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Securing Urban Water Supply and Treatment Facilities

Securing Urban Water Supply and Treatment Facilities A laboratory information management system can provide secure interoperability between laboratories and governing bodies

In the United States, with 55,000 water systems in place, the possibility of a coordinated disturbance in water sources is remote. However, the vulnerability of local treatment and supply infrastructure remains high, especially those supplying water to large metropolitan areas. Urban water supply and treatment facilities are exposed to increased risks of contamination and disruption and need attention to secure them. This multi-faceted challenge requires an effective strategy to address aspects from water supply infrastructure to information technology. The strategy must allow the exchange of information in a way that makes critical decisions expeditious.

The U.S. Environmental Protection Agency (EPA), a federal agency working with water utilities, enforces regulatory compliance under the Safe Drinking Water Act
(SDWA). This Act remained without specific requirements to address security and scrutiny of water supplies until it was amended by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. In March of this year, President Bush announced a program to better monitor urban water systems to detect contamination as quickly as possible and revealed intentions to increase appropriate budgets by 70 percent.

Many public health labs are deploying modern laboratory information management systems (LIMS) within the framework of the Public Health Information Network (PHIN) that support communications between labs in federal, state and local health departments and the healthcare community, using common messaging interfaces known as Health Level Seven (HL7) with Logical Observation Identifiers Names and Codes (LOINC) and Systematized Nomenclature of Medicine (SNOMED) as the common vocabulary for test names and observations. The importance of a unified framework is critical to better monitor these data streams for early detection of public health issues and emergencies, including bio-terrorism. Through structured data and vocabulary standards, collaborative approaches by PHIN will enable the consistent exchange of response, health and disease-tracking data between public health partners.

Side-by-side with the escalation of public health concerns, the issue of drinking water safety has led to increased testing and reporting requirements well beyond traditional levels. A LIMS system at an urban water lab functions as the central nerve center of the laboratory, managing and controlling all aspects of laboratory operations, quality assurance and management. Without a comprehensive LIMS, no modern laboratory can efficiently ensure compliance with regulatory requirements and simultaneously manage operations.

In an attempt to address complaints from the laboratory community regarding the burden of multiple accreditations due to the lack of a nationally recognized environmental laboratory accreditation program, the EPA initiated the National Environmental Laboratory Accreditation Conference (NELAC). NELAC was charged with establishing and promoting mutually acceptable performance standards for the inspection and operation of environmental laboratories. These standards are primarily designed around two International Organization for Standardization (ISO) guidance documents: ISO/International Engineering Consortium (IEC) Guide 25-1990: "General Requirements for the Competence of Calibration and Testing Laboratories," and ISO/IEC Guide 58: "Calibration and Testing Laboratory Accreditation Systems-General Requirements for Operation and Recognition."

Through its involvement in multiple public health initiatives, as well as water laboratory LIMS projects, STARLIMS Corp. has incorporated extensive reporting, surveillance and networking capabilities within a LIMS suite designed to fully support the daily functions of a multidisciplinary water laboratory in accordance with internationally accepted standards. Following is a summary of common requirements of urban water testing labs illustrated with selected examples drawn from STARLIMS.

• Remote sample login and results
Urban water labs serve customers outside the walls of the laboratory. Current Web-based technology allows remote lab customers to view analytical services provided by the laboratory via the Internet. Customers who submit samples for testing may review tests and price lists before ordering the service, pre-login their samples, view samples status and print reports. Submitters can print barcode labels locally and track sample package delivery and each sample's status. When results are published, the LIMS can provide visual notification to the submitters who can download and print the reports locally.

• Remote results entry
Field computers, including PDAs, are interfaced with the main LIMS database through various methods, including the exchange of Microsoft Excel files. For example, STARLIMS exports a sample's test information into an Excel file which is transferred to field computers. The file can include data validation checks and other error-trapping tools. When the operator returns, the LIMS processes the Excel file and extracts data into the database.

• Proactive communications
Improving communications within a laboratory and between laboratories is crucial to communicate exceptions and violations in a timely fashion. This can be accomplished with workflow-based notifications using e-mails and paging devices, including cell phones. In the case of STARLIMS, a Proactive Console is provided as a reminder and warning detection system. This allows users to intuitively navigate through the application and also to quickly identify tasks that need attention, such as approving results, calibrating or maintaining instruments and releasing a sample.

• Integrated document management
Maintaining version control for certificate of analysis (COA), standard operating procedure (SOP) and material safety data sheet (MSDS)-type documents, and their associations with test methods in use at the time the actual testing was conducted on samples is essential. This can be accomplished through tools for capturing, storing, retrieving, parsing and routing the relevant information to the appropriate decision makers.

• Security
It is crucial to secure vital laboratory data by limiting access to functionality and information. This includes support for security requirements consistent with good automated library practices (GALP), FDA's 21 CFR Part 11 and 40 CFR Part 3 and NELAC.

• Chain-of-custody
Maintaining a complete log of events related to each sample is also important. User-configurable chain-of-custody functions may be offered out-of-the-box, and logical functions can transfer samples based on system status and workflow settings. For example, STARLIMS provides
• history on status of containers
• history on samples
• history on contents locations
• history on the disposal of samples
• the genealogy of splits and aliquots
• user-configurable sample numbering schemes.

• Instrument maintenance
Ensuring maintenance and calibration of instruments is essential in meeting the lab's compliance with quality standards. Instrument information includes maintenance and calibration data, identification of tests that can be run on each instrument and the setup of quality control (QC) templates for each. This allows for the management of
• basic asset information
•service contracts
• maintenance intervals
• registration of components
• responsible teams
• maintenance event tickets
• standards and QC templates
• data capture scripts and the XML schema that may be used to parse data.

• Quality control samples
Water testing laboratories generally require comprehensive tools for managing QC samples. These include life cycle; assignment to analytical processes; and integration of result entry operations along with associated analytical samples and the evaluation of their results against specifications for each analyte in the context of the test, test plan and project. STARLIMS provides a simple interface for batching samples together into a run and allows users to establish QC templates to automate placement of QC samples. Control charts are produced with integrated Northwest Analytical (NWA) QAx ActiveX controls.

• Automated results entry
Another common requirement is maintenance of result entry business rules, such as specifications evaluation and calculations, and applying them to manual and instrument data entry. Automated results entry and instrument interfacing can be achieved through a range of options including
• parsing of instrument output files using a data capture utility
• APIs published by instrument control software
• certified interfaces
• direct RS-232 connections
• XML parsing via Web services
Automation of results entry reduces the workload and eliminates transcription errors.

• Interoperability
The major part of today's IT budgets is dedicated to solving integration issues. At the heart of many implementations is interoperability between LIMS and other key business applications. Data generated by the water laboratory is essential for decision making by other groups of the organization that employ process control systems, or even Web portals. The functional benefits of this integration include real-time updating of specifications or procedures, rapid identification of process problems and automated logging of process control analyses.

• Traceability
Maintaining an audit trail of who, what, when, how and why is important to demonstrate traceability. In the case of STARLIMS, the auditor is allowed to view
• staff certification information
• instrument maintenance and calibrations
• QC data
• audit trails
Steps involved in creating the defendable result are documented by maintaining versions of
• test methods
• certifications
• log of instrument maintenance
• standards and control charts
• material management
• storage conditions
• chain of custody
• reporting templates
• outsourcing of lab services

• Reports and queries
Trend analysis, proficiency testing, turn around times, laboratory resource planning, and QC charting are just a few examples of common reports. These reports can be specific to the user, role, instrument, group, laboratory or location. Reports can be sent to a screen, printer, fax, or e-mailed or published to the intranet.

• Effective implementations
Each lab has individual requirements that need to be accounted for during implementation. These include
• incorporating existing test workflows
• instrument interfacing for automated run scheduling and data collection
• site-specific reporting
• interfacing the LIMS with other internal or external business systems.
While the STARLIMS platform provides enriched functionality for rapid deployment of common business processes, each organization has individual characteristics that are configured, validated and tested through an iterative site-specific implementation process. The implementation follows industry best practices as defined by the Project Management Institute's 'Project Management Body of Knowledge' (PMBOK 2000) and the International Society for Pharmacoepidemiology (ISPE)'s Good Automated Manufacturing Process (GAMP4) guide for validation of automated systems.

• Future proofing
Architecture can be designed to adapt to continuous change in regulations, local business requirements and IT, eliminating the need for large periodic re-investments and loss of content experienced during major upgrades. Complete separation of the technology components from the business rule elements and from the data sources, enables total partition of ongoing development and maintenance tasks, which makes it easier to configure new requirements and to validate, certify and maintain the system throughout the LIMS life cycle.
Conclusion
U.S. water supplies face barriers between silos of information with technology gaps creating risks that cannot be mitigated merely with physical surveillance and premise monitoring. Establishing secure and seamless interoperability between laboratories and governing bodies with harmonized standards and protocols for exchanging data via a LIMS can overcome many of these gaps. Today's highly flexible and full-featured commercial LIMS can provide complete traceability leading to regulatory compliance without compromising the process versatility of a dynamic urban water laboratory.

STARLIMS Corporation
Presidential Building 4000 Hollywood Blvd., Suite 515 South
Hollywood, FL, 33021-6755

About the Author

http://www.starlims.com/

i recently purchased some microsoft server products. Can I install them in a lab environment.....?

....perform my tests and then install them in a live envionment. The products are Windows 2003 Server, Exchange 2003 Server and ISA 2004 Server. All are full pack.

You can install them as long as the computers / servers you are installing them on are not needed by the network when you are installing them.

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Investment Advisory News Letter

As our country continue to recover from the greatest financial crisis since the Great Depression, our strategy remains focused on creating long-term value and income for client portfolios.  Investments like Wal-Mart, Procter & Gamble, Merck, Johnson & Johnson, Abbott Labs, Microsoft and Sysco should deliver excellent long-term value and dividend income. Not only are these companies great businesses with sustainable competitive advantage, they deliver consistent income in the form of quarterly dividends.   Unlike bonds, where the income payments are typically fixed, they have the potential to raise their dividends over time as businesses grow with the global economy.

Protecting the Brand

While such companies are of high quality, they continue to face challenges, some of which fall into the "self-inflicted" category.  If there were a contest for "Excellent Companies Suffering from Bad Management", first prize would go to Johnson & Johnson with over 50 product recalls within the last 16 months.  I attribute recalls to management abandoning the company's credo of putting customers' interests first.  You will probably never hear a CEO say, "We've decided to cut quality control in favor of short-term profits", but that's exactly what Johnson & Johnson did without saying it.  (If you ever hear such a statement, my advice would be to sell immediately!)  Johnson & Johnson's management has given the 125-year-old brand several cuts and bruises but the financial impact of product recalls has been moderate. I do expect a full recovery as management quickly return to the once forgotten credo:

 "We believe our first responsibility is to the doctors, nurses and patients, to mothers and fathers and all others who use our products and services..."  

Our second prize would go to Wal-Mart, which decided to pursue a "New" Coke strategy by abandoning a perfectly good formula of always low prices in favor of a perfectly bad formula of sales promotions and price gimmicks.  Wal-Mart's management bruised the brand by causing customers to question their value as the trusted, low cost provider of retail goods.  Fortunately, management has quickly come to their senses and is returning to their old formula, similar to what Coke did in 1985.  Wal-Mart's customers should once again find "Classic" Wal-Mart very refreshing.

Recent troubles at Johnson & Johnson and Wal-Mart show the fragility of a company's brand and how management itself can damage it by pursuing short-term earnings growth rather than long-term shareholder value.  Every business has this management risk.  One of the best ways to mitigate such risks is to start first with high quality businesses, as they are more likely to survive periods of bad management.  Regarding our third prize winner, I hope this prize goes unclaimed.

Inflation

Rising oil prices, continued unrest in the Middle East and increasing government spending are all considered inflationary risk factors. To better understand inflation and its potential impact on investments, I suggest we first break the term inflation into two time horizons: short-term inflation and long-term inflation.  Short-term inflation is mainly influenced by short-term changes in the economy such as daily changes in labor supply, commodity prices, consumer behavior, etc.  These changes are reflected in the daily movement of markets such as the prices you pay each week for groceries.  Unlike short-term inflation which is primarily market driven, long-term inflation is ultimately determined by the actions of our government.  These actions are given the fancy term monetary policy. 

As investors, our primary concern should not be short-term inflation, which is temporary and unpredictable, but rather the wealth destroying effects of long-term inflation which is predictably permanent. Consider how the purchasing power of the dollar has declined more than 97% over the last 100 years. What has been the root cause?  The answer is not short-term changes in labor or commodity supplies, but the government's monetary policy of continuously printing money.

Prepare Rather than Predict

Just like the short-term movements in the stock market, there are simply too many factors to predict short-term inflation.  Many of these factors may cause or not cause short-term inflation.  For example, while rising commodity prices are considered inflationary, consumers may be unwilling or unable to pay higher prices. In addition, if an abundance of labor keeps wages down, the cost of rising commodity prices could be offset by lower labor costs. Commodity prices, labor supply and consumer behavior are just three of the many factors that determine short-term inflation.  Correctly predicting even three factors and in the right sequence is like pulling the lever on a slot machine with the hopes of getting three of a kind.  While we want three of a kind, we are more likely to get a cherry, a strawberry and a lemon.  So whether or not we know the root causes of short-term inflation, predicting the timing and severity is most likely impossible, which is just like playing a slot machine, but with even poorer odds.

 As an aside, the slot machine analogy is not limited to just inflation.  This analogy can also be applied to attempts to predict short-term changes in markets including the stock, bond, real estate and commodity markets.   Just like the slot machine, the odds are against us when it comes to making short-term financial predictions.

I do not believe economists, bankers, brokers, investment advisors (present company included) or the media will ever know how to predict the severity or timing of inflation.  As long-term investors, we can only prepare for high inflation just like those who live on the coast should build their homes to withstand hurricanes without knowing when the next one will hit.  If, unfortunately, our economy gets hit by a big storm of inflation, portfolios strengthened to withstand the storm should suffer far less damage than the weaker ones.  So what can we do to prepare for the next storm? A tax-efficient investment strategy that focuses on high quality businesses with the ability to quickly raise their prices with inflation is one of the best ways to protect and grow your wealth over time.  In addition, investing in companies and industries with an increasing amount of earnings in other currencies can also help reduce the effects of inflation.

 Exchange Traded Funds versus Individual Stocks

 Exchange traded funds (ETFs) are a relatively new invention in the financial world. They can be used to build a foundation of diversification for your portfolio while providing long-term growth and income opportunities.  ETFs like the Vanguard Financial Index and Vanguard Consumer Staples Index provide a very low cost way to diversify across a number of companies within specific sectors of the economy.  Like individual stocks, they are also transparent and tax-efficient if used properly.

 ETFs at times will do much better than some of the individual stocks that make up their portfolios.  But similarly, individual stocks will at times deliver much better results than ETFs investing in the same sector.  In addition, individual stocks can offer higher dividend payments compared to ETFs in their sectors.  The key benefits with ETFs are diversification and less risk, while the key benefits of individual stocks are often more income and growth potential but with higher  risks.  If we think of ETFs and stocks as tools in a toolbox, there is no perfect tool for every job.  As a result, I suggest we continue to use both tools, as the nature of the job will change over time due to changes in the markets, the economy, your personal financial goals and your comfort level with investing.

 Fixed Income

 For your fixed income investments, focusing on short-term bonds should continue to give your portfolio income with much lower risks than long-term bonds.  A scenario of higher interest rates caused by high inflation could greatly reduce the value of long-term bonds.  As a result, I recommend we favor short-term bonds due to their lower risks.  In addition, I recommend that your fixed income investments be highly diversified across a number of different bond issues and types to mitigate the risks of an individual bond defaulting. 

 Our Economic Future

The global economy will continue to become increasingly competitive with each country competing for more resources, including the most precious resource of all, human talent.   Our human talent is like a star athlete competing in a marathon with the rest of the world.  Unfortunately, we have chosen to weigh our marathon runner down with a heavy backpack of government debt, consumer debt, increased government regulations, high taxation, poorly constructed immigration policies and ever increasing healthcare and military spending.  While the path ahead is a long and arduous one for our star athlete, I am confident we will lighten our runner's load. 

As a country, we have a number of choices to help our star athlete including saving more, reducing debts,  more efficient and competitive tax codes in the global market, reducing military spending in favor of education and infrastructure investments and implementing immigration policies that favor highly skilled jobs over low skilled ones.  I believe that increased global competition will necessitate and ultimately dictate many of the hard choices.  This is not to say we will make the right choice quickly, but eventually we will do what is necessary to remain prosperous.  To quote Winston Churchill, "The Americans will always do the right thing, after they have exhausted all the other possibilities."

In summary, we have plenty of opportunities to give our star athlete a winning chance. Given these opportunities and our country's incredible ability to harness the creative energy of our people, I believe our best days are ahead of us. 

About the Author

Matthew Goff is the President and Founder of The Goff Financial Group. He is a fee-only, independent financial advisor. For nearly two decades he has devoted his professional career to helping individual investors and their families realize their investment and financial goals. With nearly 20 years of industry experience, he carries with him expertise in many aspects of personal financial planning and portfolio management including, asset allocation strategies, stock option planning and retirement planning strategies,

The Goff Financial Group manages investment portfolios and provides wealth advisory services to high net worth clients in the Houston area. To reach Mr. Goff for commentary please call 713.850.8900.  If you are interested in becoming a client of The Goff Financial Group please visit the website www.matthewgoff.com    

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