Beginning in the 1980s, point-of-care testing (POCT) departed from conventional clinical laboratory medicine by decentralizing laboratory services. Deploying POCT devices created challenges for laboratory management, especially in ensuring the proper use of these devices. Today, point-of-care coordinators use a variety of processes to maintain control over multiple devices and monitor regulatory compliance of many operators at locations across healthcare enterprises.
Early POCT methods were mostly manual, with minimal or no quality control and limited data management capabilities. Modern POCT devices are greatly improved, but capturing the data required to document compliance remains a labor-intensive process. In addition, despite rapid growth of POCT methods and use, POCT operators often have limited understanding of the regulatory and accreditation requirements for licensure, training, procedures, and documentation. Consequently, nurses and other providers often see POCT coordinators as police who indiscriminately enforce regulations that seem onerous at best, and detrimental to patient care at worst. This is an unfamiliar and uncomfortable role for laboratory medicine professionals, who are highly trained to promote quality patient care and efficient use of resources. In this brief review, we will discuss some POCT-related regulatory issues in the hospital environment, and potential ways to satisfy those requirements.
The Spectrum of Point-of-Care Testing
There is some ambiguity with the term POCT and its predecessors, bedside testing, near patient testing, and less frequently, ancillary or decentralized testing. All were derived from the proximity of the laboratory test to the patient or central laboratory, but this distinction is relative and imprecise. POCT is often regarded as tests performed outside of a central laboratory, but this definition also is unsatisfactory, as limited-service satellite laboratories staffed by laboratory personnel are considered clinical laboratories (or sometimes blood gas laboratories) but not POCT services, at least for accreditation and regulatory standards. Their location near the patient does not influence the accreditation standards they have to meet.
For regulatory purposes, satellite laboratories are generally considered extensions of the central laboratory service, rather than a separate classification such as POCT. Therefore, the location at which a laboratory test is performed does not classify it one way or the other. It is even conceivable, given the following considerations, that POCT could be performed in the central laboratory.
It is tempting to define POCT as laboratory tests that are CLIA-waived, but this distinction is too narrow. Although many tests performed at the point-of-care are CLIA-waived, many nonwaived platforms are specifically designed for use outside a central laboratory. Abbott’s iSTAT, for example, is used with waived and nonwaived test cartridges, but it is not an instrument that typically would be deployed in a laboratory: its intended use is in patient care areas and its portability is suited for that purpose. There are numerous examples of small instruments designed for portability, and many of them are nonwaived devices. These instruments include small blood gas analyzers, several coagulation and hematology testing platforms, and even general chemistry analyzers such as the Piccolo from Abaxis. So POCT does not specifically refer to CLIA-waived laboratory tests, but instead includes a wide variety of nonwaived tests and devices.
Yet another criteria for defining POCT—and possibly the most satisfactory definition from a regulatory perspective—is who performs the test. If laboratory personnel perform a test, then this test typically falls under the laboratory license, certificate, and accreditation, even if it is performed outside of the physical laboratory space, and regardless of whether the test is waived or nonwaived. On the other hand, waived or nonwaived laboratory tests performed by non-laboratory personnel are nearly always subject to a different set of regulatory and accreditation standards, and these can neatly be grouped under the POCT umbrella.
Therefore, POCT somewhat misleadingly suggests a location where the test is performed, but in fact the regulatory standards are primarily determined by who performs the test. In practice it is highly unusual for non-laboratory personnel to perform any tests within the clinical laboratory, but the converse is relatively common. Clinical laboratory personnel often perform laboratory tests outside the central laboratory (e.g., streptococcus A screening in an emergency department, sweat tests in a pediatric ward, urine drug screens in the human resources department, international normalized ratio in a coagulation clinic). Tests like these fall under the clinical laboratory CLIA certificate and, in states that issue them, the laboratory license. Consequently, POCT typically refers to waived or nonwaived laboratory tests performed at remote locations by non-laboratory personnel.
Regulatory oversight of POCT differs in several respects from that of other clinical laboratory services, and maintaining compliance with the agencies involved in POCT oversight can be a daunting task. Federal regulation of POCT is minimal, and for most tests in this category the only requirement is that the test be performed according to the manufacturer’s instructions. However, states and accrediting agencies often impose additional requirements on POCT that healthcare facilities need to deal with. These requirements focus primarily on operator competency and verification that the procedures specified by the POCT manufacturer are strictly followed.
States vary in the degrees to which they regulate POCT. For example, Florida—a state that licenses clinical laboratories and the technical personnel employed by them—has minimal regulations for waived tests but very strict requirements for nonwaived laboratory tests performed by personnel who do not have a clinical laboratory technician or technologist license. The Florida Administrative Code (FAC) specifies the qualifications necessary for non-laboratory personnel performing nonwaived tests, a category of laboratory testing the FAC refers to as alternate site testing. To perform alternate site laboratory tests in Florida, the employee must be a licensed healthcare professional under any one of several categories, including physician, dentist, physician’s assistant, nurse (RN, LPN, or ARNP), respiratory therapist, etc. Thus, the principal regulatory requirement focuses on personnel qualifications, not the proximity of the test to the patient or the laboratory.
But the FAC imposes additional requirements that disqualify the vast majority of nonwaived laboratory tests from being performed by non-laboratory personnel regardless of their qualifications. The tests must use whole blood and must not require specimen manipulations, such as manual dilution or centrifugation. In addition, the instrument must be self-calibrating and equipped with failsafe mechanisms that prevent patient results from being reported in the case of calibration or quality control failure. Therefore, even though nonwaived testing is allowed at alternate sites, Florida law strictly limits the variety of nonwaived tests that can be deployed in a POCT environment.
As with clinical laboratories, compliance with state and federal requirements for POCT are ordinarily met through accreditation by organizations with deemed authority, such as the College of American Pathologists (CAP) Laboratory Accreditation Program or the Joint Commission. Although the accreditation standards recognized by these organizations meet CMS and state requirements, they are not identical in all respects. Therefore, some hospitals may choose to have their clinical laboratories accredited by one organization, and their POCT program accredited by another.
CMS does not require that all laboratory services are accredited by the same organization as long as each CLIA certificate is covered by a deemed authority, and in some respects the accreditation standards of one organization may be easier to satisfy in a particular setting than those of another. As a result, it is not unusual for a hospital to have its clinical laboratory services accredited by, for example, the CAP, while their POCT program is accredited by Joint Commission.
In general, POCT regulatory requirements focus on two areas: training and competency of the personnel doing the testing; and verification of strict adherence to the manufacturer-specified procedure for each test. The latter focus is particularly important because waived or moderately complex laboratory methods, both of which can be performed by non-laboratory personnel under certain circumstances, become highly complex if used in a manner that deviates from the FDA-approved manufacturer’s protocol. Highly complex laboratory tests, by federal law, can be performed only by personnel meeting the qualifications specified in CLIA Subpart M, and additional educational and licensure requirements may be imposed by some states.
Since high complexity essentially eliminates a laboratory test from consideration for POCT, it is critically important that supervision of POCT in a healthcare institution includes verification that testing procedures do not deviate from the manufacturer’s instructions.
POCT device manufacturers have responded to the challenge of monitoring the use of these instruments by designing features such as access control and electronic communication with a laboratory information system (LIS) or other network system. This communication allows the LIS to download quality control and patient results. However, POCT coordinators still need a dedicated resource for managing their POCT programs. The use of connectivity via a data management system can greatly improve efficiency when managing different aspects of compliance. With the adoption of POCT1-A communication protocols, data systems evolved from vendor-specific to vendor-neutral platforms. Although there may be some functional limitations for specific devices, vendor-neutral platforms offer POCT coordinators the flexibility to connect devices from multiple manufacturers, providing better support for the compliance elements of the program.
POCT Compliance Essentials
Device management is key as central laboratory tests continue their migration to POCT platforms. POCT devices can be set up and configured remotely from a single central location with software updates manually or automatically downloaded to the devices. In addition, the data management system serves as a repository for testing locations, instrument serial numbers, and instrument service history and software versions. The data management system also tracks the status of the connected devices so that communication and connectivity issues can be addressed promptly.
Quality control (QC) is required for all waived and nonwaived tests. The QC limits and frequency intervals can be configured at the device or managed remotely with the data management system. This prevents an operator from using the instrument once the QC interval has been exceeded or the result is not within acceptable limits. QC results for each device and operator also can be reviewed and evaluated by laboratory personnel, a requirement for most laboratory accreditation programs. The data system also captures and stores comments describing corrective action for unacceptable QC results. Some data management systems allow for QC import into other software programs for peer comparison as well as capture of manual QC results for tests such as fecal occult blood.
Operator management refers to controlling access to the POCT devices and tracking the authorization of all operators, with alerts when certifications have expired (see competency management, below). Access to a POCT device can be authorized via operator list downloads when the instrument queries the data management system to determine whether an operator is currently certified. If an operator with expired certification attempts to use the POCT device, he or she will be locked out, preventing use of the device. Some data management systems notify operators when they are approaching the expiration date of their access to a device.
Data managements systems enable POCT coordinators to track the dates on which operator competencies were completed for original certification, recertification, QC performance, and patient resulting and reporting. This increases efficiency, especially when paired with other learning management systems (LMS) such as Healthstream. Although both systems currently require some manual input and maintenance of data, the ability to interface the data management system to the LMS may be on the technology horizon. Currently, data management systems include the ability to generate reports that show initial training, 6 month, and yearly competencies, all of which are required elements under waived and nonwaived testing standards. Many systems also offer automatic recertification of operators.
In order to comply with accreditation standards, POCT coordinators monitor data from activities such as correlation testing, linearity and analytical measurement range verification, proficiency testing, calibration, and patient identification. Data systems can automatically capture this data and document it for review. This data also can be entered by hand from manual tests (e.g. fecal occult blood, dipstick urine, pregnancy tests), although compliance with these standards for POCT that does not involve interfaced instruments is difficult to verify. While instrument platforms exist for each of the previously mentioned tests, they are more commonly performed manually.
Data systems also are essential for managing consumables for POCT devices. These tools include reports showing usage and device workload that laboratorians can use to establish the frequency and size of supply orders, potentially reducing costs by eliminating waste of expired reagents and controls. Reagent and control lot numbers, and established QC ranges, can be entered into the data system and uploaded to the POCT devices. In addition, alarms can be set to alert the POCT coordinator when new lots are in use that may require validation. Many POCT devices include barcode scanning capabilities that allow reagents and controls to be scanned by operators to verify the current lot number and prevent use of expired or unvalidated reagents. The current lot numbers may reside in the data management system.
Monitoring Device Status
Remote monitoring enables a POCT coordinator to determine the status of any connected devices. Inoperable devices can be immediately identified and either removed from service or repaired. For example, many POCT devices have a data buffer that, when exceeded, prevents the device from being used until the buffer is cleared. This type of error can be detected by the data management system and dealt with promptly by testing or supervisory personnel. By configuring alerts, the data system also may give coordinators the ability to investigate and resolve issues before they become critical.
Remote access enables POCT data management from a computer anywhere within or outside of the organization, based on how the system is configured. With the adoption of mobile devices such as tablets and smartphones, web-based data management applications can be accessed from virtually anywhere to exchange information and manage systems, including in some applications the ability to send remote commands to the devices.
Regulatory oversight of POCT focuses primarily on ensuring the proper training and competency of personnel performing these tests, and verifying that the tests are being conducted according to manufacturer instructions. Supervision of a POCT program requires attention to these and other aspects of laboratory tests performed by non-laboratory personnel. Connectivity via data management platforms has provided an elegant solution to the challenge of managing these regulatory and compliance aspects of a large POCT program.
With widespread implementation of wireless networks, and the built-in WiFi capabilities of most modern analytical devices, data management systems for POCT will eventually support a seamless network of POCT devices deployed throughout a healthcare facility, perhaps fundamentally changing our notion of what is meant by the clinical laboratory.
As more and more laboratory services move outside our traditional workspace, laboratory medicine professionals face expanding responsibilities to ensure the quality and integrity of laboratory services throughout the entire facility. We have outlined just a few of the regulatory and accreditation issues that accompany the supervision of a POCT program.
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Olga Camacho-Ryan is quality manager and supervisor of point-of-care testing at University of Florida Health Jacksonville Hospital.+Email: Olga.Ryan@jax.ufl.edu
Roger Bertholf is professor of pathology and laboratory medicine at University of Florida College of Medicine, and director of clinical chemistry, toxicology, and point-of-care testing at University of Florida Health Jacksonville. +Email: Roger.Bertholf@jax.ufl.edu.