Hospital Health System Shares Lessons Learned in its ISO Certification Journey

There is a growing trend across the U.S. for hospitals to seek ISO: 9001-2008 certification as a key component in their continuing commitment to be a highly reliable organization.

Lee Memorial Health System recently became the first hospital in Southwest Florida, among six in Florida, and 60 in the United States to receive the ISO: 9001-2008 Certification through DNV. “This certification has allowed the health system to better provide standardized, high quality, reliable care that positively affects patient outcomes,” explains Chuck Krivenko, M.D., chief medical officer of clinical and quality services for Lee Memorial Health System.

ISO allowed the Health System to implement a Quality Management System that encompasses all stages of healthcare processes from support staff to patient care. “Quality is now the responsibility of everyone in the health system, instead of just the quality department,” according to Krivenko.

Each department is audited yearly in order to find any variation within the system and to create a standard for all departments to uphold. Chris Crawford, vice president of quality for Lee Memorial Health System explains, “ISO pushes us to take everything one step further. For example, instead of just checking that our thermometers are calibrated, we go a step beyond and make sure that the calibrator is working properly, too.”

ISO standardization isn’t cookie-cutter or one-size-fits-all, but instead allows each hospital and department to create an individualized plan that is focused on continual improvement. “ISO helps us move past just fixing broken things and encourages us to focus on putting the right processes in place to be a highly reliable organization,” says Crawford. The objective is simple, but effective: document what you do, and do what you document.

It was the underlying structure of ISO that made DNV appealing to the health system in the first place. It was one of the main reasons LMHS switched accreditation firms in 2010. Before making the change, Lee Memorial first created a multi-disciplinary task force to review the hospital’s accreditation standards and to reach out to other hospitals that were pursuing ISO certification. While some employees were at first skeptical about DNV, it quickly gained popularity within Lee Memorial and was noted for its simplicity, transparency, and individualization.

Obtaining ISO Certification wasn’t easy, but hospital administrators learned a few lessons along the way that could prove helpful for other hospitals looking to make this change. Krivenko and Crawford suggest:

• Before deciding to pursue ISO certification, follow accreditors on survey at another hospital in order to see firsthand the differences in the process.
• Be sure to get buy-in from staff leaders. Having all employees on board is crucial in carrying out the new processes.
• Don’t staff up for certification. LMHS did not add any FTEs in its successful attempt to become certified. The process uses only the resources you already have in place.
• Be willing to grow and learn as you move along. This is not a process you can follow like a recipe. You have to make it your own.
• Fuse it into the quality processes you already have in place. ISO is not a whole new set of steps to take, but instead puts measuring and monitoring in place to avoid the back slide that inevitably occurs in non-systemic approaches.  
• Allow for innovation; creative thinking leads to continuous improvement.
• Understand that it takes time to assimilate to new quality processes and for the system to mature. Give yourself time for quantified results to become apparent.                                                                                                                                           

Crawford and Krivenko note that employees throughout the system have been more readily cooperative in their compliance to the standardization than they have in the past. As with any change, time and flexibility is required, but patience in this arena has allowed for maturation of the process, which has brought increased improvement within the health system.

“ISO certification is a rigorous process to undertake, but we chose to pursue it because the bottom line is our patients expect quality care when they come to our hospitals. ISO helps us achieve it.”