common errors in histopathology laboratory

As opposed, to false-positive diagnosis, the patient can be submitted to several unnecessary procedures, such as extensive surgical resections, radiation therapy, or chemotherapy. One factor conferred to the increase in the number of medical errors is the excessive decentralization of patient care. Optimizing your LIMS to interface with all possible software and hardware is crucial to accurately track specimens as theyre processed, especially with workflow dashboards or status monitors that require frequent updating. LabTAG by GA International is a leading manufacturer of high-performance specialty labels and a supplier of identification solutions used in research and medical labs as well as healthcare institutions. Steps to Better Grossing Geoffrey Rolls, BAppSc, FAIMS From patient to pathologist, preparing tissue specimens for histological examination requires care, skill and sound procedures. You have entered an incorrect email address! A LIMS can coordinate every step of the histological process, from sample processing to slide analysis, timestamping, and recording each sample as its passed from station to station. They found errors in 210 cases (0.37%) after analyzing 297 reports during the study conducted on 57,000 surgical pathology cases in a laboratory in Karachi in 2014. Bookshelf Unauthorized use of these marks is strictly prohibited. Quality control, which involves routine checks throughout the lab for proper specimen identification, appropriate protocols and techniques, artifact detection, and inspection of controls, is necessary to guarantee that results are reliable and documented. The main recommendations cited in the document, with strong agreement among the participants were: (1) pathologists should develop procedures for the evaluation of selected cases in order to detect divergences and possible interpretation errors, (2) pathologists should conduct case reviews timely to prevent negative impacts on patient care, (3) pathologists should have review procedures of cases relevant to their practice, as well as continuously monitor and document the results of case reviews, and (4) if case reviews show unsatisfactory concordances for a defined case type, the pathologists should take action to improve diagnostic compliance. Hanna MG, Pantanowitz L. Bar Coding and Tracking in Pathology. Disclaimer. This chapter is distributed under the terms of the Creative Commons Attribution 3.0 License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Generic audit strategies that can be used to minimize the risk of errors in reports are discussed, together with the use of audit to evaluate diagnostic criteria and pathological scoring or grading systems. The rates of identification errors were lower when the reports were reviewed by a second pathologist prior to their release (0.0 vs. 0.6/1000, p<0.001), and errors related to the specimen were less reported when released after an intradepartmental review of more difficult cases (0.0 vs. 0.4/1000, p=0.02) [11]. Distribution of errors according to the operating process phase and examples. By Antonio Gustavo Gonzlez, Mara ngeles Herrador, IntechOpen Limited To date our community has made over 100 million downloads. A study conducted at 14 laboratories in Australia examined a number of laboratory errors, including errors transcribing a patient's name from pathology requisitions to computer systems [Khoury M. Burnett L. . National Library of Medicine Misinterpretations: This category is divided into three subtypes that occurred in relation to two levels of diagnostic information. Makary MA, Epstein J, Pronovost PJ, Millman EA, Hartmann EC, Freischlag JA. in order to identify contributing factors and causes of the most common and serious errors. This proposed error taxonomy has shown a very good interobserver agreement of 91.4% (k=0.8780; 95% confidence limit, 0.84160.9144) when applied to amended reports. Departmental audit in surgical anatomical pathology. Workplace stressis related to attention deficiencies and can lead to unnecessary errors.6 There are three major things histology lab managers can do to promote a mistake-free lab:7. In this study, pathologists reviewed 7444 cases using a targeted 5% random review process and 380 cases using a focused review process and describes 195 (2.6% of reviewed cases) and 50 (13.2%) errors detected by the procedures, respectively (p<0.001). Standardized reports can provide data that contribute to quality improvement programs in health care and, when combined with other health data sources, provide important information for monitoring, improvement, possible interventions, and benefit analyses in services offered to the population. Many studies point to automation as one of the most effective ways to reduce errors in histology labs. Besides that, some expressions can lead to confusing interpretations. Dr. Alex Goldberg earned his Ph.D. in biology and previously worked as a post-doc in toxicology and medicine, studying chronological lifespan in yeast, anti-neoplastic small molecules, and the genetics of tuberous sclerosis complex. J Oral Maxillofac Pathol. 2016 Aug 5;11(8):e0160821. Methods: This study was conducted in a private histopatholgy referral center, named Delta Hospital Limited over a period of 3 days. In many instances, merely implementing a system of barcode specimen tracking significantly reduced errors associated with misidentified samples; for instance, at the Henry Ford Hospital, there was a 92% decrease in slide misidentification and a 62% decrease in total misidentified cases after barcodes were applied to the workflow. [ 3] Equally important is safety, which is defined as "freedom from accidental injury". Of 13 water baths examined, only one fragment of tissue was identified. 2009 Apr;104(4):972-5. doi: 10.1038/ajg.2008.170. Errors : Detection and minimization in histopathology laboratories Authors: Shovana Karki Tribhuvan University Abstract p>The histopathological diagnosis plays a major role in the treatment of. In the first subtype, missing or erroneous non-diagnostic information about practitioners involved in the case, procedure or dates in which the specimen was collected, or codes regarding the patient, procedure, or diagnosis, and so on. Epub 2017 Mar 16. But what is the gold standard of pathology? Van Der Linden D, Keijsers GPJ, Eling P, Van Schaijk R. Work stress and attentional difficulties: An initial study on burnout and cognitive failures. Even more complex is the situation that involves the discovery of the error of another individual: when the pathologist or the head of the laboratory discovers an error of a technician/ pathologist in their laboratory or external laboratories, or even when the pathologist discovers an error of a clinician from the same organization. Which Chemicals Do I Need to Test with My Labels, Customizing Lab Requisition Forms Enhances Sample Tracking in Diagnostic Labs, ChatGPT & the Growing Influence of AI in Science. Effectiveness of random and focused review in detecting surgical pathology error. The development and testing of a laboratory information system-driven tool for pre-sign-out quality assurance of . Barcoding can be used to audit and track every step of the histochemical process, ensuring the correct specimen is used before proceeding. and transmitted securely. During the pre-analytic phase, wrong identification can be responsible for 2738% of the errors, and specimens-related errors vary from 4 to 10%. *Address all correspondence to: monique.freire20@gmail.com. Risk assessment using a fishbone diagram. To reduce this risk, it is essential that a gross station stay clean and organized. Sometimes histology shows evidence of suspicious exogenous tissue sample, such as tumor cells with nuclear inclusions similar to arachnoidal cells in an endometrial sample, associated with the presence of eosinophilic amorphous material morphologically similar to secretory meningioma. Every woman deserves to thrive. 1 Besides causing serious harm to patients, medical errors translate into huge costs for the national economy. Perkins [36] considers that the disclosure of errors in pathology is complicated by factors intrinsic to the specialty. UNITED KINGDOM, Monique Freire Santana and Luiz Carlos de Lima Ferreira, Diagnostic errors and concordances in pathology. Raab SS, Grzybicki DM, Mahood LK, Parwani AV, Kuan SF, Rao UN. Contact our London head office or media team here. The best approach to troubleshooting and remedying these events is to (1) understand the various theories of action behind histology procedures and stains then (2) apply a problem-solving mentality to develop a corrective action. Some diagnoses have intrinsically greater variation between observers, and these differences should be considered. Furthermore, the histological diagnosis is dynamic and different terminologies can be used for the same disease. Report defects: Defects of three subtypes were observed. Deficiencies in pre-laboratory steps can occur as well. The site is secure. Registers and records were checked for efficiency and errors for pre-analytical quality variables: specimen identification, specimen in appropriate fixatives, lost specimens, daily internal quality control performance on staining, performance in inter-laboratory quality assessment program {External quality assurance program (EQAS)} and evaluatio. . The pathologic diagnosis depended on interpretative and subjective skills. Errors occur during prelaboratory, laboratory, and postlaboratory phases. Careers. HHS Vulnerability Disclosure, Help Before Despite CAP recommendation of an analytical response time of 2 days or less for most routine cases, the authors conclude that cancer care institutions should have a TAT longer than other services [34]. Reduction in Hospital-Wide Clinical Laboratory Specimen Identification Errors following Process Interventions: A 10-Year Retrospective Observational Study. Specimen defects included five subtypes: lost specimens, specimens with inadequate sample volume or size, samples with absent or discrepant measurements, inadequately representative sampling, and samples with absent or inappropriate ancillary studies. Improve quality, reduce errors, and save time with dedicated plug and play consumables. | Updated: Jul 18, 2022 | 4 min read PDF Version Hospital pathology laboratories are dangerous places to work due to the many hazardous chemicals employed during histology and molecular biology techniques, as well as equipment that contain sharp blades. Surgical pathology laboratory process is much more complex than highly mechanized processes with minimal human participation, such as clinical laboratory analysis. Measuring errors in surgical pathology in real-life practice: defining what does and does not matter. In Woods A and Ellis R eds. The result must be accurate, based on gold standards, and scientifically validated. Here are five things you can do to help prevent these costly errors in your histology lab. The second subtype may be dictated or typographical errors. The year 1989 saw the most famous quality control initiative when the CAP introduced the Q-PROBES Program, which defines quality in terms of practices of laboratory medicine and anatomic pathology. Biases such as visual anticipation, first impression, and preconceived judgments influence the critical decision-making processes [28]; however, to what extent such elements may interfere with the pathologists diagnostic decision-making is uncertain. Morphology is subjective and affected by the observers experience. Over 40% of lab mistakes occur during the pre-analytical step, whereas only 7% occur during the testing itself. In an accessioning, many errors can occur. For labs that process a high volume of samples, color coding labels are also an option that makes sorting specimens by subspecialty easier. Since the goals of pathology are multifaceted, it is easy to understand that there are multiple possibilities for error. Heher YK, Chen Y, Pyatibrat S, Yoon E, Goldsmith JD, Sands KE. Karki S1 1Department of pathology, Tribhuvan University Teaching Hospital, Kathmandu, Nepal. Arch Pathol Lab Med. In post-analytical phase, errors include typographical errors, and in some cases, it can lead to catastrophic consequences, when the expression cancer is present instead of cancer is not present. Another error in this phase included erroneous or missing non-diagnostic information, computer formatting, or transmission [29]. 5 Princes Gate Court, Surprisingly, physicians and other interested people do not understand full aspects about the harmfulness of errors in laboratory medicine. In Pakistan, Ahmad etal. The role of the pathologist Although the histology diagnosis plays an important role in the treatment of disease, errors do occur. In professional training, the academic programs and the American Board of Pathology, with their certification mechanism, help to ensure the full competence of the practice of pathology [2]. Errors in laboratory medicine and clinical pathology can occur at any point from specimen retrieval through specimen analysis; they are classified broadly as preanalytic phase, analytic phase, and postanalytic phase errors [9, 10]. Errors in histopathology reporting: detection and avoidance The histopathological diagnosis is the bedrock of modern oncology, and plays a major role in the treatment of many other types of disease. Correlation errors of freezing biopsy with conventional histology, University Hospital Getulio Vargas, Amazon, Brazil. However, in daily practice, there are multiple possibilities of errors in the pathology laboratory, with several impacts on patient care and prognosis. Detecting and preventing the occurrence of errors in the practices of laboratory medicine and anatomic pathology: 15 years' experience with the College of American Pathologists' Q-PROBES and Q-TRACKS programs. Cognitive errors, such as inadequate or incomplete macroscopic descriptions, inadequate representation of the lesion or of relevant areas necessary for its characterization, may also occur, and although some are beyond the pathologists control, the responsibility falls directly on him, with very serious damage to the patient [8]. Technology, ranging from bar-coded specimen labels to radio frequency identification tags, can be incorporated into protective systems that have the potential to detect and correct human error and reduce the frequency with which patients and specimens are misidentified. Unauthorized use of these marks is strictly prohibited. Hocking GR, Niteckis VN, Cairns BJ, Hayman JA. Among the factors that might make it less likely that they would disclose a serious error to a patient, the most common was the possibility that the patient would not understand what he or she was being told (n=84, 49.7%) and the physician would not be able to explain the error clearly to the patient (n=68, 40.2%), according to the interviewees perception. Some reviews were nonconference related. For this, barcode labels and a LIMS are crucial. . Surgical pathology--second reviews, institutional reviews, audits, and correlations: what's out there? In this chapter, we discuss the different concepts of error and diagnostic concordances in pathology, at which point in the diagnostic process the errors are more frequent, and propose solutions to minimize the chance of their occurrence. There are various types of embedding medium used in the histopathology laboratory as per . Subscribe today! Faced with a colon adenoma with high-grade dysplasia, the pathologist may believe that surgeons will interpret the presence of dysplasia as a license for an unnecessary surgical resection and feel inclined to omit such information from the report. For example, contamination of an esophageal biopsy by a very small fragment of normal tissue from the small intestine or colon may lead to a false-positive diagnosis of Barretts esophagus or, worse, when the contamination occurs by a fragment of atypical or dysplastic intestinal epithelium that may lead to a false interpretation of Barretts esophagus with dysplasia. In these cases, the productivity of the entire laboratory decreases until the pathologist discovers the source of contamination because of the longer evaluation time and the need to deepen the histological sections. Raab etal. Therefore, the surgical pathology report is a complex task with multiple steps in which there is a possibility of error. In container defects, the authors included missing specimen, container with no identified or misplaced label, absence or incorrect numeric patient identifier, absence of specimen type or source, and/or incorrect specimen type or source (or laterality). The study objective is to evaluate critical points in the process of pre-analytical histology in an Anatomic Pathology laboratory. An official website of the United States government. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Anatomic pathology, which involves multiple specimen transfers and hand-offs, may have the highest identification error rate. How? FOIA All Common Checklist, COM.06000, Specimen Collection Manual . This site needs JavaScript to work properly. By making research easy to access, and puts the academic needs of the researchers before the business interests of publishers. Quality Control in Laboratory, Submitted: September 17th, 2017 Reviewed: December 5th, 2017 Published: August 22nd, 2018, Total Chapter Downloads on intechopen.com. Rana MK, Rana APS, Jain A, Pathak A, Khera U Sr, Sharma U, Jindal A, Singh K. Cureus. The accuracy is based on scientifically validated gold standards, and it can be difficult since most of the diagnoses do not have this pattern in morphological analysis. Troxel [26] reviewed records of lawsuits against pathologists for diagnostic negligence at a US insurance company responsible for the insurance of 1100 pathologists. 2017 Sep;23(5):583-588. doi: 10.1111/tbj.12797. Errors in Pathology laboratory can result in serious adverse patient outcomes, with catastrophic results. 8600 Rockville Pike Patient and Sample Identification. That means handling stress, getting good women's health care, and nurturing yourself. Finally, the . We reviewed our experience with mislabeled specimens in the laboratory for an 18-month period. Would you like email updates of new search results? The lack of complete information is critical in pathology, where many cases depend on correct, clear, and complete clinical information for adequate clinical-pathological correlation. The errors can be further divided into errors of accuracy, that is, how much of the released diagnosis represents the true pathological process and precision errors related to concordances among pathologists in the interpretation of a case [9]. Of the 199 permanent specimens, 99 (49.7%) were misinterpretations, and the most common subspecialty/anatomic location was gastrointestinal tract (including liver, pancreas, and biliary tract) with 23.2% (n=23), followed by breast (n=13, 13.1%), and lungs, pleura, and mediastinum (n=10, 10.1%). The authors advise that if the problems become recurrent, a letter to the material source services with guidelines may help to improve the specimens. Establishing proficiency testing will also safeguard employees and prevent errors in the long run by ensuring that staff is following SOPs and performing their tasks appropriately. Cytogenetic studies by in situ or molecular hybridization are not applicable to most diseases routinely found in surgical pathology. False-negative and false-positive results for cancer accounted for 63 and 22% of claims, respectively. An extraneous tissue rate of 0.6% of slides (2074/321757) in the retrospective study and 2.9% of slides (1653/57083) was detected. Keywords: Audit; Errors; Quality control; Surgical pathology. [18] observed 69 hospitals in 3months and described identification defects in 2.9% of cases (1780/60,501; 95% confidence interval [CI]=2.04.4%), 1.2% of containers (1018/81,656, 95% CI=0.82.0%), and 2.3% of requisitions (1417/61,245, 95% CI=1.24.6%). This guide provides key facts and practical tips on women's health. Am J Clin Pathol. Below, we will address the four most common laboratory errors: environmental, procedural, human, and instrumental. Smith and Raab [9] describe how to use the Lean A3 quality control method in surgical pathology. Letting Your Samples Dry Out In general, more errors were detected by pathologists (47.4%) than by clinicians (22%). The most commonly utilized is a classification in pre-analytical, analytical, and post-analytical phases, but we note that the errors can overlap between these categories. Am J Gastroenterol. This guide provides practical advice on best practice techniques and simple ways to avoid common errors. They describe a median of amended reports was 1.5/1000 cases; of these, 19.2% were issued to correct patient identification errors, 38.7% to change the originally issued final diagnosis, 15.6% to change a preliminary written diagnosis, and 26.5% to change clinically significant information other than the diagnosis. Type of error: patient misidentification or specimen misidentification. [41] performed a nonconcurrent cohort study to compare the effectiveness and usefulness of error screening using a targeted 5% random review process (selected by a laboratory information system) and a focused review process. The last was performed in three subspecialties: gastrointestinal subspecialty, bone and soft tissue, and genitourinary pathology. Certain unavoidable cognitive failures lead to identification errors. Labels encounter many different harsh solvents throughout each step, the harshest being xylene. These studies investigate the frequency of errors occurrence: the laboratory participants submit data from the calculation of the normative rates of errors during the laboratory tests. Even when clearly written, the numbers for slide identification can lead to confusion, such as when the lower horizontal bar of the number 2 on the middle slide is rather short and can be mistaken as number 7 [21]. Either has the potential to cause patients harm. 13 A quality indicator is thus 'an objective measure that potentially evaluates all critical care . The authors identified 20% (n=4) of analytical and 39% of (n=8) post-analytical errors [15], as shown in Table 1, associated with Tosuner [16] survey data. A 12-point event-based checklist for errors of diagnostic accuracy in histopathology and cytopathology is proposed derived from Dupont's 'Dirty Dozen' HF checklist, as used in the aerospace industry for aircraft maintenance. The quality of the slides is a prime factor for the correct diagnosis. Barcodes are especially important for avoiding errors in all facets of pre-analytic sample processing. In these situations, called vicarious liability, the first pathologist assumes legal responsibility for having chosen a negligent consultant [30]. Rates were higher in institutions with pathology residency programs (8.5 vs. 5.0/1000, p=0.01) or when a percentage of cases were reviewed after release (6.7 vs. 3.8/1000, p=0.10). The focused review process detected approximately four times much more errors than the targeted 5% random review process, despite this last process involving the examination of almost 20 times the number of specimens. A quality initiative to decrease pathology specimen-labeling errors using radiofrequency identification in a high-volume endoscopy center. The .gov means its official. Tips for better grossing are highlighted in this guide. Disclaimer. The authors declare that they do not have any conflicts of interest. The inappropriate cut makes it impossible to evaluate the cellularity of this biopsy (Bone marrow, H&E, 400x). Besides that, the identification in the laboratory is critical as well. We routinely observe the widespread use of inadequate containers, too small for the specimen, which make it difficult to withdraw. Save my name, email, and website in this browser for the next time I comment. Chemical-resistant barcode labels are the most important tool for identifying histology samples. The second form of this classification is the division of errors into pre-analytic, analytic, and post-analytic errors. The third subtype is misclassifications that occur when the pathologist changes similar diagnostic categories, for example, the names of a soft tissue sarcoma, without primary diagnostic implications or secondary diagnostic informations modifying impact (the differently labeled sarcoma behaved biologically with the same degree of aggressiveness during the same treatment). The authors believe that the reasons for use for this expression may include contradictory or low probability staining results, inconsistency in clinical data, uncertain criteria in the medical literature, quantity of sample or abnormality, and possibly a concern with medicolegal consequences for an over- or under-diagnosis.

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