U.S. hospitals adopting the ISO: 9001-2008 quality management system as a component in overall care improvement is a growing trend. Chris Crawford, vice president of Quality for Lee Memorial Health System in Fort Myers, Florida, answered our questions about why her hospital recently stopped seeking Joint Commission accreditation and instead became the first hospital in Southwest Florida and one of only 60 hospitals nationwide to achieve ISO: 9001-2008 certification through DNV GL.

HealthCXO: Although seeking ISO: 9001-2008 certification is a growing trend among U.S. hospitals, it is still fairly uncommon. What does the certification do for Lee Memorial Health System that other approaches to quality improvement would be unable to do?   

Crawford: ISO:9001-2008 quality management system is more than just an approach to quality improvement. The ISO quality management system addresses all processes of Lee Memorial Health System including our clinical, supportive and business processes. Within ISO we still select an approach to quality improvement but quality improvement is only one component of ISO.   

HealthCXO: Clinicians sometimes have concerns that standardization of care delivery could mean loss of local control. How did you get employees and individual clinical departments onboard with the ISO: 9001-2008  certification effort and its focus on documentation and standardization.  

Crawford: ISO requires standardization but does not define the standards. For patient care areas, it is the clinicians that define their standards of care delivery. Clinicians involved in the processes determine care delivery based upon nationally recognized standards of practice. Once we define our standards, we are required to follow our processes.  Simply put "we do what we document and document what we do." 

HealthCXO: Healthcare providers are already subject to a fair amount of oversight, including Joint Commission surveys. Was adding an additional outside auditing process by seeking ISO: 9001-2008 certification a concern for Lee Memorial Health System?

Crawford: The leaders of Lee Memorial Health System were seeking to adhere to a higher standard of conformance. ISO, as an international standard, provided the leaders with that opportunity. We chose DNV GL as our accreditation organization instead of the Joint Commission precisely because DNV GL incorporates the ISO certification as part of its requirements in addition to adherence to the federal regulations. DNV GL requires an annual survey (instead of every three years by the Joint Commission). During the annual surveys we are evaluated for both regulatory and ISO conformance. The annual surveys and ISO auditing processes have allowed us to sustain reliability and transparency. 

HealthCXO: Considering the sometimes challenging reimbursement environment healthcare systems operate in, was cost a concern for Lee Memorial Health System when it decided to seek ISO: 9001-2008 certification? 

Crawford: Accreditation organizations charge for their oversight whether it is DNV GL or the Joint Commission. Therefore, the shift from Joint Commission to DNV GL and ISO certification was not an additional cost. We have implemented ISO without requiring additional resources. There is a cost benefit associated with ISO. Through standardization of work and driving out variation, there is reduction of costs associated with rework.

About Lee Memorial Health System

Lee Memorial Health System notes that it has been an integral part of Southwest Florida since 1916 when it first opened its doors as Lee Memorial Hospital. The health system operates 1,423 licensed beds in four acute care hospitals, a designated children’s hospital and a rehab hospital. It also operates physician practices, several outpatient diagnostic facilities, two wellness centers, a home health agency and a skilled nursing facility.

The health system provides several services unique to the region, a trauma center, Regional Cancer Center, Regional Perinatal Intensive Care Center, Neonatal Intensive Care Unit, and kidney transplant program.

It is the fifth largest public health system in the United States and the largest community-owned health system in Southwest Florida, with more than 10,000 employees.