HIV Drug Resistance Training Module 17 Laboratory Staff Experience and Training Present: In this module, we’ll talk about a critical element of the quality system—personnel. Trainer’s Note: Before the module begins, post a flipchart at the front of the room. The flipchart should be titled Personnel Qualifications. It should have a 5 x 4 table on it like the one below. Facilitate group tally: To begin the module, ask participants to look through the resumes/CVs that they brought to training and tally up the education and years of training of the molecular biology lab employees. They should put tally marks on the flipchart to indicate the range of experience and education. This tallying may be done during a break to minimize the time to transition to the module content.   Years of Experience <1 1-3 3+ Highest Level of Education No degree Certificate College degree PhD, masters or similar

Objective Identify strategies for ensuring you have the best people and then preparing those people to do their best. Present objectives for the module.

personnel What qualifications should lab personnel in a genotyping lab have? What type of training is recommended for genotyping personnel? Transition to next section. Note that we will try to answer this question.

Personnel Human resource planning Hiring Retention Training Supervision Performance management Present: Personnel issues include all six areas shown on this slide. Four of them (human resource planning, hiring, retention, and performance management) vary greatly from one location to the next and from one country to the next. We will not discuss those areas here; however, they are still important, and we encourage you to consider these factors in determining whether to establish a genotyping lab, which requires a high level of skill. Also, we encourage the measuring of quality indicators for monitoring and motivation. Let’s focus now on training and supervision.

Laboratory Personnel: Qualifications One year of experience Training certificate B.Sc. Conditions Applicant pool Current staffing Present: Minimal qualifications must be determined by each lab. You should strive for the best qualifications possible, balanced with local conditions. Goal: B.Sc. or equivalent Minimally: technical training certificate, at least 1 year full time experience Consider: Reality of available pool of applicants Existing personnel and infrastructure (e.g. if highly experienced staff already present, can hire less experienced technicians)

Laboratory Personnel: New Staff Training: HIV Genotyping Passing Scores: All training listed below Laboratory safety Bloodborne pathogens Personal protective equipment Biohazardous waste management Site specific biosafety Present: Newly hired staff should be trained and obtain passing scores in the following areas before they can be trained on HIV genotyping techniques. (The base of the pyramid). Laboratory safety Bloodborne pathogens Personal protective equipment Bioharzardous waste management Site specific biosafety walk through

Laboratory Personnel: Training/Proficiency Genotyping Technique Training Training and proficiency FIRST, then "real" survey samples Remove operator-sensitivity of assay accuracy and reproducibility Use panel of well-characterized control samples Present: Training and proficiency must be demonstrated and documented before "real" survey samples processed Goal is to remove operator-sensitivity of assay accuracy and reproducibility Use panel of well-characterized control samples to assess performance Emphasize: Rigorous training, followed by rigorous testing, is essential to ensure accurate and precise results. Discuss: What training and proficiency processes/procedure do you currently have in palce that can serve as a model for the HIVDR testing training?

Laboratory Personnel: Training/Proficiency Annual re-certification recommended for all personnel Blinded panel of known samples May be same as EQA proficiency testing Present information on slide. Photo: http://www.afrims.org/trainings.html

Laboratory Personnel: Supervision Base-calling involving mixtures – always have second person review edits In-process controls when results are unclear Sample identity questions Assessment of quality indicators (e.g. phylogenetic trees, number of mixtures, etc.) Present: Complexity of genotyping assay steps sometimes requires consultation with more experienced supervisor, especially when using in-house assays). Go over the different examples on the slide of how supervisors can add value to help ensure accurate genotyping. Photo: http://www.afrims.org/trainings.html

Where to Get Training/Experience Workshops Genotyping kit vendors Hands-on workshops Regional and Specialized accredited labs Parallel testing Present information on sources of training and learning: Workshops like this one! Genotyping kit vendors Hands-on workshops delete if we can't cite specific examples Other accredited labs in ResNet--Training is a responsibility of Regional and Specialized accredited labs For surveys where samples are being sent to a Regional or Specialized lab, perform testing in parallel and compare results

Discussion What qualifications should lab personnel in a genotyping lab have? What type of training is recommended for genotyping personnel? Facilitate a group discussion of the questions that were presented at the beginning of the section, as a review and to make sure participants understand the key points. Discuss: What implication do these points have to you at the national level?

Reflection What will our minimum and desired qualification be? What systems will we put in place to make sure our staff are adequately prepared to do genotyping? Training Proficiency testing Supervision Discuss these questions. Ask participants to write their own answers to these questions in the blank space on their handouts. Ask select participants to summarize, in one or two sentences, the key points they learned in this module.