CUSTOMIZATION GUIDE
AFB SMEAR MICROSCOPY EXTERNAL QUALITY ASSESSMENT WORKSHOP-IN-A-BOX
CUSTOMIZATION GUIDE
AFB Microscopy
Customization level: Customize at the Country Level
Specific Instructions:
Text:
Customize the text (if needed) according to your country’s specific policy on:
- Current NTP strategies regarding the number of smears to be examined for the diagnosis of pulmonary TB and the definition of a new sputum smear-positive TB case: text page 2
- Number of smears per follow-up examination, intervals for follow-up examinations: text page 2
- Type(s) of sputum to be collected (on the spot and/or morning?): text page 2
- Referrals from peripheral health units without AFB-smear laboratory: discuss only the applicable option(s)
- Tools used to make smears and the standard size of smears as prescribed by your guidelines: page 3
- Concentrations of fuchsin and methylene blue, and the type of acid used for Ziehl-Neelsen staining: text page 4
- Concentrations of auramine, the type and concentrations of acid and counterstaining solutions used for fluorescence microscopy staining: text page 5
- Format of the AFB smear register and request form: pages 7 and 8
Presentation:
Slide 3: Modify this slide to reflect the country specific strategy on the number of smears to be examined for the diagnosis of pulmonary TB and the definition of a new sputum smear-positive TB case.
According to the existing policies one to three sputum specimens have to be collected and examined for diagnostic purposes to match the following definition/exclusion of a smear-positive TB case:
- Strategy 1: two positive sputa are required to declare a smear-positive case and three negative sputa - toexclude it. Most countries have adopted the policy of collecting three specimens as the means of identifying infectious cases of tuberculosis. A TB suspect with two positive sputum specimens is then defined as a smear-positive case of pulmonary TB.
- Strategy 2: one positive sputum is sufficient to declare a smear-positive case, two negative sputa - to exclude it. According to the WHO revised policy, where functional EQA for smear microscopy is in place, where workload is very high and human resources are limited, the number of specimens to be examined for screening of TB cases can be reduced from three to two. And a single AFB in at least one sputum smear would satisfy the criterion to report a patient as having “sputum smear-positive” tuberculosis.
- The two possible smear-positive definitions / numbers of sputum specimens that need to be examined to exclude the diagnosis, can also be combined differently. For instance, three sputum specimens could be examined for screening, while a single positive could already be sufficient to declare a positive case.
Add details to reflect the country specific policy on the sputum collection strategy (i.e. on the spot/early morning specimens, intervals and timing for follow-up smears).
Slide 7: Modify this slide to reflect the country specific strategy on referral of patients, specimens or smears from the most peripheral health units without AFB-microscopy laboratory. You should only show and discuss the options applicable to your situation.
Slide 10 and 11: Smears described here are to be made by bacteriological loop or with disposable sticks. Your country may choose only one of these options. In that case, please delete the other. The standard size for smears shown (2 cm by 1 cm, or 3 cm by
2 cm) should be only what is in your country’s guidelines.
Slide 12: Modify this slide to reflect the country specific fuchsin and methylene blue concentrations, besides type of acid (and its concentration)for Ziehl-Neelsen staining. According to experts’ opinion, the bestconcentration of basic fuchsin is1%, and staining time is 10 min (or more, as long as the stain does not dry on the smear), rather than 0.3% for 5 minutes recommended in the Union and WHO guidelines. The strong carbol-fuchsin 1% solution as well as prolonged staining time result in strongly stained red AFB that are more easily seen and are also more numerous.Consequently,the concentration of methylene blue is now lower than before, only 0.1% (compared to 0.3%) with 1 min staining time. This has been recommended since a weak blue background is better than a strong blue (i.e. it will not hide AFB in thick parts).
Slide 16: Modify this slide to reflect the country specific counterstaining and acid solution for fluorescence microscopy.
Slide 26: You may want to replace the register page by the exact model of register used in your programme.
Slide 27: You may want to replace the AFB smear request form by the exact model used in your programme.
Rechecking principles and sample size - High level
Customization level: Customize at Country Level
Specific Instructions:
Presentation:
Slide 4, 8, 39 to 43 and throughout the presentation: replace the general terms “supervisor”, “first/second controller”, “coordinator” and “higher level” as much as possible by the designations of the staff and level of the service actually responsible for these tasks in your setting.
Slide 22: specify which values for the parameters decisive for sample size (d, relative sensitivity) have been retained by your programme.
Background and Principles of Rechecking - Lower level
Customization level: Customize at the Country Level (or Intermediate Level in very large countries)
Specific Instructions:
Presentation:
Slide 10:Specify the designation in your programme of the rechecking coordinator.
Slide 13:Modify this slide to include the annual sample size or selection of sizes for your country/province, and how it should be divided over the year, with for instance a quarterly sample size.
Slide 16:Sampling of smears is divided over the year, usually per quarter. Modify this slide to reflect the frequency and interval-samplesize for your country/province.
Rechecking procedures
Customization level: Customize at Country Level
Specific Instructions:
Presentation:
Slide 6, 10, 13, 15, 25: replace the general terms “supervisor”, “first/second controller” and “coordinator” as much as possible by the designations of the staff actually responsible for these tasks in your setting. Add practical details of execution as needed.
Slide 7: customize this slide specifying the annual sample size, the frequency and number of slides to be collected per visit.
Slides 11 to 17: depending on the restaining policy in your programme, you may decide to omit this part completely, or to keep it only for theoretical explanation. The restaining policy has to be decided upon at national level; if it has to be done, these slides should be adapted to specify exactly for which slides and by whom restaining will be done (all or discordant? first or second controller?). Please note that slide 18 and 19 should be kept since for auramine stained smears restaining will always be needed. Also slide 23 needs to be adapted to policy.
Slide 22, 23: modify this slide to reflect the actual restaining policy in your programme (lower level)
Slide 27, 28: keep only the smear size standard for your programme
Rechecking Discordants Management
Customization level: Customize at Country Level
Specific Instructions:
Presentation:
Slide 3, 4, etc.: replace the general terms “first/second controller”, “coordinator” and “higher level” as much as possible by the designations of the staff and level of the service actually responsible for these tasks in your setting. Add practical details of execution as needed.
Slide 8: adapt to the restaining policy in your country
Reporting of AFB lab Performance, Manual system
Customization level: Customize at the Country or Intermediate Level
Specific Instructions:
Presentation:
Slide 5: list here only the names and description of the forms for reporting the work done by AFB-microscopy laboratories, if any.
Slide 6: replace this form by the actual format used by peripheral laboratories in your country to report the work done (and stocks) to the higher levels.
Slide 7: replace this form by the actual format used in your country by the intermediate level to report performance of their peripheral laboratories to the higher levels (if any).
Slide 8 to 10: replace the general terms “supervisor”, “first/second controller” and “coordinator” as much as possible by the designations of the staff actually responsible for these tasks in your setting. Add practical details of execution, as needed.
Slide 12 to 14: replace the generic forms by those in use by your programme.
Reporting of AFB lab Performance, Computerised system
Specific Instructions:
Presentation:
Slide 4: specify at which level the data will be entered in computer, and how information will be transmitted to the higher level (manually filled reports, or already computerized) per intermediate level
Slide 5, 6: last bullet slide 5, “District”; Tables, line “Summary Districts”, slide 6 “District” on top: should be replaced by the designation of the intermediate level of your area for which totals will be analyzed in the workbook, if not called a “district”. Do this in the workbook itself, with copy / paste to the presentation afterwards.
Slides7 to 15: “Region” and “District” on top of these sheets should be replaced by the designation of the intermediate levels of your area for which totals will be analyzed in the workbook, if not called a “district” respectively “region”. Do this in the workbook itself, then copy/paste to the presentation afterwards.
Slide 21: you may want to change these minimum quality criteria to the standards set by your programme. However, theyare meant to trigger action. Labs remaining below the minimum will need an (urgent) problem solving visit.
Slides 22 to 29: designations “Division” and “District” on top of these sheets can eventually also be replaced by those of your setting. However, this is an example, so less useful. And only possible as “edit picture” since the original EXCEL workbook is not found in this package.
Interpretation of rechecking results & Feedback
Specific Instructions:
Presentation:
Slides 4, 5: specify the exact name of the non-lab TB supervisor and lab specialist responsible for certain supervision tasks (which you may also specify) in your programme.
Slides 6 through 15 are devoted to the investigation of possible causes of errors identified by means of slides rechecking. Actually, these slides duplicate the training materials presented under the “Problem-Oriented Supervision” and “Problem Solving” module (Slides 12 - 29). Therefore customize the workshop materials in such a way that the Problem Identification and Solving section is studied either under the Rechecking orthe Problem-Oriented Supervision modules.Refer to the customization notes for Problem-Oriented Supervision and Problem Solving module below foradditional comments.
Panel Testing (Full Version)
Customization level: Customize at the Country Level
Specific Instructions:
Presentation:
Slide 8: Specify the type of panel slides used in your program.
Slide 9: Specify where the panel slides used in your program come from, if they are NOT manufactured by the NRL.
Slides 12 through 15 are intended mainly for NRL staff training. The slides contain basic information on standard deviation concept and its applicability to the pre-validation of AFB smear panel batches at NRL. While this material could be of certain interest for both NRL staff and other national level participants, consider omitting these slides and pre-validation technical details if no NRL specialists are attended the workshop and timeallocated for the presentation is limited.Nevertheless,make sure to deliver a clear message on the importance of AFB smear panel batches pre-validation prior to sending panel sets to peripheral laboratories.
Slides 17, 26, 34: Replace these forms by the formats used in your program, if different.
Slide 18: Modify the example of a panel smear code, as needed.
Slide 22: Specify who is responsible for implementation, in case it is not your NRLand Public Health Directors.
Slide 24: Indicate who is responsible at which level of your country, if not the NRL and intermediate laboratories.
Slide 25: Modify the first bullet of this slide to reflect the NTP/NRL strategy on frequency of panel testing rounds in the country/province.
Slide 28: Mention the value of a successful score as determined by NTP/NRL.
Panel Testing (Condensed Version)
Customization level: Customize at the Country Level
Specific Instructions:
Presentation:
Slide 6:Customize this slide and the message to reflect the country situation on NRL and intermediate level laboratories panel testing collaboration practices. Based on each country situation (links established, resources available, etc.), NTP may decide which panel testing related functions of NRL could be delegated to intermediate laboratories. It means that in addition to ordinary distribution of panels and collection/forwarding of panel testing results/panel sets back to NRL, intermediate laboratories may participate in analysis of panel testing results, including post-validation of panel batches. In this case it can be recommended that the standard operating procedure (SOP) for an intermediate level supervisor is developed to determine his/her responsibilities and actions under the framework of the panel testing activities
Slide 9:Modify the first bullet to match with the country policy on the frequency of panel testing rounds in the country.
Slides 10, 15, 18, 19: Replace these forms by the formats used in your program, if different.
Slide 12: Mention the value of a successful score as determined by NTP/NRL; also the scoring system may need to be adapted to the practice in your country.
Slide 14 NTP/NRL should decide on participation of intermediate laboratories in post-validation practices. Customize this slide to reflect the country specific strategy.
On-Site Supervision Overview
Customization level: Customize at the Country Level
Specific Instructions:
Text:
1)Update the text to include/exclude the reference to the National Laboratory System (NLS) to follow the country-specific strategywith regard to the existence/absence/ promotion of this structure in the country. Establishment of a national laboratory system is seen as a response to the challenge of developing effective laboratory networks to meet the requirements of the evolving structure of the health-care system to assure that the laboratory components are serving the needs of various health programs and that their activities are integrated with the medical care needs. It is quite usual that laboratories have poor coordination andunderdeveloped relationships thatfrequently result in inconsistent laboratory capacity across the country. With that in mind, NLSis envisioned as a cooperative arrangement of public health, hospital and independent laboratories to foster development of strong relationships, facilitate communication and collaboration,promote best practices, and improve adherence to standards.NLS is a type of laboratory capacity building that ensuresconsistent country-wide laboratory testing capacity and,thus,contributes to community health and safety.
2)Modify the text to reflect the country specific strategy on the frequency of on-site supervision by TB supervisors versus laboratory supervisors and make changes in the summary table accordingly.
3)Modify the text to reflect the country specific strategy on the scope of laboratory supervision (laboratory operational elements to be evaluated) forgeneral TB supervisors and laboratory supervisors.
Appendices: NTP should adapt the content of the proposed checklists (both short and comprehensive versions for TB supervisors and laboratory supervisors, correspondingly) to reflect the country specific situation. NTP should develop standard definitions (criteria for acceptance) of each checklist item to be evaluated, based on the guidelines established by WHO and IUATLD and resources available in the area.
Presentation:
Part 1. On-Site Supervision General Overview
Slide 5: Modify this slide to reflect the country specific strategy on the frequency of on-site supervision visits by TB supervisors and laboratory supervisors.
Slide 6: Modify the table to reflect the country specific strategy on the frequency/scope of on-site supervision by TB versus laboratory supervisors.
Slides 7-8: Update the list of laboratory operational elements to be evaluated by TB supervisors in accordance with NTP policies.
Slide 9:Update the list of laboratory operational elements to be evaluated by laboratory supervisors in accordance with NTP policies.
Part 2. On-Site Supervision Checklists
Consider demonstration of the NTP approved country specific versions of checklists for TB supervisors and laboratory supervisors as well as appendices to checklists that contain standard definitions (criteria for acceptance) of each checklist item.Make sure all trainees receive copies of checklists and appendices as handouts.
Make sure that information stated in the NTP approved checklists corresponds to information presented on the slides. Consider modifying slides when needed.
“On-Site Supervision Short Checklist”Exercise:
OPTIONAL: consider relevant modification of the exercise if it is decided to use the NTP approved country specific checklist for practicing supervisory skills.
Problem-Oriented Supervision and Problem Solving
Customization level: Customize at the Country level
Specific Instructions:
Text:
Refer also to the customization notes to Module #16, Slide 5 as well as Module #1, Slide 3 of this Customization Guide (page 1) and modify the last bullet to reflect the country specific strategy on the number of smears to be examined for the diagnosis of pulmonary TB and the definition of a new sputum smear-positive TB case.
Presentation:
Slide 4:
Reflect the country specific strategy on the number of smears to be examined for the diagnosis of pulmonary TB and the definition of a new sputum smear-positive TB case (revised WHO policies regarding definition of a new sputum smear-positive pulmonary TB case and reduction of number of smears for the diagnosis of pulmonary TB).
Slides 11 – 28:
This set of slides is devoted to the problem identification and solving while investigating rechecking errors. In fact, this section duplicates the training material that is included in the Rechecking part of this WIB(Modules 10 and 11: Reporting and Analysis of AFB-Smear Laboratories Performance, Interpretation of Results and Feedback, Part III: Feedback, Problem Identification and Solving). Therefore, consider omitting this section in the Supervision presentation if the country workshop includes both EQA Supervision and EQA Rechecking sections, and the recommended steps in investigating rechecking errorsare studiedunder the Rechecking module.
Slide 24:
The recommendation contained in the first bullet is relevant only for countries that follow the strategy to restain sampled smears prior to rechecking. Sometimes false-negative results may in fact indicate contamination of the methylene blue staining solution or tap waterwith AFB. It means that when AFB are contained in tap water or in the methylene blue staining solution they can stickto smears after the staining with carbolfuchsin and thus remain invisible. But when the sampled smears are restained for rechecking, such AFB become visible and result in wrong impression of the initial false-negative results.