Documenting Your Laboratory's Commitment To Quality Patient CARE: Complete Accurate Reproducible Examinations [continued]

PERIPHERAL VENOUS (Lower Extremities) Representative gray scale images with and without transverse transducer compressions (figure 2): common femoral vein including the saphenofemoral junction femoral vein (formerly known as the superficial femoral vein) popliteal vein Documentation of the lack of vein compression must be included

Figure 2. Venous image without and with compression +VIEW LARGER IMAGE+

Representative spectral Doppler waveforms:

• common femoral vein
• on a unilateral study, a contralateral common femoral venous spectral waveform must be documented
• femoral vein (formerly known as the superficial femoral vein)
• popliteal vein
• Documentation of the lack of Doppler waveforms in the presence of suspected thrombus must be included

ACCURATE

The accuracy of examinations and final reports is largely dependent upon the experience, training, knowledge and attention to detail of both the technologist performing the exam and the interpreting physician.

TECHNIQUES Assuring that proper techniques are used in each type of examination performed in the laboratory is another step in producing high quality results. As with the required documentation, the Standards include a variety of techniques to be employed by the staff members performing the tests and are included in Section 3 - Techniques and Documentation of Examination Performance. Factors such as appropriate Doppler angle and cursor alignment, optimization of equipment settings and proper measurement of spectral waveforms are included in the Standards. The ICAVL Standards are written to address the practices required for quality and standardization of vascular testing, but are not meant to be a "how to" text resource explaining the proper techniques and how they are achieved. The specifics regarding how to best utilize these techniques lay with staff experience, training, education and additional referencing of published articles and textbooks (figure 3).

Figure 3. Poorly optimized CW Doppler waveform settings +VIEW LARGER IMAGE+

FINAL REPORTS

A very important factor directly impacting the accuracy of the examination findings is how the interpreting physician reports the results. The ICAVL Standards list the components required for final reports in the Organization standards Section 4 - Examination Interpretation, Reports, and Records. As with documenting incomplete exam hardcopy, case studies submitted for accreditation often include final reports that are lacking one or more components required by the Standards.

Many report formats exist and the ICAVL does not require one specific layout, but rather reviews the reports for content in compliance with the Standards. Four elements that are most frequently excluded from final reports submitted by applicant laboratories include:

1. Appropriate clinical indications leading to the examination performed

2. A report body that includes a brief description of the exam performed and the specific exam findings (i.e., plaque description, quality of exam, unusual findings)

3. A separate succinct final impression that summarizes the exam findings described within the body of the report

4. A date of interpretation, physician signature or verification

DIAGNOSTIC CRITERIA

For every type of exam performed in the laboratory, there must be a standardized set of diagnostic criteria used consistently by all interpreting physicians. The standards for diagnostic criteria can be found in the Testing standards, Section 4 - Diagnostic Criteria and Interpretation.

There are several criteria that have been published for use in the interpretation of vascular ultrasound testing. As with report format, one particular criterion is not required by the ICAVL Standards; however, the criteria must be reported accurately in accordance with the diagnostic categories that have been validated in the criteria's development.

It has been well documented that there are various factors that might affect the accuracy of the validated criteria ranges, such as an occlusion of the contralateral carotid artery, the presence of stents, or tortuous vessels. How these deviations from the standard criteria are interpreted and reported should be agreed upon by the interpreting physicians and a formal policy implemented and followed by all interpreters to ensure consistency. As well, there are times that the laboratory will find that the criteria may need to be adjusted to give the most accurate results for their individual laboratory and can do this through further documented internal validation of the criteria.

If a laboratory chooses to utilize secondary diagnostic criteria, i.e. ratios or area reduction measurements, there should be an algorithm used to specify how this secondary criterion is utilized and if the two criteria indicate discrepant findings, how they are weighted and what will be given primary consideration in the final diagnosis.

QUALITY ASSURANCE

Ongoing quality assurance (QA) is integral in identifying where the problems within the laboratory exist that can lead to unnecessary additional testing and inappropriate patient care plans/treatment. The general policy requirements for a quality assurance program are located in the Organization standards, Section 6 - Quality Assurance and Quality Control. Additionally, each area of testing includes QA standards that are located in Section 6 - Quality Assurance.

There are slight differences in the minimum number of correlations required for each area of testing, as well as some alternative methods of performing quality assurance for those areas of testing where the previously accepted "gold standard" comparison exams may be rarely performed, such as in the case of venous duplex examination.

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