ISO 9001:2000 registration improves processes through standardization

Approach looks at entire business process, not just clinical portion 

Achieving ISO 9001:2000 registration has helped Humana Inc.’s Personal Nurse service move quickly to respond to customer feedback and improve services.

"The registration process has helped us tremendously in terms of putting together very clear standards and processes and creating policies and procedures to ensure consistent delivery of our services. It makes us constantly think about whether there are things that we can be doing differently, which may result in improved service for Humana members," reports Trish Whitt, RN, director of clinical product management for Humana Inc. with headquarters in Louisville, KY. The Personal Nurse service is the fifth Humana program to receive ISO 9001:2000 certification.

ISO 9001:2000 is an international standard published by the International Organization for Standardization, which focuses on quality management and measurement and incorporates a comprehensive set of standards to ensure a quality system is in place to meet the customers’ needs, says Lowell Stevens, director of business process improvement for Humana.

For instance, when the Personal Nurse leadership team receives customer feedback, the process improvement team, which meets monthly to discuss member feedback, determines if any processes in the system could be improved, he adds.

"It puts into place a nice structure for reviewing processes, performance indicators, and customer feedback, while providing a forum for discussing changes to the system that need to be considered," Whitt says.

The ISO 9001:2000 registration has helped the Personal Nurse team, whose members work from home-based offices, establish good lines of communication, and keep up with the latest information from corporate headquarters.

"We have two representatives from the nursing staff and two Personal Nurse coaches sitting on the Personal Nurse process improvement team. They bring us issues from the frontline staff. This has allowed us to consider things that are occurring that we might not have otherwise known about," she points out.

The ISO 9001:2000 registration gives the service added credibility among employers who often are already familiar with the process, Whitt adds.

When Whitt talks to employer groups, they’re surprised and impressed that the company’s Personal Nurse service program has achieved ISO 9001:2000 registration.

"Many of these companies are in the manufacturing industry, and they can identify with the ISO 9001:2000 process, which makes them feel confident about the Personal Nurse quality management system. They tell me they never thought about the ISO registration for services in the health care industry, but after considering the value of ISO, they understand the importance of this achievement," she says.

In 2002, Humana became the first health benefits company in the country to achieve ISO 9001:2000 registration for its clinical operations. The company’s transplant management and clinical management programs also received certification at that time, followed by the pharmacy management and disease management programs in 2003 and the Personal Nurse service in 2004. The goal is to have the company’s entire Innovation Center, the replacement for the company’s medical management department, under a single certification.

Humana’s management decided to pursue ISO 9001:2000 registration because it focuses on service to the customers and looks at the entire business process, whereas other certification programs deal almost exclusively with clinical measures, Stevens notes.

ISO certification started in the manufacturing industry as a quality management system for production lines.

"We looked at it and saw that we have a similar process. Our clinical guidance process does not create a widget, but it does help people move through the health care system, Stevens says.

The registration process required Humana to define internal standards for good management and operational practices dedicated to meeting customer quality requirements.

"It involves creating policies and procedures and creating key metrics to prove that you are following them," he adds.

ISO 9001:2000 has a quality management approach that’s flexible and adaptable and isn’t bound to old business practices. ISO 9001:2000 certification requires organizations to establish policies and procedures that bring discipline into the work.

The first step in ISO certification is to understand how each process fits into the overall view of the company, then to develop policies and procedures to standardize the processes, Stevens says.

"We created a view of the system that looks at inputs, outputs, and what takes place in the middle to turn the input into a valuable output. Now everyone knows how he or she fits into the whole system. They know where the members have been, how they got there, and where they’re going," he says.

The company established a team of people representing all the functional areas and all the people who participate in the particular process being studied. The team created charts mapping the processes and showing where everybody fits into the whole system.

"When we start drawing out the processes, there typically is a lot of friction, because people are accustomed to owning’ their work. ISO standards show that people don’t own things. They work for a process and understanding that is a challenge because the managed care industry is built in silos," Stevens says.

Four key processes

The team created a detailed picture of how the processes work and developed detailed policies and procedures for each, taking the customers’ needs into account. During the registration audit, the ISO 9001:2000 auditors make sure the policies and procedures are being followed.

For instance, during the disease management registration process, the team working on the company’s outsourced disease management programs identified four key processes:

1. analyzing and evaluating opportunities for disease management;
2. evaluating vendors to find those who can meet the organization’s needs;
3. creating an agreement with the entity;
4. operating the program.

The team looked at what part of the programs needed to be tracked.

For instance, Humana policies mandate at least an annual site visit to all disease management vendors. During the visit, the Humana representative goes over 15 different items with them.

"We document that we went there and that we went through each of those 15 things," Stevens reports.

The team determines key drivers of outcomes, sets a goal, and tracks how well the program is doing at meeting the goal.

"With disease management, the ultimate outcome is that you want the member to be on a better path and to be more educated about those conditions. We set a goal and look at how we are doing in relation to the goal. Those become the metrics," he says.

After the policies and procedures are in place, the company works constantly to improve the system, regularly monitoring outcomes and ensuring that the policies and procedures are being followed. The ISO 9001:2000-required policies and procedures are fluid documents, allowing the company to easily make changes if the need arises, Stevens says.

"When we go through a management review, we look at all the things that the ISO standards require, such as looking at system improvements and determining if we understand our customer needs and are meeting them," he says.

One benefit is control of documents and records, Stevens says. For instance, any piece of paper generated within an ISO-certified area at Humana has information identifying where it came from and who created it.

"In most businesses, the policies and procedures have to be dug out from the file cabinet. In the ISO world, it’s taken care of through control of documents," he says.

The Humana departments that have received ISO 9001:2000 range in size from 10-15 people up to 60 or 70 people. It took about eight months to a year to get the various departments ready for certification.

"One key challenge is prioritizing ISO into the existing workload. You’ve got to have a commitment and the resources to do it. You can’t approach the process unprepared without understanding that it is going to take a lot of resources and time," Stevens says.

When the Personal Nurse team started the registration process, it had an advantage over other programs because the service had been modified in early 2003 and the Personal Nurse staff were well prepared to explain its design and to look at input and output to the process, Whitt says.

"We sat down and put together a view of the system, incorporating all the key inputs and outputs to our service, our mission and vision. We had a great deal of notes on the background and research documentation that had been done prior to making modifications in the service. Previous research documentation combined with minutes from the design and development meetings provided evidence supporting the application of ISO standards throughout program design," she adds.

In the beginning, the Personal Nurse multidisciplinary steering committee established direction for designing and improving the service. The committee was made up of employees from various areas throughout the organization, Whitt says.

"When we narrowed down the core team members for the purpose of establishing an ongoing management review committee, the team included people within the Personal Nurse leadership team and representatives from the Personal Nurse staff and the Personal Nurse Coaching teams," she says.

The Personal Nurse process improvement team began meeting monthly to review all the processes in place, customer feedback and complaints, business performance indicators, and breakdowns in the quality management system, and come up with corrective or preventive action steps.

ISO regulations require only quarterly management review meetings, but Whitt and her team made the decision to meet more frequently.

The Humana ISO strategic team conducted an internal audit of the Personal Nurse program approximately two months before the registration audit took place.

Internal consultants who specialize in the ISO 9001:2000 registration process helped the department establish a system that meets the requirements of ISO 9001:2000 and prepare for the required audit.

The ISO 9001:2000 internal audit team conducted an audit of the Personal Nurse program two months before the registration audit took place.

During the actual registration process, a team from the SGS U.S. Testing Co., an accredited register chosen by Humana, verified through a management audit that each part of the program conformed to the requirements of ISO 9001:2000. The SGS auditor performed a pre-assessment audit about a month before the registration audit to help identify gaps in the system.

The ISO registration process required a lot of preparation over a long time but is different from other accreditation processes in one significant area.

"Compliance with ISO standards can be demonstrated primarily through electronic documentation rather than reliance on printing significant volumes of paper documentation to support compliance," Whitt says.

The auditors wanted to see policies and procedures as well as other documentation of processes, but they primarily reviewed the documentation electronically, she adds.

"ISO registration is very different from many other accrediting agency visits. ISO doesn’t require preparation of large binders of printed documents to prove compliance with the standards. We printed only a few key items that were hard to view on a computer screen," Whitt says.