Reacting to spontaneous feedback from external customers in a university hospital laboratory

Modern quality standards for laboratories recommend the use of customer feedback in quality improvement. Spontaneous customer feedback is one method to obtain information from customers. In the present study, we analysed the feedback data from external customers (health centres and other hospitals) to our university hospital laboratory during 2001–2006. The most common subject matters of the feedback, covering 87% of a total of 95 reports, were lacking test results, suspicion of the validity of test results, return of samples in transportation boxes to customers and delays in service. On investigation, errors or defects were revealed in 78 cases. The most common errors were lacking (45 cases; 58%), erroneous (20 cases; 26%) or delayed test results (7 cases; 9%). As much as 68% of these errors took place in the pre-analytical phase of the laboratory process, occurring most commonly during specimen transfer, when entering orders into the laboratory information system at the university hospital or during sample processing. The most common underlying causes for errors were unintended errors and non-compliance with operating instructions. Latent errors were identified in 14% of the cases. Corrective actions were performed in 79% of the reported cases. It is important that the feedback reports are investigated to find out possible errors and their underlying causes so that appropriate corrective actions can be taken. When processed properly, spontaneous customer feedback is a method that can be used supplementarily to other methods to detect errors and defects in clinical laboratories and to aid in quality improvement.     

ISO 17025: practical benefits of implementing a quality system

As a laboratory certified to ISO 9001:2000 and accredited to ISO 17025, rtech laboratories has incorporated an overall system for technical and quality management, which results in benefits observed in daily laboratory practices. Technical requirements were updated to include the addition of formal personnel training plans and detailed records, method development and validation procedures, measurement of method uncertainty, and a defined equipment calibration and maintenance program. In addition, a stronger definition of the sample preparation process was documented to maintain consistency in sampling, and a more rigorous quality control monitoring program was implemented for chemistry and microbiology. Management quality improvements focused on document control to maintain consistent analytical processes, improved monitoring of supplier performance, a contract review process for documenting customer requirements, and a system for handling customer comments and complaints, with continuous improvement through corrective and preventive action procedures and audits. Quarterly management review of corrective actions, nonconforming testing, and proficiency testing aid in determining long-term trending. The practical benefits of these technical and management quality improvements are seen on a daily basis in the laboratory. Faster identification and resolution of issues regarding methods, personnel or equipment, improved customer satisfaction, meeting quality requirements of specialized customers, and overall increased laboratory business are all the result of implementing an effective quality system.     

Causes of error in analytical chemistry: results of a web-based survey of proficiency testing participants

Results of a voluntary-response survey of respondent-identified causes of unacceptable results in nine proficiency testing schemes are reported. The PT schemes were predominantly environment and food analysis schemes.?111 respondents reported 230 identified causes of error. Sample preparation (16?% of causes reported), Equipment failures (13?%), ??Human error?? (13?%) and Calibration (10?%) were the top four general causes of poor analytical results. Among sample preparation errors, sample extraction or recovery problems were the most important causes reported. Most calibration errors were related to errors in calculation and dilution and not in availability or quality of calibration materials. No failures were attributed to failures in commercial software; software-related problems were largely associated with user input errors. Corrective actions were generally specific to the particular problem identified. Review of all reported causes indicated that about 44?% could be attributed to simple operator errors.     

Proficiency testing in food microbiology “Aqua”: enumeration of Staphylococcus aureus

In 1999 the Food Microbiology laboratory of the Istituto Zooprofilattico Sperimentale delle Venezie (IZSVe) started an interlaboratory comparison program for food microbiological tests, known as “Aqua, interlaboratory comparisons for quality assurance”. Aqua produces the test samples, applies statistical methods to estimate homogeneity and stability, processes and evaluates the results. The proficiency testing results allow to evaluate the performance of the laboratories, to identify possible differences and non-conformity, to demonstrate the competence and the quality of results, in order to take suitable corrective and/or preventive action after the individuation of the causes. Moreover, elaborating the results of several proficiency testing by using the control chart method, it is possible to evaluate the trend of the laboratory and to verify that the results are in statistical quality control.     

The process of management review

Management review of the quality-management system is an item in many quality standards and a requirement of the ISO 9001:2000 standard and of laboratory standards ISO 15189 and ISO 17125, and others. These reviews are conducted to ensure that the top management is informed and involved in the quality-management system with respect to continuing adequacy and effectiveness, and opportunities for improvement of the system. The management review is a process that should be conducted and audited utilizing the process approach. A process approach is defined as “An activity using resources and managed in order to enable the transformation of inputs into outputs” (ISO 9001:2000). All identified main processes in the quality system should be monitored through data collection by appropriate methods, assuring that data are valid, representative, and adequate. For management review data must be collected and presented in an accessible form so that processes can be evaluated according to objectives, goals, resources, etc. On the basis of this information the laboratory management makes the necessary decisions and ensure that actions are taken that improve the effectiveness of the quality-management system. As output from the management review process, there should be evidence of decisions regarding: change of quality policy and objectives; plans and possible actions for improvements; corrective actions as appropriate; increased customer satisfaction; and planning of resources needs. Identification of the processes involved and using the process approach in the management review ensures the continual improvement of the quality system. Presented at the conference Quality in the Spotlight, March 2006, Antwerp, Belgium.     

Organic-Free Interzeolite Transformation in the Absence of Common Building Units

Zeolite crystals can be used as seeds or aluminosilicate sources in syntheses to control polymorphs and/or reduce the quantity of organics used as structure-directing agents. A frequently invoked hypothesis for interzeolite transformations is that zeolites share some underlying similarity in structure, most notably in cases pertaining to organic-free syntheses. Herein, we show for the first time that ZSM-5 (MFI) can be directly obtained from USY (FAU) through an interzeolite transformation between parent–daughter structures lacking common building units in the absence of a structure-directing agent and seeds. We show that interzeolite transformation leads to a crystalline product with fewer defects. Our findings also reveal that ZSM-5 is a metastable intermediate that undergoes further transformation to mordenite (MOR) and quartz. The MFI-to-MOR transition is counter to reported trends for which transformations lead to structures with reduced molar volume. Herein, we propose mechanistic arguments that suggest the driving force for interzeolite transformation is more complex than guidelines posited in the literature.     

Study of gas-liquid partitioning of alkane solutes in several organic solvents by using principal component analysis and linear solvation energy relationships

Principal component analysis (PCA) was used to extract the number of factors which can describe the 737 gas-liquid partition coefficients of five linear, four branched, and two cyclic alkanes in 67 common solvents. Based on the reconstruction of partition coefficient data matrix, we concluded that the experimental dataset could readily be reduced to two relevant factors. Using only these two factors, there were no errors larger than 3%, 7 cases had errors larger than 2%, and in 34 cases, errors were between 1 and 2%. n-Hexane and ethylcyclohexane were chosen as the test factors, and all other partition coefficients were expressed in terms of these two test factors. Prediction of the logarithmic partition coefficient of these alkanes in seven chemically different solvents, which were originally excluded from the data matrix, was excellent: the root mean square error was 0.064, only in 11 cases the errors were larger than 1%, and only 3 had errors larger than 4%.Linear solvation energy relationships (LSERs) using both theoretical and empirical solvent parameters were used to explain the molecular interactions responsible for partition. Several combinations of parameters were tried but the standard deviations were not less than 0.31. This could be attributed to the model itself, imprecisions in the data matrix or in some of the LSER parameters. Solvent cohesive parameters and surface tension in combination with polarity-polarizability or dispersion parameters perform the best.Finally, the two principal component factors were rotated onto the most relevant physicochemical parameters that control the gas-liquid partitioning phenomena.     

A practical approach to the implementation of autoverify

Autoverification is a process in which computer software will automatically evaluate laboratory test results, verify result integrity, and then release the results to the hospital interface without any technologist intervention. Autoverify release criteria are user defined and can be customized. The process of developing, implementing, and monitoring autoverify is achievable for most test results in laboratory medicine. The use of autoverification will improve result quality, increase revenue, and create faster turn-around times. All of this put together will ultimately lead to improved customer satisfaction. Computers and autoverification are survival tools in the competitive market of laboratory diagnostics services.Presented at the 8th Conference on Quality in the Spotlight, 17–18 March 2003, Antwerp, Belgium     

Accuracy and reliability of radiometric measurements – results of a laboratory proficiency test with labelled sediment

 In 1995, a laboratory proficiency test was carried out in Germany with labelled sediment which was analyzed by 40 participants (operators of nuclear power plants, officially authorized institutions of the German Federal States, and laboratories of research centers). Preparation and certification of the labelled material were described in detail. The deviations of the laboratory means from the corresponding certified reference values of ten radionuclides were determined. Outliers of type 2 were recognized by means of the Grubbs test and eliminated. The consistency of laboratory means and reference values was tested by a modified t test. To describe the reliability of the measurements performed, a radioanalytical quality index which has been defined elsewhere was used. By use of this index, the radioanalytical quality of laboratory means and the means of laboratory means could be evaluated and a very realistic picture of the "state-of-the-practice" of the participating laboratories obtained. In some cases, it was possible to identify systematic errors and to explain their causes by physical phenomena. Received: 11 June 1996 Accepted: 14 September 1996     

The view of laboratories’ clients on the value of accreditation

The Swedish National Testing and Research Institute (SP) asked its clients in its 2001–2002 customer satisfaction survey how they valued an accredited test result on a scale of 1-6. As many as 81% of the recipients answered that it was important (a score of 5 or 6 on the scale ) to have an accredited test result. 12% found the question irrelevant, which could be interpreted as that they used some of SPs non-accredited services, or were just not interested in accredited test reports.     

Analysis of nonconforming work as a tool for status analysis and continuous improvement

Absract  The methodology for statistical processing of reports on nonconforming work and unexpected situations which occur in the laboratory of Gamma-Ray Spectrometry Group at the Jožef Stefan Institute is presented. The results of statistical analyses are discussed. Pareto analysis has shown that the majority of cases of nonconforming work originates in errors made by personnel. The sociological and psychological aspects of strategies aimed at preventing careless work are discussed. It is proposed that motivation should be used as a tool against habits that lessen awareness during routine operations. Specific recommendations regarding communication with personnel are given. Received: 20 July 2001 Accepted: 24 October 2001     

The effect of implementation of the ISO 9000 on customer complaints; a 5-year follow-up study in a regional laboratory.

Although the importance of quality management in the medical laboratory has been emphasized, we are unaware of any interventional studies demonstrating benefits of implementation of recommendations of the International Standards Organization (ISO). In the following 5-year follow-up study, we implemented quality management as stipulated by the ISO, received a certificate of approval, and determined how the program affected customer complaints. From 1997 to 2001 there was only a slight decrease in the number of customer complaints, but a significant continuing downward trend in the proportion of justified complaints (chi-squared test, p<0.001). In fact in 2001 the proportion of justified complaints had decreased by nearly 80% (relative risk, 0.22; 95% confidence interval, 0.09–0.52)), to only 10.9% of the total complaints. We conclude that the use of the ISO 9000 along with good laboratory practice resulted in a significant decrease in the proportion of justified complaints.     

胎儿宫内发育迟缓90例的临床观察与分析

胎儿宫内发育迟缓（ＩＵＧＲ）是围产期的主要并发症之一,也是高危妊娠中的一个重要问题和现代医学难题。它是围产儿患病、死亡和儿童体弱、智弱的重要原因。本院围产保健自１９９５年１２月以来共收治患ＩＵＧＲ的孕妇９０人。通过对孕妇血常规及微量元素的检查发现,其中以叶酸缺乏患巨幼细胞性贫血导致ＩＵＧＲ者４９例,占５４．４４％。微量元素锌、铁、铜、钙缺乏４１例,占４５．５６％,其中以Ｚｎ、Ｆｅ缺乏为主,占３０％     

Method and kit for adsorbent performance evaluation

Commercial gas separation plants running adsorption processes, including pressure swing adsorption, vacuum pressure swing adsorption and temperature swing adsorption are intended to operate continuously and meet design performance levels over the complete service life of the facility. Performance degradation of the adsorbent materials in extended commercial usage is a common problem. Issues such as adsorbent aging and poisoning by unwanted or unexpected contaminants, represent some of the causes of declining adsorbent performance. Lower adsorption capacity can result in declining productivity and/or product purity for the gas separation plant. Adsorbent troubleshooting is usually accomplished by taking samples from the plant and sending them to off-site laboratories for analyses such as moisture content determination by Karl Fischer titration, or BET surface area or other adsorption capacity measurements. The turnaround time for these laboratory analyses is on the order of days. To short-cut this lengthy process of analysis, we have developed a simple test method and kit for rapid diagnosis of adsorbent performance issues which can be used directly at a plant site. The test method involves the determination of the gas capacity of an adsorbent by equilibrating the adsorbent with an appropriate test gas, deactivating the adsorbent and measuring the amount of test gas released. Once a sample has been acquired, the test can be executed and results obtained in less than 15 min. We show that the test method is accurate to within 5 % of the adsorption capacity determined from isotherm measurements, at equivalent temperature and pressure, and can be used to test common commercial adsorbent types, including low silica zeolites and activated carbons.     

The Making of a Solution: A Simple but Poorly Understood Concept in General Chemistry

A primary goal in many general chemistry laboratories is to teach students to properly perform dilutions and make solutions. This article presents a simple exercise to test if your students have acquired this ability from their introductory laboratory exercises. Our results indicate that approximately 50% of the students cannot perform this task on their first attempt, but with guidance and additional attempts their success rate improves. Approximately 30% of the students still fail at this task after additional attempts, but this exercise does improve the laboratory technique of all students. Students used a variety of dilution strategies to achieve the same final concentration; but the most common strategy used by the students was the one deemed most logical by the professors.     

Consideration concerning interlaboratory test for cement in the last 20 years

Since 1988, over 40 laboratories representing research institutes, cement plants, pre-cast units, hydro plant construction companies, industrial construction companies, building companies, etc. from nine countries—Romania, Republic of Moldova, Croatia, Serbia, Macedonia, Bulgaria, Hungary, Ukraine and Lebanon—take part every year in an interlaboratory test organized by our laboratory. The subject of the interlaboratory test for cement was 37 laboratory tests: 12 chemical determinations, 7 physical tests and 9 mechanical tests carried out with 2 types of sand, from CEPROCIM and from each participant laboratory. The paper presents the evolution of two statistical parameters (standard deviation of reproducibility and/or coefficient of variation) for a period of 20 years and for 11 laboratory tests. The results strongly prove that interlaboratory test is one of the most efficient tools to establish a common language for all the participant laboratories performing cement testing procedures.     

水中易释放氰化物能力验证样品的研制及应用

根据国家地表水环境质量监测网监测任务要求和环境监测的实际需要,制备了水中易释放氰化物能力验证样品。通过均匀性、稳定性检验以及量值一致性评价,研制的样品均匀性良好,在3℃~6℃冷藏避光保存条件下1年内稳定,样品配制值与多家实验室协作测定结果一致。探讨了样品在能力验证活动中的应用,共有来自全国11个省的32家实验室参加了水中易释放氰化物的能力验证计划,实验室满意率在80%以上,实验室结果出现有问题或不满意主要是由于样品前处理以及检测过程质量控制不当导致的。经检测及实验室反馈的数据验证,该能力验证样品能够应用于能力验证活动。     

The electronic partition functions of atoms and ions between 7000 and 12000 K

The electronic partition functions of atoms and singly-charged positive ions are presented, for 52 elements, in the form of the second-order polynomials of temperature, which are valid between 7000 and 12000 K. The errors in the partition functions calculated with these polynomials are, at most, of the order of 1% for most of the elements listed. The limitations of the results and the causes of errors are discussed.     

Towards accreditation of clinical biochemistry in the public sector on the island of Mauritius

Medical laboratories of the public sector as well as of the private sector on the island of Mauritius are preparing for accreditation. The clinical laboratory of the Central Health laboratory of the Ministry of Health and Quality of Life has undergone a pre-assessment by experts of the International Atomic Energy Agency (IAEA) through the aegis of a project targeted to members of the Africa Region. Several shortcomings were identified and respective corrective actions were recommended for implementation within a given time frame. In addition to ensuring the competence of the laboratory, accreditation has various positive aspects such as an increased awareness of the staff to quality and better training opportunities. The pre-assessment exercise has provided a gap analysis, which is an important aspect in the preparation towards accreditation.