News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Two New White Papers & One New Lab Product Review Just Added

There is a new resource library for clinical laboratory managers and pathologists that contains White Papers on contemporary topics involving clinical laboratory management, pathology administration, and the medical laboratory testing marketplace. This White Paper library is hosted at www.DarkDaily.com/white-papers and is a useful new information resource for the clinical laboratory profession.

The White Paper resource library is another example of how the Internet and Web 2.0 creates new educational opportunities for medical laboratory professionals and pathologists. The White Papers on clinical laboratory and pathology topics can be accessed 24/7 from anywhere in the world. Each White Paper can be downloaded immediately as a PDF.

In a typical month, DarkDaily.com is visited by pathology laboratory managers and professionals in as many as 180 different countries across the globe! That is another indication of the globalization of laboratory testing.

NEW White Papers:

NEW Lab Product Reviews:


DarkDaily.com Free White Paper Library:

NEW! Laboratory Information Systems (LIS) in the 21st Century: The Challenges and the Promises

Increasingly LIS’s offer what laboratories need: modular-based LIS’s with customizable functionality, scalability and a high level of adaptable connectivity for both institutional EMRs and physician access. In addition, laboratories increasingly expect high levels of customer service from LIS vendors. The environment for health information technology, specifically LIS’s, requires adherence to a number of national and international standards including CLIA, CCHIT, ANSI, HL7, HITSP, and LOINC.

A modern medium to large clinical diagnostic laboratory is made up of numerous specialized laboratory units – microbiology, chemistry, hematology, anatomic pathology, etc. – which all have unique needs and workflows. This presents challenges for LIS’s, which can be handled through modular systems that utilize a single database, are flexible and scalable, and can be customized for each laboratory unit or institution’s needs. Many laboratories also require customizable non-clinical applications like billing and client connectivity.

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NEW! How Internet-Based Lab Tests Access Helps Clinical Laboratories Serve Un-Insured and Under-Insured Patients

Internet-based companies that provide consumers with access to lab tests provide a significant and highly valued service for patients, particularly for those patients who are uninsured and underinsured.

The companies also provide services for patients who have high deductible health insurance plans and for any patients looking to keep the cost of lab tests low. Typically, patients who are fully insured do not need to the services of Internet-based companies that provide consumers with access to lab tests because their lab tests are paid in full by third-party insurance  company or these patients are required to pay only a small co-pay or coinsurance at the time of service.

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NEW! Reducing Manual Steps, Improving Turnaround Times, and Creating a Lean Laboratory Environment: ISD Testing on the Dimension® Integrated Chemistry Systems

The challenges facing the clinical laboratory environment in the past 10 years are well documented, and include significant medical technologist vacancy rates, increased competition, and a significant number of opportunities to inadvertently make testing errors.   With such macroeconomic challenges, the industry has used a variety of methods to identify ways to increase productivity, decrease costs, and in general, become more efficient at generating test results.

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NEW! Connecting Labs to Physicians’ Electronic Health Records: Effective Strategies for Laboratories to Add Value

The American healthcare system is in the process of significant change. Healthcare represents the fastest growing segment of our GDP, accounting for 17.3% of expenditures in 2009 and 19.3% projected for 20191, with Medicare and Medicaid representing 35% of that segment. Most metrics and outcome measures indicate that our healthcare system is operating inefficiently and that we are not getting our fair share from our investment. There is a broad consensus that these trends are unsustainable and that a change is mandated.

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Risk of Misdiagnosis Due to Tissue Contamination May be Higher for Certain Specimen Types: Changes to Laboratory Staining Techniques Offer Opportunity to Reduce Contamination Events

Tissue contamination in the anatomic pathology lab has long been accepted as a part of the working environment. While laboratories strive to reduce contamination as much as possible, it has been viewed more as an inconvenience than as a serious issue. But that view is changing. As this white paper demonstrates, the risk of misinterpretation may be greater than most pathologists currently realize, especially in certain tissue types. Also, this paper illuminates a source of significant contamination that has largely been overlooked—staining baths.

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Getting Paid for Molecular Tests: How Clinical Laboratories and Pathology Groups Should Respond to Pre-Authorization Requirements by Payers

The proliferation of molecular diagnostics is bringing a tidal wave of complexity, cost and quality issues for payers, clinicians and laboratories. Although clinical laboratory testing costs represent only 3 percent of total health care costs, diagnostic testing influences 70 percent of all health care decisions. Therefore, payers are accelerating efforts to appropriately manage the utilization and reimbursement of molecular diagnostics and genetic tests.

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A Tale of Two Solutions Achieving Balance in Automation: Optimizing Time and Staff

Diagnostic laboratories continually seek to balance the physician’s request for faster test results with the productive capacity of the lab staff. This “need for speed” is complicated by increasing test volumes and a critical shortage of lab techs. One solution provided by the IVD industry is to improve laboratory productivity by providing mechanical automation.

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ISO 15189 Medical Laboratories: Understanding the Four Components of a Quality Management System

Medical laboratories are a critical part of the healthcare system. A patient’s diagnosis and treatment are often based on test results, and an incorrect test result could lead to a misdiagnosis — which could have potentially fatal consequences. This is why accurate test results are critical — each and every time a test is conducted. The standard requires medical labs to implement a quality management system. This requires them to document all their processes and procedures.

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Getting Paid for Molecular Tests: How Clinical Laboratories and Pathology Groups Should Respond to Pre-Authorization Requirements by Payers

The proliferation of molecular diagnostics is bringing a tidal wave of complexity, cost and quality issues for payers, clinicians and laboratories. Although clinical laboratory testing costs represent only 3 percent of total health care costs, diagnostic testing influences 70 percent of all health care decisions. Therefore, payers are accelerating efforts to appropriately manage the utilization and reimbursement of molecular diagnostics and genetic tests.

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Vaginitis Diagnostics White Paper: An Opportunity to Improve Patient Care

Clinical laboratory testing plays a crucial diagnostic role in healthcare in the United States. That’s good news for pathologists, laboratory directors, and laboratory scientists. With the advancements in technology, laboratory test results are helping physicians make earlier and more accurate diagnoses. Numerous new diagnostic tests are available in the clinical marketplace. However, few of these assays possess the right combination of increased sensitivity, reasonable test cost, and the ability to significantly contribute to clinical care.

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Current Legal Challenges for Laboratory Professionals White Paper

In recent years, the Centers for Medicare & Medicaid Services (CMS) was concerned about fraud and abuse. It wanted to rein in revenue-driven arrangements that facilitate over utilization of diagnostic services. In response to these regulations urology and gastroenterologists are now establishing in-house anatomic laboratories. They often contract with local pathology practices for assistance in setting up these labs, as well as providing ongoing technical and professional services. Jane Pine Wood, along with Attorney Richard Cooper, who heads up the National Health Care Practice Group, explain how physician-owned laboratories must be structured to comply with CMS regulations. They point out contractual pitfalls for lab professionals, and offer advice on the best way to handle these arrangements.

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Using Quality Management Methods to Compare Competing Mid Volume Segment Immunoassay Systems

Stay up to date the lastest product strengths, weaknesses, opportunities and threats. (SWOT)

Many mid-sized hospitals now perform both immunoassay (IA) and infectious disease (ID) testing, but do not have the capital budget or floor space for a large integrated system. These labs require a single analyzer characterized by a small footprint, assay flexibility and high productivity that meets lab testing protocols. This article examines five analyzers currently in use and evaluates their productivity.

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Achieving Best Practices with Total Laboratory Automation in Your Laboratory

Evolution of the clinical pathology laboratory has been one long progression of advances in technology. These improvements have transformed pathology and laboratory medicine from the manual performance of individual chemistries or hematology tests to sophisticated diagnostic analyzers that perform multiple laboratory tests in an automated format. This review discusses the methods currently available to improve medical laboratory process efficiencies. It ends with discussion of the merits of “closed” versus “open” total laboratory automation applications.

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A CEO’s Guide to Molecular Diagnostic Reimbursement:

Navigating the Many Challenges of Reimbursement and Commercialization

Reimbursement and commercialization are significant challenges in this era of personalized medicine and comparative effectiveness. Many traditional clinical laboratories and early stage startup companies are trying to enter this space and are struggling to evaluate both the market and its offerings. According to Gene Tests, a publicly funded medical genetics information resource, the availability of new diagnostic tests increases 10% annually. However, there is a 20% increase in the utilization of genetic tests per year versus a 1% to 3% increase in non-genetic diagnostic tests per year.

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Digital Pathology White Paper:

Pathology Innovators Use Web 2.0 to Boost Productivity and Create Clinical Value

Web 2.0 capabilities are taking advantage of digital pathology and reaping great benefits from it. Instead of having to pack and ship slides, multiple pathologists can view the same image online from different locations, have online discussions about it and pass control back and forth while looking at the same image. Each pathologist can annotate an image in real time. As a result, pathologists employing digital pathology are saving time, increasing their profits, boosting their productivity and garnering big dividends.

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A CEO’s Guide to Increasing Laboratory Valuation:

Effective Revenue Cycle and Compliance Management are Critical Success Factors

There is no doubt that the complexity of laboratory revenue cycle management is unmatched in all of health care. With frequent regulatory and compliance rules changes, ever tightening margins, and a severely weakened economy, it is getting harder and harder for potentially acquirable independent labs to be sure they are not leaving potential profits on the table. The Dark Report and Dark Daily is happy to offer our readers a chance to download our published White Paper “A CEO’s Guide to Increasing Laboratory Valuation: Effective Revenue Cycle and Compliance Management are Critical Success Factors” at absolutely no charge. This free download will provide readers with a detailed analysis of how laboratories can maximize reimbursement to increase revenue and valuation operating margin.

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Change Your Labs Working Culture or Lose Your Medical Lab

If Lean and Six Sigma could be called hot management trends in the laboratory profession today, then a new challenge is hitting the radar screen for many laboratory directors and pathologists. “It involves the work culture in the lab—the attitudes of the med techs and lab staff—that often holds back the entire laboratory from achieving world-class performance, both clinically and operationally,” notes Jeff Smith, Vice-President of Leadership Development at Slone Partners, a Miami, Florida-based search firm that has a growing business with the laboratory profession. If you’re a lab director, pathologist, or lab manager interested in supporting positive cultural change in your laboratory, you’ll want to download this FREE Special Report featuring Jeff Smith.

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More Clinical Laboratory Management White Papers

To further expand this already growing library of clinical laboratory management White Paper topics, DarkDaily encourages lab professionals who are experts in specific areas of clinical laboratory management, operations, compliance, sales/marketing, etc. to recommend a topic and submit a proposal to produce that topic. Proposals for White Paper topics should be emailed to: jclark@darkreport.com

A list of White Paper topics on clinical pathology laboratory management follows below. Each can be immediately downloaded for free. New White Papers are added monthly. Additionally, the full archives of Dark Daily e-briefings can also be found at http://darkdaily.com/ebriefings.

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