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Cracking the LIMS Model: Technology Alternatives for Adding Online Access and Rich Content to Clinical Laboratory Results

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Cracking the LIMS Model: Technology Alternatives for Adding Online Access and Rich Content to Clinical Laboratory Results Cracking the LIMS Model: Technology Alternatives for Adding Online Access and Rich Content to Clinical Laboratory Results Author: Mark Terry Editor: Joe Bloniarz New Images needed DARK Daily Laboratory and Pathology News @ darkdaily.com Cracking the LIMS Model: Technology Alternatives for Adding Online Access and Rich Content to Clinical Laboratory Results 2 Table of Contents Introduction 3 Chapter 1: What’s Changing in Health Insurance that Requires Patients to Pay More Out of Pocket? 4 Chapter 2: Healthcare Pressured By Bad Debt and Decreased Reimbursement 9 Chapter 3: Why Clinical Labs and Pathology Groups are Unprepared to Collect Directly from Patients 13 Chapter 4: Increasing Collections and Reducing Bad Debt by Moving to a Retail Model 15 Chapter 5: Why Laboratories Need to Implement New Payment Strategies Now 19 Conclusion Update TOC 23 References 25 Appendices A-1 About tevixMD 28 A-2 About Mark Terry 29 A-3 About DARK Daily 30 A-4 About The Dark Intelligence Group, Inc., and THE DARK REPORT 31 A-5 About the Executive War College on Laboratory and Pathology Management 32 A-6 About William Todd Andros 34 Terms of Use 36 www.darkdaily.com ©2014 Dark Intelligence Group, Inc. Cracking the LIMS Model: Technology Alternatives for Adding Online Access and Rich Content to Clinical Laboratory Results 3 Introduction The trend in healthcare and in clinical diagnostics is toward adoption of health information technology (HIT). The Health Information Technology for Economic and Clinical Health Act (HITECH) of 2009, the Affordable Care Act (ACA), and other government Under the Final regulations were all designed with components that provide incentives Rule, patients for doctors, hospitals, laboratories, and other healthcare providers to can still receive adopt the use of electronic medical records (EMR), electronic health test reports from records (EHR), laboratory information management systems (LIMS), and other forms of HIT. their doctors if they choose, but In February 2014 the Department of Health and Human Services now they have the (HHS) issued an amendment to the Clinical Laboratory Improvement option to obtain Amendments of 1988 (CLIA) known as the “Final Rule” that significantly increases patient access and empowerment. The Final results from the Rule gives patients (or their authorized representative) the right to laboratory. access test reports directly from a laboratory without first receiving authorization from a healthcare provider. It does not require laboratories to interpret test results, just to provide them. Moreover, the Final Rule eliminates an exception under HIPAA that exempted CLIA-certified or CLIA-exempt laboratories from providing individuals access to their own health information. Under the Final Rule, patients can still receive test reports from their doctors if they choose, but now they have the option to obtain results from the laboratory. Surveys indicate that the vast majority of patients want that access. The burden of providing it and providing it in a way that is meaningful and reliable, is on the shoulders of the healthcare industry and the clinical laboratories. www.darkdaily.com ©2014 Dark Intelligence Group, Inc. Cracking the LIMS Model: Technology Alternatives for Adding Online Access and Rich Content to Clinical Laboratory Results 4 Although there are numerous LIMS systems available, they are often designed for the largest laboratories, with price tags to match. Small- to mid-sized clinical laboratories may develop their own “home-grown” LIMS or invest in smaller systems, but those may not be easily adapted to enabling access to laboratory records by patients and the numerous other stakeholders—doctors, hospitals, payers— Although there that require easy and secure access to that information. are numerous Besides cost, laboratories face a number of other challenges in LIMS systems attempting to provide test results to a broad range of stakeholders. available, Those challenges include security, Internet access, browser they are often compatibility, standardization and interoperability, and interpretive/ designed for content limitations. the largest This white paper will address the governmental and commercial laboratories, forces that are driving the adoption of HIT, and the challenges with price tags laboratories face in meeting those trends. It will present a case study to match. of how those challenges can be met to provide clinical diagnostic laboratories with a customizable, value-added, flexible, and scalable HIT solution that can make your laboratory more competitive, efficient, and adaptive in the face of the fast-moving trend toward electronic access to laboratory test results for all healthcare stakeholders. www.darkdaily.com ©2014 Dark Intelligence Group, Inc. Cracking the LIMS Model: Technology Alternatives for Adding Online Access and Rich Content to Clinical Laboratory Results 5 Chapter 1 Clinical Laboratory Information Management Systems and Lab With over a Test Access quarter-million The modern clinical diagnostic laboratory performs a vital role in clinical labs in healthcare. It is generally accepted that 70 to 80 percent of healthcare the U.S., it’s safe decisions are made based on laboratory test results. Laboratories to say that there process patient specimens from a variety of tissues—blood, urine, skin biopsy, tumor sample, etc.—and perform tests in a number is a wide variety of scientific modalities—microbiology, hematology, chemistry, of workflows. pathology, genetics, just to name a few. There are over 4,000 different laboratory tests available. Only a few large national laboratories offer a comprehensive laboratory test menu. As of 2013, according to CLIA (Clinical Laboratory Improvement Amendments)1, the division of the Centers for Medicare and Medicaid Services (CMS) that oversees clinical diagnostic laboratories in the U.S., there are 244,564 CLIA-certified diagnostic laboratories operating in the U.S. CLIA breaks those laboratories down into 23 different categories ranging from hospital laboratories, independent (commercial laboratories), and physician office laboratories to prison laboratories, blood banks, pharmacies and rural health clinics. Laboratory Workflow and Laboratory Test Results With over a quarter-million clinical labs in the U.S., it’s safe to say that there is a wide variety of workflows. In general, the workflow of a lab test begins with a patient seeing a healthcare provider. The healthcare provider orders a test (often many). In some environments www.darkdaily.com ©2014 Dark Intelligence Group, Inc. Cracking the LIMS Model: Technology Alternatives for Adding Online Access and Rich Content to Clinical Laboratory Results 6 the nurse or phlebotomist will draw blood or take a urine sample and send it directly to the laboratory. In other healthcare situations the patient must travel to a specific patient service center (PSC) or laboratory site in order to have the samples collected. The samples are then delivered to the laboratory. This can be onsite or to a local, regional, or national laboratory. A laboratory information Typically a sample is delivered to a central processing site at the laboratory or healthcare facility, logged into the laboratory management information management system, prepped as necessary, and delivered system is a to the specific laboratory division that performs the test. Once the computer test is performed and the results are created, the results are entered program or into the laboratory information management system (which may or information may not be automated), and the results further transmitted into the healthcare record or physician’s electronic medical record (EMR) or management electronic health record (EHR). The test results are then provided to system designed the patient in a variety of ways. Often the physician or staff member to handle the will contact the patient via telephone to let them know the results workflow and of their tests. Sometimes a letter is mailed or faxed. Sometimes the information is entered into an electronic health system portal that is data tracking accessible by the patient via the Internet. of laboratory information. What is a LIMS? A laboratory information management system (LIMS) is a computer program or information management system designed to handle the workflow and data tracking of laboratory information. Although there are subtle differences within the industry, the term LIMS is often used interchangeably with laboratory information system (LIS). For many years the clinical diagnostic lab—and healthcare in general— depended upon paper orders and requisitions and results reporting. www.darkdaily.com ©2014 Dark Intelligence Group, Inc. Cracking the LIMS Model: Technology Alternatives for Adding Online Access and Rich Content to Clinical Laboratory Results 7 Clinical diagnostic testing is a complex business with complicated and extensive workflows. It begins with test ordering, often at a myriad of geographic locations, sample collection and transport, followed by sample processing and analysis. The final step is reporting and interpretation. Every step along the way offers the possibility of error, which can lead to dimished patient care quality. Laboratory staff at all levels are involved with this workflow process, but are typically not directly involved in test selection, which is the “Most job of clinicians. clinicians simply cannot “However, without sufficient support in test selection, clinicians face several challenges, perhaps the most significant of which is that
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