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Six Sigma
Six Sigma, like Lean, is used to improve the quality and efficiency of operational processes. During the past decade, these process improvement techniques increasingly have been applied outside of the manufacturing sector, for example, in healthcare.
While Lean focuses on identifying ways to streamline processes and reduce waste, Six Sigma aims predominantly to make processes, such as those used in clinical laboratories and pathology group labs, more uniform and precise through the application of statistical methods.
Along with Lean, this process improvement technique has become popular with labs as a way to streamline laboratory processes, reduce costs, increase productivity, and improve quality in a time when labs are increasingly pressured by downward price trends for lab tests. At the same time, labs are able to increase value offered to “customers,” that is, patients.
The principles of a Six Sigma-based system were originally developed by Bill Smith of Motorola in 1986 as a way of eliminating defects in manufacturing, where a defect is understood to be a product or process that fails to meet customers’ expectations and requirements. The name refers to a quality level defined as the near-perfect defect rate of 3.4 defects per million opportunities. As a process improvement strategy, it gained much attention through its association with General Electric and its former CEO Jack Welsh.
Six Sigma also involves the training and certification of designated process specialists (called black belts, green belts, or other similar titles) within organizations to help guide Six Sigma improvement efforts. Other distinctive features include the expectation that process quality improvements be translated into financial metrics to assess value and the active involvement of top management in all initiatives.
Six Sigma is often combined with Lean management techniques to produce a methodology that relies on a collaborative team effort to improve performance by systematically removing waste (Lean) as well as defects, overproduction, waiting, non-utilized talent, transportation, inventory, motion and extra-processing (Six Sigma).
Ohio Lab Offers Lessons Learned from CAP 15189
By Joseph Burns | From the Volume XIX No. 5 – April 2, 2012 Issue
CEO SUMMARY: For a lab looking to continually improve lab operations, becoming accredited to either ISO 15189 or CAP 15189 is an ideal challenge. After hearing from other lab directors about the benefits of becoming accredited to CAP 15189, the staff at Mercy Medical Center in Canton, Ohi…
Quest Diagnostics and LabCorp Report Q-4, Full Year Earnings
By Robert Michel | From the Volume XIX No. 4 – March 12, 2012 Issue
IN RECENT WEEKS, each of the nation’s two largest public laboratory companies reported earnings for fourth quarter 2011 and full year 2011. Organic growth at both lab companies continues at low single-digit rates. This continues the pattern of relatively modest growth that has been posted by each …
Raising the Bar with Better Phlebotomy Service
By R. Lewis Dark | From the Volume XVIII No. 7 – May 23, 2011 Issue
STEP BY STEP, INNOVATIVE CLINICAL LABORATORIES AND PATHOLOGY GROUPS across the country are deliberately raising the level of service they provide to patients and physicians. In the short term, this often delivers competitive advantage—at least until competing laboratories improve their own service …
Analysis of Lab Test Error Offers Lessons for Labs
By Robert Michel | From the Volume XVIII No. 6 – May 2, 2011 Issue
CEO SUMMARY: As happens now and again, a rather typical example of an error in lab testing has made the nightly news in Indianapolis because of one justifiably irate patient who got a false positive test report for an STD. One pathologist, asked by THE DARK REPORT to assess the p…
Using Audits to Uncover Bad Data in the Lab
By Robert Michel | From the Volume XVIII No. 2 – February 7, 2011 Issue
CEO SUMMARY: Labs using Lean, Six Sigma, and similar quality management methods are now putting these tools to a new purpose. They are being employed to validate the accuracy of metrics designed to monitor and manage work processes directly related to turnaround times and custome…
Pursuing More Benefits From Next Generation Lab Automation
By Robert Michel | From the Volume XVIII No. 1 – January 18, 2011 Issue
CEO Summary: Once it was decided to replace an aging, five-year-old laboratory automation system at the laboratory of Ingalls Memorial Hospital in Harvey, Illinois, the administration at the hospital issued a challenge. It asked the laboratory team to deliver an immediate 10% cos…
Quality Strategy Earns Honor for SD Laboratory
By Robert Michel | From the Volume XVII No. 14 – October 4, 2010 Issue
CEO SUMMARY: Here’s a new lab product launch with a surprise twist. Upon earning FDA clearance for its new HIV Ag/Ab Combo Assay this spring, Abbott Diagnostics selected a hospital laboratory in Sioux Falls, South Dakota, to be the nation’s first clinical lab to offer the ass…
ISO 15189 Accreditation Requires Specific Steps For Global Recognition
By Robert Michel | From the Volume XVII No. 6 – April 19, 2010 Issue
CEO SUMMARY: This intelligence briefing is the third in an ongoing series about quality management systems (QMS) and their role in advancing the performance of clinical laboratories and improving the quality of the testing services they provide. ISO 15189 is a set of standards for medical…
Ireland Is Restructuring National Lab Test System
By Robert Michel | From the Volume XVII No. 2 – January 25, 2010 Issue
CEO SUMMARY: Working from a consultant’s report and recommendations based on studies dating back to 2006 and 2007, Ireland’s Health Service Executive is moving forward to effect a comprehensive reconfiguration of clinical laboratory testing across the nation. This ma…
New Clinical Lab Trends To Shape Events in 2010
By Robert Michel | From the Volume XVII No. 1 – January 4, 2010 Issue
CEO SUMMARY: In presenting this list of macro trends for clinical laboratories, several themes are in play. They range from a continued emphasis on improving lab operations to the need to acquire and deploy sophisticated information technology. During the next few years, the long…
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Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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