Featured Product
This Week in Quality Digest Live
Health Care Features
Jón Bergsteinsson
Understanding the standard is essential
Rob Moorey
Efficient processes and technology are key
Stephanie Ojeda
The FDA’s new QMSR will harmonize with ISO 13485 for medical device quality management
Steve Thompson
An excellent technological tool that improves quality and compliance
Delivering quality to the health industry

More Features

Health Care News
Streamlines annual regulatory review for life sciences
The company is also facilitating donations to the cause
Mass spectromic analysis from iotaSciences
Showcasing the latest in digital transformation for validation professionals in life sciences
An expansion of its medical-device cybersecurity solution as independent services to all health systems
Purchase combines goals and complementary capabilities
Better compliance, outbreak forecasting, and prediction of pathogens such as listeria or salmonella
Links ZEISS research and capabilities in automated, high-resolution 3D imaging and analysis
Creates one of the most comprehensive regulatory SaaS platforms for the industry

More News

Health Care

Establishing a Patient Safety Culture, Part Three

Process transformation using quality by design

Published: Wednesday, August 8, 2012 - 10:02

Editor’s note: This is the third of a three-part series on quality in healthcare. Part one described the Juran Model for Patient Safety, and part two identified elements of a patient safety officer program.

With between 44,000 to 98,000 patients dying each year in hospitals as a result of medical errors, patient safety has moved to the forefront as one of the most significant challenges facing the U.S. healthcare system today. In 2001, the Institute of Medicine released a report, “Crossing the Quality Chasm: A New Healthcare System for the 21st Century,” which describes a fragmented and inefficient system of care that results in medical errors, unnecessary treatments, and wasted resources.

The Institute of Medicine makes an urgent call for fundamental change to close the quality gap. Healthcare organizations are faced with the fact that patients suffer harm not only from their underlying disease and illness, but also from adverse events arising from poorly designed systems and processes. The current healthcare system is outmoded and incapable of providing consistent quality care.

Reflecting the need for change, reimbursement is increasingly tied to patient safety practices, the patient experience, and adherence to evidence-based standards. In this era of rapidly advancing technology, hospitals are challenged to change healthcare delivery. Healthcare organizations are now mandated to implement an electronic health record system to improve quality and patient safety. Technological advances are costly for an already struggling healthcare system, and the rapid implementation of technology can result in the automation of inefficient and ineffective processes. Errors in healthcare result in part from poorly designed complex systems, so there is a very real risk of perpetuating or exacerbating poor quality with electronic systems. Using an innovative approach, such as quality by design, organizations can transform patient care processes and promote patient safety prior to the implementing an electronic health record system.

The Juran Trilogy

The Juran Trilogy defines three managerial processes required by all organizations: quality planning, quality control, and quality improvement (figure 1). During the quality planning process, healthcare leaders evaluate the need for new products and services and also look at existing processes that need redesign. Quality by design is a methodology that enables healthcare organizations to revamp existing processes to meet customer needs or requirements. Designing for customer needs leads to higher quality products and services, which in turn result in innovative advances in patient safety and innovation.

Figure 1: Quality by design and the Juran Trilogy

Innovation and process redesign

Innovation is key to the survival of all organizations. Like continuous improvement, innovation is the result of a systematic approach, not a haphazard one. To avoid the implementing poorly designed processes, it is imperative to redesign and improve workflows and processes prior to electronic health record implementation. Quality by design, which can be accomplished with methodologies like design for Six Sigma, provides an avenue to remodel patient care processes and workflows to eliminate waste, reduce errors, and promote patient safety. Aligning newly improved processes designed to meet specific customer needs with EHR implementation increases the likelihood of achieving a real reduction in medical errors as well as customer, financial, and operational benefits.

Quality by design combines the concept of quality design with the goal of Six Sigma quality. It is carried out in a series of five phases: define, discover, design, develop, and deliver. The major activities of each phase are identified in figure 2. Quality by design involves significant time and effort up front, but in the long run it is cost-efficient because organizations don’t incur the costs of poor quality associated with correcting problems introduced with new healthcare technology. The quality by design methodology minimizes the need to repair and fix processes associated with full implementation by delivering patient care processes that are designed from the start to meet customer and business requirements.






  • Initiate the project
  • Scope the project
  • Plan and manage the project
  • Discover and prioritize customer needs
  • Develop and prioritize critical to quality
  • Map current state
  • Measure baseline performance
  • Develop design scorecard
  • Develop design alternative
  • Develop high-level design
  • Evaluate high-level design

  • Optimize detail level design parameters
  • Evaluate detail level design
  • Plan detail design verification tests
  • Verify detail and design of product
  • Optimize process performance
  • Execute pilot/analyze results
  • Implement production process
  • Update design scorecard
  • Transition to owners

Figure 2: Quality by design phases

Process redesign and electronic health records

The Institute of Medicine report recommends information technology as a major mechanism to reduce errors, yet introducing an electronic health record system is not a magic potion that will eliminate medical errors. The electronic health record creates a new level of departmental interdependence that affects all members of the healthcare team. Patient care processes and their relationship to patient safety is a complex, interactive, and interdependent process. Changes in roles, workflow, and communication will occur. Many lower level issues are resolved, yet a new level of issues emerge, some beneficial and some prompting concern.

As a result, changes in work processes must be carefully analyzed for potential detrimental changes before full implementation. The electronic health record design must be tailored for patient safety and quality. Using quality by design as a methodology prior to electronic health record implementation allows healthcare organizations to refocus on customer requirements, thereby ensuring greater accuracy and reduced variation in clinical care processes.

Case study: Using quality by design to improve delivery of patient medications

A children’s hospital was experiencing problems with late, missing, and discontinued medications. As part of a process redesign initiative, in advance of an electronic health record system implementation, hospital leaders recognized the need to improve the medication delivery and dispensation processes to inpatients, thereby providing more timely care, reducing waste, and preventing medication errors. Approximately 12.0 medications were reported missing per 1,000 doses dispensed, 18 percent of patient bins audited had discontinued or discharged patient medications, turnaround time from medication order entry to dispensation from the pharmacy was 60 minutes, and medication delivery times were not maintained on a schedule. These contributed to delays in the delivery of care, increased risk of medication errors, and increased costs of care.

The goals of the project were to:
• Reduce missing medications from 12 to 6 or fewer per 1,000 doses dispensed;
• Reduce the percentage of discontinued and discharged patient medications remaining in bins from 18 percent to 9 percent
• Reduce turnaround time from medication order entry to dispensation from 60 minutes to 45 minutes
• Provide a consistent, on-time delivery schedule for medications (±15 minutes of target)

Quality by design for medication management

Define. A project team was led by the pharmacy manager and sponsored by the director of clinical and family support. The vice president for quality and patient safety was selected as the project champion. The team consisted of pharmacy and nursing staff, with inpatient and emergency department providers acting as ad hoc members.

Discover. Voice of the customer information obtained from pediatric nurses, patients, and families revealed there was inconsistent on-time delivery of non-stat, patient-specific medications to the inpatient unit. This contributed to nonvalue-added work by nurses and pharmacists hunting and gathering for “missing medications.” Additionally, discontinued medications were not consistently removed from patient bins and returned to the pharmacy, generating waste and creating patient safety risks associated with discontinued medications potentially being delivered to the wrong patient.

The project team mapped current state workflows, helping to expose infrequent preparation and delivery of medications as a major contributor to missing medications, delays in administrations, and the inefficient return of medications. Using this information, the team identified and measured the baseline for four performance metrics, and established improvement goals for each (figure 3).




Missing medications per 1,000 doses dispensed



Percent patient bins with discontinued/discharge patient medications

18 percent

9 percent

Turnaround time from medication order entry to dispensation

55 minutes

45 minutes

On-time delivery per schedule (± deviation from target time)

No schedule

±15 minutes

Figure 3: Baseline and goal performance for four process metrics

Design. To address the problems, alternative high-level designs for order verification, medication preparation, and delivery were considered and evaluated against specific critical to quality requirements derived from voice of the customer information. From this analysis, the team identified three important design features to be included in the future state: decentralized order entry, small, frequent batch preparation of medications, and bus route medication delivery and removal of discontinued medications.

Develop. Following the approval of the high-level design features by the executive management team, the project team developed formal plans and documents to ensure critical components were coordinated. These included: new activity level workflows, procedures, and standard work, material and supply plan, IT plan, human resources plan, service level agreements, risk assessments, change management plan, and a communication plan. Changes were tested on a small scale to confirm effectiveness. For example, different routes and number of transport personnel were evaluated. After minor adjustments, features were ready for rollout on a larger scale as a part of normal production.

Deliver. Once the detail-level designs were created and approved, the project team developed an implementation and control plan. The implementation plan specified which actions were to be taken, by when, and by whom to integrate the new features into a routine process.

Results. Testing the increased frequency of medication preparation, delivery, and pickup showed the following results for a one-month pilot (figures 4, 5, 6):

Figure 4: 11-percent reduction in the number of reported missing medications from baseline of 12.0 to 10.7 (after) per 1,000 doses dispensed

Figure 5: Reduction in the percentage of discontinued and discharged medications remaining in patient bins after 12 hours, from 18 percent to 7 percent

Figure 6: 24-percent reduction in the turnaround from time of computerized prescription order entry to time dispensed from the pharmacy, from 55 minutes (before) to 41 minutes (after). Although results are preliminary with a small sample size, results show a reduction in both average time and variation in time across orders.

Figure 7: New bus route delivery timetable for patient-specific medications. A service level agreement provides for delivery within a 15 minute window on either side of the scheduled delivery time.

A more rapid and frequent preparation, delivery, and retrieval of medications was only part of a larger bundle of changes required to improve medication errors rates, the frequency of missing medications, and prevalence of expired medications. Additional improvement in performance metrics is anticipated as other changes are completed, including implementing an electronic health record system that will now integrate improved, rather than broken, processes.


With technology becoming an ever-present part of healthcare, the traditional roles within the healthcare system are being renegotiated. A risk for all parties (including patients, healthcare providers, hospital administrators, and software vendors) is that technology is inappropriately applied. Quality by design is a methodology that enables healthcare leaders to define their business requirements and redesign existing processes to optimize technology, promoting safe, effective, and efficient care for patients and families.


About The Authors

Tracey Lynn King’s picture

Tracey Lynn King

Tracey Lynn King, Ph.D., is a healthcare practice nurse consultant. In this capacity, King specializes in enterprisewide quality management systems, lean and Six Sigma methodologies, and clinical business process management. King’s more than 25 years of healthcare experience includes critical care nursing, cardiac nursing, nursing management, nursing education, outcomes management and quality management. Her specific areas of knowledge and expertise include nursing leadership, physician performance management, peer review, case management, electronic health record documentation, meaningful use quality measures, pay for performance initiatives, and core measure performance.


Brian A. Stockhoff’s picture

Brian A. Stockhoff

Brian A. Stockhoff, Ph.D., a senior consultant with Juran Institute Inc., delivers lean Six Sigma training, client coaching, consulting services in organizational assessments and business process reengineering, and project team leadership to service, manufacturinig, and healthcare organizations. Stockhoff’s experience includes 16 years in science and technology-based organizations, with roles in quality, research and development, commercial product development, and intellectual property management. As a Six Sigma Black Belt, Stockhoff has an additional 9 years applying a combined knowledge of statistics, process optimization, and project management to reduce defects and cycle time in client business processes.

Mary Beth Edmond’s picture

Mary Beth Edmond

Mary Beth Edmond is an executive vice president and senior nurse executive with Juran Healthcare, as well as a lean Six Sigma Black Belt. She assists clients in designing and implementing enterprisewide quality assurance systems, quality improvement deployment strategies and plans, business process management, enterprisewide patient safety programs, lean Six Sigma coaching and project support, and organizational performance assessments.  Edmond has 40 years of healthcare experience in nursing and consulting for community hospitals, academic medical centers, and ambulatory surgical centers.



It's Much Worse

The IOM report from 1999 needs some updating. Because of better record keeping we now know that:

  • 99,000 patients die each year because of hosital-acquired infections
  • 150,000 die due to medication errors
  • 150,000 die due to preventable surgical complications
  • One patient in six will suffer some complication due to their treatment, not their disease

Good news!

Dr. Peter Pronovost's check list for central lines has reduced CLBSI from 240,000/year to 40,000/year (about 1/4th of these patients still die each year).

The World Health Organization's surgical checklist cuts preventable mortality by almost half.

But healthcare is still the fourth leading cause of preventable death in the U.S.

Waste and rework in healthcare is estimated to be a Trillion Dollars out of the $2.5 Trillion we spend.

Lean Six Sigma could quickly cut these costs and boost quality of healthcare, but hospitals and other medical facilities are hesitant to embrace it because of the perceived time and cost involved. Of course, healthcare doesn't need to know everything in the Green Belt or Black Belt body of knowledge. The Magnificent Seven tools of Lean Six Sigma will solve most problems facing healthcare, but like their patients, doctors, nurses and administrators have to want to "change their lifestyle" and aggressively pursue improvements in speed, quality and cost across the board.

Improvement projects can be done in days, not months, using the right set of tools.

The shift from pay per procedure to pay per outcome will demand rapid analysis and improvement. Question is, are we in the Lean Six Sigma community willing to bend our know-everything-to-be-able-to-solve-anything approach to training and implementation? Or are we willing to teach only the key tools needed to solve most problems? Probably  not, because we resist change just like clinicians and their patients.

Are we going to listen to the voice of our healthcare customer and help them accelerate patient safety and healthcare quality, or we going to continue preaching the gospel of "know everything before you can do anything"?