DARK Daily Laboratory and Pathology NewsDARK Daily is an e-briefing service providing up-to-the minute news of relevance for anyone working in diagnostic medicine, from clinical laboratories and pathology groups to lab industry suppliers and diagnostic technology companies. DARK Daily is part of The Dark Intelligence Group, Inc. and is dedicated to bringing useful business and management intelligence to laboratory managers, pathologists and diagnostic executives. Our recognized expertise in the strategic direction of laboratory medicine and the management of laboratories is available through DARK Daily, The Dark Report, free White Papers, Lab Resource Directory, the Executive War College on Laboratory and Pathology Management, Lab Quality Confab, and strategic consulting services.
Researchers at the Stanford University School of Medicine Develop Cutting-Edge Test to Identify Whether an Infection is Bacterial or Viral
Early results are promising and this technology could lead to a clinical laboratory test that would give microbiologists and pathologists a new tool for helping diagnose infections
Infectious disease physicians and clinical laboratory scientists will be interested to learn that researchers at the Stanford University School of Medicine recently developed a new blood test that can identify whether the source of an infection is bacterial or viral.
These findings were published in Science Translational Medicine in July. The paper was authored by Stanford staff members Timothy Sweeney, MD, PhD, and Purvesh Khatri, PhD, Assistant Professor (Research) of Medicine (Biomedical Informatics Research-ITI Institute) and of Biomedical Data Science. Hector Wong, MD, of the University of Cincinnati was the third co-author of the study.
These findings are timely because, starting on January 1, 2017, hospitals and health systems will need to implement more rigorous antimicrobial stewardship programs to comply with new requirements of the Centers for Medicare & Medicaid Services (CMS) and The Joint Commission (TJC). A clinical laboratory test that makes it easier to determine whether the cause of an infection is bacterial or viral would be a welcome tool for physicians, pharmacists, pathologists, and microbiologists involved in a hospital’s infection control program. continue reading
Lean-Six Sigma Medical Laboratories Begin to Innovate in Ways That Add Value to Physicians, Payers, and Patients
With record attendance of 300 Lean-Six Sigma experts, this week’s conference was a high-energy event that provided medical lab professionals and pathologists with case studies of how to improve lab operations and contribute to better patient care
DATELINE: NEW ORLEANS—Yesterday was the conclusion of the 10th Annual Lab Quality Confab, which showcased innovators in clinical laboratories and anatomic pathology groups. Attendees traveled here from six different countries.
One new trend that emerged from this year’s presentations is that progressive medical labs are beginning to direct their Lean-Six Sigma, and process improvement efforts toward projects designed to add value to client physicians and hospitals. These projects include added-value features of benefit to patients and health insurers.
How Clinical Laboratories Are Succeeding with Lean Projects
This is a shift from prior years. At earlier Lab Quality Confabs, most speakers were describing how their labs were using Lean and quality management methods to improve workflow within their labs, increase the productivity of automation and staff, reduce errors, and cut costs. This was an “inside-the-lab” mindset.
That was not the case here in New Orleans this week. Yes, there were plenty of sessions where workflow redesign, productivity improvement, and cost reduction were discussed. But, at the same time, a significant number of labs doing presentations were describing projects that took the lab team outside of their laboratory to engage with physicians and nurses specifically to help them use clinical laboratory test data in ways that would improve patient care, reduce length-of-stay for hospital patients, and trigger worthwhile reductions of the cost of care. This is an “outside-the-lab” mindset.
One example shows how these progressive clinical laboratories are successfully collaborating with physicians to improve patient care and help clinicians better leverage the value of lab test results.
Northwell Health’s Medical Laboratory Team Tackles Acute Kidney Injury
At Northwell Health in Lake Success, New York, the clinical lab team initiated a pilot project in one of Northwell’s community hospitals. The goal was to improve the diagnosis and treatment of acute kidney injury (AKI). This project and how it contributed to improve patient care was described in two different sessions.
In his presentation about the strategic thinking of the laboratory division of Northwell Health, James M. Crawford, MD, PhD, Executive Director and Senior Vice President of Laboratory Services at Northwell, provided a summary of the project. The following day, Tarush Kothari, MD, MPH, Physician Informaticist & Assistant Professor of Pathology and Laboratory Medicine, presented a detailed case study of the AKI pilot project, including why AKI became an issue of concern, how the AKI project was implemented, and the impressive outcomes in patient care that resulted.
Clinical Laboratory Asked for Help by Hospital’s CMO
The opportunity for the clinical laboratory to deliver more value started with a request by the chief medical officer (CMO) of Forest Hills Hospital (FHH). “It was in July 2013 when the CMO at FHH approached the laboratory leadership,” recalled Kothari. “The problem was that radio contrast-induced AKI was occurring at FHH.
“Data showed that there were at least three cases of AKI per day,” he continued. “This was contributing approximately two excess days in length-of-stay. The CMO’s question for us was simple: ‘Can the laboratory do anything to prevent or mitigate this?’
“We saw the opportunity for our lab to collaborate in a more proactive and engaged way,” stated Kothari. “Our team researched the published studies and identified the relevant and accepted clinical pathways for acute kidney injury. After all the involved parties agreed on the protocols that would be used at 250-bed FHH, the necessary changes were made to the EHR [Electronic Health Record] and other software systems. A system of lab-generated alerts based on the results of creatinine tests was established.
Use of Creatinine Testing Generated Daily Alerts about Potential AKI
“We expected to see between five and 10 AKI alerts at Forest Hills Hospital,” he noted. “What actually resulted was about 40 alerts per day. This corresponded to 20 patients per day at risk for AKI. It also represented an 8% incidence rate in this busy community hospital.”
During 2013, data was collected from the baseline period and hospital staff were trained in the protocols for acute kidney injury. The study period took place for six months during 2014.
Medical Laboratory Contributes to Better Patient Outcomes
Kothari presented the following list of improvements associated with a better use of creatinine testing in support of AKI:
• The system-wide AKI capture rate has increased from 7.4% (in July 2014) to 12.9% (in July 2015) since the daily lab AKI reporting and education program for physicians began.
• Average revenue increase per diagnosis-related group (DRG) with secondary diagnosis of AKI is $700.
• Secondary diagnosis of AKI/month in 2014 (avg.) = 615 cases.
• Secondary diagnosis of AKI/month in 2015 (avg.) = 930 cases.
• Increase in secondary diagnosis of AKI from 2014 to 2015 = 315 cases.
• Increased in reimbursement/month because of secondary diagnosis of AKI = 315 x 700 = $220,500.
• Increase system reimbursement for 2015 = $220,500 x 12 = $2.65 million.
The lab team at Northwell Health further identified some of the challenges associated with the AKI program. Three of the lessons learned included:
• Lack of access to administrative data which can be readily linked to laboratory data;
• It remains very difficult to calculate total cost-of-care and therefore the effect of laboratory intervention; and
• Laboratory data is not linked to other data sets such as pharmacy and claims data.
This quick summary of the comments made by Crawford, and the full presentation delivered by Kothari, does not do justice to the full range of benefits that resulted because of a collaborative project with physicians to improve the diagnosis and treatment of acute kidney injury. The clinical laboratory team at Northwell Health intends to submit a paper describing this project for publication in a peer-reviewed journal.
Important Lab Industry First for Lab Quality Confab This Year
Lab Quality Confab 2016 delivered another distinctive first for the medical laboratory industry. Among the other sessions that took place at this year’s Confab was a one-hour panel discussion about labs’ compliance with Clinical Laboratory Improvement Amendments (CLIA) requirements. The panelists represented the four organizations that have deeming authority to certify clinical laboratories under the CLIA 1988 legislation, including the:
•College of American Pathologists (CAP); and
Panelists acknowledged that this was the first time that all four of the accrediting bodies had sat together at a lab industry meeting. They presented the top 10 deficiencies that are found during inspection of labs. They also discussed the range of changes for 2017 that are expected from the Centers for Medicare & Medicaid Services (CMS) relative to clinical laboratory certification and compliance.
These examples demonstrate the valuable information presented by the lab industry’s most accomplished experts and innovators in Lean, Six Sigma, and process management. A full set of audio recording are available for those readers of Dark Daily who were unable to attend the conference in New Orleans this week and would like to access this information and share it within their laboratories. Contact the offices of The Dark Report at 800-560-6363 for details and to order.
Your Dark Daily Editor,
Robert L. Michel
Engineers have designed a microfluidics and nano-scale diagnostic toolkit suitable for attaching directly to muscle and tissue to monitor biomarkers and stream results wirelessly to care providers and medical laboratories
What would change in medicine if physicians had sutures that could collect and report biomarker data, including the kinds of biomarkers that are used in clinical laboratory tests? Such a product may be feasible, based on newly-published research.
“Smart sutures” are a joint project between Tufts University, Harvard University, and Massachusetts Institute of Technology (MIT) engineers. They announced a thread-based diagnostic device (TDD) system capable of detecting biomarkers and analytes using 3D sutures composed of cotton and synthetic threads.
Processing the cotton and synthetic threads in various ways enhances their natural properties. The toolkit of different sutures developed by the team has exhibited a range of uses—including measuring physical stress at an incision, monitoring pH of tissues and fluids, and measuring glucose. continue reading
Mayo Medical Laboratory’s Mary Bonnerup Combines Heartland Values with Mayo Founders’ Legacy of Putting the Patient First to Win the National Lab Sales Excellence Award for Specialty Testing
Providing physicians with the clinical context and knowledge for the best use of specialty clinical laboratory tests helps this highly successful lab sales professional establish win-win client relationships
In support of the many local clinical laboratories and hospital lab outreach programs across the United States that continue to regularly add new clients and take market share away from their national lab company competitors, The Dark Report organized the 2016 National Lab Sales Excellence Award.
The award winners were announced at this year’s Executive War College in New Orleans on April 26–27. Reporting on the lab industry’s top sales producers serves two worthy goals. First, it brings recognition to the accomplishments of these lab sales professionals. Second, it helps medical laboratory administrators and pathologists at other labs and hospital outreach programs learn more about what it takes to use lab sales reps to win new clients.
What follows is a profile of the 2nd winner of the 2016 National Lab Sales Excellence Award. Dark Daily will publish profiles for each of the five laboratory sales professionals who were recognized with this unique national sales award. continue reading
University of Pennsylvania Researchers Develop $2 Zika Proof-of-Concept Test That Needs Neither Electricity Nor a Clinical Laboratory to Return Accurate Results
Using 3D printing and a chemical heat source, University of Pennsylvania researchers have created a proof-of-concept for an affordable Zika test that returns results in just 40 minutes
There’s a gap in Zika virus testing that researchers at the University of Pennsylvania hope to fill. That gap is a point-of-care test for the Zika virus that can produce a fast and accurate result, whether in developed nations or in developing countries that don’t have many state-of-the art clinical laboratories.
Although numerous Zika virus tests have earned Emergency Use Authorizations from the US Food and Drug Administration (FDA), gold standard detection is still limited to medical laboratories. To date, the FDA’s list of current and terminated Emergency Use Authorizations include no point-of-care options to help medical professionals quickly screen patients for Zika infection.
As noted by the Center for Disease Control and Prevention’s “Interim Guidance for Interpretation of Zika Antibody Test Results,” the antibodies that indicate Zika virus activity also share similarities with other flavivirus viruses. Of particular note is similarities with Dengue virus—a virus prevalent in many of the areas in which Zika is found. continue reading
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With a demonstrated track record of success, Robert Michel and the team at The Dark Intelligence Group, Inc. deliver strategic insight and market analysis that directly leads to increased revenues, improved profitability, and operational excellence. Having continuously worked with and visited laboratories, pathology groups, and lab industry vendors for more than 12 years, Robert Michel brings a unique set of skills and experience to any strategic challenge or opportunity.
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For a dynamic and knowledgeable public speaker to turbo-charge your next meeting, contact The Dark Intelligence Group. When it comes to management of clinical laboratories and pathology group practices, Robert Michel and his colleagues are consistently ranked among the industry’s keenest minds.