Methods & Tools

Defining Quality

Defining quality means developing expectations or standards of quality. Standards can be developed for inputs, processes, or outcomes; they can be clinical or administrative. Standards can be applied at the level of an individual, facility, or a healthcare system. A good standard is explicit, reliable, realistic, valid, and clear. Standards of quality can be developed according to the nine Dimensions of Quality and should be based on the best scientific evidence available. Stakeholder (including client and community) expectations of quality should also be incorporated in the definition of quality standards. Defined standards or definitions of quality are prerequisites for measuring quality. If standards don’t exist, they must be designed. Although standards are context-specific, universally accepted standards are often a good starting point for developing local standards. Sometimes, even when they exist, standards must be refined to make them usable by health workers. QA activities that are part of Defining Quality include:

• Developing and Communicating Standards
• Quality Design

Developing and Communicating Standards

Standards are explicit statements of expected quality in the performance of a healthcare activity. They may take the form of procedures, clinical practice guidelines, treatment protocols, critical paths, algorithms, standard operating procedures, or statements of expected healthcare outcomes, among other formats. Standards communicate expectations for how a particular healthcare activity will be performed in order that it achieve the desired results and define, for both health workers and clients, what is needed to produce quality services. Performance in accordance with standards is thus the cornerstone of quality assurance in healthcare and the end result to which a wide range of quality assurance activities lead, including accreditation of health facilities, external quality evaluation, and performance improvement. The field of quality assurance is also focused on performance according to standards because adherence to evidence-based standards has been shown to be associated with improved health outcomes. Moreover, failure to provide clinical care in accordance with standards has serious negative effects on patient outcomes.Standards may be explicit (written) or implicit (understood). Implicit healthcare standards derive from the expertise of professionals who work in a specific environment. For example, professionals who work on a pediatric ward may know the treatment that a dehydrated child needs, but may have different ideas about the most appropriate way to provide the treatment (e.g., dosage, duration, and frequency). Converting implicit standards to explicit standards provides consensus on the way to provide quality care, reduces variation between healthcare providers, and allows a baseline measure for monitoring quality. Explicit healthcare standards appear in a variety of forms, such as procedures, protocols, or clinical practice guidelines. These standards may be developed by ministries of health, professional organizations (e.g., nursing councils, medical associations), international organizations (e.g., the World Health Organization), accrediting organizations (e.g., Joint Commission International, Zambia Health Accreditation Council), or by a hospital itself.To achieve expected health outcomes, standards must be developed in such a way that they are:

• Realistic: The standards can be followed or achieved with existing resources
• Reliable: Following the standards for a specific intervention results in the same outcome (all factors being equal)
• Valid: The standards are based on scientific evidence or other acceptable experience
• Clear: The standards are understood in the same way by everyone concerned and are not subject to distortion or misinterpretation
• Measurable: Performance according to the standards may be assessed and quantified

The QA Project has found that there is no single best method for developing standards that meet these criteria. Instead, a menu of six steps called the Standards Development Cycle provides a flexible process for setting standards that can be adapted to each specific situation. The process for setting standards will be very different depending on the level and scope of the work, resources available, and complexity of the topic.

The Standards Development Cycle

Step 1. Define and agree. In this step, the goal is to define and agree on several areas and issues that will define the standards development task:

• Define the area or topic for which standards are being developed (for more limited, facility-level activities, skip the next two bullets)
• State the scope of care and identify the most important aspects of care, if needed, to focus standards setting where it can have the greatest impact
• State the level of the healthcare system for which the standards are being developed (e.g., national, regional, or facility)
• Clarify the consensus process, both for topic selection and approval
• Clarify the approval process for the standards

Step 2. Select who should be involved. Identify, at the outset of the process, all stakeholders, i.e., those individuals or groups with a vested interest in the successful development of the standards. Learning the stakeholders’ expectations should be incorporated in the consensus and approval process of standards development. The QA Project has found that involving stakeholders in the process of standards development will facilitate acceptance. A determination should also be made whether experts will be required. When developing clinical standards, national or international experts may be invited participate in a working group. Depending on the scope of the task, additional technical experts may be required as the work progresses and issues arise. The last part of Step 2 is to organize the working group that will develop the standards and to develop a management plan of action that provides the parameters for successful completion of the task and the process by which it is achieved. Key items that should be addressed in the plan are:

• Selection of a team leader
• Definition of the lines of authority and communication, resources available, and the process for working together (including clarifying tasks, roles, and responsibilities of team members)
• The approval process for the standards developed
• Specifications for the desired product and the deadline for completion

Step 3. Gather information. In this step, the working group gathers information about the topic under review and other resources that can help define the key elements that should be included in the standards. A flowchart may be developed to better understand the points in the current process requiring the development of standards. Even if there are no resources for extensive research, here are some areas to consider before launching into drafting standards:

• Are there existing standards related to the topic?
• Are there any laws and regulations related to the topic?
• What current practices related to this topic should be considered?
• Is clinical evidence available for best practices in this topic, or does the team have access to someone with knowledge or access to such information?
• What is the technology base available in the health system in this topic area and how does it limit or facilitate the development of standards?
• What resources are available for research, drafting, testing and communicating these standards?

Step 4. Draft standards. There are several components to drafting standards:

• Decide the structure and format of the standards, depending on their purposeAfter the format is decided, the working group drafts the standardsDevelop indicators to measure performance according to the standards
• Prior to field testing, the draft standards should be evaluated internally for quality

Step 5. Test the standards. Once indicators are developed, the working group must decide whether a field test is needed. This step might be skipped, for example, if testing has already been done at an international level. If a test is needed, a testing plan should be developed. Testing informs the wording and presentation of the standards, improves their quality, increases credibility, and continues the consensus-building process. Following an evaluation of the field test, revisions, if needed, should be made to the standards and the revised standards field tested again. The iterative process of field-testing, revision, and field-testing continues until revisions are no longer needed and standards are submitted for approval.

Step 6. Communicate the standards. Although the standards-setting process might be completed with the approval of the standards, the impact of well-developed standards depends on healthcare providers using the standards. Standards communication and implementation strategies are critical to achieving healthcare provider performance according to the standards.A well thought-out communication plan is needed to identify how the correct people will receive the correct information so they will perform the correct tasks related to the standards. Key elements of the communications plan may need to be tested. For example, if a job aid will be used to support implementation of standards, it should be tested to ensure that it is clear and reliable. If new standards are expected to change current practices significantly, testing the communications strategy will help develop the most acceptable message and identify the best messenger to ensure that providers and health administrators will modify their practices to perform according to the standards.

Rolling out the communication plan might include presenting or publicizing the standards, training health workers in the standards, and distributing job aids. The communication process should allow opportunities for feedback, both on the standards and the communication process itself.

Quality Design

Quality design involves service providers, clients, and program managers in a structured process to explicitly identify client needs and design service processes with key features to meet those needs. In the context of quality design, features are concrete, practical expressions of clients’ needs, desires, and expectations. While quality design is often applied to develop an entirely new process or service where a comparable one does not exist, it may also be used to substantially redesign an existing process or service.The QA Project has developed a systematic approach to quality design, involving the following 10 steps:

1. Select the process to be designed
2. Define objectives/aims of the new process
3. Identify clients, both external and internal, of the selected process
4. List and prioritize client needs and requirements
5. Create a high level flowchart of the new process with main activity blocks
6. Link client needs with each activity block in the high level flowchart
7. Identify key features in the new design that respond to priority needs and requirements of clients. Link key features with activity  blocks
8. Design the new process incorporating the key features
9. Test the new design for robustness (i.e., reliability, feasibility)
10. Plan, implement, and monitor the new process

QAP has applied this approach to the design of new care and support processes to ensure the timely delivery of essential obstetric care services in Bolivia, Ecuador, and Honduras through the Latin American Maternal Mortality Initiative.

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