acutecaretesting.org: The electronic system for managing ISO certification and POCT documents has been in place at Fleury Diagnostics since 1998. What are its main features?

Dr Rogério Rabelo: The system is very simple and user-friendly. Because we have developed it ourselves, it is fully customized to our needs. And it is cost-effective as well. All the programs we have used to develop the system are standard Microsoft Office programs. Anyone who has a license to them could in theory develop a similar system.

acutecaretesting.org: How does it work?

Dr Rogério Rabelo: The system has three components: document creation and modification, access and management. With the system, users can easily create and modify documents by using customized Microsoft Word templates. The entire document workflow, including the review and approval of documents, occurs online.

Once a document is created, an e-mail message is sent via Outlook to at least two reviewers chosen by the author. Once reviewers submit their comments, the document is sent back to the author, who then finalizes the document – accepting or rejecting the comments – and sends it for approval. Once approved, the document is made available online. All of this is done through Word and Outlook, while Office Assistant messages guide users in completing the necessary steps.

The second component is accessibility: all employees have access to these documents on our Intranet through Internet Explorer. This is very important, because if users cannot access documents, they tend to keep printed copies that are not updated. In our system we cannot print documents: the official version is online, and that version is always the latest one. We only use document prints for training purposes. Afterwards, these copies are destroyed.

The third element is the actual management of documents, which is restricted to administrators. The system is very robust and effective: administrators know at all times which documents are being created and when, who is currently reviewing them and when documents have been approved. They can also easily trace back all previous versions of an updated document, which are kept in a separate database for auditing purposes.

acutecaretesting.org: Why did you decide to create such a system?

Dr Rogério Rabelo: Fleury Diagnostics has always been very quality conscious. Since it was founded in 1926, it has been providing humanized and personalized services, always striving to improve the quality of its tests. 

In the mid-1990s we decided to formalize all the quality processes we had in place through an ISO certification. We chose ISO 9001, because we wanted to focus not only on technical or POCT aspects, but also on our entire organization. We developed a quality management system to oversee the entire institution and, since a document management system is an essential part of any certification, we decided to create our current system.

Today, we are both ISO 9001:2000 and ISO 14001:1996 certified, and all documents and SOPs of our Quality and Environmental Integrated Management structure are administered through this online, electronic system.

acutecaretesting.org: What was the main success criterion of the system?

Dr Rogério Rabelo: To develop it based on an interface that everybody knew, so people would use the system and not be intimidated by it.

acutecaretesting.org: Were there certain specifications common to certification and accreditation programs that the system needed to meet?

Dr Rogério Rabelo: At Fleury, we are ISO certified. We also have the Brazilian and CAP external quality control programs that we follow, as well as several Clinical Trial audits, each with their own set of requirements. But interestingly enough, most certification and accreditation programs have the same requirements for document registration and management. Some documents may need template adjustments, but that can be easily achieved in our system by using customized Microsoft Word macros.

acutecaretesting.org: How did inspectors react to this paperless system?

Dr Rogério Rabelo: In the beginning there was some resistance on the part of some external inspectors. Particularly American inspectors were a little skeptical as to whether a paperless system could deliver all the information they needed. 

But we have proven to them that the system is so comprehensive in terms of the information it provides that there was no need for paper binders. The system offers full document traceability and safety. All document versions are recorded in a separate SQL database and can easily be retrieved during an inspection.

acutecaretesting.org: One of the principles guiding Fleury's Integrated Management Policy is to reduce the environmental impact of its practices. Did this influence your decision of creating a paperless system?

Dr Rogério Rabelo: When we went for the ISO 9001:1994 certification in 1999, we knew that a new version would be coming out soon that would be closely integrated with the ISO 14001:1996 for environmental management. So we decided to include the environmental aspects of our work as part of our efforts to become certified.

Some may question how much environmental damage labs cause, since we do not deal with large amounts of reagents and chemicals as manufacturing and chemical companies do. But once we began mapping our processes, we detected around 200 ways in which our practices can affect the environment. Generating paper trash was one of them, so by having a paperless system, this impact has been minimized. 

However, the document management system is just one element of our overall effort to minimize our impact on the environment. Our entire 140,000 square-feet facility in São Paulo was built in 2000 according to strict environmental principles. Eventually, Fleury became ISO 14001 certified in 2002, as one of the first labs in the world.

Quality and Environmental Department team and Dr. Rogério Rabelo

acutecaretesting.org: Why develop your own system instead of buying it from a vendor?

Dr Rogério Rabelo: It was a combination of two things. First, at that time, the market did not offer a system that fully met our needs. Second, Fleury has a very good IT team and a tradition of developing its own IT systems. This goes back to the 1980s, when the Brazilian economy was completely closed and access to information technology developed abroad was restricted.

Developing our own laboratory information system (LIS) and being pioneers in Internet reporting of patient results since 1997, gave us the experience and a head advantage in developing technology applied to the clinical lab and lab testing. So for us, at that time, it was much easier, quicker and cheaper to build our own system. We estimate that building the system ourselves was 50 % cheaper than buying a standard system and having it customized to our needs.

While the IT team had to deliver the system, it was up to the certification team to determine its scope and main prerequisites, which in our case were ease of use, a high level of customization and a Word-Outlook-browser-based platform to allow paperless, online management of documents.

Fleury Diagnostics

acutecaretesting.org: How long did it take from defining the system to implementing it?

Dr Rogério Rabelo: Only three months. In August 1998, the system was implemented in its first version and validated by users during the following months. By May 1999, it was ready for the ISO inspection.

acutecaretesting.org: What were the milestones of this process?

Dr Rogério Rabelo: The starting point was our own philosophy of always wanting to do an excellent job and being fully committed to quality. The next step was having a Quality Management system in place, giving us a framework to map processes and optimize them. Then came the specification phase of this particular project, where we determined the scope of the system and its main characteristics. 

Only when the specifications had been made did the IT team begin developing the system and testing it. Once the system had been implemented, different employee groups began testing it: from nurses, physicians and lab professionals to call center employees, management and technicians. After the system had been validated, we began training users and putting the documents necessary for certification in the system.

acutecaretesting.org: Were there any problems in the implementation phase?

Dr Rogério Rabelo: The system was so effective that it ended up being ahead of its time! One interesting problem was that, back in 1998, not all of our users had computers and Intranet connections fast enough to download and edit complex documents online. Thus, the system could be a little slow when working with heavy documents.