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

Author: Mark Terry Editor: Joe Bloniarz

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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

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.

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.

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

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.

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 the be expected menu of available tests has expanded, in both number and complexity, to stay up-to- particularly with new molecular assays. Compounding the expanding date with every menu are time pressures placed on physicians. Most clinicians complex test simply cannot be expected to stay up-to-date with every complex and diagnostic test and diagnostic algorithm outside their specialty. Clinicians may compensate for not knowing which test to order by ordering algorithm many tests, some of which are unneeded, putting patients at risk for outside their wasteful or even harmful follow-up care. Alternatively, clinicians may specialty.” fail to order needed tests, leading to delayed or incorrect diagnoses.”2

A modern LIMS has numerous components, including computerized provider order entry (CPOE), rules-making ability, barcoding, direct interfaces with laboratory instrumentation and the LIMS, EMR, EHRs, patient portals, and potential for adding rich content and patient-oriented data interpretation. With over a quarter- million different laboratories, numerous different lab types, and the multiple complicated connections a LIMS needs to make between physicians, hospitals, clinics, insurers, and patients, connectivity and standardization is not a simple matter. The federal government in general, and specifically through legislation such as the Patient Protection and Affordable Care Act (ACA) and the Health Information Technology for Economic and Clinical Health

(HITECH) Act of 2009, have provided incentives and penalties for all healthcare providers, including laboratories, to adopt electronic health information technology (HIT) that is interoperable and accessible.

What is a SLAM?

A Slam is A supplemental laboratory application module (SLAM) refers to used to provide additional software that is added to a LIMS for specialized laboratory operations. SLAM is not a particularly common term within the additional, industry, although it’s been around since at least 2005. According to typically a 2005 CAP Today article by Drs. Raymond Aller, Michael Weilert, specialized and Hal Weiner, “The classic LIS is slowly being phased out by a functionality to a networked set of discrete systems referred to as virtual LISs and LIMS. 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.”3

As such, a SLAM is also referred to as a specialty module or as just a module. Whatever it is called, a SLAM is used to provide additional, typically specialized functionality to a LIMS. Since LIMS are increasingly being used for non-clinical laboratory applications such as billing and quality control, a SLAM typically provides that functionality.

Types of SLAMs include, but are not limited to: • Web portals • Quality Assurance (QA) • Quality Control (QC) • Enhanced analyzer work cell managers • Total lab automation systems • Business and financial systems

• Blood bank • Pathology • Imaging Modules • Genomic and proteomic testing • Rich content provision

Chapter 2

Trends in Health Information and the Regulatory Environment

The trend As the previous chapter suggests, the trend in health information in health technology is for more of it. The Office of the National Coordinator information for Health Information Technology (ONC) was created in 2004 by technology is for Executive Order and further mandated by legislation via the Health Information Technology for Economic and Clinical Health Act more of it. (HITECH) of 2009. One of the primary missions of the ONC is to promote the development of a national health IT infrastructure. The ONC and the federal government have done so through a variety of stimulus programs and incentives. For example, to-date CMS has provided almost $37.2 billion in EHR incentives. Since 2011, 90.4% of 5,011 estimated eligible hospitals have received payments; 69.6% of the estimated 527,200 physicians and other healthcare providers eligible have received payments. It’s slowing down, but it still reflects a large number of healthcare providers adopting new HIT.4

Part of what makes the trends in HIT difficult, besides political issues and costs, are technical in nature—how do you get hundreds of different HIT products to communicate with each other effectively: from EHRs, EMRs, health information exchanges (HIE), hospital- based electronic health records, physician office practice management records and electronic health records, to patient portals. Although the topic is enormous and a comprehensive study of standards in HIT would fill a book (or two), in the U.S. there are several key elements to what we will refer to as standardization and interoperability issues.

HIPAA

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) covers a number of healthcare-related topics. Title I protects health insurance coverage when individuals lose or change their jobs. Title II, called the Administrative Simplification (AS) provisions, The overarching involves national standards for electronic healthcare transactions point point is and national identifiers for providers, health insurance plans, and employers. Key aspects of Title II are also the security and privacy of to promote healthcare data. The overarching point of it is to promote healthcare healthcare efficiency and effectiveness, and to encourage the use of healthcare efficiency and electronic data interchange. effectiveness, HL7 and to

encourage the Health Level Seven International (HL7) is a “global authority on use of healthcare standards for interoperability of health information technology with electronic data members in over 55 countries.” Founded in 1987, HL7 is a not-for- interchange. profit, ANSI-accredited standards developing organization. It has over 2,300 members, including about 500 corporate members that represent more than 90% of the HIT vendors worldwide. The gist of HL7 is essentially that if any HIT product is likely to get widespread approval for use in the U.S. (and worldwide), it must meet HL7 standards and guidelines. ANSI stands for the American National Standards Institute, which oversees the creation and use of guidelines for nearly every commercial sector in the U.S., including healthcare.

CLIA

Regulation for all clinical laboratory testing performed on people in the U.S. falls under the aegis of the Centers for Medicare & Medicaid Services (CMS), specifically through the Clinical Laboratory Improvement Amendments (CLIA). CLIA’s objective is “to ensure

quality laboratory testing.” If a laboratory wants to operate in the U.S., it does so under CLIA guidelines and approval. Therefore, any HIT that affects clinical diagnostic laboratories will also need to align with CLIA regulations.

As mentioned earlier, a new amendment to the 1988 CLIA regulations Laboratories known as the Final Rule makes an important change to both patient will need to rights and laboratory responsibilities. Under this rule, laboratories can provide test reports directly to patients or their personal assess internal representatives. The Final Rule also eliminates an exception under processes HIPAA that exempted CLIA-certified or CLIA-exempt laboratories and service from providing individuals access to their own health information. capabilities to Laboratories will need to assess internal processes and service be sure they are capabilities to be sure they are able to abide by the new amendment and serve their clients efficiently. able to abide by the new What the Trends Are amendment and serve There appear to be three major trends in HIT when it comes generally to medical data and specifically to laboratory test data. They are: their clients efficiently. • Direct Patient Access • Web Access • Mobile Device Access

Direct Patient Access

As mentioned in the first chapter, HHS has made a proposal to allow direct patient access to clinical laboratory results. Although this is likely to be modified to some extent before being finalized, it seems likely that patients will be allowed access to their test results, just as they have a legal right to all of their medical records. What is primarily up for debate is whether they will get simultaneous access

at the same time as their healthcare provider, whether there will be a lag period allowing the physician time to assist the patient in interpreting the results.

Web Access

The patient may Deciding how patients will have access to their laboratory results access their typically comes down to some version of Internet access. Within that broad framework, there are a number of options. The laboratory can test results via provide its own portal specifically for patients to access test results. a physician That portal may or may not be the same access provided physicians, or healthcare i.e., the results provided may have a less technical interpretation institution and limited access. The patient may access their test results via a portal. physician or healthcare institution portal. Although use of Personal Health Records (PHR) have not been widely adopted, test results may be uploaded to a patient’s PHR, for which they have full access.

However, in a survey conducted by Accenture in 2012, 90% of respondents cited the Web as their preferred way to access health information. Of the respondents, 83% specifically cited they wanted to use the Web to access personal medical information.5

One area that hasn’t been addressed thoroughly in this context is that of images. Certain types of laboratory tests have significant imaging components, such as surgical pathology, cytogenetics, various imaging modalities, and numerous molecular techniques. These are of questionable value to a patient without technical interpretation, and create significant challenges in terms of data storage and imaging formats. However, the final rule regarding releasing test results to patients does not require that the laboratory provide interpretation. A statement made by CMS regarding this said, “Patients merely have the right to inspect and receive a copy of their completed test reports and other individually identifiable health information maintained

in a designated record set by a Health Insurance Portability and Accountability Act (HIPAA)-covered laboratory. Laboratories may continue to refer patients with questions about the test results back to their ordering or treating providers.”6

Mobile device access Mobile access presents similar It’s no secret that the trend in computing in general is mobile. The worldwide markets for smartphones and wireless tablet devices issues as Web such as the iPad or the Samsung Galaxy is exploding. An example access—security of how this is being put into use is Mayo Clinic’s Lab Catalog for and format. iPad and Lab Reference for iPhone and iPod Touch. Mobile access presents similar issues as Web access—security and format. However, according to the Pew Research Internet Project, as of January 2014, 58% of American adults have a smartphone.7 That percentage is only likely to grow.

Meaningful Use

Another fact that shouldn’t be ignored in considering the adoption of HIT is the ONC’s “meaningful use” (MU) guidelines. When the ONC created incentives to get healthcare providers to adopt HIT, part of the definition involved that they adopt “meaningful use” of HIT. Meaningful Use has several different stages with varying standards adopters have to meet in order to receive the financial incentives or to avoid any penalties. Stage 1 of MU had numerous steps to it, but of significance in terms of adoption trends is the requirement for eligible professionals to “provide more than 10% of all unique patients with timely electronic access to their health information.”

According to Rita Bowen on the HealthPort blog regarding Meaningful Use updates, Stage 2 MU cited that “eligible providers (EPs) and hospitals are set to lose incentive dollars if patients can’t

electronically view, download and transmit records. Access must be through a secure channel that encrypts and protects the content. Furthermore, the patient’s information must be available within four business days for EPs and within 36 hours of discharge in hospital settings. Fifty percent of patients must have access with 5% actually viewing, downloading or transmitting to meet the Stage 2 measure.”8 The patient’s information must be available within four business days for EPs and within 36 hours of discharge in hospital settings.

Chapter 3

Challenges to Laboratory Content Access

“Like many With patients asking and/or demanding access to laboratory test results, and increasing regulation requiring it, it seems likely to be an areas in issue all laboratories will soon be dealing with if they’re not already. medicine, There are a number of challenges, however, that have to be dealt with clinical lab before full patient access becomes a reality. testing often provides The Problems With Lab Test Interpretation

few simple First, the typical laboratory test result is not designed for a layman. answers to As the website Lab Tests Online (http://labtestsonline.org/ commonly asked understanding/) indicates on its Understanding Your Tests page aimed questions.” at the layman, “Like many areas in medicine, clinical lab testing often provides few simple answers to commonly asked questions.” They often provide numerical results that fall within a given reference range. Reference ranges vary from laboratory to laboratory. Most laboratory tests, especially those in CLIA-certified moderate- to high- complexity laboratories do not provide yes-or-no answers.

In addition, laboratory tests often require a bigger picture. Although a cholesterol reading is a useful figure, that number alone doesn’t provide an accurate picture of the patient’s cardiac health without including other test results like a lipid profile, triglyceride levels, and other factors such as blood pressure, weight, family history, and age. The physician’s job is to put all those test results into a useful context and to interpret them. One of the arguments against providing direct

access to test results for patients is the difficulty of interpreting raw test results.

This is further complicated with more complex tests, whether genetic tests like those for ApoE, BRCA1 and 2, or cancer treatment susceptibility testing. These are complicated and physicians often need assistance from geneticists or specialists in interpreting the A number of results. As healthcare moves fully into “personalized medicine” vendors are with pharmacogenetic testing, clinical lab testing interpretation will developing become both more important and more difficult. affordable Affordability and the LIMS SLAMs and/or

Web or cloud- A large regional or national diagnostic laboratory can afford a full- based services service LIMS that can cost upward of $375,000 or more. That is a that provide price that is out of reach for many smaller laboratories. As Kim Shah similar LIMS says in a Laboratory News article in 2010, “It is not cost effective for the smaller laboratories to implement the solutions created for capability at far the larger laboratories incorporating features that exceed their needs more affordable and budget of the operation. Both however are required to provide prices. accurate results with the shortest turn around at a competitive price.”9

This is a problem that continues for small to mid-sized labs. A number of vendors, however, are developing affordable SLAMs and/ or Web or cloud-based services that provide similar LIMS capability at far more affordable prices. The advantage of these services, which include Software-as-a-Service (SaaS)-type offerings, is that they are often customizable, affordable, and scalable. They frequently provide a nimbleness not offered by larger LIMS vendors simply because if the laboratory decides they no longer need a type of service offering, it’s a matter of flicking a switch or pushing a button to discontinue that service with billing adapting simultaneously.

Browser Compatibility Issues

Many commercially available LIMS systems suffer significantly from browser incompatibility issues. Most LIMS programs are very complicated software. Very robust, but complicated, and as a result, it is challenging for a LIMS system to be altered to work with different For laboratories browsers, especially as browsers are routinely being changed and to provide a updated. Further complicating the issue is the types of imaging results often included in laboratory tests, and the advent of more and more service to their mobile applications (with more and different types of browser formats patients and and capabilities), and this becomes a major concern when attempting customers, for to make laboratory information available to consumers. that service to One solution is to de-couple the LIMS system from browsers and be value-added, focus on external interfaces. This can assure browser compatibility, some type of including with mobile devices. interpretation will likely be Raw Data vs. Rich Data and Interpretation desirable. As mentioned earlier, providing patients with the raw test results comes with a number of problems. For laboratories to provide a service to their patients and customers, for that service to be value-added, some type of interpretation will likely be desirable. How to do this is difficult. Small to mid-sized laboratories rarely have budgets to hire full-service IT departments, let alone work on developing rich content and interpretation of laboratory results. However, some vendors, such as the Lab Portal Company, allow the delivery of customized test results through the Lab Connector or Lab Connections portal in a variety of formats. Their product also provides information in charts and graphs, as well as provide laboratory results in many different languages.

Chapter 5

Case Study

Physicians Lab Physicians Lab Boca Raton, Florida turned to Lab Physicians Lab specializes in delivering step-by-step guided, broad- Portal Company spectrum testing—including blood and urine testing and analysis— to partner with to clients in the comfort of their own homes. Their aim is to lead them to create the industry in technology, service, and customer satisfaction by a web portal providing state-of-the-art science and superior solutions. Physicians system that Lab turned to Lab Portal Company to partner with them to create a web portal system that would offer a customized patient experience would offer and meet all of their needs. a customized patient Expectations experience and When Physicians Lab approached Lab Portal Company, they had meet all of their done their research. They knew the various portal solutions that were needs. available, and they understood the pros and cons of each. They were up to speed on industry requirements and best practices and were well aware of the problems faced by many in the industry.

Based on their extensive investigation and analysis, Physicians Lab had developed a comprehensive “must have” list. They wanted a flexible web solution that could be integrated into their existing enterprise. They had plenty of other items on their list as well, including: • HIPAA compliance • Advanced reporting capabilities

» Online access to reports » » Automated report distribution » » Patient test-result trending » » Ease of access to completed test results » • Tools for educating patients and providers—built into the patient- user experience Lab Portal gave • Built-in efficiencies Physicians Lab » Direct integration into a Laboratory Information » the opportunity Management System (LIMS) » Capture custom gender-specific patient information online to provide users » » Display relevant gender-specific videos for specimen with a unique, » collection high-level, » Capture patient prescribed medications and over-the-counter » high-quality medications online » Display current shipping status of patient specimen experience. » » Capture patient insurance information online » » Track patient access » » Track email notifications and keep them out of spam folders » » Profile assay management » » Flexible order management » » Safeguards against duplicating patient information »

Results

Physicians Lab came to Lab Portal looking for a sophisticated yet remarkably user-friendly web-portal solution, and Lab Portal Company rose to the challenge. Lab Portal gave Physicians Lab much more than just the ability to publish laboratory test results online; they gave them the opportunity to provide users with a unique, high-level, high-quality experience. Lab Portal enabled Physicians Lab to streamline the order process by capturing patient information online, educate providers and patients about tests, and improve data

quality. Lab Portal provided Physicians Lab with a system that will increase revenue, reduce turnaround time, and reduce IT costs, while generating reports that their providers and patients love.

Ultimately, Lab Portal Company developed a portal for Physicians Lab that met all of their requirements and even delivered features Based on and benefits they hadn’t previously considered. Lab Portal Company Physicians Lab’s is committed to creating custom online portals that customers can be proud of, and Lab Portal Company enlisted the knowledge and needs, Lab experience of its highly diverse team to do just that for Physicians Lab. Portal developed an integrated, Seamless Integration online web portal that Based on Physicians Lab’s needs, Lab Portal developed an integrated, online web portal that was HIPAA compliant. Lab Portal Company was HIPAA designed their portal to fully integrate into Physicians Labs’ chosen compliant. LIMS vendor, LabLynx. LabLynx is a frontrunner in SaaS LIMS and offered an exceptional product. LabLynx’s solution assimilated directly into the portal with a high level of competency and provided Physicians Lab with seamless integration. While Lab Portal Company designed Physicians Lab’s system to integrate into LabLynx, the Lab Portal system will work effectively with a variety of LIMS solutions.

Lab Portal Company integrated the lab’s system in other ways as well. As a core offering, Physicians Lab services multiple physician networks containing several doctors in each network. These doctors are able to access their Physicians Lab test results by either logging into the online portal for results retrieval or by automatic upload to each doctor’s EMR though an integrative web service. With the portal, “external providers” are able to access test reports online with ease. This feature both maximizes Physicians Lab’s accessibility and widens their customer base and profit potential.

Customized

Physicians Lab was looking for a solution that would support their existing business processes. They didn’t want to be forced to modify workflows to match someone else’s concept of how they should do business; they wanted a solution that would mold to their processes. The Lab Portal That’s exactly what Lab Portal gave them. The Lab Portal Company’s Company’s solution uses a module-based system that allows them to adapt and customize each component to meet their customers’ unique business solution uses a requirements. module-based system that Not only does the Lab Portal system support Physicians Lab’s current allows them business processes, but it will also readily grow with them over time. With this portal they will be able to integrate new systems and to adapt and elements as the lab’s landscape evolves and grows. Far from being customize each a hindrance to innovation and change, Lab Portal technology will component propel them to success. to meet their customers’ Control

unique business Unlike some other portal solutions, the Lab Portal system gives requirements. Physicians Lab choices about hosting and system management. With this system, they can choose whether they want to host their solution internally or externally with a HIPAA compliant host. Physicians Lab also wanted to be sure they could have access to their portal’s complete source code in the event that Lab Portal Company didn’t satisfy their needs. That wasn’t a problem at all because the code is supported by both the open-source and commercial software communities.

Efficiency

Physicians Lab knew that many laboratories use a lot of manual processes for things such as entering patient data and managing report delivery. They were also aware that manual processes are slower and more apt to introduce errors. Given this, they wanted The greater the their portal to have as much automation as humanly possible—the automation, greater the automation, the better the accuracy, and the quicker the turnaround time. the better the accuracy, and Some of the extensive automated tasks and safeguards that Lab Portal the quicker the built into Physicians Lab’s portal included: turnaround time. • Automated laboratory questionnaire (based on answers provided by patient, items such as “when to collect the specimen” will be automatically calculated) • Auto email reminders to patient to collect specimen • Auto lookup and retrieval of existing patient information • Visual indicators when test results are out of range • Visual indicators comparing results from one collection date to another • Auto report distribution • Auto feedback to laboratory staff when test results are missing or in error • Capture patient insurance • Accept orders through a web service from BodyLogic MD’s EMR • Make available laboratory tests to BodyLogic MD via a web service

Lab Portal also added efficiency to Physicians Lab’s processes by enabling laboratory staff to manage files and reports. Staff can manage all user accounts and test profiles, control user access control and log-in, view saved orders/satisfied orders/pending orders in a single window, and even archive reports for CLIA compliance if the report is modified after being finalized. Rather than stalling processes or complicating them by making data inaccessible, Lab Portal One of provides Physicians Lab with the tools to keep records accurate and Physicians up to date. Lab’s greatest Satisfied Users concerns was to deliver a One of Physicians Lab’s greatest concerns was to deliver a high high quality quality and unique experience to each and every portal user. To create and unique the superior online environment that Physicians Lab desired, Lab Portal Company put quality, comprehensiveness, and personalization experience to at the heart of its portal design. each and every portal user. People enjoy their web experience when systems work well with the tools they’re using. That’s why Lab Portal Company’s portals are compatible with all modern browsers and why Lab Portal built reports that can render in HTML, PDF, and HL7 formats. Lab Portal also gave Physicians Lab the ability to enhance their users’ experience with a variety of easy-to-use features, such as: • Display videos or hints directly on reports • Offer education or additional information about any element of a report or test • Develop personalized patient reports that use non-technical language • Support multi-language reports

Lab Portal also wanted to make sure Physicians Lab could present themselves and their materials (reports, etc.) as desired. Lab Portal provided Physicians Lab with a portal that reflects their company’s marketing, brand, and look. Lab Portal also gave them customization capabilities including: • Add individual tests at any time to an existing order Lab Portal • Create groups of tests based on the practice’s needs (a profile) to provided facilitate easy ordering Physicians Lab • Custom charting of test results with a portal that reflects In the end, Lab Portal Company developed a portal for Physicians Lab their company’s that met all of their requirements and specifications, and did so before marketing, their laboratory was even 100% ready. Lab Portal Company used its knowledge and experience to develop a custom solution that worked for brand, and look. Physicians Lab’s needs. Lab Portal Company kept ahead of Physicians Lab’s wishes and provided them with a lab portal that not only met and exceeded their specific requirements but also satisfied their ultimate goal of delivering state-of-the art science and superior solutions.

Conclusion

The Affordable Care Act and the HITECH Act are two pieces of legislation that have required an increase in health information technology adoption. Combined with specific legislation requiring direct patient access to clinical laboratory test results and clear HIT adoption in indications that the public wants it is leading to clinical laboratories general requires needing to supply lab results to patients. Also, HIT adoption in that laboratories general requires that laboratories make laboratory test results make laboratory available in a secure and easily accessible manner to a variety of healthcare stakeholders—physicians, hospitals, insurers, and patients. test results available in The demand for HIT has put laboratories on the front lines in a secure and adopting laboratory information management systems that can easily accessible connect with electronic health records either directly or through portals. Although this can place a financial strain on small- to manner to medium-sized laboratories, a number of companies are offering low- a variety of cost, customizable modular systems or Web-based services that can healthcare expand their current LIMS capabilities into new areas, including to stakeholders. patient portals.

The technical requirements of these modules or web-based portals or services are compliance with CLIA, HIPAA, and HL7 standards, provisions to ensure the privacy and security of personal health information, and the ability to be viewed by a variety of browsers and devices, including mobile applications. Bonus features that can provide value-added services to patients and physicians include the ability of the portals to enrich the lab test results with interpretive information, provide the services in multiple languages, and still be reliable and secure. These systems must be affordable, customizable, and scalable.

Lab Portal Company offers an Electronic Results Portal that allows for customizable test results to your network through a dynamic secure online portal. It allows the laboratory’s clients to log on to a secure portal that provides a Web experience to view lab results in an HTML format with any browser or mobile device. Developed as a Software-as- a-Services (SaaS) portal, the Electronic Results Portal includes a suite Lab Portal of options including a unique reporting engine that can customize test Company offers results to the Lab Connector or Lab Connections portal, a lab’s internal platform or partners in HTML, PDF, and HL7 formats. and Electronic

Results Portal Lab Portal Company’s solutions allow the laboratory to shift the risks that allows for of software acquisition and to move IT from a cost center to being customizable test a proactive, value-producing part of the laboratory. Because it is results to your SaaS-based and customizable, it allows for an unlimited number of end users, does not require client software installation, and replaces network through costly annual licensing that is tied to your head count, relying instead a dynamic on services-based billing. Lab Portal Company’s solutions direction secure online produces more value for any laboratory business by providing portal. services that align closely with business goals.

References 1. Laboratories By Type of Facility. CLIA Update—December 2013. www.cms.gov/Regulations-and-Guidance/Legislation/ CLIA/Downloads/facttype.pdf 2. Baron JM and Dighe AS. Computerized provider order entry in the clinical laboratory. J Pathol Inform. 2011; 2:35. 3. Aller et al. From classic to virtual: the morphing of lab information systems. CAP Today. May 2005. 4. Conn J. March EHR adoptions slow to a trickle. Modern Healthcare. April 29, 2014. http://www.modernhealthcare.com/ article/20140429/NEWS/304299943 5. Is healthcare self-service online enough to satisfy patients? Accenture: Insight Driven Health. The Accenture Connected Health Pulse Survey, 2012. 6. Final Rule Grants Patients Access to Test Results. February 6, 2014. American Society for Clinical Pathology. http://www.ascp. org/Advocacy/CLIA-Final-Rule-Grants-Patient-Access-to-Test- Results.html 7. Mobile Technology Fact Sheets. PewResearch Internet Project. http://www.pewinternet.org/fact-sheets/mobile-technology-fact- sheet/ 8. Bowen R. Meaningful Use Updates. HealthPort. August 19, 2013. https://www.healthport.com/muupdates.aspx 9. Shah K. Making LIMS Affordable. Laboratory News. May 20, 2010. http://www.labnews.co.uk/features/making-lims- affordable/

Appendices

A-1 About Lab Portal Lab Portal Company, based in Portland, Oregon, began in 2010 when, as individual contractors, they were brought on board at a major laboratory in Beaverton, Oregon to build a new laboratory results experience. The team has a combined 50 years of programming/ integration/data systems experience and are passionate about working with labs to create results that matter. Specializing in web portal solutions, The Lab Portal Company is proud to be a “made in the USA” company, never looking to offshore any development of their systems or platforms. Visit their website at www.labportalcompany.com.

A-2 About Mark Terry

Mark Terry is a freelance writer and editor specializing in clinical diagnostics, telemedicine, and biotechnology. He worked for 18 years in clinical genetics prior to turning to writing, and has published over 700 magazine and trade journal articles, 19 books, and dozens of white papers and book-length market research reports related to the clinical lab industry. He is a member of the Association of Health Care Journalists and the Association of Genetic Technologists. For more information, visit his website at www.markterrywriter.com.

A-3 About DARK Daily

DARK Daily is a concise e-news/management briefing on timely topics in clinical laboratory and anatomic pathology group management. It is a solution to the dilemma facing anyone in the laboratory profession. New developments, new technology, and changing healthcare trends make it imperative to stay informed to be success- “Dark Daily is ful. At the same time, the Internet, cell phones, blackberries, laptop a concise e-news/ computers and wireless devices are overwhelming any one individual’s ability to absorb this crushing Tsunami of data. management briefing on DARK Daily is a quick-to-read, easy-to-understand alert on some key development in laboratory medicine and laboratory manage- timely topics in ment. It has no counterpart in the lab world. Why? Because it is clinical produced and written by the experts at The Dark Report and The Dark Intelligence Group, who know your world, understand your laboratory and needs and provide you with concise, processed intelligence on only anatomic those topics that are most important to you! pathology group You will find DARK Daily to also be an exceptionally valuable management. It resource in laboratory and pathology management. Some of the lab industry’s keenest minds and most effective experts will be offering is a solution to their knowledge, their insights and their recommendations on win- the dilemma ning strategies and management methods. Many of these experts are unknown to most lab directors. As has proven true with The Dark facing anyone in Report for more than a decade, DARK Daily will be your invalu- able— and unmatched—resource, giving you access to the knowl- the laboratory edge and experience of these accomplished lab industry profession. professionals.

A-4 About The Dark Intelligence Group, Inc. and The Dark Report

The Dark Intelligence Group, Inc., is a unique intelligence service, dedicated to providing high-level business, management and market trend analysis to laboratory CEOs, COOs, CFOs, pathologists and senior-level lab industry executives. Membership is highly-prized by the lab industry’s leaders and early adopters. It allows them to share “Membership innovations and new knowledge in a confidential, non-competitive manner. This gives them first access to new knowledge, along with is highly- the expertise they can tap to keep their laboratory or pathology prized by the organization at the razor’s edge of top performance. lab industry’s It offers qualified lab executives, pathologists and industry vendors leaders and a rich store of knowledge, expertise and resources that are unavailable elsewhere. Since its founding in 1996, The Dark Intelligence Group early adopters. and The Dark Report have played in instrumental roles in support- ing the success of some of the nation’s best-performing, most profit- It allows able laboratory organizations. them to share The Dark Intelligence Group (TDIG) is headquartered in Austin, innovations and Texas. This location makes it very accessible for any laboratory new knowledge organization seeking input, insight and support in developing their business operations, creating effective business strategies and crafting in a confidential, effective sales and marketing programs that consistently generate new non-competitive volumes of specimens and increasing new profits. The Dark Intelli- gence Group, Inc. owns and operates two Web sites in the manner. TDIG Website network:

http://www.DarkReport.com

http://www.DarkDaily.com

A-5 About the Executive War College on Laboratory and Pathology Management

Every spring since 1996, the lab industry’s best and brightest gather at the Executive War College on Laboratory and Pathology Management to learn, to share and to network. Many consider it to be the premier source of innovation and excellence in laboratory and pathology management.

Each year, a carefully selected line-up of laboratory leaders and inno- vators tell the story of how their laboratories are solving problems, tackling the toughest challenges in lab medicine and seizing oppor- tunities to improve clinical care and boost financial performance. The Executive War College is the place to get practical advice and solutions for the toughest lab management challenges. A unique case study format brings participants face-to-face with their most success- ful peers. They tell, first hand, how their laboratory solved intractable problems and successfully used new technology.

Many lab management secrets are shared, along with specific “what-not-to-do’s” gained from hard-won experience! It’s not pie-in- the-sky theory, but useful knowledge that can be put to use in any lab. The Executive War College offers superlative networking, with lab administrators and pathologists attending from countries as far away as the United Kingdom, Germany, Brazil and Australia. It makes the Executive War College a melting pot for all the best ideas, new lab technologies and management strategies now reshaping the laboratory industry. It’s also become a recruiting ground used by headhunters and major lab organizations.

In the United Kingdom, The Dark Intelligence Group and the Association of Clinical Biochemists (ACB) have co-produced a meeting every February since 2003. Known at Frontiers in Laboratory Medicine (FiLM), it attracts laboratory leaders and inno- vators in the United Kingdom. Also featuring a case study format, this meeting pioneered the international laboratory side-by-side case study, where a North American laboratory and a United Kingdom laboratory prepare a comparison of best practices and an operational assessment of their two organizations.

In September 2005, a laboratory management meeting called Executive Edge was conducted in Toronto, Ontario, Canada, by The Dark Intelligence Group and QSE Consulting. It provided pathologists and lab directors in Canada with a customized meeting devoted to the strategic and operational issues of laboratory management in Canada.

A-6 About Joe Bloniarz

Joe Bloniarz is the President of Lab Portal Company. Both technically skilled and project management focused, Joe Bloniarz is an experienced programmer and also has the technical skills and business experience to interface between his team of developers and clients to effectively reach and exceed his client’s goals.

After serving in the United States Navy for three years, Bloniarz went back to college and rekindled his childhood passion for computers. He received a Bachelor of Science in Business Information Management Systems in 2004. Throughout his 20+ years of professional experience, Bloniarz has proven to be a highly competent database architect/ administrater. He has worked directly as a programmer or managing large data systems that had to handle high OTLP systems that demanded data accuracy for many prestigious companies. Bloniarz is accomplished at keeping critical systems performing and applying that knowledge and training to his current team and the Lab Portal platforms they have created. Bloniarz and his team’s passion are creating software that exceeds customers’ expectations and delivering a quality product in a timely manner that helps disseminate information easily for their client.

Notes

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The Dark Intelligence Group, Inc. Customer Service 800-560-6363 21806 Briarcliff Drive Spicewood, Texas 78669

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