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Implementation of Rapid Testing from a Rural Perspective - Keys to Success
Susanne Norris Zanto, CLS(NCA)
Montana Public Health Laboratory
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State of Montana
147,046 square miles
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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
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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
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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
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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
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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
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Quality Assurance Program
Documentation of testing results, temperature charts, inventory logs
MPEP program enrollment Competency Testing
– Confirmatory Testing results– Completeness of documentation
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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
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▪ 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.
Examples of Feedback
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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
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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
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Sites of Training / Operators
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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)
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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
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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
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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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