Quality Control

Accurate Inside and Out

At the core of the HealthTab system is the Piccolo Xpress® point-of-care analyzer by Abaxis. Originally designed by NASA to test the health of its astronauts, the Piccolo is currently trusted worldwide by medical clinics and physician offices; government health screening programs; the Center for Disease Control and Prevention (CDC); the US military and even the White House to deliver accurate blood chemistry results right onsite. Now this technology is coming to Canadian pharmacies exclusively through HealthTab.

For its combination of convenience and quality, the Piccolo is one of the most highly regarded point-of-care instruments in the field. Its reputation is backed by data showing this shoe-boxed-sized device performs as good or even better than many of the large high-throughput analyzers used in medical labs. In addition, the Piccolo is certified by the Clinical and Laboratory Standards Institute (CLSI), the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) and the Cholesterol Reference Method Laboratory Network (CRMLN). Detailed proficiency testing data can be found under ‘Participant Data Summaries’ at https://www.api-pt.com.

Underpinning the reliability of each panel is a built-in feature called iQC, which stands for ‘Intelligent Quality Control’. This is a series of self-checks that the Piccolo runs automatically to ensure the integrity of the electronics, blood sample, and reagent disc before completing an analysis. If any of the performance criteria are not met, then the given result(s) is suppressed and the operator is notified. Download the iQC white paper from Abaxis to learn more.

HealthTab takes this excellent POCT analyzer and adds an external quality assessment (EQA) program, to further ensure the quality of our testing. The program was designed in collaboration with CEQAL – a world-leading reference method laboratory – and builds on their experience providing accuracy-based quality control for mobile diabetes screening initiatives. The HealthTab EQA program consists of two key components:

  1. Operator Training and SOP

    Inline with the CLSI guidelines for point-of-care testing and CEQAL’s own recommendations, we have developed a training program and Standard Operating Procedures to be followed in the pharmacies. This gives pharmacist operators the framework necessary to safely and effectively run the HealthTab system with lab-like discipline.

  2. Ongoing Accuracy Audits

    To help ensure the accuracy of every HealthTab panel before it is shipped, CEQAL checks each reagent lot using its accuracy-based samples as a reference. If a given lot number is not performing within the acceptable range, it is rejected and a new lot is ordered. In addition, CEQAL performs blinded accuracy checks at regular intervals to confirm that testing within our pharmacy network is on target.