FOCUS ON ALCOHOL TESTING BY BILL HAUPERT, INTOXIMETERS


Considerations on Instrumentation within a Global Breath Alcohol Testing Program


“Te devil is in the details” is a phrase that can certainly have relevance to effectively managing a breath alcohol testing program across multiple continents. Unlike a regional or country- specific program, a global program needs to account for a number of factors and testing conditions that could have legal and/or cultural consequences. It could also have financial considerations when having to defend the program in a tribunal or court-related event. Te most prudent advice is to do your


research. Undoubtedly, the best place to start is understanding the basic legal and regulatory environment of the multiple countries in which your program is providing testing services. Tis can be a time consuming effort, but it will prepare you for making decisions and documenting procedures that strengthen your overall testing program. With regard to the instruments used in


global breath alcohol testing programs, there are many topics that should be investigated, including: Sampling Requirements: Unlike


testing required by the U.S. Department of Transportation (US DOT), where there are no stated minimum volumes or sampling conditions, other jurisdictions do have set sampling requirements for breath alcohol testing. For example, the EN 15964 standard, commonly used within the European Union, requires a minimum flow rate of 0.15 liters per second and a minimum volume of 1.2 liters; while the AS 3547 specification, used in Australia, has a requirement for a Type II device to have a minimum volume of 1.0 liters and a flow rate of 0.20–0.50 liters per second. Tere are some Asian countries that have instrument standards for minimum


32 datia focus


flow rate of 0.10 liters per second and minimum volumes of just 800 cc. If you are a multi-national corporation, or a third- party administrator to a multi-national, a policy decision is needed as to whether all tests will be performed to a set corporate requirement or to standard requirements of the local testing site. Technical Support: An equally


important issue to sampling requirements is the technical support that will be needed to support the instruments used in various locations within your breath testing program. For example, what approvals are held by the manufacturer for the model of instrument being used in your program (i.e., US DOT Evidential, US DOT Screening, EN 15964, OIML R-126, AS 3547, etc.)? Should there be an issue that requires aſter-market support? If so, who will provide those services for your program in that locality? Has the organization providing the support been factory-trained by the manufacturer of the instrument to offer such support? Is the local technical support company using original equiptment manufacturer (OEM) parts? What maintenance logs will the local facilities need to maintain such that you can maintain defense of your breath testing program? Legal Assistance: Alongside the issues


of technical support are the issues of legal support, especially in the event that the result of the breath test is contested in tribunal or court. For example, does the manufacturer of the instrument being used at the local testing site have the knowledge and experience to support your program in such a case? What is the reputation of the manufacturer/supplier in terms of the quality of their products, the type of approvals they hold on their instruments,


and their ability to support your program with legal assistance? Unit of Measure: Consideration should


also be given as to what unit of measure will prevail throughout your testing program. While the United States commonly uses a breath measurement of g/210L, the United Kingdom uses µg/100ml. While most of Europe uses mg/l, the Netherlands uses µg/l, etc. Additionally, if you are testing in a country that reports results in a blood unit (i.e. g/l, Promille, mg/100ml) what partition ratio should be used for the result calculation—2000:1, 2100:1, 2300:1? Will your program require that all results, no mater where the test is conducted, be reported in one single unit of measure? Or, will your program allow reporting based in the legally relevant unit of measure in the country where the test is conducted? Verification Period: Like sampling


requirements, verification requirements need consideration, since local standards and/or regulations may vary from one county to another. Consider that programs testing against the US DOT requirements need a Quality Assurance Plan as directed by the manufacturer of the instrument, which include recommendations for minimum verification periods. While in Europe, the EN 15964 has a minimum requirement of at least three months, with a possible extension if the instrument has been tested to the condition. Tus, while your US DOT plan may state that the instrument has been successfully verified within the last 31 days prior to performing a breath test, the European Union standard would allow for at least 90 days—possibly longer—if the manufacturer had the model tested and approved for such a timeframe. Quality Assurance: With Quality Assurance, it is important to consider


fall 2017


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