Could ISO 9000 replace JCAHO, or would hospitals benefit from both?

Opinions vary, but observers say there’s overlap in systems

[Editor’s note: This is the second article in a two-part series on the introduction of the ISO 9000 quality management system into the health care industry. Hospital Access Management welcomes feedback from readers. More information on ISO 9000 is available from the American Quality Society, P.O. Box 3005, Milwaukee, WI 53201. Telephone: (800) 248-1946. World Wide Web: www.ASQ.org.]

ISO 9000, a series of standards that has its origins in the manufacturing industry, is making inroads into health care, championed by a growing number of professionals who believe this quality management system can revolutionize the way hospitals across America are run.

But no conversation about the ISO 9000 series, created by the International Organization for Standardization in Geneva, goes on for long in health care circles without mention of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). This organization, based in Oakbrook Terrace, IL, serves as the regulatory body for most U.S. hospitals, overseeing their operations through triennial surveys.

Subjects that surface for debate usually deal with the merits of one system vs. those of the other, whether ISO 9000 could or should take the place of Joint Commission accreditation, and if the two systems might complement each other.

Under the current system, hospitals that are accredited by the JCAHO are simultaneously certified for Medicare participation. Those that choose not to submit to JCAHO surveys must pass a comprehensive Medicare survey – conducted by state auditors – to keep their Medicare certification.

American Legion Hospital in Crowley, LA, was the first hospital in the country to be ISO-registered, and CEO Leonard Spears is a passionate ISO advocate, describing how he discovered the quality management system after his hospital "fired" the Joint Commission.

Disenchanted with the Joint Commission’s preoccupation with requirements he saw as peripheral to the hospital’s main mission of patient care, Spears says he likes the fact that ISO 9000 is "not industry-specific." As a consequence, he adds, "[ISO standards] don’t tell you how to run your business — they expect you to know that.

"A marked difference between [ISO and the Joint Commission] is that ISO auditors are not health care professionals," Spears points out. "They are instead quality management system auditors. They know what quality is and what a quality management system should be, and they test yours to determine whether it’s functioning properly."

A fundamental quality circle

All results of ISO 9000 audits must be reviewed by hospital management, he explains. In addition, management must document any corrective action taken, and undertake preventive action where there is reason to believe it would result in better services, Spears adds.

"The results of those preventive actions themselves must be reviewed. A very fundamental quality circle is developed that is a constant requirement to have the entire hospital personnel involved. That’s the biggest advantage that ISO 9000 has over Joint Commission," says Spears.

There is a basic difference in philosophy between ISO 9000 and the Joint Commission, says Karen Brink, a quality consultant and certified lead auditor for ISO 9000. "The ISO standard tells you the characteristics of a wellmanaged quality system and allows you to meet those in any way you can, in any creative manner that still meets them," adds Brink, president of Quality Paradigms Training and Consulting Inc., in Columbia, NJ.

"The Joint Commission tends to be prescriptive. You will be required to have certain positions, to do certain things. It tells a health care organization how they have to do things. ISO says this is the standard to meet and you will be held to meeting that standard," explains Brink.

Any doubts Spears had about ending his hospital’s relationship with the Joint Commission were dispelled when he read a news update from the Chicago-based American Hospital Association (AHA) regarding a dispute between the two organizations. "I saw that the Joint Commission and engineers from the AHA had been discussing 15 items for a year and had agreed on a settlement of nine of those issues," Spears says. "One of those was the permissible height of a stainless steel plate on a hospital door."

Spears points out that it is his understanding that the Joint Commission made some changes to its philosophy of micromanagement. That is indeed the case, says Maureen Carr, associate director for the Joint Commission’s department of standards.

"Beginning in about 1994 or 1995, we went from being very prescriptive and focused on departments to being focused more on the organization as a system and on the important functions within the health care system.

"We used to have standards for, say, the radiology department," adds Carr. "Now we are focused more on performance and outcomes of the entire organization."

The Joint Commission now looks in its review of hospitals at two categories: functions related to the care of the patient, and functions related to the organization itself, Carr says. Included under the patient care category are patient’s rights, assessment of patients, care of patients, education of patients, and the continuum of care. Organizational functions include improving organizational performance, leadership, management of the environment of care, management of human resources, management of information, and infection control.

Despite his enthusiasm for ISO 9000, Spears says he believes there is one area in which it falls short. "The single biggest thing ISO 9000 lacks is emphasis on outcome review," he contends.

"If a patient comes in alive, we want the patient to go out alive," Spears adds. "ISO is written with the manufacturing industry in mind. If you’re making widgets and one is bad, you just throw it out, but in health care, we want to avoid that one bad outcome. Outcome review is an area that the Joint Commission emphasizes."

Critical areas fall short

On the other hand, he says, JCAHO falls short in document control, process review, and management involvement — all areas in which ISO 9000 is particularly strong.

Those who advocate the ISO 9000 series stress its focus on ongoing, system-wide quality efforts, as opposed to the periodic panic they say is occasioned by the triennial Joint Commission surveys.

"Our head obstetrics nurse, who has been through numerous Joint Commission surveys, expressed to me that those all seemed to be processes in which we tried to put a certain face on, and then when [the surveyors] left, we were happy they’d gone," Spears says. "She said this [ISO] system made sense because it focuses on quality, and doesn’t concern itself with the rights of nurses, vis-à-vis physicians, and who sits on which committee and whether they vote."

Brink notes that the ISO audits, which are done internally on a quarterly basis and by an ISO registrar once a year, "are a friendlier process, I think. They’re not punitive at all. The worst thing that can happen [if a problem is found] is that you have 60 to 90 days to fix it."

Depending on the magnitude of the problem, she adds, "[the auditor] may be able to send confirmation via paperwork or may return for a re-audit, in which case you just pay for that audit day."

Carr, however, says that hospitals that gear up for the Joint Commission visit every three years and then breathe a sigh of relief when it’s over are missing the point. "The idea is that the organization is continually meeting the standards," she adds.

The Joint Commission focuses more on continuous quality improvement (CQI), and has more of a customer orientation than does ISO 9000, Carr contends.

In fact, while "CQI is a philosophy, ISO is a standard that defines specific guidelines to follow in how to develop a management system," says Bryce Carson, vice president of quality programs with Kemper Registrar Services in Flemington, NJ. Kemper is an accredited ISO registrar that recently became part of the Bureau of Veritas Quality International (BVQI), North America, in Jamestown, NY.

"[ISO] is the launching pad to other types of management systems," he adds. "It puts the framework in place, identifies and documents the processes, and evaluates them periodically. You can’t have improvement until this is done," says Carson.

Joint Commission standards "have nothing to do with CQI per se," says Carson, who also serves as standards chairman for the health care division of the American Quality Society (ASQ) in Milwaukee. "If you read the home health guidelines from the Joint Commission, they say [organizations] should devise principles which drive CQI."

Spears and others familiar with both organi- zations say there is common ground between the two. "If you take the Joint Commission and cause it to be a circle and do the same with ISO 9000, those circles will overlap and the area of the circles that will overlap is about two-thirds," he says. "About two-thirds of what the Joint Commission requires, ISO also requires. But not always is the work product that satisfies Joint Commission going to satisfy ISO."

There would be value in an association be-tween ISO and the Joint Commission, suggests Brink. "They do not need to be mutually exclusive," she adds. "At Pulaski (VA) Community Hospital, they are applying both and there is a lot of overlap."

Although Carr says she does not consider ISO registration the equivalent of meeting Joint Commission standards, she concedes that hospitals may find it helpful in certain areas, "particularly quality control and documentation. There may be other ways it can help, too," she adds.

"Organizations that want to use ISO are free to do so. That’s not contrary to anything in our standards."