Visual inputs are essential for driving a CMV. It is difficult to provide rigorous scientific evidence for the level of vision required for safe driving because driving is a highly complex task; however, in this age of evidence-based standards, it is pertinent to justify the current visual acuity standards.

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Driving research is fraught with limitations associated with the multi-factorial nature of the task and the difficulties in accessing accurate crash data. Studies have only shown a weak link between visual acuity and crash rates. Milestones:Completed:October 2016: Kick-off meeting.☑December 2016: Detailed work plan submitted.☑February 2017: Peer review meeting.☑June 2017: Draft literature review submitted; interviews with medical experts in progress.☑July 2017: Letter report with results of interviews.☑May 2018: Letter report with crash analysis findings and evaluation of vision waiver program.☐June 2018: Presentation to the Motor Carrier Safety Advisory Committee and Medical Review Board.☐September 2018: Draft final report and brief.☐November 2018: Final report and brief.☐Funding.

DescriptionDescriptionFigure 1: Shows the officer's ratings of ease or comfort when using the devicesRating of easeNumber of times an officer used this ease ratingPercentage of overall ease ratingsVery Easy71162%Easy32929%Neither706%Difficult272%Very Difficult20%Rating of comfortNumber of times an officer used this comfort ratingPercentage of overall comfort ratingsVery Comfortable71062%Comfortable34230%Neither464%Uncomfortable383%Very Uncomfortable10%Figure 1 provides the exact values of the frequency of ratings, compiled through questionnaires. The data illustrates that 711 officers most frequently described the devices as very easy (62%) and 329 officers described the devices as easy to use (29%). The officer’s comfort ratings with the devices were nearly identical with 710 officers describing themselves as very comfortable (62%) and 342 officers finding the devices comfortable (30%). Overall the figure illustrates the majority of ratings of ease of use and comfort are positive.Figure 1: Officers' Ratings of Ease of Use and Comfort with DevicesTroubleshooting of the DevicesFinding 3: Officers' ability to adapt to and troubleshoot problems with the devicesIn the very few instances where multiple attempts were required to successfully submit an oral fluid sample for analysis on the devices, officers reported that correcting the procedure was easy. The causes of multiple attempts were most frequently related to obtaining sufficient oral fluid using the Alere DDS-2 or needing to re-insert the swab into the device reader of the Securetec DrugRead, both of which could quickly be rectified at the roadside.

Officers found the procedural steps for conducting a test at the roadside simple to follow and remember. In 98% of all the samples taken, no steps were forgotten. On average, each procedure (i.e., explaining the test to the volunteer, collecting the sample, analyzing the sample through the device and debriefing the volunteer) lasted 9.3 minutes (9. 6 minutes with the Alere, 9.1 minutes with the Securetec).Weather, Temperature and Lighting ConditionsFinding 4: Successful deployment in various weather, temperature and lighting conditionsGiven Canada's harsh temperatures and weather conditions, and considering police officers conduct sobriety tests in all weather conditions, one of the main focuses of the pilot project was to determine how the devices work in all weather conditions. During the pilot project, police officers were asked to note any malfunctions that occurred due to temperature. This temperature aspect is important because the manufacturer's suggested operating temperatures for the cartridges range between 5°C and 25°C for the Securetec cartridges, and 15°C and 25°C for the Alere cartridges. The range for the devices is between 5°C and 40°C for the Securetec and -20°C and 45°C for the Alere.There was proportionally no increase in the number of tests with a reported malfunction when broken down by the weather conditions under which the sample was taken.

Overall, 219 (19%) tests were conducted in snowy or rainy conditions. Furthermore, 731 (64%) tests were conducted outside of the manufacturer's suggested operating temperatures for cartridges. While the devices worked in all weather conditions, there were some temperature-related issues that arose when the devices were used in extreme cold temperatures. Proportionally, tests conducted outside of suggested operating temperatures were more likely to produce drug-positive results (i.e., while 64% of all tests occurred outside of suggested operating temperatures, 80% of all positive results were produced outside the suggested range).

At present, it is unknown whether this finding is attributable to technical or procedural issues, for example whether the devices are more likely to show positive results when tested in extreme cold temperatures. Consequently, further research on the reliability of devices used outside of standard operating temperatures is merited. Officers did not report significant difficulties or a greater proportion of device malfunctions when using the device in the various weather conditions. Furthermore, officers only noted temperature-related difficulties causing a malfunction in just 1.2% of all samples collected. For example, one officer stated that when it was too cold for the device to operate, he “blasted the heat” from the car vents until the device started to work.As police conduct sobriety tests at all hours of the day, for the purposes of the pilot, officers were asked to deploy the devices in a variety of lighting conditions (e.g., morning, afternoon, night). Over one third of the samples taken (406) were conducted in conditions officers described as “dark”, and 730 samples were conducted in “light” conditions.

Officers were no more likely to have a malfunction or miss a procedural step based on lighting condition. Consequently, the pilot showed that officers were able to successfully deploy devices in all lighting conditions.Device DurabilityDuring the training sessions in December 2016, officers mentioned concerns related to device durability. Consequently, officers were asked to not handle the devices with any special care throughout the pilot to assess device durability. Durability was assessed during interviews through open-ended questions on how officers handled the devices. The vast majority of interview respondents did not experience any durability issues. For example, one officer mentioned having accidentally knocked the device across the vehicle and out the open passenger-side door, with the device not sustaining any damage.

Another officer mentioned having dropped the device at the roadside and had no issues afterwards. Despite initial concerns during the training session that the Alere DDS-2 was not stored in a hard case, no officers mentioned durability issues with the soft casing throughout the pilot.Three of the Securetec devices were broken during the pilot; one device was unable to power on, and two devices had their screens cracked rendering results unreadable. Any devices broken during the pilot were sent back to the manufacturers for diagnostics and repair.Standard Operating ProceduresFinding 5: Standard operating procedures and training guidelines that emphasize officer safety when deploying devicesIn order to ensure that the devices are adaptable tools for police operations, officers were asked several questions that focused on the procedural steps taken to deploy the devices at the roadside and concerns related to officer safety. The two most common concerns mentioned by officers were the amount of time required for a screening and the physical proximity to the driver being screened. Specifically, officers noted that the Securetec analysis time of approximately eight minutes could put officers in a vulnerable position. When asked to troubleshoot solutions for the length of time, officers noted that in a real situation, a possible solution could be to have a driver sit in the police vehicle. Although the Alere device can analyze results much faster, officers proposed concerns related to the length of time required to obtain enough oral fluid for analysis, as it could take more than two minutes to acquire enough fluid.

Some officers proposed that in a real situation, if a driver was physically capable, the driver could manually hold the swab personally until there was enough oral fluid in the swab. In fact, many of the officers in the pilot project put this into action and reported back that it was very easy to do with a compliant volunteer.With respect to physical proximity, officers raised concerns with needing both hands to operate the Securetec device while in close proximity to a volunteer, and with administering the Alere swab themselves. Among the officers, there was a general agreement that different actions would need to be taken depending on the device being used. For example, officers were more likely to collect swabs themselves when using the Securetec device and, although they raised chain-of-control issues with respect to having drivers collect swabs themselves, overall, the consensus was that with the Alere device, the level of safety for the officer would be increased if the driver collected the swab personally. Officers were confident that the effective use of the devices and officer safety could be achieved through standard operating procedures, training guidelines and device standards.Issues and Comparative AnalysesDevice MalfunctionsData was collected on device malfunctions, which occurred in 13% of samples. Malfunctions do not refer to instances where the device produced an incorrect result or did not function at all; malfunctions refer to instances where the devices did not function as expected by the officer (e.g., device powers off during analysis). The majority of malfunctions (46%) were related to printing issues (e.g., Bluetooth connectivity, printout paper ripped).

Considering the printer malfunctions, which could be solved easily by printing sample analysis results at the detachment (i.e., the devices store all analysis results), the true likelihood of a malfunction (e.g., issues caused by temperature, power/battery, weather or other/unknown reasons) is approximately 7 percent. It is important to note that no single malfunction captured under “other” (e.g., errors with cartridge, not properly inserted) accounted for more than 1% of tests. Although the inability to keep a device level (i.e., tilt malfunction) was commonly mentioned as a hindrance to conducting an analysis, it only occurred in 6% of all malfunctions (i.e., less than one percent of all samples). Other common malfunctions, such as the improper insertions of cartridges were the result of the device swabs not being completely inserted and could be corrected easily by re-inserting the cartridge. DescriptionThe graph above shows a breakdown of the different types of malfunctions experienced by officers using the devices during the pilot. Overall, malfunctions occurred in 151 (13.2%) of the samples collected. Originally, officers were asked to describe malfunctions as caused by temperature, weather, power/battery, unknown or other.

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As a result of the large volume of “other” responses, three additional categories (i.e., tilt, operator error, improper insertion of cartridge) were added. The remaining malfunctions reported as “unknown”, such as devices returning false positives, have been sent to device manufacturers for diagnostics. Figure 2: Malfunctions by type (excluding printer errors)Noteworthy, two of the Alere devices and one Securetec device began registering exclusively drug-positive results, including when tested on the police officers. Consequently, these devices were returned to the manufacturer to identify possible causes. One other malfunction pertains to the Alere swabs, as several swabs began to leak buffer fluid when placed in the mouth of the volunteer. The manufacturer has since stated that this fluid creates no health concerns and will be assessed.Temperature and MalfunctionsIt is noted that higher drug-positive tests at low temperatures did not correspond with device malfunction notifications of any kind. It is crucial to note that the devices did not report a temperature malfunction every time the device was used outside of the suggested operating temperature.

While the Alere device notifies users of an error code when operating outside the suggested operating temperature range, it does not distinguish if the error is with the device or the swab. Although temperature malfunctions were reported 14 times (i.e., the device alerted the officer), 717 out of the 731 tests across both devices were conducted outside the cartridge temperature range, with no error message showing.

654 tests were conducted at more than ten degrees lower than the suggested operating temperatures for the cartridges. Consequently, it is possible that “other” and “unknown” malfunctions resulted from these temperature discrepancies. As the devices have an approximate 95% reliability, false positives can occur; however, this risk can be mitigated through rigorous device standards or other screening techniques (e.g., SFST, DRE). Pilot findings related to temperature could be further investigated in a controlled setting by comparing oral fluid results to other analyses (e.g., blood) of known concentrations in live participants.Rate of Positive Drug TestsAs part of the guidelines of the pilot project, all volunteers were screened for any sign of impairment by the police officer administering the tests, and any volunteers who showed signs of impairment were not eligible to participate. Of the samples taken in the pilot project, approximately 15% registered a positive drug reading, and 43 of the 53 officers involved in the pilot project collected at least one drug-positive sample for any drug. The devices are set to indicate positive results when a specified nanogram level is detected in the oral fluid. Based on the positive samples collected, the most common drugs found were cannabis (61%), followed by methamphetamines and amphetamines (23% each), cocaine (14%), opiates (9%) and benzodiazepines (3%).

It is important to note that presence of a drug in the oral fluid does not imply impairment.Considering volunteers were screened for impairment before participating, the observed rate of drug-positive tests may be explained by the lower reliability of the devices when testing for certain drugs (e.g., benzodiazepines) compared to other drugs where there is a higher reliability (e.g., cannabis). It is crucial to note that devices will need to meet Canadian reliability standards in order to be deployed in Canada.As mentioned, two police services indicated the possibility of three defective devices, which could have artificially inflated the numbers of drug-positive tests. However, as this study was not controlled and oral fluids were not analyzed in a laboratory, it is impossible to remove these tests from analysis.“Poly-drug” UseOf the 148 drug-positive tests, 38 (26%) were positive for more than one drug. The most common combination of two drugs was methamphetamines and amphetamines (15 samples), and either methamphetamines or amphetamines were present in 89% of poly-drug instances. Cannabis was present in combination with other drugs in 42% of poly-drug instances (16 samples).Importance of TrainingEvidence supports the need for hands-on training with the devices.

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Qualitatively, the majority of officers interviewed reported that the training provided was beneficial. The majority of the feedback on training focused on providing officers more opportunity to practice with the devices. A greater proportion of officers trained at the initial training session, which provided the scientific basis of the devices, a practical hands-on component with expert device technicians, and an opportunity to ask technical questions, found the devices “Very Easy” to use (67%) or “Very Comfortable” (69%) versus the officers who did not attend the training sessions (56%, 53%). More than one of every seven tests (15.2%) conducted by officers who did not attend the initial training sessions resulted in a failure to return a result, compared to just one of every seventeen tests (5.8%) conducted by officers who attended the initial training sessions. Further, officers who were not trained at the initial training sessions were almost twice as likely to experience a device malfunction (17.8% compared to 9.7%), about one and a half times as likely to encounter at least one difficulty when collecting a swab (47% compared to 33%), and three times more likely to find that the device interfered with standard operating procedures (9% compared to 3%).Figure 3: Benefits of receiving formal training.