For those in laboratory management who are considering standardizing their laboratory system, it is worth remembering that the route is not a short one. This is evidenced by our health system’s ongoing journey of over 18 years. Almost every day brings the potential for the introduction of non-standard practices, as well as opportunities for greater standardization across the system. In both cases, we have learned many lessons, and whether your laboratory is just beginning a process of standardization, or is seeking ways to maintain standardization, access to information and experience is essential.
Herein we discuss some of our lessons learned at Norton Healthcare in Louisville, Kentucky; experiences we hope will help others undertaking laboratory standardization. This advice includes understanding that your biggest challenges will likely include disrupted communication, a clash of cultures, differing views and personalities, all while ensuring that essential logistics are addressed.
As many laboratory directors already know, standardization—of instrumentation, practices, and workflows—is a vital aspect of growth in a culture of health care consolidation. It is not irrational to believe that if the laboratory does not seek standardization for itself, such a condition will be placed upon it from outside. With this in mind, we seek to encourage laboratories in their standardization efforts.
Communication is Key
In the corporate world, mergers and acquisitions often come as a surprise to the employees in the companies. While often a necessity, this lack of transparency negatively impacts employee trust.1 This should serve as a lesson to all laboratory leaders embarking on standardization: The less transparent you are with your laboratory staff, the less likely you will be to gain or maintain their trust. When standardization of laboratory services is discussed, it can elicit substantial fear and anxiety among staff. The common fear that standardization is intended to reduce the number of employees is particularly pernicious. Thus, the clear intentions of standardization need to be addressed openly and honestly with laboratory staff, to every reasonable extent.
In addition to transparency from laboratory leadership, the team leading the standardization efforts needs to enable clear and frequent two-way communication with staff. When informing staff on project updates, it is important to include details as to why the system is undertaking particular standardization efforts. All too often, leaders can get wrapped up in communicating what and how change is to take place but lose sight of explaining why. It is worth remembering that it is practically impossible to successfully implement process change if your staff is still wondering why. The two-way nature of this communication must be sustained, and lab leadership should encourage open discussion of concerns and worries. This will help to reveal potential pitfalls that could otherwise undermine standardization if not addressed.
Cross-Pollinate System Laboratories
Effectively standardizing clinical laboratories requires recognition that the primary barrier to change is likely to be cultural rather than equipment based. Converting all the laboratories to the same instrumentation is an easier task than combining different laboratory cultures into one. Meeting this challenge requires leadership at each site that understand the value and need for standardization and can imbue this sense into laboratory operations. This can be a challenge in itself.
Traditionally, individual laboratory leaders have come up through the ranks of their respective laboratories without significant time spent working within or throughout a system. This was particularly true prior to the substantial consolidation we see in health care today. Such experience can limit a laboratory director’s awareness of the overall needs of the system and lead them to an over-prioritization of the needs of their individual laboratory. Fortunately, there are several ways to address this.
The first is to ensure there are frequent and purposeful interactions amongst the leaders at the various sites. Nurturing connections and encouraging exposure help increase the likelihood that individuals will see and realize the value of system standardization. One venue for doing this is a monthly, system-wide quality meeting where laboratory leadership from each site presents to and hears from leadership at the other sites.
The second is to prioritize and take advantage of opportunities for leadership cross-pollination across the system. That is, avoid giving de facto preferential treatment to internal candidates when a site’s leadership roles come available. There is both internal and system-wide value in hiring qualified employees from other sites into leadership positions. The system—and the standardization program—will benefit from shared experiences, as well as a broader understanding of individual-site and system challenges.
Finally, creating or developing certain universal positions, such as quality managers or technical experts, into system-wide positions can provide tremendous advantage. Nurturing employees whose job requirements involve assisting in quality efforts and process improvements, as well as technical expertise related to the entire system, also helps stabilize standardization projects. Regardless of approach, successful standardization is utterly reliant on leadership at each site buying into and promoting standardization.
Managing Resistance to Change
The myriad decision points likely to be debated during system-wide laboratory standardization will range from the minor (eg, deciding maximum dilutions for various analytes) to major (eg, choosing chemistry platforms for the system). It is important to view each of these challenges, large and small, as opportunities to improve the entire system.
Unfortunately, there will be individuals who will use these challenges and debates as opportunities to attempt to derail standardization efforts. Those most resistant to change tend to fall into two categories, one much worse than the other. The first group defaults to negative views of standardization and can be vocal with reasons why it should not be done, will not work, will jeopardize patient safety, and so on. While these complaints often arise from a desire to avoid change more than genuine concern over what the change might entail, it is important not to dismiss these complaints. Interestingly, change-resistant staff members can end up being a valuable asset in your efforts to successfully standardize. The natural desire to find reasons not to standardize make these staff members perfectly suited to root out unexpected gaps and hazards in the process. The challenge remains in ensuring that substantive concerns are addressed while negativity is mitigated.
Perhaps more damaging to standardization efforts are individuals that actively keep quiet about workflow problems in the hopes that they will derail the entire standardization effort. Laboratorians at all levels of practice can and should provide valuable insight into potential workflow differences that need to be addressed and which could prove essential to successful standardization. It is one thing for there to be numerous complaints about change and standardization, but undermining improvement is quite difficult to manage. This is why a culture of commitment to standardization must be cultivated. Obtaining a critical mass of individuals committed to successful standardization is key.
Once the technical and methodological work of standardizing your laboratory is done, the more complex part of maintaining standardization begins. This requires careful consideration for how you control changes in your laboratory. One excellent tool for helping with this is an electronic document management system that all sites utilize as a clearinghouse for policies and procedures (P&Ps). When individual sites maintain their own document management systems, especially if they are not electronic, it becomes easier for those individual sites to make small tweaks that change workflow and alter standardized practices.
For example, one laboratory site may decide to respond to a clinician request by validating a higher dilution for a particular analyte. Having a local document management system means that this change can easily be implemented without other sites noticing or being informed. These types of seemingly minor changes can occur on a regular basis and after sufficient time, a standardized laboratory system can morph back into a system of self-operating laboratories.
More important, such practice and workflow changes create discrepancies in the level of service each laboratory in the system provides (eg, one laboratory results using numeric values whereas others result using greater than [>] or less than [<] indications). Rolling out a centralized, electronic document management system means that any change an individual laboratory wants to undertake to the standardized P&Ps requires a universal change for all sites. Therefore, such a change must be communicated to and agreed on by the collective leadership and implemented at all laboratory sites. Keep in mind that this process will often be seen as a negative aspect of standardization; that is, the amount of work required of any one laboratory to adjust their workflow is increased by virtue of needing to work with other laboratories in the system. However, this also demonstrates the value of standardization; any workflow optimization that one laboratory discovers is disseminated to the other laboratories in the system. In short, the extra work any laboratory does to implement workflow improvement is balanced out by the workflow improvements they realize from the work of other laboratories. Emphasizing this balance is essential to ensuring sites see the value of standardization.
As health systems continue to grow and reimbursements continue to fall, standardization will become a necessity for hospital laboratories to remain competitive. For many laboratories, standardization is the sound of inevitability; the question is not whether our laboratories will standardize, but will laboratorians be in the driver’s seat of these efforts?
Laboratorians and laboratory leaders are the subject matter experts and need to be a primary voice in standardization decisions. Organizations should respect and solicit the expertise of their laboratory staff for this process and laboratorians should recognize and come to respect the value of standardization. Eventually, someone will standardize your laboratory services; it is better for that someone to be you.
Joshua Hayden, PhD, DABCC, FAACC, is the chief of chemistry at Norton Healthcare in Louisville, Kentucky. Prior to joining Norton, he was an assistant professor of pathology at Weill Cornell Medical College and director of the toxicology and therapeutic drug monitoring laboratory at New York Presbyterian Weill Cornell Medical Center. Joshua has expertise developing and overseeing mass spec assays in the clinical lab.
Kenette Pace, MT(ASCP), is the system director for laboratory services for Norton. She has been with Norton Healthcare most of her career in various positions from microbiology manager to central laboratory director to her current role as system director. Kenette also worked as the senior director for laboratory operations at Cincinnati Children’s Hospital.
Zora Pyevac, MT(ASCP), is the recently retired system laboratory director for Norton Healthcare. She began her career at Norton as a lab scientist and held multiple positions, including chemistry supervisor, assistant lab director, lab director, and ultimately, system lab director, before retiring in 2019.