Ensure Patient Safety Research Articles

From stable teamwork to dynamic teaming in the ambulatory care diagnostic process.

Dynamic teaming is required whenever people must coordinate with one another in a fluid context, particularly when the fundamental structures of a team, such as membership, priorities, tasks, modes of communication, and location are in near-constant flux. This is certainly the case in the contemporary ambulatory care diagnostic process, where circumstances and conditions require a shifting cast of individuals to coordinate dynamically to ensure patient safety. This article offers an updated perspective on dynamic teaming commonly required during the ambulatory diagnostic process. Drawing upon team science, it clarifies the characteristics of dynamic diagnostic teams, identifies common risk points in the teaming process and the practical implications of these risks, considers the role of providers and patients in averting adverse outcomes, and provides a case example of the challenges of dynamic teaming during the diagnostic process. Based on this, futureresearch needs are offered as well as clinical practice recommendations related to team characteristics and breakdowns, team member knowledge/cognitions, teaming dynamics, and the patient as a team member.

Strategies for Perioperative Anticoagulant Reversal in Orthopedic Surgery: A Review.

The administration of anticoagulation therapy during major orthopedic surgeries is a clinical challenge due to the risk of thrombotic events and bleeding complications. This review aims to evaluate the current strategies and emerging developments in perioperative anticoagulation reversal. We conducted a literature review on the management of perioperative anticoagulant therapy, which included the current status of anticoagulant reversal agents, as well as personalized medicine, pharmacogenomics, artificial intelligence (AI), and novel drug delivery systems. The review indicates that reversal agents such as idarucizumab and andexanet alfa are crucial in managing bleeding associated with direct oral anticoagulants (DOACs). Personalized medicine, guided by pharmacogenomics, allows for tailored anticoagulation regimens. AI and machine learning (ML) algorithms can enhance the predictive capabilities for bleeding and thrombotic risks. Additionally, nanotechnology and biomarkers offer innovative approaches to drug delivery and personalized treatment. Integrating evidence-based guidelines with innovative reversal agents, personalized medicine, AI and nanotechnology opens a new era in perioperative anticoagulation management. These advancements can ensure patient safety, minimize bleeding risks, and improve surgical outcomes. Future research should focus on the clinical validation of these strategies to ensure their effectiveness across diverse patient populations.

Intraoperative navigation in craniofacial surgery.

Craniofacial surgery requires comprehensive anatomical knowledge of the head and neck to ensure patient safety and surgical precision. Over recent decades, there have been significant advancements in imaging techniques and the development of real-time surgical navigation systems. Intraoperative navigation technology aligns surgical instruments with imaging-derived information on patient anatomy, enabling surgeons to closely follow preoperative plans. This system functions as a radiologic map, improving the accuracy of instrument placement and minimizing surgical complications. The introduction of first-generation navigation systems in the early 1990s revolutionized surgical procedures by enabling real-time tracking of instruments using preoperative imaging. Initially utilized in neurosurgery, intraoperative navigation has since become standard practice in otolaryngology, cranio-maxillofacial surgery, and orthopedics. Since the 2000s, second-generation navigation systems have been developed to meet the growing demand for precision across various surgical specialties. The adoption of these systems in craniofacial surgery has been slower, but their use is increasing, particularly in procedures such as foreign body removal, facial bone fracture reconstruction, tumor resection, and craniofacial reconstruction and implantation. In Korea, insurance coverage for navigation in craniofacial surgery began in 2021, and new medical technologies for orbital wall fracture treatment were approved in August 2022. These technologies have only recently become clinically available, but are expected to play an increasingly important role in craniofacial surgery. Intraoperative navigation enhances operative insight, improves target localization, and increases surgical safety. Although these systems have a steep learning curve and initially prolong surgery, efficiency improves with experience. Calibration issues, registration errors, and soft tissue deformation can introduce inaccuracies. Nonetheless, navigation technology is evolving, and the integration of intraoperative computed tomography data holds promise for further enhancements of surgical accuracy. This paper discusses the various types and applications of navigation employed in craniofacial surgery, highlighting their benefits and limitations.

Neuromuscular monitoring: A tutorial for pharmacists.

In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. To describe neuromuscular monitoring modalities and highlight the importance of neuromuscular monitoring to clinical pharmacy practice. A growing body of literature and clinical practice guidelines have highlighted the importance of neuromuscular monitoring practices to ensure patient safety during surgery and in the intensive care unit. Understanding neuromuscular monitoring modalities can allow pharmacists to enhance participation in institutional discussions and optimization of neuromuscular blocker administration and reversal practices. We have described the various modalities of neuromuscular monitoring and considerations for using different modalities. Neuromuscular monitoring should be performed whenever neuromuscular blocking agents are administered. This practice represents an evidence-based approach to minimizing the occurrence of residual neuromuscular blockade and its associated complications.

Newly Graduated Perioperative Nurses' Experiences of Transitioning to Clinical Practice: A Qualitative Explorative Secondary Analysis.

The aim of this secondary analysis was to explore newly graduated perioperative nurses' experiences of transitioning to clinical practice to gain more in-depth knowledge of this phenomenon. A qualitative explorative study of secondary data was used, and this study was reported following the Consolidated Criteria for Reporting Qualitative Research checklist. A secondary analysis of data collected between March 2019 and November 2020 via 16 semi-structured interviews with newly graduated perioperative nurses. The interviews were conducted 3 to 5 months after they graduated from five different educational institutions in Norway and entered clinical practice as perioperative nurses. A three-step phenomenological hermeneutical analysis inspired by Ricoeur's theory was applied: naïve reading, structural analysis and comprehensive understanding. We identified three themes: expectations of competence, facilitation for newly graduated perioperative nurses and the transition from being a student to a newly qualified perioperative nurse. Newly graduated perioperative nurses emphasised the critical role of supportive facilitation, manageable expectations and support from leaders and colleagues, which seemed essential for a successful transition to clinical practice. This study addresses knowledge essential for universities, universities colleges and clinical practice, specifically healthcare organisations, to understand the transition process for newly graduated perioperative nurses. This can support the establishment of improved practices to ensure patient safety via more specific education and mentoring and more accurate expectations of competence. No patient or public contribution.

Recent regulatory developments in EU Medical Device Regulation and their impact on biomaterials translation

AbstractWe envision this work to assist researchers and medical device developers (beside other stakeholders) to better understand biomaterial‐based medical device development and its approval process proposed by the new MDR and IVDR in the European Union, as more complex biomaterials emerge, with the MDR reflecting the progress in biomaterial discoveries. Additionally, insufficient international harmonization in regulatory laws and poor‐quality data reporting contribute to the problem. This review describes the possible reasons for a slowing biomaterials translational trend observed over the past decades, focusing on the European Market, and suggests a feasible approach for biomaterials‐based medical device translation into the clinic. Suitable solutions to upgrade biomaterial translation to the clinic have not yet been provided by the field: no additional hurdles should be imposed for researchers, clinicians, the medical device industry, and insurance companies, which all should collaborate on bringing innovative solutions to patients. The new MDR and IVDR represent a substantial advancement in ensuring patient safety and reflect a major step forward in healthcare. However, they should not constrain innovation in biomaterials‐based medical device development. Incorporating reverse engineering from patient safety and a ‘safe by design’ (SbD) strategy early into medical device development might lead to a smoother and successful approval process. A solid R&D phase, with an emphasis on device safety and performance assessment, is fundamental to ensure an effective transition into the clinic. We offer an overview of the recently implemented regulations on medical devices and in vitro diagnostics across the EU, describing a shifting paradigm in the field of biomaterials discovery. As more complex biomaterials emerge, suitable regulations will be necessary to keep bringing safe and well‐performing medical solutions to patients.

Detecting and managing cognitive impairment in cardiac patients: insights from qualitative interviews with nurses

Background: Cognitive impairment and cardiovascular disease often coexist, and nurses are ideally positioned to detect and manage cognitive impairment in cardiac patients. Objectives: This study explored nurses' perspectives on understanding, detecting, and acting on cognitive impairment in cardiac patients. Design and Methods: Using an exploratory descriptive design, nurses from acute and outpatient cardiac units were interviewed. Data were thematically analyzed. Results: Sixteen nurses were interviewed, working in acute cardiology (n=7), cardiothoracic and intensive care (n=4), and cardiac rehabilitation (n=5). Three themes emerged: (1) Cognitive screening was not routine, with no clear protocols on who, when, and how to screen; (2) Nurses had varying understanding of cognitive impairment, dementia, and delirium; (3) Nurses acted on suspected cognitive changes to ensure patient safety, including referrals and care modifications. Conclusions: Cognitive screening was inconsistent, with barriers, such as workload and lack of education. Guidelines for feasible screening across settings are needed.

Right-to-left-shunts in patients scheduled for neurosurgical intervention in semi-sitting position – a literature review based on two case scenarios

BackgroundNeurosurgery performed in the semi-sitting position provides advantages for certain procedures. However, this approach is associated with potential complications, particularly venous air embolism. Due to typically negative venous pressure at the wound site, air can be drawn into the veins. This risk is especially high in patients presenting with an intra- or extracardiac right-to-left-shunt. Transoesophageal echocardiography can be used to detect a patent foramen ovale or other possible pulmonary-systemic shunt before placing the patient in the sitting position.Case presentationIn this report, we present two young patients undergoing scheduled microsurgical vestibular schwannoma removal in a semi-sitting position who were diagnosed with congenital heart defects during routine perioperative assessment to detect possible intracardiac right-to-left shunts, using pre- and intraoperative transesophageal echocardiography (TEE) and additionally conducting an agitated saline bubble study under Valsalva manoeuvre. Patient A was diagnosed with a persistent left superior vena cava and Patient B with an unroofed coronary sinus (UCS). These findings confronted the anesthesiological and surgical teams with difficult individual decisions regarding further perioperative management.ConclusionsPerioperative transesophageal echocardiography is a diagnostic tool to both detect intraoperative position-related air embolisms and to rule out intracardiac right-to-left shunts, e.g. a patent foramen ovale, in order to decide for or against a (semi-)sitting position. Depending on the surgical circumstances a semi-sitting positioning of patients presenting with an intracardiac right-to-left-shunt, e.g. a PFO, can be feasible in individual cases if there is an implemented therapeutic algorithm to immediately terminate significant venous air entry. However, since certain other intra- or extracardiac right-to-left-shunts, such as here presented PLSVC or UCS, are rare, there is no definitive way of estimating the amount of entered air through detected shunts or anomalous vessels. Therefore, it is recommended to avoid a (semi-)sitting position in favour of a lateral or prone position for a patient undergoing intracranial surgery, once the perioperative TEE shows air bubbles in the left atrium or ventricle whose origins cannot be defined solely through TEE for certain in order to ensure patient safety by minimizing the risk of intraoperative paradoxical air embolisms.

Coil Embolization for Cerebral Aneurysm Using Low Pulse Rate Fluoroscopy.

Although coil embolization is commonly perceived as a minimally invasive procedure, the associated radiation exposure cannot be disregarded. To date, no specific study has investigated radiation exposure during coil embolization. This study aimed to investigate the potential of lowering the pulse rate to decrease radiation exposure during coil embolization while maintaining patient safety. Radiation data and clinical features of 70 patients who underwent coil embolization between 2015 and 2020 were retrospectively analyzed. Since July 2017, the pulse rate was regulated from 7.5 to 4 frames per second (f/s). Statistical analyses were performed to examine the correlation between pulse rate and radiation exposure. Out of the 70 procedures, 30 were performed at the standard pulse rate (7.5 f/s), and 40 were performed at the lower pulse rate (4 f/s). In the lower-pulse-rate group, the absorbed dose to the patient (AK) was 2580.7 (±217) mGy, whereas in the standard-pulse-rate group, it was 4760 (±411.1). Both the dose-area product (DAP) and AK were substantially reduced in the low pulse rate group (p = 0.000002). There was a significant correlation between DAP and AK and pulse rate (p = 0.004, p = 0.0017, respectively). Moreover, there was no significant correlation between pulse rate and perioperative complications. Our findings suggest that using a lower pulse rate (4 f/s) can effectively reduce radiation exposure during coil embolization for cerebral aneurysms while ensuring patient safety.

Korean Triage and Acuity Scale education using role-playing and its effects on triage competency: A quasi-experimental design.

Triage is the process of prioritizing patients in the emergency department (ED). This has a pivotal role in ensuring patient safety and that the ED operates smoothly; therefore, triage training education is an important aspect of triage nurses' preparedness in different emergency situations. This study employed a quasi-experimental research design using a non-equivalent control group pre-post-test design to verify the effect of the Korean Triage and Acuity Scale (KTAS) education using role-playing on the knowledge of triage, triage performance ability, and triage competency in nursing students. Participants were 78 fourth-year nursing students from Shinseong University in South Korea; 39 were assigned to the experimental group, and 39 to the control group. The intervention was conducted for three weeks, from January 31 to February 16, 2024. The experimental group received KTAS education through role-playing, whereas the control group received triage education through lectures. Triage knowledge (t = 2.94, p = .004) and triage performance ability (t = 3.11, p = .003) were significantly improved in the experimental group. However, there was no significant difference in triage competency between groups (t = 1.32, p = .192). The post-test score of triage record in the experimental group showed a significant improvement over time (t = 0.56, p < .001). This study demonstrated that KTAS education using role-playing was more effective in improving triage knowledge and performance ability than traditional lecture methods for nursing students. Triage education programs should be developed considering the effectiveness of various teaching methods.

Realtime and noninvasive assessment of endotracheal tube displacement using near-infrared and visible cameras

Endotracheal tube (ETT) intubation is a medical procedure routinely used for achieving mechanical ventilation in critically ill patients. Appropriate ETT placement is crucial as undetected tube migration may cause multiple complications or even fatalities. Therefore, prompt detection of unplanned movement of the ETT and immediate action to restore proper placement are essential to ensure patient safety. Despite this necessity, there is not a widely adopted tool for real-time assessment of ETT displacement. We have developed a device, a dual-camera endotracheal tube or DC-ETT, to address this unmet clinical need. This device uses a near-infrared (NIR) LED and a side-firing optical fiber embedded in the side of an ETT to light up the tracheal tissue and a visible and NIR camera module for the displacement detection. The NIR camera tracks the movement of the NIR pattern on the skin, while the visible camera is used to correct the body movements. The efficacy of the DC-ETT was assessed in two piglets with a linear displacement sensor as reference. A mean discrepancy of less than 0.5 mm between the DC-ETT and reference sensor was observed within a displacement range of ±15 mm. The results suggest that the DC-ETT can potentially provide a simple and cost-effective solution for real-time monitoring of ETT displacements in operating rooms, intensive care units, and emergency departments.

Managing COVID-19 patients with mental illness in a specialized neuropsychiatric setting: An experience from a tertiary care hospital in India.

To explore the management and outcome of COVID-19 infection in mental illness at a specialized neuropsychiatric setting. A retrospective review of the clinical profile of 100 COVID-19 patients with mental illness, admitted to the Psychiatric COVID unit (PCU) from June 2020 to June 2022, was done, with a subgroup analysis of chronic institutionalized patients (n = 36). Schizophrenia, bipolar affective disorder, and schizoaffective disorder comprised 64% of the study population. Most patients (87%) were on antipsychotics. 56% of the patients had an infection of mild severity and 38% were asymptomatic. Corticosteroids and anticoagulants were given to 33.3% and 25% of the patients, respectively. 16% of the patients encountered medical complications in the PCU, and 14% were referred to a COVID-designated hospital. Patients with diabetes mellitus and/or hypertension were more likely to be referred. The chronic institutionalized patients (n = 36) had either an asymptomatic or mild infection. Three among these patients were referred to a COVID-designated hospital. Most psychiatric patients with medical illnesses, including COVID-19, pose unique challenges including complexity of symptoms, ensuring patient safety, and the need for trained professional staff to provide specialized psychiatric interventions, which can be taken care of in psychiatric care settings.

Association Between Rapid Opioid Reduction or Discontinuation and Self-Harm, Suicide Attempt, and Suicide Death Among High-Dose Long-Term Opioid Therapy Patients in North Carolina, 2006-2018.

We examined the association between rapid opioid reduction or discontinuation and self-harm, suicide attempt, and suicide death among high-dose long-term opioid therapy (HD-LTOT) patient and examined effect measure modification by individual and neighborhood-level characteristics. Using private insurance data from North Carolina, this retrospective cohort study covered January 2006 to September 2018, with up to four years of follow-up. Participants included patients aged 18-64 years who were prescribed HD-LTOT. Time-varying exposure was ever exposed to rapid opioid reduction or discontinuation vs never exposed. The outcomes were self-harm or suicide attempt, suicide death, and the combined outcome. We estimated cumulative incidence and used Fine-Gray models to estimate sub-distribution hazard ratios (HRs). There were 21,450 HD-LTOT patients. In year 1, rapid opioid reduction or discontinuation was not associated with the combined outcome, HR: 1.09 (95% CI: 0.61-1.96). However, in years 2-4, rapid opioid reduction or discontinuation was associated with higher hazard of the combined outcome, HR: 2.77 (95% CI: 1.45-5.27). This association was stronger among patients with mental health conditions and those residing in underserved neighborhoods. These findings underscore the importance of provider training in adhering to guideline-concordant gradual tapering, offering mental health support, and ensuring patient safety throughout the tapering process.

Anatomical Considerations for Thread Lifting Procedure.

Thread lifting is a minimally invasive procedure that enhances facial aesthetics by repositioning sagging tissues with absorbable threads. It requires a comprehensive understanding of facial anatomy for safe and effective results. This study aims to highlight the critical anatomical considerations in thread lifting, including the navigation of facial vascular structures, the protection of facial nerves, manipulation of fat compartments, and engagement of retaining ligaments. These factors are essential for minimizing complications and achieving optimal outcomes. A review was conducted focusing on the anatomical elements critical to thread lifting. The study analyzed clinical outcomes related to vascular structures, nerve pathways, fat compartments, and ligaments in patients undergoing the procedure. The review revealed that careful navigation of facial blood vessels is crucial to avoid complications such as bleeding and bruising. Knowledge of facial nerve pathways is essential to prevent nerve damage, which could result in facial weakness or paralysis. Proper manipulation of facial fat compartments helps address aging-related changes, and engaging retaining ligaments is vital for a sustainable lift without tissue distortion. Thread lifting demands not only technical skill but also a deep understanding of facial anatomy to ensure patient safety and desired aesthetic results. Expertise in these anatomical considerations is essential for minimizing complications and preserving the natural function of facial structures.

Managing Adverse Events in Clinical Trials with R and Shiny

Adverse events (AEs) are critical occurrences that can significantly impact patient safety and the overall success of clinical trials. Effective management of AEs is essential for ensuring regulatory compliance and safeguarding participants' well-being. This paper explores the integration of R and Shiny as innovative tools for the real-time monitoring, visualization, and analysis of AEs in clinical trials. By leveraging R’s robust statistical capabilities and Shiny’s interactive interface, researchers can enhance data management processes, facilitate informed decision- making, and foster collaboration among stakeholders. A case study is presented to illustrate the practical application of R Shiny in tracking AEs, demonstrating its effectiveness in improving trial outcomes and ensuring patient safety. The findings emphasize the need for adopting dynamic data analysis tools to optimize adverse event management in the evolving landscape of clinical research. KEYWORDS Adverse Events, Clinical Trials, R, Shiny, Data Management, Visualization, Real-Time Monitoring, Patient Safety.

Critical patient safeguards for ambulatory surgery centers.

The role of ambulatory surgery centers in surgical care is evolving, as lower facility fees and improved patient experience increase the popularity of these venues. As care expands in ambulatory surgery center, so does the complexity of cases and patients cared for in these centers, which may pose a risk for patient safety. Anesthesiologists should lead multidisciplinary teams to screen for appropriate patients and procedures. Patient considerations go beyond physical status and include psychosocial factors. Ensuring patients understand preoperative instructions is crucial to decrease case cancellation rates and facilitate efficiency. Pediatric patients require special considerations including extra attention to preprocedure and postoperative care and instructions, PALS-certified staff, pediatric equipment and medications, as well as heightened awareness of respiratory complications. Procedural concerns start with the capabilities of the facility such as equipment, pharmacy, and staffing for each phase of care. However, nuances such as patient throughput in a given day, emergency preparedness, and after-hours staffing will affect both patient safety and staff morale. This article outlines the issues leaders need to consider to ensure patient safety in ambulatory surgery centers.

Revisiting the Environmental Impact of Inappropriate Clinical Laboratory Testing: A Comprehensive Overview of Sustainability, Economic, and Quality of Care Outcomes.

The use of laboratory resources has seen a substantial increase in recent years, driven by automation and emerging technologies. However, inappropriate use of laboratory testing, encompassing both overuse and underuse, poses significant challenges. This review explores the complex interplay between patient safety, economic, and environmental factors-known as the "triple bottom line" or "3Ps" for people, profit, and planet-associated with inappropriate use of laboratory resources. The first part of the review outlines the impact of inappropriate laboratory testing on patient safety and economic outcomes. Then the review examines the available literature on the environmental impact of laboratory activities. Several practical solutions for mitigating the environmental impact of laboratories are discussed. Finally, this review emphasizes how decreasing unnecessary laboratory testing results in cost savings and environmental benefits, as evidenced by interventional studies, without compromising patient safety. The implementation of sustainable practices in laboratories can create a virtuous circle in which reduced testing enhances cost-efficiency, reduces the environmental footprint, and ensures patient safety, thereby benefiting the 3Ps. This review highlights the critical need for appropriate laboratory resource utilization in achieving sustainability in healthcare.

Chiropractor Perceptions of Non-registered Practitioners Utilizing Spinal Manipulative Therapy in Hong Kong: A Cross-Sectional Survey.

Objective This study aimed to explore registered chiropractors' perceptions of the use of spinal manipulative therapy (SMT) by non-registered practitioners in Hong Kong, assessing the associated risks, adverse events, and patient management approaches. Method A cross-sectional survey was conducted among registered chiropractors in Hong Kong using an online questionnaire. The survey, distributed via chiropractic associations from January 26to March 20, 2024, gathered data on the practitioners' experiences with patients previously treated by non-registered practitioners, including the types of adverse events observed and subsequent interventions required. Descriptive statistics were used to analyze the data. A total of 134 valid responses were received. Results Among respondents, a significant proportion (91%) of chiropractors reported observing adverse effects in patients treated by non-registered practitioners, with the most common issues being the aggravation of existing symptoms (95.5%) and new or unexpected complaints (82.8%). The most frequently required interventions included imaging (97%), medication (58.2%), and specialist referrals (59%). Respondents indicated that these adverse events could often have been prevented if proper training and certification were in place. Common reasons cited by patients for seeking care from non-registered practitioners included a lack of awareness about licensed care (90.3%) and cost considerations (80.6%). Conclusion The study highlights concerns reported by registered chiropractors regarding the safety of SMT performed by non-registered practitioners in Hong Kong. These concerns emphasize the need for enhanced public education on potential risks and stricter regulatory oversight. Although direct data on the occurrence of adverse events was not collected, the findings suggest that many risks could potentially be mitigated with proper training, underscoring the importance of credentialed care in ensuring patient safety.

Transanal irrigation: a review of indications, key assessments, benefits, contraindications, complications, efficacy and safety

Transanal irrigation (TAI) is a therapeutic procedure designed to manage chronic bowel dysfunction, including constipation and faecal incontinence, particularly in individuals with neurogenic bowel dysfunction. TAI offers symptom relief and improves quality of life by providing autonomy in bowel management. This article explores the benefits, clinical indications and contraindications of TAI. The article also emphasises the importance of thorough patient assessments before initiating TAI, such as evaluating bowel function, manual dexterity and motivation. Furthermore, the review discusses the role of structured education programmes in ensuring long-term adherence and safety, particularly within the first 3 months. In addition, it covers the complications associated with TAI, such as bowel perforation and autonomic dysreflexia, and offers management strategies. Finally, the review outlines the conditions under which TAI should be discontinued and provides guidance on ensuring patient safety throughout the treatment.

A-189 Six Sigma for Thyroid Stimulating Hormone (TSH)

Abstract Background Effective quality control processes within clinical laboratories are crucial for monitoring and assessing the analytical performance in terms of precision and accuracy. The regular measurement of these parameters plays a pivotal role in ensuring patient safety and is often a prerequisite for accreditation by various organizations. Six Sigma metrics have emerged as one of the most efficient tools for evaluating the analytical performance of clinical laboratory systems. This approach integrates Total Allowable Error (TEa), encompassing both random and systematic errors into a single comprehensive index. This study details the establishment of Six Sigma in our laboratory for Thyroid Stimulating Hormone (TSH) for eight different modules of Siemens Atellica IM. Methods A one-year dataset was compiled from the assessment of internal quality control for evaluating the imprecision (expressed as coefficient of variation - CV%) and Bio Rad’s Unity Interlaboratory Program for inaccuracy (quantified as bias%) in TSH test processed across eight modules of Atellica IM (Siemens). The data was categorized into two groups based on QC levels. The TEa utilized in this study was set at 20% according to CLIA standards. Six Sigma metrics were subsequently calculated for each QC level and equipment based on TEa, CV%, and bias%, utilizing the formula Sigma=(TEa - bias%)/CV%. Results Six Sigma values calculated for the QC level 1 ranged from 4.92 to 6.20 across all equipment, while for the QC level 2 Six Sigma varied from 4.87 to 7.59. All values found were classified as Good, Excellent and World Class according to the normalized method decision chart. These results showed that analytical performance of all eight modules of Atellica IM were similar in terms of random and systematic error. Conclusions Six Sigma serves as potent tool for monitoring the analytical performance of the TSH test. It is crucial to independently track different levels of QC in TSH testing for enhanced control over the analytical system. The performance of Siemens TSH test in our laboratory has proven to be very satisfactory.