James Hernandez, MD, of the CLN Patient Safety Focus editorial board conducted this interview

Often leaders in laboratory medicine drive organizational patient safety efforts from within the lab, working closely with other disciplines and departments. In this interview, Paula Santrach, MD, explains her role leading institutional level quality and safety programs at the Mayo Clinic in Rochester, Minnesota. Santrach is the associate dean in the office of value creation, chair of the Mayo Clinic quality care subcommittee, and chair of the Rochester clinical practice quality oversight committee. 

You have served in many leadership positions at the Mayo Clinic in addition to your expertise in point-of-care testing. As a pathologist, how did you come to your roles in quality and safety? 

As a transfusion medicine specialist, I became interested in quality in the early 1990s when the Food and Drug Administration (FDA) began stricter enforcement of good manufacturing practice for blood banks in the wake of transfusion-transmitted HIV. At that time, FDA required a formal quality management system, and I was deeply involved in implementing the one at Mayo Clinic in Rochester. The concepts of complying with standards, performing consistently, using systems thinking/engineering, and ongoing assessment made sense to me and inspired me. To gain more experience, I became an assessor for accreditation under AABB, formerly known as the American Association of Blood Banks, and in the ensuing 20 years learned about implementation and innovation from many different facilities. 

From that beginning, all my work has had a quality component in some way, whether in blood banking and transfusion medicine, autologous blood transfusion, point-of-care testing, rapid response laboratory management, or departmental administration. I was fortunate to be first chair of the AABB multidisciplinary perioperative standards committee that developed the first standards for perioperative transfusion of salvaged blood and other autologous products. In addition, I have served on several Clinical and Laboratory Standards Institute (CLSI) committees, was chair of the Clinical Laboratory Improvement Advisory Committee, and worked on many internal process improvement projects. 

Over time, I assumed increasing responsibilities for projects and initiatives both inside and outside laboratory medicine and pathology. In 2007, I became the chief quality officer for clinical practice in Rochester and in 2012, was promoted to the same role at the enterprise level. I attribute my success in this regard to being effective in both planning and executing tasks, working on a diversity of projects, acquiring considerable knowledge in any area for which I become responsible, being willing to take on challenging projects outside of my own field, maintaining strong relationships with my clinical colleagues, and working outside of my comfort zone.  

A recent study in the British Medical Journal reported that medical error is the third leading cause of death in the United States. How does Mayo Clinic approach systematic errors, and what part does the laboratory play? How do you implement and sustain a safe culture? 

We have a robust approach to event reporting throughout our organization. We review all reported events. Serious errors are subject to intensive review or root-cause analysis in order to identify ways we can improve. These multidisciplinary reviews bring in all areas that are involved, including the laboratory. These teams identify and implement solutions through a variety of mechanisms, and share them across the enterprise. We also send to leadership a weekly summary of serious harm events. 

Our approach to safety culture is multipronged. First, we developed the Patient Safety Essentials, a list of more than 50 best practices required at all of our facilities. Second, we implemented a culture of safety program focused on the multidisciplinary, multiprofessional care team. Peer facilitators, including physicians, work with individual hospital units and clinical areas to understand their culture, help them identify improvement opportunities, utilize Plan Do Study Act cycles to make small tests of change, and use transparency techniques for employee and leadership engagement. Although time-consuming¬≠, the long-term sustainability for these groups has been excellent. This program improves both the safety and teamwork climate, and also boosts multidisciplinary communication and empowers staff to speak up. Laboratories have been engaged in this program as well. 

Third, we regularly post patient safety and quality stories on our intranet. These stories are well read and many people write supportive comments. 

Fourth, our search for improvement opportunities reaches far beyond reported harm events. Multidisciplinary teams review in-hospital deaths, looking for what could have been done better regardless of whether or not certain actions might have contributed to the patient’s death. We also review, for the same purpose, rapid response calls, code calls, and other types of occurrences. We regularly monitor our performance on external quality metrics in the same way using external benchmarks. 

Finally, we have adopted the perspective of “safety without adjectives.” This means that we include both patient and employee safety as part of our quality program. These two perspectives of safety are very tightly linked. We are just beginning our work in diagnostic error. 

How safe are your hospitals and your laboratories? How can other laboratories participate in making not only their laboratories but also their systems safer? Where should others start? 

It is very challenging to objectively measure an organization’s safety, and all approaches have shortcomings. We assess our success in improving safety by monitoring: 

  • Trends in inpatient mortality
  • Trends in the incidence and type of serious harm events
  • Performance on external safety measures such as the patient safety indicators
  • Trends in reported employee safety events
  • Trends in healthcare-acquired conditions including pressure ulcers and infections such as central line-associated blood stream infections 

The laboratories have their own event reporting system and will also send certain events to the institutional system. Laboratories can make a safety impact beyond their walls by: 

  • Applying system thinking to all quality issues and assessing how problems in the lab impact clinical practice and vice versa
  • Considering all phases of testing, including pre-pre-analytical and post-post-analytical, in solution design
  • Applying human factors principles to solution design
  • Participating in diagnostic error activities outside of the lab
  • Developing a test utilization approach
  • Defining a plan for extraordinary events
  • Being knowledgeable about care protocols and proactively preparing to provide appropriate and timely testing. A good example is the lactate testing requirements in current sepsis guidelines. 

Most importantly, build strong relationships with your clinical colleagues and listen with the intent of “how can I improve the practice?” 

Why are laboratorians, scientists, and pathologists natural systems-builders? Are others successful in analyzing and sharing data? 

System thinking is a vital skill for laboratory medicine and pathology. Data analysis and quality principles are essential. I use skills that I learned in my training and in my practice on a daily basis even when I am not in the laboratory. I’m a data nerd and love to analyze, so this is my dream job! 

What have been your biggest challenges? 

Keeping up with a rapidly changing external environment around clinical quality, and maintaining my skills in laboratory medicine while working in administration 70% of the time. And of course, that fact that there just are not enough hours in the day! 

How can AACC members learn more about safety? 

AACC members should continue to seek learning opportunities around clinical practice quality and also showcase examples of how the lab’s participation led to their organization achieving its strategic goals. One example is the AACC Patient Safety Essentials for Laboratory Professionals certificate program. Enrollment for this six-course program opens January 1. 

James S. Hernandez, MD, MS, is an associate professor of laboratory medicine and pathology, and medical director and chair of the division of laboratory medicine at Mayo Clinic in Scottsdale and Phoenix, Arizona. +Email: hernandez.james@mayo.edu



CLN's Patient Safety Focus is sponsored by ARUP Laboratories

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