**Module 13: External Quality Assessment -- On-site Evaluation and
Re-testing**

+----------------+-----------------------------------------------------+
| **Purpose**    | To provide participants an overview of External     |
|                | Quality Assessment with focus on on-site evaluation |
|                | and re-testing.                                     |
+----------------+-----------------------------------------------------+
| **P            | -   Module 5: Assuring the Quality of HIV Rapid     |
| re-requisite** |     Testing                                         |
|                |                                                     |
| **Modules**    |                                                     |
+----------------+-----------------------------------------------------+
| **Module       | 1 hour 30 minutes                                   |
| Time**         |                                                     |
+----------------+-----------------------------------------------------+
| **Learning     | At the end of this module, participants will be     |
| Objectives**   | able to:                                            |
|                |                                                     |
|                | -   Assess operations at test site to determine if  |
|                |     quality requirements are met                    |
|                |                                                     |
|                | -   Take corrective actions following External      |
|                |     Quality Assessment (EQA)                        |
|                |                                                     |
|                | -   Keep appropriate records related to EQA         |
|                |                                                     |
|                | -   Avoid common problems associated with EQA       |
|                |     specimen management                             |
+----------------+-----------------------------------------------------+

**Module Overview**

+-----+-------+--------------+---------------------+-------------------+
| **  | **T   | **Activ      | **Content**         | **Resources\      |
| Ste | ime** | ity/Method** |                     | Needed**          |
| p** |       |              |                     |                   |
+-----+-------+--------------+---------------------+-------------------+
| **  | 3 min | >            | Module introduction | Slides 1-4        |
| 1** |       | Presentation |                     |                   |
+-----+-------+--------------+---------------------+-------------------+
| **  | 7 min | >            | EQA: what, why,     | Slide 5-9         |
| 2** |       | Presentation | responsibilities    |                   |
|     |       | >            |                     |                   |
|     |       | > Discussion |                     |                   |
+-----+-------+--------------+---------------------+-------------------+
| **  | 15    | >            | EQA methods         | Slides 10-18      |
| 3** | min   | Presentation |                     |                   |
|     |       | >            |                     |                   |
|     |       | > Discussion |                     |                   |
+-----+-------+--------------+---------------------+-------------------+
| **  | 20min | >            | Implementing        | Slides 19-30      |
| 4** |       | Presentation | on-site evaluation  |                   |
|     |       | >            |                     |                   |
|     |       | > Discussion |                     |                   |
+-----+-------+--------------+---------------------+-------------------+
| **  | 30    | > Role play  | On-site evaluation  | Slides 31         |
| 5** | min   |              | visit               |                   |
+-----+-------+--------------+---------------------+-------------------+
| **  | 10    | >            | Implementing        | Slides 32-40      |
| 6** | min   | Presentation | re-testing          |                   |
|     |       | >            |                     |                   |
|     |       | > Discussion |                     |                   |
+-----+-------+--------------+---------------------+-------------------+
| **  | 5 min | > Q&A        | Summary             | Slide 41          |
| 7** |       |              |                     |                   |
+-----+-------+--------------+---------------------+-------------------+

**Material/Equipment Checklists**

-   PowerPoint slides or transparencies

-   Overhead projector or computer w/LCD projector

-   Prepared Flipchart -- content outline

-   Handouts:

    -   [Corrective Action Form]{.underline}

    -   [On-site Evaluation Checklist]{.underline}

    -   [Example Specimen Transfer Log for Re-Testing]{.underline}

**Teaching Guide**

+-----------------+-----------------------------------------------------+
| **Slide         | **Teaching Points**                                 |
| Number**        |                                                     |
+=================+=====================================================+
| ![](me          | Customize the module according to the participants' |
| dia/image1.wmf) | job positions and responsibilities (management      |
| {width="0.49166 | versus testing personnel). The icons at the bottom  |
| 666666666664in" | of each slide indicate suggested audiences.         |
| heigh           |                                                     |
| t="0.4416666666 | Other modifications are also required throughout    |
| 6666665in"}***C | the module to provide specific information on       |
| ustomization*** | in-country EQA program                              |
|                 |                                                     |
| ***Notes***     |                                                     |
+-----------------+-----------------------------------------------------+
| **1**           | **[Module 13: EQA (On-site Evaluation and           |
|                 | Re-Testing)]{.underline}**                          |
|                 |                                                     |
|                 | DISPLAY this slide before you begin the module.     |
|                 | Make sure participants are aware of the transition  |
|                 | into a new module.                                  |
+-----------------+-----------------------------------------------------+
| **2**           | **[The Quality System]{.underline}**                |
|                 |                                                     |
|                 | REMIND participants that EQA is a component of the  |
|                 | Laboratory Quality System.                          |
|                 |                                                     |
|                 | -   This is a graphic illustrating the essential    |
|                 |     elements of a laboratory quality system.        |
|                 |                                                     |
|                 | ```{=html}                                          |
|                 | <!-- -->                                            |
|                 | ```                                                 |
|                 | -   EQA methods comprise both Process Control and   |
|                 |     Assessment.                                     |
+-----------------+-----------------------------------------------------+
| **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             | WRITE the content outline on a flipchart prior to   |
| lipchart**![](m | training.                                           |
| edia/image2.wmf |                                                     |
| ){width="0.8423 | REFER to it frequently to orient participants to    |
| 611111111111in" | where they are in the module.                       |
| height="0.84236 |                                                     |
| 11111111111in"} |                                                     |
+-----------------+-----------------------------------------------------+
| **5**           | **[External Quality Assessment (EQA):               |
|                 | Definition]{.underline}**                           |
|                 |                                                     |
|                 | STATE the definition of EQA on the slide.           |
+-----------------+-----------------------------------------------------+
| **6**           | **[Why EQA?]{.underline}**                          |
|                 |                                                     |
|                 | EXPLAIN the points on the slide.                    |
|                 |                                                     |
|                 | -   Results may be compared between laboratories    |
|                 |     offering not only an opportunity for            |
|                 |     performances checks, but an opportunity to      |
|                 |     systematically identify problems with kits or   |
|                 |     operations.                                     |
|                 |                                                     |
|                 | -   Training needs may be identified and evaluated. |
+-----------------+-----------------------------------------------------+
| ![](me          | Modify the next three slides according to in        |
| dia/image1.wmf) | --country EQA process, structure, roles and         |
| {width="0.49166 | responsibilities.                                   |
| 666666666664in" |                                                     |
| heigh           |                                                     |
| t="0.4416666666 |                                                     |
| 6666665in"}***C |                                                     |
| ustomization*** |                                                     |
|                 |                                                     |
| ***Notes***     |                                                     |
|                 |                                                     |
| **7-9**         |                                                     |
+-----------------+-----------------------------------------------------+
| **7**           | **[EQA: Conducted at Three Levels]{.underline}**    |
|                 |                                                     |
|                 | PROVIDE the following points:                       |
|                 |                                                     |
|                 | -   For EQA program to be effective, the Ministry   |
|                 |     of Health must establish an organizational      |
|                 |     structure and assign responsibility to assure   |
|                 |     that on-site monitoring occurs in all           |
|                 |     locations.                                      |
|                 |                                                     |
|                 | -   In most countries, the National Reference       |
|                 |     Laboratory (NRL) has overall oversight          |
|                 |     responsibility. However, to have better reach   |
|                 |     in meeting the needs of rural test sites or     |
|                 |     points of service, this may be best             |
|                 |     accomplished with oversight by provincial labs. |
+-----------------+-----------------------------------------------------+
| **8**           | **[Management Responsibilities: An                  |
|                 | Overview]{.underline}**                             |
|                 |                                                     |
|                 | PROVIDE the following explanations:                 |
|                 |                                                     |
|                 | -   Someone of authority must take responsibility   |
|                 |     for EQA. If job titles are not the same as      |
|                 |     those on the slide, then tasks should be        |
|                 |     accomplished by designated individuals.         |
|                 |                                                     |
|                 | -   Management must designate a staff member with   |
|                 |     the responsibility to establish and implement   |
|                 |     the EQA program.                                |
|                 |                                                     |
|                 | -   Management will determine how and when they are |
|                 |     advised of the outcomes of the EQA program. The |
|                 |     best way to ensure EQA reports are reviewed by  |
|                 |     management is by including them as an agenda    |
|                 |     item in management review meetings.             |
|                 |                                                     |
|                 | -   Ideally the person conducting the on-site visit |
|                 |     should have an understanding of the Quality     |
|                 |     Management System, knowledge of testing         |
|                 |     technologies, ability to analyze situations and |
|                 |     good communication skills.                      |
+-----------------+-----------------------------------------------------+
| **9**           | **[Testing Personnel's                              |
|                 | Responsibilities]{.underline}**                     |
|                 |                                                     |
|                 | EXPLAIN the points on the slide.                    |
+-----------------+-----------------------------------------------------+
| **10**          | **[EQA Methods]{.underline}**                       |
|                 |                                                     |
|                 | STATE there are three main EQA methods:             |
|                 |                                                     |
|                 | -   Proficiency testing (PT)                        |
|                 |                                                     |
|                 | -   On-site evaluation, which is sometimes referred |
|                 |     to as on-site monitoring visits or audits       |
|                 |                                                     |
|                 | -   Rechecking or retesting of specimens            |
|                 |                                                     |
|                 | CLARIFY that:                                       |
|                 |                                                     |
|                 | -   This module will focus primarily on on-site     |
|                 |     evaluation and re-testing.                      |
|                 |                                                     |
|                 | -   Proficiency panel may be used during on-site    |
|                 |     visits.                                         |
+-----------------+-----------------------------------------------------+
| **11**          | **[What is Proficiency Testing?]{.underline}**      |
|                 |                                                     |
|                 | EXPLAIN proficiency testing by STATING the points   |
|                 | on the slide.                                       |
+-----------------+-----------------------------------------------------+
| **12**          | **[What is On-site Evaluation?]{.underline}**       |
|                 |                                                     |
|                 | EXPLAIN on-site evaluation:                         |
|                 |                                                     |
|                 | -   On-site evaluation provides a realistic picture |
|                 |     of laboratory practices.                        |
|                 |                                                     |
|                 | -   It also provides a means for assisting with     |
|                 |     problem areas.                                  |
|                 |                                                     |
|                 | EMPHASIZE the point that these visits should be     |
|                 | instructional rather than punitive.                 |
+-----------------+-----------------------------------------------------+
| **13**          | **[What is On-site Evaluation? --                   |
|                 | Cont'd]{.underline}**                               |
|                 |                                                     |
|                 | EXPLAIN further that the main purpose of on-site    |
|                 | visits is to observe the testing site under routine |
|                 | conditions in order to check that it is meeting     |
|                 | quality requirements.                               |
+-----------------+-----------------------------------------------------+
| **14**          | **[What is Re-testing?]{.underline}**               |
|                 |                                                     |
|                 | EXPLAIN re-testing.                                 |
+-----------------+-----------------------------------------------------+
| **15**          | **[EQA Should Lead to Corrective                    |
|                 | Actions]{.underline}**                              |
|                 |                                                     |
|                 | DEFINE corrective action as an action taken to      |
|                 | correct a problem or non-conformance within the     |
|                 | QMS.                                                |
|                 |                                                     |
|                 | PROVIDE examples of a non-conformance:              |
|                 |                                                     |
|                 | -   Production of an incorrect result               |
|                 |                                                     |
|                 | -   Any step within a process which contributed to  |
|                 |     an incorrect result                             |
|                 |                                                     |
|                 | -   When the documented quality system is not       |
|                 |     followed exactly as intended                    |
|                 |                                                     |
|                 | -   When the quality system does not meet the       |
|                 |     requirements of quality standards or            |
|                 |     requirements                                    |
+-----------------+-----------------------------------------------------+
| **16**          | **[Problems May Occur Throughout the Testing        |
|                 | Process]{.underline}**                              |
|                 |                                                     |
|                 | EXPLAIN the following points:                       |
|                 |                                                     |
|                 | -   The problems may lie anywhere in the testing    |
|                 |     process.                                        |
|                 |                                                     |
|                 | ```{=html}                                          |
|                 | <!-- -->                                            |
|                 | ```                                                 |
|                 | -   The integrity of the specimen may have been     |
|                 |     compromised during preparation, shipping or     |
|                 |     after receipt by improper storage or handling   |
|                 |                                                     |
|                 | EMPHASIZE the following points:                     |
|                 |                                                     |
|                 | -   Most problems occur in the pre and post         |
|                 |     analytic phase of testing.                      |
|                 |                                                     |
|                 | ```{=html}                                          |
|                 | <!-- -->                                            |
|                 | ```                                                 |
|                 | -   Due to the numbers of specimens collected and   |
|                 |     transported by various test sites, care must be |
|                 |     taken to ensure proper transcription of data    |
|                 |     throughout the testing process                  |
+-----------------+-----------------------------------------------------+
| **17**          | **[Take Corrective Actions]{.underline}**           |
|                 |                                                     |
|                 | EXPLAIN the points on the slide.                    |
+-----------------+-----------------------------------------------------+
| **18**          | **[Sample Corrective Action Form]{.underline}**     |
|                 |                                                     |
|                 | REFER participants to the form in the participant   |
|                 | manual.                                             |
+-----------------+-----------------------------------------------------+
| **19**          | **[How To Implement EQA]{.underline}**              |
|                 |                                                     |
|                 | STATE:                                              |
|                 |                                                     |
|                 | -   This module focuses on on-site evaluation and   |
|                 |     re-testing processes.                           |
|                 |                                                     |
|                 | ```{=html}                                          |
|                 | <!-- -->                                            |
|                 | ```                                                 |
|                 | -   We will discuss implementation of on-site       |
|                 |     evaluation next.                                |
+-----------------+-----------------------------------------------------+
| **20**          | **[On-Site Evaluation Process]{.underline}**        |
|                 |                                                     |
|                 | PROVIDE an overview of the on-site evaluation       |
|                 | process.                                            |
|                 |                                                     |
|                 | NOTE: For testers -- EMPHASIZE they should          |
|                 | understand the process for how the visits will be   |
|                 | conducted. This will assist them in preparing for a |
|                 | productive visit.                                   |
+-----------------+-----------------------------------------------------+
| ![](me          | The form on the slide is an example of a checklist  |
| dia/image1.wmf) | that can be used to assess the site's quality       |
| {width="0.49166 | system. Countries may need to adapt this checklist  |
| 666666666664in" | to include specific country requirements reflecting |
| heigh           | national policy.                                    |
| t="0.4416666666 |                                                     |
| 6666665in"}***C |                                                     |
| ustomization*** |                                                     |
|                 |                                                     |
| ***Notes***     |                                                     |
|                 |                                                     |
| **21**          |                                                     |
+-----------------+-----------------------------------------------------+
| **21**          | **[On-Site Evaluation Checklist]{.underline}**      |
|                 |                                                     |
|                 | REFER participants to the form in the participant   |
|                 | manual.                                             |
|                 |                                                     |
|                 | DISCUSS each section of the form.                   |
+-----------------+-----------------------------------------------------+
| ![](me          | Customize the slide to reflect standard operating   |
| dia/image1.wmf) | procedures, or additional tasks that are            |
| {width="0.49166 | site-specific for ensuring a productive visit.      |
| 666666666664in" |                                                     |
| heigh           |                                                     |
| t="0.4416666666 |                                                     |
| 6666665in"}***C |                                                     |
| ustomization*** |                                                     |
|                 |                                                     |
| ***Notes***     |                                                     |
|                 |                                                     |
| **22**          |                                                     |
+-----------------+-----------------------------------------------------+
| **22**          | **[Tester Responsibilities: Ensuring a Productive   |
|                 | Site Visit]{.underline}**                           |
|                 |                                                     |
|                 | EMPHASIZE testers play an important role in         |
|                 | ensuring a productive site visit.                   |
|                 |                                                     |
|                 | HIGHLIGHT the tasks the testers should perform      |
|                 | before, during and after the visit.                 |
|                 |                                                     |
|                 | EMPHASIZE the need to take corrective actions,      |
|                 | immediately, if any are identified. This will help  |
|                 | ensure the continued quality of testing.            |
+-----------------+-----------------------------------------------------+
| **23**          | [**On-site Evaluation:**  **Pre-Evaluation          |
|                 | Preparation**]{.underline}                          |
|                 |                                                     |
|                 | EXPLAIN the points on the slide:                    |
|                 |                                                     |
|                 | -   Someone should take responsibility for          |
|                 |     preparing for onsite visits                     |
|                 |                                                     |
|                 | -   A team consisting of both program and           |
|                 |     laboratory staff should collectively plan for   |
|                 |     and conduct the on-site visit. Doing so will    |
|                 |     provide a comprehensive view of the testing     |
|                 |     site, and will prevent vertical assessments.    |
|                 |                                                     |
|                 | -   Appropriate training should be provided for     |
|                 |     those who will serve as assessors.              |
+-----------------+-----------------------------------------------------+
| **24**          | [**On-site Evaluation:**  **Pre-Evaluation          |
|                 | Preparation**]{.underline}                          |
|                 |                                                     |
|                 | STATE the recommended frequency for site visits are |
|                 | referenced in the Guidelines for Applying Quality   |
|                 | Systems to HIV Rapid Testing developed through a    |
|                 | consensus process in Johannesburg, May 2004.        |
|                 |                                                     |
|                 | EXPLAIN frequency of the visit may be determined by |
|                 | a number of factors:                                |
|                 |                                                     |
|                 | -   Previous results where problems or deficiencies |
|                 |     have been noted, due to complaint or follow-up  |
|                 |                                                     |
|                 | -   Number of trained assessors                     |
|                 |                                                     |
|                 | -   Minimum frequency 2x year for established sites |
|                 |                                                     |
|                 | -   Quarterly for new sites                         |
|                 |                                                     |
|                 | EXPLAIN advantages and disadvantages for            |
|                 | unannounced visits.                                 |
|                 |                                                     |
|                 | -   Announcing the date of the visit will ensure    |
|                 |     that relevant staff will be present during the  |
|                 |     visit.                                          |
|                 |                                                     |
|                 | ```{=html}                                          |
|                 | <!-- -->                                            |
|                 | ```                                                 |
|                 | -   Unannounced visits will most likely give you a  |
|                 |     true picture of routine practice. These         |
|                 |     unscheduled visits aim to fix the problem and   |
|                 |     improve the system to prevent recurrence.       |
|                 |                                                     |
|                 | STATE evaluation visits may be conducted in         |
|                 | response to a problem within the system. Schedule   |
|                 | evaluation visits during a time that will minimize  |
|                 | disruption of services                              |
+-----------------+-----------------------------------------------------+
| **25**          | [**On-site Evaluation:**  **Entrance                |
|                 | Interview**]{.underline}                            |
|                 |                                                     |
|                 | EXPLAIN the points on the slide.                    |
+-----------------+-----------------------------------------------------+
| **26**          | [**On-site Evaluation:**  **Information             |
|                 | Gathering**]{.underline}                            |
|                 |                                                     |
|                 | PROIVDE the following points:                       |
|                 |                                                     |
|                 | -   It is important to gather information in an     |
|                 |     organized, consistent manner to make decisions  |
|                 |     about the site's quality system.                |
|                 |                                                     |
|                 | -   Try to minimize disruption to the work flow of  |
|                 |     testing site for your information gathering     |
|                 |     effort.                                         |
|                 |                                                     |
|                 | -   Observation of test performance. This may be    |
|                 |     accomplished by observing staff performing      |
|                 |     actual patient/client testing, or by use of     |
|                 |     proficiency panel comprised of 5-10 specimens.  |
|                 |     Site assessors should plan in advance to arrive |
|                 |     at site with proficiency panel. Provision of    |
|                 |     proficiency panel is the responsibility of      |
|                 |     reference labs.                                 |
|                 |                                                     |
|                 | ```{=html}                                          |
|                 | <!-- -->                                            |
|                 | ```                                                 |
|                 | -   At all times, respect patient privacy and       |
|                 |     confidentiality                                 |
+-----------------+-----------------------------------------------------+
| **27**          | [**On-site Evaluation:**  **Outcome**               |
|                 | **Assessment**]{.underline}                         |
|                 |                                                     |
|                 | EXPLAIN the decision algorithm in the slide.        |
|                 |                                                     |
|                 | Further EXPLAIN if problems are detected, the       |
|                 | assessor should determine the impact of the problem |
|                 | in relation to patient test outcome.                |
|                 |                                                     |
|                 | -   Does the problem result in inaccurate test      |
|                 |     results?                                        |
|                 |                                                     |
|                 | -   Does the problem result in a high probability   |
|                 |     of inaccurate test results?                     |
|                 |                                                     |
|                 | ```{=html}                                          |
|                 | <!-- -->                                            |
|                 | ```                                                 |
|                 | -   Is immediate corrective action necessary?       |
+-----------------+-----------------------------------------------------+
| **28**          | **[On-Site Evaluation:  Exit                        |
|                 | Conference]{.underline}**                           |
|                 |                                                     |
|                 | EXPLAIN the procedure in conducting an exit         |
|                 | conference.                                         |
+-----------------+-----------------------------------------------------+
| **29**          | **[On-site Evaluation:  Reporting]{.underline}**    |
|                 |                                                     |
|                 | EXPLAIN the points on the slide.                    |
|                 |                                                     |
|                 | ADD each country should determine who should        |
|                 | receive the report. It is recommended that the      |
|                 | report be submitted to Quality Manager, Site        |
|                 | Manager, Program Manger, or MoH.                    |
+-----------------+-----------------------------------------------------+
| ![](me          | Provide a real assessment report from a visit       |
| dia/image1.wmf) | actually performed in your country.                 |
| {width="0.49166 |                                                     |
| 666666666664in" |                                                     |
| heigh           |                                                     |
| t="0.4416666666 |                                                     |
| 6666665in"}***C |                                                     |
| ustomization*** |                                                     |
|                 |                                                     |
| ***Notes***     |                                                     |
|                 |                                                     |
| **30**          |                                                     |
+-----------------+-----------------------------------------------------+
| **30**          | **[Sample Assessment Report]{.underline}**          |
|                 |                                                     |
|                 | REFER participants to the Sample Assessment Report  |
|                 | in the participant manual.                          |
|                 |                                                     |
|                 | DISCUSS each section of the report, including       |
|                 | subsequent actions required by the tester.          |
+-----------------+-----------------------------------------------------+
| **31**          | **[Role Play: On-site Evaluation                    |
|                 | Visit]{.underline}**                                |
| **Role Play**   |                                                     |
|                 | FOLLOW the procedure below when conducting the role |
| **30 minutes**  | play:                                               |
|                 |                                                     |
|                 | > INFORM participants that they are going to have a |
|                 | > role play.                                        |
|                 | >                                                   |
|                 | > POINT OUT the instructions on the slide.          |
|                 | >                                                   |
|                 | > ASSIGN roles to four volunteers (or pre-selected  |
|                 | > prior to the role play).                          |
|                 |                                                     |
|                 | DEBRIEF the role play by asking:                    |
|                 |                                                     |
|                 | -   What did you observe?                           |
|                 |                                                     |
|                 | -   What did you learn?                             |
+-----------------+-----------------------------------------------------+
| ![](me          | Role Play Scenarios                                 |
| dia/image1.wmf) |                                                     |
| {width="0.49166 | These are examples of the kinds of situations that  |
| 666666666664in" | may be observed. Edit this list to reflect actual   |
| heigh           | situations that have been encountered within        |
| t="0.4416666666 | country.                                            |
| 6666665in"}***C |                                                     |
| ustomization*** | -   Improper workstation setup                      |
|                 |                                                     |
| ***Notes***     | -   Possible things to observe leading to problem   |
|                 |     areas:                                          |
| **31**          |                                                     |
|                 | -   Cell phone ringing while conducting testing     |
|                 |                                                     |
|                 | -   Used lancet on floor -- missed placing in       |
|                 |     discard bin                                     |
|                 |                                                     |
|                 | -   Time for test cut short...in hurry to go home   |
|                 |                                                     |
|                 | -   Missing or incomplete test records              |
|                 |                                                     |
|                 | -   Missing temperature logs                        |
|                 |                                                     |
|                 | -   Improper performance of test                    |
|                 |                                                     |
|                 | -   Breaching confidentiality                       |
+-----------------+-----------------------------------------------------+
| **32**          | **[How To Implement EQA]{.underline}**              |
|                 |                                                     |
|                 | TRANSITION to discussion of re-testing.             |
+-----------------+-----------------------------------------------------+
| **33**          | **[Issues to Consider Prior to Implementing a       |
|                 | Re-testing Program]{.underline}**                   |
|                 |                                                     |
|                 | STATE the points on the slide.                      |
+-----------------+-----------------------------------------------------+
| **34**          | **[Statistical Basis for Re-testing: Error          |
|                 | Detection]{.underline}**                            |
|                 |                                                     |
|                 | PROVIDE the following points:                       |
|                 |                                                     |
|                 | -   This chart is an excerpt from the CDC/WHO       |
|                 |     Guidelines for applying quality systems to HIV  |
|                 |     rapid testing. The purpose here is to           |
|                 |     illustrate the number of specimens that will    |
|                 |     need to be re-tested to statistically detect 1  |
|                 |     or 5% error at the 95% confidence level.        |
|                 |                                                     |
|                 | -   If re-testing is to be one of the EQA methods,  |
|                 |     it must be based upon statistical               |
|                 |     considerations.                                 |
|                 |                                                     |
|                 | ```{=html}                                          |
|                 | <!-- -->                                            |
|                 | ```                                                 |
|                 | -   Countries must realize the numbers of specimens |
|                 |     for re-testing will quickly overwhelm the       |
|                 |     reference laboratory.                           |
|                 |                                                     |
|                 | ```{=html}                                          |
|                 | <!-- -->                                            |
|                 | ```                                                 |
|                 | -   Outcome of re-testing must be analyzed for      |
|                 |     effective and timely feedback.                  |
+-----------------+-----------------------------------------------------+
| **35**          | **[Re-testing: Example Sampling Plan]{.underline}** |
|                 |                                                     |
|                 | STATE the following:                                |
|                 |                                                     |
|                 | This slide provides an example of how to determine  |
|                 | your sampling plan, given a specified time period.  |
|                 |                                                     |
|                 | 1.  Determine number of specimens required to       |
|                 |     detect specific error detection rate over a one |
|                 |     month time period                               |
|                 |                                                     |
|                 | 2.  For 1% error detection rate, 225 specimens will |
|                 |     need to be re-tested.                           |
|                 |                                                     |
|                 | 3.  How many specimens must then be collected per   |
|                 |     week and per day? Approximately 50 specimens    |
|                 |     per week, or approximately 11 specimens per day |
|                 |                                                     |
|                 | EMPHASIZE specimens MUST be collected randomly.     |
|                 | Every effort should be made to avoid systematic     |
|                 | sampling bias.                                      |
+-----------------+-----------------------------------------------------+
| **36**          | **[Re-testing Process]{.underline}**                |
|                 |                                                     |
|                 | STATE the re-testing process on the slide.          |
+-----------------+-----------------------------------------------------+
| **37**          | **[Tester Responsibilities:                         |
|                 | Re-Testing]{.underline}**                           |
|                 |                                                     |
|                 | EMPHASIZE the points on the slide.                  |
+-----------------+-----------------------------------------------------+
| **38**          | **[Specimen Requirements]{.underline}**             |
|                 |                                                     |
|                 | STATE the points on the slide.                      |
|                 |                                                     |
|                 | EMPHAZIE all specimens should be properly labeled.  |
|                 | At a minimum, include specimen identification       |
|                 | number and date of collection.                      |
+-----------------+-----------------------------------------------------+
| ![](me          | This form is an example of information that needs   |
| dia/image1.wmf) | to be captured for transferring EQA specimens to a  |
| {width="0.49166 | reference laboratory. Replace this form, if         |
| 666666666664in" | necessary, to reflect standard operating            |
| heigh           | procedures.                                         |
| t="0.4416666666 |                                                     |
| 6666665in"}***C |                                                     |
| ustomization*** |                                                     |
|                 |                                                     |
| ***Notes***     |                                                     |
|                 |                                                     |
| **39**          |                                                     |
+-----------------+-----------------------------------------------------+
| **39**          | **[EQA Specimen Transfer Log]{.underline}**         |
|                 |                                                     |
|                 | REFER participants to EQA Specimen Transfer Log in  |
|                 | the participant manual.                             |
|                 |                                                     |
|                 | INSTRUCT participants on how to complete the form.  |
+-----------------+-----------------------------------------------------+
| **40**          | **[Specimen Management : Common                     |
|                 | Problems]{.underline}**                             |
|                 |                                                     |
|                 | EXPLAIN the points on the slide.                    |
|                 |                                                     |
|                 | ADD:                                                |
|                 |                                                     |
|                 | -   Given the volume of specimens that may be       |
|                 |     required for re-testing, care must be taken to  |
|                 |     avoid errors that may occur in the pre-analytic |
|                 |     and post-analytic phase of testing.             |
|                 |                                                     |
|                 | -   Remember -- a test result is only as good as    |
|                 |     the specimen received for testing.              |
+-----------------+-----------------------------------------------------+
|                 | MENTION the next module will cover the skills of    |
|                 | collecting and handling Dry Blood Spots (DBS) as    |
|                 | part of the re-testing process.                     |
+-----------------+-----------------------------------------------------+
| **41**          | **[Summary]{.underline}**                           |
|                 |                                                     |
|                 | ASK participants to answer the questions on the     |
|                 | slide.                                              |
|                 |                                                     |
|                 | ANSWER any questions participants may have.         |
+-----------------+-----------------------------------------------------+