Enhance pursuit of excellence by integrating ISO 9000, Baldrige
National Baldrige winners often use ISO as platform
Health care quality professionals have, of late, modeled outstanding companies in other industries in their ongoing pursuit of excellence, adopting vehicles such as Six Sigma and ISO 9000. The next step, some observers say, is to integrate ISO standards with the Malcolm Baldrige Award criteria. The Malcolm Baldrige National Quality Award is administered by the National Institute of Standards and Technology in Gaithersburg, MD. (For more information, go to: www.nist.gov.)
"Essentially, what we see is that ISO is definitely the platform with the essential fundamentals for a business model," says Denise Bertin-Epp, COO at Pinnacle Enterprise Group Medical Division, in West Bloomfield, MI. Pinnacle is a medical process improvement consulting firm that uses the ISO platform to improve medical processes.
"ISO looks at breaking down the historical silo effect in health care, encouraging the sharing of information and model inspiration. ISO looks at reducing redundancies, limiting inefficiencies, reducing costs wherever possible, and increasing quality. It also looks at the lack of standardization of processes and improves upon that situation."
"I would say ISO is the platform through which your organization can make sure the fundamental pieces are in place," says Judy Homa-Lowry, RN, MS, CPHQ, director of patient care services at Brighton (MI) Hospital.
"With Baldrige, when you evaluate your facility, you try to look for a strategic plan and for the integration of all the pieces. ISO also makes you focus on what you want to do as an organization, but with the customer as No. 1, so you look at all these issues in terms of how they apply to the customer. When you apply Baldrige criteria, it really gives you a global perspective in terms of your ability to evaluate how well your clinical and business practices are functioning," she says.
Perhaps most telling is the fact that a number of recent national Baldrige winners from industry have integrated Baldrige criteria with ISO standards; no health care organization has ever won a national Baldrige award.
The integration pyramid’
To more readily understand this integration model, Bertin-Epp says, envision a pyramid divided into three sections (not unlike the Food and Drug Administration’s food pyramid).
"The bottom of the pyramid would be ISO 9000; the next rung would be the Joint Commission [on Accreditation of Healthcare Organizations]/IWA [International Workshop Agreement] — an integration of Joint Commission standards and the ISO 9004 standards; the top of the triangle is Baldrige," she explains. "You have a progression of strength, beginning with ISO. As you move up the pyramid, through continuous quality improvement and the strength of your business model, you progress to incorporate them all."
The ISO 9004 standards are more progressive, represent a higher standard, and require a stronger business model to support them, Bertin-Epp adds. "They are out there,’ but not publicly accepted yet. But if you want to attain a Baldrige award, these other elements earn you significant points from a Baldrige perspective."
Joint Commission standards are an important part of this triangle, Homa-Lowry emphasizes. "ISO and Baldrige, as well as the Joint Commission standards, would point you in the direction of winning a national award," she notes. "Baldrige wants to make sure you have the right systems and processes, and the Joint Commission standards make sure everything is in place for optimal patient care."
"From a Baldrige perspective, it is a high-performance business model," Bertin-Epp says. "I truly see Baldrige as the point of real excellence — exceeding customer’s expectations. When you have the systems and processes to meet their needs, you will exceed their expectations. Whereas in ISO 9000, you will meet the requirements you have defined for them — the basics."
This might even be the first time your organization has ever defined those basics, she notes. "In many health care organizations around the country there are no basic customer requirements; ISO would absolutely mandate that you have them in place," Bertin-Epp explains. "As part of that, you would ask your clients what they are seeking. If Joint Commission standards are part of the mix, it would be a minimum qualification to become ISO-certified."
With this pyramid approach, there is a much greater emphasis on keeping the patient as your focal point, Homa-Lowry says. "Traditionally, a lot of systems and processes have been created more for the benefit of the hospital," she notes.
"When you look at standards of patient care or outcomes, ISO with the Joint Commission incorporate the minimum standards for processes you need to have in place to create the patient outcome you are looking for," Bertin-Epp adds.
"For example: removing the wrong limb; no system in health care makes sure errors like that are not there. People needed the IOM [Institute of Medicine] report on errors [To Err is Human: Building a Safer Health Care System, 2002, the IOM and the Committee on Quality of Health Care in America] for organizations to wake up and smell the coffee. This is the kind of core processes you can address," she explains.
In addition, Homa-Lowry says, when you begin to look at the patient moving through the system and breaking through silos, "you really begin to see a reduction of duplication of policies and procedures that are in conflict with each other," she notes. "It is extremely costly to organizations to maintain a multiple approach to things instead of identifying a single best method."
Homa-Lowry says she has decided to put this Baldrige/ISO integration model into practice at her facility, and has contracted with Bertin-Epp to assist her in this process.
"Our first phase will be to map out all existing systems and processes, or the lack thereof," she notes. "There will be one ground rule: no problem-solving can go on when we are doing evaluation."
In other words, this first phase will be limited to discussing processes and defining issues and opportunities.
"Sitting around the table are the people responsible for each area of patient care, our regulatory payers, and our customers," Homa-Lowry says. "Then, we will go back to build the processes so that they function in the right way and train our staff. We have already made a commitment to our CEO that we will save costs, so we will monitor what we do."
"Judy will be using [total quality management] skills to define the process with line staff," Bertin-Epp notes. "In the past, staff were not even part of the decision process. She’s taken down the silos."
Without frontline involvement, she adds, you often have a disconnect between what management thinks is occurring and what really is occurring. "The typical management systems that are put in place are dysfunctional," she notes.
"Throughout this process, the admission-to-discharge continuum, we will try to define what the key processes are, what they need to be to have the outcomes you want, while meeting the ISO platform. We will have one admission process, standard criteria for patients, and shared information," Bertin-Epp says.
The process also incorporates a significant amount of benchmarking. "We will begin to use the literature to compare ourselves with best practices in all areas," Homa-Lowry says. "We have talked to other organizations, and we have visited another health care organization [that has integrated Baldrige and ISO] to make sure we are integrating the best of the clinical knowledge available to us as we design our processes."
A word of caution
Despite the promise of integrating ISO, Six Sigma, or other processes with the Baldrige Criteria, quality managers should proceed with caution, advises Patrice L. Spath, of Brown-Spath & Associates, a health care consulting firm in Forest Grove, OR.
"Consultants who are very much into ISO or Six Sigma generally think that their product is all-encompassing and will fix every problem that you have," she warns.
"The problem I have with them is that I view ISO and Six Sigma as just a process-management technique or tool, with Baldrige really being a comprehensive framework that deals with the culture or the strategic objectives of an organization," Spath says.
The good news, she says, is that both ISO and Six Sigma are beginning to add those pieces to their models. "What’s wrong with them for health care is that they are very prescriptive; they tend to appear to be the magic bullet we are looking for and want to hang our hat on."
"They could fail because things that Baldrige values — like human resources, aligning your mission, vision, and values throughout organization — if those pieces are not there and you don’t have the support of top management to achieve the vision the organization wants to achieve, then no prescriptive methodology to improve process will work successfully in your organization," she observes.
The reasons that ISO and Six Sigma could fail in health care "are the same reasons why CQI [continuous quality improvement] failed and, I fear, the same reason patient safety will fail," Spath says.
"They are tools, techniques, methodologies. Jack Welch [former G.E. CEO who helped make Six Sigma a household word] had a vision — he probably could have used any tools or techniques," she adds. "It’s not the graphics you use; it’s the vision of the leaders and how you align and excite organizations about achieving that vision."
Nevertheless, she says, ISO is integratable into the Baldrige criteria. "There are several categories — one is process management — where ISO and Baldrige can be merged together," she asserts.
"But I think Baldrige has to be the umbrella; it informs how the ideal organization should look. If an organization decides to use ISO, it’s just one piece of the many different strategies. You could use Six Sigma, too. It’s just one of the many different methodologies you can use to achieve performance excellence," Spath adds.
Key Points
- Integration links strategic approach to customer-oriented philosophy.
- ISO provides essential fundamentals for a business model.
- Breaking down silo effect key to performance improvement.
For more information, contact:
- Judy Homa-Lowry, RN, MS, CPHQ, Director of Patient Care Services, Brighton (MI) Hospital. Telephone: (734) 459-9333.
- Denise Bertin-Epp, COO, Pinnacle Enterprise Group Medical Division, West Bloomfield, MI. Telephone: (248) 706-1740.
- Patrice L. Spath, RHIT, Brown-Spath & Associates, Forest Grove, OR. Telephone: (503) 357-9185.
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