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

Susanne Norris Zanto, CLS(NCA)

Montana Public Health Laboratory

szanto@mt.gov

State of Montana

147,046 square miles

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

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

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

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

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

Quality Assurance Program

Documentation of testing results, temperature charts, inventory logs

MPEP program enrollment Competency Testing

– Confirmatory Testing results– Completeness of documentation

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

▪ 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

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

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

Sites of Training / Operators

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)

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

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

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