Journal:Utilizing connectivity and data management systems for effective quality management and regulatory compliance in point-of-care testing
|Full article title||
Utilizing connectivity and data management systems for effective quality management|
and regulatory compliance in point-of-care testing
|Journal||Practical Laboratory Medicine|
|Author(s)||Fung, Angela W.S.|
|Author affiliation(s)||St. Paul’s Hospital, University of British Columbia|
|Primary contact||Email: afung7 at providencehealth dot bc dot ca|
|Volume and issue||22|
|Distribution license||Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International|
Point-of-care testing (POCT) is one of the fastest growing disciplines in clinical laboratory medicine. POCT devices are widely used in both acute and chronic patient management in the hospital and primary care physician office settings. As demands for POCT in various healthcare settings increase, managing POCT testing quality and regulatory compliance are continually challenging. Despite technological advances in applying automatic system checks and built-in quality control to prevent analytical and operator errors, poor planning for POCT connectivity and informatics can limit data accessibility and management efficiency which impedes the utilization of POCT to its full potential. This article will summarize how connectivity and data management systems can improve timely access to POCT results, effective management of POCT programs, and ensure regulatory compliance.
Keywords: point-of-care testing, data management, quality assurance, electronic medical record
Point-of-care testing (POCT) refers to near patient testing performed outside the central clinical laboratory by non-laboratory personnel. POCT provides a faster turnaround time (TAT) for test results, which allows rapid clinical decision making. This has led to early adoption in acute care settings such as operating rooms, intensive care units, and emergency departments within hospitals. There are increasing interests in expanding POCT to chronic disease management and community health in settings such as primary care physician offices, pharmacies, remote communities, and even in disaster relief initiatives and military operations. Rapid TAT is the most commonly cited reason for POCT, yet the clinical utilization of POCT should also ideally be evidence-based, cost-effective, and focus on improving patient outcomes. A number of systematic reviews and narrative reviews on evidence-based POCT are ongoing.
As demands for POCT have increased, managing the quality and regulatory compliance of POCT programs has continually proved challenging. Since POCT is performed by non-laboratory personnel, many clinical staff may not be familiar with quality laboratory practices, including compliance to testing procedures, quality assurance practices, and regulatory requirements. Despite the availability of national and international guidance, as well as standards documents developed by professional and government bodies, a systematic review identified quality assurance, regulatory, and data management issues as recurrent, which are significant barriers to clinical implementation of POCT.
This article will summarize the benefits of connectivity and data management systems (DMS) for improving timely access to POCT results; supporting integrated patient electronic medical records (EMR), effective quality assurance, and management of POCT programs; and ensuring regulatory compliance.
Connectivity and integration with EMRs
POCT result integration with EMRs
Accreditation and regulatory standards emphasize the increasing need to integrate POCT results into the patient’s EMR. This promotes the accessibility of POCT results, promotes the ability to monitor and trend those results, prevents unnecessary repeat testing, and provides evidence for patient outcomes. As POCT results are used to make clinical decisions, it is important to document results with associated reference intervals, units of measurements, critical values (if applicable), date and time of testing, while also making the results traceable to device serial numbers, operator identification numbers, reagent lot numbers, and quality control (QC) results. POCT results should also be clearly differentiated from other central laboratory results to avoid confusion and trending of results derived from different analytical methodologies.
Manual POCT result documentation and error rates
Traditionally, POCT results and related information are manually transcribed in the patient’s paper chart at the time of testing near the bedside in the hospital. In more recent years, POCT results may be manually entered or electronically scanned into the laboratory information system (LIS) or hospital information system (HIS). In the case of outpatient POCT, such as in a primary physician office, documentation is typically filed with outpatient provider's paper-based or electronic record management system, which is often separate from an LIS or HIS and may not be interfaced to the EMR.
Handwritten records are often illegible and are at risk of transcription error and duplicate charting. Manual entry of POCT results into an LIS or HIS are similarly time-consuming and prone to transcription error. In my institution, for example, an average of 1,200 POC glucose results from 230 glucose meters are manually entered into the HIS by operators every day. If manual entry takes one minute, this approximates to 7,300 hours of staff time in manual entry of POC glucose results annually. This estimate does not include the time needed to log in to systems, confirm patient identification, and verify entered results. In the literature, manual entry for POC glucose results demonstrated an average of 3–5% transcription error rates in an inpatient medicine ward setting. Transcription errors may include inversion, addition or loss of digits, rounding errors, and entry of non-numeric characters. An audit at my institution identified cases where the operator entered the plasma glucose result from the central laboratory analyzer into the POC glucose result field, due to the desire to trend POC glucose results, but the affected result was measured above the device’s analytical measuring range. Another audit by Carraro and Plebani identified 12% of POC glucose results were omitted and never recorded into the patient’s chart, in which some of these results would have been useful for clinical and treatment decisions.
Transcription errors are more complex for POCT with multiple test components, such as POC urinalysis and POC blood gas analysis. The semi-quantitative POC urinalysis has ten or more test components (specific gravity, pH, protein, glucose, etc.), with each component having multiple result options. The operator has to scroll through each test component and select several drop-down result options to complete one manual entry of POC urinalysis. Errors may involve selecting an incorrect result, unintentionally switching a result during scrolling, and mismatching test components and results. Test components in quantitative POC blood gas analysis can range from one to over fifteen, depending on the device and cartridge selected. Although there is a lack of published reports on the error rates for blood gas analysis, it is conceivable that the risk increases with each additional test component.
In my institution, medical laboratory technologists (MLTs), instead of the POC operator, manually enter results into the LIS for POCT that are considered at a higher risk for entry errors. In the laboratory, there is a specific procedure that requires verification by a second member of the technical staff as per regulatory requirements. Despite having and following the verification procedure, an audit of the POC hemoglobin A1c program in my institution found that 50% of results missed incorporation of a comment code that identifies the result as a POCT, as well as the operator initials. This workflow often causes delay in POCT results availability and thus affects downstream care. Issues may include incomplete result forms, an increase in workload issues for laboratory staff, and a lack of result traceability. Alternatively, electronic scanning of the instrument printout into the HIS system may be a possible solution. However, these scanned documents are difficult to search and view in the HIS and lack discrete data fields, which prevents trending and data mining.
POCT connectivity and data management systems (DMS)
In the context of POCT, connectivity means interfacing POCT devices to the LIS, HIS, or EMR via a DMS (also known as a middleware). An electronic DMS is the middleware that communicates and integrates data from multiple devices and databases and provides a single comprehensive solution for data management. Connectivity permits automated, real-time, bi-directional, electronic wired or wireless transmission of POCT results and related information. This type of intefacing is the safest and most reliable method of data transfer. It reduces the time requirements, eases the burden, and minimizes the errors of POCT result documentation. The use of connectivity and a DMS, wherever possible, are recommended for all POCT programs by national professional bodies.
My institution is comprised of acute care hospitals, community hospitals, long term care facilities, primary clinics, and dialysis units. We are currently undergoing system transformation, with implementation of a new HIS, a new DMS, and POCT connectivity for the first time. When an institution is considering POCT connectivity and DMS for the first time, some features to consider (Table 1) include: 1) compliance to connectivity standard CLSI POCT01-A2 (2006); 2) the design of the DMS (e.g., open vs closed systems, remote access capabilities); 3) compatibility with existing and future growth of POCT devices; 4) the ability to communicate bi-directionally; 5) the ability to interface to an admission, discharge, and transfer (ADT) system; 6) the need for a wireless or wired network infrastructure; 7) data storage and server requirements; 8) compatibility with existing LIS, HIS, operating systems, e-learning systems, and human resources databases; and 9) compliance with privacy and security policies. Considerations should also include institution funding for ongoing software licensing, maintenance, and upgrades, as well as technical support from the information technology (IT) department.
A DMS may be an open (vendor-neutral) or closed (vendor-specific) system. An open DMS enables POCT devices from multiple vendors to be interfaced to a single DMS. Examples of open DMSs include Remote Automated Laboratory System (RALS Web 3, Abbott Laboratories, Chicago, IL, USA), Telcor QML (TELCOR Inc, Lincoln, NE, USA), and Orchard Trellis (Orchard Software, Carmel, IN, USA). An open DMS may be an integrated system or interface engine system. An integrated DMS is when multiple vendor devices interface to a single DMS, which requires the DMS vendor to have excellent relationships and experience in interfacing combinations of different POCT device vendors with different LIS, HIS, and EMR vendors. An interface engine DMS is when multiple vendors' DMSs interface to the LIS or HIS, which requires the POCT coordinator to be proficient in multiple vendor-supplied DMSs and databases. With increasing demand for open integrated DMSs, traditionally closed DMSs are now also offering options to interface to devices from other vendors. Remote access capabilities enable the POCT coordinator to monitor, review, and troubleshoot from a remote centralized location.
When considering DMS compatibility with existing and future growth in POCT devices, it is important to keep in mind desirable features for both the devices and the DMS. For instance, not all POCT devices have built-in requirements for connectivity. Some POCT may require purchase of an adaptor or software upgrade to establish connectivity. Some POCT devices also may not transmit pertinent data such as operator identification numbers, serial device numbers, reagent lot numbers, and quality control results in conjunction with the test result, as per regulatory requirements. Manual, visually-read POCT devices such as urine pregnancy, urine drug screens, urinalysis, and occult blood tests may or may not have an automated readout device for connectivity. In these cases, manual entry may still be required. A DMS that enables manual configuration and entry would also allow for comprehensive data management.
Uni-directional connectivity is when data transfers from the POCT device to the DMS (e.g., QC and patient results), but information cannot transfer from the DMS to the POCT device (e.g., updating valid operators, QC data, and reagent lot numbers). Thus, bi-directional connectivity is preferred. Additionally, POCT devices interfaced to the ADT system enable positive patient identification at the bedside, where the device can display patient demographic information when the patient wristband barcode is scanned. Positive patient identification is extremely important when discussing the connectivity of POCT devices, as test results are transmitted often immediately. Patient identification errors can cause POCT results to be recorded to the wrong patient’s chart and may include entry errors; barcode scanning failures (illegible barcodes); barcode substitutions (multiple wristbands, scanning other barcodes, etc.); and use of inactive, incorrect, and unregistered account numbers. A study-based audit comparing pre- and post-implementation of POC glucose meter connectivity demonstrated that 18% of POC glucose results were identified to have an error in patient identification. The use of a DMS can detect unusual digit patterns to patient’s medical record numbers, hold the corresponding POCT result in the DMS, and alert the POCT coordinator for investigation and resolution. Similarly, for unregistered patients, a set of temporary codes can be assigned for automatic holding in the DMS until the patient is registered.
Connections may be managed via cable wires or through wireless technology. Wired connection workflow should consider the number of docking stations in the ward, the amount of desk space required, and computer and hardware requirements such as number of power sources, network ports, and cables. Wireless connections have fewer hardware requirements but may be subject to signal strength issues and interferences. Many hospitals have old wiring and unstable wireless infrastructure, which can be costly to implement in settings such as an operating room. Thus, wireless and wired network connections require site-specific assessment in balancing convenience and cost with existing infrastructure. For privacy and security purposes, it is also important to assess the amount of patient demographic information available or stored on individual POCT devices, DMSs, and servers. Thorough security and privacy assessments such as encrypting data, implementing firewalls, and limiting access to specific locations and/or to specific operators are required.
Support from the IT department is essential for test mapping. Test mapping is the configuration of each POCT test with a unique test code paired to a defined specimen type, units of measurement, number of decimal places, age and sex partitioned reference intervals, analytical measuring ranges, critical result ranges, and instrument flags. It is also important to consider the location of POCT results in the HIS or EMR (e.g., organized by specialty) with consultation from the institution’s medical leadership. Once configured and interfaced, transmission and reporting of results should be tested thoroughly for accuracy. Workflow mapping with clinical practitioners should have a detailed communication system for ordering of POCT tests, notification of incorrect or unregistered patients, and notification for testing or resulting issues. Funding for ongoing licensing, technical maintenance, and upgrades should also be considered with institution managers. The details of technical and workflow assessment should be jointly assessed with respective departments from your local institution.
POCT program management
Within the hospital setting, a multidisciplinary POCT committee provides primary oversight for the POCT programs. This committee typically includes—but is not limited to—the POCT director, POCT coordinator, physicians, nurse practitioners and managers, infection control personnel, supply chain personnel, information technology personnel, and biomedical engineering personnel. The committee oversees and assesses the clinical needs of POCT; reviews evidence on outcomes; evaluates appropriateness of tests, patient populations, and testing locations; and ensures that all regulatory requirements are met. POCT accreditation and regulatory requirements are mostly based on the International Organization for Standardization (ISO) 22870 (2016) standard.
A subset team comprised of the POCT director, POCT coordinator, and MLTs are responsible for managing and assuring the quality of the POCT program. This includes the selection and evaluation of devices, development and updating of standard operating procedures, training of users, assessment of user competency, maintainance of quality assurance and compliance data, performance of cost-benefit analysis, and management of risk. It is essential to ensure there is an adequate number of POCT coordinators and MLTs dedicated to supporting and managing the size and scope of the POCT program.
POCT program management and documentation for regulatory compliance are labor-intensive and time-consuming, especially for large POCT programs that include multiple testing locations, a large number of operators, and an extensive POCT test menu. The use of a DMS helps reduce the manual workload and improve efficiency for the POCT coordinator. When considering a DMS as a tool for effective POCT program management, consider functions that support regulatory compliance such as management of resources, quality assurance, and training and recertification of operators.
Resource management: Device and inventory management
For management of resources, a detailed and documented record of all POCT devices, including serial numbers, facilities and testing locations, purchase and retirement dates, maintenance and service repair dates, software versions, and upgrades are required. QC materials, reagents, and consumables inventory are also documented with content, lot numbers, acceptable ranges, storage requirements, preparation dates, and expiration dates. These documents are challenging to maintain manually. This may require dedicated cabinet space for retaining paper records or creating electronic filing system on a secured shared drive.
An open integrated DMS is a comprehensive database system to maintain documentation on resources from multiple vendor devices, QC materials, reagents, and consumables. This type of DMS also enables and assists in troubleshooting for issues related to error messages on the device, device, and base unit connections, as well as missing devices in real-time and remotely. When POCT devices are bi-directionally connected, inactivation of old lots and activation of new lots of QC materials and reagents may be updated remotely and automatically to multiple same vendor devices via the DMS. This helps in preventing the use of expired or inactive devices, reagents, and QC materials for patient testing.
Quality assurance management: QC, compliance, audits and reports
Prior to patient testing, routine maintenance and QC testing are required to ensure POCT devices and reagents are functioning as expected. In my institution, much of the POCT testing and quality procedures are documented manually in various paper charts: a chart for daily QC performance, a chart for routine maintenance, and another chart for order and result documentation. The POCT coordinator is required to visit each care unit periodically and review these documents in various files and binders for regulatory compliance. These manual records are often incomplete, unreliable, or misplaced, making it difficult to perform regular reviews and audits. Errors and issues identified often cannot be investigated and resolved in a timely manner.
Similar to other reports, audits in my institution have identified common quality issues, including low compliance rates to QC testing procedures, routine maintenance, and follow up procedures such as repeat testing and critical value reporting. QC testing and maintenance are often assigned to support staff on night or weekend shifts. The clinical staff who performed the POCT may not have performed the QC testing themselves. Further communications revealed that some clinical staff were unaware of the location of QC being stored or the requirement of scheduled routine maintenance.
Quality assurance management can be improved with device technology, connectivity, and a DMS. Some DMSs can capture and monitor maintenance activities, given the device is also compatible with that function. Devices with QC lockout function can ensure QC testing compliance by locking the device and alerting the operator if the QC frequency interval has been exceeded or a QC result is outside of acceptable limits. With connectivity established, QC results for each device, operator, and testing location can be sorted and reviewed remotely and graphically displayed as Levey-Jennings QC charts. When patient demographic information, QC, and results are electronically captured in the DMS, the POCT coordinator can access and troubleshoot in real-time and extract data for audits. Reports may also be generated to monitor test performances and quality improvement initiatives such as critical results reports, utilization reports, misidentification reports, and hypoglycemic reports.
POCT operator management: Training and competency assessments
Clinical personnel performing POCT require training and competency assessments at regular intervals. Training on POCT not only includes how to use the POCT device for patient testing, but also on how and why QC is performed, how to troubleshoot and perform routine maintenance, and how and where to chart results. Typically in large institutions, the number of personnel to be trained may be in the thousands and have diverse baseline knowledge in POCT and requirements. Turnover of employees, cross-appointment to multiple wards and sites, and the diverse range of employment types (e.g., full-time, part-time, casual, and student) increase the challenge of tracking active operators who are trained and have demonstrated competency. In my institution, only a handful of POCT programs have training and competency assessments available on the electronic learning system, while the remaining programs are managed manually. In our emergency departments, where there are over 250 nurses and support staff performing four different POCT programs, it is particularly challenging to maintain an annual list of operators, training records, and competency assessment documents manually.
With many POCT operators to train and to assess competency, the use of the operator lockout function on the device and DMS can control access to POCT devices, maintain an up-to-date database for a large number of operators, and automate certification statuses. Devices with an operator lockout function will only permit valid operators with up-to-date certification to operate the device and perform patient testing. Some POCT DMSs can be linked directly to online electronic learning systems. When operators have certifications that are pending or nearing expiration, the DMS can send an automatic notification via the device itself or send an email with the electronic learning material and online assessment links. When operators have completed and met the defined criteria (e.g., passing an online quiz or completing a number of successful QCs and patient tests in a year), the DMS can be configured to automatically re-certify the operator for a specific POCT device for a defined period of time.
Many laboratories increasingly value the importance of informatic solutions for connectivity, effective data management, and regulatory compliance. Connectivity and DMS are essential tools in improving the accessibility and ability to manage POCT programs efficiently. These systems greatly reduce errors and improve compliance to accreditation and regulatory standards, and thus enhance the overall quality of the POCT programs. It is important to note that although POCT programs can be managed remotely, in reality there are benefits to periodic onsite visits and audits in identifying deficiencies, compliance issues, and required improvements. Effective management of POCT programs ultimately relies on building relationships, collaborations, and partnerships between laboratory and clinical practitioners to ensure the highest quality POCT for patients. With rapid expansion of POCT to non-traditional settings, consultation and collaboration with laboratory directors and coordinators with qualifications and expertise in POCT is strongly recommended when designing and implementing POCT programs.
DMS: data management system
EMR: electronic medical record
HIS: hospital information system
LIS: laboratory information system
POCT: point-of-care testing
TAT: turnaround time
QC: quality control
I would like to acknowledge Sheri Young, Judi London, and Dr. Andre Mattman for providing their expertise and input. I would also like to acknowledge and thank the laboratory POCT team, Sheri Young and medical laboratory technologists, for their diligence and dedication in managing and improving the POCT program at St. Paul’s Hospital and Providence Health Care.
Angela W.S. Fung: conceptualization, investigation, writing - original draft, writing - review & editing
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This presentation is faithful to the original, with only a few minor changes to presentation. Grammar was cleaned up for smoother reading. In some cases important information was missing from the references, and that information was added.