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

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

4. 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

5. 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

6. 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

7. 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

13. 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

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

15. 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

16. 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.

17. 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

18. 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

19. Sites of Training / Operators

20. 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)

21. 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

22. 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

23. 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