CERTIFICATION, FIELD TESTING, and CALIBRATION: Handout Material

CERTIFICATION, FIELD TESTING, AND CALIBRATION: Handout Material

1. Who has the authority to certify interlock devices?

·  The authority to certify interlock devices can be outlined in legislation (often within the interlock statute itself) or administrative rule.

·  Authority and responsibility to certify interlock devices should be designated to a single state agency. This helps to ensure uniformity and clarifies decision-making.

·  The designated agency should play a lead role in the development of the process and determine the requirements of device certification for a jurisdiction. In some instances, this agency will also have the authority to test devices.

·  Often, the agency best-positioned to manage the certification of devices is the agency that is designated to oversee the approval of evidential breath testing devices in the jurisdiction.

·  It is important that the designated agency understand that interlocks are designed to incapacitate a vehicle and are not designed/intended to provide evidential breath tests to measure BAC for the purposes of criminal prosecution.

·  It is necessary for courts to be aware of the state agency that has the authority to certify interlocks. It is beneficial for judges to have an understanding of the quality of the technology that is available within their jurisdiction. Courts should also have knowledge of the required state configuration profile for devices so they do not order features or conditions that are not feasible to implement or that conflict with statute/administrative rules.

2. What key elements should be included in any request for certification?

·  It is important to formalize a relationship between the state and interlock vendors/manufacturers[1] to ensure that protocols exist that prohibit vendors from doing business in a jurisdiction if the quality of devices or services is not acceptable.

·  Each jurisdiction may manage their relationship with approved alcohol interlock devices and vendors using different strategies. For example, a jurisdiction may require certification of only the interlock device, while others may additionally require certification of the vendor/manufacturer.

·  Some jurisdictions utilize a request for certification (RFC) which includes a list of interlock standards, requirements, and settings that each device is required to meet in order to be considered for certification.

·  The following components should be considered, as is practicable, for inclusion in an RFC or when certifying interlock devices:

o  NHTSA 2013 model specifications as a baseline for device testing;

o  attestation from the manufacturer that they will comply with the requirements for configuration and operation found in state administrative rules or law;

o  device specification requirements;

o  lab certification from an independent and accredited ISO-certified lab;

o  an indication as to how recently the lab certification must have been conducted (i.e., within a specified period);

o  field testing of devices as determined by the oversight agency;

o  requirement of notification of modifications (including a definition of what constitutes a device modification and to whom it should be reported);

o  business plans; and,

o  current list of contact staff and notice of new employees.

·  The certification process may be structured such that an interlock device and the vendor can be approved at any point in time, or only at specific times of year. In many jurisdictions, certification is valid for a fixed period of time after which, the vendor must renew their certification.

3. a) What are the requirements for a lab certification to be accepted?

·  In most jurisdictions, interlock manufacturers are required to submit an independent laboratory certification report that states that the device model submitted for testing meets any technical requirements or standards.

·  The laboratory that submits the certification report must be accredited. More specifically, the lab conducting the tests should be accredited to ISO 17025 and qualified to test interlock devices. All devices should be tested the same way to ensure consistency.

·  It is recommended that only lab test results from within the past five years should be accepted by the certification agency.

·  The frequency with which devices are required to be submitted for testing is often defined in administrative rule or statute. Re-certification is typically required on either an annual or biennial (every two years) basis or whenever significant modifications are made to the device that affects its breath testing function.

3. b) What tests should accredited labs perform?

·  Labs can perform a variety of tests in order to determine whether interlock devices meet state requirements for certification. Labs should also ensure that devices meet the most current NHTSA model specifications.

·  The following tests can be performed to test the performance, reliability, and durability of interlocks: BAC accuracy and precision; sampling requirements; calibration stability; lockout evaluation; service interval display; voltage/power testing; temperature range; vibration damage; radio frequency interference (RFI), re-test; re-start of stalled motor; high altitude; cigarette smoke; acetone; tampering reports; circumvention detection; and, data integrity and format.

·  For information on the European Union CENELEC standards for the testing of alcohol interlocks (specific to offender programs), please refer to: http://www.cenelec.eu/dyn/www/f?p=104:110:3768611831212088::::FSP_PROJECT,FSP_LANG_ID:23306,25

3. c) What pieces of information should be included in a lab certification?

·  The report submitted by an independent lab to the state agency responsible for device certification should include the following pieces of information:

o  confirmation that the lab that completed the certification is accredited;

o  confirmation that the device for which certification is being sought, is the device for which test results are being submitted;

o  report of tests completed on the device that was submitted for testing;

o  corresponding test results; and,

o  notarized statement from the lab stating that the device meets or exceeds the most current NHTSA model specifications.

3. d) Are there other steps beyond lab certification that jurisdictions can take?

·  Jurisdictions may opt to conduct their own in-house lab testing to ensure that the device functions are working properly and that the device adheres to NHTSA model specifications. However, jurisdictions may choose to only field test the device.

·  The purpose of field testing is to confirm that the various features of the device are properly programmed in accordance with administrative rule requirements and that it properly responds in various situations as is prescribed. Some jurisdictions conduct field testing of devices prior to certification as well as at several points throughout the certification period.

·  Field testing devices at random times throughout the certification period enables jurisdictions to monitor performance of devices in the field on an ongoing basis.

·  It is suggested that the procedures for field testing devices be described in administrative rule.

4. How frequently should jurisdictions require certification/re-certification?

·  Device certification. Jurisdictions vary in their requirements as to when and how often devices should be certified or re-certified. Preferably, devices should be tested and certified at the initial point of application to do business in the state and then again if there are modifications made to approved devices.

·  Some jurisdictions require re-certification regularly although this can be onerous and a deterrent for vendors to do business in a state as the testing process can be costly. The development of a re-certification strategy is important.

·  If devices fail the certification process, there should be a reasonable opportunity for vendors to address any identified issues and re-submit for additional testing.

·  Certain jurisdictions require re-certification if device modifications are reported to the state by the manufacturer or vendor. Administrative rule should clearly outline what changes warrant re-certification and what is required of the manufacturer.

·  Vendor certification. In most jurisdictions, certification or re-certification can occur at any point in time. However, in other jurisdictions (e.g., Minnesota) there is a specific period of time during which new vendors can apply for certification or those previously approved can apply for re-certification. Ideally, vendors should be certified annually.

·  The re-certification process is an opportunity to provide vendors with feedback in relation to their device performance and service delivery within the jurisdiction. It is important to outline the procedures and timeframes for certification/re-certification in administrative rule or statute.

5. What modifications to devices should trigger re-certification?

·  A device modification is defined as a modification, upgrade, or alteration to any of the hardware, or firmware of a device. If any of these alterations affect the form or function of the device, the jurisdiction needs to be informed and there may be a need for re-certification.

o  Firmware. The permanent software programmed into read-only memory - i.e. the “control program” for the device.

o  Hardware. The physical pieces of the device.

o  Form. The shape, size dimensions, mass, weight, and other visual parameters that uniquely distinguish a part of the device.

·  When considering what changes warrant device re-certification, the state needs to consider whether there has been a change to device functionality or to the breath sampling/breath analysis portion of the device. Some types of modifications may only require parts of the device to be re-certified.

·  Changes to the hardware, firmware, and design can create a much different operating device than the one that was originally submitted for testing and certification.

·  It is necessary for program administrators to develop a plan to ensure there is an appropriate level of oversight in relation to devices approved for use. States should consider including language in either legislation or administrative rule which requires manufacturers to notify the state in advance of any device modifications being implemented in the state.

·  The provision of clear guidelines by jurisdictions to vendors as to what modifications warrant notification and submission for further re-testing and/or re-certification is imperative.

6. What types of internal quality control processes related to service centers and devices should vendors be asked about during the certification process?

·  There are several standards involved in the calibration and installation of interlock devices which vendors and service centers need to adhere to within a jurisdiction. If a defined certification process for devices and vendors is not in place (i.e., a jurisdiction opts to certify one and not the other), program authorities should explore existing vendor quality assurance processes in detail.

·  Program authorities should inquire about vendor practices in order to increase understanding of how they maintain quality service delivery standards. This can have important implications for the quality of service delivery across a jurisdiction.

·  Focal areas include quality assurance plans, hiring and training of technicians, calibration processes, installation processes, and device servicing.

7. a) What should be the focus of lab testing by jurisdictions?

·  Jurisdictional lab testing should focus on the configuration profile and the device requirements as written in administrative rule or statute as opposed to duplicating the testing conducted by independent labs.

·  Jurisdictions should provide a clear and concise summary of the required settings for devices to vendors in order to avoid vendors incorrectly interpreting what is required by the state.

·  If jurisdictional device profiles are documented in clear language, there will be greater consistency between the configuration profile of each device and the jurisdictional requirements.

7. b) What is accuracy and precision of devices and why is this important?

·  Accuracy is defined as the degree to which an alcohol interlock device can correctly and exactly measure the BrAC of a breath sample.

·  Precision is the degree to which this can be repeated with the same result.

·  It is crucial that devices accurately and precisely measure the BrAC of a driver in order to ensure an intoxicated driver is prevented from operating the vehicle and to prevent inaccurate BrAC readings from registering as a violation.

7. c) What is linearity and why is it important?

·  Linearity is the ability of the interlock device to accurately measure BrAC over a range of BrAC levels. Devices should be able to accurately measure from low BrACs to high BrACs.

·  Of note, calibration at a higher BrAC level provides a more accurate measure as opposed to a calibration at .02, but testing must still be done at .02.

·  It is important for courts to be able to demonstrate higher BrACs are accurately measured, particularly if additional sanctions or penalties may be applied.

7. d) What is lab mode or metrological mode?

·  Lab or metrological mode is a mode in which the device is most apt for testing and should only be used for testing purposes by the designated agency.

·  When a device is switched to lab mode it facilitates smoother bench testing by allowing for non-human test samples as well as repetition of tests in a shorter time period.

8. a) What is field testing and why is it important?

·  The purpose of a field test is to confirm that devices respond to events in accordance with administrative rule or statute. The purpose is not to test the accuracy of the device but instead ensure the device meets the jurisdiction’s required configuration profile(s).

·  This encourages standardization of devices, ensures uniformity of programming, and helps to ensure that required device features are activated.

·  It is beneficial to have individuals responsible for operating the program, such as licensing staff, probation officers, treatment providers, and court officials participate in field tests.

·  Field testing can also assist in building relationships between vendors and state agencies through the provision of feedback.

·  Devices sent for testing should not be specially configured other than the normal configuration for that jurisdiction.

8. b) What does a field testing protocol generally entail?

·  One agency should be designated with the authority for and responsibility of field testing. It is important that the person who is tasked with the testing of devices is well-versed in the technical aspects of interlock devices and the conditions that may influence testing.

·  Tests that should be included in a field testing protocol include: tests of non-alcohol products and food to determine if they produce false positives; confirmation of various lockout scenarios; attempts to use non-human breath samples; disconnection of power; test configuration profile/violations; occurrence and timing of running retests; test anti-circumvention features; and, restart of stalled motor vehicle.