CLN - Feature

The Lab Is Moving From a Black Box to a Smartphone App

The 21st Century Cures Act will drive lab results directly to patients, and government penalties will catch up to those who stand in the way.

Kimberly Scott

a 3D smartphone surrounded by digitized paths

For decades, clinical laboratorians often referred to the way patients viewed the lab as a black box: Unseen by the public, clinical laboratory testing seemed like a mystery where blood tubes were whisked away and then turned into a series of sterile numbers on a patient chart. Now, Congress is accelerating the push to move healthcare into the digital age using the 21st Century Cures Act, with rules that will push lab results—and, in fact, essentially all of a patient’s medical records—to be instantly accessible via apps. Information that was once mediated by a physician will increasingly be mediated only by technology.

For now, laboratories and other healthcare providers have the option of using more traditional means to share records with patients as long as they respond to patients’ requests. But by December of 2022, the government expects standards for apps to be finalized and for certified health IT developers and providers to catch up to the law’s intent to fully digitize the experience.

Under the provision of the Cures law governing information sharing, which took effect April 5, 2021, healthcare providers may not block or delay patients’ access to any eligible information, including test and study results entered and stored in their electronic health record (EHR). Providers must make a core set of clinical data available to patients in a timely fashion to encourage interoperability and portability of health data. These requirements apply to both clinical and anatomic pathology labs.

While patients’ right to their records was codified in 1996 by the Health Insurance Portability and Accountability Act (HIPAA), the 2016 21st Century Cures Act takes patient access a step further by making access easier and virtually unrestricted. To increase interoperability across EHR platforms, the Cures Act requires vendors and users to support computer and smartphone applications that give patients full and portable access to their healthcare information. As of April 5, 2021, the following eight categories of clinical notes created in an EHR must be immediately available to patients: consultation notes, discharge summary notes, history and physicals, imaging narratives, pathology report narratives, procedure notes, and progress notes.

Developers, networks, and exchanges that are found to have engaged in “data blocking” may be subject to civil monetary penalties up to $1 million per violation. Healthcare providers that don’t release information in a timely way may also be subject to “appropriate disincentives.” Specific penalties for healthcare providers have yet to be determined, although pathologists who participate in the Promoting Interoperability Program could see an impact to their Merit-Based Incentive Payment System incentives if they are found to be information blockers, said Emily Johnson, an attorney with McDonald Hopkins in Chicago.

Prohibited practices include implementing health information technology (HIT) in ways that are likely to restrict the access, exchange, or use of electronic health information—or implementing HIT in nonstandard ways that are likely to substantially increase the complexity or burden of accessing, sharing, or using electronic health information (EHI).

The information blocking rule does not require healthcare providers to proactively make available any EHI, including lab results, to patients or others who have not requested such information; however, once a request is made, any delay in the release or availability of EHI can be viewed as prohibited information blocking. This can be especially complicated as it relates to lab results, as most healthcare providers are used to reviewing lab results before the patient receives them.

Preventing Harm Exception

As many labs have their own patient portals, once a request has been made, it is likely that patients will have access to their lab test results prior to or at the same time as the healthcare provider receiving them. If a provider believes that the receipt of test results by the patient prior to the provider having the ability to counsel the patient would cause harm, the provider can invoke the “preventing harm” exception to the rule, which may only be used on an individualized basis. Standing orders to delay delivery of laboratory results to patients would likely violate the information blocking rule.

In some cases, such as when the test results are related to cancer or to a condition that may be complicated, release of such results directly to patients can be problematic, said Karim Sirgi, MD, MBA, a pathologist and founder of Sirgi Consulting LLC.

“For patients who are faced with results that are complicated, it might be confusing or even devastating for them to read the results out of context,” he said. “The rule eliminates a barrier, but sometimes the barrier is in place for a reason.”

Sirgi believes the preventing harm exception does not go far enough as it has to be invoked for each instance where a laboratory believes the ordering physician should receive the results first and discuss them with the patient.

“It will be extremely cumbersome for a lab to go case by case to determine if the exception is needed,” he said. “There should be a blanket exception that can be used for certain tests.”

In the absence of a blanket exception, providers may want to add disclaimers to reports warning about potentially sensitive content, Sirgi added. During a recent roundtable discussion that Sirgi moderated, a provider shared that its health system was considering a disclaimer stating that the report might contain information that can be “emotionally difficult.” The disclaimer also would recommend that patients read the report in the presence of their clinical caregiver, who can explain and interpret the test results.

Sirgi advises that clinical laboratories and pathologists engage with referring practices and organizations about how patients should be educated about their results. Labs and pathologists could also come up with a script suggesting that the patient contact the referring clinician who requested the test in the context of their overall care.

If test results are sensitive and are of the type that could be misinterpreted by a patient, such as biopsy results or genetic testing, the process should be to send the results to the referring physician for communication to the patient, Johnson said. That way, the referring physician, who has a patient-facing relationship, can explain the clinical significance of the results to the patient and be available to answer questions.

“If the patient calls the lab for results, the patient should be redirected to the referring provider,” she said. “This decision should be made on a case-by-case basis. This process should be clearly documented in the lab’s policies and procedures. There remains the potential that any delay could be considered information blocking. However, if there is a clinical purpose for the delay that is in the patient’s best interests and the policy is clearly documented, that may be mitigating. For routine or nonsensitive testing that leaves little room for interpretation, the lab should not delay providing those results to the patient.”

Delivering Results

Test results can be delivered through a patient portal, but currently, they also can be delivered by mail, Johnson noted, who suggests informing patients that mail sent through the U.S. Postal Service tends to be delayed, so the results may not be received immediately.

“No patient results should be sent via regular email if the patient has not consented to the use of email for the transmission of the requested records,” she advised. “Therefore, prior to sending patient information via unencrypted email, the patient should be informed of the risks of using unencrypted email and sign a form consenting to the use of unencrypted email.”

A key to ensuring compliance with the new rules is to establish clear policies and procedures stating how patient requests will be handled, Johnson stressed. Any delays in producing records in response to a patient’s request should be clearly defined.

Ultimately, having clear policies and procedures about how test results will be shared—and communicating these policies to referring physicians and patients—is key to ensuring compliance with the information blocking provisions of the 21st Century Cures Act.

Kimberly Scott is a freelance writer who lives in Lewes, Delaware. +Email: [email protected]

Helping Patients and Labs Connect

Clinical laboratories that don’t have a patient portal and want assistance in delivering results can use a third-party vendor to serve as the conduit between the lab and the patient. LigoLab's Information Systems in Los Angeles is an example of one such vendor. LigoLab's TestDirectly Direct-to-Consumer (D2C) Portal allows consumers to order laboratory tests directly from their computer or mobile device and receive the results through the portal. TestDirectly does not need a physician referral and is only available in states that allow this type of direct-to-consumer testing.

Initially developed to eliminate bottlenecks, boost testing capacity, and improve turnaround times for COVID-19 testing, the portal now can be used for any D2C test. Patients can self-register for tests, schedule their collection appointments, upload their insurance cards and photo IDs, and receive
automated notifications (text and email) when their results are ready. TestDirectly integrates with all laboratory information systems and revenue cycle management solutions.

Suren Avunjian, co-founder and CEO of LigoLab Information Systems, said the company has about 130 clinical laboratories in its network and that the portal is being used throughout the United States.

“This allows labs to meet the requirements of the Cures Act without setting up their own systems,” Avunjian explained. “Once we are connected to the lab, we become their data repository. Each delay in providing patients their test results could place the lab at some risk for penalties. TestDirectly basically automates the entire process and removes the compliance risk for the lab.”