BEST PRACTICES BY WILLIAM HAUPERT, INTOXIMETERS, INC.
Are Your Remote Breath Testing Sites Following Good Quality Assurance Procedures?
I
t seems these days that the old adage of “the world is geting to be a smaller place” is true more than ever with
workplace-based breath alcohol programs. Whether the program is being administered with internal staff or through outside contractors, the likelihood of a program having to support remote sites outside of its primary business location seems to be more relevant today than ever before. When faced with such logistics, there
are many factors that need atention by the program administrator, such as the type of equipment to be used, the testing protocols to be used, policies for positive test results, training of operators, and frequency of testing. One area that needs particular atention is the quality assurance procedures that are to be followed. Tis area is vital as it is oſten one of
the cornerstones that will be used to defend the program during a tribunal or court proceeding. Te manner in which instruments are processed during quality assurance procedures could equally draw doubt on the reliability of the subject’s test result. Some areas to consider when assessing
your remote site’s quality assurance procedures include: • Regulated v. Non-Regulated Facilities: A situation could exist whereby your primary facility resides in a country that has mandatory regulations for workplace breath testing while a remote site may reside in a location where no such regulation exists. In these cases, it is important to have policy that explicitly states the manner in which adjustments and verifications are to be performed at remote locations such that they are in step with your primary location.
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• Contracted Testing Services v. Direct Staffing: Typically, the decision as to whether direct staffing or contracted testing services will be used is determined by factors outside the program itself due to size of the operation, local logistics, and other business concerns. If your program will be using a contracted testing service, a thorough review of the provider’s quality assurance procedures and training will need to be made. Consideration may be needed in regards to audit requirements on these procedures to make sure that they are in line with your established policies.
• Quality Assurance Supplies: Consideration should be made as to the type, specification, and source of the quality assurance supplies used at these sites. If your program uses Dry Gas Standards for their quality assurance procedures, consideration should be given as to the logistics of sourcing this item to the remote locations. National transport regulation may limit or regulate the size and capacity of the Dry Gas Standard cylinders that can be transported within the country’s borders. In some cases, specific licenses or clearances are required to clear the goods from a destination airport for local delivery to your remote site. Additional considerations for the Dry Gas Standards are the concentration (i.e., ppm of ethanol to carrier gas) and traceability of the standards. For example, if your program requires that standards used for quality assurance procedures are NIST traceable, are your remote sites purchasing standards that meet this requirement from a qualified source or are they using a local industrial gas supply company claiming to be able to produce the mixture but with no evidence of traceability?
• Training: In many tribunal and court cases, the training of the Calibration Technician who is responsible for performing quality assurance procedures is reviewed to determine their qualifications for performing these procedures as required by the program. Have they been trained on the proper quality assurance procedures for the equipment used in administering tests for your program? Who trained them in these procedures? When was the last time the Calibration Technician was trained, and is this within a reasonable timeframe for your program requirements? It is important to perform quality assurance procedures in a timely manner, but it is just as important that the person performing the tasks is sufficiently qualified to do so. Tis will avoid an otherwise valid result being questioned due to lack of training for the Calibration Technician who performed the last quality assurance on the instruments.
Documentation & Data Retention
Having a stated policy for documentation and data retention of your quality assurance procedures is also a primary consideration that needs to be made. While it’s important to have an explicit policy for the quality assurance procedures at a remote site, it is equally important to have documentation to support that these policies are being followed. Will your program require that independent calibration logs for each instrument be retained, or will quality assurance procedures be documented by some other means? Where will such records be kept—at the remote site, at the primary site, or both? How long will records be maintained, and in what format?
winter 2018
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