The benefits of point-of-care (POC) testing may seem obvious. Because the testing is done at the patient's side, immediate decisions can be made for patient care potentially resulting in overall improved outcomes. Beyond that, the need for follow-up may be reduced which can result in more efficient use of physician's time and improved overall patient satisfaction.
In order to realize the benefits of POC testing, there must be confidence in the quality of the results. While laboratorians don't usually administer point-of-care (POC) tests themselves, they're always responsible for the quality of the results, often for numerous decentralized clinics or testing locations. However, laboratorians need not be at the mercy of other health professionals to ensure high standards; provided they follow the right steps, laboratorians can ensure a high quality at every POC site.
As lab leader Alison Woodworth, PhD, Associate Professor of Pathology and Laboratory Medicine at the University of Kentucky, explains, there are four ways that lab leaders can get a handle on POC testing quality and improve care for patients.
The quality of your POC testing is only as good as the people doing the work on the ground. Be sure to assemble a multidisciplinary team that can both select appropriate POC tests for clinical use and confidently oversee operations. This team should include laboratory technologists, ambulatory clinic care specialists, and administrators, as well as the physicians and nurses performing POC tests themselves.
At the helm of the operation, be sure to select a medical director with extensive laboratory experience and training in the laboratory that matches the testing menu. If high complexity testing is offered, the medical director should be familiar with those tests. For instance if the tests are in microbiology, molecular pathology, pathology or other laboratory specialties that are deemed highly complex, the medical director should have knowledge and training at that level. The medical director must also be a team player, able to facilitate discussions with both physicians and administrators at the highest level.
One of the most important responsibilities of your team, before testing even begins, is to determine which POC tests are appropriate to administer at which sites, with which staff members, and for which patient cases. If certain POC tests are unlikely to produce reliable results, aren't certain to improve care, are too costly, or may not be easily performed by your staff, they may not be good candidates for POC sites. As Robert Sautter, PhD, of RL Sautter Consulting, notes, "[Your team] needs to know the limitations of that test, it's reliability, how it compares to the in-laboratory test, the cost as compared to the laboratory, and what that will do to the bottom line in terms of getting that patient treated accurately." Choosing ideal tests, now, is instrumental to maintaining consistency and quality, down the road.
In order to guarantee trustworthy POC test results, the professionals administering the tests must have proper training and accreditation—a legal requirement, but often a significant hurdle. The first step is making sure that POC testing personnel have the proper licensing for performing POC tests. Although proficiency testing might not be required for POC testing by complexity (moderate and highly complex testing require it), you may choose to perform regular proficiency testing at your tests sites, ensuring that there is no ambiguity as to how tests should be performed or results interpreted. It's also a good idea to send POC coordinators, along with the medical director, to regularly visit each site and personally educate testing staff.
Apart from staff, you also need to validate the performance of the POC testing assays themselves. By running periodic quality controls at predefined periods, you can help to guarantee that results are both accurate and clinically meaningful across the health system. The more frequent and rigorous the quality testing, the better.
It's easiest to establish organizational benchmarks for quality when the results of your POC tests are transferable across testing sites. Therefore, you should standardize both the platforms and procedures of POC testing, helping you to more easily understand and compare test results from clinic to clinic. This also enables you to train POC testers and perform quality control in a consistent manner. All of this not only builds confidence in your test results, but also helps streamline POC operations; for instance, you can order reagents and instruments in bulk for significant cost savings.
To maintain quality, it's vital that clinics are held accountable to organizational and legal standards. Build out a robust reporting infrastructure enabling you to closely track POC testing sites, ensuring that clinics perform in-line with their peers, maintain compliance with federal standards, and regularly perform quality control tests. The goal, of course, is not to punish aberrant sites, but rather to intervene as quickly as possible in order to bring testing quality up to acceptable levels.
Managing Risk at the Point of Care
By Sarah Njoroge, PhD and James H. Nichols, PhD, DABCC, FACB
According to The Centers for Medicare and Medicaid services (CMS), “The ‘Individualized Quality Control Plan’ (IQCP) is the Clinical Laboratory Improvement Amendments (CLIA) Quality Control (QC) procedure for an alternate QC option” in the laboratory. In this article, the authors describe how to implement the IQCP so laboratories can perform proper risk assessments.
Monitoring Point-of-Care Testing Compliance
By Olga Camacho-Ryan, MBA, MT(ASCP), and Roger L. Bertholf, PhD, DABCC
This article describes eight Point-of-Care testing compliant essentials, from quality control and device management to data monitoring and remote data access.
Practical challenges related to point of care testing
By Julie L. V. Shaw
Point-of-Care testing has become a mainstay in hospitals because it offers faster turnaround times and requires lower sample volumes. However, the conveniences of POCT come at a price. This article reviews common challenges of POCT and explains how laboratorians can play a role in ensuring quality results.