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Hospitals that have been tracking the development of ISO 9000 in the health care industry should pay close attention to a new guideline about to emerge that experts say will be the system’s next leap forward. Many hospitals know about the ISO 9000 standard series but not about its requirements. The International Organization for Standardization’s Technical Committee (TC 176) produces the international quality management and quality assurance standards known as the ISO 9000 series of standards. The Geneva, Switzerland-based ISO establishes common sets of manufacturing, trade, and communication standards.
According to Laura Preole, health care services manager of SGS International Certification Services based in Rutherford, NJ, the new guideline is the latest step in an effort to establish a more "process-oriented" method of looking at the health care environment from the moment a patient walks into a facility to the moment he or she is discharged.
The new guideline will be the product of a meeting co-hosted last month by the Standards Council of Canada and Canadian Standards Association International. The goal is a published guideline to help health care organizations understand how to interpret the existing standard for their businesses, explains Preole, who has been an active participant in its development. The current standard for ISO is only 20 pages long and lays out 20 requirements that define a quality management system.
"It gives you a set of end results so that standard can be applied to a variety of industry sectors," explains Preole. "It talks about quality management systems rather than health care accreditation standards."
According to Joe McMahon, senior program officer for the ISO Standards Council of Canada in Ottawa, which was instrumental in the meeting, the ISO health care division felt it was important to take the existing standard one step further while also providing additional guidance on ISO 9004:2000. The new standard is called 9004:2000, even though hospitals pursuing certification would be using ISO 9001:2000. "Where this goes from here will be determined at the workshop itself," explains McMahon. "This is not a training session in any respect; it is a working session."
Among the hospitals that have already moved in the direction of ISO is Memorial Medical Center of West Michigan, a 95-bed facility in Ludington. Roughly six years ago, the hospital became dissatisfied with the survey process and objectivity of the Oakbrook Terrace, IL-based Joint Commission on Accreditation of Healthcare Organizations, says Robert Marquardt, Memorial’s CFO. "We really questioned the value that we were getting from the Joint Commission," he recalls. But the hospital was concerned how its patients would respond if it made a change.
To address those concerns, Memorial implemented a novel survey. "We went out to the real world and called about 400 households in our county and asked them a series of questions related to this topic," Marquardt reports. He says the survey showed that only about six households out of 400 even knew what the Joint Commission was, and only a few of them placed any value on the process.
"What we found was that the [Joint Commission] designation really has zero meaning to the people that we take care of." Among the hospital’s large payers there was even less interest in the Joint Commission, he adds. At the same time, Marquardt says, the hospital felt rudderless without some type of external assessment to gauge the quality of its services. "We were less concerned with who that external body was than having somebody outside the organization to provide an effective assessment."
After briefly tapping an outside consultant to fulfill that role, Marquardt says, Memorial opted to use ISO for two primary reasons:
1. Memorial wanted to be able to relate its quality experience to the manufacturing community. That made the ISO process immediately attractive because many employees at the hospital already understood what is involved with that certification process. From a marketing perspective, that created a powerful tool, Marquardt says. As the process unfolded, however, he became even more interested in what the process could do for the hospital internally. "It had a very powerful impact on the manufacturing community, but the result we were most excited about was what it did for us internally."
According to Marquardt, those improvements included documenting processes that were already occurring in the organization but had never been tracked. "The strength of the process for us has been the internal auditing," he says. "We have been able to document our strategic planning process and our quality improvement process along with the results of that process."
Marquardt says the ISO process not only gauges improvements against the ISO standard itself but broader areas that take into account actual performance areas, such as customer services expectations, corporate compliance training, and safety and security. "The tool and the framework it provides are just very powerful," he says.
2. Memorial wanted to save money on survey fees. The savings were immediate, Marquardt says. At the time Memorial disengaged from the Joint Commission, those survey fees were going to run $35,000 to $40,000. By contrast, initial ISO survey fees amounted to less than $5,000.
Most of the hospitals that so far have moved in the direction of ISO have been similar in size to Memorial, and it is difficult to know how rapidly larger hospitals will follow. Marquardt says the limiting factor at the present time in Michigan is that Blue Cross and Blue Shield of Michigan will allow only small rural hospitals to forgo Joint Commission accreditation. "To the extent that Michigan and other states modify that requirement, things may start to break loose a little bit," he predicts.
Marquardt maintains that ISO is a substantially more powerful tool for improving quality and focusing management activity in key areas. But he adds that every hospital must make that assessment for itself. "We don’t necessarily advocate that everybody follow our lead and sever their ties with the Joint Commission," he says.
Hospitals that are not affected by deemed status have more opportunity to shift to ISO, notes Judy Homa-Lowry, RN, MS, CPHQ, president of Homa-Lowry Healthcare Consulting in Canton, MI. In certain parts of the country, hospitals have no choice but to attain Joint Commission deemed status. But even in those instances, she says, ISO may prove useful in maintaining accreditation.
According to Preole, some organizations use the ISO program and then subject themselves to initial annual visits by the Health Care Financing Administration (HCFA) where they are reviewed for Medicare and Medicaid compliance. When another body comes in and performs the assessment, she says, the organization still gets Medi-care and Medicaid status apart from the Joint Commission.
Preole says one issue that has been heavily discussed is what role ISO 9000 can play as a complement or a replacement to existing accreditation programs. When ISO first came out, she says, Joint Commission representatives were reluctant to embrace it because they felt it was being promoted as a replacement. But that antagonism has faded, she reports. In fact, Preole contends there can be "quite a nice marriage" between the two processes. Now she says not only providers but also other accreditation bodies are viewing ISO 9000 as an excellent complement to existing standards.
Marquardt agrees that the two processes can run in tandem. "If nothing else, I suspect some hospitals will choose to run them together as a means of differentiating themselves from their competitors."
According to Homa-Lowry, there are a lot of similarities between ISO and the Joint Commission — namely that both programs are interested in good systems and processes that lead to good outcomes. One advantage of ISO is that hospitals get to design their own systems and processes to determine outcomes, she adds. She says it is going to be interesting to monitor what impact payers and the government have on the Joint Commission. She says the organization recently has aligned itself more closely with the HCFA on core measures as well as managed care organization mandates.
"Even if you are ISO-certified, you still have to pay attention to the dictates of HCFA as well as managed care contracts," she warns. That means organizations must develop good systems and processes for patient care outcomes and evaluate which process is going to be the most helpful in evaluating good patient care outcomes.