The recently released report by the Institute of Medicine concluded that protecting patient safety in a digital environment is multifactorial, encompassing technological functions, usability of the products, and implementation and use by providers and others. Ten recommendations were made to establish the nature and extent of issues related to patient safety and health IT, how they could be monitored over time, and how they might be addressed by the public and private sectors.
One of the recommendations gave the Department of Health and Human Services 12 months to contribute to and assess progress in the public and private sectors towards these efforts, after which time the report recommended that the Secretary should make determination regarding the necessity for Food and Drug Administration regulation. If not necessary at that time, the Secretary should reassess this decision on an annual basis.
As these recommendations are considered and variously implemented the question remains on clinicians’ minds as to how they can assess whether or not their own electronic health record (EHR) supports safe care now to the greatest extent possible. While there is no one tool that can be applied to answer that question, there are practical approaches that could be used to assure that the most up-to-date functions and features are present.
A good place to start is malpractice claims. 52% of all paid medical malpractice claims in 2009 were in the ambulatory setting, with two thirds of these involving major injury or death. A recent analysis suggests that most adverse judgments fall into three categories: poor communication, poor documentation, and problems associated with diagnosis and treatment of a patient. It’s worth considering how health IT can better address these issues, and the degree to which they can currently be assessed to do so.
Communication gaps can occur within a practice, among clinicians in different locations, and between clinicians and patients. Does your system allow secure messaging with patients; does it have a patient portal through which you can communicate with your patients? Can you generate and record patient specific instructions as well as educational materials. Does your EHR support concurrent use by multiple staff and can you access, create, and allow modification of jointly managed care plans? What about clinical task assignments and routing, and the ability to co-sign notes? Are verbal, telephone, and electronic messages between users documented, along with discrete data on specified roles of each provider associated with a single patient? Recognizing that interoperability with external provider systems is beyond the scope of a single EHR, do you at least have a directory of external providers and can you capture external documents?
Documentation is the second major area to consider. Does your system support efficient but reliable documentation of your findings and results? Can you incorporate free text? Do your checklists and templates appropriately default to normal findings only when you have actually examined the patient and recorded your positive findings, including those areas not examined? Can you make modifications and corrections? Are consents and authorizations clear and easily retrieved? How easily and accurately can you manage problem lists, medication lists, and allergy and adverse reaction list as well as clinical documents and notes? As alerts and reminders are brought to your attention, is there some way to document why you may or may not choose to act on them? Lastly, check for back up. A system that can lose patient data is one with a built in patient safety risk.
Diagnosis and treatment risks can be mitigated to a large extent by good e-prescribing, medication management, and medication reconciliation functions. Alerts should optimally include drug/drug, drug/allergy, drug/diagnoses, and some form of drug/lab information, but should be meaningful to the individual clinician using the system to avoid alert fatigue. Another area where an EHR can help mitigate patient safety risk is closed loop ordering. This means that the clinician should at least be able to view active orders for a patient, display outstanding orders for multiple patients, see the status of orders, receive notification when new results are received, and link results to the original order. It also means that the clinician is notified when a test result is not returned, or a prescription has not been filled, though few systems function at that level now. Ways of assuring that patients receive appropriate testing for disease management, medication management, and preventive services should include both reminders inserted into clinical workflows and automatic reminders to patients or their guardians. The last, and arguably the most important areas in support of appropriate diagnosis and treatment are data integration and presentation. Are you informed whenever new data points enter your patients’ records? Can you easily eliminate or modify duplicative or erroneous data points? How well does your system aggregate data and present them in usable formats so that you are truly knowledgeable about your patients’ history and progress?
All three areas interdigitate. Good communication requires good documentation requires good data management requires good communication. As CCHIT certification has matured over the years, attention has been paid in all three areas with the recognition that integration of all functions is the foundation on which all other patient safety functions rest. Testing for integration using clinical workflows that support many of the patient safety functions listed here is unique to CCHIT Certified® products, and is not present in ONC certification, as many of the functions are not. As we look to the future, CCHIT will increase its focus on assuring that patient and provider needs for safer, more usable systems are met.
Karen M. Bell, MD, MMS
Chair, Certification Commission
Karen Bell, MD, MMS, is Chair of the Certification Commission for Health Information Technology (CCHIT®. Dr. Bell has wide and varied expertise in health information technology (HIT), quality assurance and clinical practice, in both the private and public sectors. Previously, she served as Senior Vice President, HIT Services, Masspro, the federally-contracted Quality Improvement Organization within Massachusetts, where she oversaw the development, implementation and distribution of products and services to support adoption of electronic health records (EHRs) within the health care system. Between 2005 and 2008, Dr. Bell was Director, Office of Health Information Technology Adoption, Office of the National Coordinator (ONC), U.S. Department of Health and Human Services (HHS), and, in 2006, served as Acting Deputy of ONC. She was ONC’s representative on CCHIT’s Board of Commissioners from 2006 to 2008.
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.
