Point of Care testing Point of Care testing Point of care testing PoCT is the provision of diagnostic testing provided at, or near the patient bedside, i. Test results are immediately available to enable urgent medical decision making. Point of care testing PoCT is now widely recognised as contributing to better healthcare by significantly reducing turnaround time for pathology testing. In lateMonash Medical Centre was the first hospital in Victoria to employ a full time Point of Care Co-ordinator to manage the current point of care analysers as well as co-ordinate and assist with the increasing demand for the implementation of new point of care tests.
Consistent, effective process improvement can be the key to reducing delays and improving data accuracy In clinical trials, turnaround time and data accuracy are critical. It is essential, therefore, that all participants in clinical trials — sponsors, CROs and IRBs — take steps to improve both efficiency and accuracy.
Doing so requires that organizations look beyond symptoms to uncover the true causes of delays and errors. The holistic, rather than granular, application of positive change allows for maximum effect and return on investment ROI. Additionally, new processes must be implemented in such a way as to become part of institutional culture, ensuring the consistent, ongoing success of future efforts.
In order to address these concerns, several successful organizations associated with the clinical trial industry have begun implementing Lean Six Sigma principles. Companies are able to respond to changing customer desires with high variety, high quality, low cost, and with very fast throughput times.
Also, information management becomes much simpler and more accurate. This is a perfection rate of Data-driven decision-making in the Six Sigma vein uncovers the root of problems, Lean principles are used to improve productivity and Kaizen Events are implemented to create rapid, lasting change.
By seeking the true root of issues, sponsors, CROs and IRBs are able to address study and review delays and paperwork-based errors, improving time-to-market and overall accuracy. The result is studies that are completed more quickly, more profitably and with the best possible ethical oversight, protecting the rights of human subjects and vulnerable populations.
In this paper, we address the use of Lean Six Sigma principles in the clinical trial industry by taking two distinct perspectives. The CGIRB board reviews research protocols and study-related information, as well as investigator qualifications and resources to ensure regulatory compliance.
CGIRB has a long-standing tradition of meeting or exceeding the standards for industry certifications. Inthe Research Triangle Park, N.
CGIRB has long focused on process improvements. After performing the intense internal audits required by ISO, CGIRB began looking at methods for reducing waste and limiting non-value-added activities, with eyes on improving response time and achieving percent data accuracy in every submission.
The goal of the Copernicus Lean and Six Sigma CLASS initiative was the minimization of non-value added activities and the reduction of variation — eliminating rework, reducing costs and improving customer satisfaction, both internal and external.
This is achieved through an employee team-based approach, led by a facilitator, which promotes employee empowerment and positive morale. Success is determined by measuring internal and external errors, client feedback and employee involvement.
Surveys, metrics review and error Sigma rates are routinely analyzed to measure the effectiveness of improvements.
The CLASS Kaizen Events were based on value-stream mapping the targeting of waste within a process or workflow for reduction or deletion. The first event was designed to improve turnaround time and reduce the already low number of errors during the review of an amendment submission.
From there, the workflow is broken down into steps, and the time it takes to complete each step is noted. Wasted time between steps is accounted for, and an ideal version of the workflow — one with less non-value-add time — is mapped out. Tools are identified allowing CGIRB team members to realistically and sustainably reach the idealized workflow, and the improved process goes into production.
This change alone resulted in an immediate decrease in turnaround time and errors. Based on continuous monitoring and user feedback, the QC checklist was moved from the routing cover sheet to a submission comments area within the document workflow, further improving adherence to best practices and decreasing processing steps.
The final result was a 20 percent reduction in turnaround time on one of the most involved submission types generally handled by IRBs. A number of non-value-added areas were identified within the department, including the shipping area being split between separate rooms and the use of separate computers for shipping study documentation via FedEx, UPS and the U.
As a result of the Kaizen Event, CGIRB consolidated the shipping department to a single room, improving communication between staff members and enhancing staff collaboration. CGIRB also implemented a best-in-breed Pitney Bowes automated shipping system, vastly reducing technological redundancies within the department and cutting the time needed to deliver documents to clients.
The goal is to further improve review turnaround time while maintaining quality and regulatory standards. Likewise, daily accountability is promoted, in three key ways: An operational dashboard, allowing all team members to access visual reports of progress on goals established in Kaizen Events.
An enhanced correction database, increasing efficiency and reducing redundancy based on survey results. Metrics on data accuracy and the reduction of clinical trial cycle time. The turnaround time for certain specific submission types have been reduced by an average of 20 percent, with a marked decrease in errors.
Soo Bang, an active clinical research professional, led a initiative at Pfizer focused on the improvement of academic medical center contract cycle time through the use of Lean Six Sigma methodology. Like all Lean Six Sigma projects, the initiative began with a data-based discovery process that challenged the original hypothesis on the cause of delays when working with academic medical centers.
In the case of the effort, it was assumed that the high percentage of oncology studies within the pool of contracts with academic medical centers was resulting in a slower average study time, due to the complicated nature of oncology research.
However, statistical analysis showed that oncology studies were not causing undue slowdowns.tine outpatient test turnaround time (TAT), to identify in-ﬂuential factors, and to study the impact of managed care Evaluating clinical laboratory specimen turnaround time (TAT) is a critical component of laboratory quality as- results were returned to the physician in addition to being en-.
Sep 14, · Laboratory analytical turnaround time is a reliable indicator of laboratory effectiveness.
whereas laboratory professionals usually use specimen receipt to reporting of results as the TAT There is a scope of further improvement in our turn around time by initiating administrative machinery for acquiring state of the art.
increases in test reporting throughput by reducing turnaround time without compromising quality or reporting standards. Equivocal test results are often due to sample insuf-Figure 1. Time-savings for literature curation and interpretation using QCI Interpret.
Bioinformatics for Clinical Oncology Testing 5 ficiency, analytical errors, or the. The BD Microtainer MAP Microtube for Automated Process is the first microtube that is fully compatible with most automated hematology instruments, reducing turnaround time and costs associated with manually run samples.
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Turnaround time (TAT) is one of the most noticeable signs of laboratory service and is often used as a key performance indicator of laboratory performance.