Sage Journals: Discover world-class research

Abstract

Health leaders must consider various solutions to alleviate the healthcare management burden within Canadian hospitals. Increased access and rapidity of Infectious Diseases (IDs) testing via multiplex Point-of-Care Tests (POCTs) is an example. Twenty-four interviews assessed the facilitators and barriers to implementing such tests in the inpatient hospital setting in Quebec, Ontario, and British Columbia. The perspective of health leaders, including provincial laboratory officials, medical and laboratory directors, POCT managers, physicians, and nurses, revealed the following major themes as being relevant to the sustainable adoption and implementation of a multiplex POCT for IDs: (1) current diagnostic methods and experience with POCTs; (2) disease burden and level of health system integration affecting a hospital; (3) the management capacity of hospitals; and (4) the anticipated impact on healthcare management efficiency. The study provides structure for health leaders to evaluate and plan for necessary organizational transformation for adopting multiplex POCTs.

Introduction

In Canada, the decentralization of diagnostic tests in the form of multiplex Point-of-Care Tests (POCTs) for Infectious Diseases (IDs) is a relevant topic for healthcare management,¹ with wide-ranging operational implications that could address the concerning wait-times for patients, burnout in the healthcare workforce,² and Antimicrobial Resistance (AMR) and Stewardship (AMS) efforts,³ especially during infection outbreaks when infection prevention decisions are critical.⁴ Equity and access to care and improved spatial justice are additional important Canadian healthcare priorities.^5-7

The objective of a POCT is to obtain results with greater speed and efficiency, for timelier decision-making, by removing the need for specimen transportation to a central laboratory.⁸ Specimens can be analyzed by an individual without laboratory science credentials.⁹ Examples of POCTs that have been implemented in Canada include those assessing a few specific molecules or biomarkers, such as blood gases, glucose, pregnancy status, drug intake, and SARS-CoV-2 antigens.^1,10 Previous studies have reported how the implementation of such POCTs required the assessment of the following factors: funding, staffing, training, documentation, quality assurance, standardization, and oversight.^1,11-13 In the case of multiplex identification panels that can detect multiple analytes simultaneously, assessing readiness for adoption and implementation can be even more challenging.^14,15 However, doing this exercise is important for health leaders seeking solutions to addressing the healthcare management burden of hospitals through a rapid diagnosis, improved bed allocation, and more judicious use of antimicrobials, in line with AMS efforts.^15-19

Multiplex POCTs have been tested in the context of sexually transmitted and blood-borne infections for their diagnostic performance and suitability within Canadian outreach community settings. They showed excellent specificity and sensitivity, and optimized patient care (e.g., same-day testing and care coordination).^20,21 In the United States, multiplex molecular POCTs for IDs have been implemented in hospitals, with evidence supporting efficient patient care management and improved patient outcomes.²² To the co-authors’ knowledge, no studies have yet investigated feasibility, preparedness, and potential impact of Canadian hospitals considering the implementation and adoption of multiplex POCTs for use within inpatient settings. This lack of evidence prevents health leaders from confidently determining if such change would improve hospital efficiency and strengthen AMS. To bridge this gap, this study explored the barriers, facilitators, and anticipated impact of implementing multiplex POCTs for the diagnosis of IDs within Canadian inpatient hospital settings.

Methods

An environmental scan methodology was selected,²³ using exploratory semi-structured interviews.^24,25 The areas of exploration and the thematic analysis were guided by the Practical, Robust Implementation and Sustainability Model (PRISM).²⁶ PRISM supports the investigation of barriers and facilitators to the sustainable implementation of a health intervention, such as a POCT.²⁶ “POCTs” were defined for participants as testing performed outside the central laboratory, while “multiplex POCTs for IDs” as POCTs that simultaneously test a panel of multiple potential viral/bacterial infection causes.

Ethics Review

The study was approved by Veritas Independent Review Board (Veritas IRB Inc, Kirkland, Quebec). All steps of the research were conducted in accordance with the Declaration of Helsinki.²⁷

Sampling Criteria

Three provinces in Canada were prioritized: Quebec (QC), Ontario (ON), and British Columbia (BC), as they account for 76% of the Canadian population.²⁸ Based on previous literature,²⁹ the following stakeholder groups were included: laboratory directors, POCT coordinators/site supervisors/committee members/chairs, administration representatives, and nurses/physicians involved in the diagnosis or treatment of IDs in the inpatient hospital setting. Exclusion criteria were: >50% of professional time spent researching/teaching, currently retired, self-rated knowledge level of POCT as “none” or “basic,” self-rated knowledge level of multiplex POCTs for IDs as “none,” and no experience using/implementing a POCT in the last 3 years. Purposive sampling criteria included a variety of hospital types (e.g., university centres/tertiary hospitals vs local hospitals with limited inpatient care) and targeted stakeholders for each province.³⁰ A sample size of 24, with an ideal quota of 8 participants per province and 12 per hospital type, was determined a priori based on studies demonstrating data saturation after 10-13 interviews in a relatively homogenous group and a minimum of 20 interviews to identify common themes among sub-groups.^31,32

Recruitment

Potential participants were identified through professional listings of diagnostic test users, decision-makers, and healthcare professionals, derived from pharmaceutical and health research industry-related organizations in compliance with the ESOMAR/ICC International Code on Market, Opinion and Social Research and Data Analytics.³³ Potential participants were sent an IRB-approved invitation to the study explaining its purpose and method. The invitation included a secure link for a brief eligibility screening, systematically applying research criteria, followed by a consent form and opt-in/out for eligible participants. Purposive sampling was applied through continuous monitoring of screening responses and coordination of remaining recruitment to obtain desired sub-group quotas. All interviewees provided informed consent prior to participation. Participants received $150 in financial compensation for their time upon study completion.

Data Collection

Semi-structured interview guides were developed in English, in line with study objectives and areas of exploration.³⁴ Questions were open-ended with follow-up probes to ensure comprehensive capture of participants’ perspectives.^24,25 The interview guide was pilot tested on 4 participants to ensure rich and relevant answers were obtained in alignment with the study objectives and a 45-60 minutes completion time. The final interview guide was translated into French. All interviews were conducted in English or French (participant preference) by co-author MA (MPH, female researcher, trained in qualitative methods, experienced in public health, performance, and quality improvement research). Interviews were conducted on-line using Zoom video communication software. The moderator adjusted the pre-determined questions to the participants’ responses and asked spontaneous open-ended questions for in-depth exploration of unanticipated topics and/or perspectives.^24,25 The moderator did not have an established relationship with the participants, and participants did not know anything about the moderator prior to the interview. A study recruiter was included only for the introduction of interviews, to ease coordination. No repeat interviews were carried out. One person refused participation without reason, and a second individual cancelled prior to the interview due to other commitments hindering participation. All interviews were audio-recorded, transcribed, and joined with notes taken by the moderator. French transcriptions were translated into English for analysis.

Analysis

A preliminary coding tree was developed based on the areas of exploration and used by the researcher/moderator to code transcripts in NVivo 12 Pro (2017, Lumivero). Transcripts were subsequently reviewed for familiarity and then coded by one coder (co-author MA). The process allowed for new codes to be created, transformed, and validated to ensure that the emerging and final coding tree was appropriately grounded in the interview content.³⁵ Final coding was reviewed to identify relationships between codes and themes/sub-themes according to what emerged from the data, in guidance with the PRISM model and areas of exploration.^26,36 Hence, a mix of inductive and deductive reasoning approaches drove analysis.³⁷ Findings were collectively interpreted by the multidisciplinary group of co-authors (with backgrounds in POCT, IDs, biochemistry, public health, health systems research, and performance/quality improvement) to triangulate the multiple perspectives of the stakeholders.³⁸

Results

The sample (n = 24) included 2 laboratory leaders overseeing POCT at the provincial level (BC = 2), 10 directors responsible for leading institutional-level POCT use (QC = 2; ON = 6; BC = 2), 5 managers for department-level POCT use (QC = 2; ON = 3), and 7 hospital employees as end-users (QC = 2; ON = 2; BC = 3). The majority (n = 18) worked in urban hospitals; the remaining worked in rural hospitals (n = 4) or overseeing diverse hospital types (n = 2). Perspectives included those of laboratory representatives, nursing staff, and physicians.

The integrated perspectives of participants revealed the following major themes relevant to the sustainable adoption and implementation of a multiplex POCT for IDs: (1) current diagnostic methods and experience with POCTs; (2) disease burden and level of health system integration affecting a hospital; (3) the management capacity of hospitals in terms of their human resources, space, and information technology; and (4) anticipated impact on healthcare management efficiency (Figure 1). The identified barriers (Table 1) and facilitators (Table 2) associated with each of these major themes are presented with representative quotes.

Figure 1.

Major Themes Related to the Perceived Sustainability of Adopting and Implementing a Multiplex POCT for Infectious Diseases

Table 1.

Barriers to a Sustainable Adoption and Implementation of a Multiplex POCT for IDs

Barriers (minor themes)	Representative quotes	Identifiers
Related to major theme #1: Current diagnostic methods and experience with POCTs
Barrier 1: The cost of in-house laboratory equipment is lower for similar or superior results compared to a multiplex POCT.	“We have a pneumatic system, so I can actually do the sample right here in my office and send it to the lab in five minutes […] we have a homemade rapid multiplex PCR test, which we’re able to do 25 tests per batch and in season we’ll run it three times a day and it’s much less costly.”	Director of Infection and Control, QC, Urban Hospital
Barrier 2: There is limited knowledge and experience with the complexity and requirements of multiplex POCTs.	“As researchers [we] have tested point-of-care testing for HIV and hepatitis in emergency, but I don’t know much about testing and how it would be done for multiple infectious diseases.”	POCT Quality Control (Registered Nurse), ON, Urban Hospital
	“In terms of the tests that are available, there’s a point-of-care urinalysis or a urine dip, urine pregnancy. There’s COVID, a rapid COVID test. Then the rapid HIV. The point-of-care glucose is probably the one we use the most.”	Physician, Emergency Medicine, ON, Urban Hospital
Barrier 3: There is skepticism towards the diagnostic performance of multiplex POCTs.	“I know they’re marketed as point-of-care without a laboratory oversight. I cannot see that as being doable even though they are marketed that way, partly because there’s lots of concern around false positives.”	Director of Infectious Diseases and/or Microbiology, ON, Urban Hospital
	“The lab test is the gold standard. The point of care […] The margin of error is significantly increased enough to cause a little skepticism. And especially when you throw in the user error in there…”	POCT Quality Control (Laboratory Technologist), ON, Rural Hospital
Related to major theme #2: Disease burden and level of health system integration
Barrier 4: A high frequency of infectious disease cases lowers the cost-effectiveness of a POCT compared to a laboratory test with greater throughput capacity.	“30 patients that need to be tested every couple of hours or so, then that throughput may not be sufficient […] what you need is an ability to test 96 at a time.”	POCT Committee Member (Physician of Microbiology), ON, Urban Hospital
	“I would say it depends on the volume. So, if I’m doing a meningitis and it’s $250 for a test, but I’m only doing it once a month, then they’ll be more willing to spend that extra money.”	Director of Infectious Disease and Microbiology, ON, Urban Hospital
Barrier 5: There is a lack of national standards for POCT implementation and use.	“The laboratory for the US, they have defined point of care based on low, moderate and complex systems […] But for Canada it’s not quite as defined […] then one laboratory may think this is very doable and implementable, another laboratory may say this is very complex and out of scope.”	POCT Chair, BC, Urban Hospital
Related to major theme #3: Management capacity of hospitals
Barrier 6: Human resources available to sustain the adoption and implementation of a multiplex POCT are too limited.	“Frontline staff are already overwhelmed […] There’s just not enough people to be running tests several times during the day.”	Physician, Infectious Diseases and/or Microbiology, BC, Urban Hospital
	“Already we’re short on nursing staff […], to ask them to then also do the point-of-care testing would be; you’d have to get their buy-in.”	Hospital Administrator, ON, Rural Hospital
Barrier 7: There is a challenge with the delegation of clear roles and responsibilities, including the use and maintenance of a POCT.	“We had a bit of a challenge with people taking ownership and responsibility for performing the testing.”	POCT Quality Control (Registered Nurse), ON, Urban Hospital
Barrier 8: There is a high risk of a laboratory to lose their accreditation.	“I think that being responsible for the implementation and quality assurance of a diagnostic test, is perhaps a little daunting for non-lab-based physicians.”	Physician, Infectious Diseases and/or Microbiology, QC, Urban Hospital
	“Some of the lab accreditation, if you’re aware, it’s very tedious and stringent. And so oftentimes we have a harder time to get the nurses to follow some of these complex procedures […] we are putting risk of our accreditation.”	POCT Chair, BC, Urban Hospital
Barrier 9: Inpatient hospital units have limited space for storage and a high risk of cross-contamination.	“[Emergency medicine departments or ED] are overwhelmed, and you often have corridor medicine…where the patients are in a bay in the ED, which is certainly not ideal.”	POCT Committee Member (Physician Microbiology), ON, Urban Hospital
	“They’re doing it in the room and there’s influenza everywhere and you can contaminate it, especially if it’s highly sensitive.”	POCT Committee Member (Physician Microbiology), ON, Urban Hospital
Barrier 10: There is a lack of interconnectivity capacity between the POCT and the charting system of the hospital.	“We’re half interfaced. Challenges are the cost of it […] And the IT [information technology] resources have been challenging for BC.”	POCT Chair, BC, Urban Hospital
	“the IT guys say, “It’s going to take us six months to be able to reconfigure the channel.”	Provincial Laboratory Leader, BC, Urban and Rural Hospitals
	“We are just manually noting the results. If a patient is positive or not, we manually note it down and we enter into the patient’s chart.”	Hospital Administrator, ON, Rural Hospital
Related to major theme #4: Anticipated impact on healthcare management efficiency
Barrier 11: Multiplex POCTs are anticipated to lack diagnostic capacity for assessing the resistance profiles of pathogens.	“Point of care testing really just provides you with the identification of the infection, it doesn’t give you any further information. […] it is incomplete, let’s say, until you get the susceptibility results for bacteria.”	Director of Infectious Diseases and/or Microbiology, ON, Urban Hospital

Table 2.

Facilitators to a Sustainable Adoption and Implementation of a Multiplex POCT for IDs

Facilitators (minor themes)	Representative quotes	Identifiers
Related to major theme #1: Current diagnostic methods and experience with POCTs
Facilitator 1: Current diagnostic methods require specimens to be sent out to an external laboratory, and the resulting transportation causes substantial delays to diagnosis.	“They’ll have a courier come to the hospital to pick up all of these samples […] maybe once a day if they’re smaller hospitals.”	Physician, Infectious Diseases and/or Microbiology, BC, Urban Hospital
Facilitator 2: The hospital has positive experience with existing molecular assays.	“I oversee the fecal transplant program for our region here, and the [molecular assay] panel is what we use because of the comprehensive identification it has for our donors. So, there’s no question there’s incredible value added.”	POCT Committee Member (Physician, Infectious Diseases and/or Microbiology), ON, Urban Hospital
	“[molecular assays] were available in some places, but it certainly expanded through COVID […] they gave hospitals and outreach areas much more capacity to do some of this testing.”	Provincial Laboratory Leader, BC, Urban and Rural Hospitals
Related to major theme #2: Disease burden and level of health system integration
Facilitator 3: Downstream savings in hospitalization can be demonstrated with the implementation of the multiplex POCT due to high disease severity.	“…years ago, they had HIV rapid test […] those patients may be lost to follow-up, they’re presenting in the moment in your clinic, and you want to be able to do everything for that patient in the moment.”	Nurse Practitioner (Inpatient), BC, Rural Hospital
Facilitator 4: An integrated health system facilitates collective efforts to POCT implementation and use.	“Understanding that on a provincial level, all health authorities are implementing point-of-care to the same degree and the same level across the system is important.”	Provincial Laboratory Leader, BC, Urban and Rural Hospitals
Related to major theme #3: Management capacity of hospitals
Facilitator 5: There is a well-established workflow and existing relationship between POCT supervisors and end-users.	“…if they have a good point-of-care supervisory team that can help them do all the communication, prepare the procedures, and really liaison with the nursing staff or clinical staff that may be using it…”	POCT Chair, BC, Urban Hospital
Facilitator 6: The proposed multiplex POCT is rapid and low complexity with minimal coordination steps required.	“Point-of-care testing needs to be user-friendly, easy to use, and intuitive.”	Nurse Practitioner (Inpatient), BC, Rural Hospital
	“For Covid, we moved away from nasopharyngeal swabs to using swish and gargle technique, which proved to be more comfortable for the patients.”	Director of Infectious Diseases and/or Microbiology, ON, Urban Hospital
Facilitator 7: The spaces within hospitals where the multiplex POCT would be used are clean, well-managed and with effective quality assurance frameworks.	“I never saw negligence…Some patients… might have … accidents regarding the body fluids. Immediately the housekeeper service will come and assess properly.”	Nurse Practitioner (Inpatient), ON, Urban Hospital
	“We can help them create a station for testing, so they don’t get interrupted. It’s clean […] we work with them to try to help them find ways to meet a very good testing area.”	POCT Chair, BC, Urban Hospital
Facilitator 8: There are information technologists available that can ensure interconnectivity between POCT and the electronic charting system of institutions.	“The biggest thing I would tell any manufacturer is make sure your IT [information technology] connectivity is seamless, make sure it’s tested.”	Provincial Laboratory Leader, BC, Urban and Rural Hospitals
	“If I have a piece of equipment that can be connected, I guarantee a better quality, a better monitoring, with as little resources as possible on our end.”	POCT Chair, QC, Urban Hospital
Related to major theme #4: Anticipated impact on healthcare management efficiency
Facilitator 9: There is an anticipated improvement in bed flow management and reduction in specimen transportation costs.	“If there’s something really quick just by the nurse’s time, then all of that downstream automatically gets impacted in a positive way.”	Director of Infectious Diseases and/or Microbiology, ON, Urban Hospital
	“From an infection point of control point of view, it helps with bed management. So that’s where I view that in terms of how successful the point-of-care testing would be.”	Medical Laboratory Director, BC, Urban Hospital
Facilitator 10: There is an anticipated improvement in the management of risk of exposure to communicable diseases of hospital staff.	“We would know for sure if someone has a viral infection through doing an extended panel versus just testing for one or three common respiratory viruses. So it would result in safer care, safer practice for nurses and physicians and anyone who’s in contact with these patients, and it would result in better tailored care for the patient themselves.”	POCT Quality Control (Registered Nurse), ON, Urban Hospital
Facilitator 11: There is an anticipated improvement in equitable access for under-served population groups (e.g., remote areas, underhoused, or living with a mental illness).	“These point-of-care tests certainly are robust to enable then those in rural remote settings to have the same kind of access, equity and equitable access as, say, somebody who’s going to [a large] hospital.”	Provincial Laboratory Leader, BC, Urban and Rural Hospitals
	“I think that particularly for individuals who are underhoused and don’t have access or have poor access to medical care, point of care devices or rapid testing of some sort is pretty critical for those patients because they may not return for results that take days or weeks to return. And so then they would be lost to follow up to manage their infectious disease that may also be communicable.”	Director of Infectious Diseases and Microbiology, ON, Urban Hospital

Current Diagnostic Methods and Experience With POCTs

Currently established laboratory practices and varying levels of familiarity and experience with POCTs were found to shape health leaders’ openness towards adopting a multiplex POCT for IDs. Substantial advantages were perceived by participants who worked in rural hospitals relying solely on specimen transportation to an external laboratory by shuttle or airplane, and thus facing significant hurdles (e.g., traffic and challenging routes) to rapid diagnosis. Contrastingly, lesser benefits were perceived by participants working in urban hospitals with well-established internal transportation systems and laboratory processes offering access to timely results for a lesser cost. Experience with POCT molecular assays for SARS-CoV-2 respiratory virus during the pandemic was associated with positive outlooks on the adoption of multiplex POCTs for IDs, as participants felt non-laboratory personnel were able to demonstrate appropriate use and reporting. Contrastingly, participants without much experience with POCTs demonstrated a greater challenge in recognizing the value of adopting such technology. Many laboratory representatives expressed skepticism towards the diagnostic performance of multiplex POCTs, especially with current limited human resources dedicated to training and quality assurance outside the laboratory. This latter factor was considered an important barrier to adoption, necessitating substantial organizational transformation.

Disease Burden and Level of Health System Integration

Disease burden, described in terms of frequency of occurrence and hospitalization requirements, affected the perceived cost-effectiveness of a POCT by health leaders. In urban hospitals, a higher frequency of ID occurrences due to high population density was noted necessitating powerful laboratory testing with greater throughput capacity than possible with a multiplex POCT. However, molecular POCTs were perceived as particularly valuable for IDs with high severity (e.g., respiratory syncytial virus) where downstream savings in hospitalization can be demonstrated. However, health system fragmentation in Canada was perceived as causing substantial variance in POCT standards, with no clear national guidance currently available. Standardization efforts for POCT use in BC were reported as important next steps in facilitating a cohesive provincial implementation of any POCT.

The Management Capacity of Hospitals

The current healthcare management burden of Canadian hospitals, reflected in the shortage of staff and heavy workloads, was reported as an important barrier to the sustainable adoption and implementation of a multiplex POCT for IDs. Training and audit concerns were voiced due to the anticipated steep learning curve related to molecular testing and the risk to laboratory accreditation if POCT protocols are not followed by non-laboratory personnel. This perceived risk was especially noted in busy hospital units with limited storage and greater chances for cross-contamination. A well-established workflow and direct POCT supervisor-staff relationships were discussed as important strategies to overcome these barriers. Further, the capacity to interconnect POCTs with the charting system of a hospital and central laboratories was discussed as necessary for efficient disease documentation and reporting aimed at alleviating healthcare management burden.

Anticipated Impact on Healthcare Management Efficiency

Participants recognized that multiplex POCTs for IDs could positively impact numerous aspects of hospitals’ management processes, including improved bed flow, cost reduction related to specimen transport, reduced risk of exposure to communicable diseases for employees, and increased equity in access to rapid diagnosis. However, participants pointed out that multiplex POCTs could not support the assessment of resistance profiles of identified pathogens as accurately as current laboratory equipment, which is necessary for the optimal use of antimicrobials.

Discussion

Based on the results of this study, the following items need to be considered by health leaders when assessing the relevance and impact of a molecular-based multiplex POCT for IDs within an inpatient hospital setting in Canada:

1. The development of a compelling business case that outlines the operational capacity and capability at the system level;

2. Cost analysis encompassing capital costs and ongoing operational requirements for POCT implementation;

3. Organization readiness emphasizing:

a. Human resources available for the performance of POCT;

b. IT expertise to integrate technology within current infrastructures;

c. Governance structures, including national standards for POCT complexity grading and appropriate use and oversight;

d. Available space for storage of POCT and appropriate decontamination;

e. POCT quality assurance processes;

f. Capabilities for training and oversight;

g. Existing familiarity and clinical experience with POCTs;

h. Culture of openness towards change, innovation and quality improvement;

4. Risk assessment and mitigation strategies related to the possibility of negative testing outcomes;

5. Value associated with capability to provide rapid molecular testing for syndromic infections to interpret surveillance and preparedness strategies during emergency response events (e.g., improved patient flow and bed allocation, infection prevention and control decisions, and facilitation of stewardship efforts); and

6. Workflow assessment, including clear delegation of roles and responsibilities leading to the obtainment of POCT results.

Our results suggest that the benefit of using a multiplex POCT for IDs outweighs the cost in rural hospitals because of the substantial delays to test results, compared to urban hospitals with in-house laboratories. However, urban hospitals may still benefit from complementary use of molecular POCTs during seasonal outbreaks.⁴ Importantly, molecular-based multiplex POCTs for IDs are not meant to replace a controlled laboratory testing environment, and peer comparisons are necessary for verification of end-user competence and instrumentation accuracy. This point is especially relevant to address concerns around transitioning testing from controlled laboratory environments to clinical spaces, including the skepticism of laboratory directors related to the performance and cost-benefit analysis of POCTs compared to laboratory-based tests.¹²

Recommendations

We recommend the following prioritized actions to facilitate the sustainable adoption and implementation of molecular multiplex POCTs for IDs in the inpatient hospital setting within Canada:

1. Recruiting IT expertise within hospitals to help connect existing information system and clinical workflows with the POCT;

2. Standardizing protocols at the national and organizational level, related to POCT complexity evaluation, approved POCTs, and enforced quality assurance processes. Such efforts have been undertaken in BC to facilitate system integration³⁹;

3. Revision of workflow with respect to the storage, training, use, oversight, and quality assurance of the POCT, ensuring a supportive relationship between POCT supervisors and end-users is established to reduce the risk of negative testing outcomes.

These actions must leverage strong collaboration between the laboratory, clinical, and hospital leaderships to ensure alignment of policies and procedures and ultimately reduce the potential risk for negative outcomes.

Limitations

This study did not fully represent the wide range of hospitals in Canada, nor rural settings, as sampling focused on the three most populated provinces. While purposive sampling was performed, participants were recruited from established lists associated with the use of diagnostic tests, which can explain larger representation of laboratory personnel. Data saturation was reached, but inclusion of participants from other provinces and stakeholder groups may have expanded the results further. Participants did not review transcripts for comments or corrections, nor did they provide feedback on the findings.

Conclusion

This original qualitative research study offers evidence on a hospital management innovation that aims to facilitate the diagnosis of infections and resulting inpatient flow in Canadian hospitals, especially during outbreaks. The study was novel in exploring the anticipated requirements and impact of implementing a molecular multiplex POCT for use by non-laboratory personnel in Canadian hospitals. Health leaders may use this evidence to design local assessment tools and strategic interventions when considering the implementation of higher complexity POCTs for IDs, as part of improved healthcare management strategies.

Footnotes

Acknowledgements

We acknowledge the support provided by bioMérieux Canada for generating interest for this study and would like to thank all participants for their time and reflections.

ORCID iDs

Monica Augustyniak

Julie Shaw

Patrice Lazure

Ethical Considerations

This study and related materials (study protocol, recruitment material, informed consent, and research tools) were reviewed and approved by an independent review board (IRB Veritas) with the following study number: GR-26-011 and tracking number: 024-3291-18112-1.

Consent to Participate

All study participants provided informed consent prior to participating in the study.

Funding

The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was supported by independent medical education funds provided by bioMérieux Canada.

Declaration of Conflicting Interests

The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: MA and PL are employees of AXDEV Group Inc. JS is the clinical lead for the POCT Expert panel for the Ontario Laboratory Medicine Program. JI and KW have no conflicts of interest to disclose.

Data Availability Statement

The interview guide with questions and probes can be accessed as by contacting the corresponding author. The coding tree can be accessed by contacting the corresponding author.*

References

Canadian Agency for Drugs and Technologies in Health (CADTH) . Environmental Scan: Point-of-Care Testing; 2017. https://www.cadth.ca/sites/default/files/pdf/es0308_point_of_care_testing.pdf. Accessed October 23, 2025.

Howe Institute

. HealthCareCAN. Better Health Outcomes: What’s Holding Canada Back?. 2024. https://www.cdhowe.org/sites/default/files/2024-02/CR_Healthcare_2024_0.pdf?target=blank. Accessed October 23, 2025.

Public Health Agency of Canada (PHAC) . Pan-Canadian Action Plan on Antimicrobial Resistance; 2023. https://www.canada.ca/en/public-health/services/publications/drugs-health-products/pan-canadian-action-plan-antimicrobial-resistance.html. Accessed October 23, 2025.

Groves

Piché-Renaud

P-P

Peci

, et al. The impact of the COVID-19 pandemic on influenza, respiratory syncytial virus, and other seasonal respiratory virus circulation in Canada: a population-based study. Lancet Reg Health Am. 2021;1:100015. doi:10.1016/j.lana.2021.100015

Reimer

. Canada Health Act clarity a positive step to improve equitable access to care: CMA. Canadian Medical Association (CMA). https://www.cma.ca/about-us/what-we-do/press-room/canada-health-act-clarity-positive-step-improve-equitable-access-care-cma. Updated January 10, 2025. Accessed October 22, 2025.

Public Health Agency of Canada (PHAC) . Social Determinants of Health and Health Inequalities. Government of Canada. https://www.canada.ca/en/public-health/services/health-promotion/population-health/what-determines-health.html. Updated July 18, 2024. Accessed October 23, 2025.

Hayes

Coxon

Bye

. Rural and remote health care: the case for spatial justice. Rural Remote Health. 2025;25(1):1-9. doi:10.22605/RRH8580

Nichols

Christenson

Clarke

, et al. Executive summary. The national academy of clinical biochemistry laboratory medicine practice guideline: evidence-based practice for point-of-care testing. Clin Chim Acta. 2007;379(1):14-28. doi:10.1016/j.cca.2006.12.025

The American Association for Clinical Chemistry (AACC) . Point-Of-Care Testing: A “How-to” Guide for the Non-Laboratorian; 2022. https://www.aacc.org/science-and-research/poct-how-to-guide-for-non-laboratorians. Accessed February 3, 2023.

10.

Testing Devices for COVID-19: Overview. Government of Canada. https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/medical-devices/testing.html. Accessed October 23, 2024.

11.

Shaw

JLV

. Practical challenges related to point of care testing. Pract Lab Med. 2015;4:22-29. doi:10.1016/j.plabm.2015.12.002

12.

Quinn

Dixon

Meenan

. Barriers to hospital-based clinical adoption of point-of-care testing (POCT): a systematic narrative review. Crit Rev Clin Lab Sci. 2016;53(1):1-12. doi:10.3109/10408363.2015.1054984

13.

Yip

Venner

Shea

, et al. Point-of-care testing: a position statement from the Canadian society of clinical chemists. Clin Biochem. 2018;53:156-159. doi:10.1016/j.clinbiochem.2018.01.015

14.

Buchan

Armand-Lefevre

Anderson

. Molecular diagnosis of pneumonia (including multiplex panels). Clin Chem. 2021;68(1):59-68. doi:10.1093/clinchem/hvab143

15.

Caldwell

Espinosa

Banerjee

Domachowske

. Rapid diagnosis of acute pediatric respiratory infections with point-of-care and multiplex molecular testing. Infection. 2025;53(Suppl 1):1-14. doi:10.1007/s15010-025-02553-5

16.

Rader

Stevens

Bearman

. Syndromic Multiplex Polymerase Chain Reaction (mPCR) testing and antimicrobial stewardship: current practice and future directions. Curr Infect Dis Rep. 2021;23(4):5. doi:10.1007/s11908-021-00748-z

17.

Bissonnette

Bergeron

. The GenePOC platform, a rational solution for extreme point-of-care testing. Micromachines. 2016;7(6):94. doi:10.3390/mi7060094

18.

Bai

Liu

, et al. A sample-to-answer digital microfluidic multiplexed PCR system for syndromic pathogen detection in respiratory tract infection. Lab Chip. 2025;25(6):1552-1564. doi:10.1039/d4lc00704b

19.

National Academies of Sciences, Engineering, and medicine Health and Medicine Division Board on Health Sciences Policy Board on Global Health Forum on Microbial Threats Forum on Medical and Public Health Preparedness for Disasters and Emergencies Forum on Drug Discovery, Development, and Translation , Shore

Forstag

, eds. Accelerating the Development and Uptake of Rapid Diagnostics to Address Antibiotic Resistance: Proceedings of a Workshop. Washington, DC: National Academies Press (US); 2023.

20.

Karellis

Webster

Boulanger

, et al. Feasibility, preference, and impact of a rapid multiplexed point-of-care digital innovation (AideSmart!) to expedite screening of sexually transmitted blood-borne infections in at-risk populations in Canada: cross-sectional study. J Med Internet Res. 2024;26:e55075. doi:10.2196/55075

21.

Singh

Ives

Gratrix

, et al. Sensitivity and specificity of two investigational point of care tests for syphilis and HIV (PoSH study) for the diagnosis and treatment of infectious syphilis in Canada: a cross-sectional study. Clin Microbiol Infect. 2023;29(7):940.e1-940.e7. doi:10.1016/j.cmi.2023.02.015

22.

Baghdadi

O’Hara

Johnson

Krein

Harris

Morgan

. Diagnostic stewardship to support optimal use of multiplex molecular respiratory panels: a survey from the society for healthcare epidemiology of America research network. Infect Control Hosp Epidemiol. 2023;44(11):1823-1828. doi:10.1017/ice.2023.72

23.

Harris

Brooker

. Environmental scanning: a look to the future. N Dir Eval. 2025;2025(185-186):33-41. doi:10.1002/ev.20633

24.

Adams

. Conducting semi‐structured interviews. In: Newcomer

Hatry

Wholey

, eds. Handbook of Practical Program Evaluation. 4th ed. Hoboken, NJ: Wiley; 2015:492-505.

25.

Kallio

Pietilä

Johnson

Kangasniemi

. Systematic methodological review: developing a framework for a qualitative semi‐structured interview guide. J Adv Nurs. 2016;72(12):2954-2965. doi:10.1111/jan.13031

26.

Feldstein

Glasgow

. A practical, robust implementation and sustainability model (PRISM) for integrating research findings into practice. Joint Comm J Qual Patient Saf. 2008;34(4):228-243. doi:10.1016/s1553-7250(08)34030-6

27.

WMA Declaration of Helsinki–Ethical Principles for Medical Research Involving Human Participants. World Medical Association (WMA). https://www.wma.net/policies-post/wma-declaration-of-helsinki/. Accessed March 26, 2024.

28.

Labour Market Indicators . October 2024: By Province and Census Metropolitan Area, Seasonally Adjusted. Statistics Canada. https://www150.statcan.gc.ca/n1/pub/71-607-x/71-607-x2017001-eng.htm. Accessed November 10, 2024.

29.

Warade

. Organization of the POCT unit. EJIFCC. 2015;26(2):125-132. https://pmc.ncbi.nlm.nih.gov/articles/PMC4975358/

30.

Campbell

Greenwood

Prior

, et al. Purposive sampling: complex or simple? Research case examples. J Res Nurs. 2020;25(8):652-661. doi:10.1177/1744987120927206

31.

Braun

Clarke

. To saturate or not to saturate? Questioning data saturation as a useful concept for thematic analysis and sample-size rationales. Qual Res Sport Exerc Health. 2019;13(2):201-216. doi:10.1080/2159676X.2019.1704846

32.

Guest

Bunce

Johnson

. How many interviews are enough? An experiment with data saturation and variability. Field Methods. 2006;18(1):59-82. doi:10.1177/1525822X05279903

33.

ICC/ESOMAR International Code on Market, Opinion and Social Research and Data Analytics; 2025. https://iccwbo.org/news-publications/policies-reports/iccesomar-international-code-market-opinion-social-research-data-analytics/#top. Accessed October 23, 2025.

34.

Supplementary File A: Interview Guide with Questions and Probes. AXDEV Group Inc. https://www.axdevsurveys.com/fs/v1/h/zZkRq9O4CJNnrqVlXmHCX8EXAamhlJnpbVfNz0GngXs/282529.pdf. Accessed October 23, 2025.

35.

Deterding

Waters

. Flexible coding of in-depth interviews: a twenty-first-century approach. Socio Methods Res. 2021;50(2):708-739. doi:10.1177/0049124118799377

36.

Supplementary File

. Coding Tree. AXDEV Group Inc. https://www.axdevsurveys.com/fs/v1/h/Rqy6MoWxGnt-IZXjbDWiH9_q7KRP2SWUBGAl_335CQI/282517.pdf. Accessed October 23, 2025.

37.

Fereday

Muir-Cochrane

. Demonstrating rigor using thematic analysis: a hybrid approach of inductive and deductive coding and theme development. Int J Qual Methods. 2006;5(1):80-92. doi:10.1177/160940690600500107

38.

Thurmond

. The point of triangulation. J Nurs Scholarsh. 2001;33(3):253-258. doi:10.1111/j.1547-5069.2001.00253.x

39.

Interior Health Administrative Policy Manual . Interior health. https://www.interiorhealth.ca/sites/default/files/PDFS/ah2000-point-of-care-testing.pdf. Accessed October 23, 2025.

From Lab to Bedside Testing: Uncovering Gateways and Roadblocks to Syndromic Multiplex Point-of-Care Testing for Infectious Diseases in Canadian Hospitals

Abstract

Introduction

Methods

Ethics Review

Sampling Criteria

Recruitment

Data Collection

Analysis

Results

Current Diagnostic Methods and Experience With POCTs

Disease Burden and Level of Health System Integration

The Management Capacity of Hospitals

Anticipated Impact on Healthcare Management Efficiency

Discussion

Recommendations

Limitations

Conclusion

Footnotes

Acknowledgements

ORCID iDs

Ethical Considerations

Consent to Participate

Funding

Declaration of Conflicting Interests

Data Availability Statement

References