Prenatal ultrasound is an indispensable tool used by obstetrical care providers to assist in the everyday care of their pregnant patients. Alongside advancements in imaging, the electronic systems that support this technology have become more advanced. However, it is currently difficult for these individual systems to communicate with each other “out of the box.” There is also minimal standardization of the type and format of data transmitted within these systems. Clinicians and system vendors must work collaboratively to create clinical and technical standards to serve as the foundation for increased interoperability among the various systems within each institutional network. Therefore, the Society for Maternal-Fetal Medicine Clinical Informatics Committee established an Ultrasound Electronic Health Record Subcommittee to facilitate collaboration between clinicians, including maternal-fetal medicine subspecialists, and ultrasound network component vendors. Based on the work of this subcommittee, the purpose of this document is to provide: (1) a basic understanding of ultrasound network architecture and capabilities, and (2) best-practice recommendations for electronic health record order design, obstetrical clinical data standards, and billing and coding practices.
Introduction
Since the introduction of fetal evaluation by diagnostic ultrasound in the mid-1950s, the technology has advanced tremendously to provide incredible visual resolution and novel methods for fetal assessment. Fetal ultrasound is now an indispensable tool used by prenatal care providers to assist in the everyday care of their pregnant patients. Alongside these advancements in imaging, the electronic systems that support this technology have individually become more advanced. In addition to ultrasound machines, prenatal care providers now work with a variety of technology-based components, including ultrasound reporting systems (URS), image archiving systems, and electronic health record (EHR) systems. Each of these components, when linked together, make up the ultrasound network and communicate with each other to some extent via a variety of interfaces. An ultrasound network can exist within or across hospital systems or individual practices.
As these technologies within the ultrasound network architecture have evolved, their design and capabilities have historically been developed by industry and information technology (IT) professionals. In addition, the components within the ultrasound network (EHRs, image archiving systems, ultrasound machines, URS, and billing systems) have typically been created by different companies with limited collaboration. Vendors focus on requirements of their particular components of the network but not on making the various components work seamlessly together. Consequently, there is currently minimal standardization of the type and format of data that are transmitted within these components. There is also often limited “out-of-the-box” interoperability among the individual components within the ultrasound network. The limited interoperability necessitates substantial institutional customization to enable more robust communication and data transfer within the network. The burden of establishing the needed interoperability has been placed on the healthcare system, rather than on the vendors. Because this customization requires institutional willingness and resources, most ultrasound networks do not seamlessly provide the clinical information necessary to improve clinical care efficiency and quality.
The fundamental barriers that have impeded current obstetrical ultrasound networks from making more robust, clinically relevant information available at the point of care include: (1) limited collaboration among individual vendors; (2) limited clinician input regarding the global ultrasound network’s data transfer needs; (3) communication gaps between clinicians and IT colleagues; and (4) lack of standardization within the network of clinically relevant obstetrical ultrasound data.
To move obstetrical ultrasound systems and networks forward, clinicians and vendors need to work collaboratively to create clinical and technical standards to serve as the foundation for increased interoperability among the various components within each institutional network. As with all collaborative efforts, this begins with effective communication of needs and capabilities. Clinicians need to develop a greater understanding of the technology, along with its capabilities and limitations. Industry and IT professionals need to build a more robust understanding of the clinical and operational requirements at the point of care. Therefore, the Society for Maternal-Fetal Medicine (SMFM) Clinical Informatics Committee established an Ultrasound EHR Subcommittee to facilitate collaboration between clinicians, including maternal-fetal medicine subspecialists, and ultrasound network component vendors. The purpose of this document is to provide: (1) a basic understanding of ultrasound network architecture and capabilities, and (2) best-practice recommendations for EHR order design, obstetrical clinical data standards, and billing and coding practices.
Procedure
SMFM invited clinician representatives from the American Institute of Ultrasound in Medicine (AIUM), American College of Obstetricians and Gynecologists (ACOG), and International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) and industry partners from AS Software, Cerner Corporation, Epic Systems, Digisonics, GE Healthcare, Philips Healthcare, Samsung Healthcare, and Vision Chips to the Clinical Informatics Committee – Ultrasound Subcommittee ( Table 1 ). The Ultrasound Subcommittee was organized into 4 working groups: billing and coding, obstetrical data, orders, and patient demographics. Each working group included clinician and industry representatives. The subcommittee initially convened virtually in July 2020, and working group meetings were held between September 2020 and January 2021. Members of each working group discussed best practices in obstetrical ultrasound data communication and data element standardization. The subcommittee reconvened monthly between March 2021 and June 2021 to review each subcommittee’s findings. Expert consensus opinion was obtained regarding best-practice recommendations, limitations of current systems, and opportunities for future work.
| Organization | Representative(s) |
|---|---|
| Society for Maternal-Fetal Medicine | Thomas Lee, MD, MBA |
| David Lagrew, MD | |
| Kelly S. Gibson, MD | |
| David McLean, MD | |
| Brian Iriye, MD | |
| Joanne Stone, MD | |
| Helen Feltovich, MD | |
| Vanita Jain, MD | |
| Sanaa Suharwardy, MD | |
| Amanda Stephens, MD | |
| Virginia Andrews, MPH (Staff Liaison) | |
| American College of Obstetricians and Gynecologists | Chris Morosky, MD |
| American Institute of Ultrasound in Medicine | Mike Pinette, MD |
| International Society of Ultrasound in Obstetrics and Gynecology | Alain Gagnon, MD |
| AS Software | Mark Scott |
| Noa Avtalion | |
| Cerner Corporation | Diane Hibbs, DO |
| Epic Systems | Joey Haddock |
| Teri Angell | |
| GE Healthcare | Greg Angst |
| Franz Stoelzle | |
| Michael Hasten | |
| Carol Grone | |
| Digisonics | Sue Maisey |
| Diane McSherry | |
| Karen Abshire | |
| Philips Healthcare | Jacqueline Wickersham |
| Ryan Fuller | |
| Dave Barr | |
| Samsung Healthcare | Dan Monaghan |
| Kelly Barrett | |
| Dennis Wisher | |
| Vision Chips | Jock Philip |
Obstetrical ultrasound network architecture and capabilities
The ultimate goals of an obstetrical ultrasound network are to: (1) provide operational information pertinent to the performance of an obstetrical ultrasound, (2) obtain clinical information regarding the pregnancy in both visual and discrete data formats, (3) refine and collate operational and clinical information into a clinically useful product, and (4) distribute this information for downstream clinical care.
The components of an ultrasound network commonly include the Hospital Information Systems (HIS) or Radiology Information Systems (RIS), the Picture Archiving and Communications System (PACS) or Vendor Neutral Archive (VNA), the imaging modality (ie, ultrasound machine), the URS, and the billing system. To effectively design, maintain, and use an ultrasound network, a basic understanding of its underlying architecture is necessary for clinicians and IT professionals. Although there can be myriad unique network configurations based on individual institutional needs, a common framework is illustrated in the Figure , and its component parts are described as follows. A glossary of terms associated with ultrasound network architecture is provided in Table 2 .
| Acronym | Term | Definition |
|---|---|---|
| ADT | Admission, Discharge, Transfer | HL7 message that is used to describe patient demographic information and trigger events such as patient admission, discharge, transfer, and registration. |
| DFT | Detailed Financial Transaction | HL7 message that is used to describe a financial transaction. |
| DICOM | Digital Imaging and Communications in Medicine | The standard for the transmission of medical imaging information and related data. DICOM includes protocols for image exchange, compression, 3D visualization, image presentation, and results reporting. |
| EHR | Electronic Health Record | EHR is a digital version of a patient’s paper chart, focused on the total health of the patient beyond the standard clinical data. EHRs are real-time, patient-centered records that make information available instantly and securely to authorized users beyond a single healthcare organization. |
| EMR | Electronic Medical Record | EMR is a digital version of a patient’s paper chart, mainly focused on the standard clinical data, typically within a single practice. |
| HIS | Hospital Information System | A broad term that refers to electronic systems designed to manage healthcare data. Examples include electronic health records, clinical information systems, practice management software, and patient portals. |
| HL7 | Health Level 7 | A set of international standards for the transfer of clinical and administrative data within health care. The term HL7 refers to “layer 7,” or the application layer, of the Open Systems Interconnection (OSI) model of computer network communication. Fast Health Interoperable Resources (FHIR) is the next-generation standards framework created by HL7. |
| MWL | Modality Worklist | A DICOM list of imaging procedures scheduled to be performed by an image acquisition device. It includes relevant patient details, the type of procedure, and the procedure order. |
| ORM | Order Entry Message | HL7 message that is used to describe general order information triggered by new order creations, cancellations, information updates, discontinuation, etc. |
| ORU | Observation Result Unsolicited | HL7 message that is used to describe observations and results. |
| PACS | Picture Archiving and Communications System | Medical imaging technology that provides storage from multiple modalities and vendor-specific access to images. |
| RIS | Radiology Information System | An electronic health record specifically designed for use in medical imaging. |
| SIU | Scheduling Information Unsolicited Message | HL7 message that is used to describe patient appointment schedule information. |
| SR | Structured Report | A DICOM component used to exchange text data, rather than image data. |
| URS | Ultrasound Reporting System | Electronic system which receives ultrasound data in DICOM format (images and/or structured reporting) and provides permanent record of standardized patient data, exam findings, and billing documentation, which can be interfaced to various systems and made accessible for data mining. |
| VNA | Vendor Neutral Archive | Medical imaging technology that provides storage from multiple modalities and access to images from multiple devices and locations, irrespective of the vendor. |
Hospital Information Systems and Radiology Information Systems
An HIS or RIS (typically an EHR) is the starting point for the collection and transmission of ultrasound-related data. The HIS or RIS serves as the source of patients’ demographic information, imaging study orders, and scheduling information. These operational data are typically communicated downstream to several different systems (eg, reporting software system, PACS/VNA) via Health Level Seven (HL7) messages. HL7 is the international standard for the transfer of clinical and administrative data between software applications within health care. For example, patient demographic information is sent via an HL7 Admission Discharge Transfer (ADT) message, whereas order information is sent via a separate HL7 Order Entry message (ORM) ( Box ). Transmitting data in a standardized format (ie, HL7) ensures that each component within the ultrasound network is communicating using the same language. Establishing a standard for the data transferred using these interface formats reduces the potential for data loss or inaccurate translation of data at different system junctures within the ultrasound network.
| HL7 | A set of international standards for the transfer of clinical and administrative data between software applications within health care. The term HL7 refers to the application layer, or “layer 7,” of the Open Systems Interconnection (OSI) model of computer network communication. |
| DICOM | The standard for the transmission of medical imaging information and related data. DICOM includes protocols for image exchange, compression, 3D visualization, image presentation, and results reporting. |
The HIS is also frequently the endpoint of the ultrasound data collection and transmission process and serves as the ultimate repository for the discrete clinical data, ultrasound report, and billing information associated with the ultrasound study. Because the HIS is also the electronic environment in which most other clinical documentation and communication occur, effectively aggregating all data generated within the ultrasound network in a single location should streamline clinical care.
Picture Archiving and Communications System/Vendor Neutral Archive
The PACS/VNA has several key functions during the collection and transmission of ultrasound-related data. The PACS’s primary function is to store images. Another important function is to generate a modality worklist (MWL), which enables the imaging modality (ie, the ultrasound machine) to obtain patient and scheduled exam information from the HIS. Obtaining this information is necessary to ensure that the subsequent images and data align with that specific patient and study. The PACS/VNA creates the MWL based on the HL7 Scheduling Information Unsolicited (SIU) message received from the scheduling module of the HIS, which is available to the ultrasound machine via a Digital Imaging and Communications in Medicine (DICOM) interface. DICOM is the standard for the transmission of medical imaging information and related data. Of note, some HIS are also able to generate the MWL independently of a PACS/VNA.
PACS/VNA systems also can serve in some configurations to: (1) receive ultrasound images and structured report (SR) data directly from the ultrasound machine via the DICOM interface; (2) display images, generate reports, and archive studies, or (3) act primarily as an archiving system, receiving final reports and images from the URS.
Imaging modality (ultrasound machine)
The ultrasound machine’s role is to obtain images and structured data for a specific patient and study based on information from the MWL. Once obtained, this operational and clinical information is transmitted via a DICOM interface to either a PACS/VNA, URS, or both.
Ultrasound reporting system
The URS provides several key clinical functions: (1) displaying images and SR data (typically ultrasound measurements), (2) generating and communicating the final report, and (3) conveying coding/billing information. The URS receives demographics and order information from the HIS via the HL7 interface and images and SR data from the ultrasound machine via the DICOM interface. This information automatically populates fields within the URS, enabling the clinical end-user to review images and data, perform calculations, display percentiles, etc. Descriptive information and clinical interpretations are also incorporated into what becomes the final report of the study findings. After the report is finalized, data from the URS can be used for data mining or research.
The report can then be communicated in 2 forms: a structured plain text report or a plain text report with an embedded PDF version. The PDF version is typically a more robust, user-friendly representation of the study findings because it can include graphics and images. Both formats can be sent via an HL7 Observation Result (ORU) message back to the HIS.
The URS can also facilitate appropriate coding and billing of the study. This information can be generated and pushed to a billing system (either standalone or within the HIS) via an HL7 Detailed Financial Transaction (DFT) message.
Billing system
Medical billing systems may be standalone software or can be embedded within the HIS. The system receives information (eg, patient identifiers, procedural codes and indications) via an HL7 DFT message to automate billing and coding processes.
Order Design Best-Practice Recommendations
Purpose of orders
The process of performing an obstetrical ultrasound begins with an order from the physician or treating practitioner. An order is fundamentally a communication tool. In the United States, according to guidelines from the Centers for Medicare & Medicaid Services (CMS), a valid order must communicate the following information: (1) the diagnostic study requested, (2) the clinical indication(s) for the study, and (3) the name and signature of the ordering physician or practitioner.
Order design considerations in obstetrics
Order design for ultrasound in obstetrics presents unique challenges not encountered in other fields. Frequently, the study initially ordered for a specified indication is found to be clinically inappropriate during the course of the exam. For example, a physician has ordered a singleton routine anatomy survey based on a suspected last menstrual period date. At the time of the study, an 18-week twin pregnancy with a short cervix is appreciated, necessitating a change to the ultrasound order and the study performed. The need for midstudy adjustment does not occur as frequently when performing chest X-rays or renal ultrasounds. Unfortunately, CMS guidelines prohibit performance of an alternate unordered diagnostic study without a new order from the treating physician or practitioner. Although this limitation may not be universal across all care settings, the challenges posed by a mismatch between the order and the performed examination remain. This disparity between the study ordered and the study that is clinically appropriate to perform also substantially impacts how the report and structured data are ultimately returned, how the coding is generated, and potentially how the study is reimbursed. Therefore, there is a need for best practices regarding the optimal design for obstetrical ultrasound orders that address the unique challenges inherent to obstetrical ultrasound and other indicated procedures.
Any particular order design will have both benefits and limitations. The optimal approach may depend on the structure and capabilities of the EHR and the workflows associated with scheduling, coding, and billing. The 2 most common design approaches use either: (1) multiple individual procedure-based orders, or (2) a few generalized orders with embedded procedural options.
The procedure-based approach uses either multiple individual orders or predefined bundled orders. For example, this approach would organize orders on the basis of individual Current Procedural Terminology (CPT) codes (eg, 76801, 76805). This approach provides clear communication and control to the provider when placing the order, may make it easier to identify individual study results on chart review within the EHR after study completion, and can simplify the coding and billing process. However, this approach can be more tedious and less efficient at the time of order entry, given that numerous individual orders may be required (ie, each individual CPT code) for a single study. This approach also provides less flexibility for the clinician in adjusting the order according to clinical circumstances during the study.
The generalized approach uses a handful of high-level orders with procedural specificity selected within the body of each order. For example, this approach could organize orders on the basis of studies performed at different gestational ages (eg, first trimester, second/third trimester) and enable selection of specific procedures (eg, second/third trimester order initially selected, and then detailed anatomy and cervical length secondarily selected within 1 high-level order). This approach provides clear communication and control to the ordering provider, and it tends to be more efficient at the time of order entry, with only a single individual order needing to be selected. Furthermore, the generalized approach enables much greater flexibility at the time of the study because changes to the order may not be required to adjust the procedures performed. This approach can make it more challenging to identify individual study results during chart review and may require additional attention to coding and billing workflows.
Best-practice recommendations for obstetrical ultrasound order design are as follows:
- 1.
Use the generalized order approach rather than a procedure-based approach. This option implements an approach designated by CMS as “test design” and allows the interpreting physician to determine the study’s parameters without notifying the treating physician/practitioner. Organizing orders on the basis of trimesters (eg, first trimester, second/third trimester) rather than individual CPT-based orders (eg, 76801, 76805) allows the interpreting physician to adjust according to study findings without requiring a new order. Desired procedural specifications can be communicated by embedding this information within the generalized order. This enables maneuvering as clinically needed at the time of the study within the same order ( Table 3 ).
