Laboratory drug testing

America as a whole is trying its best to minimize if not totally eliminates the effects of drug abuse. From the ordinary citizen who is looking for a job to the ones who are currently employed under private, state and federal companies or organizations, all are tested at random intervals for drug use and abuse. This serves as a deterrent to those who are currently using or are under threat of getting addicted to these substances that not only degrade their performance with respect to their jobs but is also attributed to be the number one cause of broken families and deaths.

Millions upon millions of Americans from 12 years of age to the elderly are either afflicted by drug-related illnesses or suffer due to the long term side effects of drug abuse. Drug use is also recognized to be one of the leading causes of crime and juvenile delinquency which further burdens taxpayers who pay for the programs initiated by the DHHS, SAMHSA and other drug treatment agencies associated with them. These accounts for billions of dollars in expenses that go to these measures like for example in 2005, 3.3 billion US dollars was allotted to the SAMSHA alone and that was not including the donations that NGO’s provide in support of their efforts.

The Federal Government has made drug testing mandatory with the release of the Revised Mandatory Guidelines for Federal Workplace Drug Testing Programs which has been in effect since September 1, 1994. This has been mandated by the FDA and has been effective as a deterrent in government agencies when it comes to drug abuse. These are governed by strict codes and exemptions that state that it is not truly mandatory without probable cause. Any result that comes up non-negative is to be further tested through SAMHSA authorized laboratories for re-testing.

After a sample that has tested non-negative is sent to a laboratory, it is again immunoassayed to determine the ones that are truly positive. After segregation, they are again tested with immunoassaying techniques and then go through the more rigorous testing such as Specific Gas Chromatography and mass Spectrometry. There are very strict rules that apply to laboratory testing that are briefly discussed below.

The testing facility shall be secure at all times to prevent unauthorized access to specimens after they have been received. The proper standardized chain of custody form is used and updated throughout the processing of the above-stated samples. All personnel who obtain these specimens and records are to be escorted at all times assuring that no alteration or switching takes place. These tests are tested and testes again for confirmation and those that fail the first round of immunoassaying tests are declared negative and will need no further examination. All positive specimens are then analyzed further with the results quantified with values given by the SAMHSA through GC and MS testing. Below is the linear confirmatory test levels in (ng/ml) nanograms per milliliter described as the baseline data for declaration of positive results.

Confirmatory test level (ng/ml) Marijuana metabolite1 15 Cocaine metabolite 2 150 Opiates Morphine 300 Codeine 300 Phencyclidine 25 Amphetamines Amphetamine 500 Methamphetamine 3 500

1 Delta-9-tetrahydrocannabinol-9-carboxylic acid 2 Benzoylecgonine 3 specimen must also contain amphetamine at a concentration > 200 ng/ml

If specimens are found negative for the above confirmatory tests, they are again declared negative and discarded with the reports stating such. Except in cases where there is a positive result all of the negative results are to be reported to the requesting authority as negative in a period not to exceed 5 working days. The rest that have tested positive are then tested again to obtain substance specific data that is also reported to the assigned MRO’s who will provide the definitive decision if the test results are indeed positive or caused by underlying contributory sickness.

MRO’s are designated personnel who will provide the necessary expertise in the interpretation of the test results. They are to be certified Physicians with knowledge in substance abuse disorders. They can be an employee of the agency or a hired third party analyst whose sole purpose would be to interpret the results of drug tests. If in case they are an employee of the agency, they should not in any way be in any position or have any interest to influence the agency’s financial interests. The MRO should not receive compensation from any product manufacturer or facility that has supplied services and or materials to the screening and testing process which would construe conflicting interests. The MRO should be converse in trying to determine any reason for the stated positive result through research of records of the individual being tested which might have had treatment in medical facilities that have administered derivatives of the specified drugs that are being screened for. If the MRO feel that there is a discrepancy with the test results that have been submitted to him, he is authorized to order a re-test at the same testing facility or an alternative facility for verification purposes. This re-verification may be necessary for the implications of being identified as being a drug abuser may affect a lot of social factors. The subject in question might loose his/her job and benefits and even suffer from incarceration if the testing was due to a post accident investigation.

Laboratories are likewise subject to pre-qualification and calibration cycling by representatives of the SAMHSA for the efficiency and compliance of the rules and regulations that apply to the operation, staffing, equipment, maintenance and security of facilities that are tested again and again to ensure the maintenance of high levels of accuracy. They are also obligated by law to keep and protect any employee records private as mandated by 5 U.S.C. 522a(m) and 48 CFR 24.101-24.104 which defines the procedures that are to be observed with respect to handling test results and samples with the highest regard for the privacy of the individuals being tested.

As seen above, the highest level of protection to employees is offered through repetitive screenings that ensures no mistakes are committed in drug testing processes. From the acquisition, equipment, transport, handling and storage, analysis and interpretation, all of these stages are covered by strict protocol that is to be observed through mandated procedures by the Federal Government. Any lapse of quality can have dire consequences for both the employee and employer in many ways than one so these steps are in place assuring full privacy and accountability.