+------------------------+---------------------------------------------+
| ![](media/image1.j     | Module 5                                    |
| peg){width="1.90625in" |                                             |
| height="               | **Assuring the Quality of HIV Rapid         |
| 1.8729166666666666in"} | Testing:**                                  |
|                        |                                             |
|                        | **A Systems Approach to Quality**           |
+------------------------+---------------------------------------------+

+----------------+-----------------------------------------------------+
|                |                                                     |
+----------------+-----------------------------------------------------+
| **Purpose**    | To provide an overview of the lab quality system so |
|                | that you will adopt a broad systems view toward     |
|                | quality and understand where errors may occur in    |
|                | the rapid testing process and your responsibilities |
|                | in preventing and detecting them.                   |
+----------------+-----------------------------------------------------+
| **P            | None                                                |
| re-requisite** |                                                     |
|                |                                                     |
| **Modules**    |                                                     |
+----------------+-----------------------------------------------------+
| **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                                         |
+----------------+-----------------------------------------------------+
| **Content      | > The approach we take to achieve quality           |
| Outline**      | >                                                   |
|                | > Essential elements of a lab quality system        |
|                | >                                                   |
|                | > Quality assurance procedures at the HIV rapid     |
|                | > testing site                                      |
|                | >                                                   |
|                | > How you can contribute to quality before, during, |
|                | > and after testing                                 |
+----------------+-----------------------------------------------------+
| **Handout**    | None                                                |
+----------------+-----------------------------------------------------+
| ![](media      | If a lab quality system has been established,       |
| /image2.wmf){w | provide specific in-country information for each    |
| idth="0.491666 | component of the quality system.                    |
| 66666666664in" |                                                     |
| height="0.     |                                                     |
| 44166666666666 |                                                     |
| 665in"}**Notes |                                                     |
| on             |                                                     |
| C              |                                                     |
| ustomization** |                                                     |
+----------------+-----------------------------------------------------+

+-----------------+--------------------------+--------------------------+
| **What is       | Quality is the ability   |                          |
| "Quality"?**    | of a product or service  |                          |
|                 | to satisfy the needs of  |                          |
|                 | a specific customer. You |                          |
|                 | may achieve it by        |                          |
|                 | conforming to            |                          |
|                 | established requirements |                          |
|                 | and standards.           |                          |
|                 |                          |                          |
|                 | An example of service    |                          |
|                 | would include providing  |                          |
|                 | and interpreting an HIV  |                          |
|                 | Rapid Test.              |                          |
+-----------------+--------------------------+--------------------------+
| **"Dining Out": | Quality can be evaluated |                          |
| A Quality       | in anything we           |                          |
| Experience**    | experience. You can      |                          |
|                 | better understand the    |                          |
|                 | concept of quality and   |                          |
|                 | quality systems by       |                          |
|                 | thinking about what you  |                          |
|                 | might experience at a    |                          |
|                 | fine restaurant:         |                          |
|                 |                          |                          |
|                 | Think about what you     |                          |
|                 | might expect for a       |                          |
|                 | quality experience at a  |                          |
|                 | fine restaurant? 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   |                          |
|                 |                          |                          |
|                 | Keep the restaurant      |                          |
|                 | scenario in mind as you  |                          |
|                 | study this module.       |                          |
+-----------------+--------------------------+--------------------------+
| **Why           |                          |                          |
| Quality?**      |                          |                          |
+-----------------+--------------------------+--------------------------+
|                 | Why is quality           |                          |
|                 | important?               |                          |
|                 |                          |                          |
|                 | 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.      |                          |
+-----------------+--------------------------+--------------------------+
| **A Systems     | The approach we take to  |                          |
| Approach to     | ensure lab quality is a  |                          |
| Quality**       | systems approach. A      |                          |
|                 | systems approach         |                          |
|                 | examines all components  |                          |
|                 | in the system, not just  |                          |
|                 | focusing on any one      |                          |
|                 | component. It places as  |                          |
|                 | much emphasis on         |                          |
|                 | identifying and          |                          |
|                 | describing the           |                          |
|                 | connections between      |                          |
|                 | system components as on  |                          |
|                 | identifying and          |                          |
|                 | describing the           |                          |
|                 | components themselves.   |                          |
|                 |                          |                          |
|                 | Let's explore 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.   |                          |
+-----------------+--------------------------+--------------------------+
| **Definition of | A lab quality system is  |                          |
| A Lab Quality   | the organizational       |                          |
| System**        | structure,               |                          |
|                 | responsibilities,        |                          |
|                 | processes, procedures,   |                          |
|                 | and resources for        |                          |
|                 | implementing quality     |                          |
|                 | management of the        |                          |
|                 | laboratory or testing    |                          |
|                 | site. In other words, it |                          |
|                 | implies all activities   |                          |
|                 | which contribute to      |                          |
|                 | quality of tests,        |                          |
|                 | directly or indirectly.  |                          |
|                 |                          |                          |
|                 | By adopting the systems  |                          |
|                 | approach to lab quality, |                          |
|                 | a lab quality system     |                          |
|                 | would encompass all      |                          |
|                 | activities that          |                          |
|                 | contribute to quality    |                          |
|                 | directly or indirectly.  |                          |
+-----------------+--------------------------+--------------------------+
| **Benefits of a | A quality system to the  |                          |
| Quality         | HIV rapid testing sites  |                          |
| System**        | has several benefits.    |                          |
|                 | It:                      |                          |
|                 |                          |                          |
|                 | -   Monitors all parts   |                          |
|                 |     of the testing       |                          |
|                 |     system               |                          |
|                 |                          |                          |
|                 | -   Detects and reduce   |                          |
|                 |     errors               |                          |
|                 |                          |                          |
|                 | -   Improves consistency |                          |
|                 |     between testing      |                          |
|                 |     sites                |                          |
|                 |                          |                          |
|                 | -   Helps contain costs  |                          |
+-----------------+--------------------------+--------------------------+
| **The Lab       | A lab quality system has |                          |
| Quality         | 12 components. Read on   |                          |
| System**        | to learn about each      |                          |
|                 | component.               |                          |
+-----------------+--------------------------+--------------------------+
| *               | Organization is the      |                          |
| *Organization** | 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 |                          |
|                 |                          |                          |
|                 | -   Secure sufficient    |                          |
|                 |     resources to         |                          |
|                 |     maintain quality     |                          |
|                 |     requirements         |                          |
|                 |                          |                          |
|                 | -   Clearly define roles |                          |
|                 |     and accountability   |                          |
|                 |                          |                          |
|                 | -   Cultivate a culture  |                          |
|                 |     committed to quality |                          |
|                 |                          |                          |
|                 | This component is        |                          |
|                 | closely linked to other  |                          |
|                 | components such as       |                          |
|                 | personnel, equipment,    |                          |
|                 | process improvement, and |                          |
|                 | customer service.        |                          |
+-----------------+--------------------------+--------------------------+
| **Personnel**   | 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.            |                          |
+-----------------+--------------------------+--------------------------+
| **Equipment**   | 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.               |                          |
|                 |                          |                          |
|                 | This component is        |                          |
|                 | closely linked to other  |                          |
|                 | components such as       |                          |
|                 | personnel, purchasing    |                          |
|                 | and inventory, documents |                          |
|                 | and records, and         |                          |
|                 | facilities and safety.   |                          |
+-----------------+--------------------------+--------------------------+
| **Purchasing    | Purchasing is primarily  |                          |
| and Inventory** | 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.         |                          |
|                 |                          |                          |
|                 | This component is        |                          |
|                 | closely linked to other  |                          |
|                 | components such as       |                          |
|                 | organization, process    |                          |
|                 | control, documents and   |                          |
|                 | records, and facilities  |                          |
|                 | and safety.              |                          |
+-----------------+--------------------------+--------------------------+
| **Process       | Process control refers   |                          |
| Control**       | 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.           |                          |
|                 |                          |                          |
|                 | This component is        |                          |
|                 | closely linked to other  |                          |
|                 | components such as       |                          |
|                 | personnel, purchasing    |                          |
|                 | and inventory,           |                          |
|                 | assessment, and          |                          |
|                 | facilities and safety.   |                          |
+-----------------+--------------------------+--------------------------+
| **Documents and | Document and records may |                          |
| Records**       | 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      |                          |
|                 |                          |                          |
|                 | This component is        |                          |
|                 | closely linked to other  |                          |
|                 | components such as       |                          |
|                 | purchasing and           |                          |
|                 | inventory, information   |                          |
|                 | management, assessment,  |                          |
|                 | and occurrence           |                          |
|                 | management.              |                          |
+-----------------+--------------------------+--------------------------+
| **Information   | Information management   |                          |
| Management**    | refers to these          |                          |
|                 | activities:              |                          |
|                 |                          |                          |
|                 | -   Manage incoming and  |                          |
|                 |     outgoing information |                          |
|                 |                          |                          |
|                 | -   Establish standards  |                          |
|                 |     for gathering        |                          |
|                 |     information          |                          |
|                 |                          |                          |
|                 | -   Ensure the privacy   |                          |
|                 |     and confidentiality  |                          |
|                 |     of patient           |                          |
|                 |     information          |                          |
|                 |                          |                          |
|                 | 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.                |                          |
|                 |                          |                          |
|                 | This component is        |                          |
|                 | closely linked to        |                          |
|                 | components such as       |                          |
|                 | personnel, documents and |                          |
|                 | records, and customer    |                          |
|                 | service.                 |                          |
+-----------------+--------------------------+--------------------------+
| **Occurrence**  | Occurrence management    |                          |
| **Management**  | 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. For |                          |
|                 | example, you should keep |                          |
|                 | a record of all          |                          |
|                 | circumstances related to |                          |
|                 | the error or problem,    |                          |
|                 | and 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.        |                          |
|                 |                          |                          |
|                 | This component is        |                          |
|                 | closely linked to other  |                          |
|                 | components such as       |                          |
|                 | process control,         |                          |
|                 | documents and records,   |                          |
|                 | and customer service.    |                          |
+-----------------+--------------------------+--------------------------+
| **Assessment**  | 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. |                          |
|                 |                          |                          |
|                 | This component is        |                          |
|                 | closely linked to other  |                          |
|                 | components such as       |                          |
|                 | organization, personnel, |                          |
|                 | and process control      |                          |
+-----------------+--------------------------+--------------------------+
| **Process       | Process improvement      |                          |
| Improvement**   | refers to activities     |                          |
|                 | designed to identify and |                          |
|                 | eliminate causes of poor |                          |
|                 | quality, and to 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 the studies don't    |                          |
|                 | always have to be        |                          |
|                 | formal. Opportunities    |                          |
|                 | for process improvement  |                          |
|                 | are everywhere if you    |                          |
|                 | pay attention. Here are  |                          |
|                 | some examples:           |                          |
|                 |                          |                          |
|                 | -   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          |                          |
|                 |                          |                          |
|                 | This component is        |                          |
|                 | closely linked to other  |                          |
|                 | components such as       |                          |
|                 | organization, personnel, |                          |
|                 | documents and records,   |                          |
|                 | process control, and     |                          |
|                 | customer service         |                          |
+-----------------+--------------------------+--------------------------+
| **Customer      | Who are your customers?  |                          |
| Service**       | The patient/client, of   |                          |
|                 | course, is the ultimate  |                          |
|                 | customer. However, we    |                          |
|                 | must not forget the      |                          |
|                 | clinician, program       |                          |
|                 | staff, and               |                          |
|                 | epidemiologists. These   |                          |
|                 | people are our internal  |                          |
|                 | customers.               |                          |
|                 |                          |                          |
|                 | 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, and then use |                          |
|                 | the data collected for   |                          |
|                 | process improvement. It  |                          |
|                 | is also a good practice  |                          |
|                 | to reward staff          |                          |
|                 | providing good service.  |                          |
|                 |                          |                          |
|                 | This component is        |                          |
|                 | closely linked to other  |                          |
|                 | components such as       |                          |
|                 | personnel, documents and |                          |
|                 | records, process         |                          |
|                 | control, and process     |                          |
|                 | improvement              |                          |
+-----------------+--------------------------+--------------------------+
| **Facilities    | It is important to       |                          |
| and Safety**    | ensure that facilities,  |                          |
|                 | testing and storage      |                          |
|                 | areas are adequate in    |                          |
|                 | order to produce         |                          |
|                 | reliable test results,   |                          |
|                 | e.g., monitoring testing |                          |
|                 | and storage area         |                          |
|                 | temperatures. It is also |                          |
|                 | important to provide an  |                          |
|                 | adequate and safe work   |                          |
|                 | environment.             |                          |
|                 |                          |                          |
|                 | This component is        |                          |
|                 | closely linked to other  |                          |
|                 | components such as       |                          |
|                 | organization, personnel, |                          |
|                 | purchasing and           |                          |
|                 | inventory, occurrence    |                          |
|                 | management, process      |                          |
|                 | control, and customer    |                          |
|                 | service.                 |                          |
+-----------------+--------------------------+--------------------------+
| **Who Is        | Quality is               |                          |
| Responsible for | [everyone]{.underline}'s |                          |
| Quality?**      | responsibility. For      |                          |
|                 | example,                 |                          |
|                 |                          |                          |
|                 | -   Laboratory           |                          |
|                 |     management           |                          |
|                 |     [and]{.underline}    |                          |
|                 |     program staff        |                          |
|                 |     establish quality    |                          |
|                 |     assurance            |                          |
|                 |     procedures.          |                          |
|                 |                          |                          |
|                 | -   Test site personnel  |                          |
|                 |     implement the        |                          |
|                 |     quality assurance    |                          |
|                 |     procedures.          |                          |
|                 |                          |                          |
|                 | How can you contribute   |                          |
|                 | to lab quality? You will |                          |
|                 | find out more about the  |                          |
|                 | specific things you can  |                          |
|                 | do to help. But, first,  |                          |
|                 | let's explain how        |                          |
|                 | quality assurance        |                          |
|                 | differs from quality     |                          |
|                 | control.                 |                          |
+-----------------+--------------------------+--------------------------+
| **Quality       | Quality assurance (QA)   |                          |
| Assurance vs.   | is the activities that   |                          |
| Quality         | ensure                   |                          |
| Control**       | [process]{.underline}    |                          |
|                 | are adequate for a       |                          |
|                 | system to achieve its    |                          |
|                 | objectives. Quality      |                          |
|                 | control (QC), on the     |                          |
|                 | other hand, is the       |                          |
|                 | activities that evaluate |                          |
|                 | a [product]{.underline}  |                          |
|                 | or work                  |                          |
|                 | [result]{.underline}.    |                          |
|                 |                          |                          |
|                 | Examples of QA include   |                          |
|                 | establishing standard    |                          |
|                 | procedures for sample    |                          |
|                 | collection and defining  |                          |
|                 | criteria for acceptable  |                          |
|                 | samples. Examples of QC  |                          |
|                 | include analyzing known  |                          |
|                 | QC sample to determine   |                          |
|                 | if a test is valid, and  |                          |
|                 | deciding if a sample is  |                          |
|                 | acceptable for testing.  |                          |
|                 | As you can see, QC is    |                          |
|                 | part of QA.              |                          |
+-----------------+--------------------------+--------------------------+
| **The Quality   | ![                       |                          |
| Assurance       | ](media/image4.wmf){widt |                          |
| Cycle**         | h="0.9118110236220472in" |                          |
|                 | height="                 |                          |
|                 | 0.7228346456692913in"}![ |                          |
|                 | ](media/image5.wmf){widt |                          |
|                 | h="0.5897637795275591in" |                          |
|                 | height="0                |                          |
|                 | .38543307086614176in"}![ |                          |
|                 | ](media/image6.wmf){widt |                          |
|                 | h="0.4826771653543307in" |                          |
|                 | height=                  |                          |
|                 | "0.452755905511811in"}![ |                          |
|                 | ](media/image7.wmf){widt |                          |
|                 | h="0.9118110236220472in" |                          |
|                 | height="                 |                          |
|                 | 0.6208661417322835in"}![ |                          |
|                 | ](media/image8.wmf){widt |                          |
|                 | h="0.5897637795275591in" |                          |
|                 | height="                 |                          |
|                 | 0.5464566929133858in"}![ |                          |
|                 | ](media/image9.wmf){widt |                          |
|                 | h="0.6429133858267716in" |                          |
|                 | height="                 |                          |
|                 | 0.6429133858267716in"}![ |                          |
|                 | ](media/image10.wmf){wid |                          |
|                 | th="0.752755905511811in" |                          |
|                 | height="0                |                          |
|                 | .5897637795275591in"}![] |                          |
|                 | (media/image11.wmf){widt |                          |
|                 | h="0.8043307086614173in" |                          |
|                 | height="0                |                          |
|                 | .7007874015748031in"}![] |                          |
|                 | (media/image12.wmf){widt |                          |
|                 | h="0.5897637795275591in" |                          |
|                 | height="0                |                          |
|                 | .5307086614173229in"}![] |                          |
|                 | (media/image12.wmf){widt |                          |
|                 | h="0.5897637795275591in" |                          |
|                 | height="0                |                          |
|                 | .5307086614173229in"}![] |                          |
|                 | (media/image13.wmf){widt |                          |
|                 | h="0.7507874015748032in" |                          |
|                 | height                   |                          |
|                 | ="0.4889763779527559in"} |                          |
+-----------------+--------------------------+--------------------------+
|                 | Quality assurance is     |                          |
|                 | applied throughout the   |                          |
|                 | testing process at all   |                          |
|                 | testing sites. It is not |                          |
|                 | a one time event. As you |                          |
|                 | can see in the graphic   |                          |
|                 | above, this is a         |                          |
|                 | continual process        |                          |
|                 | encompassing 3 phases    |                          |
|                 | and there are multiple   |                          |
|                 | activities associated    |                          |
|                 | with each phase of       |                          |
|                 | testing.                 |                          |
+-----------------+--------------------------+--------------------------+
| **Why Do Errors | Errors can occur         |                          |
| Occur?**        | throughout the testing   |                          |
|                 | process. Some causes     |                          |
|                 | include:                 |                          |
|                 |                          |                          |
|                 | -   Individual           |                          |
|                 |     responsibilities     |                          |
|                 |     unclear              |                          |
|                 |                          |                          |
|                 | -   No written           |                          |
|                 |     procedures           |                          |
|                 |                          |                          |
|                 | -   Written procedures   |                          |
|                 |     not followed         |                          |
|                 |                          |                          |
|                 | -   Training is not done |                          |
|                 |     or not completed     |                          |
|                 |                          |                          |
|                 | -   Checks not done for  |                          |
|                 |     transcription errors |                          |
|                 |                          |                          |
|                 | -   Test kits not stored |                          |
|                 |     properly             |                          |
|                 |                          |                          |
|                 | -   QC, EQA not          |                          |
|                 |     performed            |                          |
|                 |                          |                          |
|                 | -   Equipment not        |                          |
|                 |     properly maintained  |                          |
+-----------------+--------------------------+--------------------------+

The table below provides the examples of errors that may occur during
the three phases of Quality Assurance Cycle, and what you can do to
prevent them.

+--------------+-----------------+-----------------+-----------------+
|              | **Before        | **During        | **After         |
|              | Testing**       | Testing**       | Testing**       |
+--------------+-----------------+-----------------+-----------------+
| **Common     | -   Specimen    | -   Country     | -               |
| Errors**     |     mislabeled  |     algorithm   |   Transcription |
|              |     or          |     not         |     error in    |
|              |     unlabeled   |     followed    |     reporting   |
|              |                 |                 |                 |
|              | -   Specimen    | -   Incorrect   | -   Report      |
|              |     stored      |     timing of   |     illegible   |
|              |                 |     test        |                 |
|              | inappropriately |                 | -   Report sent |
|              |     before      | -   Results     |     to the      |
|              |     testing     |     reported    |     wrong       |
|              |                 |     when        |     location    |
|              | -   Specimen    |     control     |                 |
|              |     transported |     results out | -   Information |
|              |                 |     of range    |     system not  |
|              | inappropriately |                 |     maintained  |
|              |                 | -   Improper    |                 |
|              | -   Test kits   |                 |                 |
|              |     stored      |    measurements |                 |
|              |                 |     of specimen |                 |
|              | inappropriately |     or reagents |                 |
|              |                 |                 |                 |
|              |                 | -   Reagents    |                 |
|              |                 |     stored      |                 |
|              |                 |                 |                 |
|              |                 | inappropriately |                 |
|              |                 |     or used     |                 |
|              |                 |     after       |                 |
|              |                 |     expiration  |                 |
|              |                 |     date        |                 |
|              |                 |                 |                 |
|              |                 | -   Dilution    |                 |
|              |                 |     and         |                 |
|              |                 |     pipetting   |                 |
|              |                 |     errors      |                 |
|              |                 |                 |                 |
|              |                 | -   Incorrect   |                 |
|              |                 |     reagents    |                 |
|              |                 |     used (i.e., |                 |
|              |                 |     using       |                 |
|              |                 |     buffers     |                 |
|              |                 |     from a      |                 |
|              |                 |     different   |                 |
|              |                 |     kit)        |                 |
+--------------+-----------------+-----------------+-----------------+
| **How to     | -   Check       | -   Perform and | -   Re-check    |
| Prevent /    |     storage and |     review      |                 |
| Detect       |     room        |     Quality     |  patient/client |
| Errors**     |     temperature |     Control     |     identifier  |
|              |                 |     (QC)        |                 |
|              | ```{=html}      |                 | -   Write       |
|              | <!-- -->        | -   Follow      |     legibly     |
|              | ```             |     safety      |                 |
|              | -   Select an   |     precautions | -   Clean up    |
|              |     appropriate |                 |     and dispose |
|              |     testing     | -   Conduct     |     of          |
|              |     workspace   |     test        |                 |
|              |                 |     according   |    contaminated |
|              | -   Check       |     to written  |     waste       |
|              |     inventory   |     procedures  |                 |
|              |     and         |                 | -   Package EQA |
|              |     expiration  | -   Correctly   |     specimens   |
|              |     dates       |     interpret   |     for         |
|              |                 |     test        |     re-testing, |
|              | -   Review      |     results     |     if needed   |
|              |     testing     |                 |                 |
|              |     procedures  |                 |                 |
|              |                 |                 |                 |
|              | -   Record      |                 |                 |
|              |     pertinent   |                 |                 |
|              |                 |                 |                 |
|              |    information, |                 |                 |
|              |     and label   |                 |                 |
|              |     test device |                 |                 |
|              |                 |                 |                 |
|              | -   Collect     |                 |                 |
|              |     appropriate |                 |                 |
|              |     specimen    |                 |                 |
+--------------+-----------------+-----------------+-----------------+

Remember, every tester is responsible for preventing and detecting
errors before, during, and after testing.

+-----------------+----------------------------------------------------+
| **Why is        | Even the simplest Rapid Test is not foolproof.     |
| Quality System  | Quality is the foundation of everything we do. A   |
| Important to    | quality system:                                    |
| Rapid           |                                                    |
| Testing?**      | -   Sets the standard for level of quality         |
|                 |                                                    |
|                 | -   Meets/exceeds customer expectations            |
|                 |                                                    |
|                 | -   Provides means to prevent, detect and correct  |
|                 |     problems                                       |
|                 |                                                    |
|                 | -   Becomes the core of a monitoring, evaluation,  |
|                 |     and improvement system                         |
|                 |                                                    |
|                 | -   Reduces costs                                  |
+-----------------+----------------------------------------------------+

+-----------------+----------------------------------------------------+
| ![](me          | -   Quality is the foundation of everything we do. |
| dia/image14.wmf |                                                    |
| ){width="1.1701 | -   The simplest Rapid Test is not foolproof.      |
| 388888888888in" |                                                    |
| heigh           | -   Errors can occur throughout the testing        |
| t="0.8319444444 |     process.                                       |
| 444445in"}**Key |                                                    |
| message**       | -   Quality is [everyone]{.underline}'s            |
|                 |     responsibility.                                |
+-----------------+----------------------------------------------------+

+-----------------+----------------------------------------------------+
| ![](me          | Module Review                                      |
| dia/image15.wmf |                                                    |
| ){width="1.0in" |                                                    |
| height="0.96041 |                                                    |
| 66666666667in"} |                                                    |
+=================+====================================================+
| Find out how    |                                                    |
| much you have   |                                                    |
| learned by      |                                                    |
| answering these |                                                    |
| questions.      |                                                    |
+-----------------+----------------------------------------------------+
| Why do errors   |                                                    |
| occur?          |                                                    |
+-----------------+----------------------------------------------------+
| What are some   |                                                    |
| common errors   |                                                    |
| that might      |                                                    |
| occur with HIV  |                                                    |
| rapid testing?  |                                                    |
|                 |                                                    |
| \_\_\_          |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
+-----------------+----------------------------------------------------+
| Where is QA     |                                                    |
| applied in a    |                                                    |
| PMTCT or VCT    |                                                    |
| testing site?   |                                                    |
|                 |                                                    |
| \_\_\_          |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
+-----------------+----------------------------------------------------+
| What are some   |                                                    |
| steps to take   |                                                    |
| before, during, |                                                    |
| and after       |                                                    |
| testing to      |                                                    |
| assure the      |                                                    |
| quality of      |                                                    |
| results?        |                                                    |
|                 |                                                    |
| \_\_\_          |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
+-----------------+----------------------------------------------------+
| Describe the    |                                                    |
| impact that     |                                                    |
| errors will     |                                                    |
| have on the     |                                                    |
| patient/client. |                                                    |
|                 |                                                    |
| \_\_\_          |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
+-----------------+----------------------------------------------------+