Alcohol Interlock Curriculum:Certification, Field Testing, and Calibration

Certification, Field Testing, CalibrationThis module contains the following information:

>Certification» authority, request for certification (RFC), requirements for lab

certification, tests labs should perform, information in lab reports, additional testing options, frequency of certification, device modifications, vendor internal quality control, accuracy and precision, linearity, lab/metrological mode.

>Field testing» protocols, frequency, device selection, funding, service center

requirements, service center non-compliance.

>Calibration » wet bath and dry gas calibration

>Interlocks versus evidentiary devices >Legal challenges

Authority to certify> Authority can be outlined in either legislation or

administrative rules. > Certification should be designated to a single state

agency to ensure uniformity. > The designated agency should play a leading role in

the development of the certification process and determination of requirements.

> The agency that oversees the approval of evidential breath testing devices is often best-positioned to manage the certification of interlock devices.

Authority to certify> It is important that the designated agency understands

the difference between interlocks and evidential breath test devices.

> The courts should be aware of which agency has the authority to certify.

> Courts should also have knowledge of the required state configuration profile.

> This knowledge can educate judges so they do not order features or conditions that are not feasible to implement.

Request for certification (RFC)> It is important to formalize the business relationship

between the state and interlock manufacturers. > Each jurisdiction manages this relationship differently.> In many jurisdictions, certification is valid for a fixed

period after which it must be renewed. > The RFC is a common strategy to manage this

relationship. It outlines:» device standard, requirements, and settings that are

required in order to be considered for certification.

Request for certification (RFC)> The following should be included in an RFC:

» NHTSA 2013 model specifications as baseline for device testing;» attestation from the manufacturer that they will comply with the

requirements for configuration;» device specification requirements;» lab certification from an independent and accredited ISO-certified

lab;» indication as to how recently the lab certification must have been

conducted;» field testing of devices;» requirement of notification of modifications;» business plans; and, » current list of contact staff and notice of new employees.

Requirements for lab certification> Most jurisdictions require that devices be certified by

an independent laboratory. > This laboratory must be accredited, ISO 17025

certified, and qualified to test interlocks.> All devices should be tested in the same manner to

ensure consistency. > It is recommended that only lab test results from the

last five years be accepted. > Re-certification is typically required on an annual or

biennual basis. It may also be required whenever significant modifications are made to the device.

Tests labs should perform > Labs should ensure that devices meet the most current

NHTSA specifications. > The following tests should be performed:

» BAC accuracy and precision; » sampling requirements; » calibration stability; » lockout evaluation; » service interval display; » voltage/power testing; » temperature range; » vibration damage;

Tests labs should perform > The following tests should be performed (cont.):

» 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.

Information in lab reports> The report submitted to the state agency by the lab

should include:

» a confirmation that the lab is accredited;

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

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

» a corresponding test results; and,

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

Additional testing options> It is important that jurisdictions conduct either their

own in-house lab testing or field testing of devices.

> 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,

» the device properly responds in various situations as is prescribed.

Additional testing options> Many 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 in the field on an ongoing basis.

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

Frequency of certification> Device certification

» Devices should be tested and certified at the initial point of application and again if there are modifications.

» Some jurisdictions require certification regularly.

» If devices fail, there should be a reasonable opportunity for vendors to address any issues and re-submit.

» Certain jurisdictions require re-certification if device modifications are reported to the state by the manufacturer or vendor.

» Administrative rules should clearly outline what changes warrant re-certification.

Frequency of certification> Vendor certification

» In most jurisdictions, certification or re-certification can occur at any point in time.

» Other jurisdictions (e.g., MN) have a specific period of time during which new vendors can apply or those previously approved can apply for re-certification.

» Ideally, vendors should be certified annually.

» It is important to outline the procedures and timeframes for certification/re-certification in administrative rule or statute.

Device modifications> A modification is defined as a modification, upgrade, or

alteration made to either:

» Firmware - the permanent software programmed into read-only memory (i.e., the “control program” for the device).

» Hardware - the physical pieces of the device.

> If any of these alterations affect the fit, form, or function of the device, the jurisdiction needs to be informed and there may be a need for re-certification.

Device modifications> 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 certification.

Device modifications> It is necessary for program administrators to develop a

plan to ensure there is an appropriate level of oversight.

> States should consider including language in either legislation or administrative rule which requires manufacturers to notify the state in advance of any device modifications.

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

Vendor internal quality control> If a defined certification process for devices and

vendors is not in place, program authorities should explore existing vendor quality assurance processes.

> Program authorities should inquire about vendor practices to increase understanding of how they maintain quality service delivery standards.

> Focal points include:

» quality assurance plans, hiring and training of technicians, calibration processes, and installation process and device servicing.

Lab testing > Jurisdictional lab testing should focus on the

configuration profile and the device requirements.

> It should not duplicate the testing conducted by independent labs.

> Jurisdictions should provide a clear and concise summary of the required settings for devices to vendors.

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

Accuracy and precision> Accuracy – the degree to which an alcohol interlock

device can correctly and exactly measure the BrAC of a breath sample.

> Precision – the degree to which this can be repeated with the same result.

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

Linearity > 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.

> 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.

Lab/metrological mode > Lab or metrological mode is a mode in which the

device is most apt for testing.

> 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.

> This mode should only be used for testing purposes by the designated agency.

Field testing> 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 that required features are activated.

Field testing> It is beneficial to have individuals responsible for

operating the program (e.g., licensing staff, probation officers, treatment providers, and court officials) participate in field tests.

> Field testing can also build 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.

Field testing: protocols> One agency should be designated with the authority for

and responsibility of field testing.

> Tests that should be included in a field testing protocol include:

» testing 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;

Field testing: protocols> Tests that should be included in a field testing protocol

include (continued):

» testing configuration profile/violations;

» occurrence and timing of running re-tests;

» testing anti-circumvention features; and,

» re-start of stalled motor vehicle.

Field testing: protocols> The test protocol should include the creation of specific

events to verify responses to re-test refusals, high-BAC fails, and circumvention attempts.

> The device should be installed in a state vehicle for whatever length of time is needed to test all device requirements.

> At least two state employees should be present when conducting the tests.

Field testing: frequency> The first field test of devices should occur within a few

months of initial certification, but preferably a field test would be passed prior to certification.

> Frequent field testing should be conducted initially to confirm compliance with device configuration profiles.

> Once compliance is demonstrated, the frequency of field testing can be reduced.

> A timeframe should be determined which respects the capacity/resources of the agency responsible for field testing; this can be outlined in administrative rule.

Field testing: device selection> It is important that device selection is random in order

to ensure the selection is not biased.

> State agencies need to determine an efficient way to select devices at random:

» going to the service center and selecting a device from the shelf; or,

» selecting several serial numbers from a list and having the vendor send the corresponding devices.

> State agencies also need to determine the number of devices that will be submitted for field testing.

Field testing: funding> Collection of specific fees paid by service centers and

vendors for licensing, or fees paid by offenders for monitoring or interlock program participation (e.g., interlock restricted licenses) can be used to support the administration of the program including field testing.

Service center requirements> Specific expectations and requirements should be

outlined for vendors to remove ambiguity in administrative rule or during the certification process

> Oversight will help improve the quality of service delivery and program integrity as it demonstrates due diligence.

Service center requirements> Important requirements/considerations include:

» Vendors should review the jurisdiction’s administrative rule and agree in writing to comply with these requirements.

» Jurisdictions should require that vendors conduct background checks for service center technicians and staff.

» Jurisdictions should review training and certification protocols employed by vendors.

» Jurisdictions may wish to specify whether subcontractors may be used.

» Service center staff should not have the ability to make any changes to the device software, configurations, or reports.

Service center requirements> Important requirements (continued):

» Vendors should inform the program authority about selected locations for service centers.

» Vendors should ensure that all service centers possess diagnostic and other equipment, tools, and replacement parts or complete units needed to assure device functionality.

» Service centers should have liability policies and insurance and/or surety bonds to protect the jurisdiction.

» Service centers should meet all business zoning requirements and have a current business license on display.

Service center non-compliance> To ensure that service centers adhere to requirements,

an inspection or audit protocol can be put in place.

> Service centers should be officially notified of the reasons they are non-compliant and given a timeframe to resolve the issues before sanctions are imposed.

> Manufacturers should also be alerted about service center issues.

> The program authority should have a de-certification process in place to manage vendors/service centers who fail to comply.

Service center non-compliance> It is recommended that jurisdictions have in place a

series of graduated sanctions that may be applied to strongly encourage manufacturers, vendors, and service centers to be compliant.

> Jurisdictions are encouraged to consider a range of options (e.g., suspending new installations, imposing fines) designed to bring manufacturers and/or service centers in compliance.

> Removal of a vendor should only be considered as a last resort.

Calibration> Calibration is a process by which a tester uses an

alcohol reference sample to determine if an interlock device accurately measures the BrAC of a user.

> If the device is not accurately measuring the BrAC, the device can then be adjusted or re-calibrated to ensure the correct measurement of future samples.

> The observation of device calibration is an important aspect of vendor oversight.

Calibration> Important aspects of calibration in relation to interlocks

include:

» Calibration interval - the maximum time period that an interlock may be used without a calibration check, after which the ignition of the vehicle must lock.

» Calibration stability - the ability of an interlock to hold its correct calibration over a defined time period.

» Service interval - the maximum time period that an interlock may be used without maintenance or data download, after which the device must be serviced or the ignition of the vehicle will lock.

Wet bath calibration> Wet bath simulator: an electronic, temperature

controlled instrument that, when used with alcohol reference solution, will provide precise and accurate calibration standards with alcohol breath instruments.

> This type of simulator is used because it provides the ability to closely replicate a human breath sample.

Wet bath calibration> When observing the use of wet bath simulators, particular

attention should be given to:

» the simulator model and serial number;

» the date of last calibration of the wet bath simulator;

» the temperature reading on the device;

» the tubing connections;

» cleanliness of the device;

» the age and usage number of the reference solution;

» the temperature of the ambient air; and,

» the measuring of the reference solution used.

Dry gas calibration> The dry gas method requires the introduction of a

pressurized dry standard gas, which has a specified concentration of alcohol, into the interlock and compares the resulting BrAC reading with the corresponding alcohol % in the dry gas mix.

> The over-arching benefit of using a dry gas simulator as opposed to a wet bath simulator is the reduced chance of calibration errors.

> Dry gas is generally a more stable solution, is easier to use, and lasts longer than the solution used in a wet bath simulator.

Dry gas calibration> When observing the use of dry gas simulators,

particular attention should be given to:

» checking the tubing connections;

» the length of tubing;

» the age of the cylinder;

» the temperature of the ambient air where the cylinder is stored and used; and,

» the altitude conversion if needed.

Interlocks vs. evidentiary devices> Breath tests on an interlock involve a breath testing

procedure that is controlled by the end user and is not an evidential quality test.

> The procedure is different:

» there is not necessarily a deprivation period of 15 minutes;

» there is no calibration check; and,

» the breath tests will administer a pass, warn or fail, with no immediate second test.

Interlocks vs. evidentiary devices> Evidential breath tests are managed and collected by

law enforcement.

> There is often a deprivation period of at least 15 minutes as part of established breath testing procedures to avoid false positives that can result from mouth alcohol.

> The breath test instrument performs an air blank, a calibration check, more air blanks, and multiple subject tests separated in time before reaching a result.

Interlocks vs. evidentiary devices> Interlocks are not used for the same purpose as

evidential breath test devices and therefore, are not required to meet the same legal standard.

> Evidential breath test devices are subject to challenges under the Rules of Evidence whereas interlocks have the lesser legal burden of preponderance of the evidence.

> Program administrators should be prepared to testify on the scientific principles of the interlock device and the demonstrated accuracy of the device.

Legal challenges> The most common legal challenges that program

administrators face include:» showing that the device is based on a valid scientific principle;

» showing that the principle was properly applied in this particular device; and,

» showing that the device was properly used in a particular instance.

> Program administrators may receive either subpoenas or freedom of information requests in relation to the functioning of the device and/or the information collected by it.

Legal challenges> Programs should have a very specific quality

assurance plan that will demonstrate that the manufacturers, vendors, and service centers are qualified and supervised.

> The plan should also provide assurance that devices are properly certified, tested, and maintained.

Required documentation> It can be very useful to ensure that program

administrators and/or agency staff have available examples of forms and agreements that are routinely used by vendors or service providers.

> It is important that program administrators are familiar with the general operation of service centers.

» This may even include speaking with technicians at service centers to ensure understanding of the process that is utilized.

> Administrators should be knowledgeable about the availability of calibration logs for devices.

Ensuring data security> Ideally, jurisdictions will have the ability to implement

an automated data system.

> Programmers who devise an automated system must be educated about the sensitive nature of the data so the system includes built-in security measures for data transmission and storage.

> The most rigorous example of data management is found in The Netherlands. Vendors are not approved to do business until the protection file meets minimum standards.

Ensuring data security> Designing programs to ensure participant privacy must

be balanced with requests/requirements to share certain information.

> Releasing information in any other situation other than a court order, subpoena, or FOIA request is not recommended without written consent from the program participant.

> To limit liability, programs should have written policies and procedures to guide the release of information; all requests should be directed to a single individual in the program, preferably legal counsel.

Protection against legal challenges> Administrators should have legal counsel on staff to

help ensure that procedure/protocols are comprehensive in addressing any challenges.

> It is very useful to consult legal counsel to be fully informed regarding what documentation must be released in response to a subpoena or a FOIA request.

> The identification of key experts and appropriate program staff who can provide testimony is also useful.

Protection against legal challenges> Jurisdictions should have a process in place to ensure

devices meet NHTSA model specifications as well as the requirements for that jurisdiction.

> Lab tests are necessary and should be required in a program, however, lab results should not be relied upon as the sole method of device testing and certification.

> Establishing a thorough certification process will improve program integrity and provide for accountability.

Conclusions> High quality devices increase interlock program integrity.

> Jurisdictions should have a process in place to ensure an interlock device meets NHTSA model specifications as well as the device requirements for that jurisdiction.

> Jurisdictions rely on the lab test report to confirm that an interlock should be used in their program.

> Lab tests are necessary and should be required in a program, however, lab results should not be relied upon as the sole method of device testing and certification.

Conclusions> It is critical that programs understand device function,

operation, and the implications of device modification.

> Programs should be aware of and understand the legal implications and questions that may be arise with interlock devices and their functionality.

> Establishing an effective and thorough certification process will increase program integrity and provide for accountability for device operations and subsequent readings.