Primary Testing vs. Supplemental Testing

from the July 2004 issue

Included in the April 2004 edition of the ICAVL Newsletter was an article and a chart outlining the new case study requirements. The new case study requirements were implemented this year in conjunction with the updated version of the ICAVL Application, to be available later in 2004. The chart identified the required cases to be submitted for both primary and secondary testing procedures. Since the time that article was written, the term secondary has been changed to supplemental and will be referred to as such for the remainder of this article. Following the publication of the previous article, the ICAVL continues to receive questions regarding the definition of primary and supplemental testing, and exactly what the requirements involve. The following questions and answers will hopefully help to clarify the confusion in identifying your laboratory's primary and supplemental (secondary) testing procedures.

When did the ICAVL begin asking for supplemental testing cases?

Supplemental (or secondary) testing has always been addressed in the ICAVL Standards and in the application. This is not a recent addition to the application process.

What if our laboratory does not perform any supplemental testing procedures?

Laboratories are not required to perform supplemental testing in order to acquire ICAVL accreditation. The laboratory, however, must meet the minimum ICAVL standards for primary testing procedures in each area of testing for which they are applying for accreditation.

What is the difference between primary and supplemental testing?

Primary testing: The primary or most common examination performed in the laboratory for a particular area of testing. This examination will most often be the most frequently performed examination for a particular testing area and will consequently generate the highest volume in that testing area.

Supplemental testing: Any examination other than the primary testing procedure(s) performed in a given testing area.

What are the ICAVL application testing areas and what are the required primary testing modalities?

Extracranial Cerebrovascular Testing - Carotid Duplex only.

Intracranial Cerebrovascular Testing - Transcranial Doppler or Transcranial Duplex.

Peripheral Arterial - The primary exam must consist of at least one modality from both the "pressure" and "waveform" lists below. Any combination is acceptable and none are given added weight in the review of your laboratory's application.

Peripheral Venous - Duplex only.

Visceral Vascular - Duplex only.
**Note: Procedures for a variety of visceral testing are included in the ICAVL Standards for visceral testing. For the purpose of case study submission, the examination performed most frequently will be considered the "primary examination," i.e., renal artery duplex.

What are examples of supplemental examination for each of the testing areas?

Extracranial Cerebrovascular Testing - There are no longer any ICAVL standards for any type of supplemental noninvasive testing procedures in the evaluation of carotid artery disease. Previously, OPG and periorbital exams were considered supplemental.

Intracranial Cerebrovascular Testing - There are no ICAVL standards for any type of supplemental noninvasive testing procedures in the evaluation of the intracranial vasculature. It is recognized that, for specific indications, examinations are performed which may include additional techniques, such as vasoreactivity testing with Diamox or agitated bubble saline. Any examination that requires specific and additional steps included with the TCD or TCI should have a written protocol specific to that testing procedure.

Peripheral Arterial - Supplemental testing procedures for peripheral arterial testing are numerous and include all procedures not included in the primary examination. Examples of supplemental exams include (but are not limited to): exercise/stress testing, digit pressures, cold sensitivity, thoracic outlet, bypass graft duplex, and transcutaneous oximetry.

Peripheral Venous - Venous plethysmography

Visceral Vascular - There are no ICAVL standards for any type of supplemental noninvasive testing procedures in the evaluation of the visceral vasculature.

What documentation must be submitted for supplemental examinations?

Technical protocols and diagnostic criteria specific to each type of supplemental testing procedure performed in the laboratory must be included with the application.

For testing areas where the laboratory performs multiple supplemental testing modalities, only examples from one type of the supplemental exams must be submitted for review. First time applicants must submit one normal and one abnormal case study of supplemental examinations. Reaccreditation applicants will submit one abnormal supplemental case study. It is not necessary to submit examples of every type of supplemental exam performed in the laboratory, but rather an example of the laboratory's choice.

Hopefully the above descriptions will assist you in identifying the primary and secondary examinations performed in your laboratory. For additional information regarding the case study requirements, please refer to the April 2004 ICAVL Newsletter which can be located on our website at www.icavl.org/icavl/news/newsletters.htm.

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