An ISO certification calls for a continual evaluation of processes, improvements in those processes, reevaluation, more improvement--it’s an approach to quality well suited to complex, compliance-driven organizations like hospitals.
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| Frank J. Bartell III |
The commitment to quality at St. Luke’s, Maumee, Ohio, has always been a competitive differentiator. We earned accreditation with commendation and a score of 98 back when JCAHO gave out numerical ratings. Our ongoing JCAHO surveys, combined with a variety of other clinical best-practices initiatives and state and federal compliance programs, have shown our dedication to quality.
We always thought these credentials were appreciated by the community we serve. But three years ago, our constituents told us they wanted us to prove our commitment to quality in terms they could understand. As important as hospital measurements are, businesses and the general public don’t relate to them.
We operate in an economic region driven by automobile manufacturing, including many small supply and service businesses, and we realized that most of our clientele spelled quality with three letters: ISO.
Our community asked us, “If we’re using ISO to produce better products and prove that we’re continually improving, why aren’t you?”
ISO is the universal measure of quality in many other industries. And there is absolutely no reason it can’t be in health care.
ISO, the International Organization for Standards, is a nongovernmental consortium founded in 1947 to develop voluntary standards for improving industrial performance. Today, more than 90 countries are members of ISO; the U.S. representative is the American National Standards Institute (ANSI).
Initially, ISO standards focused on technical specifications geared for manufacturing and scientific industries. In 1987, ISO expanded its scope with the ISO 9000 Quality Management System, a new family of standards that addressed a broader range of business processes applicable to virtually any type of organization.
Those of you familiar with TQM, CQI and the other acronyms created during the quality revolution in the 1990s will recognize ISO 9000 as the defining standard, the “must have” certification for quality-driven companies.
The most recent update to the ISO 9000 standard is ISO 9001:2000. This is the certification we achieved at St. Luke’s Hospital.
Hospitals wishing to obtain ISO 9001 certification must work with an ISO registrar, an outside group that will conduct the audits and follow-up inspections required by the ISO process.
The basic idea of ISO 9001 is to find the things in your business that work best and turn them into standard operating procedures. The key to ISO 9001--and the feature that makes it different from all other quality initiatives--is that it’s perpetual. It doesn’t stop when a best practice has been identified and instituted. ISO 9001 is a way of approaching work that not only makes each activity as efficient as it can be, but continually searches out improvements.
ISO 9001 is a quality management system. It requires the organization to document and demonstrate a sequence and interaction of processes, conduct internal audits to evaluate processes, identify corrective and preventive action to improve processes, and monitor the processes to ensure there is continual improvement. For hospitals, ISO 9001 means identifying the elements in clinical and administrative practices that contribute to desirable outcomes, documenting those elements and instituting them as standard practice. Some examples include improved communication among staff members, revisions to policies to reflect best practice, standardization of forms used for documentation of patient care activities, and detection of problem-prone issues.
ISO 9001 is designed to prevent the “backslide” that occurs in every nonsystemic approach to quality. When actions are taken, ISO 9001 requires the organization to assess continual improvement. At St. Luke’s we maintain a database of corrective and preventive actions and we apply follow-up dates to ensure that we are sustaining the improvements made. This creates more awareness for staff and requires that monitoring be in place to ensure that problems do not recur.
While our industry has a variety of initiatives that aim to improve the quality of health care and reduce errors, none of these concepts needs to be abandoned with ISO 9001. ISO is a way of ensuring that the initiatives improve practices--and that they continue to do so. The system is entirely compatible with any health care organization.
St. Luke’s Hospital is a 302-bed multispecialty hospital that for 100 years has provided benevolent care to northwest Ohio, keeping with the tradition set by its founder, Dr. William Gillette. St. Luke’s has more than 1,200 employees including over 800 physicians on staff.
After getting a vote of confidence from our board on pursuing ISO certification, we knew we needed a partner to help us in the planning and implementation of a new process.
The organization we tapped for certification, TUV Healthcare Specialists, happened to be the same group that was already helping us with our ongoing prep for JCAHO surveys. Internally, we appointed a quality manager who acted as the overseer on the entire ISO 9001 process.
The initial phase of implementing ISO 9001 involved creating a document control system for the entire hospital, which impacted policies and procedures as well as paper and electronic forms. We also ensured that the staff used the most current revisions to these documents. It was a great learning process to identify outdated and repetitive documents and to centralize these so that we were all on the “same page.”
We created an online system for these documents that is accessible to staff and eliminates the need to maintain several manuals in multiple locations throughout the organization.
During this phase, our team leaders defined and mapped the key processes and workflow in their departments. We found that we were using more than a thousand words to describe our processes. We broke these down to identify internal and external customers, staff qualification requirements, measures used to identify effectiveness and efficiency of the process, and documentation requirements (work instructions, policies, forms used, etc.). This exercise created more of a graphical representation of our processes and provided more of a macro view of the primary processes for patient care as well as the other processes that support them.
Much of this, by the way, mirrors the “tracer” process and will be quite familiar to most hospitals.
The preparation for the ISO 9001 certification audit identified weaknesses throughout the organization that we had always thought were in good shape. We learned a great deal about ourselves as an organization; it was worth the efforts and resources that we have devoted to this process.
This initial phase took us about three months.
Most of our clinical departments adapted fairly quickly to the documentation formats and review processes demanded by ISO 9001. This was one of our most pleasant surprises. Our clinical staff did not feel like they were being hassled.
Without question, the most demanding aspect of ISO 9001 is its requirement that the hospital work even harder on maintaining its quality efforts than on starting them. We have devoted a lot of attention to measuring, monitoring and following up the issues we have addressed through our corrective and preventive actions. This ongoing, required follow-up ensures that the actions taken have been effective in sustaining improvements and continually making them better.
At St. Luke’s, we formed a 20-person ISO 9001 task force that represents all clinical and nonclinical departments. This group, which meets once a month, functions almost as an internal board of quality directors. They follow a team-based assessment doctrine that requires each department to demonstrate its adherence to quality objectives.
Getting certified for ISO 9001 is one thing; keeping that certification is another. The accountability is on St. Luke’s to ensure that the quality management system is effective. We are now subject to annual surveillance audits that require us to demonstrate our effectiveness. There is no break; this is a constancy of purpose. We have to maintain our processes and improvements to get better. Assess, improve, monitor--this will allow our quality management system to mature over time.
We believe that measurable improvements in clinical indicators will take time, perhaps a few years, to really become evident. But in terms of the everyday workflow, the motivation of the staff and the “provability” of our dedication to quality, I’d say ISO 9001 is already a small investment for a very big return.
The certification has helped us develop a process for standardization. We have combined the CMS COP regimen with the requirements of ISO to provide a comprehensive management system for quality and standardization. The ISO process also gives us a model the nonclinical departments can use.
In addition, we found our ISO certification effort to be a great structure for our documentation procedures. If you’re guessing that being data-centric in your quality efforts will help you with HIPAA, the new “surprise surveys” from JCAHO and any number of other compliance mandates, you are correct. We are eminently more prepared than we have ever been.
Because of its emphasis on standardization and documentation, ISO 9001 helps everyone in a complex organization get onto the same page. Yet for all the benefits inside the hospital, including its compatibility with our current JCAHO accreditation surveys, ISO has provided us a breakthrough in portraying our quality to the general public.
Frank J. Bartell III is president and CEO of St. Luke’s Hospital in Maumee, Ohio.
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This article 1st appeared on August 8, 2006 in HHN Magazine online site.
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