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COMPLIANCE MONITORING FAQs
Q: Why is AIT's ISO compliance important to me? A: The International Organization for Standardization (ISO) establishes strict quality-assurance standards to guarantee consistently high-quality results. Organizations certified under ISO have been inspected to ensure that all company processes and practices meet and maintain the quality of output. At AIT, we believe that meeting these standards is the best way to demonstrate our commitment to quality in all of our services.
Q: Why is the CLIA certification important? A: The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). The purpose of CLIA is to set minimum standards for all laboratories to follow and to determine if laboratories are achieving those standards. Any person or facility that performs laboratory tests on human specimens for the purpose of diagnosis and/or treatment is required by federal law to have a CLIA certificate.
Note: Although all clinical laboratories must be properly certified to receive Medicare or Medicaid payments, CLIA has no direct Medicare or Medicaid program responsibilities.
Q. How accurate are my test results? Laboratory testing results are accurate and reliable. The identification of individual drugs at AIT Laboratories is achieved using a highly selective methodology called mass spectrometry (MS), which allows the laboratory to make unequivocal identifications. For this reason, all urine specimens should be submitted to our laboratory for testing, as instant devices such as urine cups or dipsticks do not offer this level of selectivity or accuracy.
Q: How are samples sent to your lab? A: We use UPS and FedEx for all of your shipping needs. No matter where you are in the country, we can receive your sample the next day. In addition, we will provide you with specimen-collection kits that come pre-addressed and ready to ship back to us.
Q: Who supplies the collection kits? A: AIT supplies everything that you need to do your testing, at no cost to you. If you have never placed an order with AIT, contact a member of our Sales Team or Client Services at 800-875-3894 to get started.
Q: What are common sample turnaround times? A: Urine: 3-5 Business Days Blood: 7-10 Business Days Hair: 3-5 Business Days Vitreous: 3-5 Business Days Meconium: 3-5 Business Days Trace Samples: 10-15 Business Days
Q. How long does confirmation testing take?Confirmation analysis times can be quite short when employing GC/MS, LC/MS, and LC/MS/MS; however, confirmation testing encompasses additional steps both before and after the actual analysis. These steps include chemical extraction, which is performed prior to analysis in order to remove any interfering specimens, data review, and data certification, which all contribute to the time required to complete confirmatory testing which is approximately 3-4 business days.
Q: How do I get my reports? A: For your convenience, reports can be viewed online, faxed, and mailed. If you don't have a username and password for viewing reports online, contact our Client Services Department at 800-875-3894 or clientservices@aitlabs.com to obtain a registration form.
Q: What if I have questions about my results? A: Our board-certified toxicologists are always willing to assist you with the interpretation of results. Simply call Client Services at 800-875-3894. One of our representatives will connect you with an available expert. You may also e-mail questions to toxicologist@aitlabs.com.
Q: I don’t see the test I need. Can you still help me? A: AIT is a full-service reference lab. If you have specific needs or are interested in having a test created to meet your specific needs, please contact your sales representative. We will work to satisfy your request in a professional, timely manner.
Q: When reviewing a lab report, what does “Canceled: due to interference” mean?A: Interference is an unknown signal that prevents accurate identification of drugs during the confirmation analysis. Its origin cannot be determined, but it may be an endogenous compound (a naturally occurring compound within the body), a prescription medication, or something added to the specimen after collection. In instances where a definite positive or negative result cannot be determined for a drug, the test is conducted three times. After the third attempt, if the drug in question still cannot be accurately determined, the test for that drug is cancelled.
Q: Why do I keep receiving new report notifications when I have already read the report?A: After you have reviewed a report online, you must mark the “Reports Viewed” tab. If you do not mark this tab, the system assumes you have not viewed the report and will continue to send you the new report notification until the report is marked as viewed.
Q. What does a negative result mean? Did the donor have anything present in their sample at all?A: A negative result does not necessarily mean there is zero trace of a drug in a given sample. Rather, it indicates that the drug was not detected above the pre-determined cut-off concentration. For example, a cut-off of 300 ng/mL for benzodiazepines means that the combined total of cross-reacting benzodiazepines in the specimen must be above 300 ng/mL to register on the test and produce a positive result. Specimens that contain a combined total benzodiazepine concentration less than 300 ng/mL will register on the test as negative. Therefore, in some cases, low concentrations may be present, but a negative result shows up on the report and is still considered to be an accurate test result.
Q. How do urine alcohol levels compare to blood alcohol levels?A: Ethanol (drinking alcohol) may be detected in blood and urine after consumption of alcoholic beverages. Blood and urine ethanol concentrations may be very different, depending on the time between ethanol consumption and specimen collection and frequency of urination. The ethanol concentration will often be higher in urine than in blood. In some cases, urine ethanol may be highly positive and the blood completely negative. Therefore, urine ethanol cannot be used to estimate a blood ethanol concentration.
Q. Is there anything that can be used to "cheat" a urine test?There are two common ways that users attempt to "cheat" a urine drug test: modify their urine sample with chemicals or drink large amounts of water prior to testing in order to dilute their sample. Many products are available on the Internet that claim to enable a person to produce a negative test result after drug use if that product is added to a urine sample. Most of these products contain strong chemicals known as oxidants, which are capable of modifying the chemical structure of a drug. AIT Laboratories tests every urine sample for the presence of oxidants to eliminate the possibility of adulteration.
Diluted specimens are also easily identified at AIT by measuring the concentration of creatinine in each sample. Individuals who consume large quantities of water prior to a test in an attempt to dilute their sample will often have abnormally low levels of creatinine. Validation tests such as those described above ensure that individuals cannot "cheat" their urine drug tests.
Q: What is the difference between patient compliance and an instant drug test that I can use in my office?A: When testing for patient compliance, accuracy is of the utmost importance. By choosing AIT, you are providing the best care available to your patients because we measure results against a drastically reduced cut-off level. The standard cut-off level of an instant test is 2,000 ng/mL for opiates. At that cut-off, you may not detect drugs that are taken for therapeutic use, and you will not be able to detect certain drugs like fentanyl or carisoprodol (trade name: Soma). Another AIT benefit is cost. Where you might spend up to $10 per sample just for an instant test with another testing facility (not including the cost of confirmations), our testing is free to your practice, and we handle all the billing on your office’s behalf.
Q: What is the turnaround time on compliance testing? A: Specimens that screen negative are generally reported within 24 to 48 hours. If a specimen screens positive for one or more drug classes, confirmation testing is performed, which takes an additional 24 to 72 hours.
Q: Could the result be a false positive? A: The concept of false positive is limited to the screening test. AIT Laboratories reports results based on confirmation testing by GC/MS or LC/MS/MS. This type of testing provides what is effectively a “chemical fingerprint” pattern for each drug. As such, the possibility of a false positive result is eliminated.
Q: Why was the instant result positive for THC, but the AIT Labs result was negative? A: Reason 1: Patient is taking a prescription medication known to cross react with the cup and result in a THC positive (e.g. protonics). Reason 2: THC metabolizes into several metabolites of which the cup cannot differentiate meaning that the cup response is an accumulative result. Laboratory analysis only detects the presence of carboxy-THC which may be at a concentration below the reporting limit.
Q. Is there anything other than the drug itself that can cause someone to test positive for THC or cocaine? This scenario is only possible when relying on instant testing devices such as urine cups or dipsticks. Such devices recognize drug classes based on their "chemical shape" and most commonly change color when that shape is recognized. If other drugs with similar chemical shapes are present in the sample, this can result in a "false positive." Sustiva, Protonix, and other proton pump inhibitors can cause individuals to test positive for THC on certain instant devices, while common antibiotics such as amoxicillin can cause a person to test positive for cocaine.
While these drugs can generate false-positive results on instant testing devices, they will not generate a positive result at the laboratory. Because of the sophisticated instrumentation available, laboratory testing is far more selective and looks for what is effectively a "chemical fingerprint" of each drug tested. Therefore, a drug will only test positive if the specific drug of interest is actually present.
Q: Why do you report THC concentrations as a ratio of THC/creatinine? A: THC concentrations are calculated as a ratio of THC/creatinine to account for variations in hydration states. This is important for THC which can be present for up to 30 days and differences in hydration states can result in misleading results when determining "reuse" or "washout". By calculating the ratio, results are normalized and ratios can be used directly to determine if the patient has reused.
Q: My patient is taking high doses of morphine - why is codeine positive? A: Codeine is not reported in the literature as a metabolite of morphine. While it is not reported in the literature as a known metabolite of morphine, we must not forget that the literature reports primary and secondary metabolites. Codeine, may in fact be a “trace” metabolite for certain individuals on high doses of morphine. Once you reach a high enough level of the parent drug, some of the trace level metabolites reach a level that is detectable. A more likely explanation is that codeine is a minor impurity in pharmaceutical morphine. Again, at lower levels of morphine, this trace impurity goes undetected. However, at higher levels of morphine the codeine impurity is now at a level that we can detect.
Q: I have two patients taking the same dose of hydrocodone – why are their urine levels different? A: There are many variables associated with urine drug levels. Caution should be used when interpreting quantitative levels. A few common reasons for the differences in urine levels for two patients on the same dose of drug include: urine pH, co-administration of other drugs, hydration level, cardiac output, timing between dose and specimen collection, and possibly patient non-compliance.
Q: Will oxycodone metabolize to hydrocodone? A: Oxycodone is not known to metabolize to hydrocodone.
Q: My patient said he missed his dose of oxycodone last night, should the test result be negative? A: It will depend largely on three factors: Dose, frequency of dose, and excretion capabilities. If the patient is prescribed oxycodone TID or QID then the urine should still test positive for the drug. If the patient is only prescribed single daily doses and they are capable of rapid metabolism/excretion, then the result may be negative due to screening cutoffs. The patient may also test positive for oxymorphone only as the retention time in the urine for this metabolite is longer than the parent drug.
Q: I am not prescribing Serax and the results were positive for oxazepam. The patient claims she is not taking Serax – could this be a false positive? A: Oxazepam is a terminal metabolite for several benzodiazepines. The presence of oxazepam and no other drugs could indicate the use of Serax or it could indicate recent use of another benzodiazepine – but discontinued long enough ago so that only oxazepam remains.
Q: I am prescribing 40 mg methadone TID - the result is positive for methadone and EDDP. The methadone level is 1800 ng/mL and the EDDP level is 2200 ng/mL. Is this consistent? A: EDDP is normally present in blood at a concentration approximately 10 percent of the methadone meaning that it is present in urine at significantly lower concentrations as well. Excretion of the compounds depends largely on urine pH and patients with basic urine due to dietary intake can excrete more EDDP than methadone. Although this is not a textbook excretion profile for methadone users, compliance cannot be determined solely from the above results.
Q: The levels of oxymorphone are higher than oxycodone. Is my patient abusing Opana? A: Not necessarily. Clinical trials indicate that the ratio of oxymorphone to oxycodone can vary from 0-184 percent and there is no direct correlation between the dose and the resulting ratio. Oxymorphone also has a slightly longer retention time in the urine than oxycodone meaning that oxymorphone may still be detectable following complete excretion of any oxycodone.
Q: My patient tested negative for benzodiazepines and they are prescribed one tablet every night. Are they taking it? A: It is possible. Low doses of benzodiazepines (especially alprazolam and lorazepam) can sometimes screen below the cutoff and therefore be reported as negative. If your client provides this information and they wish to determine if there is a small amount of drug in the urine, we can order a confirmation test and utilize the lower detection limits.
Q: Could the low level of morphine on this report be from dietary intake? A: Literature indicates that morphine and codeine may be present in urine after consumption of poppy seeds. The levels can vary widely – even reaching 2000 ng/mL. While this phenomenon is known and documented, we do not routinely offer this as an explanation for the presence of morphine. Additionally, we typically limit this explanation to levels of 200 ng/mL or less – codeine is usually not detected. When we offer poppy seeds as an explanation, we also point out that we can test for thebaine – a component of poppy seeds, not present in pharmaceutical codeine or morphine.
Q: My patient is on a high dose of oxycodone and tested positive for trace levels of hydrocodone. Is it a secondary metabolite or are they using? A: The patient is most likely using, as hydrocodone is not a known metabolite of oxycodone. Hydrocodone can be present at trace levels in subjects whose urine codeine concentration exceeds 5000 ng/mL but excluding this, hydrocodone should not be present in patients taking high doses of oxycodone. Depending on the formulation of oxycodone, acetaminophen may be used as a diagnostic tool to determine possible hydrocodone use.
Q: My patient tested positive for methamphetamine and amphetamine. Is that due to their Adderall prescription? A: No. Adderall is a formulation containing several forms of amphetamine, NOT METHAMPHETAMINE. Adderall use will cause a patient to test positive for amphetamine but not methamphetamine. Amphetamine does not metabolize to methamphetamine.
Q: Does phentermine cause a positive result for amphetamines? A: No. Phentermine (Adipex) is a member of the same family of drugs as the amphetamines; however, it DOES NOT cross react with the cup, and it is easily distinguished from amphetamine and methamphetamine during confirmation analysis. Mass spectrometry provides a chemical fingerprint for phentermine, which is independent on those obtained for amphetamine and methamphetamine.
For any other questions, please contact our Client Services Department at 800-875-3894 or clientservices@aitlabs.com.