Panel Testing, Full version PANEL TESTING, Full Version (National, TOT and Higher Intermediate Level): Purpose: To provide a comprehensive overview of panel testing concept and panel testing implementation principles Module Time: 3 hours Learning objectives: At the end of this module, participants will be able to: Give definition to panel testing Name advantages and disadvantages of panel testing Describe the scheme of a panel testing round Understand principles of scoring system; interpretation of results and feedback Become familiar with registration forms used for panel testing Module Overview Step Time Activity/ Method Content Resources Needed 1 5 min Presentation What is panel testing? Slides 3 2 5 min Presentation What is panel testing used for? Slides 4 - 5 3 5 min Presentation Advantages and disadvantages of panel testing Slides 6 - 7 4 5 min Presentation Preparation of test smears Slides 8 -9 Presentation and Demonstration Validation of panel batches Slides 10 - 18 5 40 min 6 5 min Presentation Panels’ composition Slides 19 - 20 7 15 min Presentation Organization of a panel testing round Slides 21 - 27 8 10 min Presentation Analysis of results; scoring system Slides 28 - 31 9 10 min Presentation Interpretation and feedback Slides 32 - 35 10 5 min Demonstration Forms Panel Testing Recording and Reporting Forms 11 5 min Summary Key Messages Slide 36-38 12 30 min Exercise Errors identification, scoring and analysis of individual Exercise notes; exercise file. TRAINER’S GUIDE AFB Smear Microscopy EQA WIB Page 1 of 10 Panel Testing, Full version panel testing results 13 40 min Exercise Post-validation / analysis of aggregate results Exercise notes; exercise file. Material/Equipment Checklists PowerPoint slides Computer w/LCD projector Flipchart Calculators (scientific calculators or simple calculators that have a square root function at least) Handouts: one printed copy per participant 1. 2. 3. 4. Panel Testing Recording and Reporting Forms (handouts for participants) Validation Log for AFB Panel Testing Slide Batches at NRL Panel Sets’ Logbook / Aggregate Results Panel Testing Individual Results and Feedback Form Panel Testing Report of Multiple Laboratories for District Supervisor & NTP Exercise file and printed copies (one per participant of each of the 4 sheets of the file; do NOT staple the sheets). TRAINER’S GUIDE AFB Smear Microscopy EQA WIB Page 2 of 10 Panel Testing, Full version Teaching Guide Slide Number 1 Teaching Points Module: Panel Testing, Full Version DISPLAY this slide before you begin the module. Make sure participants are aware of the transition into a new module. 2 Flipchart Content Overview (Suggested technique for presentation) WRITE the content outline before beginning this session. REFER to flipchart frequently to orient participants to where they are in the module. EXPLAIN that these are the topics that will be covered in this module. 3 What is Panel Testing? STATE that panel testing is an EQA method that is designed to assess proficiency of an individual laboratory technician in detecting, quantifying, interpreting and reporting AFB smear results according to WHO/IUATLD guidelines, using a set of stained and/or unstained sputum smears prepared by NRL. 4 What is Panel Testing Used For? STATE the messages on the slide. Refer to the clarifying notes below the slide. STRESS that panel testing is the most effective tool to evaluate proficiency and capacity, and most valuable with regard to training. ADD that panel testing can also be useful additional to rechecking for laboratories that rarely see positives as a “refresher” of the appearance of a positive smear. 5 What is Panel Testing Used For? (2) STATE the messages on the slide. Refer to the notes below the slide. Although panel testing is considered to be less effective than rechecking (it does not monitor routine performance), it can be more cost effective (i.e. in areas with low incidence of tuberculosis or very few microscopy problems, or the only feasible option). TRAINER’S GUIDE AFB Smear Microscopy EQA WIB Page 3 of 10 Panel Testing, Full version Slide Number 6 Teaching Points Advantages of Panel Testing LIST panel testing strengths as stated on the slide. A rapid gross overview of the main problems can be obtained at moderate cost. 7 Disadvantages of Panel Testing STATE the message on the slide. STRESS that panel testing requires additional resources; NRL staff should be capable to handle the increased workload. 8 Preparation of Test Smears CUSTOMIZATION: explain which type of panel slides are used in your program. STATE the message on the slide. STRESS that panel sets are preferably specially manufactured. Reusing stained patient smears is advisable only when resources are extremely limited and NRL technical capacities and capabilities are insufficient to prepare high quality standardized panel sets. 9 Manufacturing Smears for Panel Testing CUSTOMISE this slide if the origin of panels is not your NRL. STATE the message on the slide. 10 Validation of Panel Batches STRESS that validation of the consistency of panel batches is a must for any laboratory preparing panel smears. EXPLAIN that validation of panel batches includes two parts, as stated on the slide. 11 Pre-validation DESCRIBE pre-validation steps as stated on the slide. NOTE that if the consistency of a positive batch was considered insufficient (the average minus 2 SD < 0), this batch can still be used for another quantification target (less than 2 step difference), provided that no negative smears appeared in the batch. TRAINER’S GUIDE AFB Smear Microscopy EQA WIB Page 4 of 10 Panel Testing, Full version Slide Number 12 Teaching Points Normal Distribution Country CUSTOMIZATION is recommended: Slides # 12 through #15 are intended for NRL staff training only. Consider omitting these slides if no NRL technical specialists are attended the workshop. NOTE that the next few slides will facilitate an understanding of the standard deviation conception and its applicability to the validation of AFB smear microscopy panel batches. EXPLAIN that a normal distribution curve contains values that are symmetrically distributed around the mean. The figure on the right represents a normal distribution curve for a large number of measurements of the same item. Values are plotted on the x-axis with the frequency of the measurement plotted on the y-axis. 13 Flipchart What is the Standard Deviation? EXPLAIN the meaning of standard deviation and how it is calculated. USE flipchart to write down all steps as stated – better to do it in advance prior to the training session in order to save time during the presentation. Step 1. Calculate the arithmetic mean. Step 2. Subtract the mean from each observation. Square the difference. Step 3. Sum the squared differences. Step 4. Divide the sum of the squared differences by n-1. Step 5. Take the square root of the value obtained in Step 4. The result is the standard deviation. Two and three standard deviations can be computed simply by multiplying the 1 SD value by 2 and 3 respectively. 14 Standard Deviation and Probability STRESS that the standard deviation is a measure of the distribution of values around the mean. The greater the spread of values, the larger the standard deviation and the lower the precision. In the laboratory we aim for as small a standard deviation as possible. STATE the message on the slide. TRAINER’S GUIDE AFB Smear Microscopy EQA WIB Page 5 of 10 Panel Testing, Full version Slide Number 15 Teaching Points Sample Form: Validation Log for AFB Panel Testing Slide Batches (pre-validation) Computer SHOW the Pre-Validation Log form (slide). STRESS that any laboratory preparing panels must keep the PreValidation Log electronically or in hard copy to record all batches prepared and validated. Flipchart (OPTIONAL) REFER to Slide #13 notes above and USE flipchart to DEMONSTRATE relevant calculations for panel batches as per examples provided. STRESS that intended positives should never be negative; intended negatives should never be positive. A positive batch with deviating average quantification can be used for another quantification target, provided quantification differences do not reach 2 steps on scale. DEMONSTRATE STDV&averageLog.xls file and, following recommendations contained in the file, EXPLAIN the use of the developed “Panel Test Log Validation” tool. 16 Post-validation STATE the message on the slide. STRESS that post-validation is needed mainly when high error frequencies are observed for a particular slide batch. 17 Logbook of Panel Slides Sets / Post-validation CUSTOMIZATION: you may want to replace this form by your own format. DEMONSTRATE the sample form of the panel sets’ logbook that is used for post-validation purposes. 18 Coding of Panel Smears EXPLAIN that the purpose of coding panel smears is twofold – to prevent identification of a smear result by a tested laboratory technician (thus to avoid reading bias) but to make identification of a smear clear for the laboratory supervisor who is in charge of panel testing. MODIFY the example of a panel smear code as needed. 19 Panels’ Composition STATE the message on the slide. TRAINER’S GUIDE AFB Smear Microscopy EQA WIB Page 6 of 10 Panel Testing, Full version Slide Number 20 Teaching Points Examples of Panel Sets Compositions GIVE examples of panel sets compositions as stated on the slide. EXPLAIN why larger numbers of scanty and low positive smears may be included. They represent more challenge, leading to a more accurate, sensitive and discriminating test. 21 Getting Started: Issues to Consider EXPLAIN that proper implementation of a panel testing program requires a lot of efforts; there are many issues to be considered. NAME those stated on the slide. 22 Implementation of Panel Testing CUSTOMIZATION: Specify who is responsible for implementation, in case it is not your NRL and Public Health Directors. STATE the message on the slide. STRESS that a thorough planning is highly important for a successful panel testing. 23 Sending Slides STATE each program will need to determine the best mechanism for delivering slides based on the services, regulations in force and resources available. Reasonable turn around time is expected to be between one week and one month, and must be set depending on the local situation. Appropriate care should be taken to prevent breakage when sending out panels. NOTE that panel sets might be needed to return to NRL for review after the panel testing exercise is completed at the peripheral level. 24 A Possible Scheme of a Panel Testing Round CUSTOMIZE if needed by indicating who is responsible at which level of your country, if not the NRL and intermediate laboratories. DESCRIBE a possible scheme of a panel testing round as shown in the slide. White color arrows show panel sets flow from NRL to peripheral laboratory technicians via intermediate laboratories. The broken type arrows of blue color demonstrate the panel testing results’ reporting flow. TRAINER’S GUIDE AFB Smear Microscopy EQA WIB Page 7 of 10 Panel Testing, Full version Slide Number 25 Teaching Points Performing a Panel Test Round CUSTOMISE the first bullet to match the country policy on the frequency of panel testing rounds in the country. STATE the message on the slide. STRESS that each individual technician must examine smears and report results separately. 26 Individual Results of Panel Testing / Feedback Form CUSTOMIZATION: you may want to replace this form by your own format. DEMONSTRATE the sample laboratory form designed to record individual results of panel testing and feedback. EXPLAIN that the form and/or a separate accompanying letter should provide the participating laboratory with the detailed instructions regarding the staining, time allowed for technicians to complete panel testing exercise, etc. The feedback section should present carefully considered conclusions and recommendations, not simply a bunch of scores. 27 Management of Panel Testing During a Supervisory Visit EXPLAIN the message on the slide. 28 Analysis of Panel Testing Results STATE the message on the slide. CUSTOMIZATION: mention the value of a successful score as determined by NTP/NRL 29 Types and Classification of Errors EXPLAIN the types of errors as shown in the table. 30 Example of Panel Testing Scoring GIVE an example of a panel testing scoring system as stated on the slide. 31 Analysis of Panel Testing Results STATE the message on the slide. TRAINER’S GUIDE AFB Smear Microscopy EQA WIB Page 8 of 10 Panel Testing, Full version Slide Number 32 Teaching Points Panel Testing – Interpretation of Results STATE the message on the slide. 33 Feedback to Laboratories on Panel Testing Results STATE that feedback is always required and should be timely and confidential. Participants should be informed of their own result and how it compares to the aggregate performance of other laboratories. Reports should provide appropriate background information and recommendations and not simply scores. A visit to the centers scoring poorest, with on-site identification of the problems and remedial action, is required. 34 Panel Testing Aggregate Results of Multiple Laboratories CUSTOMIZATION: you may want to replace this form by your own format. DEMONSTRATE the sample reporting form on panel testing aggregate results of multiple laboratories. 35 Panel Testing Aggregate Results Report: Example DISCUSS the Panel Testing Report presented (see slide notes). Panel Testing Recording and Reporting Forms (electronic files and paper-based handouts) Panel Testing Forms 36 Conclusion: (OPTIONAL) SUMMARIZE panel testing related recording and reporting forms. STRESS that proper data collection and analysis is a critical component of a successful EQA program and laboratory quality improvement. STATE the message on the slide. 37 Key Messages (I): STATE the message on the slide. 38 Key Messages (II) STATE the message on the slide. ANSWER any questions the participants may have. Exercises MOVE to the exercise section below. TRAINER’S GUIDE AFB Smear Microscopy EQA WIB Page 9 of 10 Panel Testing, Full version NOTES TO THE EXERCISE “ERRORS IDENTIFICATION, SCORING AND ANALYSIS OF INDIVIDUAL PANEL TESTING RESULTS” The purpose of this exercise is to develop participants’ analytical skills in examining individual panel testing results and making recommendations for appropriate actions to improve performance. Participants should demonstrate an understanding of smear microscopy errors classification principles as well as results scoring rules. Participants will be asked to review the completed form that contains the panel test results of the Technician from the Laboratory A, compare the Technician’s results with those of NRL, identify errors, if any, record each error in an appropriate abbreviated form, score results, decide whether the Technician has successfully passed the panel testing exercise or failed By doing this exercise participants will be taught how to correctly use the proposed recording form. It is also important that participants will practice their skills in providing written feedback and recommendations. Participants are given 20 minutes to read the task and complete the exercise individually, in written form. Next, the Trainer and participants discuss the exercise in a group after everyone has completed the task (10 minutes): the Trainer asks a participant to provide a verbal answer to the questions stated in the exercise and encourage other participants to add their comments and share their opinion with the group. The Trainer may also want to collect all completed forms to check participants’ answers and return the forms with remarks afterwards. NOTES TO THE EXERCISE “POST-VALIDATION / ANALYSIS OF AGGREGATE RESULTS” The purpose of this exercise is to develop participants’ analytical skills in examining aggregate panel testing results and post-validating panel batches. Participants are provided with the completed form that represents aggregate results from 10 Laboratory Technicians. Participants are asked to compare the Technicians’ results against NRL results and make conclusions about the consistency of slide batches prepared at NRL. Participants should also make a judgement on how many Technicians have successfully passed the panel test. Participants should first also select peripheral laboratories to be visited to investigate errors. This exercise is also good for gaining a better understanding of the panel smears coding principles and the importance of proper registration of panel sets. This exercise is more complicated than the previous one and therefore will require more time (40 minutes in total); it should go after the first exercise on the analysis of individual panel testing results. The Trainer should instruct participants to read the task carefully in order to be able to provide full answers as required. Participants are given 25 minutes to complete the exercise in written and then 15 minutes are devoted to the discussion of the exercise in the group. REMARK: The exercises are attached as a separate file and contain tasks and answer sheets. Please refer to the exercise body for detailed descriptions and instructions. Participants should first be provided with tasks sheets only. Answer sheets can be distributed as reference materials after everyone completes the exercise and answers are discussed in the group. TRAINER’S GUIDE AFB Smear Microscopy EQA WIB Page 10 of 10
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