As point-of-care testing (POCT) continues to grow in hospitals, physician offices, retail clinics, and other settings, professional roles are also evolving to keep pace with changes in this technology, the complexity of testing, and the need to engage with clinicians.
Once consisting of just a handful of assays, POC tests now number in the hundreds, ranging from blood glucose monitoring to rapid strep to prothrombin time/international normalized ratio (PT/INR). The market for POCT grew by an estimated 9.3% between 2013 and 2018, and worldwide, the POCT and rapid diagnostics market is projected to top $38 billion by 2022, according to industry experts.
With the growth of POCT comes challenges for laboratory directors, POC coordinators, and other professionals responsible for ensuring that instruments are maintained and that those performing testing are trained, follow quality control protocols, and remain in compliance with clinical and regulatory standards.
Brenda Suh-Lailam, PhD, DABCC, FAACC, director of clinical chemistry and point-of-care testing at the Ann & Robert H. Lurie Children’s Hospital of Chicago, said much of her time is spent ensuring the quality of testing done at patients’ bedsides by defining, implementing, and monitoring the standards of performance. Ensuring that nurses and others who do near-patient testing maintain their competency and are up to date on new technology and advancements in testing requires laboratorians to engage with healthcare professionals more than ever before.
“We really are consultants to clinicians, providing guidance on appropriate test types and test interpretation for example,” Suh-Lailam said. “More and more, we’re seeing new POC tests being developed, even in areas where we haven’t traditionally seen POC use. For example, to facilitate cancer management, microfluidic methods are being developed to detect circulating tumor cells at the POC. We are already engaging clinical teams as we work to ensure the quality of our POC program, but as new tests are acquired and the number of personnel performing testing grows, we will need to engage them even more.”
Being able to hire healthcare professionals who have advanced knowledge in POCT would be a huge advantage for Lurie Children’s Hospital, she added, noting that she hopes for the hospital’s POC coordinator to complete AACC’s new POCT professional certification program. This first-of-its-kind program, launched last year, certifies testing personnel who have demonstrated competency in all areas of POCT, including regulation and compliance, quality management, education and training, instrument selection, validation and verification, and connec-tivity and information technology.
“I think it’s great that we finally have a program that focuses on POC testing because it has different challenges from regular lab testing,” Suh-Lailam said. “POC testing is really exploding, and with this comes more personnel performing testing as additional hospital areas acquire POC tests.” The more staff there are performing POCT who have not been trained in the laboratory, the more pre-analytic, training, and competency-related challenges the POC coordinator will have to handle, she noted. “Going through a POC-specific training like this one will equip the POC coordinator to be able to take on the challenges that come with POC growth.”
A Path to Leadership Through Professional Certification
Debra Petracco, MT(ASCP), CPP, POC coordinator at Presence Saints Mary and Elizabeth Medical Center’s Alverno Laboratory in Chicago, and one of the first POC testing professionals to be certified through AACC’s professional certification program, said she feels the designation provides added value in her role as a POC coordinator and also gives her more job security. “I’ve been doing POCT for a long time, and I have always tried to keep up with the changes,” Petracco said. “Certification makes me feel more confident that I am doing things the right way. I feel like it gives me a boost in my position.”
To be eligible for POCT board certification, applicants must have a 4-year degree in a biological or physical science and 2-3 years’ documented experience in POCT. A healthcare expert who passes the certification exam is known as a Certified Point-of-Care Testing Professional (CPP). The POCT professional certification program is available to anyone with experience performing POCT, such as laboratory managers, nurses, and pharmacists.
“The exam is very thorough in testing your knowledge,” Petracco noted. “There’s a lot about chemistry, coagulation, validation processes, and instrumentation.”
Leh Chang, MT(ASCP), CPP, technical supervisor for POC at Loma Linda University Medical Center in California, said she sees receiving the professional certification as a way to validate her knowledge about POCT. She believes the certification could one day become a requirement for someone overseeing POCT. “I also think there are more opportunities to involve POCT professionals, such as providing suggestions on device and testing development,” Chang said.
Cathy Guaglianone, MT(ASCP), CPP, POC supervisor for Kaiser Permanente in Fresno, California, said becoming a CPP has increased the confidence other clinicians have in her. “I wanted to be more invested in my role as a POC coordinator,” she said. “I feel the more knowledge and education you have in a field, the more you can improve patient outcomes.”
To prepare for the professional certification exam, Petracco, Chang, and Guaglianone reviewed published information on POCT, including the materials suggested on the POCT professional certification website. Petracco also completed AACC’s online POCT specialist certificate program, which consists of eight self-paced courses, before sitting for the professional certification exam.
POCT as a Separate Discipline
Not only are POCT professional roles evolving but so is the way POCT is treated in some health systems. Cleveland Clinic – Abu Dhabi (CCAD), for example, has established a separate POCT department. While POCT often is a subdiscipline of clinical chemistry, it also incorporates testing involving other departments, such as hematology, microbiology, and molecular biology, emphasized Jonathan Harris, senior manager of point-of-care testing and quality, who said hospital leaders were unanimous in their support of treating POCT as a discipline in its own right. The department includes a POCT medical director, POCT manager, and dedicated POCT technologists.
CCAD’s POCT program is accredited by the College of American Pathologists (CAP), which was especially challenging because none of the POCT department personnel were familiar with CAP requirements and associated language. The POCT department in 2017 also received ISO 22870 and 15189 accreditations with the United Kingdom Accreditation Service, which Harris called major milestones for any POCT program.
“Only a handful of hospitals have obtained this challenging requirement. Having dedicated resources gives us the ability to achieve this,” he said. “We have a constant focus on innovation and continual improvement. Typically, in POCT, you are putting out fires, but we are able to focus on doing things better.”
Harris added that the POCT department is working on establishing clinical metrics in collaboration with nursing and medical colleagues. This adds real value to the service they provide, he said. Examples include protocols and metrics dealing with the limitations of glucometers in critically ill patients, as well as glucometrics focusing on how patients are treated for hypoglycemia and the total number of hypoglycemic events by department. “The clinical teams now see us as valued partners in the delivery of patient care,” he said. “This focus on the clinical is leading to improved patient care and outcomes.”
Education Is Key
Both Suh-Lailam and Harris agree that there is a need for increased focus on POCT in the educational system. Many colleges and universities fail to properly teach POCT methods and protocols, they said. In fact, sometimes the subject is not covered at all.
“There’s a huge gap in knowledge,” said Harris, who would like to see POCT professional certification become mandatory for testing professionals. “Lab and nursing leadership need to be educated as to what us POCT personnel do. POC seems deceptively simple but has a huge impact on patient care.”
Suh-Lailam agreed. “We definitely need more trained POCT professionals,” she said. “The more people who become certified in POCT, the more trained people there will be to develop quality POC programs that add value to patient care.”
Kimberly Scott is a freelance writer who lives in Lewes, Delaware.+Email: [email protected]