Process Design

Healthcare is a highly complex socio-technical system that contains a number of subsystems and processes needed to provide safe, efficient and effective patient care. Conventionally, process design was conducted in relative isolation, without serious consideration of the potential impact on downstream processes and functions. However, human-centered processes in rapidly changing healthcare organizations rarely operate in isolation and it is increasingly recognized that most organizational problems can be attributed to faulty processes. Processes occasionally fail to achieve intended outcomes because of concealed process design flaws, inadequate design of the human-system interface, unmitigated human errors, and environmental factors that cannot be directly controlled by a healthcare organization. A failure in an upstream process can propagate the effects of the failure to downstream processes in ways that are unforeseen or not immediately evident. The risk of the process failure in most healthcare organizations is particularly high due to complexity of modern patient care, highly variable and unpredictable process inputs that make standardization difficult, tightly coupled process steps, rapid changes in medical and information technology, unstructured communication, significant dependence on human interventions, tight time constraints, and many other factors. Process design in healthcare requires a multifaceted approach that includes systematic application of the process design and improvement principles within the defined process design framework. It is also important to ensure meaningful staff involvement, build strong safety culture, control factors that influence human performance, and foster safety‐driven innovations while keeping patients’ needs at the forefront. Depending on organizational capabilities and culture, Design for Six Sigma (DFSS) approach can also be used to design, optimize and validate new healthcare services and processes.

 

Healthcare Process Design Framework

 

Process Design and Improvement Principles

Lean Six Sigma

  • Define value from the viewpoint of patients and other key stakeholders
  • Define process goals, assumptions, constraints, and performance expectations
  • Determine critical to quality (CTQ), safety (CTS), process (CTP), and cost (CTC) requirements
  • Visually outline the flow of information, materials and people required to create value
  • Identify valued-added activities and design the process around them
  • Establish a logical and rational order of steps
  • Identify and eliminate the sources of waste in the value stream
  • Minimize waiting time between the two valued-added activities
  • Eliminate redundant work that is not needed
  • Reduce unnecessary transport of people, equipment and supplies
  • Eliminate excess, obsolete or infrequently used inventory
  • Reduce unnecessary motion when performing work
  • Eliminate work that is not valued by patients and other key stakeholders
  • Reduce waste associated with errors, rework, scrap, and process non-conformance
  • Optimize necessary value-enabling tasks and activities
  • Reduce variation in process performance and outputs
  • Differentiate common cause variation from special cause variation
  • Identify and control key process inputs to increase the predictability of outcomes
  • Mitigate the impact of uncontrollable input variables
  • Use standardized work to support sustainable improvements
  • Eliminate or reduce errors through the systematic application of error proofing methods
  • Apply methods to detect, correct or mitigate errors before further processing
  • Convert batch processing into a continuous flow processing
  • Design a Pull/Kanban system to perform tasks and deliver services when required
  • Level out the workload across the value stream and remove excess capacity
  • Identify and remove process bottlenecks
  • Remove redundant intermediaries without reducing value to the patients
  • Accelerate the process by converting a serial sequence into a parallel sequence
  • Minimize the amount of time required to set up equipment or a room
  • Use Total Productive Maintenance (TPM) to maximize equipment effectiveness
  • Calculate Takt Time to determine staffing levels for different levels of demand
  • Maintain sufficient point-of-use inventory to meet anticipated demand
  • Use Statistical Process Control (SPC) to prevent tampering with the stable process
  • Conduct process capability studies to identify additional improvement opportunities
  • Reduce excessive process controls without increasing risks
  • Perform and maintain Failure Mode and Effects Analysis (FMEA)
  • Apply 5S methods to create and maintain organized, safe and efficient workplace
  • Prevent or expose potential problems by using visual management methods
  • Build quality into the process to minimize the need for inspections
  • Establish multiple work stations to increase flexibility and maximize efficiency
  • Physically co-locate people who perform interconnected work
  • Develop and institutionalize a continuous process improvement program

 Human Factors Engineering (HFE)

  • Design a robust process that is tolerant and resilient to unavoidable human errors
  • Minimize cognitive workload and make it easy for people to do the right thing
  • Reduce excessive reliance on sustained attention and alertness
  • Minimize the need for maintaining or transforming information in working memory
  • Identify and optimize complex interactions between humans and technical subsystems
  • Establish clear behaviour expectations for safety, high reliability and process excellence
  • Reduce system complexity and increase situational awareness
  • Identify and remove inadvertent incentives for risky behaviours
  • Minimize the number of handoffs and follow a standardized handoff process
  • Implement structured communication protocols between care providers
  • Apply innovative approaches to minimize distractions and interruptions
  • Ensure the use of forcing functions or constraints in safety-critical tasks
  • Use differentiation to eliminate “look-alikes and sound-alikes”
  • Reduce the need for training and instructions by using affordances
  • Design tasks that are compatible with the skills, abilities and limitations of people
  • Identify and address organizational factors that contribute to vulnerabilities in a process
  • Examine effects of multiple performance shaping factors on human performance
  • Recognize and mitigate limitations of human cognitive systems for multitasking
  • Understand the influence of heuristics and cognitive biases on decision making
  • Provide alignment among system components and leverage interdependencies
  • Ensure that all system components operate in a predictable and consistent manner
  • Modify physical environment with the aim of reducing the probability of human errors
  • Design workstations through the application of biomechanical concepts and principles
  • Consider sociocultural characteristics, needs, expectations, and preferences of people
  • Determine implications of the alternative design solutions on human performance
  • Focus on both the physical and cognitive elements of the user-system interface
  • Design the user interface to accurately reflect the dynamics of the physical system
  • Ensure that display representations are compatible with the user’s mental model
  • Emphasize the importance of testing before full implementation of the new process
  • Perform usability evaluations throughout the design cycle
  • Leverage the use of simulation to test, evaluate and improve the process
  • Apply signal detection theory in designing alert and alarm systems
  • Reduce the learning curve associated with the new technologies, tools and tasks
  • Automate only improved, verified and validated processes
  • Ensure complementary allocation of functions between humans and technology
  • Use appropriate levels of automaton for different human information processing stages
  • Be aware that design changes may create new opportunities for errors
  • Take a broader view of the organization to reduce the risk of system sub-optimization

Leadership

  • Develop compelling vision and ensure ongoing leadership support
  • Demonstrate clear purpose, create a sense of urgency and drive for results
  • Align process goals with organizational vision, mission and core values
  • Recruit team members with complementary knowledge, skills and abilities
  • Bring an outside perspective and experience to the design team
  • Establish ground rules, clarify expectations and reach agreement on process outcomes
  • Define decision making, communication and conflict resolution processes
  • Support decision making at the level where the work is performed
  • Establish process ownership with clearly defined roles and responsibilities
  • Develop and implement a comprehensive change management strategy
  • Examine the influence of organizational culture on the likelihood of success
  • Build both an emotional and rational case for change
  • Ensure broad participation in planning, testing and implementation of change
  • Establish high standards of performance and motivate people to succeed
  • Foster open communication and promote transparency
  • Use multiple communication channels in the context of target audience
  • Keep people informed, avoid surprises and engage in active listening
  • Create positive work environment conducive to teamwork
  • Develop effective partnerships based on trust and mutual respect
  • Encourage people to express concerns, disagreements and unpopular viewpoints
  • Promptly address potentially destructive behaviours and conflicts
  • Approach the process design with flexibility, curiosity and open-mindedness
  • Stimulate both analytical and creative thinking
  • Monitor team progress against targets and make necessary adjustments
  • Identify potential roadblocks and facilitate collaborative problem solving
  • Do not support inadequate solutions just to preserve team cohesiveness
  • Determine training requirements and enable flexibility through cross-training
  • Provide ongoing feedback, coaching and mentoring
  • Use every opportunity to positively reinforce desired behaviors
  • Provide opportunities for personal growth and career development
  • Involve suppliers and leverage their technical knowledge to create value
  • Link people and processes across organizational and departmental boundaries
  • Acknowledge and value the contributions of all people involved
  • Recognize, reward and celebrate accomplishments

Information and Data Management

  • Identify organizational information needs, expectations and requirements
  • Use validated methods to continuously identify patient needs and preferences
  • Ensure confidentiality, privacy and security of sensitive information
  • Ensure compliance with all applicable laws and regulations
  • Develop a right mix of outcome, process and balancing measures
  • Ensure that selected measures are important, cost-effective and responsive to changes
  • Synthesize, integrate and make the best use of data from existing sources
  • Consider organizational goals and priorities, not just the availability of data
  • Create common operational definitions and avoid using ambiguous terminology
  • Develop data collection plans and carefully design sampling strategy
  • Focus on the key problems and detect patterns by stratifying data
  • Ensure accuracy, validity, reliability, completeness, consistency, and integrity of data
  • Convert complex data into simple, meaningful, relevant, and useful information
  • Provide easy and timely access to relevant information at any point of patient care
  • Differentiate between measurements for improvement, judgement and research
  • Design systems to ensure seamless downstream and upstream flow of information
  • Prevent information overload by controlling the timing and volume of information
  • Minimize the need to mentally sort, compare and analyze information
  • Measure, analyze and control variation within the measurement system
  • Define accountabilities for collection, analysis, distribution, use, and disposition of data
  • Assign responsibility and authority to identify and respond to trends in a timely manner
  • Eliminate redundant or repeated data entry across multiple information systems
  • Collect and combine information of strategic importance into a single repository
  • Minimize complexity by classifying large data sets into meaningful categories
  • Compile, sort and correlate the different levels, formats and granularities of information
  • Ensure that information and data displays are free from visual clutter
  • Design an accessible database that is flexible and scalable over time
  • Regularly identify, amend or discard incorrect, inconsistent and incomplete information
  • Avoid creating unintentional incentives that may result in harmful consequences
  • Identify and minimize the cumulative effects of rounding errors
  • Support decision making by turning business data into business intelligence
  • Develop a robust disaster recovery plan in conjunction with the business continuity plan
  • Enhance organizational capability and capacity for data analytics