Editor`s Opinion: Finally on Track: Quality of Care
The train has left the station. All major stakeholders are on board. The destination? A healthcare system that provides quality care and optimal outcomes.
Time and time again, regular readers of the OWM editorial pages have seen the words “safety and effectiveness.” We kept waiting for a public outcry following the 1999 Institute of Medicine’s observations, “between 44,000 and 98,000 people die in hospitals each year as a result of preventable medical errors” and that “healthcare is a decade or more behind many other high-risk industries in its attention to ensuring basic safety.”1 We wondered about the rationale for and potential risks of the 1997 changes in the Food and Drug Administration device regulations, joined the chorus of healthcare professionals concerned about the safety and effectiveness of drugs and devices, and worried about the limitations of existing post-market surveillance efforts.2-4
Change comes slowly in a complex environment not generally known for being proactive. But the exorbitant financial burden and human suffering associated with providing less-than-optimal care – along with increased access to information, heightened public awareness, and a few high-profile product recalls5,6 – have fueled the engines of change and the train is finally moving.
Who is on board? Big business is on board. The Business Roundtable, the US association of Fortune 500 chief executive officers, endorsed the efforts of the Leapfrog Initiative to improve quality in the healthcare marketplace.7 Many hospitals are on board, joining the 100,000 Lives Campaign, a nationwide effort to reduce morbidity and mortality in American healthcare.8
Realizing that current payment systems reward high volume and services instead of better health, the Centers for Medicare and Medicaid Services also is on board. In addition to efforts that include developing evidence-based surveyor guidelines for extended care facilities, the CMS launched its Pay-for-Performance initiative to accelerate the pace of quality improvement and to develop measures to assess performance.9
Many legislators are queuing up to board. For example, with hospital-acquired infections now recognized as a major source of morbidity and mortality (tripling mortality rates, length of stay, and average charges),10 Pennsylvania legislators decided that, as of this month, all hospitals in the state will be required to report their nosocomial infection rates to the Pennsylvania Health Care Cost Containment Council.
Finally, the US Food and Drug Administration is on board. Shrinking resources at the FDA and increasing concerns regarding safety have resulted in a proposal to overhaul the system in order to provide a “seamless approach to the regulation of medical devices.”11 Recommendations include improving the current passive surveillance system that relies on voluntary submission of adverse event reports, expanding real-time surveillance, and focusing on “enforcement strategies on post-market issues.”
Even though the ultimate goal of these efforts is clear, debate and concern regarding proposed methods, benchmarks, and indicators remain. For example, beyond the basics (eg, infection control), which hospital performance measures define good care and (most importantly) improve outcomes? The need for answers makes it crucial for our readers –wound, skin, ostomy, and continence experts all – to get on board. We must be part of the crew that lays the tracks. In addition to understanding and implementing currently promoted safety initiatives such as electronic medical records and rapid response teams, we must remind all stakeholders about the well-documented impact of nurse staff levels, expertise, and work environment on patient safety and outcomes such as the development of pressure ulcers and the healing of chronic wounds.12-14 We need to be at the table where the decisions are made – our expertise and the current evidence must be used to develop meaningful performance measures, outcomes, and study hypotheses for much-needed research.
Helping to lay the tracks is much easier than trying to move them afterward. If you are not on board yet, this is the time to get your ticket. Wishing you all a smooth ride this year.
This article was not subject to the Ostomy Wound Management peer-review process.
1. Institute of Medicine. To Err is Human: Building a Safer Health System. Washington, DC: National Academy Press. November 1999. Available at: http://www.nap.edu/books/0309068371/html/. Accessed January 4, 2006.
2. van Rijswijk L. Product safety and business interests: a delicate balance. Ostomy Wound Manage. 1999:45(3):4-6.
3. Wood AJ, Stein CM, Woosley R. Making medicines safer – the need for an independent drug safety board. NEJM. 1998;339(25):1851-1853.
4. McGinley L. Think tank with ties to Gingrich unveils plans to replace FDA. Wall Street Journal. February 2, 1995.
5. Topol EJ. Failing the public health – Rofecoxib, Merck, and the FDA. NEJM. 2004;351(17):1707-1709.
6. Meier B. Flawed device places FDA under scrutiny. New York Times. December 15, 2004.
7. Milstein A, Galvin RS, Delbanco SF, Salber P, Buck CR. Improving the safety of health care: the Leapfrog initiative. November/December 2000. Available at: http://www.acponline.org/journals/ecp/novdec00/milstein.htm. Accessed December 1, 2006.
8. Institute for Health Care Improvement. 100k lives campaign. Available at: http://www.ihi.org. Accessed December 1, 2006.
9. Institute of Medicine. Rewarding Provider Performance: Aligning Incentives in Medicare. Washington, DC: National Academy Press; September 2006.
10. Pennsylvania Health Care Cost Containment Council. Hospital Performance Report. September 2006. Available at: http://www.phc4.org. Accessed October 1, 2006.
11. The Center for Devices and Radiological Health. Report of the Postmarket Transformation leadership team: strengthening FDA’s postmarket program for medical devices. Bethesda, Md: United States Department of Health and Human Services, Food and Drug Administration; November 2006. Available at: http://www.fda.gov/cdrh/postmarket/mdpi-report-1106.html. Accessed December 11, 2006.
12. Institute of Medicine. Keeping Patients Safe: Transforming the Work Environment of Nurses. Washington, DC: National Academy Press;2003. Available at: http://www.iom.edu/cms/3809/ 4671/16173.aspx. Accessed December 11, 2006.
13. Cho SH, Ketefian S, Barkauskas VH, Smith DG. The effects of nurse staffing on adverse events, morbidity, mortality, and medical costs. Nurs Res. 2003;52(2):71-79.
14. Bolton L, McNees P, van Rijswijk L, et al. Wound-healing outcomes using standardized assessment and care in clinical practice. JWOCN. 2004;31(2):65-71.
