EHRs are subject to a wide range of changes and failures. In the blink of an eye, months or years of information can be corrupted or you may lose access to your EHR information. The key discovery issues will be to determine what events have occurred and whether the problems lead to or affected the medical professional liability event. As important will be the recovery strategy and process that your organization undertook to address the problem and maintain the currency of the patient medical record.
EHR Upgrades – EHR vendors release new versions on a periodic basis. Typically, new versions are released between one and four times per year. EHR upgrades may include new features, changes to existing features, and solutions to reported problems. Note that EHR upgrades can include changes to the clinical content as well as programmatic changes. An EHR upgrade may require processing existing patient data to accommodate a new feature or change the structure or presentation of patient information.
EXAMPLE:
Due to the upgrade of clinical content to a new version of the EHR, thousands of historic treatment records were missing from the EHR. The vendor recovered the vast majority of records with the exception of several hundred items.
A change in the image feature of the EHR resulted in the loss of several thousand old images. The loss was not detected for over 4 months.
A change to the clinical content resulted in new clinical findings replacing previously used clinical findings. In some cases, the new findings split previous findings into multiple findings and in other cases two or more findings were consolidated into a new combined item.
DISCOVERY ISSUES:
What changes to the EHR occurred from the time patient information was originally entered into the EHR until the discovery of the incident? Did any of the changes affect the patient record or its use?
Were there any changes to the patient chart information due to any EHR upgrade? If yes, what did the practice do to verify the accuracy of the patient information changes to the patient chart?
Did any EHR upgrades affect the presentation or reporting of patient information that contributed to the incident?
Did changes to the EHR distort the health maintenance or reporting of patient information that was entered before the upgrade was in use?
What were the acceptance and verification processes to assure that previous patient information was preserved and maintained in the course of the upgrade?
What procedure changes were made to account for the new release?
What activation and recovery procedures were used to transition patient information and operations to the new EHR version?
RISK REDUCTION STRATEGIES:
Maintain a reference book containing all release notes. Include documentation on the review of the notes and HCO/practice activities to respond to the changes.
Formally review and verify the upgrade’s affect on the EHR use or patient information. For example, a change to the image feature should be verified by checking access to previous patient record images. Similarly, a new presentation of patient orders should be verified with patient orders that were entered with the previous EHR version.
Test any EHR upgrades in a test environment before applying the new version to a production environment.
Maintain and document training programs and workflow changes related to EHR changes.
Document interactions with the EHR vendor on any issues related to EHR problems
Document remediation efforts to address any effects on patient information including changes to clinical content or presentation. The remediation effort may include training users and detailed analysis of previous record in the new EHR version.
Develop an appropriate plan for transition to the new EHR version that addresses the technical and organizational use of the new EHR version.
Update all training and procedure documents to account for the new EHR version.
Provide adequate training on new EHR version and use to all doctors and staff.
History of Problems and Remediation – The discovery process will include an examination of vendor and practice problems with the EHR. For example, we have numerous situations where information was permanently lost from the EHR due to software and hardware issues. The events are frequently exacerbated by the lack of an appropriate recovery strategy and process.
EXAMPLE:
A large practice lost over two months of scanned images due to a system problem and inappropriate backup procedure.
A practice discovered that the displayed patient information on the EHR screens were reported on the opposite side of the body on reports and exam notes.
A redundant disk drive failed in a fully backed up array of storage devices. An unqualified staff member replaced a component that was actually the unaffected disk. Patient information was permanently lost.
Due to serious performance problems, the EHR was used to only document essential treatment and not the details of patient care. Furthermore, a variety of messages and activities were documented on paper and scanned into the EHR. However, due to performance issues, scanning was two months behind.
DISCOVERY ITEMS:
What problems have been documented with the EHR by the vendor and did any of those problems affect data related to the incident?
What backup and protection strategies and procedures were used to protect against loss of information?
Has any information been lost from the patient record? What was the nature of the loss and how did the loss occur? What efforts were undertaken to recover the information?
Did any problems result in patient status or care being inappropriately presented or reported?
How was patient information recovered? What was the procedure to update the patient EHR based information? Who were the parties responsible for the recovery process? What was the quality assurance procedure for recovery of the information?
Were the recovery efforts proper designed and performed by adequately qualified staff?
How were all users informed about the problem and trained on its affects to operations and patient records?
RISK REDUCTION STRATEGIES:
Maintain a formal EHR performance evaluation on a periodic basis. Document problems and efforts to address EHR issues.
Verify backup procedures and processes to assure that there are sufficient backup resources in place to rebuild the system in the event of a failure.
Maintain a procedure to serve patients without access to the EHR as well as a procedure to update patient records when the EHR has been recovered.
Conduct a post failure review to document the effect of the failure and the recovery strategy as well as the execution of the recovery strategy.
Carefully document your efforts to analyze, and design the recovery strategy and its use.
Periodically conduct tests of the EHR to validate referential integrity of the EHR data and connections. For example, the links to externally stored images could be tested to verify that the supporting image files are still available.
Maintain periodic saved backups (Ex. weekly, monthly) to provide a fallback or recovery resources in the event of a problem.
CONCLUSION
EHRs problems can develop from a variety of maintenance and use issues over the years of EHR use that you are committing to. Over the extended period of time, a practice/HCO will encounter EHR problems based on day to day use. In other cases, new versions of the EHR will present transition errors as you take advantage of new features and answers to evolving healthcare industry requirements.
In order to adequately maintain and protect your patient data throughout the EHR life cycle, the practice/HCO needs to maintain a process to prevent the introduction of new EHR versions that could distort historic information or inhibit the entry of new information. Each HCO/practice need to maintain appropriate procedures to respond to and recover from disruptions and problems due to external or internal changes to your EHR.
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