Should you consider ISO 9000?
January 1, 1998 7 minutes read
Should you consider ISO 9000?
Companies offering QI certification seek deemed status
All the indicators point one way: Continuous quality improvement (CQI) is the wave of the future. It’s proved to be the best way for health care organizations to enhance cost control through the systematic improvement of patient care quality. With CQI, an accrediting body no longer comes to check your facility’s quality indicators every few years. The process is ongoing.
The trend toward CQI may mean good news as well as bad news for you and your job. You and your staff will have to regularly engage in quality improvement projects so you can provide measurement reports on a regular basis to whatever accrediting agency you choose. This may complicate things somewhat in the beginning, but it should solidify your standing in the hospital.
If you want to anticipate the CQI trend and respond proactively, you may soon have a viable Medicare-approved alternative to the present triennial scramble for Joint Commission accreditation. Deemed status could be in the cards for the ISO 9000 system, which could offer a less expensive, less stressful route. But Joint Commission advocates note JCAHO surveys are no more expensive than ISO’s, and that beta testing has already begun on better systems as JCAHO rises to the challenge of CQI.
"More and more quality professionals are looking into ISO 9000," says Jan Maronde, RN, CPHQ, executive director of the Healthcare Quality Certification Board in San Gabriel, CA. "I don’t know whether many will go for it, however, until its standards are modified to fit health care. The biggest stumbling block is the deemed status issue."
"Companies providing ISO accreditation are lobbying for deemed status right now," notes Laura DeVincentis, health care services manager of SGS International Certification Services in Rutherford, NJ. ISO 9000 certification for health care organizations is now available from SGS and only a few other companies in the United States. "We’re pushing at the government level to legitimize ISO 9000 for Medicare reimbursement. But it’s difficult to say how long that will take."
Because the Joint Commission on Accreditation of Healthcare Organizations in Oakbrook Terrace, IL, has deemed Medicare status, hospitals opting for its accreditation don’t have to undergo review by the Health Care Financing Administration (HCFA) for Medicare participation. "If ISO 9000 got deemed status," adds Maronde, "it certainly would be interesting."
Institutions deal with Medicare accreditation requirements in various ways. Some larger facilities register with ISO in addition to acquiring Joint Commission accreditation, which can be expensive. Some facilities opt to save money by bypassing the Joint Commission and letting HCFA do Medicare review. Those facilities typically note they find little to gain from the Joint Commission other than its deemed status.
A hospital review by HCFA costs an average of $3,516. The agency performs initial surveys, then comes in every 10 years or so to recertify, although the state can prioritize a recertification based on known deficiencies.
"An institution that bypasses the Joint Commission," continues Maronde, "might get ISO to do a review strictly for quality improvement efforts. The Joint Commission is expensive not just the survey, but the cost of preparing for the survey as well and it’s getting harder and harder for facilities to make ends meet these days."
ISO companies do not promote themselves as replacements for the Joint Commission, but rather as adjuncts complementary frameworks to help organizations better manage quality standards. DeVincentis puts it this way: "Use ISO as a means to facilitate daily compliance with Joint Commission or NCQA standards."
That daily element is missing from a traditional survey system that sends institutions scrambling every three years. In contrast to that, ISO requires that institutions evaluate themselves on an ongoing basis to ensure they’re doing what they say they’re doing. Internal audits are mandatory; then an ISO registration company comes in every six months to make sure.
"ISO makes maintenance visits twice a year," DeVincentis explains. "No longer is there a three-year gap between auditors. The value of ISO 9000 is that it helps facilities manage their initiatives."
The system aims to keep an organization up and running even when there are changes in personnel, equipment, or patient needs. There’s dialogue between auditor and staff. When the auditor comes in, he or she is familiar with existing problems and can see how the facility has addressed them or is ignoring them.
JCAHO moves toward self-reporting
This raises a question: If ISO’s main benefit is ensuring day-to-day compliance by monitoring performance improvement indicators on an ongoing basis rather than every three years, how does that differ from the direction the Joint Commission is moving in standardized self-reports containing performance improvement data ranging from medical credentialing to needlesticks? The Medical Center of Central Georgia (MCCG) in Macon is one of 50 Georgia hospitals participating in the agency’s Orion Project, which is projected to eliminate the triennial trauma of the survey visit in a few years. Instead of the Joint Commission coming every three years to examine documents and data, hospitals self-report quarterly and accommodate a consultative visit from a surveyor.
"We’re always on the lookout to offer better quality, service, and cost-effectiveness," says Nancy Dunham, RN, infection control practitioner at MCCG. "I don’t know much about ISO 9000, but if there’s some other way to become accredited, that’s a good thing simply because competition is always good. JCAHO’s fees are astronomical." But some would say ISO’s are too.
The cost of ISO 9000 accreditation depends on the size and complexity of the organization. For most facilities, say ISO proponents, the result is a less expensive certification than that offered by the Joint Commission.
"For the initial certification," says Ernie Pires, president and CEO of SGS, "we do an off-site desk review of the quality documentation, and that may take a day or two depending on the size and complexity of the organization. Then the on-site audit and the reporting may take a few days."
A small organization with 50 employees, for example, would require one day for the desk study, three days on site, and one day reporting. If certification costs $1,000 per day, that’s $5,000 plus travel expenses.
A larger organization with 300 employees may require six days on site plus a two-day desk study and two days for reporting 10 days for $10,000. "The fact that the hospital is six times larger doesn’t mean it costs six times as much," says Pires. A hospital’s auxiliary services may add to the complexity of the audit and require more days.
After a facility is registered, ISO auditors survey every six months. Hospital Peer Review asked Pires if this semiannual repetition reduces the gap between the cost of an ISO certification and one by the Joint Commission. Over three years, he said, the cost of the ISO program would include the initial visit approximately $5,000 for a small facility and $10,000 for a larger one times two, equaling $10,000 to $20,000.
"We don’t do as much on the six-month visit as during the initial audit it typically takes 25% to 35% of the time," says Pires. Some elements are always checked, such as the hospital’s internal audits and patient complaints. Over the remaining five visits during a three-year period, the ISO surveyors check compliance with the whole standard again.
"It takes two years to recover the expense of ISO certification." said DeVincentis. That’s because ISO enforces cost-efficiency as well as quality, and "helps a facility save money. The three-year certification rate is a lot lower than the Joint Commission’s rate," continues DeVincentis.
Paul Schyve, MD, senior vice president of operations at the Joint Commission, disagrees with the SGS officials as to whether ISO certification costs less than Joint Commission accreditation.
"If you wanted to have an entire organization certified," he says, "ISO would be considerably more expensive than an equivalent certification by the Joint Commission."
A hospital source who asked not to be identified says Joint Commission surveys can cost anywhere between $7,000 and $50,000, depending on the facility. The average survey price is about $21,000. Based on Pires' statement that over three years, ISO certification costs $10,000 to $20,000, all other factors being equal, that would seem to be the way to go. But the reality is, factors are not equal.
"You have to consider what the certification applies to," continues Schyve. "Even if the entire organization is covered, that may not mean the organization is meeting commonly accepted standards dealing with areas of patient care, assessment, and continuity of care."
Schyve also had some opinions about ISO 9000’s role in CQI. "The Joint Commission concentrates on continuous improvement. ISO 9000’s focus is on conformance to specified practices. ISO’s goal is not continuous improvement, but rather quality assurance or quality control." An explicit decision was made by those who developed ISO, says Schyve, that the requirements for certification were not going to be continuous improvement requirements, but rather requirements focused on conformance to specifications.
"Yes, you can ask someone from an ISO company to come in and consult with your organization," says Schyve, "and he may use ISO guidance documents and help you with continuous improvement. The ISO certification, however, is not based on CQI." The way ISO can be helpful for CQI, continues Schyve, is to provide tools for maintaining specifications.
Can ISO certification replace Joint Commission accreditation? "Clearly not," says Schyve. "And what’s more, the general public doesn’t recognize ISO certification as it does the Joint Commission.
"ISO 9000 provides techniques for quality control, management, and assurance within the larger context of quality improvement," says Schyve. "But it does not specifically address important processes in health care. We at the Joint Commission see ISO not as a replacement, but as a complementary system."
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