Many EHR designs pose challenges to accumulate the information needed to defend against a malpractice claim. For example, most EHR systems cannot present the patient medical record as it existed at a certain period of time. Thereby, one could not review the information that was available at the time in question, or even distributed notes or documents provided to the patient or other providers.
EHR focused discovery will examine whether the structure of the EHR product impacted the entry or presentation of information related to the incident.
Patient Chart Contents – EHR designs may complicate or obscure the discovery process. For example, many EHRs deal with images as an adjunct portion of the patient medical record. The discovery process would analyze the images and the importance of related information that was not directly available with the image.
EXAMPLES:
Many medical records products do not consider messages 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.
Many EHR products do not track the review status (Scanned, reviewed, accepted) of a scanned document. In order to determine when the scanned document was reviewed and the patient service action triggered by the review, a detailed search and analysis of all messages 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 a patient note after a certain period of time regardless of whether the physician has completed the note.
Some EHRs have limited tracking tools for activities and services. For example, some EHRs only track whether a patient order is open or closed.
DISCOVERY ISSUES:
Does the EHR adequately display the various images and exam information in context for the proper analysis of the patient situation? For example, can the user review the patient chart contents and the relationship between 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 information related to the patient is not considered part of the patient record?
What patient information whether connected to the patient or not is in the EHR?
Did the presentation or lack of proper presentation affect patient care?
Do providers and staff adequately understand the entry of EHR information and the presentation of EHR information?
RISK REDUCTION STRATEGIES:
Maintain appropriate training programs for all providers and staff on the use of the EHR and presentation of information from the EHR.
Define best practices presentation of patient information.
Establish a daily procedure to validate proper documentation of image and chart content review and sign-off.
Maintain quality assurance measures of chart content approval and reviews.
Analyze the relevancy of any information in the EHR to documenting patient services and care before any information is purged or deleted from the EHR.
Support for Patient Services – Sending patient reminders and distributing patient specific education are two Meaningful Use measures that are patient service focused. Practices have a wide array of other patient service needs and requirements. EHRs have a wide array of patient service tools and features. Unfortunately, not all features are structured to mitigate discovery challenges.
EXAMPLES:
Many EHR products have procedural weaknesses that could lead to problems. For example, some EHRs require entry of the treatment plan in the exam note and a separate entry into an order list to track outstanding orders. Failure to enter the same order information in both places could lead to a lapse in patient service.
Several EHR products require the user to attach operational messages to the patient chart if the information is relevant to patient care. Failure to add the messages could result in missing information about patient care and activities.
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 patient. However, some of these EHRs note that information was printed, but do not retain a copy of the information give to the patient. 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 as a source of information in the chart is not always noted.
DISCOVERY ISSUES:
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 on place to support patient service? What documentation is available to uncover the interactions with the patient 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?
RISK REDUCTION STRATEGIES:
Physicians should establish and verify any patient service standards established and tracked by the EHR.
Establish a procedure to maintain copies of all distributed documents in the EHR.
Maintain written procedures of patient service standards as well as quality assurance reviews and responses to any lapses in patient service.
Conduct daily audits of relevant patient service items and other EHR activities to maintain accuracy and closure of clinical activities.
Customization – EHRs offer a variety of customization options to control the use of the system and accommodate the needs of the practice as well as individual needs of the physicians.
EXAMPLES:
Some EHR products include tool kits that can be used to change the nature and operation of the EHR. Thereby, the practice is using a one of a kind implementation of the EHR that may differ in substantial ways from the standard product. Those customizations will have to be reinstalled in future EHR releases.
Changes to clinical content may affect other areas of the EHR. Each change will have to be analyzed in light of the E&M coding calculation and the creation of printed notes.
DISCOVERY ISSUES:
What was the clinical basis for the for EHR customization?
What effect did the customization have on the operation and use of the EHR?
Did the customization of the EHR result in any distortions to the operation of the EHR, or presentation of information from the EHR?
What was the testing process to verify the clinical efficacy of the customization?
Was the incident related to any information or functionality that worked with the standard EHR, but failed to correctly work with the customized EHR?
Was the incident related to any information or functionality that works with the original system, but does not include information added through the customization?
Was the incident related to any information or functionality that works with the original system, but does not include information added through the customization?
RISK REDUCTION STRATEGIES:
Establish a clinically driven process to frame and control customization of the EHR.
Avoid customization of an EHR driven by stylistic issues that do not affect patient care or clinical accuracy.
Verify any customization of the EHR works with the standard product and does not distort the use or presentation of patient information.
Presentation, Document, and Reporting - In an EHR, patient information presentation and reporting are 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 as well as printed on notes or documents. However, the information on the entry screen may be transformed, interpreted, or combined with other information on printed materials and other screens.
EXAMPLES:
Many EHRs allow users to use patient information on practice specific forms and documents.
A medical practice included standard text information in their exam note script that was automatically printed on the document. The standard text was subject to a number of patient specific issues and should not have been included in all patient 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 produced by their EHR.
Some EHRs produce exam notes based on user requests. However, new exam notes are not generated when exam information is updated. Thereby, the saved exam note may not contain the most current patient care information.
DISCOVERY ISSUES:
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?
RISK REDUCTION STRATEGIES:
Document changes to presentation and document generation.
Test and verify presentation and reporting of patient information with doctors and other appropriate parties.
Establish policy standards over the generation of patient documents and the maintenance of patient information in the EHR.
Train doctors and staff on presentation and documentation changes.
Annotation and Amendments - In a paper record, doctors may annotate documents and images to highlight a situation or relate the image to a continuing patient issue. Unfortunately, some EHR systems do not support image annotation. A number of EHR systems do not effectively manage amended patient notes
EXAMPLES:
In many EHRs, image observations must be documented in prose and saved as a note that is not attached to the image. Thereby, significant observations by the physician may not be clearly apparent when reviewing the image.
Amended notes in many EHRs consist of free form text that is attached to the original patient note. Structured information that may have been affected by the amendment is not changed. Any queries or processes that reference the information in the note will use the original findings and not consider the information in the amended note.
DISCOVERY ISSUES:
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 by the EHR?
What distortions or obscured presentations of amended information occurred that affected the ability of the practice to properly focus treatment related to the incident?
RISK REDUCTION STRATEGIES:
Use other features of the EHR to highlight conditions and information about images that may be relevant to patient care.
Design work around 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.
Reconstructing the Chart at a Point in Time – Investigating an incident requires understanding the sequence of events related to information provided by the patient and information available at a point in time. Unfortunately, most EHRs present and print information based on the current state of the patient record.
EXAMPLES:
Numerous EHRs do not retain copies of information distributed to patients or sent on their behalf. The products are regenerated each time the document is produced. Thereby, it may not be possible to produce a copy of a key document that may be needed to document or support patient care.
Patient chart contents include information that may have been updated due to clinical life cycle information.
One of the key benefits of EHRs is the ability to use the same information many times. For example, one prescription entry can be used in the exam note, on the patient summary screen and for drug utilization review. The discovery process may seek to define the state of the patient record that may have contributed to the incident.
DISCOVERY ISSUES:
Using the audit trail of the EHR, the current information or note in question could be manually deconstructed to determine the state of the 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 outstanding at the time of the incident? What did the practice do to compensate for any EHR issues at the time of the incident?
RISK REDUCTION STRATEGIES:
Maintain the detailed audit trail for as long as possible to offer a chance to deconstruct the medical record to 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 using the current state of the patient record and a precise backout of changes from the audit trail.
Maintain periodic backups of EHR information to minimize the deconstruction process in the event of an incident.
CONCLUSION
EHR design issues can have a significant impact on the EHR discovery process and defense of a malpractice claim. Due to a wide range of issues, the actual design of the product may present problems to defend against a malpractice claim and/or expose patient records to an unprecedented level of scrutiny and challenges. By utilizing mitigation strategies and good EHR practices, healthcare organizations and physician practices will be able to take advantage of EHRs to improve patient service and prove care that will support due diligence efforts in the event of an incident.
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