Quality Assurance Program

The Diabetes Integration Project is a mobile diabetes secondary screening program that uses specially trained nurses for the "finger stick" blood testing of patients for hemoglobin A1c, lipids (total cholesterol, HDL cholesterol, triglycerides and calculated LDL cholesterol), glucose and the testing of urine for the determination of the albumin to creatinine ratio.

The Canadian External Quality Assessment Laboratory (CEQAL) has been contracted by the Diabetes Integration Project to provide the Quality Assurance Program component. The Quality Assurance Program is very comprehensive and requires all staff to be diligent in performing the Internal Quality Control and client testing process.

Download our letter to physicians

Pre - Release Evaluation of Analyzers

The Diabetes Integration Project will operate the following Point of Care analyzers: 2 DCA 2000, 4 DCA Vantage and 4 Cholestech LDX. Each mobile team will utilize two DCA analyzers and one Cholestech LDX analyzer. The remaining analyzers will be kept at our Winnipeg Office and will be used as back up in the event there is a problem with the analyzers out in the field.

The Canadian External Quality Assessment Laboratory (CEQAL) has assessed the analytical performance of the Point of Care Testing analyzers that are being used by the North and South Mobile Teams. The performance assessment utilized sample sets of human serum covering the clinical range of interest with accuracy target values assigned by credentialed reference methods. For HbA1c, the base of accuracy was the DCCT reference laboratory at the University of Missouri. This laboratory operates the glycated hemoglobin (A1c) standardization program in the United States and served as the core laboratory for the Diabetes Control and Complications Trial (DCCT). The base of accuracy for the lipid measurements was CEQAL's Reference Method Laboratory, which is a member of the Cholesterol Reference Method Laboratory Network (CRMLN). The CRMLN operates under the aegis of the CDC/NHLBI in the United States and serves as the accuracy base for the lipid standardization program in North America and Internationally.

http://www.cdc.gov/nceh/dls/crmln/memberlabs.htm

Internal Quality Control

The day-to-day analytical performance of the analyzers is monitored in the field through the use of an Internal Quality Control (IQC) program with known performance limits and accuracy targets assigned by credentialed reference methods. Total cholesterol, HDL cholesterol, triglycerides, calculated LDL and glucose are all measured using a single testing cassette on the Cholestech LDX analyzer. The IQC performance limits for lipids have been set to comply with the total error performance goals as recommended by the NCEP (National Cholesterol Education Program). IQC testing results will be entered into an excel spreadsheet. If data entry turns green, analysis is within the acceptable IQC limits and client testing may proceed. However, if the data turns red, the mobile teams cannot proceed with client testing. Corrective action is required until the IQC data turns green. The North/South Mobile Teams will perform Internal Quality Control testing two times per day, in the morning prior to client testing and at the end of the day to ensure the analyzers are performing as required.

All data are entered into the excel spreadsheet provided by CEQAL. On a monthly basis, the spreadsheets will be sent to CEQAL to review the data to ensure the analyzers are operating in accordance with the performance standards for the project.

Quality and Competence

All Diabetes Integration Project mobile teams must meet competency requirements prior to going out in the field. To ensure quality and competency requirements are met, CEQAL has provided a Point of Care Testing Training Manual. All mobile teams will be required to read over the manual, practice the internal quality control testing, data entry, and "finger stick" blood sampling techniques. A satisfactory demonstration is required to ensure all staff meets competency requirements. Training, certification and recertification of Point of Care Testing operators will be required every two years to ensure ongoing competency.

The Point of Care Testing Training and Capacity Building includes the following:

  • Collection of Diagnostic Capillary Blood Specimens
  • Skin Puncture Techniques
  • Measurement of Lipids and Glucose in Whole Blood Using the Cholestech LDX
  • Measurement of Hemoglobin A1c in Whole Blood Using the Siemens DCA Analyzers
  • Measurement of Albumin and Creatinine in Urine Using the Siemens DCA Analyzers; Determination of the Albumin:Creatinine Ratio
  • Excel Spreadsheets
  • Instrument Maintenance-troubleshooting records
  • DCA Instrument-reagent evaluation (data collection template)
  • Cholestech Instrument - reagent evaluation (data collection template)
  • Temperature Monitoring Chart

Data Management

The Diabetes Integration Project Quality Assurance Program will contain a data management component for Point of Care Testing Results. The data will provide useful information in monitoring of system operators training and capacity building, maintenance of equipment and supplies as well as error types and frequency. Overall, the data will assist in improving the entire process from start to finish.

Letter to Physicians

A letter from CEQAL has been provided on the website so that physicians can familiarize themselves with the Quality Assurance Program developed by the Diabetes Integration Project. A lot of work and effort has been put in the planning and development of this very important component of the project.

Point of Care Testing Analyzers

Cholestech LDX - DCA 2000