of unique consent forms. Many governing bodies require that a specific consent form be signed by the donor, authorizing the collection to be performed and the specimen to be tested. Without a proper policy in place, though, many collectors simply use the provided CCF. Tis scenario can lead to costly legal problems for the laboratory and employer. While a similar consent statement is included in most CCFs in the United States, New Zealand requires a completely separate consent form before the specimen is collected. Online systems are ideal for this type of collection variation, as they allow for the customized and dynamic inclusion of unique forms in the workflow. Tese forms can also be translated, as previously noted. Trough a customized CCF system, laboratories can program an option to include a separate and unique consent form when needed. Tis form should be customized to each client’s needs, including regional language and layout, and should incorporate a physical or electronic signature. To meet New Zealand law, this customized consent form must also include an option in the online CCF system to withdraw from the collection at any point in the workflow. However, with the ability to program systems to respond to specific needs, online CCF applications are well-suited to these types of unique requirements, as paper forms would require custom layouts for different countries.
Global Date Format and Time When working internationally, even the simple recording of dates and times has become a problem for collections. In the United States, the commonly accepted date format is to abbreviate the date as Month, Day, Year (MM/DD/ YYYY). Outside of the United States, however, the commonly accepted format is Day, Month, Year (DD/MM/YYYY).
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Problems arise when the writen date doesn’t clearly indicate which format was used. Accuracy is extremely important, as this information will be included on the final Result Report. Online CCF applications can alleviate these problems by automatically stamping both the date and time on the form. A solution can be programmed into the CCF system which utilizes the user’s IP address to determine location. Te date can then be recorded in the format common to the user’s location, and stored in the data so that the correct date can be easily ascertained.
Unique Alphabets and Characters Across the globe, in addition to different languages, there are a variety of different alphabets and characters used to express those languages in writing. For paper CCFs, this has posed a problem over the years, as foreign alphabets can be recorded on the CCF, but not easily transferred to the Result Report. By using a web application with data integration, the use of different alphabets and characters no longer poses a problem. Laboratories should optimize their CCF system to accept all commonly known alphabets, allowing names to be typed with the appropriate accents, or entered in Cyrillic characters and then correctly reported using that alphabet.
Conclusion As the drug testing industry continues to grow globally, the need for international specimen collections will only increase, and along with them, the challenges that these collections pose. International collections are complicated by a number of circumstances such as language barriers, special documentation requirements, and unique alphabets. However, when properly developed for international use, the use of an online CCF application should be able to overcome many of the classic misunderstanding, errors, and confusion that these collections are known for. As is demonstrated by the Omega Laboratories Online CCF System, online collection applications should be the primary tool for turning the challenges of international collections into opportunities. ❚
Kyle A. Hicks is the Regulatory Affairs Specialist for Omega Laboratories, the worldwide leader in hair and oral fluid drug testing. Kyle has worked with congressional representa-
tives and other legislators to ensure the contin- ued progress towards acceptance of advanced specimens for federally regulated testing. Kyle has also been involved in Omega’s internation- al operations and the development of Omega’s new web applications, including their Custody and Control Form (OCCF) System.
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