Vol 25. No. 11 Page 30
Thorough evaluation and stewardship by the laboratory are necessary before and during implementation.
The demand for point-of-care testing (POCT) is increasing in response to the value-shift in healthcare and advancements in technology. A number of factors are converging to promote the value of POCT (e.g., increases in infectious diseases; increases in lifestyle diseases, such as cardiac diseases and diabetes; increased patient desire to use home-based POC devices; and technological advancements creating faster and easier-to-use devices). Testing that takes place by the patient’s side offers rapid turnaround time (TAT) and the patient-focused approach that supports healthcare’s transition toward more cost-effective and patient-centered care. The driving concept behind POCT growth is that bringing testing closer to the patient and results conveniently and quickly to the provider can speed up diagnosis and treatment.
The laboratory is often the starting point for diagnostics, and is ultimately responsible for ensuring that lab results are accurate and beneficial to the provider and patient regardless of testing location. Laboratory professionals who understand the intricacies of testing and the importance of proper laboratory processes to ensure quality have an obligation to be involved in POCT oversight and growth. Yet, because POCT can involve management of multiple devices and regulatory compliance of many operators at various locations across large healthcare enterprises, there are myriad challenges.
Considerations Before Introducing POCT
Prior to beginning a quality POCT program in any type of setting, proper forethought, planning, and preparation are critical. Below are some questions to consider (see Figure 1):
- What are the benefits as compared to the cost of testing?
- Who will manage testing? What are the regulatory requirements?
- Are there safety concerns?
- Where will testing take place and is there adequate room?
- Where will supplies be stored?
- Who will the end operators be? How will they be trained?
- What documentation and records will need to be maintained?
|Figure 1: Considerations Before Introducing POCT|
|Benefits vs. costs|
|Management & oversight|
|Regulatory & safety requirements|
|Testing & storage space|
|End operations & staffing|
|Documents & records|
Despite its growth, POCT has to be considered carefully and put in place in situations where it can provide benefit. Because POCT methodologies are often not as sensitive or precise as core lab test methods, risks versus benefits should be weighed carefully to determine if POCT meets patient needs.
Benefits of rapid TAT and less sample size come at a cost. POCT is generally more expensive than traditional laboratory testing. However, newer value-based reimbursement models require taking a look at total patient care episodes to determine cost effectiveness, rather than looking at costs from a silo-perspective. For POCT, a test that seems expensive in the lab’s budget may be able, through faster TAT, to reduce other much more expensive costs, such as length-of-stay, readmission rates, or contribute to other improvements in patient outcomes. This makes the cost analysis more difficult to pin down, but this is a better method of measuring POCT value.
Policy & Procedure Implementation
Once it has been decided to implement a POCT methodology, the point-of-care coordinator (POCC) or other designated POCT manager must develop and provide ongoing monitoring of specific policies and procedures that define the activities associated with the POCT. A POCC routinely audits all testing policies and procedures to ensure that the facility is in compliance with CLIA and/or accrediting agency regulations (see Figure 2).
|Figure 2: POCT Procedure Manual|
|Critical value reporting|
As with any clinical laboratory testing, validation and correlation studies must be performed for POCT. This may include precision, accuracy, linearity, and reference range validation. On an ongoing basis, data from calibrations, calibration verifications, QC, and QA must be monitored in order to identify risks of testing failures and comply with regulatory standards. Depending on the test and device, some of this data may be documented on hand-written forms and other data may be captured electronically.
Regulatory oversight of POCT can be different from other clinical laboratory tests, making compliance more complex. Sometimes facilities have different accrediting bodies for clinical testing than for POCT. Typically for waived POCT, the main regulatory requirement is that testing is performed according to the manufacturer’s instructions. Non-waived POCT requires documented operator training and ongoing competency assessments.
Some type of QC is required for all POCT. Facilities that use POCT software to manage their data can configure QC limits and frequency intervals at the device or within the POCT data management system, and the software can store corrective actions associated with QC. Operators can be locked out from using the device when QC is not acceptable. POCT management software allows for review of QC results for each device and operator, which is also a regulatory requirement.
A strong POCC will develop a culture that recognizes quality assurance (QA) as an integral part of daily operations. Every year, the effectiveness of the QA program must be evaluated and documented in a written summary. POCT should be considered in the QA program just as any lab testing. A QA program will encompass an evaluation of the entire testing process from the pre-analytical phase to the post-analytical phase. More often than in the core lab, for POCT, pre-analytical errors are of concern. For example, in a study for positive patient identification, operators did not confirm two patient identifiers for 45% of POCT, as compared to 0.02% in the central lab.1
Device & Inventory Management
Device management is another challenge for POC managers because in a large organization this can involve hundreds of devices from various manufacturers and each device type may have different capabilities. POCT data management software can be used to monitor device information (e.g., device location, serial number, service history, and software version) from a central location. POCT data systems can also help track inventory for POCT supplies. Reagent and control lot numbers, and established QC ranges can be entered into the POCT software and uploaded to capable POCT devices. Some POCT devices are capable of scanning reagent and control bar codes that can then be stored in the POCT management system.2
Training & Competency Assessment
One of the biggest POCT challenges is keeping track of the training and competency assessments for a multitude of operators in different locations, many of whom are non-laboratorians. See Figure 3 for a list of POCT challenges. Every operator is required to have documented training on each device prior to reporting outpatient results. Ongoing assessments are performed at the first six months, and then annually thereafter. In a large healthcare organization, this can include several device types and thousands of operators. Facilities that need to track a large number of POCT operators may opt to use an online training tool such as a learning management system (LMS). POCT management software can automate reminders to users who are due for their competency assessment. When devices are capable, the POCT management software can lock users from using a device until their certification is valid.
|Figure 3: POCT Management Challenges|
|New device evaluation|
|Compliance of users|
|Handling QC failures|
|Correlations to core lab|
|Managing competency assessments|
Having much of the testing performed by non-laboratorians means that end users may not have as much experience with the regulatory requirements for POCT, so POCCs must take this into account when designing training programs. Training should include device operation, result review and release, QC requirements and basic troubleshooting.
Data Capture & Connectivity
Today’s POCT devices are improving, but capturing the data required to document compliance is still time-consuming. Having a strong POCT management system and connectivity solution can dramatically reduce the amount of time spent manually typing in results, eliminate errors inherent to manually entered results, and facilitate real-time access to results so that providers can make timely care decisions. Additionally, as healthcare data analytics are more commonly used to support patient-centered care and population health management, it is beneficial to have POCT results electronically integrated to include results tracking metrics and key performance indicators.
Just as advancements have been made in the POCT devices, steady progression in the area of connectivity is taking place. Many newer generations of POCT devices have interfacing capabilities. Newer POC devices may involve a central desktop computer networked to instrument docking stations. The preferred connectivity solution to manage POCT results involves POCT data management software that allows multiple devices to interface with the LIS or EHR. Depending on the capabilities of a POCT device, some allow bidirectional interfacing and others cannot. Unidirectional interfaces will only allow for communication to pass from the POCT device to the data management system, not the other direction; whereas bidirectional interfacing allows uploading of operator lists, reagent lot, and QC lot information to the device and results back to the software.2
Some POCT devices have wireless communication capability, which is convenient for transmitting results from handheld devices. This functionality may include bar code scanning of operator badge, patient armband, and test reagent prior to testing. Test results are then matched to a patient medical record number and wirelessly transmitted into the LIS or EHR.
With emerging technological innovations in healthcare, including smartphone apps, biosensors, lab-on-a-chip, and wearable devices—all of which offer a closer connection to the patient—POC technologies are quickly becoming part of the transformation of the healthcare landscape.
Ultimately, the shift toward POC diagnostics is a positive one. In the goal to improve patient care, continued POCT development can help support rapid diagnosis and treatment demands. Furthermore, making sure POCT is electronically incorporated in real-time can optimize POCT benefits and allow for the inclusion of POCT results in valuable health analytics.
Placing POCT where it can have the most influence on quality patient care is another way that laboratories can increase their clinical effectiveness and demonstrate their value. To achieve maximum quality in POCT, laboratorians who understand how quality testing is achieved are best to oversee and assure compliance. Additionally, as reimbursements steadily decline, proper implementation of POCT where it can influence downstream costs can help labs re-establish their value proposition.
- Camacho-Ryan O, Bertholf RL. Monitoring point-of-care testing compliance. Available at: aacc.org/publications/cln/articles/2016/february/monitoring-point-of-care-testing-compliance
- Shaw JL. Practical challenges related to point of care testing. Practical Laboratory Medicine, 2016. 4;22-29. doi:10.1016/j.plabm.2015.12.002