CONTINUING EDUCATION :: POCT
Figure 1. POC devices connected to a single data manager.
POCT device or be a manual, lateral flow-type test. Whether your lab is inspected by the College of American Pathologists (CAP), The Joint Commission (TJC), or Commission on Office Laboratory Accreditation (COLA), the medical director and the POCC are responsible for ensuring that testing personnel, often referred to as device operators, are trained and competent to perform testing.
A POCT data management system allows the POCC to enter all operators into a single electronic data base where they can give certifications for all testing done by each operator once initial training is complete. Qualifications such as diploma or license numbers can be documented within the system as having been verified. Often, a data management system will allow the POCC to enable an automatic recertification for device operators based on very specific criteria that must be performed suc- cessfully for the operator to continue to perform testing. The criteria can include successful completion of quality control (QC), patient samples, and/or proficiency samples along with a quiz. Having a data management system also allows the POCC to document who directly observed opera- tors’ performance of routine patient testing in order to meet regulatory requirements. The observation is then captured as part of the operator competency and can be used as criteria for automatic recertification.2
Using connectivity to manage all devices at the point-of-care A POCT program can have many devices connected to the data manager (Figure 1). If the program had to connect the individual devices directly to a laboratory information system (LIS), the cost would be prohibitive. By connecting all POCT devices to a single data manager, only one interface is needed between the data manager and the LIS to get all the results to the patient record, unless there is an additional interface from the LIS to an electronic medical record (EMR). The data manager allows the POCC to view all devices and look for those that haven’t downloaded recently. In some cases, the POCC can sync
a device with the click of the mouse. Depending on the device, the POCC can view error logs sent to the data manager and can also document device maintenance in the system. Being able to view the communication status and act upon the information ensures that patient results are being transmitted to the patient record in near real time.
Device communication – bidirectional and unidirectional When devices are connected to the data manager in a bidirec- tional manner, results come from the device(s) into the system and the system can also send a list of valid, certified operators to the device. This provides true operator lock-out at the device, making it nearly impossible for an untrained, unapproved op- erator to perform testing. For unidirectional devices and manual tests, only results are
received by the data manager; operators aren’t ‘locked out’ from performing testing; however, the data manager can ‘flag’ results that are performed by an ‘uncertified operator,’ thus alerting the POCC of a potential issue. The POCC can still send those flagged results to the patient record if needed, but it gives the POCC the opportunity to be alerted and investigate the issue. In some cases, it may be that the operator was certified in the past, but the certification expired (certifications are usually for either six months or one year) and simply needs to perform his/her annual competency.
Using connectivity to manage all test results at the point of care
POCT programs range in size from a single institution with only glucose devices connected and 50 operators to a very large integrated delivery network with many institutions, device types, manual tests, and upwards of 5,000 to 10,000 operators. Along with operator management, having device connectivity and manual test entry through the data manager allows the POCC to manage all test results performed outside of the main lab. For large health networks, that translates to millions of POCT results per year.
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