of laboratory personnel at the technician and assistant levels and discuss educational issues that arose between 1962 and 1977. DESIGN: A survey of literature on the history of clinical laboratory science (CLS) was conducted. References consulted include various books and professional journals. CONCLUSION: Advances in scientific and medical knowledge and the development of new technologies created new roles and responsibilities for medical technologists (MTs) in the areas of education, research, and laboratory management. At the same time, the certified laboratory assistant (CLA) category was established as a means of providing competent personnel to work in physician office laboratories and small community hospitals in lieu of a certified MT. The growth in popularity of two-year colleges and the availability of federal funding for the development of allied health programs led to the establishment of yet another category of laboratory personnel: the medical laboratory technician (MLT). These developments prompted educators to modify their CLS curricula, develop educational programs at the CLA and MLT levels, and provide opportunities to CLAs, and MLTs for upward mobility. Furthermore, once the Board of Registry (BOR) established the baccalaureate degree as the prerequisite for MT certification, educators also began to restructure and more closely integrate the academic and clinical components of MT programs.

Education, Professional↗
PubMed2002

Can post-eradication laboratory containment of wild polioviruses be achieved?

The purpose of containment is to prevent reintroduction of wild polioviruses from laboratories into polio-free communities. In order to achieve global commitment to laboratory containment the rationale should be clear and compelling; the biosafety levels should be justified by the risks; and the objectives should be realistic. Absolute containment can never be assured. Questions of intentional or unintentional non-compliance can never be wholly eliminated. Effective laboratory containment is, however, a realistic goal. Prevention of virus transmission through contaminated laboratory materials is addressed by WHO standards for biosafety. The principal challenge is to prevent transmission through unrecognized infectious laboratory workers. Such transmission is possible only if the following conditions occur: infectious and potentially infectious materials carrying wild poliovirus are present in the laboratory concerned; a laboratory operation exposes a worker to poliovirus; a worker is susceptible to an infection that results in the shedding of poliovirus; and the community is susceptible to poliovirus infections. At present it is difficult to envisage the elimination of any of these conditions. However, the risks of the first three can be greatly reduced so as to create a formidable barrier against poliovirus transmission to the community. Final biosafety recommendations must await post-eradication immunization policies adopted by the international community.

Humans↗
PubMedDate not supplied

The value of the laboratory professional in the continuum of care.

The community laboratory often is relegated to the subterranean levels of the hospital, and it feels, at times, that the laboratory profession has been put in the basement as well. It is incumbent upon those of us who work in the clinical laboratory to ensure that the daily contributions made by the laboratory to the lives of our patients are not overlooked by our colleagues or by the future generation of laboratorians. We can expand our parochial view of the laboratory and begin to understand and to achieve the institutional goals of cost-effective patient care. Using a data-driven approach, we can articulate the real benefits of delivering quality laboratory service near the patient and secure the institution's investment in that core competency. Fostering the growth of community laboratory insourcing compounds these benefits and provides an environment for the creation of job enrichment opportunities.

Benchmarking↗
PubMed1993

[Standardization in clinical laboratory--its national and international activities].

In order to obtain comparability among laboratory results obtained by different laboratories, standardization is necessary in all steps related to clinical laboratory practice. Standardization in clinical laboratory is a consensus process among professional, industrial and governmental organizations. Everyone concerned in clinical laboratory practice should try to follow those consensus proposed. The International Organization for Standardization (ISO) is a key international body which is represented by many different national organizations. World Health Organization (WHO) plays an important role in medical field, but many non-governmental organizations (NGO) such as the World Association of Societies of Pathology (WASP), the International Federation for Clinical Chemistry (IFCC) and others also contribute significantly. In 1975, the National Committee for Clinical Laboratory Standards (NCCLS) was established in USA and has been the most active. In 1985, The Japanese Committee for Clinical Laboratory Standards (JCCLS) was established as some other CCLS in different European countries. National activity for establishing many reference materials in Japan is briefly reviewed.

Clinical Laboratory Techniques↗
PubMed1998

Comparison of routine flow cytometric DNA analysis of fresh tissues in two laboratories: effects of differences in preparation methods and background models of cell cycle calculation.

Routine flow cytometric DNA analysis was compared in two laboratories by using matched fresh-frozen breast cancer and soft tissue sarcoma biopsy specimens. Laboratory I applied the Vindelöv preparation method and an exponential background subtraction algorithm in the cell cycle calculation. Laboratory II used the Formalin-protease preparation technique and the sliced-nuclei background model. The results of the ploidy analysis showed good agreement between the two laboratories; however, the results of the cell cycle analysis showed considerable systematic differences between labs. Laboratory I obtained significantly lower values of S-phase fraction and higher values of G2-phase fraction than laboratory II. To explain these discrepancies, the effects of differences in the preparation methods and background subtraction algorithms were studied. The Vindelöv preparation method yielded higher debris and aggregation levels than the Formalin-protease technique and tended to give higher %S and %G2 values. When the two background models were used in the same histograms, the exponential background model tended to give %S values distinctly lower than and %G2 values almost identical to those obtained with the sliced-nuclei algorithm. The sum of these effects accounts for the observed inter-laboratory discrepancies. Different from the sliced-nuclei fit, the exponential background fit often did not accommodate to the original data in the <2c histogram region and resulted in a considerable inter-operator variability of %S calculation in histograms with <5% S. When aggregate correction was added to the sliced-nuclei algorithm, the differences between %S values in histograms from the two laboratories almost disappeared.

Algorithms↗
PubMed2004

Inter-laboratory analysis of endotoxin in cotton dust samples.

BACKGROUND: Currently there are no mandated exposure limits for endotoxin, but recommended limits have been proposed and interest expressed in developing quantitative standards for endotoxin. A limitation for developing a quantitative standard for endotoxin is the measurement variability between laboratories. Inter-laboratory variability of up to four orders of magnitude has been reported for replicate samples. To evaluate both the intra- and inter-laboratory variability, Round-Robin studies were conducted using replicate samples of cotton dust. METHODS: Replicate samples of cotton dust were collected using vertical elutriators (VE) in a model cardroom. Each participating laboratory evaluated the samples for endotoxin using: their normal extraction procedure; a common extraction procedure; and a common extraction procedure and the same type and lot of a commercially available endotoxin kit. RESULTS: These studies demonstrated that both intra- and inter-laboratory variability is reduced by using a common extraction protocol and a common assay kit; however, significant differences remained between the laboratories. CONCLUSIONS: The data suggest that intra-laboratory assays can be used to assess the relative differences between endotoxin samples, however, the inter-laboratory variability suggests that limitations remain for developing a reliable exposure assessment assay that could be used for a quantitative exposure standard.

Air Pollutants, Occupational↗
PubMed1994

Comparative toxicity of azinphos-methyl to house mice, laboratory mice, deer mice, and gray-tailed voles.

A laboratory toxicity study on house mice and laboratory mice (Mus musculus), gray-tailed voles (Microtus canicaudus), and deer mice (Peromyscus maniculatus) was conducted as part of a comprehensive laboratory and field study to field validate laboratory-based risk assessment of pesticides. The single dose oral LD50 for the organophosphorus insecticide azinphos-methyl (Guthion) was 10, 11, 32, and 48 mg/kg body weight in wild house mice, laboratory mice, gray-tailed voles, and deer mice, respectively. Ten-day dietary LC50s were 277 ppm for laboratory mice, 297 ppm for gray-tailed voles, and 1,180 ppm for deer mice. All treated animals lost more weight, consumed less food, and had depressed brain cholinesterase (ChE) activity compared to controls. Five-day LC50s were significantly higher than 10-day LC50s for laboratory mice and deer mice. For all three species, animals that died during dietary LC50 tests had mean ChE activity of 50-55% while survivors had 56-70% of controls. The conclusions were that: (1) Laboratory mice were not representative of deer mice or gray-tailed voles with respect to sensitivity to azinphos-methyl, but provided a conservative estimate for risk assessment; (2) 10-day dietary LC50 tests indicate substantially greater estimates of toxicity of azinphos-methyl to rodents than do 5-day tests; and (3) brain ChE depression of 45-50% was lethal in these species.

Animals↗
PubMed2004

Comparison of laboratory single species and field population-level effects of the pyrethroid insecticide lambda-cyhalothrin on freshwater invertebrates.

The toxicity of the pyrethroid insecticide lambda-cyhalothrin to freshwater invertebrates has been investigated using data from short-term laboratory toxicity tests and in situ bioassays and population-level effects in field microcosms. In laboratory tests, patterns of toxicity were consistent with previous data on pyrethroids. The midge Chaoborus obscuripes was most sensitive (48- and 96-h EC50 = 2.8 ng/L). Other insect larvae (Hemiptera, Ephemeroptera) and macrocrustacea (Amphipoda, Isopoda) were also relatively sensitive, with 48- and 96-h EC50 values between 10 and 100 ng/L. Generally, microcrustacea (Cladocera, Copepoda) and larvae of certain insect groups (Odonata and Chironomidae) were less sensitive, with 48-h EC50 values higher than 100 ng/L. Mollusca and Plathelminthes were insensitive and were unaffected at concentrations at and above the water solubility (5 microg/L). Generally, the EC50 values based on initial population responses in field enclosures were similar to values derived from laboratory tests with the same taxa. Also, the corresponding fifth and tenth percentile hazard concentrations (HC5 and HC10) were similar (laboratory HC5 = 2.7 ng/L and field HC5 = 4.1 ng/L; laboratory and field HC10 = 5.1 ng/L), at least when based on the same sensitive taxonomic groups (insects and crustaceans) and when a similar concentration range was taken into account. In the three field enclosure experiments and at a treatment level of 10 ng/L, consistent effects were observed for only one population (Chaoborus obscuripes), with recovery taking place within 3 to 6 weeks. The laboratory HC5 (2.7 ng/L) and HC10 (5.1 ng/L) based on acute EC50 values of all aquatic arthropod taxa were both lower than this 10 ng/L, a concentration that might represent the "regulatory acceptable concentration." The HC5 and HC10 values in this study in The Netherlands (based on static laboratory tests with freshwater arthropods) were very similar to those derived from a previous study in the United Kingdom (1.4 and 3.3 ng/L). This suggests that for pesticides like lambda-cyhalothrin, HC5 values based on static laboratory tests may provide a conservative estimate of the potential for community-level effects under field conditions. While these HC5 values are conservative for initial effects, they do not provide information on recovery potential, which may be important for regulatory decision-making.

Animals↗
PubMed1984

Statistical evaluation of inter- and intra-laboratory variations of the Ames test, as related to the genetic stability of Salmonella tester strains.

A statistical analysis was performed on the data resulting from an international collaborative study of the Ames test according to a standardized experimental protocol, which involved the comparative testing of 4NQO (4 doses), in 3 separate experiments for each of the 38 participating laboratories, by using a common reference (R) culture and in-house laboratory (L) cultures of 5 strains of S. typhimurium. Despite some toxicity phenomena recorded at the highest dose of 4NQO, the majority of the dose-response curves in individual laboratories were linear on a bi-log scale and their mean values fitted a linear regression framework. Scattering of data around mean values of laboratories was Gaussian-like even at the highest dose of 4NQO, toxic effects being expressed as a dose-related increase of variance. A weighted least-square analysis could therefore take into account toxic effects without resorting to a sophisticated non-linear model incompatible with log transformation. Various analytical approaches--e.g. the weighted estimates of linear regression parameters, a multifactor (laboratory, experiment, dose, culture of each strain) analysis of variance with all the possible interactions, the assessment of correlations in individual laboratories and of coefficients of variation for induced and spontaneous mutability--could detect some statistically significant differences between L and R cultures. However, at a critical evaluation on an individual basis, only few of these differences, without any peculiar involvement of given strains, were convincing in view of the existence of real phenomena of genetic drift. Therefore, on the whole, the genetic drift of Salmonella tester strains appears to lend a negligible contribution to the considerable inter- and intra-laboratory variability detected in this study. With a background variability between replications averaging 26%, a dose-related variability was evident both between experiments (28-54%) and between laboratories (44-127%).

4-Nitroquinoline-1-oxide↗