Documenting Quality Assurance:
What Does Your Laboratory Need For Accreditation?

from the July 2003 issue


The accreditation process centers on providing patients with the highest quality care possible. The development and implementation of a quality assurance program is an integral part of ICAVL accreditation, and can be invaluable in providing accurate examination results, which ultimately lend to development of the most beneficial and cost-effective treatment plans for patients undergoing assessment in a vascular laboratory.

The ICAVL application requires documentation of the quality assurance performed by the applicant laboratory. If the minimum number of correlations (as outlined below) is not available from the year immediately prior to submission of the application, data can be collected from up to three years prior. Specific requirements vary by testing section (e.g.: Extracranial Cerebrovascular) and are outlined below.


QUALITY ASSURANCE POLICY

Every laboratory applying for accreditation is required to have a quality assurance policy for each area of testing in which they are seeking accreditation. The manner in which correlation is acquired may vary depending upon the examination and the follow-up information available to the laboratory. The policy should include:
  • Who is responsible for collecting the data
  • The frequency and methods used to collect the data
  • How the information is tracked and documented
  • Method and frequency used for communicating the QA results to the medical and technical staff


ICAVL ACCEPTED METHODS OF CORRELATION

The accepted methods of correlating noninvasive examination results for accreditation are as follows:

Extracranial Cerebrovascular, Intracranial Cerebrovascular,
Peripheral Arterial and Visceral Vascular Testing
  • Angiography
  • Magnetic Resonance Angiography
  • Spiral CT Scan
  • Surgical Pathology

Peripheral Venous Testing

  • Venography
  • Double scanning by two sonographers at the same visit
  • Over-reading of examination by two physicians
  • Clinical outcome


REQUIRED NUMBER OF CORRELATIONS

Each testing application requires a minimum number of noninvasive testing correlations to one or any combination of the accepted methods listed above. If the laboratory has collected data for more than the minimum required number of correlations, the additional data can be submitted.

  • Extracranial Cerebrovascular
    30 internal carotid arteries (not necessarily 30 patients)

  • Intracranial Cerebrovascular
    15 cases (not sides)

  • Peripheral Arterial
    30 limbs (not necessarily 30 patients and not 30 vessels)

  • Visceral Vascular
    30 vessels (i.e., a duplex exam that includes 2 renal arteries, the SMA, and Celiac artery could potentially be 4 correlations)

  • Peripheral Venous
    No minimum number is required; however, a good effort must be documented and 30 limbs are suggested


REQUIRED DOCUMENTATION FOR ICAVL ACCREDITATION

When submitting your application for accreditation, it is necessary to supply documentation that validates and substantiates the laboratory's quality assurance program.

REQUIRED DOCUMENTATION

  • Written quality assurance policy

  • Example of quality assurance meeting minutes

  • Correlation matrix

    • The matrix is completed by entering the results of the noninvasive study and the results of the correlative study in their respective diagnostic ranges or categories

    • There is a matrix included within the Extracranial Cerebrovascular, Peripheral Arterial and Visceral Vascular applications. The numbers entered into the matrix should reflect those patients and results that are located in the submitted portion(s) or the laboratory's QA log

    • For venous duplex, TCD and surgical/pathologic correlation, a Chi square or summary of the data, accompanied by the QA log, may be used to reflect findings

  • Quality assurance log

    • The quality assurance log is integral in substantiating your laboratory correlation. The log should contain the following information:

      • Examination dates

      • Patient identification

      • Noninvasive examination and brief results

      • Correlation examination and brief results

      • Correlation outcome
        (positive or negative correlation)

    • Logs can be handwritten, computer-generated or database-generated

    • It is not necessary to submit examination reports or correlation (radiographic, surgical) samples when submitting the QA log

The ICAVL Essentials and Standards do not include a defined acceptable accuracy threshold. However, if the accuracy reflected in the QA matrix is found to be low, the ICAVL Board Of Directors may request a written plan for improvement.

In examining the quality assurance findings, a laboratory can better identify the areas and modalities that need additional attention, improvement and/or change. These areas can be linked to both the technical and interpretive portions of the vascular laboratory assessment.

When utilized, a well-designed quality assurance program can provide the laboratory staff with education, enhanced communication, goals and continued improvement of patient care.

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