1 Transferring Laboratory Data Into The Electronic Medical Record: Technological Options For Data Migration In The Laboratory Information System By: Mark Terry Editor: Robert L. Michel DARK Daily Laboratory and Pathology darkdaily.com
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3 Options For Data Migration In The Laboratory Information System 3 Although the concept of an LIS is not new, advances in technology have made them more sophisticated than ever, offering clinical and non-clinical applications, Web-based connectivity, customizable configurations and rule-writing, scalability, and modular units that can offer data handling for the most cutting-edge laboratory techniques and testing.!"#$%&'(#)%" In an increasingly competitive economic environment for healthcare services, clinical diagnostic laboratories are looking at tools that can improve their efficiency and increase their profits. Of primary interest are sophisticated laboratory information systems (LIS) that can interact with the facility or institution s electronic medical record (EMR) system and/or electronic health record (EHR). Although the LIS concept is not new, advances in technology have made them more sophisticated than ever, offering clinical and non-clinical applications, Web-based connectivity, customizable configurations and rule-writing, scalability, and modular units that can offer data handling for the most cutting-edge laboratory techniques and testing. Every clinical laboratory is unique, as are the needs of each laboratory s LIS. A number of different technological approaches have been developed to meet the varied needs of the heterogeneous nature of the clinical laboratory industry, including fully integrated LIS s, middleware solutions, and Software as a Service (SaaS) solutions. This report will provide an overview of the clinical laboratory industry, the impact that it has on LIS s, and an understanding of a variety of technological approaches to deciding which LIS is appropriate for your facility. In addition, case studies will be presented, suggestions made on how to decide which type of technological approach is right for your laboratory, and ideas on how to implement the LIS you choose.
4 Options For Data Migration In The Laboratory Information System 4 Chapter 1: D"E)$%">."# Overview of the U.S. Clinical Laboratory System In the United States, clinical diagnostic laboratories come under the oversight of the U.S. Department of Health and Human Services (HHS), specifically under a provision known as the Clinical Laboratory Improvement Amendments of For the most part, clinical diagnostic laboratories need to be certified under CLIA. CLIA s objective is to ensure quality laboratory testing. Certification falls under two broad categories: waived and non-waived testing. CLIA offers five types of CLIA certificates: Certificate of Waiver; Certificate for Provider-Performed Microscopy Procedures (PPMP); Certificate of Registration; Certificate of Compliance; Certificate of Accreditation. Each level depends on the types of laboratory tests performed. Waived testing applies to fairly simple laboratory tests that provide a positive or negative result, thus requiring little interpretation. Examples of waived tests are Fecal occult blood (CPT 82962), which tests for blood in the feces, and blood count (spun microhematocrit, CPT 85013) to screen for anemia. Non-waived tests are more complicated and typically require interpretation of results by a healthcare professional.
5 Options For Data Migration In The Laboratory Information System 5 As of June 2011 there were 225,746 laboratories registered with CLIA. The states of New York and Washington are CLIA exempt due to state laws. New York state has 3,336 laboratories and Washington has 3,466. A modern LIS requires an ability to interface with the institution s electronic medical record (EMR), whether that institution is a physician s office, a clinic, larger laboratory, or hospital or health center. CLIA also classifies laboratories by type, breaking them down into 29 different categories, including Ambulance, Blood Banks, Health Fair, Hospice, Hospital, Independent, Pharmacy, Physician Office Laboratory (POL), Prison, and Other. The largest category is POL, accounting for 50.70% of CLIA-certified laboratories, with 114,461 in the U.S. The next largest category is Other (8.62%; 19,467), followed by Home Health Agency (6.08%; 13,716). However, in terms of test volumes, the largest clinical diagnostic laboratories are Independent (2.40%; 5,441); Hospital (3.86%; 8,772); and Physician Office Labs. For the purposes of this report, these three categories will discussed the most in terms of laboratory information systems (LIS). What Is An LIS? A laboratory information system (LIS) is a software program that provides the IT functionality needed for a clinical laboratory. Components often included in an LIS handle patient check-in, order entry, results entry, patient demographics, specimen processing, and some level of reporting ability. In addition, an LIS should be able to route test orders and results to various users and network locations. In practical terms, the list of components above is too basic for most modern laboratories. A modern LIS requires an ability to interface with the institution s electronic medical record (EMR), whether that institution is a physician s office, a clinic, larger laboratory, or hospital or health center. The LIS needs to interface with the laboratory s instrumentation, preferably allowing test results to move directly into
6 Options For Data Migration In The Laboratory Information System 6 the database, then into the EMR. Modern LIS s typically offer Web or browser-based order entry/result inquiry. Specialized laboratories, especially labs that use molecular-based techniques or high-resolution image capture, have highly specialized LIS requirements. Increasingly, LIS s offer non-clinical functionality such as workflow monitoring and billing services. Specialized laboratories, especially labs that use molecular-based techniques or high-resolution image capture, have highly specialized LIS requirements. Although a physician office laboratory (POL) may have a single small laboratory, the typical clinic, commercial laboratory, or hospital may have many different laboratories utilizing a variety of components of an LIS, often very specialized components. What Is An Electronic Medical Record or EMR? An electronic medical record (EMR) is a computerized medical record. The distinguishing feature for an EMR versus an LIS is that the EMR encompasses the health records of the specific organization delivering care, whether that is a hospital, clinic, or physician s office. As part of the Health Information Technology for Economic and Clinical Health (HITECH) Act, which was part of the American Recovery and Reinvestment Act of 2009 (better known as the stimulus ), Congress provided incentives and penalties for physicians to begin utilizing EMRs and electronic health records (EHR)*. The incentives provided up to $44,000 per physician under Medicare, or up to $65,000 over six years under Medicaid. There were penalties as well, which decreased Medicare/Medicaid reimbursements to physicians who failed to use EMRs by * In many areas, Electronic Health Record (EHR) and Electronic Medical Record (EMR) are used interchangeably (as is Personal Health Record, or PHR, which is more easily differentiated from EHRs and EMRs). Some users define the EMR as the legal patient record, which utilizes data from the EHR. That s a fairly fine difference, and with a significant percentage of individuals using them interchangeably, it s very difficult to differentiate them. The simplest definition of an EHR is that it is an electronic health record utilized by a physician s office that interfaces with an institution s EMR. What makes this confusing is that physician s offices, especially offices with multiple physicians and specialties, may have their own EMR. For the purposes of this paper, discussion will be held to EMRs, no matter what the institution.
7 Options For Data Migration In The Laboratory Information System 7 Studies have suggested that the use of EMRs improve healthcare efficiency by 6 percent a year, although there are critics of that conclusion. Studies have suggested that the use of EMRs improve healthcare efficiency by 6 percent a year... In the U.S., a number of technical standards have been developed to ensure EMR interoperability, i.e., the ability for different brands of EMRs to communicate with each other, as well as to communicate with a variety of instrumentation, EHRs, and personal health records (PHR). A short list of regulatory bodies and standards includes: HL7 (Health Level Seven International) CLIA (Clinical Laboratory Improvement Amendments) CCHIT (The Certification Commission for Health Information Technology) ANSI (The American National Standards Institute) HITSP (The Healthcare Information Technology Standards Panel) LOINC (Logical Observation Identifiers Names and Codes) For the purposes of this paper, standards will focus on HL7, although each certification (and others) is important in certification of LIS s. What Is A Personal Health Record? A personal health record, or PHR, is a health record controlled and maintained by the patient. Although a number of big players jumped into the PHR market, including Google and Microsoft, the public has been reluctant to embrace PHRs, possibly because they require personal initiative to begin and maintain the records. In 2011 Google Health announced that it would shut its PHR service down to new consumers on January 1, 2012, and will be completely shut down a year later.
8 Options For Data Migration In The Laboratory Information System 8 The classic LIS is slowly being phased out by a networked set of discrete systems referred to as virtual LISs and supplemental lab application modules, or SLAMS. Although Microsoft Health Vault continues, as do other PHR services, there are probably several reasons why the concept hasn t been widely deployed, including physicians are too busy, lack of interest on the part of payers, and criticisms of numerous PHR interactions like health alerts and reminders. Health information security is also a significant issue. However, although PHRs are not universally in use, most of the issues relevant to LIS s and EMRs in terms of standards, security and interoperability also apply to PHRs. What Is A SLAM? A supplemental lab application module, or SLAM, is one term for additional software that adds on to an LIS for specialty laboratory operations. SLAM is not an across-the-board term, although it has been around since at least 2005, when an article in CAP Today written by Drs. Raymond Aller, Michael Weilert and Hal Weiner, said: The classic LIS is slowly being phased out by a networked set of discrete systems referred to as virtual LISs and supplemental lab application modules, or SLAMs. The latter include all functions that do not reside in the classic LIS and handle front-end, middle, and back-end processing. 1 In current language, SLAMs are just as likely to be referred to as specialty modules or simply modules. Despite the change in vocabulary, what the article says is still true today: SLAM products for the laboratory market, includ(e) such products as Web portals, quality assurance and quality control systems, enhanced analyzer work cell managers, total lab automation systems, enhanced analyzer work cell managers, total lab automation systems, business and financial systems, and blood bank, telepathology, and
9 Options For Data Migration In The Laboratory Information System 9 imaging modules. Products are being developed to meet the unique needs of genomic and proteomic testing. What Is HL7? HL7 s specific standards domain is clinical and administrative data. As mentioned above, HL7, which stands for Health Level Seven International, is the international group that determines standards for the interoperability of health information technology. HL7 has members in over 55 countries worldwide. HL7 is accredited by the American National Standards Institute (ANSI) and is one of several accredited Standards Developing Organizations (SDOs) involved in healthcare. HL7 s specific standards domain is clinical and administrative data. HL7 s mission statement reads: HL7 provides standards for interoperability that improve care delivery, optimize workflow, reduce ambiguity and enhance knowledge transfer among all of our stakeholders, including healthcare providers, government agencies, the vendor community, fellow SDOs and patients. In all of our processes we exhibit timeliness, scientific rigor and technical expertise without compromising transparency, accountability, practicality, or our willingness to put the needs of our stakeholders first. HL7 is not necessarily more important than various other standards organizations involved in HIT and LISs. Because of its international structure and membership, HL7 provides a framework for HIT vendors worldwide to follow so that their information systems in the healthcare field whether laboratory information systems, radiology information systems (RIS), hospital information systems (HIS) or electronic medical records (EMR) will have a basic alphabet in which to communicate and interface with each other. It is estimated
10 Options For Data Migration In The Laboratory Information System 10 that more than 90 percent of information systems vendors serving healthcare are members of HL7. What Is An Instrument Interface? Simply put, an instrument interface allows a laboratory instrument... to communicate with the institution s medical record. Simply put, an instrument interface allows a laboratory instrument, whether it is a hematology analyzer or a cytogenetics imaging and karyotyping system, to communicate with the institution s LIS. The LIS, in turn, forwards the patient results directly into an EMR, rather than requiring a technologist or clerical person to manually re-enter data. It s faster, more efficient, and less likely to introduce errors. Interfaces are generally uni-directional, bi-directional, or host-query, or often all of the above. Uni-directional: Test results are transmitted from the instrument to the LIS Bi-directional: Orders are transmitted to the instrument from the LIS and stored in the instrument until the appropriate specimen is loaded. Results are then transmitted back to the LIS when the order is identified. Host-Query: Upon scanning a specimen, the instruments sends an order query to the LIS. The test is performed and the result is transmitted back to the LIS when the order is identified. Host interfaces: The instruments will be able to interface with a wide selection of host products, such as EMRs and LIS s. It can t be stressed enough the importance of LIS systems having nimble Host interfacing capabilities. Agile Host interfacing allows for easy manipulation of the interface content, especially in the current marketplace where connectivity is a mandate of Meaningful Use. Systems with this built-in technology don t require external
11 Options For Data Migration In The Laboratory Information System 11 middleware to achieve easy connectivity to other, more complex external systems. Identifying The Challenges The modern clinical diagnostic laboratory is a complicated entity, interacting with patients, physicians both within and without the institution, insurers, other laboratories, and other components of hospitals or health institutions. It must also, in the U.S., meet CLIA standards and in some cases, state licensing and inspections. In addition, the field of clinical medicine is constantly changing with new techniques and testing modalities brought on regularly. There are numerous challenges for a laboratory information system, which include: LIS cost IT staffing Legacy LIS integration Adapting workflow Downtime for installation or operational maintenance Complex and unique laboratory specialties Database interfaces Instrumentation interfaces Imaging and data storage Non-clinical applications Host interfaces Test Routing to remote sites and/or reference labs These will be addressed in chapter 2.
12 Options For Data Migration In The Laboratory Information System 12 Chapter 2: *+,88."F.9/)"/#+./*'$$."#/ Most laboratories require some sort of LIS. There are, however, a number of challenges for laboratories that immediately crop up, and may vary by laboratory type and size. LIS cost A full-size laboratory information system that can be used in the largest, most complex laboratory environments can cost hundreds of thousands of dollars. Clearly such a system is beyond the economies of a physician office laboratory or a small or even medium-sized commercial or hospital laboratory. Luckily, some vendors have developed LIS approaches or products that provide fully functional applications for a reasonable price. Some systems are smaller and have limited functionality; some systems utilize middleware to expand existing (legacy) LIS s. Some vendors are offering software as a service (SaaS)-type services in which the LIS resides primarily in the cloud and is connected via the Internet or a local area network. In the SaaS model the laboratory or institution pays a monthly service fee to connect to the SaaS LIS network. IT staffing A full-sized LIS often requires regular maintenance and interaction by an IT staff. In large commercial laboratories and/or hospitals,
13 Options For Data Migration In The Laboratory Information System 13 Legacy systems that utilize outmoded programming languages present unique problems, in that there are often no IT people employed in the system or laboratory that are familiar with them. there is typically a fairly good-sized IT department that oversees the institution s health information systems. This is not practical for a physician office laboratory or small hospital or commercial laboratory. Yet laboratories of all size have a need for a fairly sophisticated LIS that can interact with institutional EMRs, regional Health Information Exchanges (HIE), and other physicians, payers, PHRs, and laboratories. Legacy LIS integration Many laboratories already have some form of a laboratory information system in place. In many cases, these LIS s were developed as early as the 1970s or 1980s and may have been built on hardware that is no longer being manufactured, or software languages that are no longer being used. Legacy systems that utilize outmoded programming languages present unique problems, in that there are often no IT people employed in the system or laboratory that are familiar with them. Earlier programming languages and LIS s suffer numerous problems, but among them are an inability or difficulty in interfacing with modern instrumentation, difficulty in interfacing with modern EMRs, and inability or difficulty in interfacing with Web or browser-based systems of any sort. Adapting workflow With 225,746 CLIA-certified laboratories in the U.S., it s fair to say that no two laboratories are identical. Each laboratory will vary by test volume, personnel, and test menu. Each laboratory will have unique workflows, which will affect the LIS needs of the laboratory.
14 Options For Data Migration In The Laboratory Information System 14 Some LIS s are not flexible, and force a one-size-fits-all workflow onto the laboratory. Larger laboratory facilities both commercial (independent) laboratories and hospital laboratories have multiple laboratories that, for the most part, run independently, have separate supervisors (and in many case PhD and MD-level directors), and unique workflows. A typical standard medium-to-large laboratory institution will have laboratories performing microbiology, chemistry, blood bank, hematology, anatomic pathology, serology, cytology, and histology labs. They may also have molecular diagnostics, cytogenetics, DNA diagnostics and molecular imaging laboratories. Each laboratory type has its own unique workflow and that workflow, especially in specialty areas like molecular diagnostics, place unique demands on laboratory information systems. In addition, these laboratories may be involved in reference laboratory activities for outside institutions and/or customers, as well as in sending out specialty testing to outside reference laboratories. These complicate LIS functions and needs. Some LIS s are not flexible, and force a one-size-fits-all workflow onto the laboratory. A desirable aspect of an LIS is a level of customizability that allows the LIS to adapt to the workflow of each laboratory. Downtime for installation or operational maintenance A large-scale LIS with an IT department often requires significant downtime for operational maintenance. In a medium-sized laboratory with lower-end weekend and evening volumes, this may cause no particular problems. Each laboratory is unique and their ability to handle maintenance issues is affected by number of instruments, technologist schedules, and any system redundancies they may have.
15 Options For Data Migration In The Laboratory Information System 15 In the same way, installation of an LIS, depending on the size, complexity and type of LIS and the laboratory, can involve significant downtime on the part of the laboratory. Very few laboratories can afford lengthy shutdown without incurring serious damage to their business and/or inconvenience to their client/patients. The LIS s at each of these laboratories performing tests for a single patient need to be able to communicate with each other. Complex and unique laboratory specialties As mentioned earlier, a typical laboratory will offer tests in a variety of areas microbiology, chemistry, hematology, blood bank, and anatomic pathology. Laboratories may additionally offer tests in parasitology, toxicology, histology, serology, genetics, cytogenetics, molecular medicine, and flow cytometry, as well as other specialty areas. Increasingly radiology is expanding into molecular imaging techniques that overlap with clinical diagnostics. Hospitals often have a STAT laboratory to perform laboratory tests for the emergency department. Each laboratory has a unique workflow, in part due to variations in incubation times, specimen samples and conditions, technological platforms and varying levels of automation. Each laboratory typically has its own LIS. Patients, however, rarely require just a single test that can be performed by a single laboratory. Even in a small physician office laboratory, a significant proportion of tests requests per patient will have to be sent out to one or several reference laboratories, while basic tests only are performed in-house. The LIS s at each of these laboratories performing tests for a single patient need to be able to communicate with each other. The data needs to be shared and integrated into a single report that can be delivered to the ordering physician. Legacy LIS s were often built separately for individual laboratories and then interfaced with each other with varying levels of success. Early legacy medical lab
16 Options For Data Migration In The Laboratory Information System 16 instrumentation did not typically have automated results distribution (or order entry), requiring that results be manually entered into the health record by a staffer. Molecular techniques change at a very fast pace, putting pressure on LIS s to be able to adapt to changing technology. Certain specialty areas bring increasingly complex problems to the LIS arena. Molecular testing is definitely on an upswing, increasing from 6% to 25% annually and is expected to continue to rise. Molecular diagnostics and genetic testing are both broad categories, but they can present unique problems for LIS s, including: specialized nomenclature; image importing and exporting; searchable karyotype concepts; integration of images and workflow; advanced statistics; sequencing and fragment analysis instrumentation interfaces. In addition, molecular techniques change at a very fast pace, putting pressure on LIS s to be able to adapt to changing technology. This applies to all of clinical diagnostics it is a fast-changing area and advances in diagnostics results in instrumentation advances, which forces LIS s to adapt along with them. Molecular, Genetic Data and the LIS, published in the April 2008 issue of ADVANCE for Administrators of the Laboratory, stated: Molecular testing generates several types of results in various modalities quantitative, cytology, pathology or microbiology interpretive text and, increasingly, related images. One common molecular report is the combination of cytology and molecular tests that have been routinely performed and reported separately. Database interfaces An LIS, even in a smaller laboratory, will have numerous interfaces: to instrumentation, to the institutional electronic medical record, to reference laboratories electronic medical records and/or LIS, and to one or several databases. Although instrumentation interfaces will be discussed in the next section, databases present their own set of problems.
17 Options For Data Migration In The Laboratory Information System 17 Further complicating this spider web of interconnectivity is that each laboratory specialty may have its own database. In a medium to large institution and/or laboratory, there are often a number of LIS s one for the microbiology lab, one for the hematology lab, one for the blood bank, etc. In an ideal world, these LIS s are all from the same manufacturer. In reality, they are often separate manufacturers, sometimes legacy home-grown systems, and they each will have an interface to the institution s electronic medical record. Further complicating this spider web of interconnectivity is that each laboratory specialty may have its own database. For instance, the LIS dumps data into a database. The database then connects to the database from another specialty laboratory and so on. In larger laboratories, especially regional and national laboratories (and in some cases, international laboratories), there can be literally hundreds of different databases with hundreds of interfaces. Although all interfacing presents problems, synchronizing data across databases is particularly complicated. The older the databases, the higher the likelihood of problems arising; the more individual databases, the more potential problems. In addition, shared databases require particular adherence to HIPAA regulations that cover health information security. A potential solution is a single database. This can sometimes be handled institutionally by a single database (and single vendor for each individually laboratory). If the institution as a whole agrees on a vendor, then that can work, no matter how unlikely that is to happen in medium and larger institutions. Another solution is to have a single database operating in a cloud into which all LIS s interface. Instrumentation interfaces As mentioned earlier, increasingly laboratories utilize automated instrumentation. These automated instruments are capable of interacting with the LIS, responding to order entry, and feeding test
18 Options For Data Migration In The Laboratory Information System 18 results directly to the database and/or LIS. In theory, these interfaces are unlimited. More problematic is that each instrument may not only require a unique interface, but a typical laboratory will have instruments that range from a decade or older to fresh-off-the shelf. Each of these systems present challenges to interfaces. A complete AP study on a single patient converted to digital images can exceed multiple terabytes. Imaging and data storage Many types of molecular diagnostics, cytogenetics, anatomic pathology (AP), and molecular radiology imaging techniques place high demands on data storage. According to a Dark Daily report (June 2011) about Paul J. Chang, MD, FSIIM, Professor and Vice Chairman of Radiology Informatics at the University of Chicago Hospitals, the contents of a single pathology slide takes up about 15 gigabytes (GB) of storage space. A complete AP study on a single patient converted to digital images can exceed multiple terabytes (TB). For even a few days of a typical lab s anatomic pathology work, imaging and data stores becomes huge. In addition, molecular diagnostics, cytogenetics, and AP reports often want to include imagery. Not all LIS s allow this. Non-clinical applications In 2008, CAP Today noted that many LIS vendors were exiting the financial aspect of the laboratory, including billing systems. Although LIS vendors may be getting out of that end of the laboratories, few laboratories are. Most laboratories, from POLs to regional and national reference laboratories, require sophisticated billing systems. The billing and regulatory environment for clinical laboratories is changing constantly. Ideally non-clinical applications such as logistics and supply inventory, billing, remote printing, insurance summaries, client connectivity and sales representative monitoring are included in a modern LIS.
19 Options For Data Migration In The Laboratory Information System 19 Chapter 3: G)&&8.J,$. Middleware is a type of software that sits in the middle between software components and applications. This allows several different processes that run on several machines to communicate and interact across a network. In the context of clinical diagnostics and clinical laboratories and laboratory information systems, middleware is used to connect laboratory information systems (LIS) with the analyzers that do the actual lab testing. It s an interface between the two. 2 The problem with that definition is that it s so broad it doesn t quite tell users what middleware does. That s part of the problem with middleware, in general. It essentially does whatever the existing software fails to do. In that respect, middleware can be considered a way of filling holes existing systems don t fill. Gary Tufel, in his 2009 CLPMag article, says, A typical use is for middleware to sit between a LIS and analyzers in labs to enhance analyzers capabilities and take advantage of the features that a LIS offers. Middleware, because of its flexible definition, can do a number of different things for LIS s, quite possibly an infinite number, giving the broadness of most definitions. However, four areas in particular are common functions for LIS middleware: Messaging Automation Inspection Preparedness/Compliance Quality Control
20 Options For Data Migration In The Laboratory Information System 20 Messaging Middleware is also used to add layers of automation to the LIS environment. At its very core definition, middleware provides communication messaging, in a word between different applications. For instance, it can communicate between an instrument and the LIS, or from the LIS to third-party software such as an HIE, EMR, or PHR. This requires middleware to function a bit like a translator, working with various programming languages and compliance guidelines. Laboratories hospital, independent, and POL of differing sizes will be able to utilize middleware to message in several different contexts. Other facilities may use middleware to add missing functionality to legacy LIS s. In the physician office laboratory environment, middleware can be used to capture and manage laboratory data from clinical analyzers and exchange demographics, orders, and lab results to an EMR or a HIS. Other users of middleware in the POL environment involve interfacing billing information with the HIS, EMR, and PMS. In the smallest environments where waived testing is allowed, middleware is used to connect point-of-care testing (POCT) with various health care management systems. 2 Automation Middleware is also used to add layers of automation to the LIS environment. This is often used by adding rules to the LIS, which is to say, by specifying responses to test result ranges. For instance, middleware can be programmed to look at a specific test result, and if the result is in a specific range, the results are forwarded to the LIS. If the result is above or below the test range, an order can be delivered to the laboratory indicating the test needs to be repeated or checked for technical and processing issues, or to reflex to another test.
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Medical Information Systems Introduction The introduction of information systems in hospitals and other medical facilities is not only driven by the wish to improve management of patient-related data for
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