Fig. 10.1.
The “no blame box”.
Specimens can be charted into one of the four categories of cancer/no cancer and good quality/poor quality. This method often illustrates that errors are multifactorial and not based on interpretive defects alone
A3 problem-solving tool (Table 10.1)
Table 10.1.
Problem Solving with an A3
Problem/current condition | Action plan |
|---|---|
• Define the problem using data | • Develop an action plan with specific tasks assigned to different people with due dates |
• Describe the current condition | |
Root cause analysis | Metric and time line |
• Perform a root cause analysis like five whys to get to the source of the problem | • Show what will be measured to evaluate success or failure of the action plan |
• Develop a time line for task completion and success monitoring |
Used by the Toyota Corporation to define, characterize, and solve problems
Single sheet of paper divided into four quadrants, problem/current condition, root cause analysis, action plan, and metrics and time line
Single page requires short, concise, and well-thought-out responses in each box
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Types of QI methodologies used to achieve quality goals. Many overlapping theories and philosophies
Toyota Production System
Principle 1 – Base your management decisions on a long-term philosophy, even at the expense of short-term financial goals
Principle 2 – Create a continuous process flow to bring problems to the surface
Redesigned work process to eliminate waste (muda) through continuous improvement (kaizen)
Types of waste include overproduction, waiting, unnecessary transport or conveyance, overprocessing or incorrect processing, excess inventory, unnecessary movement, defects, and unused employee creativity
Principle 3 – Use “pull” systems to avoid overproduction
Principle 4 – Level out the workload (heijunka)
Principle 5 – Build a culture of stopping to fix problems, to get quality right the first time
Principle 6 – Standardized tasks and processes are the foundation for continuous improvement and employee empowerment
Principle 7 – Use visual control so no problems are hidden
5S program – Sort, straighten, shine, standardize, and sustain
Principle 8 – Use only reliable, thoroughly tested technology that serves your people and processes
Principle 9 – Grow leaders who thoroughly understand the work, live the philosophy, and teach it to others
Principle 10 – Develop exceptional people and teams who follow your company’s philosophy
Principle 11 – Respect your extended network of partners and suppliers by challenging them and helping them improve
Principle 12 – Go and see for yourself to thoroughly understand the situation (Genchi Genbutsu)
Principle 13 – Make decisions slowly by consensus, thoroughly considering all options; implement decisions rapidly (nemawashi)
Principle 14 – Become a learning organization through relentless reflection (hansei) and continuous improvement (kaizen)
Six Sigma – Method to improve the quality in a process by identifying and eliminating the causes of defects or errors and variation
Trains “black belts” in the process who are specific people embedded within the organization that specializes in Six Sigma
Depends on statistical and quality management methods
Defects are defined as anything that leads to customer dissatisfaction
Achieving Six Sigma is reaching 99.9997% efficiency or only 3.4 defects per million opportunities
Total quality management – A business strategy that aims to increase overall awareness to quality throughout the entire organization
Zero defects – The philosophy that all services or products should be designed and produced to meet the immediate need of the downstream customer
If the product or service does not meet the need of the customer, it is defective
Emphasis is on the prevention of errors rather than tracking and correcting defective products
DMAIC Framework for QI
A data-driven improvement method characterized by five phases, define, measure, analyze, improve, and control
Define – The problem or gap in practice is defined and the time-limited goals/aims are expressed
Measure – Baseline metrics are obtained which document the current gap in practice
Analyze – Perform root cause analysis to identify the true sources of the problem
Improve – Develop improved practice protocols targeted to the root cause identified in the analyze phase. The analyze phase includes a remeasure of the original metrics to document improvement
Control – Design protocols on how to sustain the improvements
PDSA cycles
Originally defined by Edwards Deming as Plan, Do, Study, Act, this QI methodology focuses on small tests of change and observations on how changes affect a process
Plan – Identify a problem and the objectives and propose solutions
Do – Implement the solution
Study – Study and analyze how the solution affected the process and the expected outcomes
Act –Based on the outcomes of the study phase, either implement the new system throughout the process and look for further improvement (a new PDSA cycle) or, if it was not effective , eliminate the solution and repeat the PDSA with a new solution
Medical Error
Impact on Health Care
The Institute of Medicine estimated that between 44,000 and 98,000 patients die each year as a result of a medical error
The total financial cost of medical error was estimated between $17 billion and $29 billion in the United States each year
These estimates fail to include numbers of patient who suffer increased morbidity and outpatient medical errors
Definition
Defined by the Institute of Medicine as the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim. Specifically to anatomic pathology, an error is defined as the failure to diagnose correctly the disease process occurring in a patient
It is important to note that patient harm is not a prerequisite for medical error. The determination of error is performed independently of patient outcome or root cause analysis
Once an error is identified and the outcome is analyzed, the error may then be classified as “harm,” “near miss,” and “no harm.”
The majority of medical errors are not associated with an adverse patient outcome
Terminology is an important factor as error is often associated with a negative connotation and physician training poorly addresses medical error
Edwards Deming highlighted the process versus people issue in the setting of error. In complex systems, like laboratory medicine, 15% of defects are estimated due to “people,” while 85% are due to the “process.”
Focusing on the process can help reshape the negative connotations associated with error
Classification
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Errors in anatomic pathology may be classified based on the testing phase involved. Testing phases include the following:
Pre-pre-analytic in which the decision to test is made and the specific test is chosen
Pre-analytic in which the test material is taken from the patient (biopsy performed) and is transported to the laboratory
Analytic in which the sample is processed and interpreted. This is the domain over which the testing laboratories have the most control. Errors in each of these domains may lead to errors in the analytic phase
Accessioning
Grossing
Processing
Histology
Transcription
Pathologist interpretation
Additional testing
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Post-analytic in which the test results are reported to the clinician
Post-post-analytic in which the clinician makes a decision and acts on the test result
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Laboratories which function under two domains of control (e.g., hospital-controlled laboratory processing control and pathologist medical group-controlled pathologist interpretation control) often dichotomize the analytic phase of testing into technical or processing r elated and pathologist interpretation related
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Active versus latent errors
Active errors are those that are due to an individual interacting with a defined process incorrectly
Example. A pathologist only reviews one of the two H&E levels on a colon polyp biopsy and misses a tubular adenoma even though the procedure stipulates all sections from all slides should be reviewed
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