A Quality Control System Involving Peer Review of Abnormal Cervical Smears

An internal quality control system which is used in the centralized cytology laboratory of a population-based cervical cancer screening programme in Florence is described. It includes a peer review procedure. Abnormal cervical smears are circulated among all the cytologists and a consensus on the final diagnosis is reached. This daily procedure is designed to evaluate the performance of each cytologist and of the laboratory as a whole but can also be considered a valuable training opportunity. During an 18-month period 1197 smears were reviewed by 15 readers using a reporting form with six main categories of reporting (from ‘regative’ to ‘invasive carcinoma’), plus an ‘unsatisfactory’ category. Overall the concordance between the 15 cytologists, assessed using the kappa statistic (range 0.46–0.71; median 0.60), was good. the level of agreement increased when a weighted kappa statistic (range 0.55–0.78; median 0.68) was used. Kappa values were also calculated for specific categories and suggested an increasing concordance with increasing severity of the lesions, the categories of ‘severe dysplasia’ and ‘invasive carcinoma’ showing the highest agreement. the poor results for the ‘moderate dysplasia’ confirmed the need for combining this group with the ‘severe dysplasia’, as proposed in the Bethesda system.     

Antimicrobial susceptibility recording and reporting system for veterinary medicine

Objectives: To develop a system to (1) provide automated interpretation of antimicrobial susceptibility results using animal species, specimen site and bacterial isolate identification criteria, (2) report antimicrobial susceptibility results, according to recommended use category and animal species approval status, (3) allow for changes in antimicrobial agent being tested and result interpretations without need for programming changes and (4) allow for intuitive data entry process without need for reference material. Design: Tables are used to match results and reporting categories to a test method, specific tests, animal species, specimen sites and bacterial isolates. Information used for interpretation of test readings is maintained in tables for user reference while entering results. Results: A table driven system was developed to account for variations in reporting due to antimicrobial susceptibility method used, animal species, bacterial isolate tested and the site from which bacteria isolate was recovered. Conclusions: This process provides for accurate reporting of antimicrobial susceptibility results and is easily adaptable to changes in reporting requirements. The system minimizes reporting criteria and decision-making requirements for technical laboratory personnel, while improving antimicrobial susceptibility reports generated for veterinary practitioners.     

Interlaboratory reproducibility of atypical squamous cells of undetermined significance report: a national survey

The study was aimed at assessing interlaboratory reproducibility in the reporting of cervical smears in the atypical squamous cells of undetermined significance (ASCUS) category. A set of 50 selected slides circulated among 89 laboratories, currently involved in population-based screening programmes for cervical cancer, which provided a diagnostic report according to four main reporting categories based on the 1991 Bethesda system. Interlaboratory agreement was determined according to kappa (K) statistics: overall and weighted K values were determined for each laboratory and for single reporting categories. The results showed a very low reproducibility for the ASCUS category. This finding supports the Bethesda system 1991 recommendation to limit the use of this reporting category and suggests that the clinical response to ASCUS reports should be decided locally, based on the observed positive predictive value for cervical intraepithelial neoplasia 2 or more severe lesions.     

Implementation of a configurable laboratory information management system for use in cellular process development and manufacturing

Background aimsRegulatory requirements for the manufacturing of cell products for clinical investigation require a significant level of record-keeping, starting early in process development and continuing through to the execution and requisite follow-up of patients on clinical trials. Central to record-keeping is the management of documentation related to patients, raw materials, processes, assays and facilities.MethodsTo support these requirements, we evaluated several laboratory information management systems (LIMS), including their cost, flexibility, regulatory compliance, ongoing programming requirements and ability to integrate with laboratory equipment. After selecting a system, we performed a pilot study to develop a user-configurable LIMS for our laboratory in support of our pre-clinical and clinical cell-production activities. We report here on the design and utilization of this system to manage accrual with a healthy blood-donor protocol, as well as manufacturing operations for the production of a master cell bank and several patient-specific stem cell products.ResultsThe system was used successfully to manage blood donor eligibility, recruiting, appointments, billing and serology, and to provide annual accrual reports. Quality management reporting features of the system were used to capture, report and investigate process and equipment deviations that occurred during the production of a master cell bank and patient products.ConclusionsOverall the system has served to support the compliance requirements of process development and phase I/II clinical trial activities for our laboratory and can be easily modified to meet the needs of similar laboratories.     

Rationalisation and modification of a germ-free isolator design

A modified design of polyvinyl chloride isolator, suitable for small laboratory animals utilises room space more effectively than previous models and is particularly useful where accommodation is restricted. The standard attachments and ancillary equipment used with other flexible isolators are compatible with the modified isolator.     

东莞市预防接种不良反应监测和处理控制系统的建立及评价

为了解东莞市各种疫苗预防接种不良反应的发生情况,建立预防接种不良反应(AEFI)监测和处理控制系统,评价其运行状况,提高预防接种工作质量。根据WHO对AEFI的定义和分类方法,确定了东莞市AEFI报告范围,报告人、报告程序、报告制度以及调查内容和方法,并对该系统2005年收集的AEFI病例进行描述性分析。全市共登记预防接种不良反应560例,其中疫苗反应占了95.36%。男性多于女性。在所使用的26种疫苗中有18种出现不良反应,以Hib和百白破(DPT)的发生率最高,且百白破的报告数最多,占57.5%。在报告的预防接种不良反应中,发热、局部红肿疼痛以及皮疹等过敏性反应占了94.1%。结果认为该系统在评价疫苗的安全性,发现不良反应发生的危险因素,改善预防接种服务质量起着重要作用。     

凤眼莲-根际微生物系统的降酚效应

 在自然水体中,由于风眼莲的存在,其根际的异养细菌的数量和种类均大量增加,从而可以提高降解水体中的有机物的能力;在实验室条件下,人工组建成风眼莲—根际细菌系统,系统的降酚效应要大于单独的细菌和风眼莲,证实这是一个具高效降酚能力的共生生物系统。本文从野外原位调查和实验室模拟试验两方面,讨论了凤眼莲—根际细菌共生系统的降酚效应,以及其中的机制和应用。     

Laboratory turnaround time

Turnaround time (TAT) is one of the most noticeable signs of laboratory service and is often used as a key performance indicator of laboratory performance. This review summarises the literature regarding laboratory TAT, focusing on the different definitions, measures, expectations, published data, associations with clinical outcomes and approaches to improve TAT. It aims to provide a consolidated source of benchmarking data useful to the laboratory in setting TAT goals and to encourage introduction of TAT monitoring for continuous quality improvement. A 90% completion time (sample registration to result reporting) of <60 minutes for common laboratory tests is suggested as an initial goal for acceptable TAT.     

LabPush: A Pilot Study of Providing Remote Clinics with Laboratory Results via Short Message Service (SMS) in Swaziland,Africa

Background

Turnaround time (TAT) is an important indicator of laboratory performance. It is often difficult to achieve fast TAT for blood tests conducted at clinics in developing countries. This is because clinics where the patient is treated are often far away from the laboratory, and transporting blood samples and test results between the two locations creates significant delay.Recent efforts have sought to mitigate this problem by using Short Message Service (SMS) to reduce TAT. Studies reporting the impact of this technique have not been published in scientific literature however. In this paper we present a study of LabPush, a system developed to test whether SMS delivery of HIV related laboratory results to clinics could shorten TAT time significantly.

Method

LapPush was implemented in six clinics of the Kingdom of Swaziland. SMS results were sent out from the laboratory as a supplement to normal transport of paper results. Each clinic was equipped with a mobile phone to receive SMS results. The laboratory that processes the blood tests was equipped with a system for digital input of results, and transmission of results via SMS to the clinics.

Results

Laboratory results were received for 1041 different clinical cases. The total number of SMS records received (1032) was higher than that of paper records (965), indicating a higher loss rate for paper records. A statistical comparison of TAT for SMS and paper reports indicates a statistically significant improvement for SMS. Results were more positive for more rural clinics, and an urban clinic with high workload.

Conclusion

SMS can be used to reduce TAT for blood tests taken at clinics in developing countries. Benefits are likely to be greater at clinics that are further away from laboratories, due to the difficulties this imposes on transport of paper records.     

Comparison of Conventional Methods, the R/B System, and Modified R/B System as Guides to the Major Divisions of Enterobacteriaceae

Primary grouping of more than 2,000 members of Enterobacteriaceae, freshly isolated from clinical specimens, was performed on the basis of eight conventional laboratory tests used routinely in this laboratory and by the R/B system. Results indicate that both systems perform well in this first step in the identification of various medically significant species of the family. Difficulties encountered with certain reactions of the R/B system were corrected with a physical modification of the tubes. An additional 100 representatives of Enterobacteriaceae were compared with conventional methods and the modified R/B system. Results indicate improvement in observing and interpreting findings with the R/B system.     

A Cheap,Effective Gastric Cooling Apparatus for the Control of Gastric Hemorrhage

Gastric cooling (as opposed to freezing) is a useful adjunct in the management of upper gastrointestinal hemorrhage. Commercial machines for this purpose are expensive. A simple system is described in which cooled tap water is circulated through an extragastric reservoir, using an applicator modified slightly from the original design described by Wangensteen. The entire system can be made up in any hospital workshop at a cost of less than ten dollars. Tested in the laboratory and clinically, it has been found to be easy to set up, readily monitored, and safe. It has effectively controlled bleeding in seven of eight patients treated by this device.     

Proficiency testing in cytology laboratories in Ontario, Canada: a decade of experience. III. A precision study of consistency and reproducibility in cytology reporting

The Ontario Laboratory Proficiency Testing Program's testing model and the results of early surveys of cytology laboratories have been previously described. To test consistency and accuracy, the same slides from one survey were recirculated to the same laboratory in the next survey. There was no statistical difference in either the accuracy or consistency in reporting by the various categories of personnel. Analysis of the data by category of diagnosis showed the reporting of "no abnormal cells" and "benign atypia" to be slightly more accurate and "moderate dysplasia" and "severe dysplasia" to be slightly less accurate than the reporting in other categories. Consistency in reporting appeared to be slightly less accurate in severe dysplasia than in the other categories. The analysis, which includes the results from all licensed cytology laboratories in Ontario, provides evidence that, in the reporting of cervical cytologic material, it is feasible to differentiate among the various categories within the spectrum of squamous epithelial abnormalities with a general level of accuracy and consistency that, although satisfactory, is not yet ideal.     

Computerized recording and reporting system for cytology and colposcopy

The computerized system for recording and reporting cytologic and colposcopic data at the Madrid Provincial Hospital is discussed. Cytodiagnostic codes based on standard international nomenclature, and yet open to constant updating, were created for the anatomic sites from which samples are currently examined (vagina and cervix, endometrium, vulva and breast), with areas allocated for expansion to other sites. A similar novel code was devised for colposcopic data. Specific forms were developed for each anatomic site; the cervicovaginal and endometrial forms are used for both cytology and colposcopy. The system has provided the laboratory with automation of its managerial, clerical and administrative tasks, including (1) record keeping, (2) reporting, (3) statistics, (4) correlation of clinical, cytologic, colposcopic and histopathologic data, (5) patient follow-up, (6) technical support in research programs and (7) quality control. Use of the system led to an improvement in the efficiency of the laboratory and resulted in reports of better quality. The program has been of help in our research and has not increased the total cost of cytologic studies.     

实验动物皮肤病原真菌检测方法的改良

目的对实验动物皮肤病原真菌2种培养方法进行了比较。方法将采集到的3只皮肤真菌感染病兔样品经由沙氏平皿法和沙氏试管斜面培养法分别进行培养。结果在3只真菌感染病兔中应用试管斜面法我们只检测到1例皮肤病原真菌阳性,而采用沙氏平皿法3例阳性全部检出。结论结合临床检测经验,我们认为本研究的沙氏平皿法优于沙氏试管斜面法,在实验动物皮肤病原真菌常规检测中具有推广应用价值。     

The use of water traps for cranefly monitoring: an assessment of operator efficiency

SUMMARY
Unskilled operators used water traps to monitor cranefly populations in 48 grassland sites in the summer of 1984. For each trap operated the numbers of males and females were recorded and these counts were checked in the laboratory to give estimates of operator error. Operators also recorded the amount of time they spent implementing the scheme. The probability of reporting a correct count for male craneflies was 0.796 and for females 0.846. There was a greater tendency for the male counts to be under-rather than overestimated, and vice versa for females. Generally, the number of errors made was not related to either the number of craneflies taken or the rate at which they were sorted. Average times were calculated for different aspects of the monitoring system: 37 min for setting up four water traps; 40 min per field per week for servicing traps excluding handling craneflies; 18 flies/min sorting rate. Overall, the mean time spent implementing the scheme in one field was 209 min. It was concluded that operator error can be as important as predictive error in the implementation of a forecasting scheme and that it cannot be assumed that any monitoring system operates with complete accuracy.     

Characterization of university-level introductory genetics courses in Canada.

We conducted survey research with the intent to characterize post-secondary introductory genetics (IG) education in Canada during the 1996-1997 academic year. At least a minimum data set was obtained from 47 institutions through responses to a mailed questionnaire and on-line resources. The total reported enrollment (TRE) for IG was 10,500. Over half of the TRE used one particular text. A core curriculum of topics was identified as those given more than 30 min of lecture time in at least half of reporting institutions. Slightly more than half of the TRE had laboratory exercises associated with their IG course. Laboratory exercises tended to emphasize classical transmission genetics with very few exercises in molecular genetics. For the determination of academic equivalency between institutions, particular attention should be given to the breadth and duration of the tutorial and (or) laboratory components. The majority of personnel teaching IG were trained in Canada within the previous 15 years. We suggest mechanisms by which the Genetics Society of Canada could work to promote genetical literacy.     

DRY-ROT DISEASE OF THE POTATO

A laboratory method is described in which a modified hypodermic syringe is used to inoculate potato tubers with Fusarium caeruleum. This injection method gives consistent results and permits reliable assessments of factors such as varietal susceptibility.
The occurrence of arrested lesions is noted.
Suspensions of very high spore concentration or of spores already germinated did not greatly increase the amount of dry rot above that given by the standard too spores per inoculation, provided that spore germination was adequate.
The size of tuber and site of inoculation were found to have a considerable effect upon the results of inoculation experiments, large tubers being more susceptible than small ones and the heel end being more susceptible than the rose end. The necessity for uniformity of material used in inoculation experiments is emphasized.     

Biological waste gas treatment with a modified rotating biological contactor. Ι. Control of biofilm growth and long-term performance

In this work, we introduce a modified rotating biological contactor (RBC) system and demonstrate its feasibility by applying the newly devised process to the biological treatment of artificial waste gas. In the proposed system, the waste gas is introduced to the bioreactor in the spacings between the rotating discs through a hollow shaft, thus allowing for intimate gas–liquid contact. A 91-l modified RBC containing 20 biofilm support discs 40 cm in diameter was used in the experiments. Toluene was used as the model pollutant, and the system was operated under standard operating conditions for more than one year in order to investigate its long-term performance and assess its ability to control the growth of the biofilm. It was demonstrated that the proposed system allows to efficiently control the growth of the biofilm, thus overcoming the clogging problem inherent in most conventional methods for the biological treatment of waste gas. Moreover, the system was shown to exhibit stationary long-term performance for a period of more than one year, hence indicating its feasibility for industrial application.     

Blood cell identification using a simple neural network

Classification of blood cell types can be time consuming and susceptible to error due to the different morphological features of the cells. This paper presents a blood cell identification system that simulates a human visual inspection and identification of the three blood cell types. The proposed system uses global pattern averaging to extract cell features, and a neural network to classify the cell type. Two neural networks are investigated and a comparison between these networks is drawn. Experimental results suggest that the proposed system provides fast, simple and efficient identification which can be used in automating laboratory reporting.     

Can Patient Safety Incident Reports Be Used to Compare Hospital Safety? Results from a Quantitative Analysis of the English National Reporting and Learning System Data

Background

The National Reporting and Learning System (NRLS) collects reports about patient safety incidents in England. Government regulators use NRLS data to assess the safety of hospitals. This study aims to examine whether annual hospital incident reporting rates can be used as a surrogate indicator of individual hospital safety. Secondly assesses which hospital characteristics are correlated with high incident reporting rates and whether a high reporting hospital is safer than those lower reporting hospitals. Finally, it assesses which health-care professionals report more incidents of patient harm, which report more near miss incidents and what hospital factors encourage reporting. These findings may suggest methods for increasing the utility of reporting systems.

Methods

This study used a mix methods approach for assessing NRLS data. The data were investigated using Pareto analysis and regression models to establish which patients are most vulnerable to reported harm. Hospital factors were correlated with institutional reporting rates over one year to examine what factors influenced reporting. Staff survey findings regarding hospital safety culture were correlated with reported rates of incidents causing harm; no harm and death to understand what barriers influence error disclosure.

Findings

5,879,954 incident reports were collected from acute hospitals over the decade. 70.3% of incidents produced no harm to the patient and 0.9% were judged by the reporter to have caused severe harm or death. Obstetrics and Gynaecology reported the most no harm events [OR 1.61(95%CI: 1.12 to 2.27), p<0.01] and pharmacy was the hospital location where most near-misses were captured [OR 3.03(95%CI: 2.04 to 4.55), p<0.01]. Clinicians were significantly more likely to report death than other staff [OR 3.04(95%CI: 2.43 to 3.80) p<0.01]. A higher ratio of clinicians to beds correlated with reduced rate of harm reported [RR = -1.78(95%Cl: -3.33 to -0.23), p = 0.03]. Litigation claims per bed were significantly negatively associated with incident reports. Patient satisfaction and mortality outcomes were not significantly associated with reporting rates. Staff survey responses revealed that keeping reports confidential, keeping staff informed about incidents and giving feedback on safety initiatives increased reporting rates [r = 0.26 (p<0.01), r = 0.17 (p = 0.04), r = 0.23 (p = 0.01), r = 0.20 (p = 0.02)].

Conclusion

The NRLS is the largest patient safety reporting system in the world. This study did not demonstrate many hospital characteristics to significantly influence overall reporting rate. There were no association between size of hospital, number of staff, mortality outcomes or patient satisfaction outcomes and incident reporting rate. The study did show that hospitals where staff reported more incidents had reduced litigation claims and when clinician staffing is increased fewer incidents reporting patient harm are reported, whilst near misses remain the same. Certain specialties report more near misses than others, and doctors report more harm incidents than near misses. Staff survey results showed that open environments and reduced fear of punitive response increases incident reporting. We suggest that reporting rates should not be used to assess hospital safety. Different healthcare professionals focus on different types of safety incidents and focusing on these areas whilst creating a responsive, confidential learning environment will increase staff engagement with error disclosure.