'Defining the process' is crucial to hospitals' ISO implementation

Gaining control of documents poses biggest challenge

Perhaps one of the most dramatic illustrations of the effect adherence to ISO 9000, a series of standards created by the International Organization for Standardization, can have on a health care organization occurred during an audit at Pulaski (VA) Community Hospital, says Karen Brink, an independent consultant and certified lead auditor for ISO. The organization is based in Geneva, Switzerland.

"I was walking the halls with the management representative for [the hospital's] quality program," Brink explains, "and he said that just prior to the audit, some of the physicians had approached him and said, 'Please tell us what you did - things are different around here, and we want to know what's behind it.'"

Defining the process, a key part of the ISO approach, is behind the kind of dramatic improvement those physicians noticed, says Brink, president of Quality Paradigms Training and Consulting Inc. in Colum bia, NJ. "The way to do things better is first to know what you're doing. Very often what they do is not known [to hospitals]."

Although there is no health care customer base at present requiring hospitals to be ISO-registered, proponents contend the quality level that registration represents will become increasingly important as a marketing tool in the competitive managed care.

A huge sticking point for hospitals at the beginning of the ISO process is element 4.5, "document and data control," which requires an organization to identify all its documents, including forms, and to gain control of those documents, Brink notes. "It causes madness and mayhem. At one hospital, [staff] went to gather all the forms they were using and found 30 versions of the same form at the nursing station. At first they said, 'Forget it - we can't do this,'" Brink adds, "but when we concluded the audit, it was the one thing they saw as most valuable because now they knew what they were doing."

At American Legion Hospital in Crowley, LA, the first hospital in the country to be ISO-registered, the document and data control element was indeed "probably the toughest one for us to comply with," says Angie Wadlington, MBA, RPh, director of quality management.

"The Joint Commission did require policies and procedures, but [with ISO], the focus is different," she adds. "Before, we didn't always have the current version of a form or document out in the trenches where it needed to be. We thought we did, but we didn't take back the old form, or we didn't go back and make sure [employees] were using the new form."

With so many different forms and various people handling them, Wadlington points out, "stacks get swapped, those sorts of things. This made us more aware that if it's important enough to revise and send out a new form, we certainly want to make sure [the change] is implemented."

Well before its association with ISO began, American Legion Hospital "fired" the Joint Commission on Accreditation of Healthcare Organizations because of some "differences in philosophy with where they were heading and where we felt quality in health care should be," she notes. "We heard about ISO locally, from one of the industries that had just completed their certification. As we inquired about it, we learned it was not found in the United States in health care, but that it was very common in, for example, the United Kingdom, and in other countries throughout the world. We said, 'Why couldn't it be here?'"

After hiring some consultants familiar with ISO to help "bridge the gap," the hospital was successful in its first attempt at registration, Wadlington says. "We became registered in January 1996, and it's been a very good thing for us."

Members of the hospital's management team went through a semester-long class on ISO at a local university, sharing their new knowledge with department heads, who in turn educated their employees, she says.

"We have a better handle on our quality systems now," she notes. "We have always had good patient care, so that didn't change, but the documentation part increased the awareness of every level of employee as to the services we provide."

In addition to a sense of pride at being the first hospital to accomplish ISO registration and some national and international recognition, the process has paid off from a marketing standpoint, she points out. "ISO is widely recognized within our community and surrounding areas because we do have a lot of oil and gas industry here. It's helped us obtain some managed care contracts."

Handful of hospitals ISO 'registered'

ISO's foray into the U.S. health care industry is still in its infancy, confirms Bryce Carson, vice president of quality programs with Kemper Registrar Services in Flemington, NJ, an accredited ISO registrar that recently became part of the Bur eau of Veritas Quality International (BVQI), North America, in Jamestown, NY.

The company has certified two hospitals - American Legion and Pulaski Community Hos pital - and in mid-September was in the midst of an audit at a third, Memorial Medical Center in Ludington, MI, says Carson, who also serves as standards chairman for the health care division of the American Quality Society (ASQ) in Milwaukee.

The standards-writing body at ASQ, which is a membership organization for quality professionals in all industries, writes guidelines used by health care organizations to bridge the gap between their own terminology and that of ISO, he notes.

In addition to the hospitals, Kemper has registered the 14 locations of the Kelsey-Seybold Clinics at the Johnson Space Center in Houston, two physician practices at the Hospital for Special Surgery in New York City, and Barth Dental Labs in Indianapolis, Carson adds.

One of the challenges in working with health care organizations, he points out, is understanding how to apply standards originally written for manufacturers. One of the 20 ISO elements, for example, is 4.10, "inspection and testing," and within that element are subsets, including 4.10.2, "receiving inspection and testing," he explains. (See story on ISO elements, p. 114.)

"With manufactured products, it means the manufacturer must perform an inspection to ensure that its requirements for materials were met - that if it ordered 50 green widgets, that's what it received - before putting the materials into manufacturing," he says. "Health care is a difficult concept because patients aren't products; the service delivery is the product."

The 4.10 standard, Carson adds, roughly corresponds to what the Joint Commission calls "assessment of patients."

"Did the patient have a preadmission test, did the patient have a doctor's order before reporting for the test?" he explains. "Someone has to determine that the patient is 'acceptable' for the service that's going to be delivered."

'People get confused'

If you're thinking that sounds like something you already do, Carson is accustomed to that response. "People get confused [about ISO standards] and say, 'We already do that,' but what we're talking about is an overall systematic approach to quality," he says.

The patient admission process is just one part of "flowing" the patient through the hospital, and the difference with ISO is that it is a system, not individual standards that are auton omous to each department, he adds. "It's about organizational interfacing with other departments."

The other aspect of ISO that's new to health care is the emphasis on follow-up, he points out. "Most health care organizations conduct internal audits but don't have any real corrective mech anism. With ISO, you understand processes, document processes, implement processes and then improve upon them."

This is done through what Carson calls "the triad" in ISO for continuous improvement: corrective and preventive action, internal quality audits, and management review.

Brink, the consultant and ISO lead auditor, illustrates the ISO approach with another story from one of her hospital audits: "In the midst of the audit, one of the managers we were talking with stopped dead and said, 'I get it, I know what you're doing - you're assessing our quality system, the same as we assess a patient who comes into our area.'"