**Module 5: Assuring the Quality of HIV Rapid Testing --**

**A Systems Approach to Quality**

+----------------+-----------------------------------------------------+
| **Purpose**    | To provide an overview of the lab quality system so |
|                | that participants will adopt a broad systems view   |
|                | toward quality. Furthermore, they will understand   |
|                | where errors may occur in the rapid testing process |
|                | and their responsibilities in preventing and        |
|                | detecting them.                                     |
+----------------+-----------------------------------------------------+
| **P            | None                                                |
| re-requisite** |                                                     |
|                |                                                     |
| **Modules**    |                                                     |
+----------------+-----------------------------------------------------+
| **Module       | 1 hour and 15 minutes                               |
| Time**         |                                                     |
+----------------+-----------------------------------------------------+
| **Learning     | At the end of this module, you will be able to:     |
| Objectives**   |                                                     |
|                | -   Explain the systems approach to lab quality and |
|                |     its benefits                                    |
|                |                                                     |
|                | -   Identify the essential elements of a lab        |
|                |     quality system and how they apply to HIV rapid  |
|                |     testing                                         |
|                |                                                     |
|                | -   Recognize key factors that may compromise the   |
|                |     quality of HIV rapid testing                    |
|                |                                                     |
|                | -   Describe your responsibilities in preventing    |
|                |     and detecting errors before, during, and after  |
|                |     testing                                         |
+----------------+-----------------------------------------------------+

**Module Overview**

+-----+-------+------------+---------------------------+--------------+
| **  | **T   | **         | **Content**               | **Resources\ |
| Ste | ime** | Activity/\ |                           | Needed**     |
| p** |       | Method**   |                           |              |
+-----+-------+------------+---------------------------+--------------+
| **  | 5 min | > Pr       | Module introduction       | > Slides     |
| 1** |       | esentation |                           | > 1-4;       |
|     |       |            |                           |              |
|     |       |            |                           | Prepared     |
|     |       |            |                           | flipchart -- |
|     |       |            |                           | content      |
|     |       |            |                           | outline      |
+-----+-------+------------+---------------------------+--------------+
| **  | 5 min | >          | Dining Out: A quality     | Slide 5      |
| 2** |       | Discussion | exercise                  |              |
+-----+-------+------------+---------------------------+--------------+
| **  | 20    | > Pre      | Systems approach to lab   | Slides 6-23  |
| 3** | min   | sentation; | quality                   |              |
|     |       | >          |                           |              |
|     |       | >          |                           |              |
|     |       | Discussion |                           |              |
+-----+-------+------------+---------------------------+--------------+
| **  | 20    | >          | Are you "Positive" or     | Slide 24;    |
| 4** | min   |  Energizer | "Negative?"               |              |
|     |       |            |                           | Cabbage ball |
|     |       |            |                           | ^1^          |
+-----+-------+------------+---------------------------+--------------+
| **  | 5 min | > Pr       | Quality assurance vs.     | Slides 25-27 |
| 5** |       | esentation | quality control           |              |
+-----+-------+------------+---------------------------+--------------+
| **  | 15    | > D        | Preventing and detecting  | Flipchart;   |
| 5** | min   | iscussion; | errors before, during and |              |
|     |       | >          | after testing             | Slide 28-35  |
|     |       | > Pr       |                           |              |
|     |       | esentation |                           |              |
+-----+-------+------------+---------------------------+--------------+
| **  | 5 min | > Q&A      | Summary                   | Slide 36     |
| 6** |       |            |                           |              |
+-----+-------+------------+---------------------------+--------------+

1.  Instructions for constructing the cabbage ball are provided at the
    end of this document.

**Material/Equipment Checklists:**

-   PowerPoint slides or transparencies

-   Overhead projector or computer w/LCD projector

-   Cabbage ball (constructed prior to workshop)

-   Flipchart

**Teaching Guide**

+-----------------+-----------------------------------------------------+
| **Slide         | **Teaching Points**                                 |
| Number**        |                                                     |
+=================+=====================================================+
| **1**           | **[Module 5: Assuring the Quality of HIV Rapid      |
|                 | Testing]{.underline}**                              |
|                 |                                                     |
|                 | DISPLAY this slide before you begin the module.     |
|                 | Make sure participants are aware of the transition  |
|                 | into a new module.                                  |
+-----------------+-----------------------------------------------------+
| **2**           | **[Learning Objectives]{.underline}**               |
|                 |                                                     |
|                 | STATE the objectives on the slide                   |
+-----------------+-----------------------------------------------------+
| **3**           | **[Content Overview]{.underline}**                  |
|                 |                                                     |
|                 | EXPLAIN that these are the topics that will be      |
|                 | covered in this module                              |
|                 |                                                     |
|                 | EMPHASIZE that this module provides an overview of  |
|                 | the quality system and details on specific elements |
|                 | of the quality system.                              |
+-----------------+-----------------------------------------------------+
| **F             | WRITE the content outline on a flipchart prior to   |
| lipchart**![](m | training.                                           |
| edia/image1.wmf |                                                     |
| ){width="0.8423 | REFER to it frequently to orient participants to    |
| 611111111111in" | where they are in the module.                       |
| height="0.84236 |                                                     |
| 11111111111in"} |                                                     |
+-----------------+-----------------------------------------------------+
| **4**           | **[What is "Quality"?]{.underline}**                |
|                 |                                                     |
|                 | STATE the definition on the slide                   |
|                 |                                                     |
|                 | EMPHASIZE that a service would include providing    |
|                 | and interpreting an HIV Rapid Test.                 |
+-----------------+-----------------------------------------------------+
| **5**           | **["Dining Out": A Quality                          |
|                 | Experience]{.underline}**                           |
| **Group         |                                                     |
| Discussion**    | STATE Quality can be evaluated in anything we       |
|                 | experience.                                         |
| **5 minutes**   |                                                     |
|                 | EXPLAIN that you can better understand the concept  |
| **F             | of quality and quality systems, by thinking about   |
| lipchart**![](m | what you might experience at a restaurant:          |
| edia/image1.wmf |                                                     |
| ){width="0.8423 | ASK What you might expect for a quality experience  |
| 611111111111in" | at a restaurant.                                    |
| height="0.84236 |                                                     |
| 11111111111in"} | NOTE participants' responses on a flipchart.        |
|                 |                                                     |
|                 | STATE If your expectations as a customer are met by |
|                 | the restaurant, the restaurant has provided you     |
|                 | with "quality" service.                             |
|                 |                                                     |
|                 | Simply put: Quality Management is having systems in |
|                 | place to continually evaluate:                      |
|                 |                                                     |
|                 | -   What is being done                              |
|                 |                                                     |
|                 | -   How it is being done                            |
|                 |                                                     |
|                 | -   What are opportunities for improvement          |
|                 |                                                     |
|                 | -   How to make changes for improvement             |
|                 |                                                     |
|                 | -   What is the impact of the change/improvement    |
|                 |                                                     |
|                 | ASK participants to keep the restaurant scenario in |
|                 | mind as they view and discuss the following slides. |
+-----------------+-----------------------------------------------------+
| **6**           | **[Why Quality?]{.underline}**                      |
|                 |                                                     |
|                 | EXPLAIN why quality is important:                   |
|                 |                                                     |
|                 | -   Quality at a testing site will result in        |
|                 |     accurate and correct performance of the HIV     |
|                 |     Rapid Test                                      |
|                 |                                                     |
|                 | -   Quality at a testing site will result in        |
|                 |     accurate and reliable test results which are    |
|                 |     essential to all aspects of patient health,     |
|                 |     including prevention, care and treatment        |
+-----------------+-----------------------------------------------------+
| **7**           | **[A Systems Approach to Quality]{.underline}**     |
|                 |                                                     |
|                 | STATE the approach we take to ensure lab quality is |
|                 | a systems approach.                                 |
|                 |                                                     |
|                 | -   A systems approach examines all components in   |
|                 |     the system, not just focusing on any one        |
|                 |     component.                                      |
|                 |                                                     |
|                 | -   A systems approach places as much emphasis on   |
|                 |     identifying and describing the connections      |
|                 |     between system components as on identifying and |
|                 |     describing the components themselves.           |
|                 |                                                     |
|                 | EXPLAIN the concept further by using the human body |
|                 | as an example.                                      |
|                 |                                                     |
|                 | -   A headache may be caused by disorder in other   |
|                 |     parts of the human body system. You need to     |
|                 |     look at other parts to find out what's wrong    |
|                 |     with the head.                                  |
|                 |                                                     |
|                 | -   Similarly, to achieve total quality in the lab  |
|                 |     or testing site, you need to look at all the    |
|                 |     activities, direct or indirect, that may        |
|                 |     contribute to quality.                          |
+-----------------+-----------------------------------------------------+
| **8**           | **[Definition of A Lab Quality                      |
|                 | System]{.underline}**                               |
|                 |                                                     |
|                 | READ the definition on the slide.                   |
|                 |                                                     |
|                 | STATE by adopting the systems approach to lab       |
|                 | quality, a lab quality system would encompass all   |
|                 | activities that contribute to quality directly or   |
|                 | indirectly.                                         |
+-----------------+-----------------------------------------------------+
| **9**           | **[Benefits of a Quality System]{.underline}**      |
|                 |                                                     |
|                 | EXPLAIN the benefits of a quality system to the HIV |
|                 | rapid testing sites.                                |
+-----------------+-----------------------------------------------------+
| **10**          | **[The Lab Quality System]{.underline}**            |
|                 |                                                     |
|                 | STATE a lab quality system has 12 components, each  |
|                 | of which will be explained in further detail.       |
|                 |                                                     |
|                 | POINT OUT the 12 components.                        |
+-----------------+-----------------------------------------------------+
| **F             | REFER to the flipchart from the discussion earlier. |
| lipchart**![](m | Relate each statement to a specific quality system  |
| edia/image1.wmf | essential. For example:                             |
| ){width="0.8423 |                                                     |
| 611111111111in" | -   You notice a government certificate of passed   |
| height="0.84236 |     inspection posted near the entrance             |
| 11111111111in"} |     *(Assessment: external evaluation)*             |
|                 |                                                     |
|                 | -   The reservation you made has been recorded and  |
|                 |     honored (*Information Management; Documents &   |
|                 |     Records)*                                       |
|                 |                                                     |
|                 | -   You are treated courteously by a knowledgeable  |
|                 |     staff (*Personnel: training, supervision;       |
|                 |     Organization: standards, accountability)*       |
|                 |                                                     |
|                 | -   Your order was taken promptly and meal was      |
|                 |     served in a reasonable amount of time (*Process |
|                 |     control)*                                       |
|                 |                                                     |
|                 | -   You ordered a menu item, and the restaurant had |
|                 |     all the necessary ingredients to prepare the    |
|                 |     dish (*Inventory Management)*                   |
|                 |                                                     |
|                 | -   The food was well presented, fresh and          |
|                 |     flavorful *(Inventory management, storage,      |
|                 |     procurement)*                                   |
|                 |                                                     |
|                 | -   Your overcooked steak was promptly replaced     |
|                 |     with a properly cooked steak *(Occurrence       |
|                 |     Management: correcting error; Equipment:        |
|                 |     maintenance, troubleshooting; Customer          |
|                 |     service)*                                       |
|                 |                                                     |
|                 | -   Before paying the bill, you were asked if your  |
|                 |     experience met your expectations and what would |
|                 |     you have liked improved *(Process improvement;  |
|                 |     Organization: commitment to quality,            |
|                 |     standards)*                                     |
+-----------------+-----------------------------------------------------+
| ![](m           | For these 12 slides (lab quality system             |
| edia/image2.gif | components), your teaching should focus on not just |
| ){width="0.4479 | what each component is, but also the                |
| 166666666667in" | cause-and-effect relationships among them. The key  |
| height="0.54166 | message is: ***they are all inter-connected; each   |
| 66666666666in"} | and every component must be present to achieve      |
| ***TIPS***      | total quality in the lab***.                        |
|                 |                                                     |
| **11-22**       | This module is highly conceptual and abstract. Try  |
|                 | to provide as many concrete examples and analogies  |
|                 | as possible.                                        |
+-----------------+-----------------------------------------------------+
| ![](me          | If a lab quality system has been established,       |
| dia/image3.wmf) | provide specific in-country information for each    |
| {width="0.49166 | component of the quality system.                    |
| 666666666664in" |                                                     |
| heigh           |                                                     |
| t="0.4416666666 |                                                     |
| 6666665in"}***C |                                                     |
| ustomization*** |                                                     |
|                 |                                                     |
| ***Notes***     |                                                     |
|                 |                                                     |
| **11-22**       |                                                     |
+-----------------+-----------------------------------------------------+
| **11**          | **[Organization]{.underline}**                      |
|                 |                                                     |
|                 | EXPLAIN organization is the leadership or party     |
|                 | responsible for establishing and managing the       |
|                 | overall quality program. The quality system must    |
|                 | start with the organization.                        |
|                 |                                                     |
|                 | To ensure total lab quality, organization needs to: |
|                 |                                                     |
|                 | -   Create quality policy and standards             |
|                 |                                                     |
|                 | ```{=html}                                          |
|                 | <!-- -->                                            |
|                 | ```                                                 |
|                 | -   Secure sufficient resources to maintain quality |
|                 |     requirements                                    |
|                 |                                                     |
|                 | -   Clearly define roles and accountability         |
|                 |                                                     |
|                 | -   Cultivate a culture committed to quality        |
|                 |                                                     |
|                 | INDICATE this component is closely linked to other  |
|                 | components such as personnel, equipment, process    |
|                 | improvement, and customer service.                  |
+-----------------+-----------------------------------------------------+
| **12**          | **[Personnel]{.underline}**                         |
|                 |                                                     |
|                 | EXPLAIN personnel are the most important component  |
|                 | in the lab quality system because it is linked to   |
|                 | all other components. To achieve total lab quality, |
|                 | we need to have the right people on the right jobs  |
|                 | all motivated and competent to perform. Consider:   |
|                 |                                                     |
|                 | -   Human resource planning -- What skills do you   |
|                 |     need? How many people do you need? When do you  |
|                 |     need them?                                      |
|                 |                                                     |
|                 | -   Hiring -- What is the hiring practice that will |
|                 |     help you attract the right people? It should    |
|                 |     start with a clear job description that defines |
|                 |     duties, responsibilities, and required skills.  |
|                 |                                                     |
|                 | -   Retention -- What is your plan to retain your   |
|                 |     people once they are hired? How are you going   |
|                 |     to address the issue of high turnover?          |
|                 |                                                     |
|                 | -   Supervision -- Supervisors are critical in that |
|                 |     they communicate performance expectations,      |
|                 |     model proper behaviors, provide feedback, and   |
|                 |     motivate the employees. They make sure          |
|                 |     employees have the support required for         |
|                 |     performance, which includes information, tools, |
|                 |     and consultation for problem solving.           |
|                 |                                                     |
|                 | -   Training -- Upon assignment to a testing site,  |
|                 |     staff must be oriented to site polices and      |
|                 |     operations. Due to method changes and frequent  |
|                 |     staff turnover, training must be provided to    |
|                 |     update employee skills. Initial and on-going    |
|                 |     competency assessment is required for all staff |
|                 |     performing testing.                             |
|                 |                                                     |
|                 | -   Performance management -- This entails all the  |
|                 |     activities that ensure an employees on-the-job  |
|                 |     performance. It involves goal setting,          |
|                 |     performance coaching, feedback, monitoring,     |
|                 |     appraisal, and performance improvement          |
|                 |     measures.                                       |
+-----------------+-----------------------------------------------------+
| **13**          | **[Equipment]{.underline}**                         |
|                 |                                                     |
|                 | EXPLAIN equipment used at the HIV rapid testing     |
|                 | site may include refrigerator, freezer, and         |
|                 | precision pipettes. Laboratories that serve as      |
|                 | referral labs for HIV rapid testing site must       |
|                 | ensure that equipment used is appropriate for the   |
|                 | task and kept in optimal working order. This is     |
|                 | achieved by:                                        |
|                 |                                                     |
|                 | -   Selecting the right equipment. The purchasing   |
|                 |     contract should include installation and        |
|                 |     initial calibration; regular service; and       |
|                 |     training to operate the equipment.              |
|                 |                                                     |
|                 | -   Setting up mechanism for regular preventative   |
|                 |     maintenance and routine calibration to ensure   |
|                 |     uninterrupted service and prolonged life span   |
|                 |     of the equipment.                               |
|                 |                                                     |
|                 | -   Ensuring readily available technical expertise  |
|                 |     for timely repair in case of equipment          |
|                 |     breakdown.                                      |
|                 |                                                     |
|                 | -   Stocking up on parts that break frequently      |
|                 |                                                     |
|                 | -   Establishing troubleshooting procedures         |
|                 |                                                     |
|                 | -   Creating a maintenance log and regularly        |
|                 |     reviewing all documentation                     |
|                 |                                                     |
|                 | -   Retiring equipment properly. This involves      |
|                 |     putting up signage, removing from premise, and  |
|                 |     salvaging reusable parts.                       |
|                 |                                                     |
|                 | INDICATE this component is closely linked to other  |
|                 | components such as personnel, purchasing and        |
|                 | inventory, documents and records, and facilities    |
|                 | and safety.                                         |
+-----------------+-----------------------------------------------------+
| **14**          | **[Purchasing and Inventory]{.underline}**          |
|                 |                                                     |
|                 | EXPLAIN purchasing is primarily handled by a        |
|                 | central procurement and inventory process.          |
|                 | Laboratory staff should be involved during the      |
|                 | process of defining criteria for the materials and  |
|                 | supplies needed.                                    |
|                 |                                                     |
|                 | Purchasing and inventory involves:                  |
|                 |                                                     |
|                 | -   Defining criteria for products and services to  |
|                 |     be purchased                                    |
|                 |                                                     |
|                 | -   Establishing a system to receive, inspect,      |
|                 |     accept, store incoming materials                |
|                 |                                                     |
|                 | -   Maintaining proper inventory                    |
|                 |                                                     |
|                 | -   Developing a system to connect materials to     |
|                 |     appropriate patients, activities, or records    |
|                 |                                                     |
|                 |     -   This is important in the event of notices   |
|                 |         from manufacturers of potential problems    |
|                 |         with specific kit lot #.                    |
|                 |                                                     |
|                 |     -   You will know what lot \# was used only if  |
|                 |         this information is recorded.               |
|                 |                                                     |
|                 | INDICATE this component is closely linked to other  |
|                 | components such as organization, process control,   |
|                 | documents and records, and facilities and safety.   |
+-----------------+-----------------------------------------------------+
| **15**          | **[Process Control]{.underline}**                   |
|                 |                                                     |
|                 | EXPLAIN process control.                            |
|                 |                                                     |
|                 | -   Process control refers to the activities and    |
|                 |     techniques performed to ensure:                 |
|                 |                                                     |
|                 |     -   Testing procedures are correctly performed  |
|                 |                                                     |
|                 |     -   The environment is suitable for reliable    |
|                 |         testing                                     |
|                 |                                                     |
|                 |     -   The test kit works as expected to produce   |
|                 |         accurate and reliable results               |
|                 |                                                     |
|                 | -   Process control concerns all aspects of the     |
|                 |     laboratory, not just the testing procedures.    |
|                 |     Examples include ensuring that:                 |
|                 |                                                     |
|                 |     -   Test methods are appropriately evaluated.   |
|                 |                                                     |
|                 |     -   Testing sites have on hand up-to-date       |
|                 |         standard operating procedures.              |
|                 |                                                     |
|                 |     -   All staff follow SOPs (Standard Operating   |
|                 |         Procedures) exactly as written.             |
|                 |                                                     |
|                 |     -   Specimens are appropriately collected,      |
|                 |         handled/processed, stored, transported, and |
|                 |         discarded.                                  |
|                 |                                                     |
|                 |     -   QC (quality control) is performed and       |
|                 |         monitored.                                  |
|                 |                                                     |
|                 | INDICATE this component is closely linked to other  |
|                 | components such as personnel, purchasing and        |
|                 | inventory, assessment, and facilities and safety.   |
+-----------------+-----------------------------------------------------+
| **16**          | **[Documents and Records]{.underline}**             |
|                 |                                                     |
|                 | EXPLAIN document and records may be paper-based or  |
|                 | computer-based. Regardless of the format, a system  |
|                 | must be established in order to:                    |
|                 |                                                     |
|                 | -   Create standards for forms                      |
|                 |                                                     |
|                 | -   Manage document revision, approval, and         |
|                 |     distribution                                    |
|                 |                                                     |
|                 | -   Manage patient test records                     |
|                 |                                                     |
|                 | -   Maintain document storage, retrieval, and       |
|                 |     destruction                                     |
|                 |                                                     |
|                 | INDICATE this component is closely linked to other  |
|                 | components such as purchasing and inventory,        |
|                 | information management, assessment, and occurrence  |
|                 | management.                                         |
+-----------------+-----------------------------------------------------+
| **17**          | **[Information Management]{.underline}**            |
|                 |                                                     |
|                 | EXPLAIN information management refers to these      |
|                 | activities:                                         |
|                 |                                                     |
|                 | -   Manage incoming and outgoing information        |
|                 |                                                     |
|                 | -   Establish standards for gathering information   |
|                 |                                                     |
|                 | -   Ensure the privacy and confidentiality of       |
|                 |     patient information                             |
|                 |                                                     |
|                 | EXPLAIN that these activities can often be          |
|                 | facilitated by computers. If computers are used,    |
|                 | personnel must be trained in relevant computer      |
|                 | skills such as word processing, spreadsheet, and    |
|                 | database.                                           |
|                 |                                                     |
|                 | INDICATE this component is closely linked to other  |
|                 | components such as personnel, documents and         |
|                 | records, and customer service.                      |
+-----------------+-----------------------------------------------------+
| **18**          | [**Occurrence** **Management**]{.underline}         |
|                 |                                                     |
|                 | EXPLAIN occurrence management.                      |
|                 |                                                     |
|                 | -   It deals with lab problems and errors as they   |
|                 |     occur.                                          |
|                 |                                                     |
|                 | -   Examples of occurrences include accidental      |
|                 |     spills or needle injuries.                      |
|                 |                                                     |
|                 | -   There must be a pre-defined approach and system |
|                 |     for dealing with errors.                        |
|                 |                                                     |
|                 |     -   Keep a record of all circumstances related  |
|                 |         to the error or problem.                    |
|                 |                                                     |
|                 |     -   Keep a record of corrective action taken    |
|                 |         and any communications with affected        |
|                 |         persons.                                    |
|                 |                                                     |
|                 |     -   This information is useful for those        |
|                 |         monitoring the testing, for any internal    |
|                 |         audits, and for use if further inquiries    |
|                 |         from patients or physicians occur.          |
|                 |                                                     |
|                 | INDICATE this component is closely linked to other  |
|                 | components such as process control, documents and   |
|                 | records, and customer service.                      |
+-----------------+-----------------------------------------------------+
| **19**          | **[Assessment]{.underline}**                        |
|                 |                                                     |
|                 | EXPLAIN assessment is the periodic examining and    |
|                 | monitoring of laboratory operations to established  |
|                 | requirements. It involves external and internal     |
|                 | evaluation.                                         |
|                 |                                                     |
|                 | -   It is good practice for testing sites to        |
|                 |     periodically conduct self-evaluation of their   |
|                 |     operations against quality requirements. Any    |
|                 |     gaps identified can be addressed immediately.   |
|                 |                                                     |
|                 | -   There are two types of external evaluation or   |
|                 |     assessment.                                     |
|                 |                                                     |
|                 |     -   Testing sites may be routinely monitored in |
|                 |         the form of supervisory visits.             |
|                 |                                                     |
|                 |     -   External assessments may be conducted by    |
|                 |         external agencies for accreditation         |
|                 |         purposes. This is usually done by an        |
|                 |         independent body to objectively assess      |
|                 |         compliance with established quality         |
|                 |         requirements of published standards.        |
|                 |                                                     |
|                 | INDICATE this component is closely linked to other  |
|                 | components such as organization, personnel, and     |
|                 | process control                                     |
+-----------------+-----------------------------------------------------+
| **20**          | **[Process Improvement]{.underline}**               |
|                 |                                                     |
|                 | EXPLAIN process improvement refers to activities    |
|                 | designed to:                                        |
|                 |                                                     |
|                 | -   Identify and eliminate causes of poor quality   |
|                 |                                                     |
|                 | -   Reduce waste and improve efficiency by          |
|                 |     eliminating non-value added activities          |
|                 |                                                     |
|                 |     -   Sometimes formal studies are conducted and  |
|                 |         results are statistically analyzed. An      |
|                 |         example might be efficiency of a testing    |
|                 |         site in reporting client results. Does it   |
|                 |         take 2 hours to report a result that can be |
|                 |         reported within 30 minutes?                 |
|                 |                                                     |
|                 |     -   But it doesn't always have to be formal.    |
|                 |         Opportunities for process improvement are   |
|                 |         everywhere if you pay attention.            |
|                 |                                                     |
|                 | DISCUSS the following examples to help participants |
|                 | understand the concept.                             |
|                 |                                                     |
|                 | -   You are required to dispose of sharps after     |
|                 |     each test. But the sharps container is located  |
|                 |     in a separate room from the testing area. This  |
|                 |     situation discourages testers from following    |
|                 |     the recommended safety practice and increases   |
|                 |     potential hazard if used sharps are transported |
|                 |     to the container next door. What should you do? |
|                 |                                                     |
|                 | -   You are required to retrieve a test record or   |
|                 |     report from a given day, but it takes you a     |
|                 |     long time to sort through the piles of paper.   |
|                 |     After locating the record, there is missing     |
|                 |     information                                     |
|                 |                                                     |
|                 | INDICATE component is closely linked to other       |
|                 | components such as organization, personnel,         |
|                 | documents and records, process control, and         |
|                 | customer service                                    |
+-----------------+-----------------------------------------------------+
| **21**          | **[Customer Service]{.underline}**                  |
|                 |                                                     |
|                 | ASK participants, "who are your customers?"         |
|                 |                                                     |
|                 | -   The patient/client is the ultimate customer.    |
|                 |                                                     |
|                 | -   However, we must not forget the clinician,      |
|                 |     program staff, and epidemiologists. These       |
|                 |     people are our internal customers.              |
|                 |                                                     |
|                 | EMPHASIZE everyone at the HIV rapid testing site    |
|                 | has responsibility for providing good customer      |
|                 | service, from the receptionist, counselor, and lab  |
|                 | staff.                                              |
|                 |                                                     |
|                 | -   Each test site should actively seek information |
|                 |     on both internal and external satisfaction      |
|                 |     through customer surveys and interviews.        |
|                 |                                                     |
|                 | -   Use data collected for process improvement      |
|                 |                                                     |
|                 | -   Value and reward staff providing good service   |
|                 |                                                     |
|                 | INDICATE this component is closely linked to other  |
|                 | components such as personnel, documents and         |
|                 | records, process control, and process improvement   |
+-----------------+-----------------------------------------------------+
| **22**          | **[Facilities and Safety]{.underline}**             |
|                 |                                                     |
|                 | EXPLAIN it is important to:                         |
|                 |                                                     |
|                 | -   Ensure that facilities, testing and storage     |
|                 |     areas are adequate in order to produce reliable |
|                 |     test results, e.g., monitoring testing and      |
|                 |     storage area temperatures                       |
|                 |                                                     |
|                 | -   Provide an adequate and safe work environment   |
|                 |                                                     |
|                 | INDICATE this component is closely linked to other  |
|                 | components such as organization, personnel,         |
|                 | purchasing and inventory, occurrence management,    |
|                 | process control, and customer service.              |
+-----------------+-----------------------------------------------------+
| **23**          | **[The Lab Quality System]{.underline}**            |
|                 |                                                     |
|                 | POINT OUT some components (highlighted in yellow)   |
|                 | will be further explored in later modules.          |
|                 |                                                     |
|                 | ASK if participants have any questions.             |
+-----------------+-----------------------------------------------------+
| ![](m           | The next activity is an energizer. Energizers are   |
| edia/image2.gif | short, fun activities that "break up" periods of    |
| ){width="0.4479 | concentrated learning. They often involve physical  |
| 166666666667in" | movement and a lot of fun. They serve as "mental    |
| height="0.54166 | breaks" so participants are refreshed and ready for |
| 66666666666in"} | more learning that follows.                         |
| ***TIPS***      |                                                     |
|                 | Some energizers incorporate learning content. The   |
|                 | following is an example. It summarizes the 12       |
|                 | components of Quality Lab Systems and furthers      |
|                 | participants' understanding of the concept by       |
|                 | providing concrete examples.                        |
+-----------------+-----------------------------------------------------+
| **24**          | **[Activity: Are You "Positive" or                  |
|                 | "Negative?"]{.underline}**                          |
| **Activity**    |                                                     |
|                 | CONSTRUCT the cabbage ball prior to the module.     |
| **20 minutes**  | (NOTE: Instructions are located at the end of this  |
|                 | module.)                                            |
|                 |                                                     |
|                 | FOLLOW the procedure below when conducting the      |
|                 | activity.                                           |
|                 |                                                     |
|                 | > INFORM participants of the activity.              |
|                 | >                                                   |
|                 | > POINT OUT the instructions on the slide.          |
|                 | >                                                   |
|                 | > DESIGNATE one corner of the room as "Positive"    |
|                 | > (statement that describes a factor contributing   |
|                 | > to quality), and another as "Negative" (statement |
|                 | > that describes a factor contributing to lack of   |
|                 | > quality).                                         |
|                 | >                                                   |
|                 | > START the activity by tossing the cabbage ball to |
|                 | > any participant.                                  |
|                 | >                                                   |
|                 | > ENSURE the activity proceeds in an orderly        |
|                 | > fashion following the sequence below. (Consider   |
|                 | > playing the first two rounds as demonstration to  |
|                 | > familiarize the participants with the procedure.) |
|                 | >                                                   |
|                 | > A participant:                                    |
|                 |                                                     |
|                 | -   Catches the ball                                |
|                 |                                                     |
|                 | -   Peels one statement off the ball                |
|                 |                                                     |
|                 | -   Reads the statement to the entire group and     |
|                 |     decides whether it is positive or negative      |
|                 |                                                     |
|                 | -   Tosses the ball to the next person              |
|                 |                                                     |
|                 | -   Walks to the appropriate corner based on the    |
|                 |     statement                                       |
|                 |                                                     |
|                 | > (The process repeats)                             |
|                 |                                                     |
|                 | CONCLUDE the activity by answering any questions    |
|                 | participants may have.                              |
|                 |                                                     |
|                 | If time allows, repeat this activity using new      |
|                 | cabbage balls.                                      |
+-----------------+-----------------------------------------------------+
| **25**          | **[Who Is Responsible for Quality?]{.underline}**   |
|                 |                                                     |
|                 | STATE quality is everyone's responsibility.         |
+-----------------+-----------------------------------------------------+
| **Transition**  | STATE:                                              |
|                 |                                                     |
|                 | -   We just had an overview of what the lab quality |
|                 |     system encompasses.                             |
|                 |                                                     |
|                 | -   Next we will talk about what you can do to      |
|                 |     contribute to lab quality.                      |
|                 |                                                     |
|                 | -   But first, let's define some terms -- QA and    |
|                 |     QC.                                             |
|                 |                                                     |
|                 | -   You play an important role in both.             |
+-----------------+-----------------------------------------------------+
| **26**          | **[Quality Assurance vs. Quality                    |
|                 | Control]{.underline}**                              |
|                 |                                                     |
|                 | EXPLAIN the difference between quality assurance    |
|                 | (QA) and quality control (QC).                      |
|                 |                                                     |
|                 | STATE QC is part of QA.                             |
+-----------------+-----------------------------------------------------+
| **27**          | **[The Quality Assurance Cycle]{.underline}**       |
|                 |                                                     |
|                 | STATE quality assurance is applied throughout the   |
|                 | testing process at all testing sites. It is not a   |
|                 | one time event. The slide illustrates that this is  |
|                 | a continual process.                                |
|                 |                                                     |
|                 | EXPLAIN the 3 phases and the activities associated  |
|                 | with each phase.                                    |
+-----------------+-----------------------------------------------------+
| **28**          | **[Why Do Errors Occur?]{.underline}**              |
|                 |                                                     |
|                 | STATE each bullet on the slide.                     |
|                 |                                                     |
|                 | RELATE each error to the appropriate lab quality    |
|                 | system components. For example, if the error of     |
|                 | "kits not stored properly" occurs, ask participants |
|                 | which part of the quality system breaks down that   |
|                 | caused such an error.                               |
+-----------------+-----------------------------------------------------+
|                 | ASK participants, "What are some errors that may    |
|                 | occur during pre-testing, testing, and post-testing |
|                 | phase in the QA cycle?"                             |
|                 |                                                     |
|                 | NOTE participant responses on a flip chart.         |
+-----------------+-----------------------------------------------------+
| **29**          | **[Pre-testing Errors]{.underline}**                |
|                 |                                                     |
|                 | PRESENT the slide.                                  |
|                 |                                                     |
|                 | ACKNOWLEDGE points that have been mentioned by the  |
|                 | participants in the discussion.                     |
+-----------------+-----------------------------------------------------+
| **30**          | **[Preventing and Detecting Errors -- Before        |
|                 | Testing]{.underline}**                              |
|                 |                                                     |
|                 | PRESENT the slide.                                  |
|                 |                                                     |
|                 | EMPHASIZE every tester is responsible for           |
|                 | preventing and detecting errors.                    |
+-----------------+-----------------------------------------------------+
| **31**          | **[Testing Errors]{.underline}**                    |
|                 |                                                     |
|                 | PRESENT the slide.                                  |
|                 |                                                     |
|                 | ACKNOWLEDGE points that have been mentioned by the  |
|                 | participants in the discussion.                     |
|                 |                                                     |
|                 | EXPLAIN "incorrect reagents used" (last bullet)     |
|                 | refers to using buffers from a different kit.       |
+-----------------+-----------------------------------------------------+
| **32**          | **[Preventing and Detecting Errors -- During        |
|                 | Testing]{.underline}**                              |
|                 |                                                     |
|                 | PRESENT the slide.                                  |
|                 |                                                     |
|                 | EMPHASIZE every tester is responsible for           |
|                 | preventing and detecting errors.                    |
+-----------------+-----------------------------------------------------+
| **33**          | **[Post-testing Errors]{.underline}**               |
|                 |                                                     |
|                 | PRESENT the slide.                                  |
|                 |                                                     |
|                 | ACKNOWLEDGE points that have been mentioned by the  |
|                 | participants in the discussion.                     |
+-----------------+-----------------------------------------------------+
| **34**          | **[Preventing and Detecting Errors -- After         |
|                 | testing]{.underline}**                              |
|                 |                                                     |
|                 | PRESENT the slide.                                  |
|                 |                                                     |
|                 | EMPHASIZE every tester is responsible for           |
|                 | preventing and detecting errors.                    |
+-----------------+-----------------------------------------------------+
| **35**          | **[Why is Quality System Important to Rapid         |
|                 | Testing?]{.underline}**                             |
|                 |                                                     |
|                 | REVIEW the points on the slide.                     |
+-----------------+-----------------------------------------------------+
| **36**          | **[Summary]{.underline}**                           |
|                 |                                                     |
|                 | ASK participants to answer the questions on the     |
|                 | slide.                                              |
|                 |                                                     |
|                 | ANSWER any questions participants may have.         |
+-----------------+-----------------------------------------------------+

**Instructions for Making A Cabbage Ball**

1.  Determine the number of participants in the workshop.

2.  Print out as many statements (listed below) as the participants.
    PRINT EACH STATEMENT ON A SEPARATE PIECE OF PAPER.

3.  Sort these statements into a [random]{.underline} order so that not
    all positive statements are together.

4.  Start by crumpling the first statement into a tight small ball.

5.  Add the next layer with another statement.

6.  Repeat the process until all statements have been added to the ball.

**Positive Statements**

The Ministry of Health announced that a system for monitoring Quality
Assurance would be implemented throughout all levels of rapid HIV
testing.

The reference laboratory provided proficiency samples to test sites to
help them evaluate their testing performance.

The Ministry of Health established a team to periodically monitor
testing sites.

A test site is keeping records of the number of tests used each month in
order to assure that an adequate supply of kits and reagents will be
maintained.

A test site used standard forms and log sheets to make recording and
review of data easier.

The competency of each staff performing HIV rapid tests was assessed
twice a year to assure they have maintained the appropriate knowledge
and skills to perform their job.

The testing site established a protocol for taking corrective actions to
address adverse events.

Temperature logs were maintained for recording, twice a day, the
temperature of the reagent/test kit storage area.

At the beginning of each day of testing, a responsible staff person
evaluated the HIV rapid test kits by analyzing a known positive and
known negative HIV control sample.

The testing site established a "chain of command" and assigned specific
quality management tasks to responsible individuals.

New employees demonstrated competency before they were allowed to
perform HIV rapid tests.

The testing site implemented a plan for maintaining and servicing
equipment used at the HIV rapid testing.

Test site staff helped define criteria for the materials and services
needed to carry out quality HIV rapid testing.

The testing site assigned a person to receive and inspect incoming
supplies and reagents.

**Negative Statements**

A new staff member failed to record the test results for 3 clients
tested early in the day. Based on her memory, she entered the results
later in the day.

New test kits were received and placed on the storage shelf in front of
test kits that were already there.

A new staff member received no orientation to site policies and
procedures before beginning to perform HIV rapid tests.

For three days a testing site manager did not return a call from a
physician who had requested a copy of test results for her patient.

You noticed the standard operating procedure was missing from the test
site. You decided to follow the SOP you borrowed from a neighboring
country.

Due to staff shortages, the testing site cancelled the first scheduled
internal assessment for the year.

Due to frequent problems with transport, the reference laboratory
suspended shipping quality control materials to the sites in its
province.

During lunch, the testing site manager overhead that a "sharps" incident
had occurred earlier in the week but had not been reported.

Following an on-site assessment, several deficiencies were noted. The
testing site manager decided that the deficiencies were minor and did
not require any remedial action.

You noticed that the sharps container was missing from the testing area.
You decided to use a plastic bag to collect the lancets until the end of
the day when you had time to look for the sharps container.

The refrigerator that stored test reagents and controls stopped
functioning overnight, but the temperature only went up 3 degrees above
the acceptable range. You felt this was not a significant change and
proceeded to test the clients.