ECG Management Processes and Progress Overview The Challenges: Provide ubiquitous access to ECG s across the enterprise, while delivering role-based functionality based on clinical requirements, with the added benefit of accessing the complete cardiac record in PACS, while sharing the PACS infrastructure, interfaces and EMR integration. The Solution: Market focus on the implementation of electrocardiographs and ECG Management systems that are proven to adhere to industry standards for exchange of ECG waveforms, related metadata and exam orders. Provide single source access to the complete cardiac record by integrating ECG Management into the PACS environment. The Results: Single source access to the complete cardiac record within cardiology PACS. Reduced initial outlay with a single system interface to HIS for orders. Reduced annual maintenance cost with one less system under contract. Reduced IT costs with one less system to support. Single EMR integration point. The Implementation: PACS based ECG Management can be implemented as a stand-alone system, offering a growth path to include the balance of cardiac exams. The Challenges: ECG Management systems are like many other specialty clinical applications; all were designed for an exclusive task and thus remained an island of information with a singular purpose. Today, clinical interpretation processes demand immediate access to a patient s complete clinical record, often making silos of valuable clinical data intolerable and obsolete. In addition, increasing demands on the reading cardiologist s workload, coupled with reimbursement reductions for correlated examinations, beg for efficient workflow alternatives. Such alternatives may include remote interpretation capability or trusted super-users for editing. Finally, interoperability with clinical information systems and PACS demand the ability to share diagnostic objects and related metadata, though these connections come at a steep price. It is economically imprudent to replicate the costs of HIS orders and results interfaces, along with object-level interfaces with EMR systems. These interface costs alone consume nearly one-third of an ECG management system s installation budget. Resistance to the adoption of standards. Growth and innovation in the electronic world of ECG acquisition required the creation of methods to store, retrieve and electronically analyze ECG waveforms. While each ECG vendor designed and promoted their own electronic interpretive algorithm, they also created their own proprietary storage format. Ergo, if you liked a vendor s cardiograph, you ultimately had to buy their ECG management system. Unlike the adoption of DICOM for standardizing the transfer of image data between systems, no standard existed for waveforms.
Standardization Benefits The adoption of a standardized storage format for ECG waveforms offers the potential to include ECG s as part of your cardiology PACS initiative and presents the buyer with a choice of best-of-breed technologies, with open-market, competitive bidding. Enabling cardiographs with Modality Worklist provides efficiency in data entry while virtually eliminating manual conflict resolution and electronically misplaced ECG records. As information systems evolved in healthcare, order generation and processing of exams became more interconnected and automated. The Health Level 7 community enabled systems to communicate using a common language and share important process information. HL7 orders could be passed on to supporting systems electronically, providing enormous efficiencies. Similar to HL7 communication between disparate systems, the advent of Modality Worklist (MWL) enabled communication of order data directly to disparate devices. The MWL standard closed the electronic loop of order / exam data and virtually eliminated misplaced exams due to errors in the patient identifier cluster. However, to date, a scant few cardiograph manufactures are known to have enabled their products with external Modality Worklist interfaces. Widespread adoption of the MWL standard will only occur when market forces reject proprietary order communication between the ECG Management system and the cardiograph. The adoption of a standard for exchanging waveforms and worklist data, such as DICOM and XML, will further empower the buyer with an open-market, competitive bidding process.
The Solution: Standardization. Open market demands are the driving force behind specification and implementation of standardized communications and exchange formats. In 2000, DICOM created a standardization model for waveform interchange in supplement 30 of version 3.0. DICOM Modality Worklist is already specified and suitable for incorporation into cardiographs. Other open formats based on XML have also greatly contributed to the liberation of proprietary ECG data. A significant force driving standardization of ECG waveforms came in the way of an FDA announcement in 2004 requiring sponsors of clinical trials to provide regulatory submissions in electronic format 1 in the form of annotated ECG s. The pursuit and implementation of these standards will enable care-givers to purchase best-inclass devices for their facilities and enable healthcare systems to realize considerable savings in systems consolidation. The Results: Improved workflow. Most imaging specialties in the healthcare world that have implemented PACS systems are already reaping the benefits of electronic closed loop data interchange. The process is logical, simple and requires little if any manual intervention. HL7 orders are generated by an order management system based on exam requests and scheduling. A typical order message contains patient demographics, ordering provider, accession number, exam code, description and scheduled time. Orders are sent electronically to the PACS, or in this case, the ECG Management system. The ECG Management system transmits modality worklist information to the acquisition device, virtually eliminating errors inherent in the manual entry process. A worklist is presented on the console of the acquisition device (i.e., electrocardiograph) with all relevant information about the patient and the exam request. The ECG is acquired and sent (usually via wireless LAN) to the ECG Management system. When the ECG is confirmed, it sets off a chain of events that can update the progress of the order to the ordering system; send a copy of the confirmed ECG to the ordering physician of record (via fax or email); send an HL7 results reporting message consisting of final interpretative statements to the HIS; and send an active link to the Electronic Medical Records host. This link points to a web accessible ECG, rendered from the raw waveforms, for diagnostic review as well as clinical reference. All events related to the transaction are recorded in the system s audit log.
Benefits of Electronic ECG Management Improved workflow using electronic data interchange virtually eliminates misplaced records and increases throughput potential of exams. Creates a more complete cardiac record when ECG Management is incorporated into the cardiology PACS. Having a clinical database as part of the implementation provides a foundation for outcomes investigations. Considerable savings can be realized by eliminating redundancies when ECG Management is built into the cardiology PACS system. A more complete cardiac record Nothing happens in cardiology without an ECG. This is often the case with pre-surgical investigations too. And with certainty, no patient presents to the emergency department with any evidence of chest pain without a 12-lead ECG as the primary investigative tool. As an investigational physician, wouldn t it be beneficial to get the complete cardiac picture? Having simultaneous access to the patient s prior interventional cath or diagnostic echo will most certainly support the decision making process. With ECG Management embedded in the cardiology PACS, physicians not only have access to the complete cardiac record, but immediate knowledge of the existence of related exams; all without the burden of logging into separate systems. Metadata database for cross-platform outcomes analysis It is also possible to extend the ECG Management system s capabilities by incorporating a clinical database for research studies. Data passed to the cardiograph from the ordering system is aggregated with metadata from the exam to create an abundance of important clinical data. This data can be combed and filtered for outcomes analysis, population studies, serial comparison and for pharmacological investigation studies. When the database is combined with other cardiac records, reports and clinical specialties, a complete cross modality research platform blossoms. Considerable savings Including ECG Management as part of the cardiology PACS or the enterprise PACS creates significant savings in eliminating redundant HIS & EMR interface costs; disaster recovery systems, maintenance contracts and IT support resources.
The ECG Interpretation Process: Self Interpretation: In this scenario, when the cardiologist logs in to their worklist, he or she is presented with a list of unread ECG s. Opening the first study from the list creates an event where the system automatically retrieves x number of prior ECG s based on the user s preference. Prior ECG s can be viewed simultaneous to the current waveforms. If the physician agrees with the interpretation created by the cardiograph, they simply click one button to Confirm the ECG and open the next case. If there is a conflict in the interpretation, the user may edit the interpretation via user-defined acronyms or keywords. Relevant tools are available to verify rate, rhythm and axis, along with magnification. Paper based interpretation: This tried & true process is popular among reading physicians for its speed. All inbound ECG s are automatically printed to some nominated network printer, along with a pre-defined number of priors. The cardiologist will edit the preliminary interpretation as needed and physically sign the document to confirm the record. Since prior ECG s are automatically printed, this method still saves considerable time in pulling prior hard-copy ECG s from medical records. For electronic storage and distribution of these ECG records, support staff may edit the electronic interpretation in the ECG Management system and confirm on behalf of the physician, or the physician may batch confirm the corrected ECG s subsequently. The expectation here is that the hard copy is the legal final report, not the electronic version. Paper based interpretation / electronic record: While the interpretation process is seemingly quicker on hard copy ECG s, this only applies to abnormal ECG s and the cardiologist s time. A duplicated effort on behalf of the staff editing the electronic ECG remains. Normal ECG s require nothing more than a single click to Confirm and Go to Next. If the confirming physician is required to confirm ECG s electronically, but they choose not to self-edit in the ECG Management system, a process exists where a). The paper ECG is edited, b). The edited interpretation is entered and saved in the ECG Management system by departmental staff, and c) The cardiologist subsequently confirms all edited ECG s in their worklist. 1 FDA Code of Federal Regulations, Title 21, Part 11. The format adopted by the FDA followed the Health Level Seven (HL7) Annotated ECG Waveform Data Standard (aecg) accredited by the American National Standards Institute.