Patient safety secured by management standards

2007-10-19

It’s a health crisis every medical professional fears: due to an improper sterilizing procedure, within a one-month period, seven patients in a Vegreville, Alberta hospital caught an antibiotic-resistant bacterial infection. Health officials decided to temporarily close the 25-bed facility. Former patients from as far back as April 2003 were notified that they should be tested for hepatitis B and C, as well as HIV.

A subsequent report by the Alberta Health Quality Council found management deficiencies not only at the sterilization unit, but also at the hospital and the regional health authority. The council recommended, among other things, that sterilization procedures be standardized.

The incident underlines the many challenges faced by Canada’s healthcare system as it grapples with chronic under-funding, high operating costs, long waiting lists, and the very real threat of pandemics and superbugs.

To meet those challenges, health networks are looking for better ways to manage their businesses – with the ultimate goal of providing better service to their patients.

One such network is the Fraser Health Authority, in British Columbia’s Lower Mainland. In October 2006, Fraser Health’s sterile processing department (SPD) received ISO 9001:2000 certification.

The international standard for quality management, ISO 9001:2000, is used worldwide by industries ranging from oil and gas to electronics. It provides a framework to improve management systems by setting goals and targets, evaluating processes and measuring performance.

According to Sheila Konishi, director of Fraser Health’s SPD, the journey to ISO certification took time. In 2002, Konishi had to co-ordinate operations among the 10 SPD units in the authority’s 12 acute-care hospitals. The department later hired a consultant, in 2004, to assess its operations. Although the SPD was meeting certain technical standards, the consultant saw room for improvement on the management side.

“Our documentation was our weakest link,” says Konishi. The SPD’s policies and procedures, work instructions (for sterilizing instruments and setting up instrument cases), and record-keeping all required updating and standardization.

Konishi admits the process was not easy. “The expectations for document control and the process of documentation required to meet the ISO standard are very stringent. The SPD team of managers worked together to get this done, while carrying their regular workload.”

The department hired QMI, a management systems certification body accredited by the Standards Council of Canada, to conduct the certification audit. In a pre-audit assessment, the certification body found another deficiency in SPD management.

“We didn’t have an internal partnership agreement with other departments – plant services, or purchasing or logistics,” Konishi says. ISO 9001:2000 requires that a department have quality-control management over any work supplied by other departments. That meant the SPD needed documentation about any work provided by plant services (from maintenance reports to equipment manuals) and by the purchasing and logistics departments.

Looking back at the 18-month process of becoming certified, Konishi says, “It was a lot of work, but it is absolutely worthwhile. The present SPD management system is far better than it was. Not only are we providing a better level of service, but we track our service in a way that we had never done before. We manage our system in a proactive way. We can anticipate, plan and identify not just service failures, but potential service failures. And we can prevent those service failures because of the way we track trends.”

There are material benefits to the process, Konishi says. “It’s very difficult at times to turn the instruments around through reprocessing and get them back into service quickly, efficiently and effectively. We invested quite a lot of money in increasing inventory so that we can be efficient in turning over instruments and not delay surgeries.”

After the SPD received ISO certification, Konishi got queries from other sterile processing departments in British Columbia and Alberta. “They were admiring, supportive, but also daunted by the prospect of obtaining certification to ISO 9001. They wanted to know what was involved, how much work it was.”

In response to the interest, Konishi and Jill Sporidis, product manager for healthcare at QMI, produced a “webinar” to explain the ISO 9001 certification process.

Sporidis is emphatic that the greatest benefit of ISO 9001:2000 certification is the cost savings. “The healthcare industry is screaming for something to help it become more efficient. Top decision-makers are concerned about the bottom line. Implementation of these standards is not a cost, but an investment.”

Sporidis says the management system standard does more than improve the bottom line. It also improves patient safety and satisfaction. “Really forward-thinking and visionary boards and CEOs understand that by process mapping and concentrating on improving processes, they will end up with top-notch patient satisfaction. They will significantly reduce errors in diagnosis and treatment, they’ll reduce waste and, overall, they’ll make their process more efficient.”

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This article first appeared in Volume 34 of CONSENSUS Magazine, 2007.  The information it contains was accurate at the time of publication but has not been updated or revised since, and may not reflect the latest updates on the topic.  If you have specific questions or concerns about the content, please contact the Standards Council of Canada.

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