Laboratory Survey Research Articles

Medical laboratories in sub-Saharan Africa that meet international quality standards.

A recent survey of laboratories in Kampala, Uganda, demonstrated that only 0.3% of laboratories (3/954) met international quality standards. To benchmark laboratory quality throughout the rest of sub-Saharan Africa (SSA), we compiled a list of SSA laboratories meeting international quality standards. Accrediting bodies were queried via online registries or direct communication in May 2013. There were 380 laboratories accredited to international standards in SSA. Ninety-one percent were in South Africa. Thirty-seven of 49 countries had no laboratories accredited to international quality standards. Accredited laboratory density (per million people) in South Africa, Namibia, and Botswana were similar to those in many European countries. Single variable linear regression showed a correlation between accredited laboratory density and health expenditures per person (adjusted R(2) = 0.81, P < .001). Most SSA countries do not have an accredited clinical laboratory. For those that do, there is a strong correlation between country-specific accredited laboratory density and per-capita health expenditures.

Clinical value of laboratory survey of mumps

Clinical value of laboratory survey of mumps

Lyme disease testing by large commercial laboratories in the United States.

Laboratory testing is helpful when evaluating patients with suspected Lyme disease (LD). A 2-tiered antibody testing approach is recommended, but single-tier and nonvalidated tests are also used. We conducted a survey of large commercial laboratories in the United States to assess laboratory practices. We used these data to estimate the cost of testing and number of infections among patients from whom specimens were submitted. Large commercial laboratories were asked to report the type and volume of testing conducted nationwide in 2008, as well as the percentage of positive tests for 4 LD-endemic states. The total direct cost of testing was calculated for each test type. These data and test-specific performance parameters available in published literature were used to estimate the number of infections among source patients. Seven participating laboratories performed approximately 3.4 million LD tests on approximately 2.4 million specimens nationwide at an estimated cost of $492 million. Two-tiered testing accounted for at least 62% of assays performed; alternative testing accounted for <3% of assays. The estimated frequency of infection among patients from whom specimens were submitted ranged from 10% to 18.5%. Applied to the total numbers of specimens, this yielded an estimated 240 000 to 444 000 infected source patients in 2008. LD testing is common and costly, with most testing in accordance with diagnostic recommendations. These results highlight the importance of considering clinical and exposure history when interpreting laboratory results for diagnostic and surveillance purposes.

Research Methods in Child Language: A Practical Guide. By ErikaHoff, ed. First Edition. Blackwell Publishing Ltd., 2012. 362 pp. $39.72 (paperback).

Research Methods in Child Language: A Practical Guide. By ErikaHoff, ed. First Edition. Blackwell Publishing Ltd., 2012. 362 pp. $39.72 (paperback).

Forensic Analysts’ Perspectives

Properly collected evidence from a sexual assault examination can assist in the prosecution of the suspected perpetrator or in the exoneration of the wrongfully accused. Previous studies have documented the increased quality of evidence collected by sexual assault nurse examiners (SANEs) versus non-SANE trained providers (Ledray & Simmelink, 1997; Sievers, Murphy, & Miller, 2003) as well as the effectiveness of SANE programs (Campbell, Patterson, & Lichty, 2005; National Institute of Justice, 1999). SANE nurses attempt to collect appropriate specimens through the correct means and in sufficient quantities for forensic analysis with every examination. Samples of good analytical quality offer the best chance of obtaining deoxyribonucleic acid (Burg, Kahn, & Welch, 2011). As one method of quality improvement, SANE nurses can learn to increase the consistency of quality evidence collection by eliciting feedback from the analysts who receive and process the specimens. A national survey of crime laboratories that analyze sexual assault kits was conducted. This paper will present forensic analysts' perspectives about the quality of data collection, feedback for improvement, and resources for further education.

Distribution, burden, and impact of acute gastroenteritis in Dominica, 2009-2010.

Acute gastroenteritis (AGE) is an important public-health issue in Dominica. To determine the burden of AGE in Dominica, a retrospective, cross-sectional population survey was conducted in March-April 2009 and October 2010 (low- and-high-AGE seasons) and a laboratory survey from April 2009 to March 2010. The overall monthly prevalence of self-reported AGE was 8.6 % (95% CI 7.0-10.6); the incidence rate was 1.1 episodes/person-year and 79,157.1 episodes of AGE for the total population/year. Monthly prevalence of AGE was the highest in the 1-4 year(s) age-group (25.0%), higher in females (10.8%) and also varied by health district, with the highest monthly prevalence of AGE being reported in the Portsmouth district (13.1%). This difference in gender and across the health region was statistically significant. The estimated underreporting of syndromic AGE to the Ministry of Health was 83.3%. Furthermore, for every reported laboratory-confirmed case of AGE and foodbome disease (FBD), there was an estimated underreporting factor of 280. Overall, 47% of AGE specimens tested were positive for FBD pathogens. The predominant pathogens isolated were norovirus, followed by Giardia, Salmonella, and Shigella. The total annual estimated cost of AGE was US$ 1,371,852.92, and the total cost per capita due to AGE was US$ 19.06, indicating an economic burden of AGE-related illness on a small island of Dominica.

Estimating the burden of acute gastrointestinal illness in Grenada.

This is the first study conducted in Grenada, with a population of approximately 108,000, to quantify the magnitude, distribution, and burden of self-reported acute gastroenteritis (AGE). A retrospective population survey was conducted in October 2008 and April 2009 and a laboratory survey from October 2008 to September 2009. The estimated monthly prevalence of AGE was 10.7% (95% CI 9.0-12.6; 1.4 episodes/ person-year), with a median of 3 days of illness. Of those who reported AGE, 31% sought medical care (stool samples were requested from 12.5%); 10% took antibiotics; 45% took non-prescribed medication; and 81% reported restricted activity. Prevalence of AGE was significantly higher among children aged <5 years (23.5%, p < 0.001). Of the AGE stool samples submitted to the laboratory for analysis, 12.1% were positive for a foodborne pathogen. Salmonella enteritidis was the most common foodborne pathogen associated with AGE-related illness. The estimated percentage of underreporting of syndromic AGE to the Ministry of Health was 69%. In addition, for every laboratory-confirmed foodborne/AGE pathogen, it was estimated that there were 316 additional cases occurring in the population. The minimum estimated cost associated with treatment for AGE was US$ 703,950 each year, showing that AGE has a potentially significant economic impact in Grenada.

Distinctive Features of Melanoma and Its Management in Elderly Patients

Life expectancy is increasing in most developed countries, and elderly people have the highest incidence of melanoma. To identify characteristics of melanoma and its management in the elderly compared with younger patients. Retrospective population-based study of incident cases of primary melanoma in 1621 patients with stage I or II melanoma in 2004 and 2008. Questionnaires administered to physicians and a survey of cancer registries and pathology laboratories were used to obtain data. The study was conducted in 5 regions in northeastern France. Characteristics of patients and tumors, circumstances of diagnosis, and further management in older patients (≥70 years, 487 patients [30.0%]) compared with younger ones (<70 years, 1134 [70.0%]). Older patients had more frequent melanomas of the head and neck (29.4% vs 8.7%; P < .001) and of the nodular, lentigo maligna, or acral lentiginous histologic subtypes. They had thicker and more frequently ulcerated tumors, categorized as T3 or T4 in 36.7% of cases vs 20.1% in younger patients. Diagnosis of melanoma occurred more frequently in a general practice setting and less frequently in direct consultation with a dermatologist or regular screening for skin cancer. Time to definitive excision was longer in older patients, and 16.8% of them compared with 5.0% of the younger population had insufficient excision margins (P < .001). A sentinel lymph node biopsy was performed in 23.3% of the older patients with melanoma thicker than 1 mm vs 41.4% in the younger patients (P < .001). Adjuvant therapy was less frequently started in older patients and was prematurely stopped in a higher proportion of that population. Age-related variations are observed at every step of melanoma management. The most important concerns are access of elderly people to settings for early diagnosis and excision with appropriate margins.

Comparison of methods for geologic storage of carbon dioxide in saline formations

Preliminary estimates of CO2 storage potential in geologic formations provide critical information related to Carbon Capture, Utilization, and Storage (CCUS) technologies to mitigate CO2 emissions. Currently multiple methods to estimate CO2 storage and multiple storage estimates for saline formations have been published, leading to potential uncertainty when comparing estimates from different studies. In this work, carbon dioxide storage estimates are compared by applying several commonly used methods to general saline formation data sets to assess the impact that the choice of method has on the results. Specifically, six CO2 storage methods were applied to thirteen saline formation data sets which were based on formations across the United States with adaptations to provide the geologic inputs required by each method. Methods applied include those by (1) international efforts – the Carbon Sequestration Leadership Forum (Bachu et al., 2007); (2) United States government agencies – U.S. Department of Energy – National Energy Technology Laboratory (US-DOE-NETL, 2012) and United States Geological Survey (Brennan et al., 2010); and (3) the peer-reviewed scientific community – Szulczewski et al. (2012) and Zhou et al. (2008). A statistical analysis of the estimates generated by multiple methods revealed that assessments of CO2 storage potential made at the prospective level were often statistically indistinguishable from each other, implying that the differences in methodologies are small with respect to the uncertainties in the geologic properties of storage rock in the absence of detailed site-specific characterization.

Modelling the expected rate of laboratory biosafety breakdowns involving rinderpest virus in the post-eradication era

Now that we are in the rinderpest post-eradication era, attention is focused on the risk of re-introduction. A semi-quantitative risk assessment identified accidental use of rinderpest virus in laboratories as the most likely cause of re-introduction. However there is little data available on the rates of laboratory biosafety breakdowns in general. In addition, any predictions based on past events are subject to various uncertainties. The aims of this study were therefore to investigate the potential usefulness of historical data for predicting the future risk of rinderpest release via laboratory biosafety breakdowns, and to investigate the impacts of the various uncertainties on these predictions.Data were collected using a worldwide online survey of laboratories, a structured search of ProMED reports and discussion with experts. A stochastic model was constructed to predict the number of laboratory biosafety breakdowns involving rinderpest that will occur over the next 10 years, based on: (1) the historical rate of biosafety breakdowns; and (2) the change in the number of laboratories that will have rinderpest virus in the next 10 years compared to historically.The search identified five breakdowns, all of which occurred during 1970–2000 and all of which were identified via discussions with experts. Assuming that our search for historical events had a sensitivity of over 60% and there has been at least a 40% reduction in the underlying risk (attributable to decreased laboratory activity post eradication) the most likely number of biosafety events worldwide was estimated to be zero over a 10 year period. However, the risk of at least one biosafety breakdown remains greater than 1 in 10,000 unless the sensitivity was at least 99% or the number of laboratories has decreased by at least 99% (based on 2000–2010 during which there were no biosafety breakdowns).

Laboratory Practice Guidelines for Detecting and Reporting JAK2 and MPL Mutations in Myeloproliferative Neoplasms: A Report of the Association for Molecular Pathology

Recurrent mutations in JAK2 and MPL genes are genetic hallmarks of BCR-ABL1-negative myeloproliferative neoplasms. Detection of JAK2 and MPL mutations has been incorporated into routine diagnostic algorithms for these diseases. This Special Article summarizes results from a nationwide laboratory survey of JAK2 and MPL mutation analysis. Based on the current practice pattern and the literature, this Special Article provides recommendations and guidelines for laboratory practice for detection of mutations in the JAK2 and MPL genes, including clinical manifestations for prompting the mutation analysis, current and recommended methodologies for testing the mutations, and standardization for reporting the test results. This Special Article also points to future directions for genomic testing in BCR-ABL1-negative myeloproliferative neoplasms.

The outcome of patients with renal involvement in pediatric-onset systemic lupus erythematosus – a 20-year experience in Asia

Systemic lupus erythematosus (SLE) predominantly affects women of childbearing age, but 15-20% of cases are diagnosed during childhood. It is important for physicians to understand the epidemiology and clinical presentation for early detection and diagnosis of this disease in difference races. The aim of this retrospective review was to provide a 20-year experience for initial clinical and laboratory manifestations and outcomes in pediatric-onset SLE (pSLE) in a medical center in Asia. We reviewed medical records between April 1990 and June 2012 of patients with a diagnosis of International Classification of Diseases, Ninth Revision (ICD-9) code 710.0 (SLE), who admitted or received follow-up in the Department of Pediatrics at Chang Chung Memorial Hospital. Patients with a diagnosis of SLE prior to their 18th birthday and followed up at our hospital were eligible for inclusion in this study. Medical records regarding age, gender, date of birth and diagnosis, clinical manifestations at diagnosis, laboratory results, image studies and the classification criteria were reviewed. Patients received regular outpatient department follow-up and laboratory survey every 1-6 months. The study cohort consisted of 189 patients; 164 females (86.87%) and 25 males (13.23%). The overall mean age at pSLE diagnosis was 12.62 ± 2.77 years. The most common clinical symptom was malar rash, followed by arthritis and oral ulcers. There was no significant difference in clinical and laboratory manifestations between females and males. More than half of the patients presented with renal involvement initially. The most common histological finding was Class IV lupus nephritis (LN), especially in males (p = 0.034) and young age. Even with severe LN, the rate of end-stage renal disease (ESRD) was low if adequate treatment was initiated. The 5, 10 and 15-year ESRD-free survival rates were 95.4%, 94.0% and 89.9% in patients with biopsy-proven LN. However, infection was the leading cause of mortality. Therefore, aggressive treatment for major organ involvement is important, but physicians must also be aware of fatal infection. The overall survival rates were 5 years: 93.4% and 10-20 years: 89.6%.

AB0740 Laboratory and imaging studies used by french rheumatologists to diagnose polymyalgia rheumatica

BackgroundThe BSR recommends for the diagnosis and management of polymyalgia rheumatica (PMR) blood cells count, blood electrolytes and renal function, liver function, bone metabolism tests, thyroid hormones, muscle enzymes, rheumatoid...

Adaptating Organization in Science: How Contextual Environment Affects Task Allocation of Academic Biology Laboratories

This study examines the contingency of organizational design in academic organizations drawing on a survey of biology laboratories in Japanese universities. It investigates the intra-laboratory task allocation between a lab head and members (e.g., junior staff, PhD students) in three research phases (i.e., planning, execution, and writing) and how different patterns of task allocation affect lab-level scientific productivity. Results suggest that organic organizational structure with limited division of labor suits basic research, where exploratory approach is common with high unpredictability, while mechanistic structure is fitter for applied research, which is relatively exploitative and predictable. Thus, academic organizations, just as industrial organizations, need to adapt their organizational design to contextual environment to maximize their performance.

Ethnic Discrimination in Recruitment and Decision Makers’ Features: Evidence from Laboratory Experiment and Survey Data using a Student Sample

This article examines which individual-level factors are related to people’s likelihood of discriminating against ethnic minority job applicants. It moves beyond describing to what extent discrimination occurs by examining the role of individuals’ interethnic contacts, education and religion in shaping their behavior towards ethnic minority job applicants. We derive expectations from theories from the interethnic attitudes literature. Data are collected via (1) a laboratory experiment in which student participants (n = 272) reviewed resumes of fictitious applicants who varied regarding ethnicity, gender, education and work experience and (2) a survey amongst the same participants. During the experiment, participants assess applicants’ suitability for a job and select applicants for an interview. Additionally, participants complete a questionnaire including questions on several personal and background features. Results show that individuals who have more positive interethnic contacts, higher educational levels and higher educated parents are less likely to discriminate against ethnic minority applicants. Individuals whose parents are church members are more likely to discriminate, as are males. We find interesting differences regarding the role of decision makers’ features between different stages of the recruitment process. First assessments of applicants’ suitability for a job are predominantly affected by applicants’ features. Differences between decision makers here are relatively small. Eventual choices about which applicants to invite for a job interview, however, are affected by both applicants’ and decision makers’ features; here differences between decision makers are more pronounced. Theoretical implications of these findings are discussed.

Guidelines for the review of pathology in the research context

Research involving a retrospective review of a patient's pathology could change the original pathologist's diagnosis and alter management, treatment, and prognosis. In the interests of patient safety, this review diagnosis needs to be validated and the impact on patient care assessed before disclosure to the patient occurs. The Canadian Association of Pathologists-Association Canadienne des Pathologistes (CAP-ACP) did not have a guideline for managing this scenario. Under CAP-ACP executive committee sponsorship, a working group was formed to develop a comprehensive guideline for this scenario. To inform the document's development, the group carried out an extensive literature review, surveyed practices in laboratories across Canada, and reviewed practices in pathology colleges in the United Kingdom, Australasia, and the United States. The Tricouncil Interagency in Research Ethics in Canada, the Canadian Medical Protective Association and members of the CAP-ACP were consulted. Neither the published literature nor the trans-Canadian laboratory survey identified a guideline document. The Royal College of Pathologists of Australasia had a policy and procedure for the scenario; other colleges did not. The guideline developed by the working group listed roles for the ethics committee, researcher, original pathologist, and laboratory in managing the scenario and incorporated the input acquired in the consultation phase. The final document was endorsed in 2012 by the CAP-ACP executive committee and is available on the website (available from: http://www.cap-acp.org/psqa.cfm). The guideline is anchored in principles of patient safety and can be used to minimize and/or manage changes in the pathologic diagnosis which arise from a research-based review of prior pathology reports.

Legionnaires' disease in France: sensitivity of the mandatory notification has improved over the last decade

The notification rate of Legionnaires' disease (LD) in France was 2.4/100 000 population in 2010, varying across regions with an increasing rate from west to east. Two sources [mandatory notifications (MN) and a survey of hospital laboratories] were used in a capture-recapture study to estimate the number of LD cases and the sensitivity of the MN system at national and regional levels in 2010. The number of missed cases was estimated using Chapman's method. The estimated sensitivity of MN was 88.5% (95% CI 88.0-89.0) and ranged from 70% to 100% by region. The estimated incidence was 2.7/100 000 population. Sensitivity of the MN system improved since the previous capture-recapture estimates (10% in 1995, 33% in 1998). This study confirmed that the observed west-east gradient is not related to regional notification disparities. Ecological studies should be conducted to better understand the observed spatial variations in LD incidence.

Canine breed predispositions for marked hypocobalaminaemia or decreased folate concentration assessed by a laboratory survey

The aim of this study was to determine canine breed predispositions for decreased serum folate or markedly decreased cobalamin concentrations. Retrospective analysis of samples from dogs that had serum folate and cobalamin concentrations measured, from 1990 to 2002 at the Comparative Gastroenterology Laboratory of Liverpool, were enrolled. A total of 13,069 samples were analysed. Those with trypsin-like immunoreactivity < 5·0 lg/L were excluded, and only breeds with at least 30 individuals tested were further analyzed. Breed predisposition was determined by calculating odds ratios and 95% confidence intervals for hypocobalaminaemia or decreased folate concentration. Significance was tested with a two-sided Fisher's exact test, and the level of statistical significance was set at P<0·05. A total of 9960 dogs fulfilled the inclusion criteria. Forty breeds contained at least 30 individuals. Predispositions for hypocobalaminaemia were identified in shar peis, Staffordshire bull terriers, German shepherd dogs and mixed breeds. Predispositions for decreased folate concentration were found in golden retrievers and boxers. Predisposition for marked hypocobalaminaemia and decreased folate concentration differed between breeds. The shar peis had a markedly increased odds ratio for hypocobalaminaemia, as previously reported in North America, but other at-risk breeds were also identified.

Mycobacterium chelonae Facial Infections Following Injection of Dermal Filler

A cluster of 3 facial Mycobacterium chelonae infections occurred after cosmetic dermal filler injections at a plastic surgery clinic. Pulsed-field gel electrophoresis showed that M chelonae isolated from the clinic tap water were identical to the patient wound isolates. Review of injection procedures identified application of nonsterile ice to the skin prior to injection as a possible source of M chelonae. Surveys of regional laboratories and a national plastic surgery listserv identified no other cases related to the injection of this brand of dermal filler. This is the first report of cutaneous M chelonae infections following the injection of dermal fillers. It adds to a growing body of literature on postinjection M chelonae infections and reinforces the importance of optimal skin disinfection steps prior to percutaneous procedures. 5.

General Quality Practices in Gynecologic Cytopathology: Findings From the College of American Pathologists Gynecologic Cytopathology Quality Consensus Conference Working Group 3

There are many long-standing quality monitors for cytopathology laboratories and their cytotechnologists and pathologists. Many of these monitors are based on tradition and empirical good intentions. There is no established standard as to how results of these monitors should be used in a quality assurance program. To review practices that are typically part of a general quality program in cytopathology laboratories and to provide statements regarding good laboratory practices that laboratories may find useful in a quality assurance program in their own setting. An expert working group evaluated results from a national laboratory survey, responses from follow-up questions posted on a Web site, and findings from the literature. The group created statements on good laboratory practices related to general quality practices and quality assurance in gynecologic cytopathology. These were discussed and voted on at a consensus conference. Laboratories follow many metrics. Most laboratories facilitate comparison of individual metrics against the laboratory's metrics: 81.1% for cytotechnologists and 59.6% for pathologists. The majority of laboratories facilitate comparison of individual cytotechnologist metrics with other cytotechnologists, but less frequently metrics from pathologists with other individuals. The most common methods to recognize variance in performance in individuals were by identifying outliers from the data or by user-defined action limits. The most common method to address variance was an attempt to identify the cause of the variance and conduct a focused review. Quality metrics should be monitored for the laboratory as a whole and in selected cases for both individual pathologists and cytotechnologists. Results should be shared with individuals, and newly hired primary screeners should be monitored. Reviewing selected cases is a useful quality tool. Low-volume methodologies, such as conventional Papanicolaou tests, should have additional oversight.