How many times have you noticed that the details of a laboratory automation interface to another device varies from one device to another?  Have you noticed that there is no standard 100ul pipette tip?  Have you spent hours trying to understand the format of data output from a workstation?  If you answered "yes" to any of the above questions, then you've been impacted by the lack of standards in the field of laboratory automation.  What would it take to do something about it?  How difficult is it to create standards?  The LabMan decided to talk to someone who has been through the process, Carol Homon, one of the key forces behind the creation of the SBS standards for microplates.

Before her recent retirement to focus full-time on geology, Carol was the Director of Biomolecular Screening at Boheringer Ingleheim, in Connecticut.  As she become involved in the automation of microplate assays, she became frustrated by the variability amongst microplates and the impact this had on the reliability of automated tools.  She and some of her colleagues from the SBS decided to set about to create a microplate standard to remedy this situation.  At first, they tried to do this task simply as an eager but standards-uninformed committee, without any formal liason with any of the worlds standards organizations.  Carol indicates that not getting involved with a standards organization from the start was their biggest mistake, one that cost them about four years of time.

They eventually chose to get involved with ANSI, the American National Standards Institute, a membership organization founded in 1918 that coordinates the development of U.S. voluntary national standards in both the private and public sectors. It is the U.S. member body to ISO and IEC, so any standards that meet ANSI specifications will also meet international (ISO) specs.  To work with ANSI, the sponsoring organization (in this case the SBS) must become an ANSI member as a standards developer.  Carol says the process is quite easy and all the information needed can be found on the ANSI website.  The collaboration with ANSI really got the effort on track and the ANSI staff were very helpful in educating the committee about all the aspects of standards development.  Still, the process took an additional 4-5 years to complete, which Carol thinks is a reasonable guess for the time to create any new standard.

When asked what part of the process was the most difficult, Carol says it involved the ANSI guideline that any new standard should not adversely impact the business of a company.  In this case, the group had to endeavor to create a standard that ideally would not put a microplate manufacturer out of business.  As you might imagine, this can be difficult, because it's a rare standard that pleases everyone.  To reach this state of nirvana, the various versions of proposed standards must be placed out for public review and commentary by all the "stakeholders", i.e. anybody or any company that may be impacted.  This is a long, time-consuming, iterative process, but the goal in the end is to reach a consensus.  The key consensus point related to the microplate standard was to actually create four individual standards, to better accommodate all the stakeholders needs.

Technology changes over time, so who is responsible for maintaining and updating standards?  It is the original standards developer, in this case the SBS.  If a standard is to have longevity and recognition, the originating group must have a commitment to stay engaged over time.

As to why the field of laboratory automation has so few standards, Carol thinks it's mainly because of the time and effort it takes to go through the consensus process, and the difficulty of proposing a standard from the start that is well targeted with real potential for success.  She points out that their effort to create a standard for deep-well plates was not meant to be because the high degree of diversity among those products made developing a consensus impossible.  Carol (and The LabMan) feels that we certainly could benefit from more standards, and encourages anyone considering such an effort to get involved with a standards organization early on.

What standards would you like to see?  Post a comment!  Experiences to share?  Post a comment!  Even if you just read this and found it even slightly interesting, post a comment!

Until next time,

Domo Arigato, Mr. Roboto