Volume 38 Number 3 | June 2024

Shawn Luby, MS, MLS(ASCP)CM, ASCLS Patient Safety Committee

Shawn LubyAs I was strolling through the showroom floor at my first Association for Diagnostics & Laboratory Medicine (formerly AACC) Annual Scientific Meeting last summer, I marveled at the new technologies. I was mesmerized by delivery systems; I teared up during a presentation on digital smear review; and I was simply not prepared for the amount of food and drink being offered to booth visitors every afternoon. As exciting as it is to stand in awe amidst the technological advances of the clinical laboratory, in thinking about this article and in imagining the future of our profession, I continue to return to the patient’s experience. In doing so, the following questions come to mind:

  • How are patients introduced to “the lab”?
  • How are patients educated regarding laboratory testing and technologies?
  • How are patients supported when receiving their laboratory results?

Of course, these questions have been asked in various ways throughout our profession’s history, but the arrival of immediate access to patient results ushered in by the 21st Century Cures Act has fundamentally changed the nature of the laboratory-patient relationship.1

Historical Context

During the lead up to the Cures Act, the 2014 Center for Medicare and Medicaid issued a Final Rule, which amended CLIA ’88 and HIPAA requirements limiting patient access, noting that laboratories were particularly concerned about patients accessing results prior to communication with providers and clarified that “this final rule does not require that laboratories interpret test results for patients.”2 Seeking to reassure laboratories that patient impact would be minimal, the Final Rule noted that at the time, most patients did not routinely request access to laboratory results until after consulting with a provider, stating “We expect this trend to continue to generally be the case.”2

Ten years and one global pandemic later, it seems almost impossible to imagine having to wait for one’s provider to communicate laboratory results. Today, the experience of immediate access to testing results has become the norm, and in the process, laboratory testing has moved from a private facing operation, reliant on providers to curate, summarize, and deliver laboratory test results, to a now immediate, largely unfiltered, and public facing service.

One recent study in JAMA examining patient experience with portals showed that a majority of patients (96 percent) preferred immediate access to test results, regardless of prior consultation with a provider.3 Immediate access also brings new concerns for patients, and studies have reported an increase in patient confusion and anxiety when viewing portals and a need to seek outside guidance (in absence of provider communication) for support when interpreting laboratory reports.3,4

“Today, the experience of immediate access to testing results has become the norm, and in the process, laboratory testing has moved from a private facing operation, reliant on providers to curate, summarize, and deliver laboratory test results, to a now immediate, largely unfiltered, and public facing service.”

The question therein remains: What is the laboratory’s role in patient education, and importantly, if laboratories engage in patient education, how will they deliver information to patients? Perhaps notable to laboratory professionals, the National Kidney Foundation’s 2022 Laboratory Engagement Working Group, which developed implementation recommendations for the adoption of the race-free CKD-EPI 2021 equation for calculating eGFR, identified patients as stakeholders to include in laboratory issued communications, alongside physicians and advanced practitioners, pharmacists, clinical researchers, nutritionist and dieticians, and patient advocates.5 Recently, I had the opportunity to examine laboratory communications issued during CKD-EPI 2021 implementation and found that the majority of participating laboratories had limited options for delivering communication to patients, and most (89.3 percent) did not identify patients as being included in communications.6 Ultimately, this specific and limited communication with patients during CKD-EPI 2021 implementation might best serve to illustrate that post-Cures Act, if we aim to better support patients as a profession, then the time to revisit and re-envision how the clinical laboratory engages in patient education is now.

Communications Potential

Currently, the ASCLS Patient Safety Committee is modernizing the Laboratory Safety Tips Brochures to include digital resources and a more visible and interactive patient information hub on the ASCLS website. Even still, we continue to brainstorm about how best to deliver this information to patients. It is perhaps local laboratories, already engaged with patients, who might be best positioned to explore new patient education strategies. And while it might seem impossible to generate information for all patient testing, laboratories may want to start by considering the following:

  • Does your laboratory have a public facing website designed to introduce your lab and your services to patients? (i.e., Who do you serve? Who performs your testing?)
  • Does your laboratory provide general laboratory testing information? (i.e., What is in a tube? What is a reference range? What testing is new at your lab?)
  • Does your laboratory provide guidance on common tests for patients? (i.e., What is a CBC? CMP? A1C?)
Who to Involve

It is no secret that those of us who have worked at the bench have served informally throughout our careers as advisors to friends and communities regarding laboratory testing. Importantly, when laboratories envision creating accessible materials for patients, medical laboratory professionals working at the bench must be included. By engaging entry level to director level professionals, we create new opportunities for professional collaboration and better highlight the unique knowledge and skill sets of the many different professionals working in the clinical laboratory. In my own conversations with fellow educators, it also appears that MLS/MLT programs across the country are increasingly engaging students in the practice of developing public health materials. Familiar with using design concepts, artistic skill, and scientific knowledge to create materials from the viewpoint of medical laboratory professionals, it is likely that new members of the profession will have had academic instruction on health communication and information design.

It will certainly take an effort to create new models for laboratory engagement in patient education. In a time of staffing shortages and urgent efforts aimed to increase professional visibility, investment in laboratory developed educational materials offers a largely untapped avenue for laboratory professionals to support patients while creating visibility for the profession. As we look toward a future of rapid information exchange and unchecked digital resources, the creation of visible and trusted spaces for engagement with patients will be essential if we aim to support our patients and communities in accessing and understanding the laboratory services of the future.6

References
  1. Arvisais-Anhalt S, Ratanawongsa N, Sadasivaiah S. Laboratory Results Release to Patients under the 21st Century Cures Act: The Eight Stakeholders Who Should Care. Appl Clin Inform. 2023;14(1):45-53. doi:10.1055/a-1990-5157
  2. Federal Register: CLIA Program and HIPAA Privacy Rule; Patients’ Access to Test Reports. Accessed March 25, 2024. https://www.federalregister.gov/documents/2014/02/06/2014-02280/clia-program-and-hipaa-privacy-rule-patients-access-to-test-reports
  3. Steitz BD, Turer RW, Lin C-T, et al. Perspectives of patients about immediate access to test results through an online patient portal. JAMA Network Open. 2023;6(3):e233572. doi:10.1001/jamanetworkopen.2023.3572
  4. Zhang Z, Lu Y, Kou Y, Wu DTY, Huh-Yoo J, He Z. Understanding patient information needs about their clinical laboratory results: A study of social Q&A site. Stud Health Technol Inform. 2019;264:1403-1407. doi:10.3233/SHTI190458
  5. Miller WG, Kaufman HW, Levey AS, et al. National Kidney Foundation Laboratory Engagement Working Group Recommendations for Implementing the CKD-EPI 2021 Race-Free Equations for Estimated Glomerular Filtration Rate: Practical Guidance for Clinical Laboratories. Clin Chem. 2022;68(4):511-520. doi:10.1093/clinchem/hvab278
  6. Luby SW. Evaluating Laboratory Communications to NKF-WG Recommended Stakeholders during Implementation of the CKD-EPI 2021 Equation. J Appl Lab Med. March 20, 2024. doi:10.1093/jalm/jfae019

Shawn Luby is Assistant Professor in the Division of Clinical Laboratory Science at the University of North Carolina at Chapel Hill, NC.