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Justifying a LIMS for your Small Water/Wastewater Laboratory


Justifying a LIMS for your Small Water/Wastewater Laboratory

by: Alan Vaughan - LIMS Advocate, Laboratory Informatics Institute

Overview

A currently popular and well-known definition of insanity is the repetition of the same behavior with the expectation of different results. Moreover, it is a key principle of laboratories that processes be repeatable with predictable results. Why is it, then, that many small water/wastewater or environmental labs continue to labor using paper and pencil and, at best, Excel spreadsheets for information management and yet expect to magically meet or exceed regulatory standards including NELAC/NELAP (TNI) and 21 CFR 11, increase efficiency, handle instrument calibration and maintenance (never mind results files!), generate all reports and trend analyses quickly and distribute them effectively, and interface with outside systems when it has ALWAYS been a struggle?

 

There are a couple of answers (if you discount the insanity plea).

 

Probably first on the list is budgetary concern. LIMS have always been a huge investment – not only in the licenses themselves, but in the whole process of identifying exact needs and assembling them into a comprehensive and accurate RFP (Request for Proposal), selecting the right solution and then spending vast amounts of time on infrastructure and the implementation process. Then there’s the matter of ongoing maintenance and support.

 

Physics is another reason labs often don’t seek a LIMS. Specifically, Newton’s first law of motion: objects (labs) in motion tend to stay in motion and those at rest tend to stay at rest. Is your lab at rest? This principle often manifests itself in denial that there is a problem or a need. It’s a case of “we’ve always done it like this, so it must be the only way to do it, or at least it’s ‘good enough’.”

“We’re not big enough”  Lab managers or other decision-makers will also make the mistake of deciding that LIMS are only for big labs. Things have changed in the world of laboratory informatics…

LIMS functionality you need...

The old paradigm of an expensive sample tracker with one-trick functionality is dead. Today’s laboratories demand and get systems that not only manage your sample flow, but regulate user access to data and functions, allow remote access and reporting, send alerts and emails, interface with outside systems and designated external users, schedule and manage sample routes and site-specific restrictions including federal, state and municipal limits, monitor analyst training/qualifications and track their time, provide for barcoding and much, much more. Today’s LIMS more than justifies itself by taking over many of the labor-intensive functions of the lab that were previously taking many man-hours or requiring other costly applications.

 

Here are some of the functions a small water/wastewater lab can expect to receive from a LIMS:

 

·    Sample Login (Sample-Based, Project-Based, Case-Based, Study-based)

·    Batching

·    Barcoding

·    Handheld & Tablet Device Integration

·    Work Load Management

·    Workflow

·    Scheduling

·    Multi-Location Support

·    Sample Analysis

·    Instrument Interfacing

·    Electronic Data Exchange (incoming)

·    Sample Results Entry

·    Calculations

·    Sample Management and Tracking

·    Trending/Control Charting

·    Faxing & Emailing Reports

·    Audit Trails

·    Chain of Custody

·    Document Management

·    Instrument Calibration and Maintenance

·    Chemicals, Equipment, other consumables, tissues, samples, specimens, other various entities

·    Storage Management

·    Training Tracking

·    Event Driven Alerts

·    Support for industry standard compliance initiatives - NELAC, 21CFR11, GALP, Section 508, ISO17025...

·    Version Control of Tests, parameters, limits, reports, configuration changes, software upgrades, etc.

·    User Configurable Database Tables, Fields and other DB objects, Screens, Calculations, Workflow, Business Logic, Reports, Charts, External System Interfaces

·    Configurable Tests, parameters, limits, etc.

·    Configurable Security

·    Data Mining and Data Warehouse

 

All of these functions are now expected as standard in a Laboratory Information Management System, and the fact that you have these capabilities included means your cost/benefit justification ratio just got a giant vitamin B-12 shot.

 

That Time and Budget Thing (Cost of Ownership)

If your lab is one of those that has been hesitating about getting a LIMS, there’s good news. The Laboratory Informatics Institute (“LIMStitute’) has published a free tool that vastly improves the process. You can download a  LIMSpec that contains quite a comprehensive list of common laboratory LIMS requirements gleaned from scores of real RFPs. They are arranged by functional areas so you have a great platform for creating an RFP that suits your lab. And the LIMStitute will soon be issuing industry-specific LIMSpecs (water/wastewater is slated to be the first) so that it comes already tailored to your type of lab. That saves a ton of time and money just gathering requirements and building a Request for Proposal, so your staff can concentrate on their real jobs.

 

The other good news is that prices are plummeting. As the leading companies refine implementation processes and standardize offerings, the market is becoming more commoditized, and that means more bang for the buck. Your costs will include the license, implementation and maintenance and support. The system proposal may or may not include hardware and any related software, and you can designate your own preferences in those areas. And as mentioned in the function list above, a couple of the companies at the forefront of web LIMS technology even offer hosted systems that can be operational in a matter of days with annual subscription replacing license fees. Even those offering standard systems, however, are reaching new levels of efficiency so that full-featured LIMS are more than ever affordable no matter how small your lab is.

 

Buy vs Build

One way many labs try to circumvent the LIMS acquisition process is by designing one in-house - or hiring a developer to make a custom one. While these options may look cost-effective in the short term, every lab eventually comes to the realization that they need to buy one. Why? Mostly flexibility and longevity. It turns out that a hard-coded LIMS built to suit your lab's workflows and processes in 1995 doesn't tend to match the needs of your lab in, say, 2002. In fact, most find they have had to write additional code in 1996, 1997, 1998 and four times in 1999...you get the picture. Each time you need to adjust to different conditions you need to root out that developer guy and pay him (or her) to dash off a few modifications. And let's hope he or she hasn't in the meantime decided their true life's destiny lies in a remote district of Nepal... And good luck integrating it with a national reporting system or other applications! Sadly, most find that after a larger investment in time and money than they thought they would have to make at first, they end up with an inflexible, limited LIMS of significantly inferior quality than everybody else's, and a lifetime relationship with a rather pale-complected, stubble-faced young man who speaks in a foreign language, even though he's from Queens.

 

This is borne out in a poll by Ocimum showing respondents preferred buying (58%) over custom-built (42%) http://www.ocimumbio.com/web/poll/v2is3.html .

 

In an article entitled "The Struggle for 'Perfect' Software: Compliance Considerations" by Gloria Metrick, MBA, Owner of GeoMetrick Enterprises and Nadejda Segal, Ph.D. Information Services Senior Consultant for Apotex Inc. (http://www.spconsultants.org/articles/Struggle-for-Perfect-Software.pdf - Journal of GxP Compliance, July 2003 •  Volume 7, Number 4), the authors point out that whereas in building a custom LIMS the lab tends to be involved in the entire process from start to finish, "...the process can become more focused on the creation of the software than on its quality." In the case of buying a COTS (Commercial Off-the-Shelf) LIMS, the product already exists, and the lab becomes involved more in working with the vendor to tailor it to its needs, raising the quality of the product - not just for that lab, but as an ongoing system, which the vendor has a stake in, and a good vendor will be motivated to meet those needs for that reason if no other. Additionally, in-house or contracted "...software developers also tend to place a heavy emphasis on technology over usability." They add, "The most popular argument against using software development procedures is that they are a lot of work and are not much fun. This particular argument is entirely true."

Regulatory Compliance

As a small water/wastewater lab, one of your main concerns is compliance with federal, state and municipal standards, including NELAC/NELAP (now TNI), NPDES, 21 CFR 11, 40 CFR 3 (CROMERR) and the like. In governmental labs which involve sensitive data, and environmental or water/wastewater labs which are subject to governmental scrutiny, it's important that all known regulatory compliance standards are supported by the leading LIMS, including:

 

·             21 CFR Part 11 and 40 CFR 3: Your LIMS should meet FDA and EPA requirements in that electronic signatures and documents are stored in the system database and only accessible by authorized personnel based on login. These data are securely and accurately transmitted to appropriate parties in whatever ways are mandated, including the interfacing to systems like STORET, WARN, eLEXNET and others for reporting and data sharing with state and federal departments and agencies.

·             Section 508: In the case of a federal agency needing to meet this regulation, the desirable LIMS suite offers the best disabled accessibility available since it is Windows browser based and thus configurable to the Microsoft Windows accessibility options native to that operating system.

·             ISO/IEC 17025: Compliance with this laboratory management standard will also fulfill the more generic ISO 9001. The items for accreditation are both managerial and technical, and are aimed at traceability, standardization and consistency. The modern LIMS supports these elements in all of the applicable areas, applying methodologies evenly across different procedures and tracking all data necessary to support the lab in meeting this standard.

·             NELAC/NELAP (TNI): Limit alerts, storing of SOPs and standards, monitoring of training  and qualifications, instrument calibration and maintenance...these are some of the many ways your LIMS should help you to meet these requirements comfortably.

 

The biggest thing to remember is that a LIMS helps you to eliminate errors in transcription (the more times you have to write something down, the more chances for error), control access to data and reports, and especially the tracking of any modifications to those data, and alert you when there are potential non-compliance issues. Those issues may be in the form of out-of-limits results, analyst qualification expiry, holding time exceedance and countless other metrics. To leave each of these to reliance on the sharp eye and diligence of lab staff shows a high level of trust, and is very commendable. Albert Einstein was a very trustworthy and diligent person. On one occasion we are told, however, he called up the Library of Congress to enquire as to his home address because it seems he had forgotten it for the moment.

 

The point is, obviously, no matter how good you and your staff are, we are all human, and we will make mistakes. Unfortunately, while being very nice people generally, the government tends not to view non-compliance with a great degree of forgiveness.

 

All Things Considered...

On balance, when you factor in all of these items - increased functionality, reduced cost, quicker implementation and significantly reduced risk of non-compliance - and just the overall efficiency and productivity that results from a cleanly organized workflow system, it is clear that now, more than ever before, is the right time to bring your lab into the 21st century with a LIMS. The math speaks for itself: reduced labor costs + increased functionality + compliance * lower investment = no brainer. Now you can let your staff concentrate on what they were hired to do instead of repetitive transcriptions, filing, limit and qualification monitoring and report preparation.

To get the ball rolling, why not download the LIMStitute LIMSpec now at

http://files.limstitute.com/ebooks/limspec/li2-lsl/index.html?download_limspec_library.htm

 

The LIMStitute is your advocate for LIMS acquisition and use and all related informatics issues. You can contact us anytime to speak with an advocate who can help to make the processes easier by calling 770.313.5827 or emailing avaughan@limstitute.com with any questions or for guidance. Good luck with your move into quality laboratory management!

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Posted by: LABLynx, Inc. on Mar 12,08| Profile| LIMS - Laboratory Information Management Systems

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