ASCLS Voice: Transparency Ensures Patient Safety in Clinical Labs

The Thernos scandal highlights the importance of clinical laboratory professionals in providing safe testing information.

Over the past couple of years, there have been numerous articles about Theranos in scientific literature as well as mainstream media. Articles in scientific journals have questioned the lack of independent evaluation, validation of test results and peer review of the Theranos technology that is customary in science and medicine.^{1,2,3,4,5,6,7,8,9} Articles in Fortune and The Washington Post exposed problems at Theranos.^10,11,12,13 Although none of these articles infer that testing in all clinical laboratories have problems, however, it is critical to remind the public who is responsible for the quality of clinical laboratory testing.

Clinical laboratory tests are not a commodity; they are sophisticated analytical procedures performed on blood and other body fluids that permit clinicians to assess a patient’s health status, determine a diagnosis and evaluate treatment effectiveness.¹⁴ Clinical laboratory testing is a key component of healthcare delivery and efforts to reduce it to a commodity have the potential to do significant harm to patients.

A clinical laboratory test is a clinical laboratory test regardless of where procedures are performed— be it in a hospital laboratory, outpatient medical office, independent laboratory, walk-in clinic or a patient’s home.¹⁵ Advances in technology permitted the expansion of clinical laboratory testing beyond the walls of the hospital laboratory and increased the number and complexity of tests performed in hospital and reference laboratories. The benefits of which include molecular testing to identify infectious agents and genetic testing to pinpoint changes in the genome that impact a cancer diagnosis. The expansion of testing beyond the walls of the hospital clinical laboratory does not mean that standards of good laboratory practice should be bypassed or eliminated. Doing so can result in patient harm.

Clinical laboratories may seem like black boxes where specimens arrive and test results leave printed on a laboratory report or released to an electronic medical record. The science that happens in clinical laboratories every day throughout the United States (and the rest of the world) is the work of professional scientists. It is the responsibility of clinical laboratory professionals, medical laboratory scientists and medical laboratory technicians, along with clinical pathologists and other clinical scientists. They are key members of the healthcare team responsible for patient safety with respect to clinical laboratory testing, ensuring that each patient receives care that is safe, effective, patient-centered, timely, efficient and equitable.¹⁶

Ensuring patient safety requires the monitoring of the entire laboratory testing process, beginning with identifying the correct test (often the test request does not match the type of specimen collected or diagnosis indicated on the test requisition); collecting the appropriate specimen properly (ensuring specimen integrity—refusing to analyze specimens that are hemolyzed, clotted or insufficient); analyzing the specimen (evaluating quality controls procedures prior to analyzing specimens); evaluating the test results for clinical significance (validating unexpected test results, evaluating for compatibility with life); and reporting the test results to clinicians.

Before new analyzers and methods are sold to clinical laboratories, rigorous testing and validation is performed by the manufacturer to determine whether procedures are analytically valid. The U.S. Food and Drug Administration (FDA) has oversight over this approval, as well as in determining whether a procedure qualifies for waived status. When clinical laboratory professionals purchase a new instrument for use in their laboratories, they validate that the analyzer performs appropriately for each analyte assayed on the instrument. They ensure that each test result is accurate—does it measure what it is intended to measure? Are the results consistent, or do they increase or decrease with time? How do the test results for the new analyzer compare with the older analyzer that is currently in use?

Clinical laboratory professionals submit their entire laboratory process to peer review through participation in proficiency testing programs, along with bi-annual accreditation that evaluates the entire laboratory. Each of these programs provides evidence to the public as to the quality of the test results. Laboratories that do not comply with these requirements or receive sanctions are listed on the Centers for Medicare and Medicaid Services (CMS) website.¹⁷ This transparency is important to ensure patient safety.

Clinical laboratory professionals base their practice upon a code of ethics—duty to each patient whose specimen they analyze; duty to their colleagues and the profession through honesty, integrity and competence when performing each procedure; and duty to society through their compliance with laws and regulations pertaining to clinical laboratory science.¹⁸

Although the media has exposed Theranos’ problems, and CMS has fulfilled its regulatory responsibility, it is critical that we uphold our promise to our patients described in our code of ethics, work on interprofessional healthcare teams to communicate the value of laboratory test information and continue to improve patient care as members of the clinical laboratory science profession. Consider this an invitation to put this on your list of 2017 New Year’s Resolutions. Clinical Laboratory Professionals are the key to safe laboratory test information.

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References

1. Plebani M. Evaluating and using innovative technologies: a lesson from Theranos? Clin Chem Lab Med 2016; 53(7): 961-962. DOI 10.1515/cclm-2015-0411
2. Diamandis EP. Theranos phenomenon: promises and fallacies. Clin Chem Lab Med 2015: 53(7): 989-993. DOI 10.1515/cclm-2015-0356
3. Li M, Diamandis EP. Theranos phenomenon–part 2. Clin Chem Lab Med 2015; 53(12): 1911-1912. DOI 10.1515/2015-0775
4. Li M, Diamandis EP. Theranos phenomenon–part 3. Clin Chem Lab Med 2016; 54(5): e145-e146. DOI 10.1515/cclm-2016-0107
5. Diamandis EP. Theranos phenomenon–part 4: Theranos at an international conference. Clin Chem Lab Med 2016; 54(8): e243-e244. DOI 10.1515/cclm-2016-0389
6. Lackner KJ, Gillery P, Lippi G, Melichar B, Schlattmann P, Tate JR, Plebani M. The Theranos phenomenon, scientific transparency and freedom of speech. Clin Chem Lab Med 2016; 54(9): 1403-1405. DOI 10.1515/cclm-2016-0520
7. Diamandis EP, Plebani M. Theranos phenomenon–Part 5: Theranos’ presentation at the American Association for Clinical Chemistry Annual Conference 2016. Clin Chem Lab Med 2016; 54(10): e313-e314. DOI 15.1515/cclm-2016-0737.
8. Ioannidis JPA. Stealth Research, Is biomedical innovation happening outside of the peer-reviewed literature? JAMA 2015; 313(7): 663-664
9. Ioannidis JPA. Stealth Research and Theranos, Reflections and update 1 year later. JAMA; 316(4): 389-390
10. Parloff R. This CEO is out for blood. Fortune. June 12, 2014. http://fortune.com/2014/06/12/theranos-blood-holmes/. Accessed December 30, 2016
11. Parloff R. How Theranos misled me. Fortune. December 17, 2015. http://fortune.com/2015/12/17/how-theranos-misled-me-elizabeth-holmes/. Accessed December 30, 2016.
12. Cha AE. To your health: Harsh Sanctions for Theranos founder Elizabeth Holmes: Two year ban on running labs. The Washington Post. July 8, 2016. https://www.washingtonpost.com/news/to-your-health/wp/2016/07/08/harsh-sanctions-for-theranos-founder-elizabeth-holmes-two-year-ban-on-running-labs/?utm_term=.240ac7bd84dc. Accessed December 30, 2016.
13. Cillizza C. The worst year in business: Elizabeth Holmes. The Washington Post. December 11, 2016. http://www.washingtonpost.com/sf/opinions/2016/12/06/2016-worst-year-in-washington/?tid=a_inl#holmes. Accessed December 30, 2016.
14. American Society for Clinical Laboratory Science. Position Paper: Value of clinical laboratory services in healthcare. 2005. http://www.ascls.org/position-papers/177-value-of-clinical-laboratory-services/153-value-of-clinical-laboratory-services. Accessed December 30, 2016.
15. Clinical Laboratory Improvement Amendments of 1988. Public Law 100-578. https://www.gpo.gov/fdsys/pkg/STATUTE-102/pdf/STATUTE-102-Pg2903.pdf. Accessed December 30, 2016.
16. American Society for Clinical Laboratory Science. Position Paper: Patient safety and clinical laboratory science. 2015. http://www.ascls.org/position-papers/185-patient-safety-clinical-laboratory-science. Accessed December 30, 2016.
17. 17.Centers for Medicare and Medicaid Services. Laboratory Registry. https://www.cms.gov/Regulations-and -Guidance/Legislation/CLIA/Laboratory_Registry.html. Accessed December 30, 2016.
18. American Society for Clinical Laboratory Science. Code of Ethics. http://www.ascls.org/about-us/code-of-ethics. Accessed December 30, 2016.