Engaging in Quality Improvement
High-quality patient care is the ultimate goal of any laboratory. Therefore, it is important to use a continuous quality improvement (CQI) approach when investigating your quality issues. The idea is that identifying and evaluating quality issues is not a singular event but rather involves continuous monitoring of corrective action to prevent recurrences.
CQI Activities
One way you can think about the continuous approach to quality is with a repeating spiral of activities. These activities are performed by the pathologists and laboratory staff. With each iteration of these activities, quality improves.
The cycle begins with identifying a quality issue and progresses through a series of steps designed to remediate the issue and ending with ongoing monitoring for future quality improvement opportunities.
CQI Roles and Responsibilities
It is important to remember that quality is everyone’s responsibility. This includes the laboratory director, laboratory pathologists and staff, the quality manager, and the quality assurance (QA) team.
The QA team is typically more involved in conducting causal analysis, developing corrective action plans, and evaluating the success of corrective action plans.
Whereas, the laboratory staff is more involved in monitoring and identifying quality issues; as well as taking
CQI Tools
There are a variety of tools that can be used to support CQI; each one serving a specific purpose. It is important to remember that no one tool should be used for every problem. Here are few:
1. Flow charts are used to define and analyze processes, identify bottlenecks, troubleshoot a problem, or communicate steps to others.
2. Swimlane diagrams are used to define and analyze processes across departments or functional areas in order to identify where a process may be breaking down.
3. Spaghetti charts are used to identify inefficiencies in the layout of the lab and possible risk areas for contamination.
4. RACI charts are used to define roles and responsibilities for specific tasks in a process (ie, who is responsible, accountable, consulted, and informed).
Six Sigma is a method used to identify and remove causes of errors and minimizes variability in the process.
The term Six Sigma comes from statistical analysis associated with manufacturing. Six Sigma is its clear commitment to making decisions on the basis of verifiable data, rather than assumptions and guesswork. Six Sigma improvement projects follow a five-phase methodology referred to as DMAIC (Define, Measure, Analyze, Improve, Control). It is important that these steps are followed in their correct order.
DMAIC steps:
1. Define the problem and document the problems and improvement goals.
• Activities occurring during this step are: project charter, identification of team members, and documentation of the current process using a flow chart, mapping, or other such tool. • Activities to avoid during this step include assigning blame, suggesting a solution, stating
personal opinions.
2. Measure key aspects of the current process and collect relevant data.
• Activities occurring during this step include observing and reviewing the current process (eg, mapping the process), and measuring the current process to establish a baseline through various analysis tools (Pareto chart, Control chart, Cause and Effect diagram, etc). • Critical step at this point is the selection of the correct identification of data to measure;
otherwise, the improvement effort will likely fail.
3. Analyze the data to determine cause-and-effect relationships to expose the root cause of the problem.
4. Improve the process based upon the Root Cause Analysis by creating and implementing solutions to eliminate the problems.
5. Control the new process to detect and correct errors before they occur. A Control chart (eg, Levey Jennings chart) can be used for continuous monitoring.
SIPOC (Suppliers, Inputs, Process, Outputs, and Customers) Analysis is used to identify all relevant
elements of a process improvement project before the work actually begins. It is a visual tool for documenting a business process from beginning to end.
Steps to complete the SIPOC diagram include: 1. Map four to five high-level steps. 2. Identify the outputs of the process.
3. Identify the customers that will receive the outputs of this process. 4. Identify the inputs required for the process to function properly. 5. Identify the suppliers of the inputs that are required by the process.
Lean Production (or Lean) is a process-improvement manufacturing philosophy that seeks to eliminate
anything that doesn’t create value (ie, waste) for the customer. Value for the customer is defined as whatever product or service the customer is willing to pay for. Lean attempts to create products and services with the minimum amount of effort, and thus minimize cost.
Lean principles are composed of the following elements:
• Value is any action or process that a customer would be willing to pay for. • Minimum waste is the elimination of anything that does not provide value. • Customer need performs only what is required.
• Employee engagement gives the workers authority to make changes. • Continuous quality improvement continuously improves the work process. The five steps to Lean thinking include:
1. Specify the value (of service, process, and procedure): Is a critical starting point to define the value from the customer's perspective and express value in terms of a specific product.
2. Map the value stream: Is the mapping of the steps that bring the product or process to the customer. (Value-added are items that bring value to the customer; while value-enabling are items necessary for the process. Nonvalue-added are items that don't create value and should be
Failure Mode and Effects Analysis (FMEA) analyzes actual and potential failure modes (ways of failing)
and their effects on the final product. A laboratory produces external products consisting of diagnoses and reports for patients and clinicians; internal products at every step of the laboratory’s process. A laboratory is an operation of great complexity and exacting standards, and thus has a large number of ways in which things can fail. FMEA is often applied to a laboratory in an effort to improve the quality of the operation. An FMEA project seeks to identify potential failures based on past experience with the process. Once discovered, failures are prioritized according to the seriousness of their consequences, frequency of occurrence, and how easily they can be detected. The risks of failure are documented by the FMEA team and are used to mitigate the severity or likelihood of these failures reoccurring. FMEA also specifies actions that will reduce the impacts of risks.
FMEA is a ten-step process:
STEP 1: Review the process
• Use a process Flow chart to identify each process component. • List each process component in the FMEA table.
• If it starts feeling like the scope is too big, it probably is. Break it down into small components.
STEP 2: Brainstorm potential failure modes
• Review existing documentation and data for clues about all of the ways each component can failure. • The list should be exhaustive – it can be paired down and items can be combined after this initial list is
generated.
• There will likely be several potential failures for each component.
STEP 3: List potential effects of each failure
• The effect is the impact the failure has on the end product or on subsequent steps in the process. • There will likely be more than one effect for each failure.
STEP 4: Assign Severity rankings
• Determine the consequences of each failure mode including any domino effects on the other failure modes.
• It is useful to describe the effect in terms that the user might see or experience, such as “specimen damaged.”
• Rate the severity of each effect using a 1 to 5 or 1 to 10 scale.
STEP 5: Assign Occurrence rankings
• Look at the cause of the failure mode and how many times it occurs. All potential causes for the failure mode should be identified and documented.
• Assign an occurrence ranking to the failure mode using a 1 to 10 scale. The actions in following steps will determine if the occurrence rating is high.
STEP 6: Assign Detection rankings
• Inspection methods must be chosen that detect the failure before it reaches the customer, ideally during production or at least during testing.
• Assign a detection number using a 1 to 5 or 1 to 10 scale that ranks the ability of planned tests and inspections to remove defects or to fix failures.
STEP 7: Calculate the RPN
• After rating the severity, occurrence, and delectability of the failure mode, a risk priority number (RPN) is calculated by multiplying the previous three numbers together (Severity X Occurrence X Detection = RPN).
• The failure modes are then prioritized in terms of this RPN number. The failure modes that have the highest RPN are given the highest priority for corrective action. Corrective actions are devised and assigned to a person for implementation.
STEP 8: Develop the action plan
• Decide which failures will be worked on based on the Risk Priority Numbers. • Focus on the highest RPNs.
STEP 9: Take action
• Implement the improvements.
STEP 10: Calculate the resulting RPN
• Re-evaluate each of the potential failures once improvements have been made and determine the impact of the improvements.
Root Cause Analysis (RCA) is used after you discover an error. At this point, you need to determine the
error's “true cause” so it can be corrected. The term “true cause” is used, because often there is a chain of causes and effects leading up to the error. You need to do an RCA to discover the underlying cause of each of the causes you expose.
This analysis starts with the problem and asks the question, “What could be the cause of this effect?” You should do this in an organized way by asking the question about the equipment, materials, environment, people, process, and management. The result is usually several possible causes for each category. Afterwards, take each of these possibilities in turn and ask the same question about them to uncover their subcauses. Keep doing this until you have determined the root cause of the risk.
If you lay your analysis out on paper, it might look like the skeleton of a fish. For this reason, it is called a Fishbone Analysis (other names include Ishikawa Analysis or a Cause and Effect diagram.
FOCUS-PDCA is an extension of the Plan, Do, Check, Act (PDCA) cycle based on the Shewhart/Deming
cycle. It is a process improvement method to achieve and maintain laboratory quality improvement. This process can be used for prospective and retrospective error prevention or correction.
FOCUS is an acronym that stands for:
1. Find a process to improve. These are identified through your organization’s key risk indicators (KRI). 2. Organize a team that knows the process.
3. Clarify current knowledge of the process by using data collection tools such as, Run chart, Pareto chart, or brainstorming. Use a Flow diagram to identify where the problem exists.
4. Understand sources of process variation by using a Cause and Effect diagram to understand why an existing problem is occurring.
5. Select the process improvement.
Once the problem is identified you are ready to implement the second part of the process known as PDCA which stands for:
1. Plan the improvement action
2. Do a test of planned improvement action 3. Check to determine the effects of the action 4. Act to implement or solidify improvement action
• High-quality patient care is the ultimate goal of any laboratory. It is important to use a continuous quality improvement approach when investigating your quality issues.
• The idea is that identifying and evaluating quality issues is not a singular event but rather involves continuous monitoring of corrective action to prevent recurrences.
