Pump Teardown Review Process Improvement

Lean Systems ◽  
2013 ◽  
pp. 249-274
2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e17554-e17554
Author(s):  
D. C. Stahl ◽  
C. J. Song ◽  
R. A. Figlin

e17554 Background: The duration and complexity of regulatory review processes are increasingly associated with the slow pace and high cost of clinical trials. To evaluate and minimize the impact of these factors, City of Hope (COH), a NCI-designated Comprehensive Cancer Center, developed a strategic initiative to improve the efficiency and effectiveness of its clinical research review processes. The ongoing initiative is supported by Six Sigma-based techniques for problem identification and process optimization that have been successfully applied in other industries. Methods: The Six Sigma process improvement methodology known as DMAIC (Define, Measure, Analyze, Improve, and Control) was applied to five different clinical trial submission types (new study submissions, amendments, continuations, internal adverse events, external adverse events) reviewed by the COH Institutional Review Board (IRB), Cancer Protocol Review and Monitoring Committee (CPRMC), and Data and Safety Monitoring Board (DSMB). A consistent set of metrics and expectations were created for each review process to evaluate pre-review queue times, review process durations, submissions returned for corrections, and submissions returned with conditional approvals. Results: Over 7,900 submissions received during a 15 month period were evaluated quarterly to identify opportunities for improvement and the effects of previously implemented solutions. Multiple root causes for submission defects and delays were identified, including: (1) staffing and training deficiencies, (2) suboptimal workload distribution, (3) unclear policies and processes, (4) submission standardization opportunities, and (5) workflow automation and other information technology opportunities. Ongoing remediation efforts have yielded substantial improvements. Conclusions: Although Six Sigma process improvement techniques were originally developed for manufacturing applications, they can be applied in a clinical research setting to improve regulatory review processes. The methodology was most effectively introduced incrementally via application to specific problems rather than a traditional top-down implementation. Support provided by NCI P30 CA33572. No significant financial relationships to disclose.


Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Abbigayle M Doerr ◽  
Anne Lindstrom ◽  
Harish Shownkeen ◽  
Laura Pittner

Background: The Comprehensive Stroke Center (CSC) standards set by the Joint Commission (TJC) include process and quality improvement. Specifically, there is to be a process to review complex stroke cases for a complications, treatment specific situations and sentinel events. The review is at program level by an interdisciplinary team. Purpose: To maintain consistency, function and process related to complex stroke patients. To focus on issues and/or barriers with regards to complex stroke patients. To assure the hospital is meeting requirements set up by TJC for CSC designation. Methods: Advance practice nurses (APN) within the stroke program created a stroke summary template using data elements from the inpatient hospitalization of all stroke patients. The summary data is reviewed for positive outcomes and complications related to the complex stroke population including but not limited to: ventriculostomy, decompressive craniectomy, endovascular revascularization, carotid endarterectomy, carotid artery stenting, periprocedural stroke and death. All data is collected and monitored by subcommittee inclusive of APNs and leaders from the stroke, quality and neurointerventional surgery departments. Quarterly, a team of physicians including stroke neurology, neurointerventional surgery, quality, medical executive committee, neurosurgery, emergency medicine, neurocritical care and physical rehabilitation medicine meet to further discuss cases related to the designated criteria above. A stroke review pathway created and designates all unusual findings to be reported to the physician and/or nursing peer review committees for formal inquiry. Results: Following implementation of the stroke review process there was documented 100% review of ischemic and hemorrhagic stroke patients with special consideration for intravenous tissue plasminogen activase administration and endovascular treatment of stroke by a interdisciplinary team of physicians and nurses. Conclusions: The developed stroke summary and interdisciplinary review process provides opportunities for quality and process improvement initiatives while demonstrating conclusive documentation supporting TJC requirements for CSC program level stroke case review.


1986 ◽  
Vol 50 (12) ◽  
pp. 726-727
Author(s):  
RS Mackenzie ◽  
RE Martin
Keyword(s):  

1990 ◽  
Vol 78 (1) ◽  
pp. 1-1
Author(s):  
M. J. Brown

From this issue, Clinical Science will increase its page numbers from an average of 112 to 128 per monthly issue. This welcome change — equivalent to at least two manuscripts — has been ‘forced’ on us by the increasing pressure on space; this has led to an undesirable increase in the delay between acceptance and publication, and to a fall in the proportion of submitted manuscripts we have been able to accept. The change in page numbers will instead permit us now to return to our exceptionally short interval between acceptance and publication of 3–4 months; and at the same time we shall be able not only to accept (as now) those papers requiring little or no revision, but also to offer hope to some of those papers which have raised our interest but come to grief in review because of a major but remediable problem. Our view, doubtless unoriginal, has been that the review process, which is unusually thorough for Clinical Science, involving a specialist editor and two external referees, is most constructive when it helps the evolution of a good paper from an interesting piece of research. Traditionally, the papers in Clinical Science have represented some areas of research more than others. However, this has reflected entirely the pattern of papers submitted to us, rather than any selective interest of the Editorial Board, which numbers up to 35 scientists covering most areas of medical research. Arguably, after the explosion during the last decade of specialist journals, the general journal can look forward to a renaissance in the 1990s, as scientists in apparently different specialities discover that they are interested in the same substances, asking similar questions and developing techniques of mutual benefit to answer these questions. This situation arises from the trend, even among clinical scientists, to recognize the power of research based at the cellular and molecular level to achieve real progress, and at this level the concept of organ-based specialism breaks down. It is perhaps ironic that this journal, for a short while at the end of the 1970s, adopted — and then discarded — the name of Clinical Science and Molecular Medicine, since this title perfectly represents the direction in which clinical science, and therefore Clinical Science, is now progressing.


2009 ◽  
Vol 19 (1) ◽  
pp. 4-9
Author(s):  
Jill Parmenter ◽  
Sheryl Amaral ◽  
Julia Jackson

Abstract The Professional Performance Review Process for School-Based Speech-Language Pathologists (PPRP) (ASHA, 2006) was developed in response to the need for a performance review tool that fits school district requirements for performance review management while addressing the specific roles and responsibilities of a school-based speech-language pathologist (ASHA, 2006). This article will examine the purpose and components of the PPRP. A description of its use as a tool for self-advocacy will be discussed. Strategies for successful implementation of the PPRP will be explained using insight from speech-language pathologists and other professionals familiar with the PPRP.


2008 ◽  
Vol 13 (1) ◽  
pp. 1-12
Author(s):  
Christopher R. Brigham ◽  
Robert D. Rondinelli ◽  
Elizabeth Genovese ◽  
Craig Uejo ◽  
Marjorie Eskay-Auerbach

Abstract The AMA Guides to the Evaluation of Permanent Impairment (AMA Guides), Sixth Edition, was published in December 2007 and is the result of efforts to enhance the relevance of impairment ratings, improve internal consistency, promote precision, and simplify the rating process. The revision process was designed to address shortcomings and issues in previous editions and featured an open, well-defined, and tiered peer review process. The principles underlying the AMA Guides have not changed, but the sixth edition uses a modified conceptual framework based on the International Classification of Functioning, Disability, and Health (ICF), a comprehensive model of disablement developed by the World Health Organization. The ICF classifies domains that describe body functions and structures, activities, and participation; because an individual's functioning and disability occur in a context, the ICF includes a list of environmental factors to consider. The ICF classification uses five impairment classes that, in the sixth edition, were developed into diagnosis-based grids for each organ system. The grids use commonly accepted consensus-based criteria to classify most diagnoses into five classes of impairment severity (normal to very severe). A figure presents the structure of a typical diagnosis-based grid, which includes ranges of impairment ratings and greater clarity about choosing a discreet numerical value that reflects the impairment.


2005 ◽  
Vol 35 (5) ◽  
pp. 86
Author(s):  
MARY ELLEN SCHNEIDER
Keyword(s):  

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