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The foundations of the healthCHECK 10 Risk Assessments are precise equipment and employee training. Our measurements rely on three important pieces of equipment which include:

• Cholestech LDX System
• Blood Pressure Monitors
• Tanita Body Composition Analyzer

All instruments are designed for easy operation and require little operator training to meet standards. We had elected to train our LDX employees/operators in exceedance of industry standards. Our organization and lab certifications are governed under ND statutes and the federal CLIA (Clinical Laboratory Improvement Amendments) regulations. Although advancements in design and technology have made the instruments very "simple" to operate we continue to focus on advanced training to ensure a quality process which includes:

• Annual recertification training
• Daily calibration of instruments
• Lot and frequency QA & QC testing
• Recommended biomechanical servicing

At the heart of the SWAP healthCHECK 10 Risk Assessment is the Cholestech LDX System. This system has been certified by the Cholesterol Reference Method Laboratory Network (CRMLN). This certification validates that the system meets the gold standards for accuracy and reproducibility developed by the Centers for Disease Control and Prevention (CDC) for the measurement of total and HDL cholesterol, consistent with the National Cholesterol Education Program (NCEP) analytic goals. Unlike with noncertified systems, health care professionals can be confident that the Cholestech LDX delivers quality lab accurate results that our customers can trust.

A number of reference studies have been completed by various organizations, not associated with the manufacturer, comparing the results of Cholestech LDX System to laboratory testing and to other finger prick systems and the conclusions are:

"The accuracy and reproducibility of the LDX has been proven over and over. That is why the instrument remains certified and a choice for many health care providers."

Like all analytical measurements, no system is perfect, but the LDX is recognized as accurate as laboratory testing. The coefficients of variation range between 2% and 5% for the LDX which is well within the ranges established by the NCEP (National Cholesterol Education Program) guidelines.

Even so, we do not solely rely on the LDX when making diagnosis. We, like many medical providers, will use differing analytical methods to obtain confirmatory results. As health care providers we understand there can be variations with results, but the additional information allows for improved medical decision making.

However, for wellness screening, the Cholestech LDX is a proven method to obtain accurate blood chemistry results.

Blood pressure screening is an important part of hypertensive management. We select automatic blood pressure instruments that are very simple to operate and whose accuracy is tested according to the protocols of the Association for the Advancement of Medical Instruments (AAMI). We also train our employees on proper technique to obtain accurate measurement which includes: Proper cuff placement, body positioning and biometric servicing. Our blood pressure screens are designed to be as accurate at those obtained in a clinical setting.

Body Mass Index and Composition measurements are obtained by height and weight assessment and analysis using the Tanita 310GS body composition analyzer. Our scales are accurate and comply with nationally recognized weight and measurement standards. Body fat and composition is obtained using bioelectrical impedance, which we believe is the best screening method available.

BIA (Bioelectrical Impedance) - The only body fat method that is based on measuring something, not estimating anything, is Bio-Impedance measurement. Bio-Impedance is a means of measuring electrical signals as they pass through the fat, lean mass, and water in the body. Through laboratory research we know the actual impedance or conductivity of various tissues in the body, and we know that by measuring current between two electrodes and applying this information to complex proven scientific formulas accurate body composition can be determined. The fact that the measurement is based on a reading of lean mass and not an estimate of fat mass, lends to a much more comprehensive testing method and results.

The employee training and analytical methods used at Essentia for healthCHECK services meet quality control and assurance standards. Our own as well as nationally recognized standards. However, whenever measurements or analyses are completed, there can be variation in results. No method can eliminate this deviation, because no method has been perfected, especially in medicine.

We've completed thousands of healthCHECK, and we often receive remarks from patients who state "I was just at my doctor and these result are very close to theirs." Although rare, we have also received comments questioning results because they did vary from an previous result or one from another lab.

The results you receive from the healthCHECK screenings are valid, but may vary from results you obtained months ago, or that you obtained from another provider. What is important is to review the data with a health care provider to understand if the variance is medically significant for you and your health and wellness.