Choosing a Test: Quality Assurance

Effective quality assurance programs minimize the risk of mistakes that can occur in terms of:

• Storage and testing-area temperature
• Test-kit shelf life
• Specimen collection
• Test performance
• Results interpretation
• Confirmatory testing

Hospital laboratory staff are responsible for oversight of quality assurance for any point-of-care testing. They should be involved in developing and maintaining:

• Clear and concise procedures
• Training of personnel
• Verification of competence of personnel
• Proper performance of quality control procedures
• Recognition of when testing does not comply with procedures

For CLIA-waived rapid HIV tests performed at the point of care, nurses or other designated staff can assume responsibility for both collection and testing. Staff must be trained in how to administer the test and provide appropriate quality assurance to ensure that the test continues to be administered pursuant to manufacturer instructions. Hospitals will need to work to develop, implement, and maintain capacity to provide training and quality assurance on an ongoing basis to staff conducting rapid HIV testing. For more information, see Training Staff.

Alternatively, you may decide to send rapid HIV tests to the laboratory. In a laboratory, these duties would be managed by a Quality Control or Quality Assurance (QA) Compliance Officer.  In a point-of-care testing setting, it is important to establish a POC coordinator (typically a laboratorian) who is responsible for training, quality control, and quality assurance issues.

The College of American Pathologists Commission on Laboratory Accreditation has developed a comprehensive checklist for point-of-care testing that can inform the implementation of point of care testing. In addition, the CDC maintains comprehensive rapid HIV testing web resources, which include detailed and up-to-date information on CLIA, quality assurance and studies on rapid HIV testing.

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