The Importance Of Validating Examination Results
DEVELOPING, MAINTAINING AND EXPANDING
YOUR LABORATORY'S QUALITY ASSURANCE PROGRAM

Over the past decade, the improvements and innovations made to noninvasive testing equipment have provided skilled technologists and physicians with the enhanced technology necessary to assess and document disease states and pathology with improved accuracy and detail. Because of this enhanced ability to identify and diagnose peripheral vascular disorders, an increased reliance on noninvasive examination findings has developed. This confidence has brought about differences in patient care management such as surgical intervention and anticoagulation therapy based solely upon results of the ultrasound findings. Regardless of the technological advancements, confidence and skill of the sonographer and the experience of the interpreting physician, it is imperative that ongoing quality assurance be performed to assure complete, accurate, high quality laboratory results.

QUALITY ASSURANCE AND ICAVL STANDARD REQUIREMENTS

ICAVL accredited laboratories are required to maintain an ongoing quality assurance program that includes documentation of correlation findings for each area of testing in which they are accredited.

QUALITY ASSURANCE POLICY

The laboratory must have a written policy regarding all procedures performed in the laboratory. In the development of this policy, the laboratory should identify quality indicators and thresholds.

• Quality indicators define the areas of the laboratory to be assessed and can include not only examination results, but the quality of the examination documentation and techniques, review of final reports for adherence to diagnostic criteria, interpretation quality and timeliness, and the appropriateness of the indications for examination.
• Thresholds for each of the quality indicators should then be defined as a percentage of acceptable deficiency. For example, the ICAVL Standards require an overall accuracy of greater than 70%.

After identifying the indicators and determining the thresholds, a policy should be written and include:

1. Who is responsible for collecting the data
2. The frequency and method used to collect the data
3. How the information is tracked and documented
4. The method and frequency that the information is communicated to the medical and technical staff
5. How discrepancies are addressed

A minimum of two (2) biannual quality assurance meetings that include all medical and technical staff members are required by the Standards. These meetings should include a review of the results of comparative studies, the addressing of discrepancies, and a discussion of difficult cases and laboratory issues. The meeting must be documented in the form of meeting minutes which reflect the cases and issues discussed.

CORRELATION REQUIREMENTS

A minimum number of correlations are required for each type of testing procedure performed in the laboratory over the three-year accreditation period. It is important to keep in mind that these are considered minimum guidelines, and efforts to obtain as many comparative results as possible will increase the value of the quality assurance. The correlations can be made to one or more of the accepted correlation methods.

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