By Deborah Borfitz
August 26, 2021 | When implementing a point-of-care testing (POCT) program in an organization with thousands of users across multiple sites, it helps to have a multidisciplinary committee to provide needed oversight, match the scope of testing to clinical need, and keep the lines of communication open, according to Edward Ki Yun Leung, Ph.D., director of the core lab at Children’s Hospital Los Angeles (CHLA). The hospital IT department is an “often overlooked” friend in the process.
Leung was speaking yesterday at the Next Generation Dx Summit on POC governance models, strategies, and informatics support, based on the experience of CHLA. While POC tests are available to everyone at retail pharmacies, rules and laws apply when they are used in a clinical setting, he says.
Accreditation is available via CLIA well as COLA and the Joint Commission, Leung says, but the regulatory laws are the same. The requirements are designed to ensure tests are validated before use, written procedures are in place, testing personnel are properly trained, test results are appropriately managed, and that biohazardous materials are safely handled and disposed of.
At testing sites, the focus is on the supervision of equipment and personnel and that quality and safety practices are comparable to a typical central lab, Leung shares. More broadly, regulations address the validation and monitoring of devices, evaluation of reagent lots and preventing use of expired products, and keeping temperature and humidity levels within the bounds established by test manufacturers.
Well-known interferences—drugs, metabolites, and diet—may not be “directly transferable” to POC devices, continues Leung. And even a good device can deliver poor testing results when administered by a poor-performing operator.
A study conducted by the Centers for Disease Control and Prevention suggests non-lab personnel trained by lab-trained consultants to administer a POC glucose test were the “intermediate performers” between the best (medical technologists in an accredited hospital lab) and worst (untrained non-lab personnel) performers, he adds. Oregon Health & Science University additionally reports that it sustainably elevated performance by standardizing training and competencies.
Whole Systems Approach
Key ingredients for a successful POCT program include understanding the regulations, good communication, and organization and planning, says Leung. CHLA has done all three by adopting a clinical governance model, leveraging the strengths of people in various departments.
Risk management, quality control, monitoring compliance, and continuing education are among the areas where the lab can take a leadership role, Leung says. Barriers to compliance include missing documentation, failure to capture all the necessary data, and technology being viewed by physicians and nurses as detracting from the “art of practice” and not easily integrating into the clinical workflow.
Leung is an advocate of the “whole systems approach” to moving from concept to practice. That means a full-scale evaluation of POCT prior to implementation, which is “difficult to achieve” due to the many silos in healthcare preventing cross-disciplinary understanding, he says.
A multidisciplinary POCT committee is invaluable in unblocking the communication channels, Leung quickly adds. The necessary members are administrators, the POCT manager or coordinator, nursing and medical staff, and representatives from the lab, education, quality, and IT and informatics. Ad hoc members hail from purchasing and distribution, pharmacy, and nutritional services.
The POCT manager or coordinator is a critical role, he notes, and works with clinical units to assist with training, validation, documentation, inspections, and quality improvement. The committee as a whole is responsible for the development of high-level policy, maintenance of best lab practices, ensuring compliance with policies, establishing a system for training, reviewing and approving new POC test requests, and addressing compliance issues.
Informatics Support
Results of POC tests variably make it into the electronic health record by being scanned from paper, directly entered, transmitted from a device through enterprise middleware (and often also vendor middleware), or cloud-based solutions, says Leung. “The complexity of point-of-care connectivity is that there are possibly hundreds of different devices that need to connect to at least one middleware solution.”
Informatics use cases for POCT listed by Leung are exceptions management, competency assessment for testing personnel, POCT analytics, and creating an interface for “dumb” (unconnected) devices.
Rules reside on middleware and, if not followed, result in a test being held for manual review, he explains. Such exceptions might be triggered by missing or incorrect patient information, ADT (admission, discharge, transfer) mismatch, or results being outside a predetermined range.
The problem is there is “no advanced rules engine in current middleware solutions, so there is no way to match up different exceptions,” Leung points out. The IT department at CHLA therefore came up with a few clever workarounds, including limiting the scope of information and using a medical record number in the absence of an account number, to deal with most of the mismatches.
For competency assessments, IT is helping to develop a way to electronically record six training elements CHLA requires annually (semi-annually the first year) for personnel administering either CLIA-waived or non-waived testing, he continues. More than 2,000 CLIA-waived tests are done by the institution.
In terms of analytics, IT is supporting new POCT requests, optimization of POC clinical workflow, continuous validation of POCT performance, and monitoring of CLIA-required Individualized Quality Control Plan parameters, Leung says. To interface non-connected devices, the team is leveraging the “other test entry” field available in connected devices to eliminate results going to flowsheets and encourage real-time data entry.