**Module 12: Quality Control**

+----------------+-----------------------------------------------------+
| **Purpose**    | To help participants understand the importance of   |
|                | quality control for HIV rapid testing, and acquire  |
|                | the knowledge and skills required for conducting    |
|                | quality control at a rapid testing site.            |
+----------------+-----------------------------------------------------+
| **P            | -   Module 3: Overview of HIV Testing Technologies  |
| re-requisite** |                                                     |
|                | -   Module 4: HIV Testing Strategies & Algorithms   |
| **Modules**    |                                                     |
|                | ```{=html}                                          |
|                | <!-- -->                                            |
|                | ```                                                 |
|                | -   Module 5: Assuring the Quality of HIV Rapid     |
|                |     Testing                                         |
+----------------+-----------------------------------------------------+
| **Module       | 45 minutes                                          |
| Time**         |                                                     |
+----------------+-----------------------------------------------------+
| **Learning     | At the end of this module, participants will be     |
| Objectives**   | able to:                                            |
|                |                                                     |
|                | -   Differentiate between internal and external     |
|                |     controls                                        |
|                |                                                     |
|                | -   Use external quality controls at designated     |
|                |     frequencies                                     |
|                |                                                     |
|                | -   Analyze common problems associated with invalid |
|                |     test results                                    |
+----------------+-----------------------------------------------------+

**Module Overview**

+-----+-------+---------------+-----------------------+----------------+
| **  | **T   | **Activity/\  | **Content**           | **Resources\   |
| Ste | ime** | Method**      |                       | Needed**       |
| p** |       |               |                       |                |
+-----+-------+---------------+-----------------------+----------------+
| **  | 3 min | >             | Module introduction   | Slides 1-4;    |
| 1** |       |  Presentation |                       | prepared       |
|     |       |               |                       | flipchart --   |
|     |       |               |                       | content        |
|     |       |               |                       | outline        |
+-----+-------+---------------+-----------------------+----------------+
| **  | 7 min | >             | Internal Vs. external | Slides 5-11    |
| 2** |       | Presentation; | quality control       |                |
|     |       | >             |                       |                |
|     |       | > Discussion  |                       |                |
+-----+-------+---------------+-----------------------+----------------+
| **  | 10    | >             | Troubleshooting       | Slides 12-15   |
| 3** | min   | Presentation; | invalid results       |                |
|     |       | >             |                       |                |
|     |       | > Discussion  |                       |                |
+-----+-------+---------------+-----------------------+----------------+
| **  | 15    | > Activities  | Exercise #1:          | Slides 16-18;  |
| 4** | min   |               | [Interpreting Rapid   | Exercises #1 & |
|     |       |               | Test                  | #2 sheets      |
|     |       |               | Results]{.underline}  |                |
|     |       |               |                       |                |
|     |       |               | Exercise #2:          |                |
|     |       |               | [Resolving            |                |
|     |       |               | Un-reportable Test    |                |
|     |       |               | Results]{.underline}  |                |
+-----+-------+---------------+-----------------------+----------------+
| **  | 5 min | >             | Quality control       | Slides 19-21;  |
| 5** |       | Presentation; | records               | [Quality       |
|     |       | >             |                       | Control        |
|     |       | > Discussion  |                       | recording      |
|     |       |               |                       | workshee       |
|     |       |               |                       | t]{.underline} |
+-----+-------+---------------+-----------------------+----------------+
| **  | 5 min | > Q&A         | Summary               | Slide 22-23    |
| 6** |       |               |                       |                |
+-----+-------+---------------+-----------------------+----------------+

**Material/Equipment Checklists**

-   PowerPoint slides or transparencies

-   Overhead projector or computer w/LCD projector

-   Prepared flipchart -- content outline

-   Handouts:

    -   [Exercise #1: Interpreting Rapid Test Results]{.underline}

    -   [Exercise #2: Resolving Un-reportable Test Results]{.underline}

    -   [Daily Record of Quality Control Results]{.underline}

```{=html}
<!-- -->
```
-   **Teaching Guide**

+-----------------+-----------------------------------------------------+
| **Slide         | **Teaching Points**                                 |
| Number**        |                                                     |
+=================+=====================================================+
| **1**           | **[Module 12: Quality Control]{.underline}**        |
|                 |                                                     |
|                 | DISPLAY this slide before you begin the module.     |
|                 | Make sure participants are aware of the transition  |
|                 | into a new module.                                  |
+-----------------+-----------------------------------------------------+
| **2**           | **[The Lab Quality System]{.underline}**            |
|                 |                                                     |
|                 | REMIND participants that quality control is one     |
|                 | component of the laboratory quality system.         |
+-----------------+-----------------------------------------------------+
| **3**           | **[Learning Objectives]{.underline}**               |
|                 |                                                     |
|                 | STATE the objectives on the slide.                  |
+-----------------+-----------------------------------------------------+
| **4**           | **[Content Overview]{.underline}**                  |
|                 |                                                     |
|                 | EXPLAIN the topics that will be covered in this     |
|                 | module.                                             |
+-----------------+-----------------------------------------------------+
| **F             | REFER to it frequently to orient participants to    |
| lipchart**![](m | where they are in the module.                       |
| edia/image1.wmf |                                                     |
| ){width="0.8423 |                                                     |
| 611111111111in" |                                                     |
| height="0.84236 |                                                     |
| 11111111111in"} |                                                     |
+-----------------+-----------------------------------------------------+
| **5**           | **[What is Quality Control (QC)?]{.underline}**     |
|                 |                                                     |
|                 | STATE that the primary benefit of quality control   |
|                 | is that:                                            |
|                 |                                                     |
|                 | -   It shows the tester that the test is working    |
|                 |     correctly.                                      |
|                 |                                                     |
|                 | -   Accurate test results can be reported with      |
|                 |     confidence.                                     |
|                 |                                                     |
|                 | HIGHLIGHT there are 2 levels of QC for HIV rapid    |
|                 | testing:                                            |
|                 |                                                     |
|                 | -   Testing of samples with known results to verify |
|                 |     if the procedure is working properly            |
|                 |                                                     |
|                 | -   Interpreting the presence or absence of control |
|                 |     bands/lines within the device itself            |
|                 |                                                     |
|                 | EMPHASIZE that if problems or errors occur, we must |
|                 | immediately take corrective actions                 |
|                 | [before]{.underline} we give results to patients.   |
+-----------------+-----------------------------------------------------+
| ![](m           | SHARE stories from personal or others' experiences  |
| edia/image2.gif | about the consequences of negligence or lack of     |
| ){width="0.4479 | quality control.                                    |
| 166666666667in" |                                                     |
| height="0.54166 | Stories or scenarios that evoke emotions (fear,     |
| 66666666666in"} | shock, sympathy, sorrow, etc.) are excellent ways   |
| ***TIPS***      | in getting participants to pay attention and        |
|                 | adopting the right attitudes about quality control. |
|                 | This is especially important when teaching          |
|                 | participants without medical or lab experience.     |
+-----------------+-----------------------------------------------------+
| **6**           | **[Sources of Controls]{.underline}**               |
|                 |                                                     |
|                 | STATE that there are two types of quality control   |
|                 | for HIV rapid testing: internal and external to the |
|                 | test kit.                                           |
|                 |                                                     |
|                 | EXPLAIN [Internal]{.underline} quality control.     |
|                 |                                                     |
|                 | -   Control samples with known reactivity may be    |
|                 |     included with the test kit that you would test  |
|                 |     as you would patient/client specimens.          |
|                 |                                                     |
|                 | -   Another type of internal control is an area or  |
|                 |     region within the individual testing device.    |
|                 |     This area or region is also termed the          |
|                 |     procedural or in-built control. This type of    |
|                 |     control verifies the flow of either specimen    |
|                 |     and / or buffer through the test device         |
|                 |     resulting in an appearance of a line or dot in  |
|                 |     the control region. In other words, in some     |
|                 |     test devices, a line in the control area may    |
|                 |     appear even if a specimen is not added, unlike  |
|                 |     other test devices with an anti-IgG control. In |
|                 |     this instance, a control line will not appear   |
|                 |     if IgG is not detected.                         |
|                 |                                                     |
|                 | -   Since it is not always known if the test        |
|                 |     devices include a true IgG control, it is       |
|                 |     important to test an external control sample.   |
|                 |                                                     |
|                 | EXPLAIN [External]{.underline} quality control.     |
|                 |                                                     |
|                 | -   Control samples that do not come with the test  |
|                 |     kit. They are provided by an external source    |
|                 |     such as your regional reference laboratory or a |
|                 |     commercial supplier.                            |
|                 |                                                     |
|                 | ```{=html}                                          |
|                 | <!-- -->                                            |
|                 | ```                                                 |
|                 | -   This type of control should also be tested in   |
|                 |     the same manner as you would test a patient or  |
|                 |     client specimen.                                |
|                 |                                                     |
|                 | EXPLAIN that for both internal and external control |
|                 | samples, you already know whether the control is    |
|                 | positive or negative. Once tested, you should       |
|                 | receive the expected results. If not, this is one   |
|                 | sign that there is a problem with your testing      |
|                 | operation.                                          |
+-----------------+-----------------------------------------------------+
| **7**           | **[Internal and External Quality                    |
|                 | Control]{.underline}**                              |
|                 |                                                     |
|                 | HIGHLIGHT the types of quality control previously   |
|                 | discussed.                                          |
|                 |                                                     |
|                 | POINT OUT the control band on the test device.      |
|                 |                                                     |
|                 | DISCUSS the photo on the left -- control samples    |
|                 | are often received in tubes called cryovials. This  |
|                 | photo illustrates control samples neatly stored in  |
|                 | a Styrofoam container.                              |
+-----------------+-----------------------------------------------------+
| **8**           | **[Examples of Tests that Include Internal          |
|                 | Control]{.underline}**                              |
|                 |                                                     |
|                 | STATE that all the rapid tests listed on the slide  |
|                 | have internal control as part of their kits.        |
|                 |                                                     |
|                 | ASK, "One of these tests differ from the rest in    |
|                 | that it does not have internal control incorporated |
|                 | into its test device.                               |
|                 |                                                     |
|                 | Which one is it?"                                   |
|                 |                                                     |
|                 | SOLICIT responses from the participants. (PROVIDE a |
|                 | hint if participants have difficulty coming up with |
|                 | the correct answer: this test is based on           |
|                 | agglutination format.)                              |
+-----------------+-----------------------------------------------------+
| **9**           | **[Capillus Kit Comes with Internal Control         |
|                 | Samples]{.underline}**                              |
|                 |                                                     |
|                 | PROVIDE and EXPLAIN the correct answer: Capillus.   |
|                 |                                                     |
|                 | -   Its test format is based on agglutination, and  |
|                 |     therefore does not have a built-in control on   |
|                 |     the strip within the device.                    |
|                 |                                                     |
|                 | -   The kit includes controls from the manufacturer |
|                 |     -- also considered control internal to the test |
|                 |     kit.                                            |
|                 |                                                     |
|                 | -   These control samples internal to the kit       |
|                 |     should be test in the same way as client        |
|                 |     samples.                                        |
+-----------------+-----------------------------------------------------+
| **TRANSITION**  | STATE Even though the kit supplies internal         |
|                 | controls, other non-kit controls from external      |
|                 | sources must also be tested to validate the kit     |
|                 | itself. This applies to all types of kits.          |
+-----------------+-----------------------------------------------------+
| ![](me          | Customize these two slides with in-country          |
| dia/image3.wmf) | information such as where the external control      |
| {width="0.49166 | materials come from, and the designated frequencies |
| 666666666664in" | for testing control samples.                        |
| heigh           |                                                     |
| t="0.4416666666 |                                                     |
| 6666665in"}***C |                                                     |
| ustomization*** |                                                     |
|                 |                                                     |
| ***Notes***     |                                                     |
|                 |                                                     |
| **10-11**       |                                                     |
+-----------------+-----------------------------------------------------+
| **10**          | **[Sources of External Quality Control              |
|                 | Samples]{.underline}**                              |
|                 |                                                     |
|                 | STATE that external controls may either be obtained |
|                 | from commercial manufacturers, or from another      |
|                 | laboratory that has prepared validated quality      |
|                 | control samples in-house.                           |
|                 |                                                     |
|                 | STATE It is important to [store controls            |
|                 | appropriately.]{.underline} For controls obtained   |
|                 | commercially, it is important to store according to |
|                 | the manufacturer instructions. For in-house         |
|                 | prepared controls, these should be refrigerated     |
|                 | upon receipt                                        |
|                 |                                                     |
|                 | EMPHASIZE the following points for both types of    |
|                 | controls.                                           |
|                 |                                                     |
|                 | -   Label vial with date when first used            |
|                 |                                                     |
|                 | ```{=html}                                          |
|                 | <!-- -->                                            |
|                 | ```                                                 |
|                 | -   Test before expiry date                         |
|                 |                                                     |
|                 | -   Take care as to not contaminate the control     |
|                 |     materials.                                      |
+-----------------+-----------------------------------------------------+
| ![](m           | When teaching laboratory technicians, consider      |
| edia/image2.gif | adding the following content.                       |
| ){width="0.4479 |                                                     |
| 166666666667in" | STATE:                                              |
| height="0.54166 |                                                     |
| 66666666666in"} | -   Regardless of where external control materials  |
| ***TIPS***      |     come from, it is important to have procedures   |
|                 |     and logistics in place for a regular and        |
|                 |     ongoing supply of controls to all testing       |
|                 |     sites.                                          |
|                 |                                                     |
|                 | EXPLAIN:                                            |
|                 |                                                     |
|                 | -   The process for requesting supply of control    |
|                 |     materials                                       |
|                 |                                                     |
|                 | -   How the batches of control materials are        |
|                 |     transported to the testing sites                |
|                 |                                                     |
|                 | -   How often controls are transported              |
|                 |                                                     |
|                 | -   Who should be contacted if a problem arises     |
|                 |     with the controls                               |
+-----------------+-----------------------------------------------------+
| **11**          | **[Frequency of Use: When Should You Test External  |
|                 | Control Samples?]{.underline}**                     |
|                 |                                                     |
|                 | EXPLAIN the key points on the slide. At a minimum,  |
|                 | controls should be tested:                          |
|                 |                                                     |
|                 | -   Once a week                                     |
|                 |                                                     |
|                 | -   When a new shipment of control materials or     |
|                 |     test kits are received at the testing site      |
|                 |                                                     |
|                 | -   Beginning of a new lot number                   |
|                 |                                                     |
|                 | ```{=html}                                          |
|                 | <!-- -->                                            |
|                 | ```                                                 |
|                 | -   Most kits do not require refrigeration, but     |
|                 |     some (such as Capillus) do. If these kits have  |
|                 |     been stored under non-refrigeration             |
|                 |     temperatures, then the lot must be tested using |
|                 |     external controls to verify the integrity of    |
|                 |     the test kit.                                   |
+-----------------+-----------------------------------------------------+
| **12**          | **[Invalid Results -- What Do You                   |
|                 | Do?]{.underline}**                                  |
|                 |                                                     |
|                 | EXPLAIN the key points on the slide.                |
|                 |                                                     |
|                 | MAKE SURE everyone is aware of an alternate testing |
|                 | algorithm in the event of repeated invalid on any   |
|                 | one test kit                                        |
+-----------------+-----------------------------------------------------+
| ![](me          | For these two slides, add any other problems,       |
| dia/image3.wmf) | causes and actions that have been observed in your  |
| {width="0.49166 | country, if necessary.                              |
| 666666666664in" |                                                     |
| heigh           |                                                     |
| t="0.4416666666 |                                                     |
| 6666665in"}***C |                                                     |
| ustomization*** |                                                     |
|                 |                                                     |
| ***Notes***     |                                                     |
|                 |                                                     |
| **13-14**       |                                                     |
+-----------------+-----------------------------------------------------+
| **13**          | **[Troubleshooting Invalid Results]{.underline}**   |
|                 |                                                     |
|                 | STATE the problems on the slide.                    |
|                 |                                                     |
|                 | ASK participants what may cause each problem.       |
|                 |                                                     |
|                 | EXPLAIN what may cause the lack of reddish, pink,   |
|                 | or purple line or dot in the control window         |
|                 |                                                     |
|                 | STATE the importance of always following the        |
|                 | Standard Operating Procedure (SOP) for each type of |
|                 | test being used, as the following may differ from   |
|                 | kit to kit:                                         |
|                 |                                                     |
|                 | -   Sample volume -- This may differ from kit to    |
|                 |     kit, and might differ depending on the sample   |
|                 |     type (e.g. whole blood vs. serum).              |
|                 |                                                     |
|                 | -   Buffer volume -- Some kits require different    |
|                 |     volumes of buffer.                              |
|                 |                                                     |
|                 | -   Incubation time -- This time may also differ    |
|                 |     from kit to kit. Always follow the time         |
|                 |     required by the manufacturer.                   |
+-----------------+-----------------------------------------------------+
| **14**          | **[Troubleshooting Invalid Results --               |
|                 | Cont'd]{.underline}**                               |
|                 |                                                     |
|                 | STATE the problems on the slide.                    |
|                 |                                                     |
|                 | ASK participants what may cause each problem.       |
|                 |                                                     |
|                 | EXPLAIN what may cause positive band using negative |
|                 | control (i.e. false positive).                      |
|                 |                                                     |
|                 | ASK participants what may cause the next problem.   |
|                 |                                                     |
|                 | EXPLAIN what may cause an extremely faint control   |
|                 | line                                                |
|                 |                                                     |
|                 | NOTE other potential problems, potential causes,    |
|                 | and actions to take on a flipchart.                 |
+-----------------+-----------------------------------------------------+
| ![](me          | For this slide, reflect possible test outcomes      |
| dia/image3.wmf) | based on country specific testing algorithm.        |
| {width="0.49166 |                                                     |
| 666666666664in" |                                                     |
| heigh           |                                                     |
| t="0.4416666666 |                                                     |
| 6666665in"}***C |                                                     |
| ustomization*** |                                                     |
|                 |                                                     |
| ***Note***      |                                                     |
|                 |                                                     |
| **15**          |                                                     |
+-----------------+-----------------------------------------------------+
| **15**          | **[Possible HIV Test Outcomes: Parallel             |
|                 | Algorithm]{.underline}**                            |
|                 |                                                     |
|                 | REMIND participants that there are a variety of     |
|                 | combinations of outcomes when following a           |
|                 | multi-test algorithm.                               |
+-----------------+-----------------------------------------------------+
| **16**          | **[Exercise #1: Interpreting Rapid Test             |
|                 | Results]{.underline}**                              |
| **Activity**    |                                                     |
|                 | READ the instructions on the slide.                 |
| **5 minutes**   |                                                     |
|                 | ALLOW 3 minutes for the exercise.                   |
|                 |                                                     |
|                 | DEBRIEF the exercise by discussing the correct      |
|                 | answers.                                            |
+-----------------+-----------------------------------------------------+
| ![](me          | Consider replacing the three tests here with tests  |
| dia/image3.wmf) | in your country's algorithm.                        |
| {width="0.49166 |                                                     |
| 666666666664in" |                                                     |
| heigh           |                                                     |
| t="0.4416666666 |                                                     |
| 6666665in"}***C |                                                     |
| ustomization*** |                                                     |
|                 |                                                     |
| ***Notes***     |                                                     |
|                 |                                                     |
| **17**          |                                                     |
+-----------------+-----------------------------------------------------+
| **17**          | **[Exercise #2: Resolving Un-reportable Test        |
|                 | Results]{.underline}**                              |
| **Activity**    |                                                     |
|                 | REFER to the exercise sheet in the participant      |
|                 | manual. EXPLAIN the scenario for this exercise.     |
|                 |                                                     |
|                 | -   Tester received discordant test results from    |
|                 |     test 1 (Determine) and test 2 (Uni-gold).       |
|                 |                                                     |
|                 | -   The algorithm called for a third test (or tie   |
|                 |     breaker) to determine HIV status of patient.    |
+-----------------+-----------------------------------------------------+
| **18**          | **[Exercise #2: Resolving Un-reportable Test        |
|                 | Results]{.underline}**                              |
| **F             |                                                     |
| lipchart**![](m | **[(Cont'd)]{.underline}**                          |
| edia/image1.wmf |                                                     |
| ){width="0.8423 | ASK participants to answer the questions in the     |
| 611111111111in" | exercise.                                           |
| height="0.84236 |                                                     |
| 11111111111in"} | ALLOW 3 minutes for the exercise.                   |
|                 |                                                     |
|                 | DEBRIEF the exercise by discussing the correct      |
|                 | answers.                                            |
|                 |                                                     |
|                 | NOTE their responses on a flipchart.                |
|                 |                                                     |
|                 | ASK participants to think of the role of quality    |
|                 | control in providing confidence with reporting      |
|                 | results and determining actions to take.            |
|                 |                                                     |
|                 | DEBRIEF the discussion by summarizing key learning  |
|                 | points.                                             |
+-----------------+-----------------------------------------------------+
| **19**          | **[Maintaining Quality Control                      |
|                 | Records]{.underline}**                              |
|                 |                                                     |
|                 | EXPLAIN the key points on the slide.                |
+-----------------+-----------------------------------------------------+
| ![](me          | If your country uses a different form from the      |
| dia/image3.wmf) | example provided on the slide for recording and     |
| {width="0.49166 | monitoring quality control results, insert it here. |
| 666666666664in" |                                                     |
| heigh           |                                                     |
| t="0.4416666666 |                                                     |
| 6666665in"}***C |                                                     |
| ustomization*** |                                                     |
|                 |                                                     |
| ***Notes***     |                                                     |
|                 |                                                     |
| **20**          |                                                     |
+-----------------+-----------------------------------------------------+
| **20**          | **[Quality Control Record: An                       |
|                 | Example]{.underline}**                              |
|                 |                                                     |
|                 | EXPLAIN the following points:                       |
|                 |                                                     |
|                 | -   This is one example of the type of record that  |
|                 |     can be kept on site.                            |
|                 |                                                     |
|                 | ```{=html}                                          |
|                 | <!-- -->                                            |
|                 | ```                                                 |
|                 | -   During a review of QC results, it is easier to  |
|                 |     have one log of all QC results rather than      |
|                 |     going from page to page in a logbook.           |
|                 |                                                     |
|                 | -   A format such as this also provides an easy     |
|                 |     glance at consistent frequency in testing QC    |
|                 |     samples, and readily identification of          |
|                 |     problems.                                       |
+-----------------+-----------------------------------------------------+
| **21**          | **[Periodic Review of Records]{.underline}**        |
|                 |                                                     |
|                 | STATE that QC results must be reviewed              |
|                 | periodically. WHY? For early detection of problems  |
|                 |                                                     |
|                 | -   As indicated, daily review before accepting     |
|                 |     results, and weekly or monthly review by site   |
|                 |     supervisor.                                     |
|                 |                                                     |
|                 | -   QC results will also be reviewed by any         |
|                 |     external assessment or audit visits.            |
|                 |                                                     |
|                 | -   Keep in mind that if problems are detected,     |
|                 |     corrective actions must be immediately taken.   |
+-----------------+-----------------------------------------------------+
| **22-23**       | **[Summary]{.underline}**                           |
|                 |                                                     |
|                 | ASK participants to answer the questions on the     |
|                 | slide.                                              |
|                 |                                                     |
|                 | ANSWER any questions participants may have.         |
+-----------------+-----------------------------------------------------+