It is not uncommon for recently hired pathologists to be given new responsibilities for which they feel unprepared. Assuming oversight over one or more sections of a laboratory can require a level of comfort with informatics that newly minted pathologists may not yet have developed.
Regardless of the clinical or laboratory information systems (CIS/LIS) used in your particular setting, many of the challenges in informatics are universal. Consider the guidance below a brief introduction to navigating those challenges and shifting your focus from how to implement specific technologies to how to manage processes.
Understand the Local IT Landscape
Responsibilities and Reporting Structures
In any directorship role, knowledge of the local informatics landscape is the key to making changes that can optimize efficiency, quality of testing, and patient care. Start by understanding the relationships among your laboratory informatics team and your institution’s clinical informatics organization and IT groups (i.e., who is responsible for what and who reports to whom). This includes knowing the responsibilities and reporting structures of these groups. For example, if the LIS staff are paid from a centralized hospital budget, aligning any request to the institution’s current objectives can help “grease the wheels” to secure the resources you need.
Informatics has a wide scope. The teams that a pathologist is most likely to work with generally oversee applications such as the LIS or the electronic health record (EHR) system. But there are likely completely separate teams responsible for infrastructure (hardware or cloud systems) and data management. Although one may expect that an enterprise-level informatics organization would coordinate the work of its various internal teams, this is not always the case. You as the pathologist may need to be involved to ensure timely and accurate communication among different IS groups. If your informatics team will support it, suggest establishing a liaison position between pathology and the informatics organization to help centralize and streamline communication.
Next, investigate the specific mechanisms by which your informatics organization allocates resources. Some health systems and hospitals recognize that informatics staff time is a scarce resource, and they have therefore established formal project intake mechanisms for work that goes above and beyond routine support for day-to-day operations. These mechanisms assign “scores” to projects based on criteria such as alignment with organizational goals, potential for financial benefit, impact on patient safety, or compliance with regulations. Framing your request around these criteria will help your informatics organization understand the potential impact of your request and why resources should be allocated to the work you are asking to be done.
Whether or not your organization has a very structured informatics team with clear project intake processes, building a relationship with your informatics team will pay dividends. The fastest way to do this is to volunteer your expertise on issues related to pathology informatics. Remember: even if you do not have a significant background in informatics, you will have a better understanding of pathology and laboratory medicine than most, if not all, of the informatics staff. Serving as a consultant for test names or identifying the best testing panels for order sets are relatively low-effort activities that can benefit the laboratory, healthcare providers, and patients while helping you build rapport with the IT team. Strengthening that relationship also allows you to consult your informatics team more informally about changes to the LIS or other systems without necessarily having to push through the project intake maze.
As your time allows, join and stay visible on committees that have the authority to make significant changes to the work that you do or oversee.
Advocate for structured decision-making for laboratory purchases
The predominant trend in most healthcare IT organizations is the centralization of information systems and services. Hospital-based laboratories are therefore encouraged (or nudged or forced) to transition to an LIS integrated with the EHR system. These labs are also often asked to consider other vendor software solutions (such as middleware) that can be deployed and administered by central IT resources rather than locally within the lab. As a pathologist you may not have the final word in such decisions, but you can help ensure your laboratory runs smoothly.
Insist that purchasing decisions for major software such as an LIS follow a structured process that includes assembling a request for proposal (RFP), a request for information (RFI), or a similar document. The most important aspect of this exercise is identifying key workflows and functionality. Even if the preferred LIS solution is expected to be aligned with the EHR, going through this exercise can help identify any gaps in functionality that may require additional applications or dramatic changes to the current or expected workflow. Time spent up front establishing the needs of the lab can help prevent avoidable disasters at go-live.
When evaluating instrument purchases, it is important to consider the middleware that will be used to control and interface those instruments. If you do not have a centralized middleware product across all areas of the laboratory (to handle workflows such as autoverification), the quality of the vendor-provided middleware should be rigorously interrogated. A high-performance, high-quality instrument saddled with low-quality software may be close to unusable for lab staff, and may seriously jeopardize the instrument’s functionality and throughput. To help determine the usability of their products, always push vendors for hands-on testing that includes complex scenarios.
If operational support of mission-critical software is transitioned to or already lives with a centralized IT group, advocate for a clear set of service level agreements (SLAs) that outline the expected turnaround time for addressing different types of issues. For example, a prompt response and escalation pathway (requiring a response time of minutes) should be outlined to support automated lines that handle the highest volume of testing.
Keep Regulatory Requirements in Mind
Understanding your internal laboratory workflows and applications is of course paramount. But it is also critical to know about any external systems that connect to internal and external laboratory data. This data is increasingly exchanged between health care systems via both vendor-specific and vendor-agnostic health information exchange technologies. The use and display of data from external laboratories warrants particular attention to ensure the fidelity of transmitted data. It is thus important to understand how outside data flows into the LIS and/or EHR and how that data is presented to providers because the laboratory director is ultimately responsible for compliance with accreditation requirements.
In addition to requirements about the use and display of external results, there are a number of other requirements that fall under the purview of the laboratory director, despite being the day-to-day responsibility of another group (such as central IT). Areas covered by such requirements include but are not limited to risk assessment, data preservation, adequate downtime procedures, environmental controls for computer facilities, and the fidelity of reporting to downstream systems.
The laboratory IT landscape continues to increase in complexity as other fields in medicine digitize workflows and centralized IT departments expand. Pathologists can provide significant value to their health care organizations, not only by contributing to local improvements and laboratory-based decisions but also by serving as a source of knowledge to the IT organization. To maximize your potential contributions, you should understand the structure of your IT operation and the resources within it. This will allow you to offer subject matter expertise when build decisions intersect with your clinical domain, and to advocate for best practices when the organization makes IT decisions that will impact your laboratory.
CAP members Ibrahim Khalda, MD and Mathias C. Patrick, MD. FCAP are authors of this article.