Electronic Health Record (EHR) information and news

I enjoyed the recent reminiscence in HISTALK of a reprinted editorial from January 2006 describing the beginning days of EHR certification. It was written even before CCHIT launched its first certification program in May 2006, a full five years ago. We would go on to announce the first CCHIT Certified EHR products in July.

That was in the heady days of CCHIT’s “start-up” phase when–like all new ventures operating on a lot of passion and not much funding–neither our small staff nor our dedicated volunteers could predict where this would eventually take us. So here’s a little recounting.

First, I have to chuckle at the early reference to our name and its unfortunate phonetic pronunciation. While I’ve spent the last six years trying to get folks to say C-C-H-I-T, I long ago accepted that this marketing faux pas is the result of hiring the marketing director after the founders–all brilliant physicians and IT executives—who came up with an elegant name with initials not even a mother could love.

C’est la vie. You’ve got to be prepared to laugh at yourself.

Much has changed since those early days. We’ve seen certification blossom from begrudging acceptance to deeper Federal involvement with associated financial rewards. During that time, the industry has truly moved from stick to carrot. The work that CCHIT pioneered beginning in 2005 has grown to become a prerequisite, now managed by the government, for federal incentive funding intended to further encourage health IT adoption.

CCHIT continues to develop its own programs with its broadly representative volunteer stakeholders to fill in the gaps left by the government’s program. Those gaps are most notable in special care settings–behavioral health and long term and post acute care–and in special populations or medical practices–child heath, women’s health, cardiovascular medicine, dermatology and oncology–or for special purposes, such as clinical research.

Some things stay the same. We’ve certified more than 400 individual products, including both those in our independently developed CCHIT Certified® program and those in the newer ONC Authorized Testing and Certification Body (ONC-ATCB) program. Yet this comment: “Some vendors are complaining about the cost of certification and interference with their business” is still largely true. Most vendors, however, would probably agree that product certification has now become a necessity for competing in the health IT market. And most, if not all, buyers know to ask about certification.

Some things that this missive from the past asked for as additions to the first proposed CCHIT program have been added incrementally:

• “Release the individual scoring sheets of the products it evaluates.” This was never necessary since all CCHIT Certified products meet 100 percent of the criteria in a juried pass/fail inspection. Clinicians shouldn’t have to worry about which EHR capability isn’t there or isn’t working. For, ONC-ATCB products, each tested criteria is listed separately on our product pages so buyers can easily see if it’s a complete EHR or an EHR module.
• “Add a category for patient safety.” Though this category was not called out separately in CCHIT development activity after 2006, many criteria were added in subsequent years to support this need. Additional attention was given to CPOE, the medication administration record and medication reconciliation, alerts and reminders, performance and quality reporting, and exchange of information across care settings. CCHIT does not certify EHR implementations but, in its independent program, it verifies with live reference sites that key capabilities are implemented and working properly before full certification is granted.
• “Add criteria for usability.” With the CCHIT Certified 2011 Ambulatory EHR program, launched in October 2009, we began requiring basic usability testing, allowing vendors to opt-in or out of reporting their usability score. There was great concern about how objective this testing would be but, with a clear Usability Testing Guide, most vendors embraced the opportunity to demonstrate these first steps in improving the usability of their products. Later this month, CCHIT has been invited to testify at a hearing held by the Certification/Adoption Workgroup of the HIT Policy Committee on usability of EHRs to help the committee formulate recommendations to the National Coordinator for Health IT for inclusion of usability testing in the government’s program.

Finally, I would agree with the writer’s original assessment from 2006: “Damned if CCHIT’s work groups didn’t go off and actually get some real work done that will have a significant impact on the industry.”

That work hasn’t stopped.

Recently, the Meaningful Use Workgroup of the Health IT Policy Committee (a federal advisory committee responsible for recommendations to the Office of the National Coordinator) requested public comment on their proposed Stage Two and Three meaningful use objectives and measures. As the Commission developed its response, in order to better represent the diverse group of health IT stakeholders with whom we work, we fielded a survey requesting that respondents rate the objectives and measures with respect to the ease of implementation – both from the clinical workflow perspective and any technological challenges. Our 468 responders included different types of providers (36%), EHR vendors (29%), and others (29%).

The following measures and objectives were considered to be too aggressive by at least one third of the respondents. Several were considered too aggressive by most of the respondents. Note that all nine are enhancements of existing Stage One objectives and measures, and reflect current experience in the field.

• Syndromic Surveillance. Over 50% of providers and 40% of vendors and others felt that this was not ready to be a core measure for Stage Two. Public Health agencies, facing budget cuts now, do not have an infrastructure to accept and analyze data; there is no infrastructure to support information exchange from technical and policy perspectives; and the standards and implementation guidance are not sufficiently constrained. The remaining respondents felt that this would require significant investment of resources and effort if it became a core measure.
• Drug Formulary Checks will require that a large percent of patients seen have formularies available in the system. This will be difficult for certain providers who see patients with a large variety of insurance plans and separate formularies, or who see patients whose formularies are not readily available. A target of 80% was not considered reasonable, even for providers who are using an e-prescribing network to retrieve formulary information. Availability of this information is dependent on making an accurate insurance eligibility match with the patient and insurance companies publishing their formulary through Surescripts and/or a Pharmacy Benefit Manager. There is wide variance in the degree to which both of these conditions are met.
• Medication Reconciliation. Few settings are actually doing this as part of Meaningful Use Stage One and responders recommended making it core in Stage Two, but not increasing the percent of patients to which it applies (from 50% to 80%) until Stage Three. Limited by lack of good standardized data and HIE, much of the input necessary to perform medication reconciliation is currently manual, even if data are generated elsewhere electronically.
• Patient Access to Health Information within 4 days. This objective has progressed from providing a “copy of the patient summary” to a “timely access” requirement to the ability of patients to “view on demand.” Any change of this degree which anticipates a final rule in the second quarter 2012, with users live on Stage Two just six months later, is fraught with significant risk. Since the HIT Standards Committee still needs to define standards, there is lack of clarity about what constitutes “relevant” information. The objective will require major workflow change at the provider level and a change of this magnitude at the national level could become a patient safety issue. Respondents recommend staying at Stage One level until this can be further evaluated.
• Submission of Immunization Data. Ongoing submission of immunization data to state registries is premature given the lack of transmission mechanisms and state systems that can accept these data. Bidirectional flow will require sustainable health information exchange (HIE) models which are in the very early stages of planning and will likely not be ready nationwide by 2014. Respondents recommended no expansion beyond Stage One.
• Capability to Exchange Key Clinical Information. This measure is similar to the above in that anything beyond using an EHR with the capability to submit data requires significant technological and policy work far beyond the scope of clinical practice and individual providers. Most states have not yet addressed either the policy or technical challenges necessary to create the supporting infrastructure to meet these objectives in either Stage Two or Three.
• Clinical Decision Support. This is another area where respondents felt that it was premature to go beyond Stage One at this point because a supporting infrastructure is not yet built beyond a few simple decision support rules. Full implementation of sound and reliable clinical decision support (CDS) will need a designated set of evidence based rules that can be incorporated into a decision support structure that integrates with multiple data sources within the EHR. While this may be possible by Stage Three, until this infrastructure can be built, providers should not be held accountable to any CDS beyond what is currently available.
• Submission of Reportable Lab Data (and reconciliation with orders). Respondents believe that this measure is not appropriate until we have more standardized lab results coding (beyond numerical values), transmission and implementation guidance.
• Drug Allergy/Etc Checks. Respondents registered minimal concern with this becoming a core requirement in Stage Two. There was, however, significant concern about the Stage Three proposal. Commentary identified that there is no consistent library of evidence- based interactions for more complex interactions and the field is more dynamic than existing technology can accommodate. Basic alert fatigue is a problem must be solved first. Lastly, chemotherapy should not be included in a measure that would be applicable to all providers because of its highly specialized nature.

It is important to note that, in general, respondents believed that the proposed new Stage Two objectives and measures could be accomplished by 2012. Many of the features necessary to meet some of these new objectives and measures were already included in EHRs as part of the pre- HITECH EHR certification process. Concerns were registered, however, with respect to one of the Stage Three enhancements of these measures and objectives: providing educational materials in a common primary language. These could be made available in multiple other ways than through the physician of record and have the potential for errors using current translational technologies.

We also received numerous comments with respect to proposed Stage Three objectives and measures for which Stage Two had not yet been determined. Virtually all reflected the need for further maturation that would take longer than the implementation timeline necessary to have them included in EHR technology by 2014.

Lastly, we received numerous comments about the importance of assuring that finally adopted objectives and measures reflect those processes that are, in fact, in the providers’ control. While many of the objectives, and measures proposed by the Workgroup are laudable in their own right, putting individual providers financially at risk for results beyond their control is counterproductive to the overall goal of widespread provider adoption of HIT that is used in a meaningful manner.

Karen M. Bell, MD, MMS
Chair, Certification Commission

Prior appointments held by Dr. Bell include Division Director, Quality Improvement Group/Office of Standards and Quality for the Centers for Medicare and Medicaid (CMS), and Medical Director of Blue Cross Blue Shield (BCBS) of Rhode Island and of Anthem BCBS of Maine.
She received her medical degree from Tufts University School of Medicine, Boston, and her master of medical science degree from Brown University, Providence, R.I. Dr. Bell has clinical experience as a board certified physician in internal medicine and also was an Associate Professor at the University of Rochester, and Clinical Instructor at Harvard University School of Medicine.

CCHIT will be responding to the HIT Policy Committee’s invitation for public comment on the proposed Stage Two and Stage Three Meaningful Use Objectives and Measures by February 25. We would like to include the opinions of those who are involved or interested in our work and invite you to express yours by responding to our survey.

As you have probably observed, some of the proposed objectives and measures are new, some are expansions of existing Stage 1 objectives and measures. We also recognize that there are two aspects to the measures: the degree to which they may add complexity to the EHR technology used and the degree to which they may add increased burden on clinical workflows in the health care setting. We have therefore divided the measures into four categories and ask you to rate each measure as you see fit, using the scales provided. You will also have the option of commenting on the proposed objectives and measures as you choose.

To share your opinions, please respond to the CCHIT survey.

The National Coordinator at the helm of the Federal Government’s HITECH funded health information technology programs is returning to his roots as planned, having steered a steady and successful course over his tenure. Dr. David Blumenthal left his practice in internal medicine and his position as Director of the Institute of Health Policy at Massachusetts General Hospital to guide the development and implementation of initiatives designed to overcome the barriers to HIT adoption. Not only did all of the mandated programs came to fruition during his time in office, but his leadership in health care policy and in consensus building assures that these programs will successfully grow to meet their goals over time. The HIT Policy Committee, the HIT Standards Committee, and all of their work groups have risen to meet the challenges that he presented and they will continue to carry his legacy of thoughtful dedication to HIT supported health care reform forward into the foreseeable future.

Dr. Blumenthal’s accomplishments and accolades are currently being codified in multiple other settings, so I will not list them here. What I will say is this: Thank you, David. You chose to take on a daunting task and you’ve performed gracefully under pressure to guide us all through a tumultuous time of change and uncertainty. You’ve set a course that we can all follow, albeit at different paces, that aligns the complicated and confusing set of necessary policies and technologies that will assure that every patient’s information is available to the clinician at the time it is needed, to the patient him or herself, and to those who assure the public’s health and safety. As a former member of the ONC team, I know that this has been more difficult than most of our colleagues in the HIT world can imagine. But you’ve done it, and you’ve done it well. So, again, on behalf of CCHIT, I extend our deepest appreciation and wish you continued success as you return to your post at Harvard.

As we look back and then forward to the next phase of ONC’s evolution, we see that there is still much work to be done. ONC was born in April 2004 as the result of an Executive Order signed by then President Bush. Dr. David Brailer, the first National Coordinator quickly developed a Strategic Framework for HIT that included and addressed all of the elements that we are still working with today and created the Office of the National Coordinator. As a poorly funded “start up” within the machinery of the Federal government, the first iteration of ONC was able to create and oversee the first certification process for HIT, the first set of unified interoperability standards, the first set of privacy policies and regulations with respect to HIT, and the first standardized way of measuring EHR adoption nationwide. These initial efforts matured and the National Health Information Network became a major focus of ONC under the leadership of Dr. Robert Kolodner, who had honed his skills in HIT throughout a long career in the Veterans Administration. During his tenure, large federal and private systems healthcare systems developed the ability to exchange health information with each other. Governance efforts also matured through the American Health Information Community, a Federal Advisory Committee conceived and developed under Dr. Brailer. It wasn’t until the ARRA passed, however, that significant funding became available to the point where Dr. Blumenthal and the Office could move forward on all fronts and with the benefit of two collaborating Federal Advisory Committees whose recommendations could be incorporated into the cohesive set of programs with which we are all familiar. The “start up” has evolved into an Office that is integral to national health care policy.

The question now is: what comes next? And who should lead? I would suggest that ONC will now need to focus on Execution and Value.This means that the next National Coordinator will need strong operations experience in addition to being an inspiring physician leader who understands the interplay between policy and technology. Each program will need to be reviewed and retooled to maximize effectiveness and efficiency and its contribution to the overall goal. As health payment reform is more clearly defined, new HIT programs may need to be developed to better support care in new systems. As new technologies become available, ONC will need to accommodate to the changing market place. And there is need to demonstrate, beyond all doubt, that HIT, properly designed, implemented , and used, will mitigate the cost of our rising healthcare bill and provide better, safer care. Our new National Coordinator who can meet these needs is waiting in the wings. In the meantime, let’s continue to be grateful for the guidance and leadership of those who have gone before.

Karen M. Bell, MD, MMS
Chair, Certification Commission

Prior appointments held by Dr. Bell include Division Director, Quality Improvement Group/Office of Standards and Quality for the Centers for Medicare and Medicaid (CMS), and Medical Director of Blue Cross Blue Shield (BCBS) of Rhode Island and of Anthem BCBS of Maine.
She received her medical degree from Tufts University School of Medicine, Boston, and her master of medical science degree from Brown University, Providence, R.I. Dr. Bell has clinical experience as a board certified physician in internal medicine and also was an Associate Professor at the University of Rochester, and Clinical Instructor at Harvard University School of Medicine.

We’ve introduced, through webcasts, press releases and outreach to representative hospital organizations, a planned program designed to assure that hospitals with self-developed, customized or uncertified vendor technology can demonstrate that they use ONC-ATCB Certified EHRs. Now we are opening this program to you.

CCHIT’s five year experience in testing and certifying EHRs has taught us that this can be a complicated process, made more so now that there are so many government dollars at stake. While the optimum approach for hospitals is to have vendor supplied technology with full ONC-ATCB certification for either a Complete EHR or a bundle of EHR modules, we recognize that this is not the case for many. In response to that need, we have developed a program that will help hospitals achieve ONC authorized certification as efficiently and quickly as possible, whether they have partially certified vendor systems and need to fill certification gaps, or are using self-developed or older EHRs requiring full ONC-ATCB certification.

The EHR Alternative Certification for Hospitals program (EACH™) includes the following tools and educational resources made available in three phases:

Preparation – This first phase offers Preparation for EACH, an online orientation to both EACH and CCHIT’s ONC- authorized testing and certification program. It includes a glimpse of the tools and support offered prior to certification application so you can decide if EACH is right for you. You will be introduced to the online community of hospitals participating in the EACH program to prepare you to ask questions and begin to share best practices in your next phase.

Readiness – With the Using the Assessment Tool learning program and the Assessment Tool, this second phase moves you through an inventory of your EHR technology, a gap analysis and team building to prepare you for your certification application.
The Certification Readiness learning program and the EACH Certification Toolkit including test scripts, an interoperability guide and other guidance prepares you for your inspection. In addition to the support offered by an online community, you will be
invited to attend weekly phone calls with CCHIT’s EACH program staff.

Certification – This final phase is where the actual work of testing and certification begins. It includes a virtual, Web-based inspection of your EHR technology using ONC 2011/2012 criteria and standards and the NIST test procedures and tools required by federal rules. The goal in this phase is the completion of certification of your complete EHR or EHR module to meet the first step in qualifying your hospital for incentive payments.

In addition to eliciting hospital input in the development of these tools and educational material, we have pilot tested them in a number of settings, including Beth Israel Deaconess Medical Center, Boston; Huntington Hospital, Pasadena, Calif.; and NYU Langone Medical Center, New York City.
Dr. John Halamka, CIO of BIDMC, CIO of Harvard Medical School, and co-chair of the HIT Standards Committee has included his pilot experience in his blog, Life as a Healthcare CIO. He advises other hospital CIOs to “Take certification very seriously – it’s not easy. I have a staff of very experienced IT professionals and we had to do a great deal of preparation. This is… a function of the certification requirements and the NIST test scripts. The educational materials and staff of the ATCB make a huge difference. In my case, I relied on CCHIT staff to guide me through the process and CCHIT inventory tools and test scripts to make the process as easy as possible.”

These CCHIT-developed tools, educational materials, and test scripts are part and parcel of EACH, CCHIT’s ONC-ATCB certification program for hospitals that need ONC authorized certification beyond that which can be obtained through a vendor. The cost of certification of your modules and or complete EHR through our EACH program includes access to these preparatory materials and to our highly experienced staff. The program and certification are done entirely remotely, assuring that your costs are minimized. Whether you require complete EHR certification or certification of a limited number of modules to be eligible for Meaningful Use incentive payments, we can help you certify your EHR in the timeframe needed if you are prepared. As long as an EHR system is certified by the 90th day of your Meaningful Use measurement period, the certification requirement is met.

Click here for more information on the EACH program. Applications are now being accepted and our staff are looking forward to working with you through successful certification.

Beth Israel Deaconess Medical Center was recently certified under the CCHIT EHR Alternative Certification for Hospitals (EACH). John D. Halamka, MD, MS, Chief Information Officer of Beth Israel Deaconess Medical Center, has been sharing his thoughts on the process.

We demonstrated all our Intersystems Cache-based hospital systems and our Microsoft SQL Server-based business intelligence systems.

The process was rigorous, requiring us to follow over 500 pages of scripts and implementation guides in a single 8 hour demonstration.

How did it go? Read more in Reflections on the Certification Experience.

Interested in participating in the new CCHIT EHR Alternative Certification for Hospitals (EACH) program? John Halamka, MD, MS, has a few tips.

On Friday, Beth Israel Deaconess is doing its certification inspection via the CCHIT EACH program.  The inspection is divided into three major areas – interoperability. clinical functionality, and security.

To prepare for interoperability, my engineers and I have used several resources which I’ll share with you.

See what he recommends.