Courtesy of Columbia University and the ONC Health IT Workforce Curriculum program

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1 Special Topics in Vendor-Specific Systems: Quality Certification of Commercial EHRs Lecture 5 Audio Transcript Slide 1: Quality Certification of Electronic Health Records This lecture is about quality certification of commercial Electronic Health Records (EHRs). This unit will define and describe quality certification of commercial Electronic Health Records in the context of current federal incentive programs and patient safety goals. Slide 2: Lecture Objectives At the end of this unit you will be able to: 1. Describe the Certification Commission for Health Information Technology (CCHIT) 2. Describe examples illustrating how CCHIT criteria are used for certification of EHR systems 3. Identify the benefits of meaningful use of EHRs and identify examples of meaningful use of EHRs in given scenarios 4. Identify the three stages of implementation requirements for meaningful use of EHRs 5. Identify the role of governing bodies certifying commercial EHRs, including FDA oversight, the Joint Commission and National Patient Safety Goals Slide 3: Overview During this lecture I will first introduce what certification of Electronic Health Records is and why it's important. We will discuss one of the certifying organizations, the Certification Commission for Health Information Technology, also known as CCHIT. Next I will introduce the concept of Meaningful Use of electronic health records, and how this relates to certification. I will discuss the role of the Joint Commission in the certification of electronic health records, including the relationship to National Patient Safety Goals. Finally, I will touch upon issues of safety and regulatory oversight of electronic health records by the Food and Drug Administration (FDA). Slide 4: Why Certify Why do we need to certify electronic health records? We want to evaluate whether a specific system meets criteria to help us achieve particular clinical goals. For instance, an electronic health record should foster collaboration, communication, information exchange among clinicians and patients, support high quality patient care and clinical decision making, and support quality assurance and efficiency measures to evaluate patient care. Currently the deployment of electronic health records is expanding rapidly, and there are many

2 stakeholders in the marketplace and within healthcare organizations advocating the development and the use of electronic health records. Certification may help to promote the integration of findings from scientific studies involving electronic health records into next-generation systems. Furthermore, the quality of an electronic health record system impacts patient safety, clinical workflow, acceptance and adoption by clinicians, information reuse, health information exchange, and return on investment for the implementing organization. Therefore, a robust certification process ensures that EHR systems are up to certain quality standards. Slide 5: Why Certification is Important This study, by Koppel et al in 2005, The role of computerized physician order Entry Systems in Facilitating Medication Errors, was a landmark study that demonstrated that, without proper assessment, implementation, and evaluation, EHRs may have unintended consequences for patient safety. And we'll talk more about that later in the lecture. Slide 6: Who Certifies So who exactly certifies these electronic health records? Today, certification is voluntary, not mandatory. Two of the organizations that are involved with certification processes are the Certification Commission for Health Information Technology (or CCHIT) and the Joint Commission. CCHIT s role is to verify that an EHR system meets requirements for managing patient information. The Joint Commission verifies that a health care organization, such as a hospital, is using the electronic health records correctly in providing patient care. One way to think about the differences in the way these two organizations certify is that CCHIT certification relates to the functionality within an electronic health record system itself, while Joint Commission certification relates to how the electronic health record system is used in a healthcare setting. Slide 7: Certification Commission for Health Information Technology (CCHIT) Certified Program Let s talk about the CCHIT certified program. CCHIT is an independent, nonprofit organization that was founded in 2004, and it's a recognized certification body by the Office of the National Coordinator for Health Information Technology. CCHIT is financed by industry partners such as the American Health Information Management Association, Health Information and Management Systems Society, National Alliance for Health Information Technology, the American Academy of Pediatrics, and the American College of Physicians. CCHIT consists of expert workgroups, who develop criteria for the certification of EHR systems.

3 Slide 8: CCHIT Certified Program (cont.) The CCHIT certified program certifies electronic health records that are used in ambulatory settings, inpatient, and emergency department settings. There are three criteria areas which are used to certify the electronic health record and they are derived from existing standards. The three areas are: functionality, security, and interoperability. Functionality criteria refer to the evaluation of the functions that an EHR provides. For example, this provides a means of distinguishing between systems that have or don t have a particular function such as Computerized Provider Order Entry (CPOE). Examples of security features that are evaluated include whether or not an EHR implements appropriate access control procedures and whether information that is exchanged is encrypted. An example of evaluation of interoperability criteria is whether or not an electronic health records uses HL7 standards. Additionally there are domain-specific topic areas for certification. Some of these are cardiovascular health, child health, and diabetes. For instance, does this electronic health record have features that meet criteria for a diabetes registry? The process of certification includes providing system vendors with certification handbooks and test scripts for self-evaluation as an EHR is developed. Slide 9: CCHIT and the American Recovery and Reinvestment Act (ARRA) 2009 The certification of electronic health records, though voluntary, is part of a policy through the American Recovery and Reinvestment Act of The American Recovery and Reinvestment Act, which is also known as the Stimulus Bill, states that under the Health Information Technology for Economic and Clinical Health, the HI-TECH act, hospitals and health care professionals are required to become meaningful users of certified electronic health record technology to receive incentive payments under Medicare and Medicaid, and to avoid future financial penalties. However, simply using a certified system does not mean that you are a meaningful user. Slide 10: CCHIT and the ARRA (cont.) Meaningful Use From the American Recovery and Reinvestment Act of 2009, thirty-two billion dollars are available to incentivize health care providers to adopt and meaningfully use certified electronic health records within the next ten years. Therefore, it is imperative to specify what is a certified electronic health record. To do this, the CCHIT has established the 2011 comprehensive certification program. If the electronic health record is certified by CCHIT, it is said to meet or exceed the preliminary American Recovery and Reinvestment Act of 2011 requirements. Slide 11: Meaningful Use (cont.) What is meaningful use? The Center for Medicaid and Medicaid Services has defined meaningful use of electronic health records and the Office of the National Coordinator has defined certification standards for electronic health records

4 technology. These definitions are to prevent users from simply computerizing administrative functions in the clinical setting, such as appointment times, and not using patient care information within the EHR in a manner that is meaningful to clinical care, clinical decision making, patient outcomes, and eventually population health. More information on meaningful use can be accessed at the website below. Slide 12: Meaningful Use: Non-Hospital Based Incentives We are going to discuss meaningful use as it relates to non-hospital settings, such as physician outpatient practices. Starting in 2011, there are incentives for providers who are deemed to be meaningful users of electronic health records. These providers are eligible to seek a maximum of forty-four thousand dollars in incentive payments through Medicare over five years, from 2011 until If a provider waits to join the program, these incentives decrease starting in For example, if you join in 2013, the maximum incentive that you can get is thirtynine thousand dollars; if you wait even longer and join in 2014, the maximum incentive that you can get is twenty-four thousand dollars. Finally, for providers who join after 2014, incentive payments will no longer be available. The ultimate calculation of the payments that a provider will receive is based on seventy five percent of the amount he or she bills to Medicare. Eligible professionals who do not demonstrate that they are meaningfully using an electronic health record by 2015 will see that their Medicare reimbursement is penalized by one percent per year up to a cap of three percent reduction in It is worth noting that, as the law is now written, it actually does allow up to a five percent reduction. Slide 13: Meaningful Use: Phasing in 3 stages now-2015 Meaningful use will be phased in as three stages between now and The first stage consists of the following criteria: collecting electronic health data in a coded format, implementing clinical decision support tools, reporting clinical quality measures and public health data, using electronic health record data to track conditions and coordinate care, submitting eighty percent of providers orders electronically (for ambulatory clinics), submitting at least ten percent of their orders electronically (for hospitals), using the electronic health record to check for drug interactions, and providing patients with electronic copies of their medical records within forty-eight hours of a patient's request. Slide 14: Meaningful Use: Phasing in 3 Stages Now-2015 (cont.) Stage two and stage three of the meaningful use criteria are still evolving. As it currently stands, stage two will include criteria related to structured data exchange and continuous quality improvement and stage three will focus on advanced decision support and population health. In summary, if a provider joins in 2011, they will have two years to achieve each of the three meaningful use stages. If the provider waits to join after 2011 and a consecutive stage has already been phased in, such as the criteria has already moved on to stage two, that provider will have one year to achieve the next stage.

5 Slide 15: Joint Commission We are going to transition to the Joint Commission s role in electronic health records certification. The Joint Commission is a Patient Safety and Quality Health Services Accreditation Certification Organization. It is an independent, not-forprofit organization, and it is the oldest of its kind in the United States. Accreditation through the Joint Commission is voluntary for health care organizations such as hospitals, yet it's required by many states for licensing and Medicare reimbursement eligibility. This accreditation is performed by on-site surveys every three years. As part of its current accreditation and certification criteria, the Joint Commission verifies that a health care organization is using an electronic health record correctly in providing patient care. One way it does this is by assessing compliance with HIPAA requirements such as the management of information, electronic health record management and personal health information management. Slide 16: National Patient Safety Goals and EHRs The Joint Commission s certification that a health care organization is using electronic health records correctly in providing patient care relates directly to the Commission's National Patient Safety Goals. It is important to note that four of these goals relate to the use of electronic health records and the implementation of an EHR may help an organization achieve these goals. These four goals are: identifying patients correctly, improving communication amongst caregivers, improving the safety of using medication, and accurately reconciling medications. Slide 17: Patient Safety and Food and Drug Administration (FDA) We discussed earlier that certification of electronic health records may help increase and ensure patient safety. Currently, a national program to monitor patient safety problems and health information technology systems is being developed. The organization to oversee this may be the Food and Drug Administration, or the FDA, however, a responsible agency has not yet been named. The FDA s role in overseeing patient safety problems for health IT systems may be to collaborate about what the certification criteria should be and focus on electronic health record implementation in areas that have safety risks. For example, the implementation of computer provider order entry may have some unintended medication safety risks and that may be an area of focus for the FDA. Slide 18: FDA Oversight of EHRs The oversight of electronic health records by the FDA may extend the safety of electronic health records systems. A focus of the FDA as an organization is on serious injuries and deaths. However, more commonly, patient safety issues as they relate to electronic health records may cause unsafe conditions and hazards in clinical care, as oppose to actual injuries. Therefore, it's unclear if the FDA would be the organization to oversee patient safety in terms of unsafe conditions and hazards in clinical care that relate to the implementation of electronic health

6 records. Additionally, some individuals and organizations argue that FDA oversight of electronic health records may stifle innovation and increase the cost of these systems. Slide 19: Stay Current To remain knowledgeable about all the information regarding certification of electronic health records and the meaningful use policy, you must stay current because these policies are new and criteria are continuously evolving. Please be sure to review the website of The Office of the National Coordinator for Health Information Technology, which can be accessed at: Healthit.hhs.gov. Slide 20: Summary In summary EHRs are increasingly being regulated through certification requirements by the CCHIT to ensure their safety and effective use. Meaningful Use program provides financial incentives through the American Recovery and Reinvestment Act of 2009 for providers that use a certified EHR and meet the requirements set forth for each stage, some of which are in still development. We talked about EHRs and the Joint Commissions National Patient Safety Goals and the potential role of the FDA for oversight of EHR patient safety. As you begin work remember that it is important to stay up to date as these programs and requirements are new and are quickly evolving. Slide 21: References No Narration end

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