Field Test of On-Site
Drug Detection Devices
Final Report -- October 2000
ISA Associates, Inc. and the University of Utah's Center for Human Toxicology (CHT) are conducting a field test of on-site drug testing devices for use by law enforcement personnel. The primary purpose of the field test is to determine the accuracy and utility of commercially available on-site drug testing devices when used by trained police personnel. The study is being funded by the National Highway Traffic Safety Administration (NHTSA).
The project has multiple objectives. The first objective is to ensure that the best commercially available on-site screening devices - for the purposes of police detection of drug presence" are being assessed. We will be evaluating the accuracy of the devices against the most accurate laboratory standard available - GC/MS testing. However, perhaps the key distinguishing feature of this project is that it is a field test. NHTSA and the Center for Human Toxicology have already conducted a thorough laboratory test of the leading on-site drug screening devices. The goal of this project is to assess how well these devices perform when placed in the hands of trained law enforcement personnel as they conduct their routine duties. Techniques that perform well in the laboratory may falter when brought into the "real world" of law enforcement. The research will evaluate how law enforcement officers can use these screening devices as supporting evidence in the detection of drugs in the driving population.
The field test will also allow us to assess how the on-site screening devices can provide additional information for the Drug Evaluation and Classification (DEC) program. DEC officers in the participating sites will assist the project staff in the evaluation of the on-site devices. However, this project will not evaluate the performance of the DEC officers. At the sites, trained Drug Recognition Experts will conduct DEC assessments on DUI and DUID suspects and will also conduct some of the on-site drug testing devices. The officers can then provide their views on various aspects of the on-site drug tests including, ease of use, time necessary to conduct the test, ease of interpreting the drug test results, and the perceived utility of the devices for the detection of drugs. The results of the field test should provide information on the extent to which these devices can be used to strengthen and enhance the DEC program. This research began in October, 1997 and will be conducted over two years.
The specific objectives of the study are as follows:
Sponsors of the study. This project is being funded by the National Highway Traffic Safety Administration, part of the Federal Department of Transportation. The Principal Investigator for the study is Royer Cook, Ph.D., President, ISA Associates (ISA) and the Project Director is Dennis Crouch, Assistant Director, Center for Human Toxicology. Rebekah Hersch, Ph.D., Vice President, ISA, is the Field Test Coordinator and will be directly responsible for training and supervising the Research Analysts. ISA Associates is a behavioral science research firm dedicated to research and development in health promotion, substance abuse prevention, and criminal justice.
As a Research Analyst for the Study you should be able to describe the study in brief, summarize the purpose of the survey, and identify the sponsors of it to anyone who asks.
The data collection principles in this section may be familiar to you, but we feel certain aspects should be emphasized. The following review covers the central principles you need to know before you start data collection.
Persons working in jobs and professions that deal with the behavior of people have a moral duty toward these people. Social science research is one of these occupations, and researchers must honor the ethics of the profession. Thus, all information obtained from participants is privileged, and the Research Analyst must respect their confidentiality and privacy completely.
The Research Analyst will have confidential information about the participant to which they would not normally have access. Your protection of all information about participants gained during the conduct of research is, therefore, essential. We have promised participants that we will not reveal the results of their tests (unless they provide their consent). Participants' data will be combined with those of others in the data collection and the results will be reported as group percentages and totals in such a way that no participants name could be associated with any results.
IT IS YOUR DUTY TO KEEP THE PROMISE OF CONFIDENTIALITY. NEVER TELL FACTS ABOUT, OR REVEAL INFORMATION ABOUT ANY PARTICIPANT. Information or results collected during the study can be shared only with the research team, whose members are under the same ethical and moral duty to the people interviewed as you are.
The Privacy Act of 1974 deals with the rights of privacy of research participants. These laws require that data collected for the federal government be kept absolutely confidential, and that the participant must be told the purpose of the data collection, what use will be made of the data, and that participation is voluntary. Violation of the Privacy Act of 1974 can involve substantial criminal penalties. The procedures developed for this data collection are in accordance with the Privacy Act of 1974. By adhering to these procedures, the Research Analyst (RA) will help ensure that the data are collected in compliance with the law.
Procedures to ensure confidentiality. ISA is firmly committed to the principle that the privacy of individuals who provide data through our data collection methods must be protected. To ensure this privacy, the following procedures will be followed:
The purpose of the this study is to determine the accuracy and utility of commercially available on-site drug testing devices when used by trained police personnel. The data that will be collected will be used solely to determine the validity, reliability, and utility of these devices for the enforcement of DUI laws. At no time will the results of the tests be used to prosecute the research participants. The results of the data collection will be summarized in reports to NHTSA, published reports, and articles on the study. These reports and articles will be disseminated to interested practitioners, policy makers, and researchers across the U.S., and should be of special interest to law enforcement practitioners. All results will be reported in group fashion, with no individual identities revealed.
The Research Analyst is to assist ISA in actual data collection. You will have primary contact with the law enforcement officers and, to some extent, the research participants. The data we collect will only be as good as the researchers who conduct the data collection. Private and public agencies will depend on accuracy of the data collected to make decisions that may affect people in all walks of life. Therefore, the Research Analyst's job is especially important and meaningful.
The Research Analyst must conduct the tests in an objective, unbiased manner and assist the law enforcement officers to also conduct the tests in a uniform and unbiased manner.
You will be working approximately 8-hour shifts. There will, of course, be the necessity to take a break to eat and to use the rest rooms. Please be sure that you secure the test results and data collection materials before leaving the area for any reason. All food and beverages must be kept away from the test devices, urine samples, and work areas. ISA has obtained the cooperation of the Field Test Sites and they will allow us to use their offices and facilities. However, we are guests of the Police Department. Please keep all work areas neat and orderly and leave the offices in the same condition you found them. In addition, please follow all Officer requests involving security issues.
Five devices have been selection for inclusion in this study. They represent a range of manufacturers and technology - from relatively simple to more complicated. The tests selected for use in this study are:
TesTcup, Roche Diagnostic Systems, Inc, Somerville, NJ
Triage, Biosite Diagnostics, San Diego, CA
AccuSign, Princeton Biomedical Corporation, Princeton, NJ
Rapid Drug Screen, American Bio Medica Corp, Ancramdale, NY
TesTstik, Roche Diagnostics Systems Inc., Somerville, NJ
Information about how these tests were selected is available and can be provided if requested. A brief description of each of the five tests is provided below. Additional information about each test is appended.
TesTcup - 5. TesTcup-5 is an integrated urine collection and testing device. Typically, the urine collection and testing is conducted using the collection cup with no urine or reagent handling. For the purposes of this study, however, it is likely that the urine sample will be collected in a separate specimen collection cup and transferred to the TesTcup. TesTcup allows for the simultaneous detection of amphetamines, cocaine metabolite, morphine (opiates), PCP, and THC metabolite. Results are obtained in approximately 5 minutes without timing. The test results are obtained using the following steps:
Negative Results: A sample is positive if a color bar appears in any of the Drug Detection Zones adjacent to the drug names.
Positive Results: A sample is negative if no color bar appears in any of the Drug Detection Zones adjacent to the drug names.
Triage. Triage also simultaneously tests for amphetamines, cocaine metabolite, morphine, PCP, and THC metabolite. Triage requires more handling and manipulation of the urine sample and reagents than the other devices. The procedure for using Triage is as follows:
Positive Results: A sample is positive if a color bar appears in any of the Drug Detection Zones adjacent to the drug names.
Negative Results: A sample is negative if no color bar appears in any of the Drug Detection Zones adjacent to the drug names.
AccuSign. AccuSign is a single step procedure that simultaneously tests for the presence of the five drugs listed previously. Precise timing is not required for the AccuSign test, although the test should be read within 10 minutes. Procedures for AccuSign are all follows:
CONTROL LINE: A colored line indicates the test is complete and the system has work properly.
NEGATIVE: A colored line for the specified drug indicates the test is negative and the drug was not detected.
POSITIVE: No colored line for the specified drug indicates the test is positive and the drug was detected.
Rapid Drug Screen. Rapid Drug Test is a single step process that simultaneously tests for the presence of the NIDA-5 drugs. Results can be obtained in 3 minutes and must be read within 10 minutes. Procedures for Rapid Drug Screen are all follows:
NOTE: The intensity of the line is not important. The appearance of any line, no matter how strong or weak it appears, should be considered a line in the test area.
TesTstik. The TesTstik assay is a single-analyte test that can detect for the presence of a specific illicit drug. Each TesTstik is specifically designed to detect one illicit drug. Several TesTstiks may be dipped into the specimen container simultaneously as long as there is sufficient sample to reach the "DIP LINE." This can be accomplished by holding the TesTstiks back to back so the Dip Line is visible. Five TesTstik Tests will be conducted (one for each of the five drugs) for each sample. The procedure for each TesTstik is as follows:
KEEP THE TESTSTIK IN THE SPECIMEN FOR A COUNT OF 10
Once the TEST VALID line appears, remove the tab to expose the results window
Dr. Rebekah Hersch and Mr. Dennis Crouch will monitor and supervise your work. Dr. Hersch will have weekly contact with you to discuss the data collection and any issues that arise. In addition, she or Mr. Couch (or Dr. Royer Cook) will conduct periodic site visits. Data collection forms should be sent to ISA each week. Samples with a positive screen for any drug on any of the kits will be stored in a refrigerator on-site and shipped in batches via Airborne Express Lab Pack to the Center for Human Toxicology. In addition, if a participant tests is charged with a drugs and driving offense and tests negative on all five of the on-site devices, the specimen will also be labeled, stored, and shipped to the Center for Human Toxicology. ISA will supply all of the materials needed for storing and shipping the specimens. Dr. Hersch will be available anytime by telephone if a problem arises. Dr. Hersch's number at ISA is 703/739-0880.
The following sections provide most of the necessary information, procedures, and forms needed for the successful completion of the study.
Review your manual and the data collection forms and procedures until you are sure you understand all aspects of your job. This includes understanding the purpose of the study and your role in it, going over general principles of data collection, learning the field procedures, and understanding the specifications of the data collection devices and forms.
Before you begin your first data collection session, review the device inserts and practice using the devices and forms until you feel confident. Successful data collection requires an RA who fully understands and can easily and correctly use the materials.
Be sure you know which materials you need before you go to the police department, to ensure that you have everything that you will need. Also, organize your materials and be accustomed to handling them so you don't find yourself fumbling or dropping the materials.
ISA has requested that officers in the DUI Central Testing/Processing Section ask each DUI arrestee brought into the Section whether they would be willing to participate in a voluntary study. In some cases, arrestees may not be approached to participate (e.g., too inebriated, too belligerent, etc.). Arrestees will be informed that information obtained as part of this study WILL NOT be used against them in a criminal or civil proceeding. If the arrestee declines to participate, a notation should be made so that the RA can obtain an accurate count of the number of arrestees asked to participate and the number who refused to participate. If the arrestee agrees to participate, s/he must sign the informed consent document and be given a copy for her/his records. The Officer will then obtain a urine sample from the participant. Because the test results will not be used as evidence in any legal proceeding, the Officers will not be required to use chain-of-custody procedures. Participants can provide a sample privately at the Officer's discretion.
The Participant's sample will be given to the RA. The RA will be responsible for assigning the appropriate identification number to the sample. (The RA should also record the name and identification number on the Master List. In addition, the RA should indicate on the Master List, the name of the Officer who conducted the test and the name of the device the Officer used.) Prior to data collection, ISA will provide a Test Order Form so the RA will know in what order to conduct the tests. The order of the tests will rotate for each sample to avoid any bias. For each sample, the Testing Officer will be assigned the first kit in the order. (In the case of TesTstik, the Officer will conduct all five TesTstiks on the sample). If possible, those tests will be conducted first. If not, the device will be set aside so that the Officer can complete the testing as soon as feasibly possible. The Testing Officer will conduct the test according to the directions -- from preparation to interpretation of results. Prior to testing, the RA should review the testing procedures and test interpretation with the Officer to ensure that the Officer feel confident using the device. The Officer's test results will then be recorded on the RESULTS LOG. The Testing Officer should interpret the results of the test without assistance from the RA. The RA should observe the Officer conduct the test and note any problems. After the test is completed, the Testing Officer will be asked to complete the Test Rating Form (see below). Officers will need to complete a Test Rating Form for each test device/sample they complete. The RA will proceed to conduct the remaining four tests on the sample in the assigned order (again, if necessary, the Testing Officer can conduct his or her test after the RA conducts the remaining tests). The results of the tests should be recorded on the RESULTS LOG. For a negative result, the " - " sign should be circled, for a positive result, the " + " sign should be circled. Be sure to circle the results clearly, so there will be no confusion when the data is summarized. If a DRE evaluation is conducted, please indicate the results of the DRE evaluation as well.
If ALL FIVE DEVICES test NEGATIVE for ALL five drugs, dispose of the urine sample in the bathroom toilet and discard the used devices and collection cups in the biohazard box provided. There is one EXCEPTION to this procedure. If the arrestee is charged with a drugs and driving offense (driving under the influence of something other than alcohol) and we obtained only negative results on all five devices, we need to note that on the master list (a simple * is sufficient) and store the sample for shipment to the CHT. That information (the fact that we failed to obtain any positive test results) will need to be provided to the District Attorney's Office.
Whenever ANY of the five devices tests POSITIVE for ANY of the five drugs, the sample should be sealed and stored for shipment to CHT. The RA will need to record on the sample which drugs require confirmation. For example, for Sample X, two devices resulted in a drug positive for marijuana (THC) and one device also tested positive for cocaine (COC), then a GC/MS confirmation will be needed for both THC and COC. If for Sample Y, five devices tested positive for amphetamines (AMP) and one tested positive for THC, then again there would be two GC/MS confirmations needed (THC and AMP). Finally, if for Sample Z, only one device tested positive for cocaine only, then the sample would be sent to CHT to be confirmed for COC. Samples requiring confirmation will be sent weekly to CHT. Information on specimen collection and shipping is presented below.
CHT will provide 100 mL inert plastic collection cups for urine collection. Following collection, use the markers provided containing indelible black ink to label the cup. At a minimum, the label should include:
(1) study identification number, and
(2) date and time of collection.
Urine from the collection cup will be used to dispense aliquots for on-site device testing. After testing, specimens may be stored (refrigerated) in the collection cup. If storage space is a problem, the specimen may be transferred to a shipment bottle (see below). Be sure to label the bottle with the information that was on the specimen cup label.
CHT will provide sample shipment kits containing the following materials --
(1) 30 mL screw cap specimen bottles;
(2) Specimen labels;
(3) Fluid tight, leak proof, self-sealing specimen bags; and
(4) Each bag contains an absorbent packet.
You will also be provided with a specimen manifest form; pre-printed shipping labels and 'bill recipient' overnight courier shipment forms. Costs associated with the shipment of urine specimens from the site by Airborne Overnight service will be billed to CHT. Our cost estimate is based on 15 urine specimen/shipment. However, you should send specimens at least every other week to avoid prolonged storage.
Use indelible black ink to write on labels. At a minimum the label should include:
(1) study number,
(2) date and time of collection, and
(3) drug(s) to be confirmed.
Attach the label securely to the bottle and record information on the inventory and shipment form.
When an appropriate number of specimens have accumulated (approximately 15), ship samples to:
Bobbie Smith or Dennis Crouch
University of Utah
Center for Human Toxicology
20 South 2030 East
Salt Lake City, UT 84112-9457
Phone 801-581-5117 FAX 801-581-5034
Also, please notify Ms. Smith or Mr. Crouch at the Center for Human Toxicology (801) 581-5117 when specimens are shipped.
As noted above, Officers will be asked to complete a Test Rating Form for each test they conduct. The form consists of a series of Likert-type scales, designed to assess the Officer's ratings of the test on a number of variables including, easy of use, time needed to conduct the test, time needed to interpret the test results, interpretability of the test results, etc. The RA will provide the Test Rating Form to the Officer and ask the Officer to return it to him/her. Officers will ultimately complete multiple rating forms for each device. The Test Rating Form along with the Results Log will be sent to ISA every two weeks via Federal Express. ISA will provide the Fed Ex packaging and labels.
The RA will be responsible for recording the results of each device for each drug category. Participants will be identified by unique Identification Number only. Samples that require GC/MS confirmation will also be identified by the same unique identification number. In addition to recording the results, the RA will be responsible for maintaining a Master Code List. This list will link names and identification numbers. The list will only be used in the event that a defense attorney requests information from the District Attorney about the results of the testing. The Master List must be secured in a separate location from the Results Log. Finally, the RA will be responsible for maintaining a Response Rate Record; that is, the number of DUI arrestees asked to participate, the number who refused and the number who agreed. The RA will also be responsible for maintaining and sending the Officer Rating Forms to ISA.
Terms of employment. On-Site Research Analysts are hired as independent contractors. As such, no taxes will be deducted from your pay and you are responsible for paying any resultant taxes. ISA will issue a Tax Form 1099 to each RA at the end of the Tax Year. As in most instances of temporary employment, paid vacations and holidays, medical insurance, retirement benefits, and worker's compensation are not included.
Each Research Analyst has signed an Independent Contractor's Agreement. This agreement outlines the rate of pay, schedule, and responsibilities of the RA. This agreement is in force for the duration of the field work.
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