Even with the best of efforts to select and implement electronic health record (EHR) systems,

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2 F EATURE S TORY B Y R ON S TERLING EHR Design and Medical Professional Liability Discovery Even with the best of efforts to select and implement electronic health record (EHR) systems, medical practices may find that many EHR products have design flaws that may be difficult to detect and even more difficult to address with workarounds and additional procedures. These EHR design flaws will present problems to practices trying to preserve the integrity of their medical records or using electronically stored information to prove that quality care was provided, or defend against a medical professional liability (MPL) claim. Your insured providers need to consider many important design issues, and find out whether the structure of the EHR product will impact the availability of information needed to defend against an MPL claim. Indeed, the key issue is how the design of the product may impact the discovery process and the information available to prove care. What is considered part of the patient medical chart in the EHR? EHR designs may complicate, or obscure, the information needed to reconstruct what happened in patient care and the physician s decisions about it. Many medical-records products do not consider messages to be part of the patient medical record. The messages are not displayed on the patient summary screen and the messages cannot be viewed in context with the patient medical record. Indeed, some EHR products delete completed patient messages. Many EHR products do not track the review status ( scanned, reviewed, accepted ) of a scanned document. To determine when the scanned document was reviewed and the patient service action triggered by the review, a detailed search and analysis of messages and clinical notes would be required. Some EHR products fail to adequately track the clinical lifecycle of patient information and activities. For example, some EHRs will automatically lock access to a patient note after a certain period of time, regardless of whether the physician has completed or signed the note. Also, some EHRs have limited tracking tools for activities and services. For example, some of them track Ron Sterling, CPA, MBA is President of Sterling Solutions, Ltd. W W W. P I A A. U S P HYSICIAN I NSURER 1

3 EHR D ESIGN EHR designs may complicate, or obscure, the information needed to reconstruct what happened in patient care and the physician s decisions about it. only whether a patient order is open or closed. Does the EHR adequately display the various images and exam information in context, for a full analysis of the patient s situation? For example, can the user review the patient chart contents and the relationship between the documents and messages? Does the audit trail, from the date of the incident, indicate adequate review of related images and notes during the interaction with the patient? What patient information, whether connected to the patient s current status or not, is included in the EHR? For example, some practices may have paper records external to the content of what is captured in the EHR or images on diagnostic devices. Maintain appropriate training programs for all providers and staff on the use of the EHR and presentation of information from the EHR. Establish a daily procedure to validate proper documentation of image and chart content review and sign-off. Maintain quality assurance measures of approval and reviews of the charts contents. Analyze the relevance of any information contained in the EHR for documenting patient services and care before any information is purged or deleted from the EHR. How does the EHR support patient services? Sending patient reminders and distributing patient-specific education are mentioned in two Meaningful Use measures that are patient-service-focused. Many EHRs use several different tools to manage patient- specific care, as well as industry standards of care, for patients based on age, sex, and diagnoses. Many EHR products require multiple entry of patient treatment information to manage patient service. For example, some EHRs require entry of the treatment plan in the exam note and another, separate entry into an order list for tracking outstanding orders. Failure to enter the same order information in both places could lead to a lapse in patient service. Most EHR products include a repository of patient education information that can be printed directly from the EHR. In some cases, patient education information can be modified and customized for the individual patient. However, some of these EHRs note only that information was printed, but do not retain a copy of the actual information given to the patient. With that limitation, in a discovery process, the exact contents of the patient education piece cannot be determined or reproduced. Patient portals allow patients to enter information and exchange messages with the practice. However, the patient portal is frequently not noted as the source of information in the EHR. How were patient-service items recorded and tracked in the EHR? What were the health maintenance items in effect at the time of the incident? How are patient-specific orders recorded and maintained by the physicians? What are the patient service strategies and follow-up procedures in place to support patient service? What documentation is available to detail the interactions with the patient that are related to the incident? Are there any discrepancies between the patient chart, messages, and other EHR-based features about the patient service issues associated with the incident? What documents were distributed to the patient, and what did the documents contain? 3 P HYSICIAN I NSURER W W W. P I A A. U S

4 Many EHRs use several different tools to manage patient-specific care, as well as industry standards of care, for patients based on age, sex, and diagnoses. Establish and verify any patient-service standards established and tracked by the EHR. Maintain copies of all distributed documents within the EHR. Conduct daily audits of relevant patient-service items and other EHR activities, to maintain accuracy and indicate closure of specific clinical activities. How is patient information presented on documents and reports? In an EHR, how the patient s information is presented and reported is subject to a wide array of changes and transformations. In many cases, the same information may be presented on several different screens, and the original entry screen, and also printed on notes or documents. In addition, the information displayed on the entry screen may be transformed, interpreted, or combined with other information that is contained in printed materials and other screens. Many EHRs allow users to incorporate patient information on practice-specific forms and documents. One medical practice included standard text information in its exam note script that was automatically printed on the document. The standard text was complex, and subject to patientspecific issues, but was printed on every patient s notes. Some EHR systems produce patient notes based on a script that may transform information from the patient record, or even add in information that is not found elsewhere in the record. Some EHR systems produce patient exam notes on demand, but do not save a copy of the report or document that was given to a patient. Many doctors do not review the note that is produced by their EHR. What documentation exists to explain the selection and presentation of patient information on the produced documents? Can the system reproduce the information that was presented to the patient? Are there any discrepancies between the information entered in the EHR and the information that was contained on the exam report or other document? What was the condition and status of the program that produced the report or exam note? Were there any documented errors on the presentation of information on screens or reports? Did the documented errors affect patient care related to the incident? Document any changes to the presentation of information and the generation of documents. Test and verify how, and what, patient information is presented and reported, with doctors and other appropriate parties. Establish policy standards for the generation of patient documents and the maintenance of patient information in the EHR. Train doctors and staff on any changes in presentation and documentation. What will amended notes indicate? In a paper record, doctors may amend documents and images to highlight a situation or record updated information. Many EHR systems do not manage amended patient notes or images effectively. Amended notes in many EHRs consist of free-form text that is attached to the original patient note. Structured information (for example, Findings on the Physical Exam ) that may have been affected by the amendment is not changed. Any queries or processes that reference the information in the note will refer to the original findings and not consider the information in the amended note. W W W. P I A A. U S P HYSICIAN I NSURER 4

5 EHR D ESIGN The documents are generated anew each time the document is produced. So, it may not be possible to produce a copy of a key document needed to document or support patient care. How was the annotated information presented or highlighted when reviewing the patient note or image? How did the amended information impact the inclusion of, or exclusion from, care standards and health maintenance items managed within the EHR? What distortions or obscured presentations of amended information occurred that affected the ability of the practice to properly focus the treatment that was related to the incident? Design workaround strategies to insure that relevant observations are properly documented and used by the EHR. Conduct training sessions to insure that physicians and staff adequately research information in comments on images that may be contained in other areas of the EHR. Can the patient record be reconstructed at a particular point in time? Investigating an incident requires understanding the sequence of events related to information provided by the patient and knowing which information was available at a specific point in time. Unfortunately, most EHRs present and print information based on the current state of the patient record. Numerous EHRs do not retain copies of information distributed to patients or sent to other parties on their behalf. The documents are generated anew each time the document is produced. So, it may not be possible to produce a copy of a key document needed to document or support patient care. Patient chart contents include information that may have been updated as a result of the clinical life-cycle. state of the patient record at the time of the incident? Did the provider bypass any EHR-generated warnings that could have mitigated the severity of the incident? What outstanding maintenance or system error issues were present at the time of the incident? What did the practice do to compensate for any EHR issues at the time of the incident? Maintain the detailed audit trail for as long as possible, so that it is possible to deconstruct the medical record to obtain information from the time of the occurrence of the incident. Note that deconstructing the medical record back to the day of the incident would involve a complex paper-based exercise, starting from the current version of the patient record and adhering to a precise itemization of changes that derive from the audit trail. Maintain periodic backups of EHR information to minimize what is needed for the deconstruction process in the event of an incident. Conclusion EHR design issues can have a significant impact on the EHR discovery process as well as the overall confidence in the information that is maintained in the EHR. Indeed, the EHR design may affect the availability of key patient information components essential to proving appropriate care and due diligence. By avoiding products that have design issues, or using procedures to work around design problems, healthcare organizations and physician practices will be better positioned to substantiate appropriate care, in light of the clinical data stored in the EHR. For related information, see Can the audit trail of the EHR, and the current information or note in question, be manually deconstructed to determine the 5 P HYSICIAN I NSURER W W W. P I A A. U S