Pathologists and medical laboratory professionals heard speakers from Sweden, Australia, New Zealand, and Canada discuss the latest developments in POCT
TORONTO, ONTARIO—Spirited discussion always results when pathologists and clinical laboratory professionals discuss point-of-care testing (POCT). That was certainly true during a special POCT workshop that took place here this week.
Attendees came from as far away as Sweden, Australia, and New Zealand to attend “Point-of-Care Testing: Today and Tomorrow.” The conference was produced by the Toronto-based Institute for Quality Management in Healthcare (IQMH).
Point-of-Care Testing Has an Essential Role in Patient Care
As most medical laboratory scientists know, POCT can be both a blessing and a curse. When used properly, POCT plays an essential role in patient care and can guide physicians in ways that improve outcomes. However, problems associated with the ongoing management and performance of an organization’s POCT program regularly frustrates laboratory scientists tasked with oversight of POCT.
Some of the most common problems associated with POCT include the following:
- Operators of POCT devices lack proper training and supervision.
- When appropriate QA and QC procedures are not followed, operation of POCT devices bring the accuracy and reliability of the clinical results into question.
- Use of out-of-date cartridges, consumables, and QC materials with POCT devices.
Not All Clinical Laboratory Managers View POCT Favorably
These problems are among the reasons why POCT has a somewhat tarnished reputation among many lab administrators and pathologists who manage central laboratories. Over the past 25 years, these individuals have regularly seen examples of POCT where obvious problems in the pre-analytical, analytical, and post-analytical phases caused them to distrust both the POTC test results and testing processes within their parent organizations.
Despite these issues, however, the message of the speakers at this POCT workshop was generally optimistic. Case studies of POCT in Sweden, Australia, New Zealand, and Canada were featured. Some highlights are shared below:
- Sweden and other Scandinavian countries have implemented initiatives to formally organize the management and performance of POCT . Accreditation to ISO 15189: Medical Laboratories is one element, and some organizations have accredited to ISO 22870: Point-of-Care Testing.
- Lab organizations in Australia that perform POCT are also earning accreditation to ISO 15189 and ISO 22870. There are several nationwide initiatives to improve healthcare that utilize POCT. One example is the Quality Assurance for Aboriginal and Torres Strait Islander Medical Services (QAAMS). This program is organized to support the quality-assured processes of POCT for hemoglobin A1c (HbA1c) and urine albumin: creatinine ratio (ACR) specifically to assist diabetes management in more than 110 sites across Australia that provide Aboriginal and Torres Strait Islander medical services.
- It is a similar story in New Zealand where labs in that country have earned accreditation to ISO 15189 and ISO 22870. One case study use of POCT involved performing INR tests in pharmacies to support patients being managed for anticoagulation therapy. It was reported that, when testing was done at general practice sites, 61.8% of patients were complying with their care protocols. However after implementing POCT in pharmacies, patient compliance increased to 78.8%.
- In Canada, the host country for this workshop, several speakers explained different aspects of POCT. One regional lab’s POCT program involves 5,000 nurses in the parent health organization, which includes three hospitals and satellite clinics. It has implemented a software system that identifies new staff members authorized to perform POCT. The software links to POCT training modules and automatically tracks users and keeps them POCT-certified in a timely manner.
While recognizing all the problems associated with POCT, each of the speakers shared developments in their country that reflect its positive aspects overall. They described how medical laboratory professionals in their respective countries are participating in regional or national programs specifically organized to ensure that users of POCT properly perform these tests and produce accurate, reliable results.
Globally, There is Momentum to Support Increased Use of POCT
There is recognition that momentum for POCT globally is now unstoppable. In his presentation, your Dark Daily editor offered the following facts in support of that assertion:
- In a report on POCT issued last month, the company MarketsandMarkets estimated that the market for POCT will be $27.5 billion by 2018.
- MarketsandMarkets predicts that POCT sales will grow at a compounded annual rate of 9.83% between 2013 and 2018.
- Another firm, ReportLinker, issued its own POCT market report last month. It says that as of 2012, the global POC diagnostics market (excluding the blood glucose monitoring kits market) was dominated by: Roche (Switzerland) (OTC: RHHBY); Alere, Inc. (U.S.) (NYSE: ALR); Siemens AG (Germany) (DE:0P0000X6R5); and Beckman Coulter, Inc. (U.S.) (NASDAQ: BEC).
- ReportLinker.com says that these four companies represent about a 72% market share of the non-glucose POC blood testing market.
For POCT advocates, today’s presentations represented a consistently optimistic vision of the future for POCT. There was recognition that continuing technology advances will allow lab test developers to create POCTs and devices that can perform with more sensitivity, specificity, and reliability, at a steadily decreasing cost.
Central Medical Laboratories Will Have Ongoing and Essential Role
It was also acknowledged that the role of the central medical laboratory would not be eliminated. The unique expertise of pathologists, biochemists, and other laboratory professionals working today in central labs will be essential—not just in handling the more complex reference and esoteric tests that will continue to be done in the core lab—but in supporting users of POCT and physicians consulting on how to interpret the test results and develop the right therapy for the patient.
Given the expectations of most of the workshop’s speakers that POCT development and use will increase, maybe one of the day’s most insightful comments was made by Dr. Edward Dunn, Ph.D., who is the Director of Product and Service Development at Gamma-Dynacare Laboratories in Brampton, Ontario. In his presentation, he said, “The term ‘point-of-care testing’ is no longer accurate. With the expansion of devices and assays in this field, the term that is much more appropriate now is ‘point-of-care diagnostics!”
Your Dark Daily Editor
Robert L. Michel