Many individuals in health care have stated, “If you’ve seen one POCT program, you’ve seen one POCT program.” The programs are all so different in size, scope, and type, even within a single institution or organization.
As this division of the laboratory has grown in the past 10 to 15 years, so have the number of devices from which to choose. Now the multitude of devices for the same analyte have so many operational and connectivity differences that it makes the process of device selection complex and daunting.
Point-of-care coordinators and ancillary testing personnel must not only choose, implement, and monitor point-of-care testing (POCT) devices, but also cooperate with many different departments within a health care institution in areas such as quality assurance, regulations, and accreditation.
Additionally, physicians can be enticed by vendors with devices that appear to have all the attributes needed to support the test they want but may not live up to the physician’s expectations.
Without going through the proper processes, the implementation of a new point-of-care (POC) test chosen by an individual can have a negative impact on staff, patient care, and financials.
A guide to help in the proper selection of a POCT device has been sorely needed and is now available.
Earlier this year, the Clinical and Laboratory Standards Institute (CLSI) published Selection Criteria for Point-of-Care Testing Devices; Approved Guideline (POCT09-A) to enable health care organizations to evaluate, select, negotiate, and purchase POCT instruments that meet the specific needs of that institution.
It also provides a number of checklists, worksheets, comparison grids, and evaluation sheets – the very tools needed to address the issue of selecting the right POCT device.
As with all CLSI documents, this guideline was developed through a consensus process with expert international input from providers, industry, and government.
Investing time and effort
Before the device-selection process is spelled out step by step, a nice overview of POCT is presented to allow individuals new to this arena to get a handle on the basics.
To understand the device-selection process, it is important to note that in some situations, there is no positive benefit to using POCT devices. To realize this, institutions must ask themselves, “Why POCT?” and use the “determination of need” request available as an appendix within this document. Once this is filled in, it may show no justification and no positive patient impact for obtaining and maintaining a POCT device. If patient care is not positively impacted, the POCT approach may be inappropriate and unnecessary.
Solid documentation developed during the determination of need can demonstrate the potential for the positive benefits of POCT in terms of finances, operations, and most critically, patient outcomes. Without this documentation, a physician may be sold a POCT device and later discover a negative impact on time, maintenance, regulatory oversight, and cost.
After the overall need has been determined, it is important to think about the clinical and operational needs, the device selection itself, regulatory and accrediting requirements, and the implementation to get the device up and running within an institution. Without these detailed components, it is difficult to effectively select and implement a device.
The clinical need addresses such things as manufacturer support information, test use characteristics, patient demographics, and the impact on medical outcomes expected.
The operational needs address things such as convenience, time management, inventory management, supply storage, and other important factors.
Once the clinical and operational needs are assessed, the identification of device candidates can proceed. A number of sources can help in selecting the devices that may be the right fit for the defined needs. These include laboratory periodicals and buyers guides, vendor websites, medical alert websites to look for recalls and complaints, and peer-reviewed literature.
Once a short list of devices has been selected using the clinical and operational needs assessments, it is time to perform a side-by-side comparison of the instruments. The information that has already been gathered now can be placed in a spreadsheet that enables potential buyers to compare the device characteristics.
More details about the physical features, performance claims, calibration, and quality control (QC) features, software and firmware features, consumable storage, shelf life, preparation, and vendor support are specifically addressed through this spreadsheet.
During the side-by-side comparison, the cost of the device, testing, and all the ancillary activities that can have a cost impact should be addressed. Direct costs such as reagents, supplies, and labor need to be added to indirect costs such as depreciation, maintenance, and site preparation.
Implementation costs also need to be considered when preparing to introduce a new POCT device into an already existing workflow on the patient floors. Connectivity costs and involvement of the information technology department must be considered. Formulas for determining these costs are provided using easy calculations in the appendix of this document.
The data from the side-by-side comparison and cost analyses will lead to a “short list” of potential devices that can now go to the next phase, which includes a complete evaluation of the devices from the operator and the laboratory perspectives. The operators who will use the devices on the floor need to be trained and feel comfortable with the devices. These individuals look at time-to-result, preanalytical processes, and ease of use. The evaluation from the laboratory needs to include precision, verification of reportable range, as well as regulatory and accreditation requirements.
The laboratory also needs to focus on the validation of accuracy using the slope, intercept and R values, and the validation of precision measured in percent coefficient of variation. During this evaluation, the need to implement altered target times and normal ranges between the current and new systems can be determined.
Once a device has been selected, it is important to follow proper implementation steps that coordinate with the facility’s procedures and POCT policy. The selection of a device can be done effectively, but if the proper implementation process is not followed, even the best device may not live up to the improvement in outcomes anticipated.
Maintenance, QC, and operator records, and proper reporting of results are additional pieces not addressed in this document but must not be forgotten.
For a continuing process improvement plan to be complete, the last phase is the corrective action steps that need to occur if there is an issue or a problem with any of the POCT devices.
Although the steps outlined in this new guideline may seem complex, investing the time and effort before implementing a new POCT device will enable the best possible solution for each institution.
Marcy Anderson, MS, MT(ASCP), is director of development and education for Clinical and Laboratory Standards Institute, Wayne, Pa. Marcia L. Zucker, PhD, director of clinical support, Response Biomedical Corp., Vancouver, was chair holder for the CLSI document. Visit www.clsi.org for more information.
