Marianne Porter BS MS
Director, Division of Laboratory Improvement
Pennsylvania Department of Health
Issues: Implementation of rapid HIV testing programs faces several hurdles, including issues of maintaining a reliable testing environment, accessing training resources for testing personnel, making appropriate changes in counseling practices, and complying with federal and state laboratory licensure requirements. This presentation addresses lessons learned for implementation of a rapid testing program in publicly funded sites as well as a sampling of private initiatives.
Description: The Pennsylvania Department of Health has implemented a three-site pilot program, and successfully worked through training, staffing, and regulatory issues with the pilot sites, as well as with other, privately funded sites in the Commonwealth. There was an initial perception that the personnel requirements defined under the regulations pertaining to the Pennsylvania Clinical Laboratory Act would be a major impediment to implementation, but other factors, including clinic access, funding, and counseling have been as significant. Preliminary proficiency testing results have underscored the critical role of training and testing environment.
Recommendations: Deal directly with program implementers, to increase their confidence in the Department’s commitment to making rapid testing both available and reliable. Plan carefully, train well, and begin slowly. Determine a system for data monitoring, including elements prone to human error, such as the time, temperature, and lighting under which the test is conducted, and the use of controls to ensure test kit functionality, and provide potential testing sites with guidance on preparing procedures and setting up record keeping formats. Work closely with those individuals actively providing rapid testing services, to be sure that proposed procedures will be feasible in practice.

Last Update: April 8, 2005