Enhancing Pharmaceutical Product Quality With a Comprehensive Corrective and Preventive Actions (CAPA) Framework: From Reactive to Proactive.

Corrective and preventive actions (CAPA) are crucial components of quality assurance (QA) within the pharmaceutical industry, essential for maintaining product quality, safety, and regulatory compliance. The review explores the multifaceted role of CAPA in pharmaceutical manufacturing, emphasizing its structured approach to detecting, addressing, and preventing quality issues. CAPA systems are integral to the broader quality management system (QMS), functioning as a dual-loop mechanism that is reactive and proactive approach aligned with continuous improvement principles outlined by the International Organization for Standardization (ISO) 9001:2000. It details the three distinct phases of CAPA: correction or remedial action, corrective action (CA), and preventive action (PA). It highlights the importance of root cause analysis and the necessity for immediate corrections and long-term preventive measures to avoid recurring issues. Regulatory expectations, such as those from the Food and Drug Administration (FDA) under the Code of Federal Regulations (CFR) title 21 part 820 and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q10, are discussed, underscoring the need for a comprehensive CAPA plan that integrates data analysis and ongoing process enhancements. Additionally, the paper introduces the 8D methodology as a structured problem-solving approach to complement CAPA efforts. By providing an in-depth examination of CAPA procedures and their implementation, this article aims to contribute to the understanding and effectiveness of quality systems in pharmaceutical manufacturing.

Clot in the Blood Bag: A Case Report.

Clot formation within a blood bag is a rare but significant issue, posing risks to the safety and quality of transfused blood products. We report the root cause analysis of a large clot found in a blood bag during routine component preparation. The analysis identified three potential contributing factors: improper vein selection leading to low flow rates, delays in tube stripping, and the use of a faulty blood collection monitor. These factors together facilitated the activation of coagulation, resulting in clot formation. To address these issues, corrective actions were implemented, including enhanced staff training on vein selection and phlebotomy techniques, timely and proper tube stripping procedures, and the replacement of faulty blood collection monitors with regularly calibrated equipment. Additionally, standard operating procedures (SOPs) were updated to incorporate these corrective measures. The implementation of these actions aims to prevent the recurrence of such incidents, ensuring the integrity of blood products and the safety of transfusion practices. This case highlights the importance of continuous monitoring and adherence to established protocols in blood collection and processing.

Noise Exposure and Hearing Loss Among Landscape and Groundskeepers.

Excessive noise exposure within the working population is a health concern that has received increased attention in recent years. Levels have been established by national organizations that reflect safe exposure, but many kinds of equipment used in the landscaping and groundskeeper industries still exceed them. While noise risks are often long-term in nature and occur with cumulative exposure, prevention and exposure methods can still be used by employers to protect their workers' long-term health. Recalling the hierarchy of controls established by the National Institute for Occupational Health and Safety (NIOSH), various strategies can be implemented without creating excessive supervisory burden and with minimal costs. Occupational health nurses can further help reduce excessive noise exposure by encouraging the use of an easy-to-use noise-level assessment app created by NIOSH.

Current situation and influencing fctors of oral frailty for community-dwelling older adults in the northeastern border areas of China: A cross-sectional study.

OBJECTIVES: Unique lifestyle and cultural factors in China may lead to distinct patterns of risk factors for oral frailty among older adults, especially in regions inhabited by northeastern border minority groups. METHODS: From July to November 2023, a convenience sampling method was employed to select older adults from three communities in Yanji City as the subjects. Data were collected by a set of questionnaires. RESULTS: A total of 478 older adults were included, revealing a prevalence rate of 71.6 % for oral frailty. Factors influencing were found to include age, ethnicity, gender, income, number of chronic diseases, body mass index, drinking, physical frailty, sleep disorders, and attitudes towards aging (p < 0.05). CONCLUSIONS: There is a higher prevalence of oral frailty. It is crucial to prioritize the oral health issues of older adults with high-risk factors and implement targeted intervention measures to reduce and control the occurrence and progression of oral frailty.

Root cause analysis of cases involving diagnosis.

Diagnostic errors comprise the leading threat to patient safety in healthcare today. Learning how to extract the lessons from cases where diagnosis succeeds or fails is a promising approach to improve diagnostic safety going forward. We present up-to-date and authoritative guidance on how the existing approaches to conducting root cause analyses (RCA's) can be modified to study cases involving diagnosis. There are several diffierences: In cases involving diagnosis, the investigation should begin immediately after the incident, and clinicians involved in the case should be members of the RCA team. The review must include consideration of how the clinical reasoning process went astray (or succeeded), and use a human-factors perspective to consider the system-related contextual factors in the diagnostic process. We present detailed instructions for conducting RCA's of cases involving diagnosis, with advice on how to identify root causes and contributing factors and select appropriate interventions.

Bridging the gaps: A prospective analysis of root causes for rejection and incompleteness in blood requisition forms.

INTRODUCTION: Blood request form (BRF) stands as a pivotal document in ensuring safe and effective blood transfusions within healthcare settings. Incomplete or erroneous data on BRF can heighten risk of adverse reactions and compromise patient safety. Aim of study was to assess level of completion of BRFs by clinicians and to evaluate root cause analysis (RCA) of incompleteness of BRFs and factors leading to their rejection. MATERIALS AND METHODS: This prospective study was carried out from February 2024 to April 2024 on BRFs received in the blood centre. They were audited and RCA for factors leading to their incompleteness and rejection were analysed. RESULTS: Total number of BRFs received in blood centre was 14,468. 13,358 (92.3%) BRFs were accepted and 1,110 (7.7%) BRFs were rejected. 12,804 (95.85%) of accepted BRFs were incomplete. Weight was the most common missing parameter (89% {n = 11403}) while name of the requesting clinician was least common (2.5% {n-318}). 3.52% n = 510) BRFs were rejected due to mismatch in name and patient registration number on BRF and samples. 0.14% n = 21) BRFs were rejected due to hemolysed samples. RCA for incompleteness of BRFs showed that main reason was manpower (61-83%) while environment was least common (17-67%). RCA for rejection of BRFs showed that environment was most common cause (13.3-80.15%) while manpower was least common (9-19.85%). CONCLUSION: Regular audits and personnel training, and quality assurance measures can help identify and address deficiencies in BRF completion to enhance patient safety and reduce incidence of transfusion-related errors and complications.

NDSRIs Crisis in Pharmaceuticals; Insights on Formation Pathways, Root Causes, Risk Management, and Novel Analytical Techniques.

The discovery of a new class of nitrosamine impurities called N-nitroso drug substance related impurities (NDSRIs) in pharmaceuticals has emerged as a significant challenge for the pharmaceutical sector due to their significant genotoxic and mutagenic effects. Regulatory bodies globally in active collaboration with all the concerned stake holders, are taking effective measures to prevent and control NDSRIs. This comprehensive review on NDSRIs discusses formation pathways, root cause analysis, acceptable intake limits, case studies, control strategies and regulatory responses pertaining to recent NDSRI incidents. This review discusses the novel liquid chromatographic techniques (LC- MS/MS, GC-MS/MS) used to identify and quantify of NDSRIs. This review would aid pharmaceutical professionals, R&D analytical and formulation scientists, and regulatory bodies in gaining deeper insights into the NDSRIs crisis, facilitating formulation of NDSRI-free drug products, and ensuring their sensitive detection with accurate risk evaluation.

Root Cause Analysis of Increased Referral Rates in a Sub-district Hospital, Tamil Nadu: A Quality Improvement Initiative.

Background Sub-district hospitals in Tamil Nadu are critical in providing essential healthcare services, but they face significant challenges that can lead to increased patient referrals to higher-level facilities. High referral rates can overburden tertiary care centers, delay specialized treatment, and affect patient outcomes. This study aims to identify the root causes of increased referral rates in a sub-district hospital and implement targeted interventions to reduce unnecessary referrals. Methods A descriptive study was conducted at Sriperumbudur sub-district hospital in Tamil Nadu from May to August 2023. The study utilized a root cause analysis (RCA) approach, incorporating qualitative data from brainstorming sessions with healthcare providers and administrative staff, and quantitative data from hospital records on referral rates. A fishbone (Ishikawa) diagram was employed to map causal factors, and Pareto and bar charts were used to analyze and present referral trends. Interventions were implemented using the Plan-Do-Study-Act (PDSA) cycle. Results The analysis identified several key factors contributing to high referral rates, including inadequate diagnostic services, insufficient staffing, and lack of essential resources such as CT scans and blood components. Following targeted interventions, referral rates decreased significantly from 101 cases in May-June 2023 to 52 cases in July-August 2023 highlighting a reduction of over 48%. The most notable reductions were seen in referrals for road traffic accidents with head injury (38.7%) reduction, chronic kidney disease (CKD)/hypertension (HT)/diabetes mellitus (DM) (46.2%) reduction, and crush injuries (45.5%) reduction. Conclusions The RCA revealed systemic issues that were contributing to increased referral rates at the sub-district hospital. Implementing targeted interventions based on the RCA findings led to a significant reduction in referrals, improving patient care at the local level and alleviating the burden on tertiary care centers. This study underscores the importance of continuous quality improvement initiatives in strengthening healthcare delivery at the sub-district level.

NLP-based ergonomics MSD risk root cause analysis and risk controls recommendation.

An ergonomics assessment of the physical risk factors in the workplace is instrumental in predicting and preventing musculoskeletal disorders (MSDs). Using Artificial Intelligence (AI) has become increasingly popular for ergonomics assessments because of the time savings and improved accuracy. However, most of the effort in this area starts and ends with producing risk scores, without providing guidance to reduce the risk. This paper proposes a holistic job improvement process that performs automatic root cause analysis and control recommendations for reducing MSD risk. We apply deep learning-based Natural Language Processing (NLP) techniques such as Part of Speech (PoS) tagging and dependency parsing on textual descriptions of the physical actions performed in the job (e.g. pushing) along with the object (e.g. cart) being acted upon. The action-object inferences provide the entry point to an expert-based Machine Learning (ML) system that automatically identifies the targeted work-related causes (e.g. cart movement forces are too high, due to caster size too small) of the identified MSD risk (e.g. excessive shoulder forces). The proposed framework utilises the root causes identified to recommend control strategies (e.g. provide larger diameter casters, minimum diameter 8" or 203 mm) most likely to mitigate risk, resulting in a more efficient and effective job improvement process.

We propose an ergonomics framework that identifies the root causes of MSD risk and recommends control actions. A key insight exploited using artificial intelligence is that when the estimated risk is high for a body joint, the actions of the worker in question and the associated objects constitute valuable information.

A Comparative Study of Causality Detection Methods in Root Cause Diagnosis: From Industrial Processes to Brain Networks.

Abstracting causal knowledge from process measurements has become an appealing topic for decades, especially for fault root cause analysis (RCA) based on signals recorded by multiple sensors in a complex system. Although many causality detection methods have been developed and applied in different fields, some research communities may have an idiosyncratic implementation of their preferred methods, with limited accessibility to the wider community. Targeting interested experimental researchers and engineers, this paper provides a comprehensive comparison of data-based causality detection methods in root cause diagnosis across two distinct domains. We provide a possible taxonomy of those methods followed by descriptions of the main motivations of those concepts. Of the two cases we investigated, one is a root cause diagnosis of plant-wide oscillations in an industrial process, while the other is the localization of the epileptogenic focus in a human brain network where the connectivity pattern is transient and even more complex. Considering the differences in various causality detection methods, we designed several sets of experiments so that for each case, a total of 11 methods could be appropriately compared under a unified and reasonable evaluation framework. In each case, these methods were implemented separately and in a standard way to infer causal interactions among multiple variables to thus establish the causal network for RCA. From the cross-domain investigation, several findings are presented along with insights into them, including an interpretative pitfall that warrants caution.

A Data-Driven Approach for Leveraging Inline and Offline Data to Determine the Causes of Monoclonal Antibody Productivity Reduction in the Commercial-Scale Cell Culture Process.

The monoclonal antibody (mAb) manufacturing process comes with high profits and high costs, and thus mAb productivity is of vital importance. However, many factors can impact the cell culture process, and lead to mAb productivity reduction. Nowadays, the biopharma industry is actively employing manufacturing information systems, which enable the integration of both online data and offline data. Although the volume of data is large, related data mining studies for mAb productivity improvement are rare. Therefore, a data-driven approach is proposed in this study to leverage both the inline and offline data of the cell culture process to discover the causes of mAb productivity reduction. The approach consists of four steps, namely data preprocessing, phase division, feature extraction and fusion, and cluster comparing. First, data quality issues are solved during the data preprocessing step. Next, the inline data are divided into several phases based on the moving window k-nearest neighbor method. Then, the inline data features are extracted via functional data analysis and combined with the offline data features. Finally, the causes of mAb productivity reduction are identified using the contrasting clusters via the principal component analysis method. A commercial-scale cell culture process case study is provided in this research to verify the effectiveness of the approach. Data from 35 batches were collected, and each batch contained nine inline variables and seven offline variables. The causes of mAb productivity reduction were identified to be the lack of nutrients, and recommended actions were taken according to the result, which was subsequently proven by six validation batches.

Application of root cause analysis and TEAMSTEPPS post intravesical gas explosion during transurethral resection of the prostate: a rare case report.

BACKGROUND: An intravesical gas explosion is a rare complication of transurethral resection of the prostate (TURP). It was first reported in English literature in 1926, and up to 2022 were only forty-one cases. Injury from an intravesical gas explosion, in the most severe cases appearing as extraperitoneal or intraperitoneal bladder rupture needed emergent repair surgery. CASE PRESENTATION: We present a case of a 75-year-old man who suffered an intravesical gas explosion during TURP. The patient underwent an emergent exploratory laparotomy for bladder repair and was transferred to the intensive care unit for further observation and treatment. Under the medical team's care for up to sixty days, the patient recovered smoothly without clinical sequelae. CONCLUSIONS: This case report presents an example of a rare complication of intravesical gas explosion during TURP, utilizing root cause analysis (RCA) to comprehend causal relationships and team strategies and tools to improve performance and patient safety (TeamSTEPPS) method delivers four teamwork skills that can be utilized during surgery and five recommendations to avoid gas explosions during TURP to prevent the recurrence of medical errors. In modern healthcare systems, promoting patient safety is crucial. Once complications appear, RCA and TeamSTEPPS are helpful means to support the healthcare team reflect and improve as a team.

Root cause analysis and strategies for reducing falls among inpatients in healthcare facilities: A narrative review.

Background and Aims: Root Cause Analysis (RCA) is a systematic process which can be applied to analyze fall incidences in reactive manner to identify contributing factors and propose actions for preventing future falls. To better understand cause of falls and effective interventions for their reduction we conducted a narrative review of RCA and Strategies for Reducing Falls among Inpatients in Healthcare Facilities. Methods: In this narrative review, databases including Scopus, ISI Web of Science, Cochrane, and PubMed were searched to obtain the related literature published. Databases were searched from January 2005 until the end of March 2023. The Joanna Briggs Institute (JBI) tool was used for quality assessment of articles. To analyze the data, a five-stage framework analysis method was utilized. Results: Seven articles that fulfilled the inclusion criteria were identified for this study. All of the selected studies were interventional in nature and employed the RCA method to ascertain the underlying causes of inpatient falls. The root causes discovered for falls involved patient-related factors (37.5%), environmental factors (25%), organizational and process factors (19.6%), staff and communication factors (17.9%). Strategies to reduce falls involved environmental measures and physical protection (29.4%), identifying, and displaying the causes of risk (23.5%), education and culturalization (21.6%), standard fall risk assessment tool (13.7%), and supervision and monitoring (11.8%). Conclusion: the findings identify the root causes of falls in inpatient units and provide guidance for successful action plan execution. Additionally, it emphasizes the importance of considering the unique characteristics of healthcare organizations and adapting interventions accordingly for effectiveness in different settings.

Identification and Root Cause Analysis of the Visible Particles Commonly Encountered in the Biopharmaceutical Industry.

Visible particle is an important issue in the biopharmaceutical industry, and it may occur across all the stages in the life cycle of biologics. Upon the occurrence of visible particles, it is often necessary to conduct chemical identification and root cause analysis to safeguard the safety and efficacy of the biotherapeutic products. In this article, we present a number of typical particles and relevant root cause analysis in the categories of extrinsic, intrinsic, and inherent particles that are commonly encountered in the biopharma industry. In particular, the optical images of particles obtained both in situ and after isolation are provided, along with spectral and elemental information. The particle identification was carried out with multiple microscopic and microspectroscopic techniques, including stereo optical microscopy, Fourier-transform infrared microscopy, confocal Raman microscopy, scanning electron microscopy, and energy dispersive X-ray spectroscopy. Both commercial and in-house spectral databases were used for comparison and identification. In addition to particle identification, we placed significant efforts on the root cause analysis of the addressed particles with the intention to provide a relatively whole picture of the particle-related issues and practical references to particle mitigation for our peers in the biopharmaceutical industry.

Factors impacting clinical data and documentation quality in Australian aged care and disability services: a user-centred perspective.

BACKGROUND: Research has highlighted a need to improve the quality of clinical documentation and data within aged care and disability services in Australia to support improved regulatory reporting and ensure quality and safety of services. However, the specific causes of data quality issues within aged care and disability services and solutions for optimisation are not well understood. OBJECTIVES: This study explored aged care and disability workforce (referred to as 'data-users') experiences and perceived root causes of clinical data quality issues at a large aged care and disability services provider in Western Australia, to inform optimisation solutions. METHODS: A purposive sample of n = 135 aged care and disability staff (including community-based and residential-based) in clinical, care, administrative and/or management roles participated in semi-structured interviews and web-based surveys. Data were analysed using an inductive thematic analysis method, where themes and subthemes were derived. RESULTS: Eight overarching causes of data and documentation quality issues were identified: (1) staff-related challenges, (2) education and training, (3) external barriers, (4) operational guidelines and procedures, (5) organisational practices and culture, (6) technological infrastructure, (7) systems design limitations, and (8) systems configuration-related challenges. CONCLUSION: The quality of clinical data and documentation within aged care and disability services is influenced by a complex interplay of internal and external factors. Coordinated and collaborative effort is required between service providers and the wider sector to identify behavioural and technical optimisation solutions to support safe and high-quality care and improved regulatory reporting.

Rapid Root Cause Analysis: Improving OBGYN Resident Exposure to Quality Improvement and Patient Safety Curricula.

Introduction Each year, millions of patients in the United States experience harm as a result of the healthcare they receive. One mechanism used by health systems to learn how and why errors occur is root cause analysis (RCA). RCA teams develop action plans to create and implement systemic changes in healthcare delivery in order to prevent future harm. The American Council on Graduate Medical Education (ACGME) recognizes the importance of analyzing adverse events, and it requires that all residents participate in real or simulated patient safety activities, such as RCAs. Often, institutional RCAs necessitate the assimilation of participants on short notice and demand considerable time investment, limiting the feasible participation of graduate medical education (GME) trainees. This presents a gap between ACGME expectations and the reality of resident involvement in patient safety activities. We present the first iteration of a quality improvement project encompassing a three-hour resident physician training course with simulated RCA-experiential learning. The purpose of this project was to produce a condensed, educational RCA experience that adequately trains all GME learners to serve as informed healthcare safety advocates while also satisfying ACGME requirements. Methods The course ("rapid RCA") was conducted during protected weekly academic training. All residents of the San Antonio Uniformed Services Health Education Consortium (SAUSHEC) Obstetrics and Gynecology (OBGYN) residency program who had not previously participated in a real or simulated RCA were required to take the "rapid RCA." Pre- and post-course surveys were completed anonymously to assess baseline knowledge, new knowledge gained from the course, and attitudes toward the course and its importance to resident training. Results Fourteen OBGYN residents attended the "rapid RCA," indicating that 64% (14 out of 22) of the program had no previous experience or opportunity to participate in a real or simulated RCA. Participation in the course demonstrated a significant gain of new knowledge with an increase from 0/14 to 10/14 (71%) residents correctly answering all pre- and post-course questions, respectively (p < 0.001). Additionally, on a Likert scale from 1 to 5, with 5 indicating "expert level," residents indicated they felt more comfortable on patient safety topics after taking the course (mean pre-course score 1.85 to post-course score 3.64, p < 0.001). All participants indicated they would prefer to take the "rapid RCA" as opposed to the only available local alternative option for a simulated RCA, currently offered as a full-day intensive course. Conclusion A meaningful increase in patient safety knowledge and attitudes toward topics covered in an RCA was demonstrated through the implementation of a "rapid RCA" in OBGYN residents. We plan to incorporate this into our annual curriculum to satisfy ACMGE requirements. This format could be adapted for other specialties as applicable.

[Investigation on the current situation and influencing factors of sitting time and health literacy among high school students in China].

OBJECTIVE: To investigate the current situation of sitting time and health literacy among high school students in China, in order to provide a basis for improving their physical and mental health levels. METHODS: A stratified random cluster sampling method was used to investigate the length of sitting time and health literacy of first and second grade high school students from 31 provinces, cities, and autonomous regions in China(data did not include that of Hong Kong and Macao Special Administrative Region, and Taiwan Province of China). The Kruskal-Wallis H method, independent sample Mann-Whitney U test, and regression model were used to analyze the influencing factors of sitting time and total health literacy score. RESULTS: (1) The total score of health literacy was statistically significant (P < 0.01) in different regions, urban and rural distribution, annual family income, parents' educational background, age, and gender. (2) The length of sitting was statistically significant (P < 0.01) among multiple groups in different regions, family annual income, parental education, and gender. However, there was no statistically significant difference between groups of different ages and urban-rural distribution (P>0.05). (3) The analysis of multiple linear regression model showed that the total score of health literacy was positively correlated with the family' s annual income and the mother' s education, and negatively correlated with the father' s education and the length of sitting. Standardized regression coefficient ß comparison: Father' s education (-0.32) > family annual income (0.15) > mother' s education (0.09) > average daily sitting time (-0.02), with father' s education having the greatest impact, followed by family annual income. The length of sitting was positively related to the family' s annual income and the mother' s educational background, and negatively related to the total score of health literacy. Standardized regression coefficient ß comparison: Annual family income (0.14) > education background of mother (0.13)> total score of health literacy (-0.02), with the impact of annual family income the largest, followed by education background of mother. CONCLUSION: China' s first and second grade high school students generally spend a long time sitting every day, and the level of health literacy is generally low. The level of health literacy and sitting time are negatively correlated with each other, and are most influenced by the educational background of high school students' parents and their family economic levels.

Safety incident reporting and barriers (SIRaB) study: Strategies and approaches for investigating patient safety events in a hospital set-up.

BACKGROUND: Unsafe patient events not only entail a clinical impact but also lead to economic burden in terms of prolonged hospitalization or unintended harm and delay in care delivery. Monitoring and time-bound investigation of patient safety events (PSEs) is of paramount importance in a healthcare set-up. OBJECTIVES: To explore the safety incident reporting behaviour and the barriers in a hospital set-up. METHODS: The study had two sections: (a) Retrospective assessment of all safety incidents in the past 1 year, and (b) Understanding the barriers of safety reporting by interviewing the major stakeholders in patient safety reporting framework. Further root cause analysis and failure mode effect analysis were performed for the situation observed. Results were statistically analyzed. RESULTS: Of the total of 106 PSEs reported voluntarily to the system, the highest reporting functional group was that of nurses (40.57%), followed by physicians (18.87%) and pharmacists (17.92%). Among the various factors identified as barriers in safety incident reporting, fear of litigation was the most observed component. The most commonly observed event was those pertaining to medication management, followed by diagnostic delay. Glitches in healthcare delivery accounted for 8.73% of the total reported PSEs, followed by 5.72% of events occurring due to inter-stakeholder communication errors. 4.22% of the PSEs were attributed to organizational managerial dysfunctionalities. Majority of medication-related PSE has moderate risk prioritization gradation. CONCLUSION: Effective training and sensitization regarding the need to report the patient unsafe incidents or near misses to the healthcare system can help avert many untoward experiences. The notion of 'No Blame No Shame' should be well inculcated within the minds of each hospital unit such that even if an error occurs, its prompt reporting does not get harmed.

Primer Part 1 - Preparing a laboratory quality improvement project.

Quality in laboratory medicine encompasses multiple components related to total quality management, including quality control (QC), quality assurance (QA), quality indicators, and quality improvement (QI). Together, they contribute to minimizing errors (pre-analytical, analytical, or post-analytical) in clinical service delivery and improving process appropriateness and efficiency. In contrast to static quality benchmarks (QC, QA, quality indicators), the QI paradigm is a continuous approach to systemic process improvement for optimizing patient safety, timeliness, effectiveness, and efficiency. Healthcare institutions have placed emphasis on applying the QI framework to identify and improve healthcare delivery. Despite QI's increasing importance, there is a lack of guidance on preparing, executing, and sustaining QI initiatives in the field of laboratory medicine. This has presented a significant barrier for clinical laboratorians to participate in and lead QI initiatives. This three-part primer series will bridge this knowledge gap by providing a guide for clinical laboratories to implement a QI project that issuccessful and sustainable. In the first article, we introduce the steps needed to prepare a QI project with focus on relevant methodology and tools related to problem identification, stakeholder engagement, root cause analysis (e.g., fishbone diagrams, Pareto charts and process mapping), and SMART aim establishment. Throughout, we describe a clinical vignette of a real QI project completed at our institution focused on serum protein electrophoresis (SPEP) utilization. This primer series is the first of its kind in laboratory medicine and will serve as a useful resource for future engagement of clinical laboratory leaders in QI initiatives.