Hazardous to Your Health

Quality professionals must unite to improve healthcare

by R. Dan Reid

One hospital chain in my area has a snappy ad saying your selection of a hospital could be the most important choice you will ever make. This might be true—going into the hospital these days can be hazardous to your health.

"As many as 98,000 people die in any given year due to medical errors that occur in hospitals," according to estimates in the Institute of Medicine's (IOM) 2000 report "To Err Is Human."1

If true, this exceeds the number of people who die from attention-getting motor vehicle accidents, breast cancer or AIDS. Further, the estimate of nearly 100,000 does not include patient injuries or near-misses in hospitals, or deaths outside of hospitals.

Has it improved?

"In a nutshell, U.S. consumers and taxpayers get a bad deal," one writer says. "We pay double what any other country does and we get inefficient, unsafe, poor quality healthcare."2

"The average ICU patient experiences 1.7 errors per day, nearly one-third of which are potentially life-threatening. Most involve communication problems," another study found.3

Some progress had been made: "In 2003, the Accreditation Council for Graduate Medical Education began enforcing limits on residents' duty hours (maximum of 80 hours per week or 30 hours per shift)."4 Would you want somebody who had been on duty for more than 20 straight hours operating on you?

Last November, a medication error made headlines when twins born to actor Dennis Quaid and his wife were given 1,000 times the intended dosage of blood thinner at Cedars-Sinai Medical Center.

At that time, the Institute of Medicine (IOM) reported that at least 1.5 million Americans a year are injured after receiving the wrong medication or the incorrect dose and that such incidents have more than doubled in the last decade.5

Serious injuries associated with medication errors reported to the Food and Drug Administration also increased—from about 35,000 in 1998 to nearly 90,000 in 2005.

Of those cases, more than 5,000 deaths were tallied in 1998, but more than 15,000 deaths were reported in 2005.6

From this information, it is not clear whether healthcare is getting worse or incident reporting is getting better.

In 2007, the Institute for Healthcare Improvement (IHI) ramped up its successful "100,000 Lives Campaign" to a two-year "Protecting 5 Million Lives From Harm Campaign."

How much harm? IHI says there are some 37 million hospital admissions each year in the United States and 40-50 patient injuries for every 100 hospital admissions. At this rate, there are some 15 million patient injuries per year in the United States.7

Rising costs

This February, the Associated Press estimated overall healthcare spending in 2017 would increase to $4.3 trillion. The report says that in 2006, people and the government spent $2.1 trillion on healthcare, an average of $7,026 a person, and that in 2017, health spending will cost an estimated $13,101 a person.8

The Journal of the American Medical Assn. (JAMA) recently said, "Rising healthcare costs in America continue to be a stumbling block to improved care, but researchers discovered that improving care by preventing errors and falls could bolster the value of healthcare and patient outcomes. Researchers estimate waste from illegible prescriptions, poor preventive care and other failures accounts for up to 50% of healthcare spending."9

"A recent American Society for Quality/Harris Interactive poll of U.S. adults 18 years of age or older confirms that this group is more concerned about the rising cost of healthcare than the Iraq war," Martin Merry, M.D., said. "Could this elevated concern about healthcare costs, and arguably value, be the catalyst that drives true change in our healthcare system?" 10

Systems thinking

Significant change is needed. Merry points out that Secretary of Health and Human Services Mike Leavitt refuses to use the term "U.S. healthcare system" and speaks of a healthcare sector seeking to become a system, which he predicts will happen over the next 10 years.11 Systems thinking and quality management systems are key elements of the quality body of knowledge.

Error-proofing methods implemented in other industries can be effectively applied to healthcare to virtually eliminate many errors. For example, anesthesiology is one hospital discipline that has used unique coupling devices for each type of gas to virtually eliminate errors.

Auto industry response

In response to the first IOM report on medical errors, the Automotive Industry Action Group (AIAG) and ASQ Healthcare Division published a guidance document for healthcare organizations, Quality Management Systems—Guidelines for Process Improvements in Healthcare Organizations (AIAG HC-1).12

The document, which is based on ISO 9004:2000, also includes a substantial glossary of terms, proven quality improvement practices and methods that could be easily applied to healthcare, such as error proofing, document control, quality and business planning processes, internal communications process and internal auditing.

Late quality guru Philip Crosby taught that communication in large organizations is hard at best, pointing out that unless it is worked on, it will not happen. The impact of poor communication in the ICU was discussed earlier,13 and it was implicit in Secretary Leavitt's comments.14

The stated goal of the AIAG HC-1, released in January 2001, was, "To aid in the development or improvement of a fundamental quality management system for healthcare organizations that provides for continuous improvement, emphasizing error prevention, the reduction of variation and organizational waste, for example nonvalue-added activities."15

Interest from other countries led AIAG and ASQ to release HC-1 under the auspices of the International Organization for Standardization, as the first industry workshop agreement (IWA-1) with the same basic goal, name and guidance.

IWA documents expire after a maximum of six years, so last fall, AIAG released a new hybrid standard, Business Operating System (BOS) for Health Care Organizations—Requirements for Process Improvements to Achieve Excellence (HF-2),16 which is based on the Baldrige healthcare criteria and ISO 9001:2000, to replace the now-expired IWA-1.

While these documents have evolved to include more healthcare terminology and examples, the intent and much of the content has remained the same. It includes methodology from the global automotive industry, including some elements of the Toyota Production System (TPS), such as workplace organization, pull systems of inventory management, visual controls and support for the employee.

Merry points out that Washington state's Virginia Mason Health System has virtually adopted TPS. "One of Mason's vice presidents said, 'We're now six years into our Toyota journey and achieving remarkable results in both quality improvement and cost containment. But our mentors tell us that we have another 15 years' hard work if we wish to fully realize the potential of Toyota's current and always evolving methods.'"17

Healthcare will need many more such mentors in the coming years to help implement the needed process and quality improvements.

What is needed now?

A strong cultural resistance to outside help within healthcare organizations is generally found today. This culture drives a premature and false conclusion that if you are not from healthcare, you don't have anything to contribute.

While there are pockets of excellence and they are growing in number, many in healthcare will dismiss outside attempts to help, content to practice as they have been until forced to change from within.

Barry Chaiken, M.D., said:

If we continue to approach the problem the same way, looking for some silver bullet, we can only expect the same outcome. Therefore, it is time for us to try something new.

A comprehensive approach to healthcare reform is necessary. Everyone, including physicians, nurses, patients, administrators, and insurers, must work together to form the solution.

Continuing to approach illness and deliver care the same way we have been doing for decades is sure folly. Physicians and nurses must begin to see their responsibilities in a different light and begin to do their tasks differently. Administrators and insurers must assist and incent them. Patients must take responsibility for their care and work to prevent illness rather than wait passively for resource-intense medical miracles to fix them. Physicians must direct care and prescribe therapies according to science and rational thinking rather than habit and personal preference.18

Note this includes a role for patients. Quality practitioners from all sectors should be the first among patients to accept this challenge and take it even further. ASQ's Automotive Division recently mobilized volunteer quality coaches to work with interested healthcare organizations on process and quality improvement.

Chaiken actually forgot one critical player and its potentially helpful role: the organizational purchasers of healthcare services, such as the U.S. automotive Big Three. These organizations could help break the gridlock by either requiring an independent management system, such as the BOS certification of healthcare plans and providers. Or, the purchasers could at least make certification a preferred supplier credential.

Healthcare has independent clinical accreditation programs, but these have not produced the desired result. As Chaiken said, we need to try something new. The BOS certification would generate momentum in the sector toward real improvement in cost, quality and patient safety.

JAMA adds, "Researchers suggest that to affect change, data should be collected and mapped to provide healthcare professionals with a clear understanding of how often hospital-acquired infections, for instance, occur per year and how much those infections and their subsequent treatment add to the direct and indirect costs of healthcare."19

Data collection and analysis

This type of data collection and analysis is fundamental for quality practitioners. Data can be effectively used to persuade healthcare practitioners to acknowledge what must be done to improve. To sustain the gains and drive continual improvement, quality practitioners should help organizations implement a management system, such as BOS.

A significant, sustained grass-roots and concerted effort to drive quality proactively into healthcare is needed. If you are a quality practitioner, the nation's healthcare delivery sector needs your time and expertise.

In my previous column in QP's November 2007 issue, I described the AIAG BOS document in some detail and suggested that the use of standards like BOS need to be integrated into undergraduate college curricula. Business and quality management science should incorporate lessons from industry.

In late January, the ASQ Healthcare Division launched a Quality Education in Healthcare Committee with more than 60 volunteers to address issues including:

  • What healthcare content should be in Quality 101 type introductory lessons for all healthcare professionals?
  • What content should be in more comprehensive advanced programs?
  • What are the best ways to influence new students throughout the health professions, and what are the best ways to support continuing education of working professionals?
  • Should ASQ remain just another provider of educational materials and courses, or become the accrediting body for academic programs in quality offered by other institutions?
  • Is certificate-level training of technicians sufficient, or is an applied graduate degree for professionals the more appropriate credential for leaders?
  • How can ASQ best serve members of its Healthcare Division who are engaged in education through schools of laboratory technology, medicine, nursing, public health and others?
  • What type of relationship should ASQ foster with secondary and postsecondary institutions?

Call to action

As this issue of QP was going to press, this committee was developing initial recommendations. Much work lies ahead in getting appropriate curricula into education. Perhaps you have experience that can help the committee with this work.

Consider this column a call to action, with several opportunities to serve listed. There are others. The healthcare sector needs you. Quality practitioners need each other to respond to this challenge. Get involved today—the life you save might be your own.


  1. Institute of Medicine, "To Err Is Human—Building a Safer Health System," National Academy Press, 2000, (Link).
  2. Arthur Levin, "The Medical Consumer: A Trillion Here, a Trillion There," Indenews.com, (Link).
  3. Robert M. Wachter, "The End of the Beginning: Patient Safety Five Years After 'To Err Is Human,'" (Link).
  4. Ibid.
  5. Rong-Gong Lin II and Teresa Watanabe, "Hospital Drug Errors Far from Uncommon," Los Angeles Times, Feb. 15, 2008, (Link).
  6. Ibid.
  7. Institute for Healthcare Improvement, "An Introduction to the 5 Million Lives Campaign," (Link).
  8. "Healthcare Bills May Hit $4 Trillion By 2017, Sector Could Grab 20% of Spending," Associated Press, Feb. 26, 2008, (Link).
  9. Thomas F. Boat, Samantha M. Chao and Paul H. O'Neill, "From Waste to Value in Healthcare," Journal of the American Medical Assn., Feb. 6, 2008, pp. 268-271.
  10. Martin Merry, M.D., "A Shift in Thinking," Hospital and Healthcare Networks Online, Sept. 18, 2007.
  11. Ibid.
  12. Quality Management Systems—Guidelines for Process Improvements in Healthcare Organizations (AIAG HC-1), Automotive Industry Action Group and ASQ, 2000.
  13. Wachter, "The End of the Beginning: Patient Safety Five Years After 'To Err Is Human,'" see reference 3.
  14. Merry, "A Shift in Thinking," see reference 10.
  15. AIAG HC-1, see reference 12.
  16. Business Operating System (BOS) for Health Care Organizations—Requirements for Process Improvements to Achieve Excellence (HF-2), AIAG, 2007.
  17. Merry, "A Shift in Thinking," see reference 10.
  18. Barry P. Chaiken, M.D., "Healthcare IT: Slogan or Solution?" Patient Safety and Quality Healthcare, Feb. 24, 2008, (Link).
  19. Boat, "From Waste to Value in Healthcare," see reference 9.

R. Dan Reid, an ASQ fellow and certified quality engineer, is a purchasing manager at General Motors Powertrain. He is co-author of the three editions of QS-9000 and ISO/TS 16949; the Chrysler, Ford, GM Advanced Product Quality Planning With Control Plan; Production Part Approval Process and Potential Failure Modes and Effects Analysis manuals; ISO 9001:2000; ISO IWA 1; and the new AIAG Business Operating Systems (BOS) for Health Care Organizations (HF-2).

Having just lost a parent to a medical error, this article really summarized my concerns and highlighted an area where there is clearly a need for quality improvement. Having been through the hospital complaint process, and received their final feedback, I was struck by the lack of system level response. I was also surprised to find out that there is no adverse event reporting requirements in effect for medical errors (except for specific medical device malfunctions or adverse pharmaceutical reactions).
--Elizabeth Nichols, 05-03-2008

Average Rating


Out of 1 Ratings
Rate this article

Add Comments

View comments
Comments FAQ

Featured advertisers