Many modern LIMS now incorporate features of QMS systems, such as audit trails and reporting functions, to consolidate sample tracking and product quality into one platform. This is a boon for many labs: fewer programs to learn and train on, less time spent on data entry and more time for the science, etc.
For other labs—particularly highly regulated ones—a hybrid LIMS/QMS may not suffice, and dedicated platforms for each will be needed.
Since shopping software is far from the first priority for an up-and-coming lab, many lab managers are left unaware of what solutions exist that can scale alongside their lab and, inadvertently, select suboptimal platforms.
A new lab has many options for both LIMS and QMS programs, ranging from “skeleton” platforms to “all the bells and whistles,” according to Jose Cobar, MS, MLS(ASCP), CLS, lab manager of Sutter Health Novato Community Hospital. But in the end, he says, the decision often boils down to the cost. Lab staff want a tightly integrated system while lab leadership can’t rationalize the price tag of a QMS-enabled LIMS. As a result, Cobar has most often seen a “hodgepodge” approach adopted: because new labs typically don’t have the funds or time to implement a thoroughly researched and comprehensive program that will grow with their lab, they choose disparate programs for quality management and sample tracking and then “Frankenstein a system together” with those components.
It is far harder to migrate to a better product than it is to tolerate a subpar system.
A Frankenstein system may suffice for a while. But eventually, the lab will outgrow it. The challenge then becomes organizational inertia. It is far harder to migrate to a better product than it is to tolerate a subpar system. Cobar describes this as the laboratory’s “original sin”: once ingrained, it can take a “Herculean effort” to change systems given the logistical issues it creates, which is something to keep in mind as initial systems choices are made.
The case for choosing scalable software from the start
Cobar understands that business needs may necessitate quickness, spurring pressure to make swift decisions or cut corners. However, as a clinical lab manager, he is responsible for ensuring quality in his lab; he emphasizes that one laboratory error can result in tragedy. Additionally, errors can warrant the recall of patient diagnostic reports, which may result in significant negative financial impacts for the lab. Cobar has found that framing the argument for implementing systems carefully in terms of financial impact resonates with lab owners, who may be the ones pushing for speed.
He emphasizes, “A good quality program reduces harm and financial issues, too . . . if it’s done right: no recall of reports [and] no injury [to] the brand.”
The takeaway: Lab leaders should select scalable LIMS that offer quality management features suitable for their lab. If no such LIMS fits the bill, leaders should consider implementing distinct LIMS and QMS platforms. By implementing a long-term solution from the beginning, labs can avoid operational inefficiencies and costly migrations later.
