Quality Assurance and Test Validation*
David Del Pizzo
Holly M. Gray
*Based on the chapter in the fourth edition authored by Cindy Weiland and Sandra L. Katanick.
Ongoing improvement in imaging technologies provides sonographers and physicians with improved ability to assess vascular pathology, with better accuracy and more detail. Advances in clinical informatics provide new tools for data management in the vascular laboratory, including use of data for correlations to validate testing methods and interpretation standards.
Ensuring reliability of vascular laboratory reports is important, as there is increasing reliance on noninvasive examinations for clinical decision making. For example, venography is seldom used for diagnosis of deep vein thrombosis (DVT). Routine surveillance after aortic endograft procedures with duplex scanning is the norm in many centers. Critical clinical judgments, such as decisions about surgical interventions, the need for additional invasive studies, or treatment with anticoagulation therapy, are often based solely upon the results of ultrasound examinations. This reliance on the vascular laboratory makes it essential that testing and reporting are accurate and relevant. Therefore, vascular laboratories need ongoing quality programs to ensure complete, accurate, and high-quality results and reporting.1
Third-party payers, government agencies, and the public expect medical imaging facilities to document the reliability of their results. Regular reviews of laboratory processes, examination findings, and quality measures are essential parts of the process of good patient care and ensure the overall success of the vascular laboratory. Audit processes in the vascular laboratory may also confirm that testing is done for appropriate indications and in compliance with applicable standards for documentation of medical necessity. Additionally, it is important to the role of the vascular laboratory in the safe delivery of patient care. Laboratory protocols should incorporate standards that help meet established safety and outcomes priorities, such as National Patient Safety Goals (NPSGs) of The Joint Commission,2 which include correct identification of patients, prevention of infections, and prevention of mistakes in surgery. Appropriate practices in the vascular laboratory, accurate reporting of results, and use of workflow practices to catch and correct errors will contribute to success in meeting NPSGs.
ELEMENTS OF QUALITY PROGRAMS
A comprehensive quality improvement (QI) program should include three components: quality control (QC), quality assurance (QA), and continuous quality improvement (CQI). All three components are required to be effective in ensuring safety, improving services, and enhancing the level of patient care.3
In the vascular laboratory, quality control generally relates to the calibration and maintenance of equipment. As part of the laboratory’s QI program, there should be a standardized method of QC for all technology being used in the laboratory, thus minimizing the risk of inaccuracies arising from defective or uncalibrated equipment. Typically, manufacturers of ultrasound systems provide recommended QC schedules and specify the methods to be used to ensure proper equipment function. Equipment servicing and QC checks must be documented to provide a record of maintenance that can be referenced or audited.
Quality assurance is the systematic monitoring and evaluation of various aspects of a project, service, or facility to ensure that standards of quality are being met. The QA program in the vascular laboratory assesses compliance with established standards, policies, and protocols. QA programs also document the accuracy and outcomes of the testing procedures. Laboratory personnel should take into consideration current industry standards, published clinical research, evidence-based practice guidelines, and accepted thresholds when developing or updating their own QA policies, keeping in mind that some policies may be unique to their particular setting. It is important to ensure that the written technical protocols are followed by all members of the staff when performing examinations. Protocols should clearly define the scanning technique, the assessment of vessels and surrounding organs or tissues, what to document in a normal study, and how to evaluate and document any abnormalities. In addition, there need to be standardized diagnostic criteria for each examination that are applied in the same manner by all interpreting physicians. These
criteria should be validated either by comparison to reports in the published literature or through validation procedures performed by the laboratory. Routine monitoring of these two aspects of laboratory practice—protocols and diagnostic criteria— will help ensure a systematic approach to the services provided by the laboratory and lead to improved standardization and more consistent test results.
criteria should be validated either by comparison to reports in the published literature or through validation procedures performed by the laboratory. Routine monitoring of these two aspects of laboratory practice—protocols and diagnostic criteria— will help ensure a systematic approach to the services provided by the laboratory and lead to improved standardization and more consistent test results.
Continuous quality improvement is the process by which a vascular laboratory becomes more successful overall. It is not a single activity; rather, it is an ongoing effort that addresses different aspects of the laboratory over time. Often, this component of the program is driven by the most urgent issues facing the laboratory. Data collection and analysis are most valuable if they address a current problem or are used to improve an already functional system.
Steps in organizing vascular laboratory quality programs include identifying (1) the individual(s) responsible for data collection, (2) where and how data will be obtained, (3) how often data collection will occur, (4) the format to be used to record the information, (5) how improvement will be measured, and (6) how the findings will be shared with laboratory staff. In addition, a dedicated forum is needed to review laboratory operations and the QA data; for example, monthly or quarterly meetings. These meetings should review the results of comparative studies, address discrepancies, discuss difficult cases, and address facility issues that affect quality of care. Minutes of these meetings should be documented.
The need for standards and accreditation of vascular laboratories was recognized early on, as vascular testing transitioned from a research tool to become a core element of vascular care.4 Laboratories with a commitment to high-quality testing often seek accreditation or take measures to maintain the standards of accreditation. Accreditation specific to vascular laboratory testing is provided by the Intersocietal Accreditation Commission (IAC), which has several divisions (see Chapter 3). The first IAC division to be established was Vascular Testing, formerly known as the Intersocietal Commission for the Accreditation of Vascular Laboratories (ICAVL). As part of the process of applying for accreditation, facilities conduct a detailed self-evaluation using the IAC Standards and Guidelines for Vascular Testing Accreditation.5 Description of a comprehensive, ongoing QI program is a mandatory component of the application.
The IAC standards state that:
QI must be performed and there must be a written QI policy for all laboratory procedures.
Results of studies must be correlated with other measurements; a log of these comparisons must be maintained, and for each area of testing, there must be greater than 70% accuracy agreement.
TABLE 4.1 SAMPLE QUALITY ASSURANCE LOG FOR CAROTID DUPLEX TESTING
DATE
PATIENT
DUPLEX FINDINGS RIGHT ICA
ANGIOGRAPHY FINDINGS RIGHT ICA
RIGHT CORRELATION
DUPLEX FINDINGS LEFT ICA
ANGIOGRAPHY FINDINGS
LEFT CORRELATION
2/5/13
J. Smith
1%-15%
30%
No
80%-99%
95%
Yes
2/5/13
M. Jones
Occlusion
Occlusion
Yes
80%-99%
70%
No
2/6/13
N. Bass
Normal
Normal
Yes
16%-49%
25%
Yes
2/7/13
M. Reynolds
80%-99%
99%
Yes
16%-49%
40%
Yes
2/9/13
R. Ricci
100%
Occlusion
Yes
Normal
Normal
Yes
2/9/13
S. Smith
50%-79%
60%
Yes
100%
99%
No
2/9/13
J. Ryan
50%-79%
75%
Yes
50%-79%
60%
Yes
QI meetings must be held to examine the results of comparative studies, review discrepancies, discuss difficult cases, and address facility issues.
DATA COLLECTION
Prospective gathering and organization of correlative data are essential to a successful quality program. The tracking methods used may be part of a commercial software package for vascular laboratory reporting, a radiology information system (RIS), or an electronic health record (EHR), or the method may be based on internally developed forms. Positive test results that could be expected to lead to clinical follow-up, another correlative examination, or surgical intervention should be tracked. The laboratory should have a method to maintain a log of patients with positive or unusual test findings. This may be as simple as a notebook kept in the testing rooms to catalog patients, but a secure electronic record consistent with the facilities documentation and information assurance policies is preferred. Electronic data collection may be a requirement in some large health systems, such as the Department of Veterans Affairs. The Picture Archiving and Communication System (PACS), RIS, or EHR used by the laboratory may include this capability. Using the lists created, assigned staff can gather information about treatment, further testing, or clinical outcomes, which can be compared with the findings of the noninvasive vascular examination.
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