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Implementation of Rapid Testing from a Rural Perspective - Keys to Success

This article discusses the successful implementation of rapid testing for HIV in rural areas, highlighting the importance of training, quality assurance, and collaboration between public health laboratories and HIV programs.

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Implementation of Rapid Testing from a Rural Perspective - Keys to Success

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  1. Implementation of Rapid Testing from a Rural Perspective - Keys to Success Susanne Norris Zanto, CLS(NCA) Montana Public Health Laboratory szanto@mt.gov

  2. State of Montana 147,046 square miles

  3. Concern for Quality Testing • Began in June 2003 with selection of pilot sites • Three CTS and three CBO sites • MTPHL entered into agreement with HIV Program for training and oversight of QA program • Costs are supported by the HIV Program, not the Laboratory • HIV Program obtained CLIA waived status for sites

  4. Pilot Site Training • Customized training adapted from CDC and Michigan guidelines • Selection of personnel done by pilot sites • Prerequisite: Had to have completed the HIV Prevention Counseling Testing Course offered by the HIV program • One day session to be held at the MT DPHHS • Only operators trained at this session would be allowed to perform the rapid HIV testing

  5. Training Curriculum • Background on Waived Testing, including avoidance of problems found in CLIA COW lab pilot inspections • Quality Assurance Program • Biohazard Exposure Control Plan • Lab practicum – performing testing on external quality controls • Lab practicum – practice fingerstick procedure • Counseling Techniques – giving the preliminary positive result • Incorporates the six steps of HIV Prevention Counseling into this testing format

  6. Training Curriculum, cont’d • Role Playing • Client is given a scenario • Counselor interviews, make decision to test • Testing is performed (unknown specimens) • All required documentation is completed • QA documentation • Laboratory Requisition Form (includes demographics) • Results are given to the client based on test results, and further counseling performed

  7. Quality Assurance Program • At initial training, each site receives a notebook for CLIA compliance • Procedures for fingerstick, actual OraQuick test performance • Quality Assurance Plan • Biohazard Exposure Plan • Product Insert • Master copies of worksheets

  8. Quality Assurance Program • Documentation of testing results, temperature charts, inventory logs • MPEP program enrollment • Competency Testing • Confirmatory Testing results • Completeness of documentation

  9. Quality Assurance Program • Each site is required to submit QA documentation to the MTPHL each month • Records are examined for completeness and compliance • Feedback letters are sent to each site and to the HIV Program

  10. Examples of Feedback ▪ The QA Committee would like to commend you for your efforts. Your documentation is all in order, and everything looks good. I am confident your QA program is working well, which assures quality test results. ▪ Please record your results as “Pos”, “Neg”, or “Invalid”, not “+” or “-”. It is too easy to change a negative sign into a positive sign. ▪ I am assuming that your controls for the kit lot# 0303769 were run in a previous month (July – September) – but that is the type of documentation I look for each month.

  11. Lessons Learned During Pilot • All preliminary positive tests must be confirmed • A mechanism for obtaining a specimen for confirmatory testing must be in place for CBOs that are doing testing after hours • Documentation was not nearly as onerous as they thought during training

  12. Expansion to Additional Sites • Operators still had to attend the mandatory rapid testing training • Rolled out gradually • Lessons learned from sites and trainings are shared • Expansion to Family Planning sites

  13. Sites of Training / Operators

  14. Overcoming Obstacles • The MT PHL/HIV Program partnership was instrumental in implementation • CLIA waivers • Setting up and monitoring the QA program • Training • Enrolling sites in MPEP • Speaking with one voice • Availability for answering questions • Local sites convinced that adherence to a comprehensive QA program leads to high quality results (and it is worth any additional expense)

  15. Importance of Early Planning • Willingness of MTPHL lab to partner with HIV program and share expertise • Cooperation and existing relationship between MTPHL and HIV Program • Decision to start first with pilot sites • Gradual roll out to other sites

  16. QA Increases Confidence in the Integrity of HIV CTS • Work closely with those individuals actively providing rapid testing services • Adherence to QA program increases the “comfort level” of operators • Emphasize that QA is performed to produce high quality results, not just for regulatory compliance

  17. In Conclusion….Keys to Success • Laboratory professionals are QA experts – utilize their expertise - involving the PHL helped in a smooth implementation • Starting with pilot sites was a good idea • Willingness to train in various places around the state increases attendance • Maintaining a good working relationship between the PHL, HIV Program, and local sites is instrumental • Monthly contact (feedback) keeps everyone involved in QA compliance

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