Quality Of Laboratory Results Research Articles

From big data to better patient outcomes.

Among medical specialties, laboratory medicine is the largest producer of structured data and must play a crucial role for the efficient and safe implementation of bigdata and artificial intelligence in healthcare. The area ofpersonalized therapies and precision medicine has now arrived, with huge data sets not only used for experimental and research approaches, but also in the "real world". Analysis of real world data requires development of legal, procedural and technical infrastructure. The integration ofall clinical data sets for any given patient is important and necessary in order to develop a patient-centered treatment approach. Data-driven research comes with its own challenges and solutions. The Findability, Accessibility, Interoperability, and Reusability (FAIR) Guiding Principles provide guidelines to make data findable, accessible, interoperable and reusable to the research community. Federated learning, standards and ontologies are useful to improve robustness of artificial intelligence algorithms working on big data and to increase trust inthese algorithms. When dealing with big data, the univariate statistical approach changes to multivariate statistical methods significantly shifting the potential of bigdata. Combining multiple omics gives previously unsuspected information and provides understanding of scientific questions, an approach which is also called the systems biology approach. Big data and artificial intelligence also offer opportunities for laboratories and the InVitro Diagnostic industry to optimize the productivity ofthe laboratory, the quality of laboratory results and ultimately patient outcomes, through tools such as predictive maintenance and "moving average" based on the aggregate of patient results.

Assessment of Lab request forms: How do our clinicians communicate with Laboratory?

Central clinical laboratory is an important division in the health care setup. Laboratory results help clinical decisions, follow up care and ensure patient safety. Laboratory request Form [LRF] is an important medium between the patient, a treating clinician and Laboratory. A meticulously filled LRF is important for patient care. Providing accurate and complete information in LRF is the doctor's responsibility. Erroneous LRF will have an impact on the quality of laboratory results. Present study evaluates the degree of completeness and correctness of quality indicators on laboratory request forms [LRF] to examine preanalytical standards of laboratory services.This study is a single center, prospective, cross sectional, descriptive type conducted at a 650 bed teaching hospital from Gujarat. In the span of a six months study period, 3735 [20% of total] LRFs were selected by simple random sampling method from the total LRF received at OPD blood collection center. They were analyzed for patient, clinician and sample identifier quality indicators along with completeness and correctness. Qualitative information was converted to quantitative by using two point scale, 0 score for incomplete information and 1 score for complete information.Among patient identifier quality indicators name, age, gender and location were filled in more than 75% forms whereas, very poorly filled 2% provisional diagnosis and 42% MRD number. Clinician identifier quality indicator was attended to in less than 50% forms. Time and date of request were absent on 100% forms. Sample identifier quality indicator shows 97% forms with the nature of the sample and 92% having investigation requests. Test requests on one third forms were invalid and inappropriate. 38% forms were incomplete and inappropriate whereas 46% forms had error in filling one or other data indicators.Appropriately filled LRF communicates well with the Central clinical laboratory. It will help in providing quality reports in time and benefit clinicians to manage quality care for patients. Hand written, poorly legible, inappropriately abbreviated, erroneous LRF are misleading and may compromise laboratory service and patient safety. Training and change in attitude towards LRF writing is required to maintain the standard of the health care system.

Analysis of preanalytical errors in a clinical chemistry laboratory: A 2-year study.

Patient safety and medical diagnosis of patients are mainly influenced by laboratory results. The present study aimed to evaluate the errors in the preanalytical phase of testing in a Clinical Chemistry diagnostic laboratory.A review was conducted at the Clinical Chemistry Laboratory of a hospital in Saudi Arabia from January 2019 to December 2020. Using the laboratory information system, the data of all canceled tests and requests were retrieved and evaluated for preanalytical errors.A total of 55,345 laboratory test requests and samples from different departments were evaluated for preanalytical errors. An overall rate of 12.1% (6705) was determined as preanalytical errors. The occurrence of these errors was found to be highest in the emergency department (21%). The leading preanalytical errors were nonreceived samples (3.7%) and hemolysis (3.5%). The annual preanalytical errors revealed an increasing rate in outpatient and inpatient departments, while a decreasing rate was observed in the emergency department. An increased rate of errors was also noted for the 2-year study period from 11.3% to 12.9%.The preanalytical phase has a significant impact on the quality of laboratory results. The rate of error in the study was high and the leading causes were nonreceived samples and hemolysis. An increased occurrence of hemolyzed samples in the outpatient department was noted. Enhanced educational efforts emphasizing specimen quality issues and training in sample collection among hospital staff must be carried out.

Comparative cross-sectional assessment of knowledge, attitude and practice among university students and employees towards the use of the microbiology laboratory equipment

Background: Continuous evaluation of students and employee’s knowledge and attitude in clinical laboratories is mandatory to ensure a high level of competency, proper practice and to assess the need for training, which shall be reflected on the quality of laboratory results. The aim of the present study was to evaluate the knowledge, attitude, and practice in microbiology laboratories among employees (at King Fahd Hospital of the University) and clinical laboratory students (at Imam Abdulrahman Bin Faisal University) Methods: This was a cross-sectional survey of 30 2nd year students, 26 3rd year students, 24 4th year students in the Clinical Laboratory Sciences department, and 30 employees. Participants completed a survey comprising 30 questions to assess their knowledge and attitude towards the use of equipment and practice in the microbiology laboratory. Results: The results indicated that there was no significant difference between the average scores of all levels of students regarding their knowledge (p = 0.85, 0.999, and 0.869), attitude (p = 0.883, 0.996, 0.853), and practice (p=0.633, 0.325, 0.858) in the microbiology laboratory. Employees scores (knowledge;5.03±2.646, attitude; 12.03±4.89, and practice; 7.7±6.11) were quite poor, as indicated by the lower average results than that of students (knowledge; 5.65±3.08, attitude; 13.25±5.33, and practice; 13.46±5.7). Conclusions: It is concluded that the knowledge, attitude, and practice of students and employees in the microbiology laboratory needs to be meticulously monitored and improved to ensure high achievement of learning outcomes and better overall performance in the laboratory. This may be achieved through using frequent quizzes and continuous education programs.

Comparative cross-sectional assessment of knowledge, attitude and practice among university students and employees towards the use of the microbiology laboratory equipment

Background: Continuous evaluation of students and employee’s knowledge and attitude in clinical laboratories is mandatory to ensure a high level of competency, proper practice and to assess the need for training, which shall be reflected on the quality of laboratory results. The aim of the present study was to evaluate the knowledge, attitude, and practice in microbiology laboratories among employees (at King Fahd Hospital of the University) and clinical laboratory students (at Imam Abdulrahman Bin Faisal University) Methods: This was a cross-sectional survey of 30 2 nd year students, 26 3 rd year students, 24 4 th year students in the Clinical Laboratory Sciences department, and 30 employees. Participants completed a survey comprising 30 questions to assess their knowledge and attitude towards the use of equipment and practice in the microbiology laboratory. Results: The results indicated that there was no significant difference between the average scores of all levels of students regarding their knowledge (p = 0.85, 0.999, and 0.869), attitude (p = 0.883, 0.996, 0.853), and practice (p=0.633, 0.325, 0.858) in the microbiology laboratory. Employees scores (knowledge;5.03±2.646, attitude; 12.03±4.89, and practice; 7.7±6.11) were quite poor, as indicated by the lower average results than that of students (knowledge; 5.65±3.08, attitude; 13.25±5.33, and practice; 13.46±5.7). Conclusions: It is concluded that the knowledge, attitude, and practice of students and employees in the microbiology laboratory needs to be meticulously monitored and improved to ensure high achievement of learning outcomes and better overall performance in the laboratory. This may be achieved through using frequent quizzes and continuous education programs.

Comparative cross-sectional assessment of knowledge, attitude and practice among university students and employees towards the use of the microbiology laboratory equipment.

Background: Continuous evaluation of students and employee's knowledge and attitude in clinical laboratories is mandatory to ensure a high level of competency, proper practice and to assess the need for training, which shall be reflected on the quality of laboratory results. The aim of the present study was to evaluate the knowledge, attitude, and practice in microbiology laboratories among employees (at King Fahd Hospital of the University) and clinical laboratory students (at Imam Abdulrahman Bin Faisal University) Methods: This was a cross-sectional survey of 30 2 nd year students, 26 3 rd year students, 24 4 th year students in the Clinical Laboratory Sciences department, and 30 employees. Participants completed a survey comprising 30 questions to assess their knowledge and attitude towards the use of equipment and practice in the microbiology laboratory. Results: The results indicated that there was no significant difference between the average scores of all levels of students regarding their knowledge (p = 0.85, 0.999, and 0.869), attitude (p = 0.883, 0.996, 0.853), and practice (p=0.633, 0.325, 0.858) in the microbiology laboratory. Employees scores (knowledge;5.03±2.646, attitude; 12.03±4.89, and practice; 7.7±6.11) were quite poor, as indicated by the lower average results than that of students (knowledge; 5.65±3.08, attitude; 13.25±5.33, and practice; 13.46±5.7). Conclusions: It is concluded that the knowledge, attitude, and practice of students and employees in the microbiology laboratory needs to be meticulously monitored and improved to ensure high achievement of learning outcomes and better overall performance in the laboratory. This may be achieved through using frequent quizzes and continuous education programs.

Questionnaire-based Study to Assess Knowledge of Preanalytical Phase of Laboratory Testing Among Trainee Doctors in a Tertiary Care Hospital Medical College.

Objective To determine the knowledge base of common laboratory practices related to preanalytical phase of laboratory testing among medical interns and first-year postgraduate residents in a tertiary care hospital medical college. Materials and methods Questionnaire-based survey on preanalytical phase of laboratory testing was conducted among 208 participants, who volunteered and were MBBS interns and first-year postgraduate residents in a medical college, over the period from June 2018 to December 2019. A total of 15-item, multiple-choice questions (MCQs) were included, of which four were opinion-based and not considered for analysis. Responses were further categorized based on percentages with correct response, so we could identify specific knowledge points which need training. Statistical analysis Results were analyzed using Microsoft Excel functions and a simple calculator. Results A total of 208 participants were included in the study, which consisted of an equal number of interns (104) and first-year postgraduate residents (104). The term “preanalytical error” was known to 62.5% of participants. Only 9.62% participants took formal training in phlebotomy. Topics related to questions like coagulation testing, ideal fasting duration, mixing of blood, and order of draw received less than 40% correct response which meant that it requires more training. Conclusions In this era of evidence-based medicine, central laboratory plays a pivotal role in patient management, and quality of laboratory results are of paramount importance. Over a period of time, automation technology has reduced analytical phase errors to the minimum. Most errors reported are part of the preanalytical phase, and it has been found that a majority of them are committed due to a lack of knowledge and skills. In order to improve the preanalytical phase and make it as error-free as possible, the staff (technicians, nurses, and trainee doctors) should be constantly motivated and trained.

Haematology Request Forms at a New Tertiary Health Institution in North central, Nigeria: Evaluation of Level of Compliance with Entries and the Impact on Results

Meticulous completion of the haematology request forms is an essential component of pre-analytical protocol. This process that contributes to the quality of laboratory results is critical for patient management. We set out to determine the level and adequacy of information provided when haematological investigations are requested and its impact on patient management.Requests forms submitted for haematological examinations were checked for completeness. The number of times items on the forms that were properly filled and omitted were recorded. The rate of compliance with filling in each item was determined. Comparisons were made between physicians and surgeons and among departments. Descriptive analysis of the data generated was carried out. Four thousand request forms were analyzed for completeness. 26.5 % (1060) were completely filled while 73.5% (2940) had one or more omissions. Client's name was filled in 100% of the forms while the item with the lowest level of compliance (56.3%) was the time of specimen collection. On the average, the rate of completeness of the forms was 86.6%. Physicians significantly completed the request forms more than the surgeons (32.8% vs 19.2%, p=0.0001). Department of Medicine had the highest completion rate of 43.7%, followed by Paediatrics 20.6%, Obstetrics and Gynaecology was 19.5% and the least was Surgery 18.8%. Incomplete information on the request forms lead to non-interpretation of 21.5% of the laboratory requests by the laboratory physicians. This study revealed low compliance with the supply of information required in the request form at the Benue State University Teaching Hospital, Makurdi. This negatively impacted on the interpretation of the laboratory results. Modification of medical curriculum, education of clinicians, introduction of electronic requesting and rejection of request forms lacking critical items are being recommended.Keywords: Haematology request form, Evaluation, Nigeria, and Tertiary Hospital

Determination of Ochratoxin A in Food by High Performance Liquid Chromatography

Ochratoxin A (OTA) is an important mycotoxin that is produced by Aspergillus and Penicillium species. Ochratoxin A is a common contaminant of various foods including cereals, spices, coffee, cacao, beer, wine, raisins, pulses, meat, meat products, or edible offal. Due to a wide range of its toxic effects in humans and animals, ochratoxin A needs to be monitored. With regard to this necessity, a sensitive HPLC-FD method for purposes of the quantification of trace amounts of ochratoxin A in foods of plant and animal origin was developed, validated and applied for analysis. Food samples were cleaned using commercial immunoaffinity columns and analyzed by means of a high performance liquid chromatography method with fluorescence detection. Limit of quantification of the method ranged between 0.01–0.30 µg/kg depending on the sample matrix. Recoveries were 80–88% in the concentration range of 0.01–0.30 µg/kg, depending upon sample type. The quality of laboratory results was confirmed by successful participation in international inter-laboratory proficiency testing. This laboratory was accredited accordance to CSN ISO/EN 17025. The developed method was applied to the determination of ochratoxin A in samples from 61 types of foodstuffs of plant and animal origin, that were collected in 4 sampling terms at 12 regions of the Czech Republic in years 2011–2012. In total, 732 food samples were gathered and analyzed.

Effectiveness of the biological monitoring of chemical exposure in the workplace: Results of a survey in an area of Northern Italy

A survey of biological monitoring results from 2000 to 2008 was carried out as a part of institutional activities performed by the Workplace Prevention and Safety Service (SPSAL) of the south area of Modena district (Italy). The survey involved 18 companies employing 945 workers altogether. According to workplace exposure, routine biological monitoring had been carried out yearly or 6-monthly in private laboratories chosen by each company. Analysis of consecutive data from six plants showed fluctuating biomarker levels inconsistent with expected occupational exposure and sometimes exceeding biological exposure indices. Surveillance samplings were thus organized for comparison to be carried out in a public reference laboratory. Overall results showed systematic underestimation of marker levels by the laboratories in charge of routine biomonitoring that, together with inappropriate biomarker selection and timing of sample collection, led to insufficient and/or ineffective corrective measures. These results raise major concerns on the reliability of laboratory assessments performed for the routine biomonitoring of exposed workers. Continuous surveillance of the consistency between biological and ambient monitoring data, together with the systematic evaluation of the analytical quality of laboratory results, would be essential for a reliable assessment of health risk in the workplace.

Diagnostic samples: From the patient to the laboratory The impact of preanalytical variables on the quality of laboratory results 4th, updated edition Walter G. Guder, Sheshadri Narayanan, Hermann Wisser and Bernd Zawta Wiley-Blackwell Ed. ISBN: 978-3-527

http://eu.wiley.com/WileyCDA/WileyTitle/productCd-3527323074.html Sara, a fictional postdoctoral fellow of Midtown University Hospital, has made a major discovery in human immunology; however, she cannot reproduce her observations despite repeatedly trying for a few months. All the blood samples she has been processing show aberrant restriction fragments in genotyping, despite fully concordant cell phenotypes in flow cytometry. When she presents her results at the lab meeting, her supervisor simply invites her to check her protocols more carefully before further discussion. Overall, the day of the lab meeting was a truly bad day for Sara. Sara then spends the night going through her lab book, without finding any inaccuracies that could explain the discrepancies in the experimental results. She does, however, find a note indicating that, from a given date onwards, the blood samples were delivered to the research laboratory in tubes with a different color code, namely green instead of lavender. Could this detail explain the mystery? She believes it does. The next day Sara knocks several times on the door of her supervisor's office, but more urgent matters keep him very busy and unable to meet with her. Only in the evening is Sara admitted to his office. Her explanation regarding the inconsistent results is that the anticoagulant contained in the green-coded tubes that were used to deliver the later blood samples interferes with the genotypic analysis; Sara provides experimental evidence in support of her hypothesis. Her supervisor sees the trouble clearly now, and immediately calls a plenary meeting to discuss this urgent matter with the entire research team. Could all of this trouble been avoided? Definitely, by carefully considering the preanalytical variables that can interfere with the quality of laboratory results. This is a crucial aspect that must be taken into account when planning either diagnostic laboratory tests or research. The book of Guder et al., in its fourth updated edition, provides vital information on the correct European and international standard procedures for collection, transport, storage and management of human biological material, encompassing biosafety aspects and, very importantly, the many variables that can represent sources of laboratory errors. Several factors account for disease-independent variability of experimental results. These not only include sample preparation and handling, but also individual intrinsic aspects such as age, gender, race, pregnancy and diet. Every aspect is illustrated with real-life examples, the figures are clear, easy to understand and identify the key parameters to be considered, and practical information is easy to find in each specific chapter or by consulting the associated bioinformatics tool (www.diagnosticsample.com). This practical book increases the awareness of the effects of preanalytical variables in laboratory results and provides essential guidelines for daily laboratory practice. It is a must for anyone involved in clinical and, very importantly, human basic research.

Document Control Practices in 120 Clinical Laboratories

A variety of document control practices are required of clinical laboratories by US regulation, laboratory accreditors, and standard-setting organizations. To determine how faithfully document control is being implemented in practice and whether particular approaches to document control result in better levels of compliance. Contemporaneous, structured audit of 8814 documents used in 120 laboratories for conformance with 6 generally accepted document control requirements: available, authorized, current, reviewed by management, reviewed by staff, and archived. Of the 8814 documents, 3113 (35%) fulfilled all 6 document control requirements. The requirement fulfilled most frequently was availability of the document at all shifts and locations (8564 documents; 97%). Only 4407 (50%) of documents fulfilled Clinical Laboratory Improvement Amendment requirements for being properly archived after updating or discontinuation. Policies and procedures were more likely to fulfill document control requirements than forms and work aids. Documents tended to be better controlled in some laboratory sections (eg, transfusion service) than in others (eg, microbiology and client services). We could not identify document control practices significantly associated with higher compliance rates. Most laboratories are not meeting regulatory and accreditation requirements related to control of documents. It is not clear whether control failures have any impact on the quality of laboratory results or patient outcomes.

Aspects of auditing in clinical laboratories

Quality and patient safety are terms that both providers and recipients of healthcare are very familiar with. Accreditation is another term that is closely linked to quality and patient safety. Audit is a systematic, independent, and documented process for obtaining evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled. Accreditation and audit are integral components of the same process. Three different types of audit are well recognized—internal, external, and co-operative. Reading of relevant documents, observation of laboratory practices, and asking open-ended probing questions are important auditing techniques. For auditing to be successful, experienced, qualified, and well trained auditors are essential. Furthermore, the auditor should be open-minded, not prejudiced, a team player and effective communicator, both in writing and verbally. In many instances, the emphasis for seeking laboratory accreditation has shifted from building quality systems—to produce reliable results and ensure patient safety—to just passing the inspection. Recently, the emphasis for laboratory quality improvement has been placed on pre and post-analytical processes in preference to analytical quality. The analytical quality of laboratory results is still far from ideal and it may be detrimental if less emphasis is placed on this aspect of laboratory medicine. Auditing or on-site inspection as a regulatory tool does not work or present a realistic picture of laboratory quality. A continuous quality improvement approach will help laboratories to build quality into their systems.

Section 1: The Fourth International Radiocarbon Intercomparison (Firi)

Radiocarbon dating is universally used as an essential dating tool in the archaeological and earth (Quaternary) sciences. The technique has enjoyed considerable success with ongoing developments in both the sophistication of experimental practice and an ever-widening range of applications. Most recently (since the 1980s), a new generation of laboratories has been created, based on the exploitation of accelerator mass spectrometry (AMS) for the differentiation and measurement of carbon isotope abundances in natural materials. Worldwide, there are over 100 14C laboratories now operational in universities, research organizations, museums, and as commercial enterprises. There is an inevitable diversity of experimental approaches and applied priorities within these facilities. Some are well established, while others are relatively recent members of the international 14C community. Consequently, as a group, the laboratories reflect to varying extents the progress achieved over several decades of experience and methodological options. Furthermore, since progress in archaeology and related earth sciences cannot respect geographical and/or present political boundaries, there has been, and continues to be, an inevitable consequence that sample materials from specific cultural contexts are submitted to different laboratories and at different times. In this situation, the issue of comparability between results and amongst laboratories becomes paramount. Users of the results from 14C dating are also concerned with the comparability and quality of laboratory results and the quality assurance programs that laboratories undertake are thus important in ensuring user confidence. The harmonization of measurements and the traceability of results to internationally recognized standards are also major goals of the program of work described in this special issue.

Quality management in laboratory medicine.

In the context of total quality management the paper is focused on analytical quality with special emphasis on the preanalytical steps from the patient to the sample. At the present time those are the most important limiting factors of the quality of laboratory results.

Is accreditation useful for quality improvement?

The Laboratory of the Government Chemist (UK) and the Institute for Reference Measurements and Materials (Belgium) evaluated the correlation between accreditation and performance in proficiency tests. It was concluded that accreditation does not have the expected positive effect on the quality of laboratory results. In this journal discussions conducted on this subject during the CITAC workshop at Pittcon in 1998, were published. No satisfactory explanation for this phenomenon was put forward. In this article, it is proposed that the main effect of accreditation is a decrease of intralaboratory spread. The effect on the trueness of laboratory results is not significant due to the lack of certified reference materials and the low frequency of participation in proficiency tests. Proficiency tests cannot be used to find a correlation between accreditation status and quality without changing the set-up of the proficiency test.

Development and use of analytical quality specifications in the in vitro diagnostics medical device industry

Manufacturers of in vitro diagnostic (IVD) medical devices have become integral partners with their customers in determining the quality of laboratory results. Design controls imposed by ISO 9001 quality system standards and various regulations require manufacturers to implement a formal design process, which begins and ends with customer requirements. For IVD systems, this means that manufacturers must establish analytical quality specifications as part of their design input. This provides greater assurance that commercial products will satisfy customer requirements. In the case of quantitative IVD measurement systems, analytical quality specifications include total allowable uncertainty (bias, imprecision, non-specificity). The primary source of customer requirements is the laboratory-customer, who should have established analytical quality specifications based on the needs of its physician-clients. The total allowable uncertainty budget is allocated in the design process to the individual components of the system, such as reagents, instrumentation, calibrators and accessories, and to other factors such as operator, specimen and environmental interactions. Their performance must collectively meet the total allowable uncertainty specification when they are finally integrated into a measurement system. The design control model requires objective evidence that design specifications have been met (verification) and, finally, that the system will satisfy the needs of its intended users (validation). Compliance with the quality system standards is monitored through independent audits, government inspections and post-market surveillance.

The Impact of the Pre-Analytical Phase on the Quality of Laboratory Results Second Symposium Oxford, UK

The Impact of the Pre-Analytical Phase on the Quality of Laboratory Results Second Symposium Oxford, UK

Cost Containment, Quality Assurance, and Physician Microscopy of Cerebrospinal Fluid with Normal Cell Counts: Analysis of 1,677 Consecutive Specimens

During a six-month interval, 1,677 cerebrospinal fluid (CSF) specimens with cell counts of 0 to 5 X 10(6)/L were examined by one of six physician microscopists. Malignant cells were found in ten of these CSF specimens. In seven, unidentified cells had been noted on prior review by a technologist. Technologists had a frequency of false negative errors of 0.12%. Physicians had a frequency of apparent false positive errors of 0.12%. There is little or no benefit from physician microscopic examination of all CSF specimens that have normal cell counts. Adoption of a different policy would reduce medical care costs by $40,000 for this entire series of 1,677 specimens without adversely affecting the quality of laboratory results.

The Quality of Laboratory Staff and the Accuracy of Results-Reply

In Reply. —The study was designed for the purpose of ascertaining the relationship of a single variable, the qualifications of medical technologists, and the quality of laboratory results. From Dr Peddecord's comments it seems that he is accustomed to using parametric statistical techniques such as multiple regression. Multiple regression makes assumptions about the sample distributions. If these assumptions are violated, then the results must be suspect. In this study, to avoid any distribution peculiarities in the sample(s), nonparametric statistics were used to analyze the data. A Spearmanrscorrelation of.34 (P