Saturday, March 09, 2019

by IRWIN Z. ROTHENBERG, MBA, MS, CLS(ASCP) 

As we enter the third decade of the twenty-first century, the practice of medicine continues to undergo rapid change, led by advances in molecular diagnostics and genetics, enabling the practice of personalized medicine; advances in mobile and point of care testing technology, enabling medical care in remote as well as non-traditional settings; an ever-more intensely information-driven society where ready access to one’s personal medical information  is now expected, enabling and encouraging patient involvement  in their own healthcare; and finally, change is led by the growing realization of financial constraints due to demographic changes leading to the adoption of a value-based approach to healthcare delivery.

While all aspects of healthcare delivery are changing, it is the clinical laboratory profession that is at the center of this dynamic due to the direct implementation of molecular diagnostic and genetic testing; the massive increase in patient data generated; the increased need for consultative physician communication; and the demand by patients for direct access to test ordering and test results. This has led to the increased visibility, importance, and responsibilities of the laboratory within healthcare delivery. 

Healthcare providers recognize the need for encouraging patients’ engagement in their own health care, for they know that an empowered patient:

• Understands their health condition and its effect on their body
• Feels able to participate in decision-making with their health care professionals
• Feels able to make informed choices about treatment
• Understands the need to make necessary changes to their lifestyle for managing their condition
• Is able to challenge and ask questions of the health care professionals providing their care
• Takes responsibility for their health and actively seeks care only when necessary
• Actively seeks out, evaluates and makes use of information

Patient Education Promotes Patient Empowerment

An estimated 7-10 billion laboratory tests are performed each year in the United States, and laboratory test results influence approximately 70% of medical decisions.  Yet the importance of lab tests reaches much further. They enable physicians and patients to:

• Identify disease and begin treatment earlier than ever before 
• Individualize care to meet the unique needs of the individual patients
• Monitor patient progress and adjust treatments accordingly
• Foster cost-savings and greater productivity in health delivery

When the patient understands the reasons specific tests are ordered, what the results mean, and how they are utilized in the diagnosis, treatment, and monitoring of their conditions, the more likely it is that the patient will do what is needed to attain and maintain a healthier state.  

Educating patients about the meaning of their laboratory tests is even more important now, because in the past, individuals had to visit a healthcare facility—a physician’s office, hospital, or clinical laboratory—to have blood or other specimens collected for clinical testing, and they had to wait a period of days to weeks for a call from their doctor with the results. 

What has changed?

Direct Access Testing (DAT)

Direct access testing (DAT), permits consumers to order laboratory tests directly from a laboratory without necessarily having to work with their healthcare provider. These test results may be used to monitor an existing health condition, identify a previously unknown medical disorder, or provide data regarding personal health characteristics. Direct access testing is a key element of ongoing efforts to increase individuals’ engagement in managing their healthcare, and it is critical that directly accessed test results are accurate and well understood. Laboratory professionals play a vital role in this process.

Currently almost 40 states and the District of Columbia permit consumers to order some or all of their laboratory tests directly— without the involvement of a physician. Similarly, the federal government joined this trend by issuing a regulation directing clinical laboratories to provide individuals with access to their test data upon request.  With these new policies in place, consumers are increasingly involved in guiding the health decisions that affect their lives.

Testing is no longer confined to the laboratory.  Technological innovations have led to testing that can be performed in other settings.

Point of Care Testing (POCT)

Consumers can also identify, order and buy laboratory services directly in a variety of convenient non-traditional settings, such as retail centers, pharmacies, mobile testing facilities, and wellness centers. These point of care testing (POCT) options provide individuals with immediate access to timely services and results.  Many of these tests are performed on waived devices, free from most Federal oversight requirements (as waived tests), by personnel with little or no professional experience. 

Direct to Consumer Testing (DTC)

Many more options exist for today’s consumers. Individuals now can buy over-the-counter test kits that allow them to collect a sample and mail it to a laboratory that performs the test, or, in some cases, conduct the test themselves in their own homes. This is known as Direct to Consumer Testing.  A major boost in utilization of DTC testing is the advent of home DNA testing. This provides information on an individual’s genetic disposition or risk for certain diseases or conditions.  This knowledge may help individuals make decisions about lifestyle choices. 

A concern about DTC laboratory testing:

While this can provide valuable information to individuals about their health status in a timely and convenient manner, questions have arisen about whether consumers have enough background knowledge and information to make sound decisions based on their test results. Consumers might not understand the limitations associated with some tests nor do they necessarily have the knowledge to interpret the tests without input from healthcare professionals. Over the past decade policymakers have been struggling to balance these concerns with a growing desire of individuals to take a more active role in making decisions affecting their health. Regardless of the method or setting, by which patients order their own tests, they must have the correct and complete information to understand what the results mean, when it is necessary to follow up with physicians visits, and when to seek immediate help.

Personalized Medicine: 

Personalized medicine, defined as the tailoring of medical treatment to the individual characteristics of each patient, is profoundly impacting all aspects of patient care, including prevention, diagnosis, treatment, and follow up. This approach relies on understanding how a person’s unique molecular and genetic profile makes them susceptible to certain diseases. 

If a person's genomic information indicates a higher-than-average risk of developing diabetes or a particular form of cancer, that person may choose a lifestyle, or sometimes be prescribed medications, to better regulate the aspects of health and wellness over which he or she has control. The person may benefit in the long run from making preventive lifestyle choices that will help counteract the biological risk. To have successful patient management of these potential health issues, there must be buy-in by the patient to the necessary regimens, including appropriate laboratory testing.  Educating the patient on how these tests work, what the results mean in terms of potential for developing these diseases, and the ramifications that can follow are vital.  

Test Reporting and Interpretation

Laboratory reports have been developed to provide specific information to highly trained and knowledgeable healthcare providers. As such, the reports typically provide a numeric value and a reference interval, and may also include a brief description of the result. This minimal information, when considered with all other factors such as any symptoms of disease that may be present, is sufficient for healthcare professionals to make clinical decisions. An individual consumer likely will need far greater context to fully understand the meaning of the test and to determine next steps. For example, an abnormal test result outside the reference interval may or may not indicate an underlying health problem. Alternatively, an individual may be falsely reassured by a test result in the normal range even when signs and symptoms warrant medical attention. Finally, consumers may not understand the limitations of the tests and therefore may interpret the results of their tests incorrectly.

Laboratory professionals can play a vital role in all aspects of this consumer-driven process, including educating individuals about the benefits and limitations associated with tests and assisting in the selection of the most appropriate test for that particular person. In addition, highly trained and experienced laboratorians can assist in the interpretation of test results and can provide consumers guidance on whether additional testing is required to confirm or clarify results, directing them to medical professionals for any necessary follow-up care. Patients can also access reliable information electronically. 

Resources for Educating Patients About their Test Results

In summation, patient education about lab testing can be provided in many ways, including through:

• The physician directly
• Laboratory staff and other ancillary healthcare providers who have the education to provide this information, such as nurses, and pharmacists
• Reference laboratories, where patients can visit directly or receive information via mail or online 
• Government information sites such as the FDA, and the CDC
• Private laboratory information sites, such as Lab Tests Online; or Health Network Laboratories 
• Laboratory testing information provided online by major medical clinics and hospitals
• Health insurance companies
• Laboratory profession sites such as the American Association for Clinical Chemistry (AACC); the American Society for Microbiology(ASM), and the American Society for Clinical Pathology(ASCP)
• Laboratory Accreditation organizations, such as the American College of Physicians (CAP), COLA and The Joint Commission 

Patient’s Preferences for Receiving Laboratory Test Results

An important consideration when setting up a system for educating patients about their lab test results is an awareness of preferences for receipt of these results.  In a study conducted in 2015 to identify these preferences, all 200 patients in this study preferred online delivery. Also, 82.5% (n = 165) preferred to receive both normal and abnormal test results this way. The main reason for receiving results online was time savings, which was reported by 77% of participants, followed by lowering the chance of missing the results (31%). About 40% of participants thought e-mail notification was more secure than accessing the results through a facility website.  Findings showed that although patients wanted to benefit from online services for receiving their test results, they were concerned about confidentiality and security. Before using online technologies, security measures necessary to protect patient privacy and to gain the trust of patients should be assured.

Conclusion

Patient education about their laboratory test results is the most effective response for patient empowerment by the healthcare profession, whether for testing performed in the traditional setting of a physician office laboratory, a hospital, or a clinic; or in a non-traditional setting such as a pharmacy, a shopping mall, or at home.  Patient education is vital for achieving the best value-based healthcare, and to promote long-term partnerships between physicians and their patients. 

IRWIN Z. ROTHENBERG, MBA, MS, CLS(ASCP) 

Irwin Z. Rothenberg is a Technical Writer/Quality Advisor for COLA’s Educational subsidiary, COLA Resources, Inc. (CRI), a leader in online continuing education for physicians, laboratory personnel, and allied health professionals.  CRI offers continuing education through online courses, informational products in both electronic and hard copy form, webinars on cutting-edge technology and regulatory issues, and CRI on-site Symposia for Clinical Laboratories, providing live educational sessions and interactive workshops with leading industry organizations. For more information, visit their website at www.criedu.org or call 1-800-981-9883.