Context.—

Emergency medical services (EMS) programs have been using point-of-care testing (POCT) for more than 20 years. However, only a handful of reports have been published in all of that time on POCT practices in field settings.

Objective.—

To provide an overview of POCT practices and failure modes in 3 of Alberta's EMS programs, and to propose risk-mitigation strategies for reducing or eliminating these failure modes.

Design.—

Details about POCT practices, failure modes, and risk-mitigation strategies were gathered through (1) conversations with personnel, (2) in-person tours of EMS bases, (3) accompaniment of EMS personnel on missions, (4) internet searches for publicly available information, and (5) a review of laboratory documents.

Results.—

Practices were most standardized and robust in the community paramedicine program (single service provider, full laboratory oversight), and least standardized and robust in the air ambulance program (4 service providers, limited laboratory oversight). Common failure modes across all 3 programs included device inoperability due to cold weather, analytical validation procedures that failed to consider the unique challenges of EMS settings, and a lack of real-time electronic transmission of results into the health care record.

Conclusions.—

A provincial framework for POCT in EMS programs is desirable. Such a framework should include appropriate funding models, laboratory oversight of POCT, and relevant expertise on POCT in EMS settings. The framework should also incorporate specific guidance on quality standards that are needed to address the unique challenges of performing POCT in field settings.

Point-of-care testing (POCT) is defined by the International Organization for Standardization1  as testing that is performed near or at the site of a patient. Point-of-care testing is increasingly used in a variety of settings because of its potential to provide testing in the absence of a central laboratory, speed up clinical decision-making, reduce iatrogenic blood loss, and increase patient and clinician satisfaction.25  As is true of laboratory testing, errors that are made while performing POCT may lead to medical adverse events or near misses.3,68  Risk-mitigation strategies to reduce or eliminate such errors include securing point-of-care systems and operations, ensuring data integrity and confidentiality, implementing and enforcing regular quality checks, and POCT oversight by laboratory professionals.6,7,911

One setting where POCT is of growing interest is emergency medical services (EMS). Point-of-care testing of glucose, blood gases, and a limited number of other chemistry analytes has been part of EMS care delivery for more than 20 years,12,13  and the utility of other tests is continuously being explored.1416  Point-of-care testing practices in EMS field settings are poorly characterized, with only a handful of reports existing on this topic.13,1722  As a consequence, failure modes that may to lead to errors are inadequately understood, as are the most appropriate risk-mitigation strategies to address them.

The primary aim of this report is to provide a preliminary overview of POCT practices and associated failure modes in the EMS programs of the Canadian province of Alberta. A secondary aim is to propose risk-mitigation strategies for reducing or eliminating errors from these failure modes. This report has several unique features compared with previous reports on EMS programs. First, to our knowledge it is only the second report to date that focuses on multiple EMS programs within a single health authority. Second, to our knowledge it is the first report to discuss POCT practices in detail in newer EMS programs such as community paramedicine and ambulance-based acute stroke intervention.

## METHODS

### Health Care in Alberta

Alberta Health Services (AHS) is the single health authority in the Canadian province of Alberta and delivers health care on behalf of the Government of Alberta's Ministry of Health. Alberta Health Services provides health care services to Albertans either directly through self-owned and self-operated programs or through contracted service providers. Alberta Health Services is organized into 5 geographic zones. Health care teams in each zone focus on addressing the zone's local needs, while also collaborating with other zones to standardize care across the province.

Point-of-care testing in AHS is governed and overseen by Alberta Precision Laboratories (APL), a wholly owned subsidiary of AHS. Prior to December 2018, each AHS zone had a local POCT group that independently oversaw daily operations. The decision to provide oversight (or to not do so) was left up to the local POCT groups, and so were decisions regarding appropriate quality assurance (QA) requirements. Over time, APL came to view this approach as problematic and collaborated with AHS to implement an AHS-wide policy on mandatory laboratory oversight of POCT in 2016. In 2018 APL also brought the local POCT groups under the supervision of a provincial leadership team in order to promote and facilitate standardization of practices across the province. Together, the 5 local POCT groups and the provincial leadership team now form APL's POCT department (referred to henceforth as APL POCT).

### EMS Programs in Alberta

The population of Alberta relies on a variety of EMS programs to provide emergency and critical care outside of the hospital environment (Table 1).

Table 1

Overview of Alberta's Emergency Medical Services Programs

#### Ground Ambulances

More than 500 ground ambulances operate in the province, providing services 24 hours a day, 7 days a week, 365 days a year. Ground ambulances are owned and operated either by AHS or by one of 33 contracted service providers. Ground ambulances use some POCT systems in their daily operations, but APL POCT has very limited information on these practices. Therefore, the remainder of this report will exclude this EMS program from its discussions.

#### Air Ambulances

Alberta's air ambulance program is delivered with fixed-wing airplanes and helicopters. Alberta Health Services contracts 11 fixed-wing aircraft to deliver 24-hour services from 10 bases across the province. Two of the bases are operated directly by AHS, and the remaining bases are operated by Advanced Paramedic Ltd and Alberta Central Air Ambulance. Point-of-care testing in the air ambulance program is performed with the Abbott i-STAT1 or Siemens epoc system. Alberta Precision Laboratories POCT provides full oversight at one base in southern Alberta, and the remaining 9 bases operate independently of the laboratory.

Alberta Health Services does not own or operate any helicopter-based EMS programs, but rather contracts them out to the Shock Trauma Air Rescue Society, the Helicopter Emergency Response Organization, and the Helicopter Air Lift Operation. The Shock Trauma Air Rescue Society operates 3 bases across the province and uses the i-STAT1 for POCT. Alberta Precision Laboratories POCT does not provide any oversight for this testing. The Helicopter Emergency Response Organization and the Helicopter Air Lift Operation each operate one base, and are local to the northeastern and southern regions of Alberta, respectively. Neither service provider uses POCT.

#### Stroke Ambulance

The Alberta Stroke Ambulance was established in 2017 as a pilot study by AHS in partnership with the charitable foundation of the University of Alberta Hospital (Edmonton, Alberta, Canada).23  It is a specially designed ambulance that enables the assessment and treatment of acute ischemic stroke with onboard tools that include a computed tomography scanner, POCT, videoconferencing, and tissue plasminogen activator therapy. Point-of-care testing includes glucose testing with a Roche Accu-Chek Performa meter, prothrombin time/international normalized ratio testing with a Roche CoaguChek XS Pro system, blood gases and chemistry testing with an i-STAT1, and platelet counts with a Sysmex pocH-100i hematology analyzer. Alberta Precision Laboratories POCT participated in the initial planning for POCT and continues to oversee it to the present day.

#### Community Paramedicine

Alberta Health Services launched its first EMS community paramedicine program in 2012 in the city of Calgary, and expanded it shortly thereafter to the provincial capital of Edmonton. Community paramedicine relies on specially trained paramedics, called community paramedics, to provide health care that extends beyond the usual emergency response/transport model.24  Although community paramedicine was first conceived to address rural health care challenges, it has since found applications in urban environments, especially in the care of the elderly, the homeless, and those with mental health issues or substance use disorders.24,25

In 2018, Alberta's Ministry of Health announced CAD $11 million (approximately US$8.4 million) in new funding for community paramedicine in the province. Therefore, AHS expanded its program to all 5 of its geographic zones, standardized processes across the province, and rebranded the program as the Mobile Integrated Health (MIH) Community Paramedic Program. The full scope of services provided by the program includes medical assessments, diagnostics, treatments, and timely referrals for patients in continuing care facilities, in private residences, or experiencing homelessness. Point-of-care testing is performed with the Abbott i-STAT Alinity and is fully overseen by APL POCT.

### Information Gathering

Details about POCT practices, failure modes, and risk-mitigation strategies in Alberta's EMS programs were gathered through (1) informal conversations with personnel of APL POCT and various EMS programs, (2) in-person tours of EMS bases, (3) accompaniment of EMS personnel on ground and flight missions, (4) a search of the Internet for publicly available information, and (5) a review of APL POCT documents.

### Ethics Review

This study was part of a quality improvement project and did not constitute clinical research. Review by the University of Alberta Human Research Ethics Board was therefore not required.

## RESULTS

### POCT Practices: Overview

The POCT workflow in Alberta's EMS programs is illustrated in Figure 1, and selected aspects are described in more detail in Tables 2 through 7 and in Supplemental Tables 1 through 5 (see the supplemental digital content at https://meridian.allenpress.com/aplm in the November 2020 table of contents). The typical workflow is divided into preanalytical, analytical, and postanalytical phases. The preanalytical phase encompasses procurement, validation, and storage of POCT systems (including devices and reagents); operator training and competency; preparation of POCT systems and the testing environment; patient identification; and sample collection. The analytical phase encompasses entry of operator and patient identifiers into the POCT device; sample testing; and, if necessary, troubleshooting of suspect results, measuring errors, or system malfunctions. The postanalytical phase encompasses discarding of reagents, samples, and other supplies; result communication and interpretation; clinical decision-making; and result charting.

Figure 1

Typical point-of-care testing (POCT) workflow in 3 of Alberta's emergency medical services programs. The workflow is separated into 3 phases: preanalytical, analytical, and postanalytical. Abbreviation: QC, quality control.

Figure 1

Typical point-of-care testing (POCT) workflow in 3 of Alberta's emergency medical services programs. The workflow is separated into 3 phases: preanalytical, analytical, and postanalytical. Abbreviation: QC, quality control.

Table 2

Validation and Storage of Point-of-Care Testing (POCT) Systems Used by Alberta's Emergency Medical Services (EMS) Programs

### POCT Practices: Preanalytical Phase

#### Supplies Procurement, Validation, and Storage

With very few exceptions, Alberta's EMS programs are responsible for procuring their own POCT systems. Requirements for the validation of new devices vary across programs, across service providers within a single program, and across different types of POCT systems (Table 2; Supplemental Table 1). Requirements for the validation of new reagent lots and new reagent shipments show a similar heterogeneity (Table 2; Supplemental Table 1). Validation requirements are more rigorous whenever APL POCT oversight is present. The actual hands-on work and data review are completed by EMS in some cases and by APL POCT in others. One similarity across all programs is that the hands-on work is completed in a climate-controlled environment such as a laboratory or an EMS building.

When not in use for longer periods (eg, overnight), POCT systems are stored at EMS bases across the province or at the University of Alberta Hospital (Table 2; Supplemental Table 1). The only exceptions to this are the Alberta Stroke Ambulance's hematology analyzer and its reagents, which remain on the vehicle overnight while it is parked in the ambulance bay (Figure 2, A). At the beginning of a work shift, EMS personnel of each program either stock the vehicle/aircraft with all necessary POCT supplies or replenish their preassembled POCT kits (Figure 2, B through F). The majority of preassembled kits lack temperature/humidity control, although one air ambulance service provider does store its i-STAT cartridges with ice packs during flight missions. Temperature monitoring of preassembled kits while on missions is performed only by the MIH Community Paramedic Program.

Figure 2

A, Hematology analyzer on board the Alberta Stroke Ambulance. The analyzer's securement prohibits it from being easily moved. B, Kit for CoaguChek and i-STAT1. C and D, Kit for i-STAT1. E and F, Multipurpose kit that includes the i-STAT1. F, part of what is placed inside the kit shown in E.

Figure 2

A, Hematology analyzer on board the Alberta Stroke Ambulance. The analyzer's securement prohibits it from being easily moved. B, Kit for CoaguChek and i-STAT1. C and D, Kit for i-STAT1. E and F, Multipurpose kit that includes the i-STAT1. F, part of what is placed inside the kit shown in E.

#### Training and Competency

A variety of different models are in place for EMS operator training and competency (Table 3; Supplemental Table 2). With the exception of one base in southern Alberta that is overseen by APL POCT, air ambulance service providers set their own training and competency requirements, decide on the most appropriate documents and tools for these purposes, and monitor themselves for compliance. Although all of the providers ensure some form of initial training for their personnel, many do not have requirements for the demonstration or documentation of ongoing competency. Moreover, operator lockout is not enabled on most POCT devices, thereby allowing anyone to operate them regardless of level of training or competency.

Table 3

Operator Training/Competency Practices and Testing Environments for Point-of-Care Testing (POCT) Systems Used by Alberta's Emergency Medical Services (EMS) Programs

The Alberta Stroke Ambulance and the MIH Community Paramedic Program both collaborate with APL POCT on operator training and competency (Table 3). Alberta Precision Laboratories POCT is responsible for (1) specifying the requirements for initial training and ongoing competency, (2) developing and periodically updating relevant documents and tools, (3) approving the use of any third-party documents and tools, and (4) reviewing training and competency records for compliance. In turn, the EMS service providers are responsible for ensuring and documenting that their personnel meet the requirements set forth by APL POCT. It is worth noting that at the present time neither the MIH Community Paramedic Program i-STATs nor the majority of devices on board the Alberta Stroke Ambulance are set up to lock out untrained users or those with lapsed competency. However, work is underway to reconfigure all of these devices with an operator lockout feature.

#### Testing Environment

Manufacturers' instructions for suitable testing environments are easily accessible to Alberta's EMS programs from the operator's guide and instructions for use of various POCT systems, as well as from APL POCT documents (where applicable). Requirements tend to include temperature and humidity specifications as well as the availability of a flat, stable surface. Most EMS programs have challenges in consistently meeting these requirements (Table 3; Supplemental Table 2). The cold Alberta winters are particularly problematic when POCT is performed on the street or in a vehicle/aircraft cabin that has rapidly cooled because of its doors being opened. A well-lit, flat, and stable surface may also be absent, especially during evening or night flight missions and when testing patients on the street.

#### Indication for POCT

Air ambulance medical flight crews rely heavily on Critical Care Medical Control Protocols to determine if an indication exists for POCT. These protocols consist of a set of evidence-based clinical treatment pathways that have been developed by a provincial committee of EMS personnel, physician leadership, and Alberta Health. The community paramedics of the MIH Community Paramedic Program work closely with each patient's regular health care providers or with on-call physicians to determine if POCT is needed during a patient encounter. Alberta Stroke Ambulance personnel who are on board the ambulance assess the need for POCT through a diagnostic algorithm that was developed specifically for this program, and, if needed, they also consult through satellite-assisted videoconferencing with a stroke neurologist at the University of Alberta Hospital.

#### Startup, Quality Control, Reagent Preparation

Some opportunities were afforded to the authors of this study to observe EMS personnel as they performed their device startup, quality control (QC), and reagent preparation procedures. These observations suggested that EMS personnel largely follow startup and reagent preparation requirements for their POCT systems. However, a larger number of observations will allow a more comprehensive understanding of the degree of compliance. For more details on QC, see POCT Practices: QA.

#### Patient Identification

Patient identification is handled by EMS personnel in 2 different ways. Patients who are picked up from a hospital for interfacility transfer have hospital-issued wristbands, and these provide both the patient's name and the patient's unique Alberta medical record number. Patients who are picked up on scene for transport to a hospital will lack such a wristband, but may be able to provide some (or all) of this information themselves. When a patient is unable to provide this information, either because of lack of consciousness or for another reason, EMS personnel may assign the patient a temporary identifier or proceed with POCT in the absence of any identifiers.

#### Hand Hygiene

Please see POCT Practices: Infection Prevention and Control.

#### Sample Collection

Sample collection occurs in a similar manner to hospital-based processes. Like all other clinical staff, EMS personnel receive some training on blood sample collection either during their formal education or as part of on-the-job training. One difference compared with hospital-based processes is that sample labeling with the patient's name and medical record number and the date and time of collection is an infrequent occurrence. Emergency medical services personnel usually provide care to only one patient at a time, and samples are analyzed beside the patient immediately after collection. Therefore, the risk of mixing up samples with those of another patient is minimal and sample labeling is not considered to be a value-added activity.

### POCT Practices: Analytical Phase

#### Information Entry

The POCT analytical phase in Alberta's EMS programs begins with the entry of operator and patient identifiers into the POCT device. A heterogeneity of practices exists across EMS programs and device types (Table 4; Supplemental Table 3). Differences exist in the type of information that is entered as well as in the manner of entry. Practices appear to be a function of (1) the presence or absence of laboratory oversight, (2) requirements set by the service provider, (3) the capability of a POCT device to accept operator and/or patient information, and (4) historical, zone-based practices of APL POCT. If information is entered into a device, it is predominantly entered manually. However, 3 groups do rely on the scanning of bar codes on employee ID cards for operator identifier entry.

Table 4

Device Information Entry and Troubleshooting for Point-of-Care Testing (POCT) Systems Used by Alberta's Emergency Medical Services (EMS) Programs

#### Sample Testing

Some opportunities were afforded to the authors of this study to observe EMS personnel as they performed sample testing on their POCT devices. These observations suggested that EMS personnel largely follow sample testing requirements for their POCT systems. However, a larger number of observations will allow a more comprehensive understanding of the degree of compliance.

#### Troubleshooting

The lack of POCT system redundancy on board EMS vehicles/aircraft and at EMS bases means that options for real-time troubleshooting of suspect results, measurement errors, and system malfunctions are limited (Table 4; Supplemental Table 3). One option available to all EMS programs is to repeat the measurement with either the same sample as was used initially or a freshly collected sample. If the second measurement also is suspect or gives an error, the clinical team has to create a management plan in the absence of the test result(s). If a nearby laboratory can provide timely backup testing, then decision-making may be delayed until the laboratory results are available. However, the only EMS program that can consistently rely on this backup option is the MIH Community Paramedic Program.

### POCT Practices: Postanalytical Phase

#### Sample and Reagent Disposal, Hand Hygiene

Please see POCT Practices: Infection Prevention and Control.

#### Result Interpretation and Decision-Making

Point-of-care testing results that are neither associated with error flags nor clinically suspect are interpreted and acted on by EMS personnel in a program-specific manner (Table 5; Supplemental Table 4). Air ambulance medical flight crews rely heavily on their Critical Care Medical Control Protocols, as mentioned previously, and they also may consult with an EMS physician if necessary. The community paramedics of the MIH Community Paramedic Program work closely with each patient's regular health care providers or with on-call physicians to develop customized treatment plans. Alberta Stroke Ambulance personnel who are on board the ambulance assess their patient and create a treatment plan in consultation with a stroke neurologist at the University of Alberta Hospital through the use of satellite-assisted videoconferencing.

Table 5

Point-of-Care Testing (POCT) Result Follow-Up and Infection Prevention and Control Practices in Alberta's Emergency Medical Services (EMS) Programs

#### Result Communication and Charting

Despite these differences in the decision-making process, all EMS personnel communicate POCT results to consultant physicians in a similar manner (Table 5; Supplemental Table 4). Real-time communication of results always occurs verbally, as POCT devices in Alberta's EMS programs are not currently enabled to transmit results into the provincial electronic health record. Once an EMS team completes a mission and has some downtime, a team member manually enters the patient encounter (including POCT results) into a provincial EMS electronic patient care reporting program. Although these notes do not transmit into the provincial electronic health record either, they can be faxed to relevant health care providers if necessary. With few exceptions, POCT results make it into the provincial electronic health record only if consultant physicians comment on them in patient care notes.

### POCT Practices: Infection Prevention and Control

Infection prevention and control practices in EMS programs are based on policies and guidelines developed by AHS's Infection Prevention & Control team (Table 5; Supplemental Table 4). These include requirements for assessing the risk of spreading infection during a patient care encounter, hand hygiene, personal protective equipment, handling of patient care items and equipment, waste and sharps handling, and environmental cleaning. These guidelines make only very general recommendations for equipment cleaning, so many service providers follow manufacturer instructions for POCT system cleaning and disinfection. For EMS programs that are fully overseen by APL POCT, cleaning and disinfection requirements for POCT systems are also provided in training documents and standard operating procedures.

### POCT Practices: QA

Quality assurance practices vary based on POCT system, EMS program, and service provider within an EMS program. The number and type of QA components for POCT in Alberta's EMS programs are detailed in Tables 6 and 7, as well as in Supplemental Table 5.

Table 6

Quality Assurance Components for Point-of-Care Testing (POCT) Systems Used by Alberta's Emergency Medical Services (EMS) Programs

Table 7

Quality Assurance Failures for Point-of-Care Testing (POCT) Systems Used by Alberta's Emergency Medical Services (EMS) Programs

#### Air Ambulances

Quality assurance practices vary widely among the different air ambulance service providers (Table 6; Supplemental Table 5). One provider does not perform on a regular basis any QC, patient sample cross-checks with the laboratory, or proficiency testing (PT). A second provider does not perform any of these checks regularly either, but does perform the i-STAT external electronic simulator every 24 hours and a thermal probe check every 6 months. A third provider requires the external electronic simulator every 24 hours, and also subscribes to a PT program offered by Oneworld Accuracy (Vancouver, British Columbia, Canada). The fourth provider has different QA practices at its 2 bases: one base only performs the external electronic simulator every 24 hours, whereas the other base has a comprehensive QA program that includes monthly QC, monthly patient sample cross-checks with the laboratory, and PT from the College of American Pathologists (Northfield, Illinois). Of note, the first base operates independently of the laboratory whereas the second base's POCT is fully overseen by APL POCT.

Quality control, patient sample cross-checks, and PT for 2019–2020 could be obtained only for the base that is overseen by APL POCT (Table 7). Quality control and PT performed well overall, but patient sample cross-checks were less reassuring. The early part of 2019 was plagued by poor compliance with cross-check requirements, and the remainder of that year and the first half of 2020 yielded several failures. Records of follow-up investigations were unavailable, but the local POCT group overseeing this base indicated that EMS personnel feel uncomfortable using their current POCT system.

#### Stroke Ambulance

Quality assurance practices associated with the different POCT systems on board the Alberta Stroke Ambulance are heterogeneous as well (Table 6). The CoaguChek XS Pro has not been subject to any regular quality checks in the past. Therefore, any performance problems (eg, strip lot manufacturing issues) came to light either through the observations of astute EMS personnel or through manufacturers' notices. The Accu-Chek Performa and i-STAT1 are both enrolled in PT programs from the College of American Pathologists, and use of the i-STAT1 also requires that the external electronic simulator be performed every 24 hours. The most comprehensive QA practices are associated with the pocH-100i and include daily QC, biannual calibration verification, biannual patient sample cross-checks with the laboratory, and PT from the College of American Pathologists. Quality control, patient sample cross-checks, and/or PT in 2019 and 2020 indicated satisfactory performance overall for the Performa, i-STAT1, and pocH-100i (Table 7).

#### Community Paramedicine

Quality assurance practices for the i-STAT Alinity systems of the MIH Community Paramedic Program include daily external electronic simulator, monthly QC, biannual patient sample cross-checks with the laboratory, and PT from the College of American Pathologists (Table 6). Quality assurance data from 2019 and 2020 indicate satisfactory performance overall, although the systems of 1 zone showed a higher number of patient sample cross-check failures than those of the other 4 zones (Table 7). Follow-up investigations revealed that these failures were likely due to the acceptability criteria being set too tight, thus insufficiently considering the bias that exists between the i-STAT Alinity and this zone's mainframe chemistry analyzer.

### POCT Failure Modes

Failure modes for POCT in Alberta's EMS programs have yet to be characterized in a thorough and systematic manner. Based on the practices described in the previous sections, many failure modes are likely to be similar to those documented previously for traditional POCT in hospitals.2,7,9,10,2631  Examples of this include the lack of annual competency assessment, noncompliance with operating procedures, the absence of appropriate QC and/or other QA components, and incomplete or erroneous result documentation.

Some failure modes, however, may be more unique to Alberta's EMS programs or may occur at a different frequency than in hospitals. For example, inoperability of the i-STAT in winter because of overly cool cabin temperatures was mentioned by personnel from the air ambulance program as well as the Alberta Stroke Ambulance. Such occurrences force clinical teams either to delay decision-making until the i-STAT is operational again or to develop treatment plans in the absence of test results. A handful of previous reports17,19,20,32  suggest that such temperature-related challenges are not restricted to Alberta's EMS programs, but rather occur universally wherever care provision is in an environment with little to no climate control. In contrast, such challenges are rarely cited as a concern in hospitals with good climate control.

Table 8 summarizes additional failure modes that have been noted by other groups and may be of relevance to Alberta's EMS programs. Multiple studies3339  have investigated the analytical performance of POCT systems when subjected to thermal stresses such as might be seen during Alberta's winters and summers. All but two studies34,38  concluded that POCT systems produce inaccurate measurements after being exposed to such conditions, regardless of whether the measured analyte is glucose, blood gases, cardiac markers, or lactate. Similar studies for coagulation and hematology systems are lacking, but it seems reasonable to hypothesize that they too may be affected by such stresses.

Table 8

Previously Reported Failure Modes That May Be of Relevance to Point-of-Care Testing (POCT) in Alberta's Emergency Medical Services (EMS) Programs

Reports on other failure modes in EMS programs are scarce (Table 8). One study21  described the initial malfunction of a Radiometer ABL 90 blood gas analyzer in a moving critical care vehicle; the problem was solved by creating additional cushioning around the analyzer and adding a newly constructed sample inlet. The authors13  of a second study postulated that operator errors with the i-STAT were partly due to the moving environment of their critical care transport vehicles/aircraft. Finally, a third study18  described the challenges associated with linking POCT results to the correct patient record when using the i-STAT in air ambulances. The authors pointed out that bar-coded patient wristbands are not always available for scanning, forcing flight medical crew to have to manually enter patient information in a moving, dimly lit, and stressful environment.

### POCT Risk-Mitigation Strategies

#### Overarching Strategies

Table 9 presents overarching risk-mitigation strategies for Alberta's EMS programs that aim to establish a provincial framework for high-quality POCT in EMS programs. These strategies include (1) development and implementation of an AHS-wide policy on laboratory oversight of POCT, (2) enhancing POCT capacity through appropriate funding models and the expansion of staffing and infrastructure, (3) nurturing relationships between the laboratory and EMS programs, and (4) tailoring laboratory oversight of POCT to EMS needs.

Table 9

Overarching Point-of-Care Testing (POCT) Risk-Mitigation Strategies Proposed for Alberta's Emergency Medical Services (EMS) Programs

Alberta is making slow but steady progress in implementing these strategies. Alberta Health Services implemented an organization-wide policy on POCT in 2016, which assigned authority for POCT governance, oversight, and quality to APL. In practice, this means that all POCT that is performed in AHS-owned environments has to be done under the guidance of the laboratory. The main limitation of the policy is that it does not outline expectations for contracted service providers that own and operate their own programs. Therefore, this policy will need to be revised in the future to also encompass the POCT that is performed by contracted service providers such as Advanced Paramedic Ltd, Alberta Central Air Ambulance, and the Shock Trauma Air Rescue Society.

Capacity for POCT within AHS environments is being slowly built through the allocation of additional funds to APL POCT. At the present, these funds are being used to hire additional technical and medical personnel, as well as to implement a provincial POCT middleware. Cost sharing between APL POCT and EMS programs is also being explored. For example, all POCT systems and supplies for the validation of the MIH Community Paramedic Program's i-STATs were purchased by the MIH group, and they also performed a large part of the hands-on validation work. Moreover, funds have been transferred from the MIH budget to APL POCT in order to cover the laboratory staff time required to provide ongoing oversight for the MIH group's POCT activities. Similar funding models remain to be explored with other EMS programs, and may prove particularly challenging for programs that rely on contracted service providers.

Establishment and nurturing of relationships between the laboratory and Alberta's various EMS programs is of key importance to develop relevant expertise and to build mutual trust, respect, and interdependence in regard to POCT. Relationships between APL POCT and an air ambulance base in southern Alberta, as well as between APL POCT and the Alberta Stroke Ambulance, have been in existence for several years. In 2019, a formal working relationship was also established between APL POCT and the MIH Community Paramedic Program. Because of a personal interest in EMS programs, one of the authors of this report has also initiated informal conversations with a number of other air ambulance programs in the province. However, formal working relationships between APL POCT and these programs remain to be established.

The last overarching strategy in Table 9 is to tailor laboratory oversight of POCT to the specific needs of Alberta's EMS programs. As mentioned in the previous paragraph, APL POCT already has some experience with overseeing EMS programs. However, the expertise that has been developed through this experience is relatively new, still very much incomplete, and/or restricted to a few individuals. Because of this, the oversight that is currently in place does not take into account the unique challenges of EMS programs, but rather is based on the needs of POCT in hospitals. It will be important for APL POCT to adapt its oversight of POCT in EMS programs as it builds relationships with them and develops further expertise in this area.

#### Targeted Strategies

A wide variety of risk-mitigation strategies aimed at reducing or eliminating errors in the preanalytical, analytical, and postanalytical phases of POCT have already been proposed by others based on experiences in hospitals.2,7,9,10,27,28,31 Table 10 proposes some additional strategies to help with addressing the particular challenges faced by Alberta's EMS programs. These strategies are based on the authors' current understanding of the POCT practices in these programs, past experience, and the insight shared by other groups as described in previous sections of this report. The authors recognize that the list in Table 10 is nonexhaustive, and expect it to grow and change as APL POCT gains more familiarity and expertise with POCT in Alberta's EMS programs.

Table 10

Risk-Mitigation Strategies Targeted at Specific Parts of the Point-of-Care Testing (POCT) Workflow in Alberta's Emergency Medical Services (EMS) Programs

## DISCUSSION

The present report provides a high-level overview of POCT practices in 3 different EMS programs in the Canadian province of Alberta, including an air ambulance program, a community paramedic program, and a stroke ambulance. The report also discusses relevant failure modes and proposes risk-mitigation strategies for implementation at the organizational level and in specific phases of the POCT workflow. Although further work is required to characterize in detail the POCT practices in each of these programs, several important messages are evident from the preliminary findings in this report.

First, a large heterogeneity of POCT practices exists across different EMS programs within Alberta and across different service providers within a single program. This may seem surprising given that a single health authority (ie, AHS) is responsible for health care delivery across the entire province. However, a closer inspection reveals several contributing factors that have led to this state: (1) a lack of collaboration between EMS service providers and laboratories on POCT, (2) a lack of clearly defined expectations for POCT practices from AHS to contracted service providers, (3) a historical lack of standardized POCT quality management practices across the 5 AHS geographic zones, and (4) use of POCT systems with limited information technology capabilities. Future work will need to focus on standardizing practices across service providers and programs as much as possible, thereby ensuring that POCT is always performed consistently regardless of the particular EMS setting.28,40,41

Second, AHS's overall attitude toward POCT is a key enabler of improved POCT practices in Alberta's EMS programs. Point-of-care testing was implemented in the air ambulance program at a time when AHS displayed very relaxed organizational attitudes toward POCT (Figure 3). This resulted in little laboratory oversight and very heterogeneous practices. However, 2016 saw the adoption of an AHS-wide policy on POCT, and 2018 marked the formation of a provincial POCT department with a focus on quality and standardization. Point-of-care testing in the MIH Community Paramedic Program was implemented after both of these changes, and the result was a POCT program with full laboratory oversight and robust, standardized practices. This indicates that high-quality POCT practices are indeed possible in Alberta's EMS programs, and that they are most likely to be achieved if AHS continues to make POCT a high priority within the entire organization.

Figure 3

Timeline of point-of-care testing (POCT) implementation in 3 of Alberta's emergency medical services (EMS) programs in relation to Alberta Health Services' overall approach to POCT.

Figure 3

Timeline of point-of-care testing (POCT) implementation in 3 of Alberta's emergency medical services (EMS) programs in relation to Alberta Health Services' overall approach to POCT.

Third, APL POCT and the wider laboratory medicine community need to develop more expertise with POCT in EMS programs. There is currently a paucity of reports on POCT workflows, failure modes, and risk-mitigation strategies, despite the fact that some of these programs have been in existence for more than 20 years. It may be that laboratories lump these programs together with all of their other programs and oversee them in an identical manner. Alternately, it may be that laboratories oversee such programs minimally, if at all. Regardless of which is true, the time has come for the laboratory community as a whole to acknowledge that it needs to better understand the strengths and challenges of performing POCT in such programs. Additional reports on POCT practices in other EMS programs would be a great way to start developing this expertise.

The work in this report has several limitations. First, specific error rates in each phase of the POCT workflow remain to be quantified in individual EMS programs as well as across all programs. Moreover, prioritization of errors according to the seriousness of their consequences, their frequency, and their ease of detection also remains to be completed. It may be possible that additional risk-mitigation strategies will be required once such work has been completed. Second, this report did not include ground ambulances in Alberta because of the limited knowledge of the authors about this EMS program. As a result, it is not possible to estimate the total POCT test volume performed by EMS programs in Alberta or the fraction of this test volume performed by ground ambulances alone.

## CONCLUSIONS

Emergency medical services programs have been relying on POCT for more than 20 years to assist them in the provision of urgent medical care. However, only a handful of reports have been published in all of this time on POCT practices in such settings. This report examined 3 different EMS programs in Alberta: an air ambulance program, the Alberta Stroke Ambulance, and the MIH Community Paramedic Program. Point-of-care testing practices varied widely across programs and across service providers within a single program. Practices were most standardized and robust in the MIH Community Paramedic Program (single service provider, full laboratory oversight), and least standardized and robust in the air ambulance program (4 service providers, limited laboratory oversight). Common failure modes across all 3 programs included device inoperability due to cold winter weather, device/reagent validation procedures that failed to consider the unique environmental stresses of EMS settings, and a lack of real-time electronic transmission of POCT results to all members of the patient's health care team.

Achieving robust, standardized, and high-quality POCT practices in Alberta's EMS programs is desirable and very much possible, as exemplified by the progress that has been made to date. The establishment of an all-encompassing provincial framework for high-quality POCT in this setting will be a key enabler of the progression from today's state into the future (Figure 4). Such a framework will need to include funding models for staffing and infrastructure, requirements for laboratory oversight of POCT, and the development of relevant expertise by both the laboratory and EMS service providers. The framework will also need to incorporate specific guidance on quality standards that are needed to address the unique challenges of performing POCT in field settings. This may be particularly beneficial for the for the air ambulance program, which seems to have the most complex field environment of the 3 programs examined in this report.

Figure 4

Laboratory oversight and point-of-care testing (POCT) practices in 3 of Alberta's emergency medical services (EMS) programs today and in the future. Zones 1 through 5 refer to the 5 geographic zones within Alberta Health Services. Blue color signifies laboratory oversight + robust, standardized, high-quality POCT practices. Abbreviation: MIH, Mobile Integrated Health.

Figure 4

Laboratory oversight and point-of-care testing (POCT) practices in 3 of Alberta's emergency medical services (EMS) programs today and in the future. Zones 1 through 5 refer to the 5 geographic zones within Alberta Health Services. Blue color signifies laboratory oversight + robust, standardized, high-quality POCT practices. Abbreviation: MIH, Mobile Integrated Health.

The authors wish to thank Alberta's EMS programs for their enthusiasm and collaboration on this manuscript. In particular, thank you for the opportunities to visit EMS bases and to accompany EMS personnel on missions, and for the many insightful discussions about POCT practices and challenges. Thank you also to the POCT department of APL for many insightful discussions related to POCT practices in Alberta.

## References

References
1.
International Organization for Standardization
.
ISO/TS 22583:2019(en)—guidance for supervisors and operators of point-of-care testing (POCT) devices. Geneva, Switzerland: International Organization for Standardization; 2019.
2.
Kost
GJ,
Ehrmeyer
SS,
Chernow, et al. The laboratory-clinician interface: point-of-care testing
.
Chest
.
1999
;
115
(4)
:
1140
1154
.
3.
Sohn
AJ,
Hickner
JM,
Alem
F.
Use of point-of-care tests (POCTs) by US primary care physicians
.
J Am Board Fam Med
.
2016
;
29
(3)
:
371
376
.
4.
Klepser
DG,
Klepser
ME.
Point-of-care testing in the pharmacy: how is the field evolving?
Expert Rev Mol Diagn
.
2018
;
18
(1)
:
5
6
.
5.
Ransohoff
JR,
Melanson
SEF.
What's new in point-of-care testing?
Point Care
.
2019
;
18
(3)
:
92
98
.
6.
Kost
GJ.
Guidelines for point-of-care testing: improving patient outcomes
.
Am J Clin Pathol.
1995
;
104(4)(suppl 1):S111–S127.
7.
Meier
FA,
Jones
BA.
Point-of-care testing error: sources and amplifiers, taxonomy, prevention strategies, and detection monitors
.
Arch Pathol Lab Med
.
2005
;
129
(10)
:
1262
1267
.
8.
Frias
JP,
Lim
CG,
Ellison
JM,
Montandon
CM.
Review of adverse events associated with false glucose readings measured by GDH-PQQ-based glucose test strips in the presence of interfering sugars
.
Diabetes Care
.
2010
;
33
(4)
:
728
729
.
9.
Kost
GJ.
Preventing medical errors in point-of-care testing: security, validation, performance, safeguards, and connectivity
.
Arch Pathol Lab Med
.
2001
;
125
(10)
:
1307
1315
.
10.
Khanna
S,
Baron
J,
Gregory
K,
Lewandrowski
K.
Implementation of an expanded point-of-care site inspection checklist in an academic medical center: an eight year experience
.
Clin Chim Acta
.
2018
;
476
:
173
177
.
11.
Yip
PM,
Venner
AA,
Shea
J,
et al.
Point-of-care testing: a position statement from the Canadian Society of Clinical Chemists
.
Clin Biochem
.
2018
;
53
:
156
159
.
12.
Tortella
BJ,
Lavery
RF,
Doran
JV,
Siegel
JH.
Precision, accuracy, and managed care implications of a hand-held whole blood analyzer in the prehospital setting
.
Am J Clin Pathol
.
1996
:
106
(1)
:
124
127
.
13.
Gruszecki
AC,
Hortin
G,
Lam
J,
et al.
Utilization, reliability, and clinical impact of point-of-care testing during critical care transport: six years of experience
.
Clin Chem
.
2003
;
49
(6, pt 1)
:
1017
1019
.
14.
Stopyra
JP,
Snavely
AC,
Scheidler
JF,
et al.
Point-of-care troponin testing during ambulance transport to detect acute myocardial infarction
[published online
March
3,
2020]
.
Prehosp Emerg Care
.
15.
Brant
EB,
Martin-Gill
C,
Callaway
CW,
Angus
DC,
Seymour
CW.
Prehospital identification of community sepsis using biomarkers of host response
[published online
February
24,
2020]
.
Intensive Care Med. doi:10.1007/s00134-020-05975-x
16.
Harpaz
D,
Eltzov
E,
Seet
RCS,
Marks
RS,
Tok
AIY.
Point-of-care testing in acute stroke management: an unmet need ripe for technological harvest
.
Biosensors (Basel)
.
2017
;
7
(3)
:
30
.
17.
Burritt
MF,
Santrach
PJ,
Hankins
DG,
Herr
D,
Newton
NC.
Evaluation of the i-STAT portable clinical analyzer for use in a helicopter
.
Scand J Clin Lab Invest Suppl
.
1996
;
224
:
121
128
.
18.
Di Serio
F,
Petronelli
MA,
Sammartino
E.
Laboratory testing during critical care transport: point-of-care testing in air ambulances
.
Clin Chem Lab Med
.
2010
;
48
(7)
:
955
961
.
19.
Rust
MJ,
Carlson
NA,
Nichols
JH.
A thermos-modulating container for transport and storage of glucose meters in a cold weather environment
.
Point Care
.
2012
;
11
(3)
:
157
160
.
20.
Beynon
C,
Erk
AG,
Potzy
A,
Mohr
S,
Popp
E.
Point of care coagulometry in prehospital emergency care: an observational study
.
Scand J Trauma Resusc Emerg Med
.
2015
;
23
:
58
.
21.
Mikkelsen
S,
Wolsing-Hansen
J,
Nybo
M,
Maegaard
CU,
Jepsen
S.
Implementation of the ABL-90 blood gas analyzer in a ground-based mobile emergency care unit
.
Scand J Trauma Resusc Emerg Med
.
2015
;
23
:
54
.
22.
Blanchard
IE,
Kozicky
R,
Dalgarno
D,
et al.
Community paramedic point of care testing: validity and usability of two commercially available devices
.
BMC Emerg Med
.
2019
;
19
:
30
.
23.
Shuaib
A,
Jeerakathil
T.
The mobile stroke unit and management of acute stroke in rural settings
.
CMAJ
.
2018
;
190
(28)
:
E855
E858
.
24.
Choi
BY,
Blumberg
C,
Williams
K.
Mobile integrated health care and community paramedicine: an emerging emergency medical services concept
.
Ann Emerg Med
.
2016
;
67
(3)
:
361
366
.
25.
Agarwal
G,
Angeles
R,
Pirrie
M,
et al.
Evaluation of a community paramedicine health promotion and lifestyle risk assessment program for older adults who live in social housing: a cluster randomized trial
.
CMAJ
.
2018
;
190
(21)
:
E638
E647
.
26.
Jacobs
E,
Hinson
KA,
Tolnai
J,
Simson
E.
Implementation, management and continuous quality improvement of point-of-care testing in an academic health care setting
.
Clin Chim Acta
.
2001
;
307
(1–2)
:
49
59
.
27.
Kost
GJ.
Preventing problems, medical errors, and biohazards in point-of-care testing: using complex adaptive systems to improve outcomes
.
Point Care
.
2003
;
2
(2)
:
78
88
.
28.
Nichols
JH.
Reducing medical errors at the point of care
.
Labmedicine
.
2005
;
36
(5)
:
275
277
.
29.
O'Kane
MJ,
McManus
P,
McGowan
N,
Lynch
PLM.
Quality error rates in point-of-care testing
.
Clin Chem
.
2011
;
57
(9)
:
1267
1271
.
30.
Shaw
JLV.
The dark side of point-of-care testing
.
Clin Biochem
.
2017
;
50
(9)
:
466
467
.
31.
Price
CP,
Smith
I,
Van den Bruel
A.
Improving the quality of point-of-care testing
.
Fam Pract
.
2018
;
35
(4)
:
358
364
.
32.
Vanholder
R,
Borniche
D,
Claus
S,
et al.
When the earth trembles in the Americas: the experience of Haiti and Chile 2010
.
Nephron Clin Pract
.
2011
;
117
(3)
:
c184
c197
.
33.
Louie
RF,
Sumner
SL,
Belcher
S,
Mathew
R,
Tran
NK,
Kost
GJ.
Thermal stress and point-of-care testing performance: suitability of glucose test strips and blood gas cartridges for disaster response
.
Disaster Med Public Health Prep
.
2009
;
3
(1)
:
13
17
.
34.
Ferguson
WJ,
Vy
JH,
Louie
RF,
et al.
Preliminary evaluation of a point-of-care blood gas-electrolyte analyzer potentially robust in cold during emergencies and disasters
.
Point Care
.
2012
;
11
(3)
:
152
156
.
35.
Louie
RF,
Ferguson
WJ,
Curtis
CM,
Vy
JH,
Tang
CS,
Kost
GJ.
Effects of environmental conditions on point-of-care cardiac biomarker test performance during a simulated rescue: implications for emergency and disaster response
.
Am J Dis Med
.
2013
;
8
(3)
:
205
212
.
36.
Lam
M,
Louie
RF,
Curtis
CM,
et al.
Short-term thermal-humidity shock affects point-of-care glucose testing: implications for health professionals and patients
.
J Diab Sci Technol
.
2014
;
8
(1)
:
83
88
.
37.
Louie
RF,
Ferguson
WJ,
Curtis
CM,
Vy
JH,
Kost
GJ.
Vulnerability of point-of-care test reagents and instruments to environmental stresses: implications for health professionals and developers
.
Clin Chem Lab Med
.
2014
;
52
(3)
:
325
335
.
38.
Truong
AT,
Louie
RF,
Vy
JH,
et al.
Effects of humidity on foil and vial packaging to preserve glucose and lactate strips for disaster readiness
.
Disaster Med Public Health Prep
.
2014
;
8
(1)
:
51
57
.
39.
Tang
CS,
Ferguson
WJ,
Louie
RF,
Vy
JTH,
Sumner
SL,
Kost
GJ.
Ensuring quality control of point-of-care technologies: effects of dynamic temperature and humidity stresses on glucose quality control solutions
.
Point Care
.
2012
;
11
(3)
:
147
151
.
40.
Lehmann
CU,
Miller
MR.
Standardization and the practice of medicine
.
J Perinatol
.
2004
;
24
(3)
:
135
136
.
41.
Church
DL,
Naugler
C.
Benefits and risks of standardization, harmonization, and conformity to opinion in clinical laboratories
.
Crit Rev Clin Lab Sci
.
2019
;
56
(5)
:
287
306
.

## Author notes

The authors have no relevant financial interest in the products or companies described in this article.