By Julie Coffey, Director, Education
On November 2, 2018, IQMH hosted our third large event for the year, a forum titled Point-of-Care Testing – Is it the Best Choice?
Gathered in the beautiful Westin Harbour Castle on a rainy November day, the over 150 attendees were treated to a panorama of perspectives surrounding point-of-care testing. Various barriers, questions and considerations were explored by fourteen speakers who each presented their own energetic 30-minute burst.
Setting the Stage
Dr. Paul Yip,
Head of Clinical Biochemistry at Sunnybrook Health Sciences Centre set the stage for our day, with reference to Dr. Spock’s tricorder, Theranos and Fentanyl. We kicked off with some audience polling that showed the following:
84% of the audience felt that POCT can offer healthcare savings, 16% did not.
48% of the audience knew that their organization is planning to implement new POC tests in the next 12 months.
He concluded by urging us to consider POCT an adjective instead of a noun, meaning we should think of POCT as testing that can be safe, effective, and done with quality.
Dr. Carl Wittwer from the University of Utah gave a presentation titled Critical and POC Testing: Real World and Emerging Applications for Improved Clinical Outcomes. Starting with the premise that laboratory testing becomes more powerful when it’s fast, Dr. Wittwer reviewed molecular panels such as FilmArray for syndromic testing and introduced extreme PCR which can reduce the time for PCR from twelve minutes using rapid cycle PCR to a mere 17.9 seconds.
In recent years, Ontario’s laboratory system has undergone significant changes on the technology front specifically related to Point-of-Care Testing (POCT) and its impact on the delivery of patient care. Advancements in POCT technology offer an opportunity to reexamine the framework governing such activities. Maricon Sanelli and Sal Matteliano provided a look at a realignment of the MOHLTC that occurred as of October 18, 2018. The Laboratory and Genetics Branch is now under the Ontario Health Insurance Plan Division. It’s Assistant Deputy Manager and General Manager is Lynn Guerriero. The key priorities of the Laboratories and Genetics Branch are:
- Community Laboratory Service Modernization
- Genetic Services Strategy
- Laboratory Licensing Modernization
The Branch engaged in a discussion regarding future considerations around licensing, accountability practices and quality assurance in POCT. Feedback to the Branch can be submitted to IQMH via firstname.lastname@example.org who will collate and share with the MOHLTC.
Compliance and Competency
Dr. Julie Shaw, Director for POCT, the Ottawa Hospital led us through a thoughtful look at barriers and challenges to compliance and competency assessment of POCT using pre-recorded candid and honest interviews with nurses. She focused on issues around positive patient identification, training and competency, quality control and results documentation. The video interviews shown dramatically illustrated the sometimes conflicting priorities and needs of laboratory vs primary care providers.
Barriers can be broken down through:
- Appropriate use of POCT
- Sufficient staffing to oversee POCT
- Avocation for education on lab testing as part of Nursing and Medicine curriculum
- Laboratory working more collaboratively with clinical areas
21st Century POCT Challenges
Dr. David Kinniburgh from the University of Calgary used his 30 minutes to highlight POCT challenges arising from:
- The increasing volume, scope and complexity
- Financial considerations
- Regulation of POCT
- Quality considerations
- The increasing demand on IT
- The increasing demand on physicians
- Utilization management
- Lack of guidelines and clinical protocols
The global market for POCT will rise from 17-23 billion in 2016 to 30-37 billion in 2021 with F. Hoffmann-La Roche Ltd is going to dominating, followed by Siemens AG and Abbott Laboratories, Inc.
Cartridge Blood Gas Testing in the Laboratory
Sponsored by Radiometer, Tina Henderson, POCT coordinator at the Hospital for Sick Children presented operational achievement attained by implementing a device typically used by point-of-care as the device used in the central laboratory. The following slides from Tina’s presentation provide a glimpse at just two of the improvements achieved:
Point of view of a Perfusionist
Mark Vallelonga, a perfusion from Sunnybrook Health Sciences Centre gave a compelling presentation on the value of POCT in the OR. Perfusion is the largest user of POCT AGB and ACT in the hospital. The primary role of a perfusionist is to manage the cardiopulmonary bypass, a technique that temporarily takes over the role of the heart and the lungs and maintains the circulation and oxygenation or the patients’ blood. The perfusionist has an approximate 15-second margin of error before mortality or morbidity occurs. They rely heavily on the results and reliability of POCT devices for fast and precise determination of Gas/Metabolite/Electrolyte testing. The significance of this is also highlighted with cases that involve deep hypothermic circulatory arrest which involves cooling the patient to 18 degrees Celsius and stopping the circulation for up to 60 minutes.
INR Clinic Testing
Dr. Rita Selby provided comprehensive insight into the use of POCT at Sunnybrook’s anticoagulant management clinic in which near patient INR testing is performed and warfarin doses are administered to patients with a 10-15 minute turnaround from test-to-dosage. Rita provided a summary of POC INR devices and their uses. She touched on patient INR self-testing as well, an area that deserves greater attention to ensuring quality since it is used when there are significant barriers to accessing laboratory testing.
Dr. Selby was joined by a patient from the INR clinic, Ms Candace Allman who provided a powerful testimony to support the use of POCT INR in the clinic setting.
POCT and Highly Infectious Disease
Dr. Gerald Kost, also known as a founding father of point-of-care testing provided a fascinating presentation focused on how outbreaks such as Ebola adversely impact national economies and devastate limited-resource countries. Titled Molecular and POCT diagnostics for Ebola and Other Highly Infectious Diseases, Dr. Kost’s presentation showed how the Ebola virus disease demonstrated unequivocally the need for point-of-care testing in isolation laboratories and field sites. He concludes that rapid response and community resilience must be enhanced by appropriate diagnostic testing in isolation POCT units in our facilities. He calls for more robust POCT guidelines and policy to stop epidemics and referenced the SARS crises in Toronto. Outbreaks of highly infectious diseases have demonstrated unequivocally the need for POCT to support critically ill patients placed in isolation, to quickly detect and stop outbreaks where they start, and to improve the efficiency and effectiveness of quarantine worldwide. We discussed the lack of isolation laboratories in Canada and the gap in the training of personnel to perform POCT while wearing PPE.
Use of Capillary Whole Blood for Glucose Monitoring in Critically Ill Patients
Sponsored by Nova Biomedical, Dr. Jeffrey DuBois presented a summary of glucose meter performance problems and the consequences of using inaccurate meters.
He presented how Nova Biomedical’s StatStrip is the only glucose meter cleared by the US FDA for use with all patients and was intentionally designed for use in hospital patients, particularly critically ill patient on intensive insulin therapy to:
- Eliminate interferences
- Eliminate “non-glucose” sugar interferences
- Eliminate hematocrit effect
- Correct whole blood glucose measurement to plasma equivalence
- Specimen type: arterial, capillary, neonatal capillary, and venous
Continuous Glucose Monitoring
Dr. Sarah McDowell, Health Quality Ontario gave an overview of the Health Technology Assessment process and method at Health Quality Ontario and their assessment of continuous glucose monitoring for type I diabetes. A health technology assessment is a systematic evaluation of the properties, effects and/or impacts of a health technology in order to inform decision making. The purpose is to determine the clinical benefits and harms of the technology:
- How does the technology affect patient outcomes?
– e.g., mortality, function, quality of life, adverse events
- How does the technology affect health system outcomes?
– e.g., length of stay in hospital
Dr. McDowell reported the following HQO recommendation:
Health Quality Ontario, under the guidance of the Ontario Health Technology Advisory Committee, recommends publicly funding continuous glucose monitoring in patients with type 1 diabetes who are willing to use continuous glucose monitoring for the vast majority of the time and who meet one or more of the following criteria:
- Severe hypoglycemia without an obvious precipitant, despite the optimized use of insulin therapy and conventional blood glucose monitoring
- Inability to recognize, or communicate about, symptoms of hypoglycemia
IQMH President & CEO, Jeff Sumner concluded the day with a summary titled Moving Forward – Present and Future Impact of POCT. We took a final look at the following:
- Fundamental Premise/Benefits of POCTPresent & Future Market Trends
- What’s really driving the adoption of POCT?
- Impact of POCT on Primary Care, Hospitals and other Healthcare delivery modalities
- Future Impact of POCT
Mr. Sumner’s conclusions were that POCT will continue to grow and have a significantly increasing impact over the next few years with increased use in hospital emergency departments’ operating rooms and intensive care units. Smartphones, home care, patient self-testing and primary care will see the most growth. POCT will have a unique and expanded role in developing countries. Finally, central lab testing continues to be the better, more cost-effective option for high volume non-urgent tests or quantitative samples requiring high precision for the foreseeable future.
Thank-you to our sponsors
The following sponsors were vital contributors to this event:
- Radiometer, who sponsored Tina Henderson’s presentation and provided a lunchtime product highlight AQT - Point of Care Biomarker Testing Made Simple
- Nova Biomedical, who sponsored Dr. Jeffrey DuBois’ presentation and provided a product highlight Introducing Prime Plus!
- Roche Diagnostics, who presented a break session on Cobas® Liat® PCR System and Connectivity: Taking PCR technology further, faster!
- Abbott Point-of-Care, who provided a product highlight titled i-STAT Alinity- Easiest Device Yet
- Abbott Rapid Diagnostics, who provided a product highlight titled POC testing for CRP, a tool in antibiotic stewardship
Exhibit Floor Sponsors:
- Nova Century Scientific Inc.
- Instrumentation Laboratory
IQMH offers gratitude to the 14 speakers who took the time to prepare and present at this unique event, to those who attended, to our sponsors and to our staff who worked energetically to bring this all together. The Centre for Education is planning three exciting events for 2019, the details of which will be available soon.