Research ArticleClinical Practice

Challenges and Opportunities for the Medical Laboratory in the Era of Direct Patient Access to Test Results

Letycia Nuñez-Argote and Joanna Veazey Brooks
American Society for Clinical Laboratory Science September 2024, DOI: https://doi.org/10.29074/ascls.2021003164

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  1. Letycia Nuñez-Argote
  2. Joanna Veazey Brooks
  1. University of Kansas Medical Center
  2. University of Kansas Medical Center
  3. University of Kansas Medical Center
  1. Address for Correspondence: Letycia Nuñez-Argote
    , University of Kansas Medical Center, lnunezargote{at}kumc.edu

ABSTRACT

Providing patients access to their health records promises to improve patient safety. However, there are concerns that clinical laboratory test results are not optimized for patient interaction through web portals. We asked medical laboratory professionals (MLPs) about the current state of direct patient access (DPA) to electronic health records to assess their knowledge and attitudes on how this may affect laboratory practice. Data were collected through interviews with MLPs working in clinical laboratories in the United States (n = 15), which were analyzed following a grounded theory qualitative approach. We found that MLPs’ perspectives on DPA were informed by the area of the laboratory where they worked and by perceptions about patients’ understanding of test results. Knowledge and attitudes differed based on test type, laboratory process, and laboratory setting. While respondents agreed that web portals could support patient self-advocacy, they cautioned that test information could be misconstrued by patients who see values without the guidance of a clinician. The level of MLPs’ interactions with patients varied, but they all agreed that communicating results to patients was outside their scope of practice. Additional efforts must be directed at empowering the laboratory workforce to share pertinent medical information adequately and effectively to patients.

ABBREVIATIONS:INDEX TERMS:

INTRODUCTION

Recent policy changes and investment in health information infrastructure have facilitated consumer adoption of secure web portals in which patients can access the electronic health record (EHR).1 In the Health Information Technology for Economic and Clinical Health Act, enacted as part of the American Recovery and Reinvestment Act of 2009, the US government called for meaningful use of the EHR and mandated that healthcare providers give patients access to information that can empower them to be more informed about their health.2⇓⇓-5 Similarly, the 2010 Clinical Laboratory Improvement Amendments of 1988 Issuance of Revised Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services asserted that patients are “responsible for using test results” and that they may receive test results directly from clinical laboratories.2⇓-4,6 Direct patient access (DPA) to clinical laboratory test results (CLTRs) is considered a measure that can improve patient safety and help increase understanding regarding test results by patients.3 Despite limited involvement in direct patient care, in alignment with the 2002 Institute of Medicine competency recommendations for healthcare practitioners, medical laboratory professionals (MLPs) are responsible for promoting patient-centered laboratory care by disseminating information through the EHR.2,7

There is considerable literature documenting the attitudes and opinions of clinicians and patients on the topic of DPA via online portals.8⇓⇓⇓⇓-13 A systematic review and meta-analysis of the impact of DPA on health records found that access improved overall patient safety and efficacy measures.14 However, in this review only 1 of the included papers asked about the use of personal EHR data in helping patients understand tests.15 Another study focused on access to CLTRs documented that 82.7% of patients found the test feature useful but thought the information about abnormal results should be better explained to address patient anxiety and be actionable.12 On the provider side, while one study found physicians who had personally missed addressing an abnormal test result with their patients welcomed DPA, another study reported that 54% of emergency room physicians disagreed with patients receiving abnormal test results directly, suggesting “patients lacked the necessary expertise or knowledge to interpret test results.”8,10

EHR systems with DPA have created an expectation for the availability of complex information, potentially increasing the pressure on the personnel who generate this data to adjust their protocols and satisfy regulatory requirements. While access to laboratory test results is a central area impacted by policy and regulatory changes, little is known about the practice and perceptions of MLPs regarding patient DPA, with no current published studies, to our knowledge, reporting MLPs’ point of view. This qualitative study aimed to understand current laboratory connectivity with patients through the EHR, document MLPs’ perspectives regarding DPA to CLTRs through web portals, and explore how DPA may influence laboratory professionals’ practice in order to improve patient safety.

MATERIALS AND METHODS

This study was qualitative and descriptive, using grounded theory to design and implement a semistructured interview guide for data collection.16,17 Qualitative methodology is appropriate for topics like these, wherein there is little published knowledge and salient factors and theories have not been developed.18 Following the tenants of the constant comparative method, data collection and transcription took place simultaneously, which allowed an iterative development of the study instrument, informing subsequent interviews as new data emerged.19,20 The semistructured interview assessed 3 main domain areas: (1) knowledge of how laboratory systems report results to patients; (2) MLPs’ opinions, perceptions, and attitudes regarding DPA; and (3) implications of DPA for patients and laboratory professionals. At the end of the interviews, respondents answered a short demographic survey. The institutional review board at our institution approved this project.

Eligible respondents were adults 18 years or older who were employees of a clinical laboratory conducting tests using human samples and approving results to be reported to the EHR. Initially, theoretical sampling was used to recruit respondents through professional contacts, through which 5 individuals were recruited and completed in-person interviews. Subsequently, a recruitment survey was shared through a national laboratory professionals’ society listserv seeking additional respondents that would allow us to capture further variation in laboratory type, size, and practice setting. We received 31 responses to our online query, but 10 of these individuals did not meet inclusion criteria or provide complete contact information. Of the remaining 21, we were able to reach19 via email with a copy of the informed consent letter, but only 10 (52%) scheduled and completed a telephone interview by the time data collection ended, which brought our total sample to 15 respondents.

Interviews were conducted between March and December of 2019. Verbal, electronic, or physical informed consent was obtained for each participant. Interviews lasted an average of 25 minutes and were recorded with a digital recorder. All interviewed respondents received a $5 gift card. Interviews were transcribed verbatim, and the transcripts were coded by L.N.A., in frequent consultation with J.V.B. Interviewees were designated aliases for anonymization (randomly selected names of colors), which were used for quote identification. Data analysis using thematic analysis and grounded theory techniques was conducted, allowing subthemes to be identified inductively within the 3 interview domains.21⇓⇓-24 NVivo qualitative analysis software was used to manage the data analysis process.25 Demographic information was summarized using basic descriptive statistics.

RESULTS

Table 1 shows respondent characteristics (N = 15). Over one-third of MLPs reported working as generalists, which involves working across multiple laboratory areas. Geographically, respondents were distributed as follows: 10 from the Central United States region, 3 from the Eastern region, 1 from the Western region, and 1 from the Mountain region. Our findings are organized according to the 3 domains from our interview guide into 7 themes (see Table 2).

View this table:
Table 1.

Characteristics of interviewed medical laboratory professionals (N = 15)

View this table:
Table 2.

Domains and categories describing MLPs’ knowledge and perceptions of patient direct access to laboratory test results via web portals

Knowledge of How Laboratory Systems Report Results to Patients

Autoverification versus manual entry of results

Respondents explained that technological advances have made MLPs’ work safer for patients and allowed faster turnaround times for result reporting. The changing laboratory environment “requires for laboratorians to be more computer savvy” (MAGENTA) and enables them to focus their scientific and critical skills on complicated laboratory processes. Reflective of most current laboratory operations, MLPs classified test result reporting depending on whether results were relayed through automated algorithms (autoverification) or entered manually. One participant, INDIGO, explained, “the 2 reasons autoverification works is, one, [the patient’s test] values are normal, […] within reference range, and the second reason is, they agree with previous history.”

According to MLPs frequently working with these automated processes, the results do not transfer automatically to the EHR if a patient sample produces values that do not comply with autoverification rules. The CLTRs are reviewed or even entered manually into the system either because the results are abnormal and flagged for review or because the test’s specialized nature requires entry or confirmation by an MLP. Some differences in test result entry were associated with an area of the clinical laboratory and are listed in Table 3.

View this table:
Table 3.

Variation in laboratory systems’ result reporting

Information systems and patient portals

Most respondents knew how CLTRs transferred from the laboratory to patient portals. “[T]he lab uses [software name] as its LIS [laboratory information system], and it uses Epic or [software platform] as its EHR. […] Epic has their own software MyChart, […] the patient web portal,” explained GRAY. More than half of respondents reported Epic Systems software (Verona, WI) as the EHR at their facility, with MyChart as the patient interface. They also indicated the need to use middleware to communicate with various EHR systems. MAGENTA mentioned, “We have partnerships with several other hospital systems, and they all run on different medical record software. So, we have to use a lot of middleware to communicate laboratory results.” In 2 instances, MLPs said their workplace did not have an EHR system.

Knowledge of patient portals varied among MLPs, with some learning about these systems because they were patient-users themselves. In contrast, others had become familiar with the EHR through employer-provided education. KHAKI explained, “I was first exposed to [the patient portal] because like when we had our HIPPA training […] one of those things that violate HIPAA is if you look up your own results” (HIPAA is the Health Insurance Portability and Accountability Act, which protects patient health information from disclosure without patient consent). All MLPs reported they enjoyed seeing their CLTRs as users of patient portals, although they could not always provide precise details about what results look like on the patient side. ORANGE disclosed, “I can’t remember […] you can see your test results and you can see like the past results, and I think it has a reference range.”

Opinions, Perceptions, and Attitudes About DPA

Tests that can and cannot go directly to patients

MLPs reported mixed perspectives about DPA to CLTRs, explaining that certain kinds of tests were appropriate while others were not. Table 4 includes a list of characteristics and examples illustrating why some tests were considered appropriate or inappropriate. Interviewed participants expressed concern about possible errors or technical issues in test results. They highlighted the need for ample time for the results to be confirmed by clinicians before patients gained access to them. INDIGO explained:you have a super critically low sodium […] and then we find out an hour later that the [chemistry] instrument has a cloggage in the electrode or something like that, and we correct it […] we notify the doctor or nurse when we correct a result, and hopefully that information hasn’t yet got to the patient.

View this table:
Table 4.

Variation in MLPs opinions, perceptions, and attitudes about direct patient access

MLPs also raised concerns about DPA to CLTRs based on situations they had experienced in their career. One respondent, BLUE, shared that test results for infectious and sexually transmitted diseases, which are monitored by the public health authorities, had in the past led to unexpected news for patients. For example, BLUE said, “We’ve had cases where the result crossed the interface […] and the State called the patient… the patient wasn’t aware the testing was being performed on them.”

Perceptions of patient understanding of CLTRs

Although all MLPs believed ready access to test results could be positive for patients, they gave multiple reasons in favor of and against the practice of providing CLTRs directly to patients. These examples had emphasized perceived patient knowledge of medical history and the potential to create unnecessary worry and anxiety (see Table 4). All MLPs agreed that one of the more negative aspects of DPA was that viewing abnormal results may lead patients to look up the information online, which could be at best inappropriate and at worst detrimental. GRAY illustrated this: “Nowadays when social media and other nonconfirmable sources do put out articles or clickbait…. it can be very dangerous for patients to see their test results and try to interpret them themselves.”

MLPs and other health professionals as patients

In contrast, MLPs reported they would not personally have these same concerns when receiving CLTR information as patients themselves, since their specialized training would enable them to comprehend what they were seeing. The same was not the case for healthcare professionals with training that did not focus on laboratory testing. Examples respondents provided to illustrate these points are listed in Table 4. When MLPs were asked about sources of information they commonly utilized for themselves or that they would recommend for patients to help provide additional understanding about test results, only 2 MLPs mentioned the patient portals. In addition, only half of the participants volunteered names of websites they considered contained reliable information, including LabTestsOnline.org, WebMD, and United States government sites such as those managed by the Centers for Disease Control and Prevention.

Implications of DPA for the Patient–Laboratory Relationship

DPA and differences in laboratory communication practices

When asked about the relationship between MLPs and patients, most MLPs described a natural barrier between them and patients, which they believed exists for several reasons. One is related to their purported role. Overall, respondents felt that communication with patients is not the laboratory’s role, and they consistently voiced their support for clinicians communicating test results directly to patients. Also, MLPs considered a separation between their work and patients was necessary to avoid having to answer questions outside of their scope of practice. One respondent, YELLOW, indicated that patients should rely on established relationships with clinicians for information about their tests, explaining “[a] doctor is the one who’s going to interpret those results and make a diagnosis based on those results and the treatment plan, which we are not trained to do.”

In addition to scope of practice concerns, some MLPs reported an affinity for the built-in separation and anonymity afforded by their role. Remaining anonymous, however, was not always easy. MLPs conveyed that whether to communicate an interpretation of test results was not always straightforward, with several laboratorians sharing personal or family experiences that highlighted these tensions (see Table 5).

View this table:
Table 5.

Opinions about implications of DPA for the patient–laboratory relationship

DPA and changes in the visibility of the laboratory profession

When asked how DPA impacts communication with patients, MLPs revealed a range of practices that varied by practice setting (see Table 5). MLPs recognized that the separation between the laboratory and patients creates challenges for the visibility of their role as critical healthcare team members. Participant MAGENTA provided an example:[Patients] don’t even recognize that we exist you know? You watch television shows of hospitals and whatnot and it’s the provider orders the tests, the phlebotomist comes in, or the nurse and takes a sample and the next thing you know the results are in the physicians’ hands. So, the laboratory testing itself is like this magic black box that is faceless and unrecognized.”

MLPs provided several arguments as to how DPA to CLTRs may or may not aid in increasing the visibility of laboratorians (see Table 5). For example, the ability to see test results without the intervention of a physician may help patients think about testing as a process separate from clinical consultation done by professionals trained for this purpose.

DISCUSSION

This interview study is the first to investigate the individual and professional attitudes of MLPs toward implementing DPA to CLTRs. Through this qualitative approach, we better appreciated the current landscape of DPA information from a laboratory practitioner’s lens. Overall, MLPs know of the technological systems currently in place to facilitate DPA. They reported mixed attitudes about DPA, with most highlighting vital differences between reporting CLTRs for common tests versus uncommon or unexpected ones. Finally, respondents shared that DPA to CLTRs might help improve the visibility of the laboratory profession, bringing direct attention to their typically overlooked role. While some thought this was positive, others worried about the scope of practice and professionalism considerations.

Like other healthcare professionals in previously reported studies, MLPs were apprehensive about the implications of DPA and patients’ ability to interpret test results.8,10 These concerns are not without merit. Prior research assessing patients’ aptitudes to interpret laboratory test values found low levels of health literacy and the potential for unnecessary stress and anxiety in patients.12,26⇓-28 MLPs agree that when patients access CLTRs directly, they can exert self-advocacy but only when there is enough understanding about the test’s meaning in the context of their overall health. The perceptions voiced in our study suggest what other researchers have found, that in order for DPA to become an effective healthcare tool that has a meaningful impact on patient safety, additional work is needed to provide adequate linkage to care.12,29,30

MLPs viewed DPA as an opportunity to increase the visibility of the laboratory by providing patients with tangible evidence of what happens inside the “magic black box” of healthcare. There have been some attempts to expand the reach of laboratory medicine in the direction of patient-centered care, particularly by pathologists, through initiatives such as Pathology Explanation Clinics and data management interventions.31,32 Currently, most of these communication strategies are designed for personnel trained as physicians and do not include laboratory technologists and technicians, a combined workforce in the United States of over 344 000 individuals, compared with approximately 29 000 pathologists.31⇓⇓⇓-35 In addition, based on our respondents’ statements, there is no consensus on how laboratorians should participate in the DPA process, which may speak to MLPs’ perception of themselves as generators, but not necessarily communicators of healthcare data. The entry-level MLP scope of practice and physical location of the laboratory may also limit their involvement in patient safety initiatives that utilize DPA to CLTRs.

With additional experience, training, and admittance to spaces that facilitate patient contact, like those reported by respondents working in small healthcare settings, MLPs’ level of comfort communicating with patients may increase. Areas of opportunity included improved awareness of EHR web portals as places where MLPs can refer patients for viewing of their test results, increased understanding by MLPs of what test results look like as they are displayed through patient portals, and establishing consensus on authentic online resources MLPs can share with patients. Issues of trust and appropriate communication by the laboratory are critical. They must be addressed, particularly in the context of health emergencies, such as the COVID-19 pandemic, because these situations lead to increased scrutiny of the laboratory profession and pressure to provide fast turnaround times on testing.36,37

This study has several limitations. While we were able to include opinions from respondents with diverse clinical backgrounds, age groups, and work experience in the profession, MLPs from small facilities, rural settings, and the coastal regions of the United States were underrepresented. By design, this is a qualitative study, and the number of participants was low. Although this is typical of the nascent field research archetype wherein the aim of the study is pattern identification of theories that will invite further research, we acknowledge that our small sample is not representative of MLPs at large. Also, this study did not include perspectives of employees within the clinical laboratory who share resulting and reporting duties, such as cytologists, pathologists, and others, who may have different opinions than those expressed by the MLPs who were interviewed. Additional quantitative survey studies and qualitative studies focusing on these populations of MLPs are needed.

In their current position, MLPs, “the silent heroes in lab coats who also serve as detectives of disease,” are limited in their ability to impact patient safety through increased access to laboratory data.38 But, policy and regulatory changes requiring direct communication of CLTRs have set the stage for a potential increase in the scope of practice of laboratory-trained health professionals. This research provides insight into laboratory processes and reporting practices and highlights the tensions around DPA for MLPs. Given the established concerns with DPA, a key opportunity exists for training and integration of MLPs into the clinical team, as they could contribute to implementation efforts in DPA through evidence-based practice use of EHR-based informatics and analytics.4,39

  • Received December 15, 2023.
  • Accepted April 20, 2024.

American Society for Clinical Laboratory Science

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Challenges and Opportunities for the Medical Laboratory in the Era of Direct Patient Access to Test Results
Letycia Nuñez-Argote, Joanna Veazey Brooks
American Society for Clinical Laboratory Science Sep 2024, DOI: 10.29074/ascls.2021003164
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