CEO SUMMARY: In Brampton and Etobicoke, Ontario, the hospital laboratories of William Osler Health System are using the quality management system of ISO 15189 to stay ahead of two powerful trends. Combining the QMS with Lean methods allows the labs’ management and staff to continuously improve performance in four important dimensions: decreasing turnaround times, reducing or eliminating the systemic source of errors, boosting productivity of lab staff, and reducing costs across the laboratory.
EACH YEAR, THERE IS MORE PRESSURE on clinical laboratories to improve patient safety, reduce errors, and increase the quality of lab testing. In parallel with these developments, government health programs want more transparency in laboratory performance, particularly as it relates to improved quality and reduced errors.
Meanwhile, both the public and the media are holding clinical laboratories and pathology groups to a higher standard. Even though clinical laboratory errors which negatively impact an individual patient’s health are infrequent, such episodes often generate national headlines.
QMS Used by ISO 15189
In recognition of these important trends, a small, but intrepid, number of first-mover clinical labs are implementing a quality management system (QMS) into their organizations. Most frequently, they opt to accredit to ISO 15189: Medical Laboratories and the QMS which is embedded within it.
These labs share a common goal. They recognize that the traditional models of laboratory management and operation do not give them the tools they need to meet the ever-tightening standards of modern medicine as well as the changing public expectations of quality and patient safety.
These lab organizations want a management system that allows them to deliberately and continually drive the rate of errors down to zero. They also want a management system that generates objective, real time data that their lab staff can use to continually improve the quality of laboratory testing. ISO 15189 and its QMS meet both of these strategic requirements.
This step should not be taken casually. “When a clinical lab decides to pursue accreditation to ISO 15189, it is making a major commitment that affects every aspect of daily operations within the lab,” stated Patricia Burton, MLT, Quality Coordinator, Laboratory, at Brampton Civic Hospital in Brampton, Ontario, Canada.
“The QMS within ISO 15189 requires every staff member in the laboratory to think and act differently as they perform their daily duties,” she added. “It can be quite a challenge to train everyone in the lab to handle their work within the specifications of the QMS, but the benefits are significant.”
Hospital Labs Adopt QMS
In July 2010, the two hospital laboratories of the William Osler Health System in Brampton, Ontario, earned accreditation to ISO 15189. The laboratories are located at the 608-bed Brampton Civic Hospital and at the 262-bed Etobicoke General Hospital.
“The laboratories in our health system run about four million tests annually,” said Burton. “There are approximately 147 lab FTEs, including 13 pathologists. Both hospitals have a core laboratory. Histology, cytology, microbiology, PCR, and flow cytometry are centralized at the Brampton Civic site.
In the 19 months since earning accreditation to ISO 15189, the two labs have produced impressive improvements across a wide range of lab operations. For example, turnaround times for key tests have been shortened. Errors in blood culture contamination and other areas of lab testing have been substantially reduced.
Population to Double
“William Osler Health System is one of Canada’s largest community hospital corporations,” she noted. “The two-hospital system serves more than 1.3 million residents in the communities just outside of Toronto. Moreover, population in this area is predicted to double by 2020—just eight years from now. That creates a challenge for our laboratory organization.
“We consider accreditation to ISO 15189—and implementation of its QMS—as an important component of our strategy to handle the substantial increases in workload that will accompany this rapid population growth in the coming years,” added Burton. “Further, ISO 15189 accreditation is recognized by the public as our labs’ commitment to patient safety, and to error reduction.
“Our accreditation to the ISO 15189 standard has established our laboratories as leaders in quality management in our organization and in our communities,” added Burton.
“Leadership at Osler laboratories is using the QMS of ISO 15189 as the foundation for giving lab staff the management tools and methods necessary to continuously improve work flow and productivity in the lab,” she continued. “By eliminating systemic sources of errors we have raised the overall quality of laboratory testing.
Meeting Lab Challenges
“The lessons from our use of QMS are instructive for labs seeking to increase efficiency and handle increased workload,” observed Burton. In November, Burton presented a poster on the labs’ QMS results at the Lab Quality Confab in San Antonio. The poster won the top prize as the best poster at the conference.
“The Osler laboratories are accredited to the OLA 15189Plus standard of the Ontario Laboratory Accreditation (OLA) division of the Province of Ontario’s Quality Management Program-Laboratory Services (QMP-LS),” Burton said. “This standard is accepted internationally and is based on ISO 15189 and Canadian standards for safety and point-of-care testing. It provides clinical laboratories with the tools needed to standardize processes, address diminishing resources, and set a quality benchmark.
“Our experience to date is that the QMS provides the framework that allows our management and staff to analyze all our operations and various work practices for the purpose of improving the value of our lab testing services,” she stated. “In these operational reviews, we involve management, technical leads, and all staff in tracking, reporting, and monitoring processes. We use the Deming cycle plan-do-check-act (PDCA) method.
“The results of the QMS review are reported in a quarterly scorecard system for our labs,” continued Burton. “Benchmarks are tracked in four key areas related to service quality: service excellence, access, effectiveness, and safety
. “One source of problems we identified through the QMS was errors in the handling, processing, and reporting of surgical pathology specimens,” she noted. “In particular, there was an unacceptable level of labeling errors involving histology blocks.
“Because testing surgical pathology specimens is a complex, multi-step process, it involves many staff members and errors can occur at any stage in the process,” noted Burton. “These errors can result in serious clinical outcomes for patients.
“In 2010, we used a failure modes effects analysis (FMEA) procedure to identify potential failures in the handling of pathology specimens,” she explained. “The FMEA included these steps: 1) mapping the overall processes for surgical pathology specimens from receipt to report; 2) identifying problems or barriers to ideal efficiency (including the causes of these problems or barriers); and, 3) redesign of existing processes.
“The team reviewed the factors that contribute to errors and devised error-reduction strategies,” stated Burton. “This resulted in approval of our business case for the purchase of a patient specimen identification tracking system. We anticipate a significant decrease in errors following implementation of the barcoding system that will replace manual processes for labelling containers, blocks, and slides, a major source of errors.”
Contaminated Blood Cultures
Another project focused on reducing errors that contribute to contaminated blood cultures. “The benchmark for blood culture contamination is less than 3% of specimens,” state Burton. “In 2008, prior to accreditation to ISO 15189, we were consistently over that level. There were some months when this problem exceeded 5%.
“This was a big opportunity for improvement,” she continued. “As lab professionals know, blood culture contamination is a serious problem that can consume substantial health care resources when we have to identify and correct the problem. Clinicians rely on blood culture results to diagnose and monitor febrile patients. Contaminated blood cultures increase patients’ length of stay and lead to unnecessary repeated tests and use of antibiotics.
“Through education, the rate of contaminated blood cultures was reduced to less than 3% by early 2009,” Burton explained. “Then, guided by our QMS, continuous improvement efforts have lowered that rate to 1% and they have been sustained close to that level for many months now. (See Figure 1 in sidebar below.)
Decreasing Turnaround Time
“A third area of concern that is universal in all laboratories is reducing lab test turn-around time (TAT),” she declared. “One issue related to TAT is critical results reporting. These are the results that can lead to patient death or other serious adverse patient outcomes if they are not reported quickly.
“The process improvement team looked at TAT for potassium tests and analyzed TAT versus potassium workload and full-time staff,” she said. “In August 2008, it was taking the lab more than 40 minutes from the time a potassium test was received until the result was verified.
“Since then, TAT has been reduced to about 30 minutes each month,” Burton noted. “This outcome is remarkable because the number of full-time staff has remained about the same while the volume of potassium tests rose 25%—from about 8,000 per month to about 10,000 per month!” (See Figure 2 in sidebar below.)
“We consider this to be an important demonstration of how the QMS helps our hospital laboratories meet the challenges of increased volumes of specimens (from the growing population in our community), even as lab budgets are held constant and we are asked to perform this additional testing with the same number of staff in the lab.”
Value of QMS to Every Lab
These examples demonstrate how adopting a quality management system can give the organization a proven framework and structure that can help it achieve continuous improvement in work processes throughout the laboratory.
Guided by the ISO 15189 QMS and Lean Methods, Hospital Labs Achieve Continuous Improvement