The ability to perform laboratory testing with a short turnaround time and close to the patient is high on the list of desirables for most clinicians. They argue that point-of-care testing (POCT) can contribute significantly to improved patient care, including better outcomes due to a more rapid diagnosis and treatment. In recent years, the menu of tests available through point-of-care devices has expanded tremendously due to increased sophistication, ease of operation, and more robust technology.
The number of devices, device attributes, operational concerns, and connectivity attributes can make the selection process daunting. Therefore, many health care organizations, laboratory professionals, and clinicians continue to experience challenges in developing, implementing, and maintaining a credible POCT program that enhances patient care while meeting quality and regulatory standards.
The Clinical and Laboratory Standards Institute (CLSI) recently published a definitive document to address this important need. The document, Selection Criteria for Point-of-Care Testing Devices; Approved Guideline (POCT09-A),1 was developed by a group of international experts from health care, industry, and government, using a consensus process.
Marcia L. Zucker, PhD, chairholder of the CLSI subcommittee that developed the document, explains that POCT09-A is significant in several ways. Perhaps most importantly, it is the first guideline dealing with the selection of POCT devices in such a comprehensive manner. It addresses all the important steps such as evaluation, selection, negotiation, and consideration of information management needs. The document incorporates a criteria checklist, which is suitable for use by laboratories of all sizes and can either be used as published or customized to meet individual needs.
“There are a number of appendices, checklists, and forms, all of which laboratory professionals will find very useful,” continues Dr. Zucker. “In fact, the very first form deals with determination of the need for a point-of-care device. By simply going through this form, an organization can document whether or not there is a real need for such a device in a particular setting.” This step might justify the need for a fuller evaluation, indicate abandonment of the project before additional resources are consumed, or possibly even simply suggest changing current organizational processes.
“It is ultimately about a cost-benefit analysis of how to realistically provide the best patient care possible,” according to Dr. Zucker. “So, initially, the organization should decide if there is really a need for a certain test or device. They should ask themselves ‘will patient care be positively impacted?’ They must also be very clear about who will be responsible for performing the tests on a daily basis, and whether there will be any potential cost savings—or maybe any additional costs—compared to their current system. Again, regardless of the reason for the initial request for POCT, is this the very best way to provide patient care in this population, in this setting, and in this organization?”
Dr. Zucker believes that conducting initial due diligence and providing clear documentation cannot be overemphasized. If there is a net benefit in terms of patient outcome, finances, and operations, then it is easier to obtain the buy-in of all major stakeholders in the organization; even those who might have been initially skeptical. On the other hand, if the disadvantages outweigh the advantages, the existence of sound documentation also helps to make a more powerful argument. One example cited by Dr. Zucker is that clinicians sold (by a vendor) on adding a point-of-care test are not always aware of all the downstream costs, staff training, or regulatory and quality implications until they see the full organizational analysis in writing.
POCT09-A will be of benefit to various constituencies. For point-of-care coordinators and laboratory management, it provides a systematic guideline of evaluating, acquiring, and implementing POCT—or documenting why optimum patient care can be achieved in other ways. For end users and clinicians, the document contains some essential background on POCT, optimizing devices to the setting and patient population served. Additionally, it addresses the importance of considering aspects they might not otherwise have been aware of, such as personnel needs, associated risks, ensuring patient safety, and regulatory and quality compliance.
Vendors are provided with insight on the interests of facility management, the laboratory, and the end user. Those without a clinical laboratory background can better tailor sales presentations toward a prospective customer. They can address concerns upfront, encourage customer feedback, and also strategize on how to provide ongoing support. On the other hand, regulatory agencies will find ideas on adopting tools laboratories might use to verify and document that they meet essential aspects of regulations.
Asked how the guideline is not meant to be used, Dr. Zucker explains further. This guideline purposely excludes discussion of centralized laboratory analyzers, noninstrumented testing (such as dipsticks, visual change-only devices), and handheld glucose meters. Although the approved guideline is not a recipe book or procedure manual, according to Dr. Zucker, it does provide much information that is immediately usable by most laboratories in some form. “If any item or discussion appears impractical for your institution or your particular need, there is a lot of other information to use—and still meet all the recommendations.” It can be used to compare the features of various devices side by side using the same criteria. It can also form the basis of documentation for regulatory agencies and provide ideas to be incorporated into organizational policies and procedures, even for the devices and tests specifically excluded from detailed discussion.
This CLSI guideline provides the most comprehensive guidance for the selection, evaluation, and implementation of any contemplated point-of-care device, with customization possible based on the organizational size and setting. It contains valuable information for clinical laboratorians, management, clinicians, end users, and device manufacturers. Like other CLSI guidelines, POCT09-A is suitable for international application.
Marcia L. Zucker, PhD, is Director of Clinical Support at Response Biomedical Corporation in Vancouver, British Columbia, Canada.
CLSI is a global, nonprofit organization promoting the development and use of voluntary consensus standards and guidelines within the health care community.