 "Accurate & Affordable Drug Testing"
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Welcome To the BioTechScreening Blog
Sunday, August 26, 2012
BACKDROP: These devices have been around since the mid-nineties and their accuracy and reliability have increased quantum leaps so that today they are as accurate as laboratory screening. Why have immediate results triumphed over delayed result testing? COST SAVING, 1. The initial savings is substantial with onsite screening generally costing less than half that of a laboratory screen with similar accuracy. The shipping cost of sending a specimen to the lab will always militate against it being a cost effective alternative. 2. Onsite devices yield a high percentage of admissions. When admissions obviate the need for confirmations, dramatic savings are realized in that confirmatory testing will always be the most expensive part of any testing process. SUPERIOR PROCESS 1. With a delayed result, when the officer hears back from the lab he/she must either track down and confront the individual at which time an admission is highly unlikely 2. Additionally when a couple of days have lapsed before usage is detected, a potentially hazardous situation arises in that drug supporting criminal behavior may continue. 3. With an immediate result is negative, the officer can reward and support the donors sobriety, the positive role of drug testing. 4. When results are delayed, the deterrent effect of drug testing is diminished or non-existent. LABOR INTENSIVE With a lab screen a specimen must be collected, sealed, bagged a Chain-of-custody completed, shipped and then reported out when the results are returned. With a onsite device in the majority of cases the process in done in a very few minutes. OFFICER SAFETY When I met with the assistant warden at Sheridan in Oregon he listened to my pitch before saying all the features that I was promoting were well and fine, but he was only interested in the safety of his officers and the sooner he could identify an active drug user and segregate him from the population the better for all concerned. COMMUNITY PROTECTION With delayed results an offender can continue their drug supporting criminal activities until they are held accountable. Immediate results, therefore, afford a far higher degree of community protection. DETERRENCE In order for deterrence to be effective, consequences must be swift and certain. Long term addicts have told us that they must know that they will have to pay the piper at the time of the test or else they’ll convince themselves that the drug will degrade in the delay while sending it to a laboratory or that it will be lost or mixed-up with another’s specimen. Deterrence is the main goal that most effective programs seek to achieve. FLEXIBILITY AND KEEPING DONORS GUESSING In order to be effective, a process must keep offenders “guessing.” When panels are not changed they become predictable and donors will find drugs they can use that are “safe” from detection. Onsite tests enable you to frequently change panels so that a donor does not know on a given day for what they will be tested. It also enables you to customize panels per geographic areas to test only for those drugs being used in a given location. Labels: justice, laboratory, matrix, testing by: BioTechScreening 0 Comments 
LABORATORY CERTIFICATIONS
From Norchem Laboratory
Urinalysis drug-testing conducted under the authority of the Court should require or mandate a high “Forensic Standard” that will insure the accuracy and “Legal Defensibility” of those test results. This “Forensic Standard” is directly aligned with the level of “Certification” of the laboratory conducting the urinalysis testing. The following details the historic development of the three (3) major “Certification Programs” for drug testing laboratories.
 SAMHSA was created in response to demands for scientific and technical standards for Federal Workplace Drug Testing Programs and for the certification of laboratories engaged in urine drug testing for federal agencies. SAMHSA is distinguished from CLIA by its strict emphasis on “Legal Defensibility” and by its deliberately restricted regulatory scope; it is limited to urine testing for five drug classes. The SAMHSA Guidelines that insure “Legal Defensibility” include: 1) rigorous chain-of-custody for the collection, testing, and storage of the specimens, 2) strict laboratory security with restricted laboratory access and locked specimen storage, 3) precise requirements for quality assurance, 4) performance testing specific to urine assays for five drug classes, 5) specific educational requirements for laboratory personnel to insure their credibility as Forensic Drug Testing Experts. The SAMHSA Guidelines make it clear that they do not apply to drug testing performed under any legal authority other than the Mandatory Federal Workplace Drug Testing
CAP-FUDT - 1988 (College of American Pathologists/Forensic Urine Drug Testing)The gap left between CLIA and SAMHSA made the development of a separate laboratory certification program essential to insure the protection of individual rights and the “Legal Defensibility” of forensic urine drug testing outside the limited context of federal programs. In 1988 CAP, in consultation with the American Association for Clinical Chemistry, developed the FUDT accreditation program designed specifically for non-federal workplace drug testing. It was modeled after the SAMHSA program and includes the five items above to insure “Legal Defensibility” but the scope of the program was expanded to cover any drug test performed on urine. The objective of the CAP-FUDT program is to improve the quality of laboratory services so that all testing is performed in a scientific and “Legally Defensible” manner. The CAP-FUDT program emphasizes the importance of confirmatory tests to meet forensic requirements.
CLIA – 1988 (Clinical Laboratory Improvement Act of 1988)
CLIA was enacted to insure that all laboratories provide accurate results for medical diagnosis and treatment decisions. CLIA has applied a single set of requirements that apply to almost all laboratory testing of human specimens. CLIA also established enforcement procedures and sanctions applicable when laboratories fail to meet standards. Compared to most clinical tests, the legal consequences of a positive urine drug test may be severe and present a heightened probability of a legal challenge. Therefore, drug tests are considered “Forensic Testing”. However, the CLIA laboratory certification program does not provide for chain-of-custody procedures and documentation, quality assurance and performance testing specific to forensic urine drug testing (FUDT) such as confirmation procedures. Additionally, CLIA does not specifically have trained inspectors to perform on-site evaluation of forensic laboratories. Labels: clia, fda, justice, laboratory, testing, urine, workplace by: BioTechScreening 0 Comments
Sunday, March 4, 2012
BEST PRACTICES EVALUATING YOUR URINE DRUG-TESTING PROGRAM By Eric, Ryan and James Fitzsimons There are several matrices available to test for drugs of abuse. The use of urine as the primary means to conduct these tests will not be supplanted in the near future. Drugs and their metabolites are highly concentrated in urine and more in known about this matrix than any other. It is the most legally defensible method. It is also a quick and inexpensive means to test and enables agencies to test more frequently thereby enhancing deterrence, the positive role of drug testing. Drug testing processes vary widely state-to-state, county-to-county, and office-to-office. There are many features that, in our opinion, separate effective drug-testing programs from those less effective. The following are the rank ordered features that are characteristic of the best programs, those that maximize detection and deterrence: Is your drug testing process fully randomized (no scheduled submissions)? In order to be truly effective, a drug testing process must be fully randomized. With the defeating of drug tests a multi-million dollar business in this country, any predictability will inevitably lead to test tampering. Scheduled drug tests invite donors to try to beat your system either by substitution, hydration or adulteration. Conducting fewer drug tests on a random basis is probably superior to conducting more tests on a scheduled basis. Do you at least occasionally test on weekends? The essence of deterrence is no safe drugs to use and no safe periods to use drugs. Testing on weekends is absolutely essential in deterring the casual user. For example, when testing does not occur on weekends, donors can safely use on Friday night and generally be “clean” by Monday. Absent at least occasional weekend tests, you give tacit approval to drug use. Are you using rapid-result testing devices? Any type of delayed-result testing is not a good fit with the criminal justice system. There are a myriad of advantages associated with rapid results including, but not limited to, a high degree of admissions. When admissions obviate the need for confirmatory testing, dramatic savings may be realized since confirmatory testing will always be the most expensive part of any testing process. Rapid results allow you to confront the user immediately and implement a curative course of action. It also allows you to know definitively when a donor is clean so that this behavior may be supported and/or rewarded. Is the rapid-result product that you use available over-the-counter or over the Internet? A product readily available to the donor enables them to: 1. Pre-test themselves before meeting with their correctional officer. If they test positive, they may delay the meeting until the drug has passed through their system. 2. Purchase the identical product so that they may analyze its performance characteristics, e.g. how much water must be ingested in order to fall below the cutoff level, how sensitive a product may be for a specific drug, etc., etc. With any sophistication, a donor will soon learn how to minimize the chances of submitting a positive specimen. 3. If the product is a cup device, it provides the donor a far better and easier means to substitute the urine of another. Do you use a SAMHSA or CAP Certified Laboratory for Confirmations? An essential component of any drug-testing process is the inclusion of a high-standard laboratory for confirmations. With either of these certifications, we know about the accuracy of a lab since there is a built-in check and balance system. When using a lab that holds neither of these certifications, we virtually know nothing about what or how well they are performing GC/MS confirmations. Some labs do not even perform GC/MS confirmatory tests. A true confirmation test must be able to provide semi-quantitative results, should include a routine validity check and have the capacity to report results at less than SAMHSA cutoff levels. Are confirmatory results reported out in LOD or LOQ levels? SAMHSA cutoffs were set for the workplace and are far too conservative for the criminal justice system. Limit of Detection (LOD) or Limit of Quantitation (LOQ) levels will establish that the donor absolutely used the drug in question but this is a lower level than SAMHSA. SAMHSA is, in fact, currently considering reducing the screen and confirmation levels for amphetamine, methamphetamine and cocaine in the belief that too many users are circumventing detection. A lower level of detection is a good fit with criminal justice in that it provides a much higher level of protection for your community. Some other areas, though not as critical: Do you always test for the same panel of drugs? Donors soon learn for which drugs they are likely to be tested. Drug substitution, such as switching stimulants, is commonplace when a donor’s freedom is on the line. In order to have an effective drug-testing program, donors should never be able to predict for what they will be tested on a given day. Is the supervising officer quickly notified of a positive screen? In order to be effective, a decision maker must be notified of a positive submission in a timely manner. With rapid-result testing, a probation officer may decide on a course of action before the drug-usage reaches addiction. The earlier in the addiction cycle that usage is detected, the less intensive and therefore less expensive the treatment response. Once again the community is best protected by early intervention. With laboratory, or delayed-result testing, once the result is finally received, the donor must be tracked-down and confronted. Most delayed-result testing results in denial of usage and the penetrating of this denial can be a difficult and time-consuming process. Ideally the PO should be notified on the same day the test is administered. Are you using a formalized admission form for positive submissions? In most instances an admission form obviates the need for a confirmatory test. Admissions are generally considered preferable to a confirmation in that the donor admits usage and a course of action may be formulated. With admissions there is no denial to penetrate and treatment may commence immediately. Many donors will also admit and sign an admission form prior to the test, which may save precious funds as well. Finally, many sites report that they get admissions, even when the screening and/or confirmation tests are negative. This is dealt with in different ways in different locations. Are collectors aware of subterfuge and how donors beat the test? Collectors must be aware of when to, and when not to, accept a specimen as creditable. Specimens which appear dilute, are a “neon” yellow, appear “strange” in any other manner or where the donor is exhibiting other substance abusing cues, should be held to a higher standard. The usage of a simple dipstick device on a judicious basis adds measurably to the credibility of any program. Strategically placed mirrors, etc., demonstrate that we care enough to make beating the test difficult. When donors can easily defeat a drug test, word spreads and impacts on the credibility of your program. Is every specimen tested for temperature? This is the number one guard against specimen substitution and provides additional integrity for your program. Are the testing devices you are using considered “aggressive”? An “aggressive” device is one that does not yield false-negative results. With false-negative results the donor knows they’ve used, as do their friends, but they are told they’re “clean” and sent on their way. This affords the community little in the way of protection. An aggressive device will detect usage at or around the cutoff level. It may occasionally yield a low level positive result, but this will be rectified during a confirmatory procedure. Devices need to be tested with “at-cutoff” controls to evaluate this criterion. Are the consequences for trying to beat a drug test greater than for a positive test? Absent greater consequences, this becomes a cat and mouse or catch-me-if-you-can process. What has a donor to lose if there is not a great sanction imposed? Is some “action” taken as a result of the first positive test? If a certain number of “positives” are condoned before action, this is tantamount to giving permission to limited “usage.” In order for a program to truly deter usage, there must be some “consequence” for any positive submission. Do you have access to 24/7/365 technical support? When questions such a cross-reactivity, interpretation, accuracy, sensitivity, etc., arise, they need to be addressed promptly. Do you have an evaluative process for measuring the actual effectiveness of your testing program? Many testing programs are perfunctory in nature with no means to measure effectiveness. What drugs do you commonly see? Are there drugs for which you routinely test that are rarely seen? Could you test for fewer drugs more often and have a better program? Are you keeping donors guessing or can they easily predict for what drugs they will be tested? Do you at least occasionally test for drugs not commonly seen (e.g. Oxycodone (OxyContin), Ecstasy, Darvon, etc.)? It is my belief that the most effective drug testing program at this time is the use of an aggressive rapid-result urine test on a random basis, a focus on admissions and the judicious use of a SAMHSA or CAP Certified laboratory with results reported out at LOQ or LOD levels. Labels: ecstasy, laboratory, oxy, testing, urine by: BioTechScreening 1 Comments
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