Laboratory experts examine point-of-care testing
The substantial impact of point-of-care testing (POCT) options in the healthcare industry has been unprecedented, especially in clinical laboratories. Not only has POCT allowed for increased convenience for the patients on-site, at the bedside and even off-site, but the evolution of these tests mirrors the standard for continued growth in the clinical industry. ADVANCE recently spoke with Roger L. Bertholf, PhD, DABCC, FACB, FACSc, professor of pathology and laboratory medicine at the University of Florida College of Medicine; and director of clinical chemistry, toxicology and point-of-care testing at UF Health Jacksonville; and Olga R. Camacho-Ryan, MT(ASCP), MBA, lab quality manager at UF Health Jacksonville, about some regulatory concerns in the delivery of POCT and the respective roles of both waived and non-waived testing.
“All aspects of clinical laboratory practice are regulated by a combination of federal and state authorities; POCT is no exception,” said Bertholf. “There are certain regulatory requirements unique to POCT, mostly related to the qualifications and competency of individuals performing these tests.”
One of the beneficial mainstays of POCT is that medical laboratory professionals (MLPs) don’t have to administer the test directly-instead focusing mainly on the results provided by the tests. Other healthcare professionals, such as nurses or even physicians, typically perform waived POCT testing. Despite the decreased responsibilities from the clinical lab, there are also many obstacles that arise from having non-laboratory staff perform laboratory testing. Within a hospital system, state and CLIA guidelines provide oversight – along with the standards of the facility and the manufacturer’s recommendations – for both waived and non-waived testing. Off-site, however, these become significantly harder to monitor for quality purposes.
“POCT presents enormous challenges with regard to quality,” Bertholf said. “These challenges begin with convincing non-lab personnel that every test, whether at the point-of-care or in the central laboratory, has the potential for misguiding medical care if the test is not carefully and properly performed.”
The issue with CLIA guidelines is that they only apply to non-waived tests, which have greater oversight and usually require a laboratory professional to perform the test. Waived testing, on the other hand, is reserved for “simple point-of-care laboratory tests that are exempt from most federal and state oversight.”1 As such, these tend to be administered by non-laboratory professionals, but the lack of oversight has left many laboratorians uncomfortable.
“The new CLIA quality system is intended to help a lab identify failures in a testing process, which can, in turn, drive quality and ensure high patient test result reliability,” explained Camacho-Ryan. “Unfortunately, POC waived tests are not subject to CMS’ IQCP requirement.”
Recent regulatory measures and proposed guidelines from the FDA have also raised red flags in the laboratory community, including the proposed rules on laboratory-developed tests (LDTs).2 With the exception of certain rare in-house LDTs, the overall impact on POCT should be minimal according to Camacho-Ryan and Bertholf.
“Today, there are only a handful of POC tests, such as manual pH testing of ocular and other body fluids such as vaginal secretions, semen, etc., that could be considered in-house LDTs,” said Camacho-Ryan. “Yet, The FDA has generally not exercised enforcement discretion to ensure compliance with the regulatory requirements governing the analytical effectiveness and clinical validity of such tests.”
Regardless of the regulatory issues surrounding POCT options, the endgame is the outcome for patients. Labs must be prepared to train the non-lab personnel responsible for delivering these tests to the highest quality standards. Moreover, as Bertholf noted, it is vital to communicate the importance of properly administering and gathering POCT options to the healthcare staff delivering them as the results will directly impact patient outcomes.
“Training POCT personnel in the proper ways to perform these tests is the single most important element in the success of a POCT program,” said Bertholf. “Regulatory authorities clearly recognize its importance as well, as demonstrated by their intense focus on assessment of competency.”
The clinical laboratory is responsible for so much of the data and patient information utilized during treatment. In the lab, MLPs are rigorously trained, certified and reviewed to ensure the most accurate results and analysis is available. Ensuring consistent competency and quality in POCT requires extensive training and enthusiasm throughout the entire healthcare organization.
- Beigel, D. With waived testing, quality must be job one. Available at: http://laboratory-manager.advanceweb.com/Features/Articles/With-Waived-Testing-Quality-Must-be-Job-One.aspx
- Neff Newitt, V. A Tale of Two Assays. Available at http://laboratory-manager.advanceweb.com/Features/Articles/A-Tale-of-Two-Assays-Part-1.aspx