A Closer Lab-Patient Connection

Whether through private tech companies offering on-device health record storage,¹ government initiatives such as MyHealthEData in the US or the NHS App in the UK,^2,3 or provisions opened up by legislature,⁴ patient access to health data has steadily increased in recent years. This evolution, although not universally experienced due to varying legislative and infrastructure challenges between countries,⁵ is one patients generally desire.⁶ And, once patients are given access to their healthcare data, they are more engaged and satisfied with their care.⁷ As developments in this area continue, clinical labs may increasingly find themselves a key, more visible component in ensuring the data they generate isn’t lost in translation.

Open (data) access

Since the start of this millennium, several key pieces of legislature have shaped the landscape of healthcare data access in the US. This includes the Health Information Technology for Economic and Clinical Health (HITECH) Act, which was enacted in 2009 and drove large increases in hospital electronic health record adoption,⁸ and the 21^st Century Cures Act of 2016. The Cures Act aimed at supporting patients in accessing their electronic health data and preventing information-blocking practices. The Cures Act’s final rule, issued in 2020, mandated that all electronic health records, including laboratory results, be made freely accessible to all patients.⁹

“This is revolutionary because it removed a substantial barrier for patients to have access to their personal healthcare data,” explains Letycia Nuñez-Argote, associate professor in the Department of Population Health Management and Policy, North Carolina Agricultural and Technical State University. “Looking specifically at laboratory testing, these laws have allowed patients the opportunity (with some caveats) to request orders for tests they want done and to see their health information without visiting an in-person provider. These two bills have truly moved the field of direct patient access (DPA) forward.”

But now that patients have more access to their laboratory data, have their interactions with the clinical lab changed? Nuñez-Argote, who authored a study that analyzed US-based medical laboratory professionals’ perspectives on DPA,¹⁰ says that this can vary depending on the lab. “There was an attitudinal distinction due to geography and size of the facility,” she explains. “Laboratory personnel who worked in smaller hospitals said that they constantly interacted with patients because their more generalist role meant that they were involved in the majority of the process, from blood collection to running one or more tests; and even providing printed results for the patient to take back to their appointment. This closer contact with patients was mostly positive and made them build a rapport that was discouraged in larger institutions, where laboratory professionals said there were policies explicitly stating that they were not to communicate results to patients.”

Perspectives from the laboratory

Like most things, DPA brings both opportunities and challenges for clinical lab professionals.

“A positive impact mentioned was the potential to use this direct communication with patients to become more of a ‘person’ to them, because they are getting the results from us [laboratory professionals] and not from a physician or nurse,” Nuñez-Argote explains. “This makes it evident that clinicians are not the ones generating the data and that there is a whole other group of people caring for [patients] by providing this service.”

However, this potential hasn’t been realized yet, leading many of those interviewed in the study to feel that having direct access to test results wouldn’t change patients’ behaviors or attitudes toward the lab. “Since the time of this research, the technology providing access to laboratory information has continued to evolve, but it is still imperfect,” says Nuñez-Argote. “Unless patients can make a direct connection between their data and the people behind it, these advances will likely continue to mask the hard work and dedication that laboratory professionals put into their craft.”

Conversely, Nuñez-Argote also worries that laboratory personnel may face increased scrutiny and expectations to provide almost instant results, pointing to those generated from the rapid testing for COVID-19 as an example. “Before, clinicians were the buffer between a patient and their test results. Now, if the test result is not there, patients will join in with clinicians to point the finger at ‘the lab’ for delaying care,” she says.

But by far the biggest concern of those interviewed was the potential for lab data to be presented in a manner comprehensible to healthcare providers, but not patients.

“One of the things the policymakers have yet to accomplish is requiring that a translation to an appropriate health literacy level takes place between what is posted on the chart and what the patient sees,” says Nuñez-Argote. “Some patient portals are adopting reporting that uses a ‘traffic light’ approach. Normal test results are green and results that aren’t are red. Also, commercial laboratories are adding explanatory language to test reports upon release, even if a clinician will be following up with the patient on a call later.”

Accessing the future

Continued developments in policy and direct access technologies are bringing more control and equity to the healthcare arena, reducing the information imbalance patients experience, and rebuilding the direct line of communication between patients and the clinical lab. This is something Nuñez-Argote believes should be embraced. “The barrier separating us from patients has been shattered and many in the field refuse to see it. Some laboratory workers may continue trying to work behind closed doors, but that’s not how reality will work for the profession moving forward.”

Consequently, she encourages all medical laboratory personnel, especially those in technician and scientist capacities, to develop their communication and interpersonal skills. She also recommends staying informed about upcoming technological advancements, such as AI, that will be used to provide even more accurate and detailed data to patients.

“As the main members of the healthcare team who actually understand what is happening inside the laboratory, we are best positioned to help develop tools and algorithms to explain how the testing process leads to results for patients and data for clinicians. We should be working to promote an appropriate flow of information to patients. When our institutions’ laboratory information or electronic health systems are being revamped, we must participate in the process so that those involved understand how it works from the laboratory personnel perspective. Otherwise, other stakeholders in the organization will make decisions about how we report the data that may be uninformed and potentially harmful.”

References:

1. Apple. View health records on your iPhone or iPad. October 29, 2024. https://support.apple.com/en-us/105016.
2. Centers for Medicare & Medicaid Services. Trump Administration Announces MyHealthEData Initiative to Put Patients at the Center of the US Healthcare System. March 6, 2018. https://www.cms.gov/newsroom/press-releases/trump-administration-announces-myhealthedata-initiative-put-patients-center-us-healthcare-system.
3. NHS England. Access to patient records through the NHS App. December 5, 2023. https://transform.england.nhs.uk/information-governance/guidance/access-to-patient-records-through-the-nhs-app/.
4. S Arvisais-Anhalt et al. Laboratory results release to patients under the 21^st Century Cures Act: the eight stakeholders who should care. Appl Clin Inform. 2023;14(1):45–53. doi:10.1055/a-1990-5157.
5. S Howard. Patients’ access to medical records around the world. BMJ. 2024;386:q1481. doi:10.1136/bmj.q1481.
6. Pew. Most Americans Want to Share and Access More Digital Health Data. July 27, 2021. https://www.pewtrusts.org/en/research-and-analysis/issue-briefs/2021/07/most-americans-want-to-share-and-access-more-digital-health-data.
7. A Tapuira et al. Impact of patient access to their electronic health record: systematic review. Inform Health Soc Care. 2021;46(2):192–204. doi:10.1080/17538157.2021.1879810.
8. J Adler-Milstein, AK Jha. HITECH Act drove large gains in hospital electronic health record adoption. Health Aff (Millwood). 2017;36(8):1416–1422. doi:10.1377/hlthaff.2016.1651.
9. 45 CFR Parts 170 and 171. 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program. Federal Register. October 8, 2020. https://www.federalregister.gov/documents/2020/05/01/2020-07419/21st-century-cures-act-interoperability-information-blocking-and-the-onc-health-it-certification.
10. L Nuñez-Argote, JV Brooks, Challenges and opportunities for the medical laboratory in the era of direct patient access to test results. Clin Lab Sci. 2024; online ahead of print. doi:10.29074/ascls.2021003164.