By: Colin Thurston
The U.S. water infrastructure is impressive: More than one million miles of pipes located beneath our streets, towns and highways provide drinking water to more than 240 million Americans every day— and the number of people served by this massive system continues to grow. At the same time, significant portions of this infrastructure, including water treatment and delivery systems, provide water for critical uses such as public health protection, fire protection and economic prosperity.
As impressive as the U.S. water infrastructure is, however, it is also fast approaching the age where it needs to be replaced—some pipes and supporting infrastructure are almost 100 years old, and other large sections are 50+ years old. Giving the enormity of the infrastructure it should come as no surprise that dollar estimates for replacing this aging system run in the billions and even trillions. The Environmental Protection Agency’s (EPA) Drinking Water Infrastructure Needs Survey and Assessment report, released in 2009, estimates that continuing to provide safe drinking water to the American public will require an estimated $334.8 million between 2007 and 2027.
A more recent report from the American Water Works Association (AWWA), titled Buried No Longer: Confronting America’s Water Infrastructure Challenge , estimates the investment at a significantly higher dollar amount. The AWWA report states that “restoring existing water systems as they reach the end of their useful lives and expanding them to serve a growing population will cost at least $1 trillion…between 2011 and 2035 and exceed $1.7 trillion by 2050.”
At the same time the water infrastructure is reaching a critical inflection point, the standards for environmental testing have become more rigorous and far reaching than ever. Over the last few years new requirements have been introduced via the National Environmental Laboratory Accreditation Program (NELAP) and the EPA. The EPA’s Safe Water Drinking Act empowers the agency to specify the legal limits for levels of contaminants in drinking water, and the EPA also determines the water-testing methods and sampling schedules that water providers must follow.
These regulations provide a set of protocols outlining what is acceptable regarding the daily processes within a multi-disciplinary water laboratory in accordance with internationally-accepted standards. The laboratories charged with adherence to this ever-growing number of regulations work closely with municipalities, municipal utility districts, water control and improvement districts, drinking water vending companies and federal and state regulatory authorities to ensure safe drinking water. Meeting these stringent requirements for water and environmental samples has introduced labor-intensive procedures to ensure compliance, such as sample tracking, Chain of Custody (COC), record keeping, Demonstration of Capability (DOC), document control, reagent and standard traceability, proof of training and reporting. (See figure 1). These laboratories also have additional needs to automate manual and paper processes and increase sample throughput in order to create efficiencies, secure data, improve scientist and laboratory professional productivity and more.
The Crucial Role of a LIMS
One solution being used to address these growing challenges is a Laboratory Information Management System (LIMS). LIMS have become much more prevalent and necessary in water laboratories and testing facilities as demands and regulations have grown and paperbased systems are no longer effective. A LIMS works by scheduling and holding sampling plans, which are then used to generate a collection run for each sampler. The collection run defines where samples must be taken from, what sample bottles must be collected and what onsite tests have to be performed. Samples are then analyzed in the laboratory and water-quality data, as well as details of what testing has been carried out in the field, is entered into the LIMS. This is important, as water companies must collect and analyze their water samples in a closely-regulated environment, maintaining complete quality control records in case of inspection or audits. (See figure 2).
There are many benefits to using a LIMS. This automated solution allows managers to make informed decisions to improve throughput and quickly resolve environmental issues and risks. At the same time a LIMS allows organizations to comply with strict regulatory guidelines while providing the flexibility necessary to cope with changing demands and practices as regulations and testing protocols change. A LIMS can also improve operational efficiency, as it provides the laboratory with a centralized tool for comprehensive sample record keeping, management and reporting. By automating and integrating the LIMS with laboratory instrumentation as well as external systems, time-consuming manual processes and transcription errors can be eliminated.
While a LIMS can offer built-in functionality specifically designed for the water and environmental industry, it can also be configured to meet a company’s evolving business model practices. With the right LIMS, a laboratory can be confident that the data system does not dictate how operations are run. Rather, its flexibility can allow the system to reflect how a company wants to operate.
An Application Example
To illustrate exactly how a LIMS can benefit a laboratory in the water testing industry, consider the case of Nova Biologicals. The organization is one of the nation’s largest providers of water testing for drinking and wastewater and has provided nationwide testing services to the industry, specializing in microbiologi cal, chemical and toxicological testing. The laboratory performs comprehensive diagnostic testing of specimens for the presence of infectious disease organisms and water testing under the Federal Safe Drinking Water Act. As such, water testing makes up 53% of the agency’s total revenue, and coliform testing makes up the largest percentage of tests, with approximately 10,000 water samples being processed on a monthly basis.
Prior to implementing a LIMS, Nova managed its work using paper supported by an outdated laboratory information system. The laboratory’s system had significant deficiencies in that it only allowed entry of certain data, and it had limited reporting capabilities. Nova realized that continuing to use the aging system and paper-based procedures could not sustain its growing business in microbiology, medical device and pharmaceutical testing. In addition, since the old system was located on a single computer, only one employee could use the system at a time, which created bottlenecks in the laboratory and significantly limited the volume of samples that could be processed in a given day.
Knowing it needed to update its systems, Nova commissioned a consultant to help draw up requirements for the vendor selection process. The system needed to be user-friendly, easily maintained, configurable and web-based. It also needed to support flexible functionality, be capable of complex reporting requirements and meet all of the agency’s regulatory requirements. Specifically, the new system had to be able to:
- Centralize all data in a single database that supports multiple departments across the site
- Expand and evolve in order to meet changing requirements and regulations
- Track the status and workflow throughout the lab lifecycle, from submission to final analysis
- Automate processes to eliminate error-prone or redundant data entry and paper trails
- Accommodate multiple users, both internally and externally
- Manage documents and training records for audit purposes and traceability
- Migrate data to and from customers both easily and efficiently
Reaping the Benefits
Nova Biologicals is realizing both expected and unexpected benefits from implementing the LIMS. The solution has been instrumental in helping Nova maintain its accreditation, refine work processes and improve the quality and speed of reporting to customers.
The new LIMS has also allowed Nova to increase sample throughput. While the legacy system only allowed one user to process samples at a time, the new solution allows five people to process samples at any one time, enabling Nova scientists to handle very high sample volumes in a shorter amount of time. This has eliminated bottlenecks, in turn saving man hours across the company. The system also provides location flexibility—users can access the system from any computer using a web browser.
The new system has eliminated costly, error-prone paper-based procedures, in turn improving data quality, and it has significantly improved the process for audits, as data is easily tracked and/or generated. Last but not least, Nova has improved efficiencies via the built-in document management capabilities, report generation and distribution functionalities.
Conclusion Water and environmental laboratories and testing facilities are facing a series of challenges, from the aging U.S. water infrastructure to stricter and expanding environmental regulations. A LIMS can assist these laboratories and facilities with solving these challenges and, at the same time, significantly improving operational efficiencies.
Figure 1. The EPA’s list of 12 Quality Control Elements These 12 essential quality control (QC) checks must be clearly documented in the written SOP (or method) along with a performance specification or description for each of the 12 checks.
1. Demonstration of Capability (DOC)
2. Method Detection Limit (MDL)
3. Laboratory reagent blank (LRB), also referred to as method blank
4. Laboratory fortified blank (LFB), also referred to as a spiked blank, or laboratory control sample (LCS)
5. Matrix spike, matrix spike duplicate or laboratory fortified blank duplicate (LFBD) for suspected difficult matrices
6. Internal standards, surrogate standards (for organic analysis) or tracers (for radiochemistry)
7. Calibration (initial and continuing), initial and continuing performance (ICP) solution, also referred to as initial calibration verification (ICV) and continuing calibration verification (CCV)
8. Control charts (or other trend analyses of quality control results)
9. Corrective action (root cause analyses)
10. QC acceptance criteria
11. Definitions of a batch (preparation and analytical)
12. Specify a minimum frequency for conducting these QC checks
Author: Colin Thurston, Director of Process Industries Product
Strategy, Thermo Fisher Scientific