Journey around the country and walk through even some of the most elaborately equipped laboratories and it will not take long to encounter a paradox, perhaps the greatest paradox of laboratory automation. Roughly stated it is this:
(1) Manual transcriptions of laboratory instrument data and subsequent checking for accuracy is a time consuming, error prone, tedious and essentially anti-human activity.
(2) LIMS instrument interfacing eliminates this entire step, with associated improvements in accuracy, throughput, turn-around time, employee job satisfaction and costs.
(3) Only a small minority of labs have implemented instrument interfacing even when they have a comprehensive LIMS installation.
Some of you are of course saying that this is not a real paradox, but bear with me as we follow the old saw “When faced with a paradox, examine the hypothesis.”
Certainly it is possible to find people for whom the manual transcription and checking of data provides a great deal of inner joy, and who consequently do it with excellence, but I think we can dispense with that as a significant factor in the paradox.
For the most part the issue revolves around (2) and boils down to “Is the view worth the climb?” For a variety of reasons the inclination seems to lean naturally toward “No.” Here are some of the myths which I believe tilt the table in ways contrary to the best outcome.
Myth 1: Instrument interfacing has a high initial investment.
Reality: It all depends. Instrument interfaces can be simple and low cost. A unidirectional non-intrusive configurable COTS interface that simply captures an instrument or CDS report and uploads its analyte values and raw data file to the LIMS can be licensed and configured for less than a month’s worth of transcription and checking time. On the other hand, an instrument interface can consist of an elaborate bi-directional communication with tight integration to LIMS data on standards, batches, patients, and testing protocols, capture entire CDS methods, and include extensive handshaking according to a proprietary or standards (e.g. ASTM E1578) based protocol. In this extreme the cost can multiply many fold. Here the 80-20 rule can be quite useful in deciding how far to go.
Myth 2: Instrument interfacing won’t work for us because we almost always review and often intervene to re-process or even re-run the analysis or parts of it.
Reality: There are a variety of ways to readily allow this kind of review and re-run process in an instrument interfaced system, either before releasing data to the interface or via provisions of the instrument interface package itself. These are standard provisions in most COTS interfacing packages.
Myth 3: We have a huge set of instrument methods. We can’t afford to configure an instrument interface to handle all of them. A variation on this says that our instrument methods are in a constant state of flux as we deal with new situations. We can’t afford to also re-configure the instrument interface or have it frequently fail.
Reality: With sufficient pre-knowledge of such behavior, a single instrument interface configuration can be set up to robustly handle a wide range of actual behavior.
Myth 4: Instrument interfacing is ultimately a system integration job involving multiple vendors, a lot of interchanging of specs and requirements, and a lot of hassle to pin down who is responsible for what, with the inevitable finger pointing.
Reality: Many LIMS vendors can act as single source providers of the entire instrument interfacing solution including complete hardware and software connectivity. Such solutions tend to be much less expensive and hassle free both in the initial project and for ongoing support.
Myth 5: We require a validated GxP system and validating an instrument interface is too elaborate and expensive.
Reality: The validation of configuration based COTS software is substantially less demanding than custom systems, and this includes instrument interfaces, particularly of the simple type described under Myth 1 and when dealing with a single vendor source. It is likely the vendor can provide templates and examples of many of the required validation protocols.
Of course it is wise to keep in mind that every myth contains an element of truth. Certainly the types of instruments, number of each type, usage levels, quantities of analytes, the value of rapid turn around to the enterprise, etc. must be taken into account to determine if the justification is there. But it is time to separate myth from reality in evaluating the prospects for instrument interfacing as part of any LIMS installation. The benefits can be substantial.
Larry DeHeer 10/1/2009