Applying Laboratory Quality Principles to Real World Point-of-Care Testing Systems
August 3, 2023
Kathleen David, MT (ASCP)
Jeanne Mumford, MLS (ASCP)
Upon completion of this article, the reader will be able to:
1. Discuss the need for a quality management system (QMS) in point-of-care testing (POCT).
2. List the quality system essentials that are recommended for a laboratory QMS.
3. Describe how each quality system essential can be applied to a POCT program.
4. Differentiate between quality assurance (QA) and quality control (QC).
In the Continuing Education article in the April 2023 issue of MLO, laboratory quality management systems were discussed and details provided on each component.1 When it comes to maintaining quality in point-of-care testing (POCT), we are often presented with very different sets of challenges than our laboratory counterparts. While POCT is subject to the same CLIA regulations, minimal guidance is offered on how to meet those needs in POCT systems. One challenge is that testing personnel who perform POCT are non-laboratorians, meaning that some of the guidance available may not be written in language that non-laboratorian staff can easily understand. Another is that POCT is performed in a variety of settings that can include hospital units, ambulatory sites such as doctors’ offices, and a variety of other settings. A final challenge is understanding local, state, and/or federal laboratory regulations. Laboratory staff will have a basic understanding of regulations through schooling and on-the-job training, however, clinical staff whose background and training is strictly focused on patient care, may not have the same knowledge of these requirements.
When setting quality standards in POCT, no national standards exist for quality improvement management. The most common metrics measured for improvement across POCT systems include patient identification (ID) errors, ID limit errors, specimen collection errors, and manual test result entry errors. As stated in the July 2020 “AACC Guidance Document on Management of Point-of-Care Testing” published in JALM, “A quality assurance program is vital to managing errors and the reliability of POCT results.”2 The purpose of this article is to directly compare the contents of the April 2023 MLO article on laboratory QMS in order to help the reader relate the Quality System Essentials that can be utilized in a POCT system. We will specifically discuss how the key components of a laboratory QMS can be developed to addresses the many challenges in POCT.3