Secondary Case Studies:
Have You Provided Adequate Hard Copy?

Many self study documents are submitted to the ICAVL with complete documentation, attached policies and procedures, and five primary case studies for each clinical area of testing. Even with such good documentation, secondary case studies are often necessary for the ICAVL to assess the quality of testing performed in a laboratory.

The self study documents for each clinical area of testing describe the case study requirements in Section 4. Five representative case studies (one normal and four abnormal) are required for primary testing procedures in each clinical area. For all other secondary instrumentation procedures, two additional case studies (one normal and one abnormal) are required. Examples of secondary instrumentation procedures would be periorbital Doppler and continuous wave Doppler for extracranial cerebrovascular testing; venous plethysmography (i.e., venous photoplethysmography, venous outflow and capacitance, air plethysmography or strain gauge plethysmography) for peripheral venous testing; stress testing, digital arterial photoplethysmography or transcutaneous oximetry for arterial testing.

For peripheral arterial and peripheral venous testing, if upper extremity examinations are performed, then two representative case studies (one normal and one abnormal) are required in each area. Duplex scanning may also be considered a secondary testing technique, as in the instance of bypass graft surveillance and assessment of arteriovenous fistulae. Such types of procedures also need to be documented with representative case studies.

For visceral vascular testing, five representative case studies (one normal and four abnormals) of the most frequently performed vessel group are required. For all other vessel groups studied, two cases (one normal and one abnormal) are required. Please see the related article on the first page of this issue.

As one of the most important aspects of the accreditation application, the case studies are pivotal to the evaluation of your laboratory's self study documents. It is in the best interest of the laboratory to submit the full complement of required cases, with complete high quality hard copy, technical worksheets and signed final reports.

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