Sepsis—a life-threatening organ dysfunction in response to systemic infection—affects more than 26 million people worldwide each year. Nearly all cases (approximately 92%) start in the community, underscoring the role of emergency departments (ED) in identifying and promptly treating this high-mortality condition. Early detection offers the possibility of better outcomes, but definitive diagnostic biomarkers are lacking.
Despite its imperfections, lactate testing has been advocated for a long time, and recently procalcitonin (PCT) has emerged as a promising tool to improve sepsis diagnosis and management. Unfortunately, PCT testing has not been implemented effectively in many organizations due to costs, difficulties synchronizing efforts among care teams, and concerns over whether PCT results actually affect care outcomes.
The Collaboration Quotient
At our health system, the path to embracing and integrating PCT testing to improve sepsis care was a collaborative journey. We worked closely with stakeholders system-wide to keep processes standardized and get buy-in on how to implement and utilize PCT testing.
Our review of the scientific literature found many advantages of PCT testing, including efficient turnaround times, rapid increases in levels after an infectious challenge, and a direct correlation be-tween high concentrations and the severity of infection. These findings only increased our interest in offering PCT testing.
Despite this strong interest, however, we faced challenges on the road to effectively implementing PCT testing. These included harmonizing our approach system-wide, standardizing equipment and PCT reference ranges, justifying implementation costs, and educating staff about the test’s availability and appropriate utilization.
Our first step was to identify key stakeholders whose collaboration we needed to make change possible, including lab workgroups, hospital- and system-level physician and nursing groups, and the system sepsis accelerated change team (ACT). Our collaborative approach paid off by identifying problems early on as we began implementing PCT testing. For example, our medical staff wanted critical value criteria for PCT results, but we encountered difficulties in achieving system-wide consensus as neither our community nor the scientific literature had concrete agreement on this issue.
The interdisciplinary system-wide sepsis ACT team played a vital role in implementing new stand-ardized processes. Collaboration through sepsis ACT led to consensus on PCT critical values as well as development of sepsis treatment algorithms and order protocols, including laboratory tests. Our criteria for PCT results included an abnormal high >0.50 ng/mL and a critical value >2.0 ng/mL.
Changing the Rules
While a big part of our sepsis initiative involved implementing PCT testing, we also sought to tighten procedures on lactate testing, including improving the percent compliance with repeating this test within 6 hours after initial results >2.0 mmol/L. Since this threshold did not fall under our critical val-ue criteria, we needed to work closely with our information technology team to develop alert rules for what we called “notifiable results,” as well as reflex rules to automatically order repeat lactate testing within 6 hours.
Considering the complexity of this testing, we coordinated a 1-month pilot study at our hospital to assess how both these new rules and our notification process worked in operation. Through the pi-lot we tested a lactate alert that notified technologists to call ED about results >2.0 mmol/L. We developed a reflex rule to automatically order repeat lactate testing within 6 hours of an initial result >2.0 mmol/L. However, to avoid a continuous cycle of reflexing any result >2.0 mmol/L, we built a separate test in our laboratory information system called “lactate reflex.” Physicians must order any additional lactate testing after the reflex test.
In our pilot we gathered sufficient data to identify challenges and make necessary changes prior to implementing these alerts system-wide. During this time, we learned how important it was to edu-cate both physicians and staff about the new reflex process to avoid duplicate orders. We also adjusted the lactate reflex rule so that the second test would be ordered within 3 hours after the initial >2.0 mmol/L value. This would ensure that the second test would be completed with the 6-hour time-line.
In addition to the pilot, our hospital’s ED and laboratory conducted a study to compare the sensitivity and specificity of lactate and PCT testing. We found that PCT values had a higher predictive utility for ED patients than lactate results. In addition, the receiver operating characteristic curve for PCT results at first presentation was significantly larger and the validity coefficients generally better than those of lactate. Moreover, the suggested lactate cutoff >2.0 mmol/L did not seem to be appropriate when a patient first presents at the ED. We found a cutoff >1.4 mmol/L more clinically relevant for emergency physicians ruling out sepsis.
Our study also showed a significant decrease in hospital costs not directly related to length of stay after we implemented the PCT protocol. We hope our experience will inform other organizations as they consider implementing PCT testing in the workup of suspected sepsis.
Maria Elena Gauthreaux, MSHSA, BS, MT(ASCP), is laboratory director at West Kendall Baptist Hospital in Miami, part of the Baptist Health South Florida system. Email: MariaGau@baptisthealth.net