A business case for patient safety.

Publication of the Institute of Medicine's report, To Err is Human, in November 1999 represented a landmark event for advancing patient safety and reducing error in the American health care system. (1)

The federal government, business community, media and public's responses were swift to the revelation that as many as 98,000 patients are dying each year in American hospitals because of medical errors.

In early December 1999, President Clinton tasked the Quality lnteragency Council to review the IOM report and develop a plan for implementation of its recommendations within the branches of the federal government that provide or purchase health care services. (2)

Business leaders and purchasers of health care services also became galvanized, and initiatives such as the Leapfrog Group began to apply economic pressure for health care reform designed to reduce error and to enhance patient safety. (3)

Thought leaders like the late John M. Eisenberg, MD of the Agency of Healthcare Research and Quality and Dennis M. O'Leary, MD, president of the Joint Commission for Accreditation of Healthcare Organizations, also zeroed in on the problems of medical error and patient safety.

An idea that coalesced from these efforts was the development of a rigorous argument for a business case to support the concepts of patient safety and reduced medical errors. Such a case would be persuasive for health care executives and trustees to direct scarce investment dollars into quality improvement projects.

AHRQ and JCAHO convened a conference for hospital chief executives that met in Arlington, Virginia in September 2002, to articulate the business case for patient safety. The Department of Defense and the Centers for Medicaid and Medicare Services also support ed the conference. About 150 hospital and health system chief executive officers and other governmental and health care industry professionals attended the confer ence. The preliminary report of this symposium can be reviewed online. (4)

Making a case

The business case for patient safety is not only a financial argument. Rather, it encompasses a wide range of business activities and concerns. These include:

* Business ethics 

* Socio-political considerations

* Empirical evidence of efficacy of patient safety and error reduction interventions

* Medico-legal considerations

* Improved market share

* Human resources factors

* Financial and capital budgeting decisions

Here's a closer look at each of these elements that will help physician executives better understand the business case for patient safety.

1. Ethical argument

The business ethics argument for patient safety is expressed in the dictum, "First, do no harm." Health care providers must assure that their activities, at the very least, do not have adverse effects on their patients.

This fundamental principle of medicine was probably first expressed by Hippocrates in 400 B.C. in his Epidemics. The well-known Latin translation, "primum, non nocere," has been subsequently attributed to the ancient physician, Galen, who practiced in Rome in 400 A.D. (5)

The earliest modem restatement of the principle is found in Florence Nightingale's Notes on Hospitals, published in 1865. (6) Since then, "do no harm" has become a standard presented at the earliest point of modern medical education. (7)

As an extension of the golden role of ethics, the primum non nocere principle is the foundation of modern medical ethics and it serves as the ethical standard and moral imperative fundamental to the business case for patient safety.

2. Socio-political argument

The socio-political argument to support businesses' promoting patient safety is that this is a prudent course of action because patient safety issues and reducing medical errors are significant concerns for the public.

The general population's interest in patient safety issues is reflected in the lay press (8) and has been studied and reported in the medical literature as well.

A recent survey conducted by file University of Colorado shows that 68 percent of the general population has serious concerns about the overall quality of health care in the United States and 87 percent agree that error reduction in medical practice should be a national priority. (9)

It is of interest in this study that in a concurrent national sample of physicians, only 35 percent agreed with the first premise that the quality of health care was suboptimal and only 75 percent agreed with the second premise that medical error reduction should be a national priority.

3. Evidence-based strategies argument

The evidence-based strategies argument is that scientifically established practices that improve patient safety should become the standard of high quality health care.

AHRQ published a comprehensive review of current strategies for improving patient safety and reducing medical error. (10) This review identified 79 practices with potential for reducing error and improving patient safety.

After a thorough review of the relevant literature, 11 practices were identified as having the strongest objective evidence supporting more widespread implementation.

Although cost data were not included in tiffs analysis, many of the practices such as the appropriate use of prophylaxis to prevent venous thromboembolism in patients at risk and the use of perioperative betablockers in appropriate patients to prevent perioperative morbidity and mortality are relatively inexpensive and would be expected to provide a strong return on investment.

4. Medico-legal argument

The medico-legal argument flows from the evidence-based strategies. It says that patients are due compensation if they suffer injuries as a result of negligence due to deviation from the established standard.

The tort system in the United States is believed to be a major barrier to the implementation of the reporting system that is an integral part of a national patient safety program. (11) Efforts at reforming the tort system and malpractice liability are underway in many states.

From the perspective of the business case, reduction in liability cases with a subsequent decrease in liability insurance premiums is a strong argument to improve patient safety and to reduce medical errors.

(5.) Market share growth argument

There are anecdotal data that support the contention that health care systems that focus on quality are rewarded by achieving a relatively larger market share than their competitors. (4)

These data support the argument that investments made in patient safety and reducing medical error--when accompanied by appropriate marketing and with effective recognition by the news media--will ultimately be beneficial to the organization.

Many local factors drive market share, however, and this argument cannot stand alone in developing the business case for patient safety.

6. Human resource management argument

To the nurses, pharmacists, house officers and other practitioners employed in a health care system, patient safety is not just a theoretical concern. It is a daily battle, and it is a battle for survival of the patient and, at times, the practitioner.

An effective system-wide commitment to a culture of safety is of prime importance in recruiting and retaining high quality staff in an era of staff shortages. (12)

It will become a major differentiation among health systems as they compete in the labor marketplace for employees. the health care system with a well-defined patient safety and medical error prevention program will have the competitive advantage.

Published studies are documenting the relationship between sub optimal staffing levels and poor patient outcomes, (13) and, recognizing the dangers inherent in the current status quo, AHRQ is funding a major initiative to study and improve the impact of working conditions on patient safety. (14)

7. Financial argument

The ultimate argument for the business case for patient safety is the financial argument. This argument is ideally based on returns on investment.

There are, however, few specific studies that provide such analyses for patient safety and medical error reduction strategies.

Impressive data for cost savings have been recently presented and there appears to be financial evidence supporting strategies to:

* Reduce adverse drug events ($3,000 savings per event)

* Curtail postoperative wound infections ($14,000 savings per case)

* Properly manage patients with Type II diabetes mellitus ($30,000 over 15 years per patient) (14)

These examples, however, include only the estimated cost savings and do not give the figures for the estimated investments required achieving these ends.

Rigorous analyses of return on investment for patient safety and medical error reduction interventions have not been performed. Meaningful data are needed in order for these analyses to be performed.

In recent dialog with health system CEOs, a strong request for resources to fund such studies has been made to AHRQ. (4)

As health care organizations consider choices for investing in patient safety and medical error reduction, physician executives can provide valuable input on these decisions.

Physician executives must understand the seven arguments that comprise the business case for patient safety in order to bring the greatest value to their organizations.

References

(1.) Kohn, LT, Corrigan, JM, Donaldson, MS, eds. To Err is Human: Building a Safer Health System. Washington, D.C, National Academy Press, 2000.

(2.) Quality Interagency Coordination Task force (QulC) http://www.quic.gov/report/

(3.) The leapfrog group for patient safety: rewarding higher standards. http://www.leapfroggroup.org/

(4.) The business case for patient safety: a symposium for CEOs. http://bizcase.dnsalias.com/summary.html

(5.) Primum non nocere, http://www.geocities.com/everwild7/noharm.html

(6.) Nightingale, E Notes on Hospitals. London, England, Longman, Robert& and Green; 1863.

(7.) Oetgen, WJ. Medical heuristic. Ann Intern Med. 1996 Jul 1;125(1):77-8.

(8.) Boodman, SG. "No end to errors." Washington Post December 3, 2002: F1, F6.

(9.) Robinson, AR, Hohmann, KB, Rifkin, JI, Topp, D, Gilroy, CM, Pickard, JA, Anderson, RJ. "Physician and public opinions on quality of health care and the problem of medical errors" Arch Int Med. 2002;162:2186-2190.

(10.) Making Health Care Safer. A Critical Analysis of Patient Safety Practices: Summary July 2001. AHRQ Publication No. 01 E057. Agency for Healthcare Research and Quality, Rockville, MD. http://www.aheq.gov/clinic/ptsafetv/summary.htm

(11.) Brennan, TA. "The Institute of Medicine report on medical errors--could it do harm?" N Eng J Med 2000; 342:11231125.

(12.) Selberg, JD. The architecture of the business case for patient safety: more than just a financial argument. http://bizcase.dnsalias.com/slideshows.html

(13.) Aiken, LH, Clarke, SP, Sloane, DM, Sochalski, J Silber, JH. "Hospital nurse staffing and patient mortality, nurse burnout, and job dissatisfaction." JAMA 2002; 288 (16): 1987 1993.

(14.) Impact of working conditions on patient safety. Fact sheet At1RQ Publication No. 03 P0003, October 2002. Agency for Healthcare Research and Quality, Rockville, MD. http://ahrq.gov/news/workfact.htm

William J. Oetgen, MD, MBA, is chief medical officer of HealthScribe, Inc., an Internet-enabled outsourcing company specializing in data management and transcription services to health care organizations. He is a practicing cardiologist and an adjunct faculty member of Georgetown University's School of Medicine and McDonough School of Business. He is an advisor to the Department of Defense Patient Safety Center at the Armed forces Institute of Pathology. He can be reached by phone at 301-535-2493 and by e-mail at [e-mail].

Phyllis M. Oetgen, JD, MSW is the president of MedTrans, L.L.C, a medico-legal consulting firm. She is an advisor to the Department of Defense Patient Safety Center al the Armed Forces Institute of Pathology and is the editor of Patient Safety, the Department of Defense newsletter devoted to medical error reduction and the patient safety program. She can be reached by phone at 301-535 2494 and by e-mail at [e-mail].